США - англійська - NLM (National Library of Medicine)

ascend laboratories, llc - lacosamide (unii: 563ks2pqy5) (lacosamide - unii:563ks2pqy5) - lacosamide tablets are indicated for the treatment of partial-onset seizures in patients 4 years of age and older. additional pediatric use information is approved for ucb, inc.'s vimpat® (lacosamide) tablets. however, due to ucb, inc.'s marketing exclusivity rights, this drug product is not labeled with that pediatric information. none. pregnancy exposure registry there is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to antiepileptic drugs (aeds), such as lacosamide, during pregnancy. encourage women who are taking lacosamide during pregnancy to enroll in the north american antiepileptic drug (naaed) pregnancy registry by calling 1-888­ 233-2334 or visiting http://www.aedpregnancyregistry.org/. risk summary available data from the north american antiepileptic drug (naaed) pregnancy registry, a prospective cohort study, case reports, and a case series with lacosamide use in pregnant women are insufficient to identify a drug associated risk of major birth defects, miscarriage or other adverse maternal or fetal outcomes. lacosamide produced developmental toxicity (increased embryofetal and perinatal mortality, growth deficit) in rats following administration during pregnancy.  developmental neurotoxicity was observed in rats following administration during a period of postnatal development corresponding to the third trimester of human pregnancy. these effects were observed at doses associated with clinically relevant plasma exposures (see data).    the background risk of major birth defects and miscarriage for the indicated population is unknown. all pregnancies have a background risk of birth defect, loss, or other adverse outcomes. in the u.s. general population the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively.  data animal data oral administration of lacosamide to pregnant rats (20, 75, or 200 mg/kg/day) and rabbits (6.25, 12.5, or 25 mg/kg/day) during the period of organogenesis did not produce any effects on the incidences of fetal structural abnormalities. however, the maximum doses evaluated were limited by maternal toxicity in both species and embryofetal death in rats. these doses were associated with maternal plasma lacosamide exposures (auc) approximately 2 and 1 times (rat and rabbit, respectively) that in humans at the maximum recommended human dose (mrhd) of 400 mg/day. in two studies in which lacosamide (25, 70, or 200 mg/kg/day and 50, 100, or 200 mg/kg/day) was orally administered to rats throughout pregnancy and lactation, increased perinatal mortality and decreased body weights in the offspring were observed at the highest dose tested. the no-effect dose for pre- and postnatal developmental toxicity in rats (70 mg/kg/day) was associated with a maternal plasma lacosamide auc similar to that in humans at the mrhd. oral administration of lacosamide (30, 90, or 180 mg/kg/day) to rats during the neonatal and juvenile periods of development resulted in decreased brain weights and long-term neurobehavioral changes (altered open field performance, deficits in learning and memory). the early postnatal period in rats is generally thought to correspond to late pregnancy in humans in terms of brain development. the no-effect dose for developmental neurotoxicity in rats was associated with a plasma lacosamide auc less than that in humans at the mrhd. in vitro data lacosamide has been shown in vitro to interfere with the activity of collapsin response mediator protein-2 (crmp-2), a protein involved in neuronal differentiation and control of axonal outgrowth. potential adverse effects on cns development related to this activity cannot be ruled out. risk summary data from published literature indicate that lacosamide is present in human milk. there are reports of increased sleepiness in breastfed infants exposed to lacosamide (see clinical considerations). there is no information on the effects of lacosamide on milk production.  the developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for lacosamide and any potential adverse effects on the breastfed infant from lacosamide or from the underlying maternal condition. clinical considerations monitor infants exposed to lacosamide through breastmilk for excess sedation. partial-onset seizures safety and effectiveness of lacosamide for the treatment of partial-onset seizures have been established in pediatric patients 4 years to less than 17 years of age. use of lacosamide in this age group is supported by evidence from adequate and well- controlled studies of lacosamide in adults with partial-onset seizures, pharmacokinetic data from adult and pediatric patients, and safety data in 328 pediatric patients 4 years to less than 17 years of age [see adverse reactions (6.1), clinical pharmacology (12.3), and clinical studies (14.1,14.2) ]. safety and effectiveness in pediatric patients below 1 month of age have not been established.    animal data lacosamide has been shown in vitro to interfere with the activity of collapsin response mediator protein-2 (crmp-2), a protein involved in neuronal differentiation and control of axonal outgrowth. potential related adverse effects on cns development cannot be ruled out. administration of lacosamide to rats during the neonatal and juvenile periods of postnatal development (approximately equivalent to neonatal through adolescent development in humans) resulted in decreased brain weights and long-term neurobehavioral changes (altered open field performance, deficits in learning and memory). the no-effect dose for developmental neurotoxicity in rats was associated with a plasma lacosamide exposure (auc) less than that in humans at the maximum recommended human dose of 400 mg/day. additional pediatric use information is approved for ucb, inc.’s vimpat® (lacosamide) tablets. however, due to ucb, inc.’s marketing exclusivity rights, this drug product is not labeled with that pediatric information. there were insufficient numbers of elderly patients enrolled in partial-onset seizure trials (n=18) to adequately determine whether they respond differently from younger patients.  no lacosamide dose adjustment based on age is necessary. in elderly patients, dose titration should be performed with caution, usually starting at the lower end of the dosing range, reflecting the greater frequency of decreased hepatic function, decreased renal function, increased cardiac conduction abnormalities, and polypharmacy [see dosage and administration (2.1, 2.4, 2.5) and clinical pharmacology (12.3) ]. no dose adjustment is necessary in patients with mild to moderate renal impairment (clcr ≥30 ml/min). in patients with severe renal impairment (clcr <30 ml/min as estimated by the cockcroft-gault equation for adults; clcr <30 ml/min/1.73m2 as estimated by the schwartz equation for pediatric patients) and in those with end-stage renal disease, a reduction of 25% of the maximum dosage is recommended [see dosage and administration (2.4) and clinical pharmacology (12.3)]. in all patients with renal impairment, dose initiation and titration should be based on clinical response and tolerability. lacosamide is effectively removed from plasma by hemodialysis. dosage supplementation of up to 50% following hemodialysis should be considered. for adult and pediatric patients with mild to moderate hepatic impairment, a reduction of 25% of the maximum dosage is recommended. patients with mild to moderate hepatic impairment should be observed closely for adverse reactions, and dose initiation and titration should be based on clinical response and tolerability [see dosage and administration (2.5), clinical pharmacology (12.3) ]. the pharmacokinetics of lacosamide has not been evaluated in severe hepatic impairment. lacosamide use is not recommended in patients with severe hepatic impairment. lacosamide tablets contains lacosamide, a schedule v controlled substance.  abuse is the intentional, non-therapeutic use of a drug, even once, for its desirable psychological or physiological effects. in a human abuse potential study, single doses of 200 mg (equal to the maximum single dosage) and 800 mg lacosamide (equal to twice the recommended daily maintenance dosage) produced euphoria-type subjective responses that differentiated statistically from placebo; at 800 mg, these euphoria-type responses were statistically indistinguishable from those produced by alprazolam, a schedule iv drug. the duration of the euphoria-type responses following lacosamide was less than that following alprazolam. a high rate of euphoria was also reported as an adverse event in the human abuse potential study following single doses of 800 mg lacosamide (15% [5/34]) compared to placebo (0%) and in two pharmacokinetic studies following single and multiple doses of 300 to 800 mg lacosamide (ranging from 6% [2/33] to 25% [3/12]) compared to placebo (0%). however, the rate of euphoria reported as an adverse event in the lacosamide development program at therapeutic doses was less than 1%. physical dependence is a state that develops as a result of physiological adaptation in response to repeated drug use, manifested by withdrawal signs and symptoms after abrupt discontinuation or a significant dose reduction of a drug. abrupt termination of lacosamide in clinical trials with diabetic neuropathic pain patients produced no signs or symptoms that are associated with a withdrawal syndrome indicative of physical dependence. however, psychological dependence cannot be excluded due to the ability of lacosamide to produce euphoria-type adverse events in humans.

США - англійська - NLM (National Library of Medicine)

avkare - lacosamide (unii: 563ks2pqy5) (lacosamide - unii:563ks2pqy5) - lacosamide tablets are indicated for the treatment of partial-onset seizures in patients 4 years of age and older. additional pediatric use information is approved for ucb, inc.’s vimpat ® (lacosamide) tablets. however, due to ucb, inc.’s marketing exclusivity rights, this drug product is not labeled with that pediatric information. none.  pregnancy exposure registry  there is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to antiepileptic drugs (aeds), such as lacosamide, during pregnancy. encourage women who are taking lacosamide during pregnancy to enroll in the north american antiepileptic drug (naaed) pregnancy registry by calling 1-888-233-2334 or visiting http://www.aedpregnancyregistry.org/.  risk summary  there are no adequate data on the developmental risks associated with the use of lacosamide in pregnant women.  lacosamide produced developmental toxicity (increased embryofetal and perinatal mortality, growth deficit) in rats following administration during pregnancy. developmental neurotoxicity was observed in rats following administration during a period of postnatal development corresponding to the third trimester of human pregnancy. these effects were observed at doses associated with clinically relevant plasma exposures  (see data) .  in the u.s. general population the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively. the background risk of major birth defects and miscarriage for the indicated population is unknown.  animal data  oral administration of lacosamide to pregnant rats (20, 75, or 200 mg/kg/day) and rabbits (6.25, 12.5, or 25 mg/kg/day) during the period of organogenesis did not produce any effects on the incidences of fetal structural abnormalities. however, the maximum doses evaluated were limited by maternal toxicity in both species and embryofetal death in rats. these doses were associated with maternal plasma lacosamide exposures (auc) approximately 2 and 1 times (rat and rabbit, respectively) that in humans at the maximum recommended human dose (mrhd) of 400 mg/day. in two studies in which lacosamide (25, 70, or 200 mg/kg/day and 50, 100, or 200 mg/kg/day) was orally administered to rats throughout pregnancy and lactation, increased perinatal mortality and decreased body weights in the offspring were observed at the highest dose tested. the no-effect dose for pre- and postnatal developmental toxicity in rats (70 mg/kg/day) was associated with a maternal plasma lacosamide auc similar to that in humans at the mrhd.  oral administration of lacosamide (30, 90, or 180 mg/kg/day) to rats during the neonatal and juvenile periods of development resulted in decreased brain weights and long-term neurobehavioral changes (altered open field performance, deficits in learning and memory). the early postnatal period in rats is generally thought to correspond to late pregnancy in humans in terms of brain development. the no-effect dose for developmental neurotoxicity in rats was associated with a plasma lacosamide auc less than that in humans at the mrhd.  in vitro data  lacosamide has been shown  in vitro  to interfere with the activity of collapsin response mediator protein-2 (crmp-2), a protein involved in neuronal differentiation and control of axonal outgrowth. potential adverse effects on cns development related to this activity cannot be ruled out.  risk summary  there are no data on the presence of lacosamide in human milk, the effects on the breastfed infant, or the effects on milk production. studies in lactating rats have shown excretion of lacosamide and/or its metabolites in milk.  the developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for lacosamide and any potential adverse effects on the breastfed infant from lacosamide or from the underlying maternal condition.  partial-onset seizures safety and effectiveness of lacosamide for the treatment of partial-onset seizures have been established in pediatric patients 4 years to less than 17 years of age. use of lacosamide in this age group is supported by evidence from adequate and well-controlled studies of lacosamide in adults with partial-onset seizures, pharmacokinetic data from adult and pediatric patients, and safety data in 328 pediatric patients 4 years to less than 17 years of age [see adverse reactions (6.1),  clinical pharmacology (12.3) and  clinical studies (14.1, 14.2)] . safety and effectiveness in pediatric patients below 1 month of age have not been established. animal data  lacosamide has been shown  in vitro  to interfere with the activity of collapsin response mediator protein-2 (crmp-2), a protein involved in neuronal differentiation and control of axonal outgrowth. potential related adverse effects on cns development cannot be ruled out. administration of lacosamide to rats during the neonatal and juvenile periods of postnatal development (approximately equivalent to neonatal through adolescent development in humans) resulted in decreased brain weights and long-term neurobehavioral changes (altered open field performance, deficits in learning and memory). the no-effect dose for developmental neurotoxicity in rats was associated with a plasma lacosamide exposure (auc) less than that in humans at the maximum recommended human dose of 400 mg/day.  additional pediatric use information is approved for ucb, inc.’s vimpat ® (lacosamide) tablets. however, due to ucb, inc.’s marketing exclusivity rights, this drug product is not labeled with that pediatric information. there were insufficient numbers of elderly patients enrolled in partial-onset seizure trials (n=18) to adequately determine whether they respond differently from younger patients. no lacosamide dose adjustment based on age is necessary. in elderly patients, dose titration should be performed with caution, usually starting at the lower end of the dosing range, reflecting the greater frequency of decreased hepatic function, decreased renal function, increased cardiac conduction abnormalities, and polypharmacy  [see dosage and administration (2.1,  2.3,  2.4)  and   clinical pharmacology (12.3)] .  based on data in adults, no dose adjustment is necessary in adult and pediatric patients with mild to moderate renal impairment (cl cr ≥30 ml/min). in adult and pediatric patients with severe renal impairment (cl cr <30 ml/min) and in those with end-stage renal disease, a reduction of 25% of the maximum dosage is recommended  [see dosage and administration (2.3)  and   clinical pharmacology (12.3)] .  in all patients with renal impairment, dose titration should be performed with caution.  lacosamide is effectively removed from plasma by hemodialysis. dosage supplementation of up to 50% following hemodialysis should be considered.  based on data in adults, for adult and pediatric patients with mild to moderate hepatic impairment, a reduction of 25% of the maximum dosage is recommended. patients with mild to moderate hepatic impairment should be observed closely during dose titration  [see dosage and administration (2.4),  clinical pharmacology (12.3)] . the pharmacokinetics of lacosamide has not been evaluated in severe hepatic impairment. lacosamide use is not recommended in patients with severe hepatic impairment.  lacosamide is a schedule v controlled substance. in a human abuse potential study, single doses of 200 mg and 800 mg lacosamide produced euphoria-type subjective responses that differentiated statistically from placebo; at 800 mg, these euphoria-type responses were statistically indistinguishable from those produced by alprazolam, a schedule iv drug. the duration of the euphoria-type responses following lacosamide was less than that following alprazolam. a high rate of euphoria was also reported as an adverse event in the human abuse potential study following single doses of 800 mg lacosamide (15% [5/34]) compared to placebo (0%) and in two pharmacokinetic studies following single and multiple doses of 300 to 800 mg lacosamide (ranging from 6% [2/33] to 25% [3/12]) compared to placebo (0%). however, the rate of euphoria reported as an adverse event in the lacosamide development program at therapeutic doses was less than 1%.  abrupt termination of lacosamide in clinical trials with diabetic neuropathic pain patients produced no signs or symptoms that are associated with a withdrawal syndrome indicative of physical dependence. however, psychological dependence cannot be excluded due to the ability of lacosamide to produce euphoria-type adverse events in humans. 

США - англійська - NLM (National Library of Medicine)

golden state medical supply, inc. - lacosamide (unii: 563ks2pqy5) (lacosamide - unii:563ks2pqy5) - lacosamide tablets are indicated for the treatment of partial-onset seizures in patients 4 years of age and older. additional pediatric use information is approved for ucb, inc.'s vimpat ® (lacosamide) tablets. however, due to ucb, inc.'s marketing exclusivity rights, this drug product is not labeled with that information. none. pregnancy exposure registry there is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to antiepileptic drugs (aeds), such as lacosamide, during pregnancy. encourage women who are taking lacosamide during pregnancy to enroll in the north american antiepileptic drug (naaed) pregnancy registry by calling 1-888-233-2334 or visiting http://www.aedpregnancyregistry.org/. risk summary available data from the north american antiepileptic drug (naaed) pregnancy registry, a prospective cohort study, case reports, and a case series with lacosamide use in pregnant women are insufficient to identify a drug associated risk of major birth defects, miscarriage or other adverse maternal or fetal outcomes. lacosamide produced developmental toxicity (increased embryofetal and perinatal mortality, growth deficit) in rats following administration during pregnancy. developmental neurotoxicity was observed in rats following administration during a period of postnatal development corresponding to the third trimester of human pregnancy. these effects were observed at doses associated with clinically relevant plasma exposures (see data) . the background risk of major birth defects and miscarriage for the indicated population is unknown. all pregnancies have a background risk of birth defect, loss, or other adverse outcomes. in the u.s. general population the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2-4% and 15-20%, respectively. data animal data oral administration of lacosamide to pregnant rats (20, 75, or 200 mg/kg/day) and rabbits (6.25, 12.5, or 25 mg/kg/day) during the period of organogenesis did not produce any effects on the incidences of fetal structural abnormalities. however, the maximum doses evaluated were limited by maternal toxicity in both species and embryofetal death in rats. these doses were associated with maternal plasma lacosamide exposures (auc) approximately 2 and 1 times (rat and rabbit, respectively) that in humans at the maximum recommended human dose (mrhd) of 400 mg/day. in two studies in which lacosamide (25, 70, or 200 mg/kg/day and 50, 100, or 200 mg/kg/day) was orally administered to rats throughout pregnancy and lactation, increased perinatal mortality and decreased body weights in the offspring were observed at the highest dose tested. the no-effect dose for pre- and postnatal developmental toxicity in rats (70 mg/kg/day) was associated with a maternal plasma lacosamide auc similar to that in humans at the mrhd. oral administration of lacosamide (30, 90, or 180 mg/kg/day) to rats during the neonatal and juvenile periods of development resulted in decreased brain weights and long-term neurobehavioral changes (altered open field performance, deficits in learning and memory). the early postnatal period in rats is generally thought to correspond to late pregnancy in humans in terms of brain development. the no-effect dose for developmental neurotoxicity in rats was associated with a plasma lacosamide auc less than that in humans at the mrhd. in vitro data lacosamide has been shown in vitro to interfere with the activity of collapsin response mediator protein-2 (crmp-2), a protein involved in neuronal differentiation and control of axonal outgrowth. potential adverse effects on cns development related to this activity cannot be ruled out. risk summary data from published literature indicate that lacosamide is present in human milk. there are reports of increased sleepiness in breastfed infants exposed to lacosamide (see clinical considerations) . there is no information on the effects of lacosamide on milk production. the developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for lacosamide and any potential adverse effects on the breastfed infant from lacosamide or from the underlying maternal condition. clinical considerations monitor infants exposed to lacosamide through breastmilk for excess sedation. partial-onset seizures safety and effectiveness of lacosamide tablets for the treatment of partial-onset seizures have been established in pediatric patients 4 years to less than 17 years of age. use of lacosamide in this age group is supported by evidence from adequate and well-controlled studies of lacosamide in adults with partial-onset seizures, pharmacokinetic data from adult and pediatric patients, and safety data in 328 pediatric patients 4 years to less than 17 years of age [see adverse reactions (6.1), clinical pharmacology (12.3), and clinical studies (14.1, 14.2)]. safety and effectiveness in pediatric patients below 1 month of age have not been established. animal data lacosamide has been shown in vitro to interfere with the activity of collapsin response mediator protein-2 (crmp-2), a protein involved in neuronal differentiation and control of axonal outgrowth. potential related adverse effects on cns development cannot be ruled out. administration of lacosamide to rats during the neonatal and juvenile periods of postnatal development (approximately equivalent to neonatal through adolescent development in humans) resulted in decreased brain weights and long-term neurobehavioral changes (altered open field performance, deficits in learning and memory). the no-effect dose for developmental neurotoxicity in rats was associated with a plasma lacosamide exposure (auc) less than that in humans at the maximum recommended human dose of 400 mg/day. additional pediatric use information is approved for ucb, inc.'s vimpat ® (lacosamide) tablets. however, due to ucb, inc.'s marketing exclusivity rights, this drug product is not labeled with that information. there were insufficient numbers of elderly patients enrolled in partial-onset seizure trials (n=18) to adequately determine whether they respond differently from younger patients. no lacosamide tablets dose adjustment based on age is necessary. in elderly patients, dose titration should be performed with caution, usually starting at the lower end of the dosing range, reflecting the greater frequency of decreased hepatic function, decreased renal function, increased cardiac conduction abnormalities, and polypharmacy [see dosage and administration (2.1, 2.4, 2.5)and clinical pharmacology (12.3)] . no dose adjustment is necessary in patients with mild to moderate renal impairment (cl cr ≥30 ml/min). in patients with severe renal impairment (cl cr <30 ml/min as estimated by the cockcroft-gault equation for adults; cl cr less than 30 ml/min/1.73m 2 as estimated by the schwartz equation for pediatric patients) and in those with end-stage renal disease, a reduction of 25% of the maximum dosage is recommended [see dosage and administration (2.4)and clinical pharmacology (12.3)] . in all patients with renal impairment, dose initiation and titration should be based on clinical response and tolerability. lacosamide is effectively removed from plasma by hemodialysis. dosage supplementation of up to 50% following hemodialysis should be considered. for adult and pediatric patients with mild to moderate hepatic impairment, a reduction of 25% of the maximum dosage is recommended. patients with mild to moderate hepatic impairment should be observed closely for adverse reactions, and dose initiation and titration should be based on clinical response and tolerability [see dosage and administration (2.5), clinical pharmacology (12.3)] . the pharmacokinetics of lacosamide has not been evaluated in severe hepatic impairment. lacosamide use is not recommended in patients with severe hepatic impairment. lacosamide tablets contains lacosamide, a schedule v controlled substance. abuse is the intentional, non-therapeutic use of a drug, even once, for its desirable psychological or physiological effects. in a human abuse potential study, single doses of 200 mg (equal to the maximum single dosage) and 800 mg lacosamide (equal to twice the recommended daily maintenance dosage) produced euphoria-type subjective responses that differentiated statistically from placebo; at 800 mg, these euphoria-type responses were statistically indistinguishable from those produced by alprazolam, a schedule iv drug. the duration of the euphoria-type responses following lacosamide was less than that following alprazolam. a high rate of euphoria was also reported as an adverse event in the human abuse potential study following single doses of 800 mg lacosamide (15% [5/34]) compared to placebo (0%) and in two pharmacokinetic studies following single and multiple doses of 300-800 mg lacosamide (ranging from 6% [2/33] to 25% [3/12]) compared to placebo (0%). however, the rate of euphoria reported as an adverse event in the lacosamide development program at therapeutic doses was less than 1%. physical dependence is a state that develops as a result of physiological adaptation in response to repeated drug use, manifested by withdrawal signs and symptoms after abrupt discontinuation or a significant dose reduction of a drug. abrupt termination of lacosamide in clinical trials with diabetic neuropathic pain patients produced no signs or symptoms that are associated with a withdrawal syndrome indicative of physical dependence. however, psychological dependence cannot be excluded due to the ability of lacosamide to produce euphoria-type adverse events in humans. dispense with medication guide available at: www.bpirx.com/products/patientinformation read this medication guide before you start taking lacosamide tablets and each time you get a refill. there may be new information. this medication guide describes important safety information about lacosamide tablets. this information does not take the place of talking to your healthcare provider about your medical condition or treatment. what is the most important information i should know about lacosamide tablets? do not stop taking lacosamide tablets without first talking to your healthcare provider. stopping lacosamide tablets suddenly can cause serious problems. stopping seizure medicine suddenly in a patient who has epilepsy can cause seizures that will not stop (status epilepticus). lacosamide tablets can cause serious side effects, including: - like other antiepileptic drugs, lacosamide tablets may cause suicidal thoughts or actions in a very small number of people, about 1 in 500. call a healthcare provider right away if you have any of these symptoms, especially if they are new, worse, or worry you: - thoughts about suicide or dying - attempt to commit suicide - new or worse depression - new or worse anxiety - feeling agitated or restless - panic attacks - trouble sleeping (insomnia) - new or worse irritability - acting aggressive, being angry, or violent - acting on dangerous impulses - an extreme increase in activity and talking (mania) - other unusual changes in behavior or mood - pay attention to any changes, especially sudden changes, in mood, behaviors, thoughts, or feelings. - keep all follow-up visits with your healthcare provider as scheduled. - call your healthcare provider between visits as needed, especially if you are worried about symptoms. - suicidal thoughts or actions can be caused by things other than medicines. if you have suicidal thoughts or actions, your healthcare provider may check for other causes. - lacosamide tablets may cause you to feel dizzy, have double vision, feel sleepy, or have problems with coordination and walking. do not drive, operate heavy machinery, or do other dangerous activities until you know how lacosamide tablets affect you. - lacosamide tablets may cause you to have an irregular heartbeat or may cause you to faint. in rare cases, cardiac arrest has been reported. call your healthcare provider right away if you: - have a fast, slow, or pounding heartbeat or feel your heart skip a beat - have shortness of breath - have chest pain - feel lightheaded - fainted or if you feel like you are going to faint - lacosamide tablets are a federally controlled substance (cv) because it can be abused or lead to drug dependence. keep your lacosamide tablets in a safe place, to protect them from theft. never give your lacosamide tablets to anyone else, because it may harm them. selling or giving away this medicine is against the law. what are lacosamide tablets? lacosamide tablets are a prescription medicine used: - to treat partial-onset seizures in people 4 years of age and older. it is not known if lacosamide tablets are safe and effective for partial-onset seizures in children under 1 month of age. what should i tell my healthcare provider before taking lacosamide tablets? before you take lacosamide tablets, tell your healthcare provider about all of your medical conditions, including if you: - have or have had depression, mood problems or suicidal thoughts or behavior. - have heart problems. - have kidney problems. - have liver problems. - have abused prescription medicines, street drugs or alcohol in the past. - are pregnant or plan to become pregnant. it is not known if lacosamide tablets can harm your unborn baby. tell your healthcare provider right away if you become pregnant while taking lacosamide tablets. you and your healthcare provider will decide if you should take lacosamide tablets while you are pregnant. if you become pregnant while taking lacosamide tablets, talk to your healthcare provider about registering with the north american antiepileptic drug pregnancy registry. you can enroll in this registry by calling 1-888-233-2334. the purpose of this registry is to collect information about the safety of antiepileptic medicine during pregnancy. - if you become pregnant while taking lacosamide tablets, talk to your healthcare provider about registering with the north american antiepileptic drug pregnancy registry. you can enroll in this registry by calling 1-888-233-2334. the purpose of this registry is to collect information about the safety of antiepileptic medicine during pregnancy. - are breastfeeding or plan to breastfeed. lacosamide passes into breast milk. breastfeeding during treatment with lacosamide tablets may cause your baby to have more sleepiness than normal. if this happens, contact your baby's healthcare provider. talk to your healthcare provider about the best way to feed your baby if you take lacosamide tablets. - breastfeeding during treatment with lacosamide tablets may cause your baby to have more sleepiness than normal. if this happens, contact your baby's healthcare provider. - talk to your healthcare provider about the best way to feed your baby if you take lacosamide tablets. tell your healthcare provider about all the medicines you take , including prescription and over-the-counter medicines, vitamins, and herbal supplements. taking lacosamide tablets with certain other medicines may cause side effects or affect how well they work. do not start or stop other medicines without talking to your healthcare provider. know the medicines you take. keep a list of them and show it to your healthcare provider and pharmacist each time you get a new medicine. how should i take lacosamide tablets? - take lacosamide tablets exactly as your healthcare provider tells you. - your healthcare provider will tell you how many lacosamide tablets to take and when to take them. - your healthcare provider may change your dose if needed. - do not stop lacosamide tablets without first talking to a healthcare provider. stopping lacosamide tablets suddenly in a patient who has epilepsy can cause seizures that will not stop (status epilepticus). - lacosamide tablets may be taken with or without food. - swallow lacosamide tablets whole with liquid. do not cut lacosamide tablets. - if you take too many lacosamide tablets, call your healthcare provider or local poison control center right away. what should i avoid while taking lacosamide tablets? do not drive, operate heavy machinery, or do other dangerous activities until you know how lacosamide tablets affect you. lacosamide tablets may cause you to feel dizzy, have double vision, feel sleepy, or have problems with coordination and walking. what are the possible side effects of lacosamide tablets? - see " what is the most important information i should know about lacosamide tablets? " lacosamide tablets may cause other serious side effects including: - a serious allergic reaction that may affect your skin or other parts of your body such as your liver or blood cells . call your healthcare provider right away if you have: - a skin rash, hives - fever or swollen glands that do not go away - shortness of breath - tiredness (fatigue) - swelling of the legs - yellowing of the skin or whites of the eyes - dark urine the most common side effects of lacosamide tablets include : - double vision - headache - dizziness - nausea - sleepiness these are not all of the possible side effects of lacosamide tablets. for more information ask your healthcare provider or pharmacist. tell your healthcare provider about any side effect that bothers you or that does not go away. call your doctor for medical advice about side effects. you may report side effects to fda at 1-800-fda-1088. how should i store lacosamide tablets? - store lacosamide tablets at room temperature between 68°f to 77°f (20°c to 25°c). keep lacosamide tablets and all medicines out of the reach of children. general information about the safe and effective use of lacosamide tablets. medicines are sometimes prescribed for purposes other than those listed in a medication guide. do not use lacosamide tablets for a condition for which it was not prescribed. do not give lacosamide tablets to other people, even if they have the same symptoms that you have. it may harm them. this medication guide summarizes the most important information about lacosamide tablets. if you would like more information, talk with your healthcare provider. you can ask your pharmacist or healthcare provider for information about lacosamide tablets that is written for health professionals. for more information, contact breckenridge pharmaceutical, inc. at 1-800-367-3395 or at www.bpirx.com. what are the ingredients in lacosamide tablets? active ingredient : lacosamide tablet inactive ingredients : colloidal silicon dioxide, crospovidone, hydroxypropyl cellulose, lecithin, low-substituted hydroxypropyl cellulose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, talc, titanium dioxide and additional ingredients listed below: - 50 mg tablets: red iron oxide, black iron oxide, fd&c blue #2 / indigo carmine aluminum lake - 100 mg tablets: yellow iron oxide - 150 mg tablets: yellow iron oxide, red iron oxide, black iron oxide - 200 mg tablets: fd&c blue #2 / indigo carmine aluminum lake additional pediatric use information is approved for ucb, inc.'s vimpat ® (lacosamide) tablets. however, due to ucb, inc.'s marketing exclusivity rights, this drug product is not labeled with that information. manufactured by: msn laboratories private limited telangana – 509 228, india distributed by: breckenridge pharmaceutical, inc. berlin, ct 06037, usa this medication guide has been approved by the u.s. food and drug administration trademarks are the property of their respective owners. revised: 11/2023 marketed by: gsms, inc. camarillo, ca 93012 usa

Австралія - англійська - Department of Health (Therapeutic Goods Administration)

ucb australia pty ltd t/a ucb pharma division of ucb australia - levetiracetam, quantity: 1000 mg - tablet, film coated - excipient ingredients: macrogol 6000; croscarmellose sodium; colloidal anhydrous silica; magnesium stearate; titanium dioxide; purified talc; polyvinyl alcohol; macrogol 3350 - keppra (film coated tablets and oral solution) is indicated for - use in epileptic patients aged 4 years and older, initially as add-on therapy, in the treatment of partial onset seizures with or without secondary generalisation, - monotherapy in the treatment of partial onset seizures, with or without secondary generalisation, in patients from 16 years of age with newly diagnosed epilepsy. - add on therapy in the treatment of myoclonic seizures in adults and adolescents from 12 years of age with juvenile myoclonic epilepsy (jme), and - add on therapy in the treatment of primary generalised tonic-clonic seizures in adults and children from 4 years of age with idiopathic generalised epilepsy (ige). keppra concentrate solution for iv infusion after dilution is an alternative for patients when oral administration is temporarily not feasible.

Австралія - англійська - Department of Health (Therapeutic Goods Administration)

ucb australia pty ltd t/a ucb pharma division of ucb australia - levetiracetam, quantity: 500 mg - tablet, film coated - excipient ingredients: magnesium stearate; colloidal anhydrous silica; croscarmellose sodium; macrogol 6000; titanium dioxide; purified talc; iron oxide yellow; polyvinyl alcohol; macrogol 3350 - keppra (film coated tablets and oral solution) is indicated for - use in epileptic patients aged 4 years and older, initially as add-on therapy, in the treatment of partial onset seizures with or without secondary generalisation, - monotherapy in the treatment of partial onset seizures, with or without secondary generalisation, in patients from 16 years of age with newly diagnosed epilepsy. - add on therapy in the treatment of myoclonic seizures in adults and adolescents from 12 years of age with juvenile myoclonic epilepsy (jme), and - add on therapy in the treatment of primary generalised tonic-clonic seizures in adults and children from 4 years of age with idiopathic generalised epilepsy (ige). keppra concentrate solution for iv infusion after dilution is an alternative for patients when oral administration is temporarily not feasible.

Австралія - англійська - Department of Health (Therapeutic Goods Administration)

ucb australia pty ltd t/a ucb pharma division of ucb australia - levetiracetam, quantity: 250 mg - tablet, film coated - excipient ingredients: magnesium stearate; croscarmellose sodium; macrogol 6000; colloidal anhydrous silica; titanium dioxide; purified talc; polyvinyl alcohol; macrogol 3350; indigo carmine aluminium lake - keppra (film coated tablets and oral solution) is indicated for - use in epileptic patients aged 4 years and older, initially as add-on therapy, in the treatment of partial onset seizures with or without secondary generalisation, - monotherapy in the treatment of partial onset seizures, with or without secondary generalisation, in patients from 16 years of age with newly diagnosed epilepsy. - add on therapy in the treatment of myoclonic seizures in adults and adolescents from 12 years of age with juvenile myoclonic epilepsy (jme), and - add on therapy in the treatment of primary generalised tonic-clonic seizures in adults and children from 4 years of age with idiopathic generalised epilepsy (ige). keppra concentrate solution for iv infusion after dilution is an alternative for patients when oral administration is temporarily not feasible.

Ірландія - англійська - HPRA (Health Products Regulatory Authority)

ucb (pharma) ireland limited - cetirizine dihydrochloride - film-coated tablet - 10 milligram(s) - piperazine derivatives; cetirizine - piperazine derivatives - in adults and paediatric patients 6 years and above: cetirizine is indicated for the relief of nasal and ocular symptoms of seasonal and perennial allergic rhinitis. cetirizine is indicated for the relief of symptoms of chronic idiopathic urticaria.

США - англійська - NLM (National Library of Medicine)

ucb, inc. - levetiracetam (unii: 44yrr34555) (levetiracetam - unii:44yrr34555) - levetiracetam 500 mg - keppra xr® is indicated for the treatment of partial-onset seizures in patients 12 years of age and older. keppra xr is contraindicated in patients with a hypersensitivity to levetiracetam. reactions have included anaphylaxis and angioedema [see warnings and precautions (5.4)] . pregnancy exposure registry there is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to antiepileptic drugs (aeds), including keppra xr, during pregnancy. encourage women who are taking keppra xr during pregnancy to enroll in the north american antiepileptic drug (naaed) pregnancy registry by calling 1-888-233-2334 or visiting http://www.aedpregnancyregistry.org/. risk summary prolonged experience with keppra in pregnant women has not identified a drug-associated risk of major birth defects or miscarriage, based on published literature, which includes data from pregnancy registries and reflects experience over two decades [see human data] . in animal studies, levetiracetam produced developmental toxicity (increased embryofetal and offspring mortality, increased incidences of fetal structural abnormalities, decreased embryofetal and offspring growth, neurobehavioral alterations in offspring) at doses similar to human therapeutic doses [see animal data] . in the u.s. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2-4% and 15-20%, respectively. the background risk of major birth defects and miscarriage for the indicated population is unknown. clinical considerations keppra xr levels may decrease during pregnancy [see warnings and precautions (5.10)]. physiological changes during pregnancy may affect levetiracetam concentration. decrease in levetiracetam plasma concentrations has been observed during pregnancy. this decrease is more pronounced during the third trimester. dose adjustments may be necessary to maintain clinical response. data human data while available studies cannot definitively establish the absence of risk, data from the published literature and pregnancy registries have not established an association with levetiracetam use during pregnancy and major birth defects or miscarriage. animal data when levetiracetam (0, 400, 1200, or 3600 mg/kg/day) was administered orally to pregnant rats during the period of organogenesis, reduced fetal weights and increased incidence of fetal skeletal variations were observed at the highest dose tested. there was no evidence of maternal toxicity. the no-effect dose for adverse effects on embryofetal developmental in rats (1200 mg/kg/day) is approximately 4 times the maximum recommended human dose (mrhd) of 3000 mg on a body surface area (mg/m2 ) basis. oral administration of levetiracetam (0, 200, 600, or 1800 mg/kg/day) to pregnant rabbits during the period of organogenesis resulted in increased embryofetal mortality and incidence of fetal skeletal variations at the mid and high dose and decreased fetal weights and increased incidence of fetal malformations at the high dose, which was associated with maternal toxicity. the no-effect dose for adverse effects on embryofetal development in rabbits (200 mg/kg/day) is approximately equivalent to the mrhd on a mg/m2 basis. oral administration of levetiracetam (0, 70, 350, or 1800 mg/kg/day) to female rats throughout pregnancy and lactation led to an increased incidence of fetal skeletal variations, reduced fetal body weight, and decreased growth in offspring at the mid and high doses and increased pup mortality and neurobehavioral alterations in offspring at the highest dose tested. there was no evidence of maternal toxicity. the no-effect dose for adverse effects on pre- and postnatal development in rats (70 mg/kg/day) is less than the mrhd on a mg/m2 basis. oral administration of levetiracetam to rats during the latter part of gestation and throughout lactation produced no adverse developmental or maternal effects at doses of up to 1800 mg/kg/day (6 times the mrhd on a mg/m2 basis). risk summary levetiracetam is excreted in human milk. there are no data on the effects of keppra xr on the breastfed infant, or the effects on milk production. the developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for keppra xr and any potential adverse effects on the breastfed infant from keppra xr or from the underlying maternal condition. safety and effectiveness in patients 12 years of age and older have been established based on pharmacokinetic data in adults and adolescents using keppra xr and efficacy and safety data in controlled pediatric studies using immediate-release keppra [see adverse reactions (6.1), clinical pharmacology (12.3), and clinical studies (14.1)]. safety and effectiveness in pediatric patients below the age of 12 have not been established. a 3-month, randomized, double-blind, placebo-controlled study was performed to assess the neurocognitive and behavioral effects of immediate-release keppra as adjunctive therapy in 98 pediatric patients with inadequately controlled partial seizures, ages 4 to 16 years (keppra n=64; placebo n=34). the target dose of immediate-release keppra was 60 mg/kg/day. neurocognitive effects were measured by the leiter-r attention and memory (am) battery, which assesses various aspects of a child's memory and attention. although no substantive differences were observed between the placebo- and keppra-treated groups in the median change from baseline in this battery, the study was not adequate to assess formal statistical non-inferiority between the drug and placebo. the achenbach child behavior checklist (cbcl/6-18), a standardized validated tool used to assess a child's competencies and behavioral/emotional problems, was also assessed in this study. an analysis of the cbcl/6-18 indicated a worsening in aggressive behavior, one of the eight syndrome scores, in patients treated with keppra [see warnings and precautions (5.1)] . juvenile animal toxicity data studies of levetiracetam in juvenile rats (dosed on postnatal days 4 through 52) and dogs (dosed from postnatal weeks 3 through 7) at doses of up to 1800 mg/kg/day (approximately 7 and 24 times, respectively, the maximum recommended pediatric dose of 60 mg/kg/day on a mg/m2 basis) did not demonstrate adverse effects on postnatal development. there were insufficient numbers of elderly subjects in controlled trials of epilepsy to adequately assess the effectiveness of keppra xr in these patients. it is expected that the safety of keppra xr in elderly patients 65 and over would be comparable to the safety observed in clinical studies of immediate-release keppra tablets. there were 347 subjects in clinical studies of immediate-release keppra that were 65 and over. no overall differences in safety were observed between these subjects and younger subjects. there were insufficient numbers of elderly subjects in controlled trials of epilepsy to adequately assess the effectiveness of immediate-release keppra in these patients. levetiracetam is known to be substantially excreted by the kidney, and the risk of adverse reactions to this drug may be greater in patients with impaired renal function. because elderly patients are more likely to have decreased renal function, care should be taken in dose selection, and it may be useful to monitor renal function [see clinical pharmacology (12.3)] . the effect of keppra xr on renally impaired patients was not assessed in the controlled study. however, it is expected that the effect on keppra xr-treated patients would be similar to the effect seen in controlled studies of immediate-release keppra tablets. clearance of levetiracetam is decreased in patients with renal impairment and is correlated with creatinine clearance [see clinical pharmacology (12.3)] . dose adjustment is recommended for patients with impaired renal function [see dosage and administration (2.2)] .

США - англійська - NLM (National Library of Medicine)

ucb, inc. - fenfluramine (unii: 2ds058h2cf) (fenfluramine - unii:2ds058h2cf) - fintepla is indicated for the treatment of seizures associated with dravet syndrome (ds) and lennox-gastaut syndrome (lgs) in patients 2 years of age and older. fintepla is contraindicated in patients with: - hypersensitivity to fenfluramine or any of the excipients in fintepla [see description (11)] - concomitant use, or within 14 days of the administration, of monoamine oxidase inhibitors because of an increased risk of serotonin syndrome [see warnings and precautions (5.7)] pregnancy exposure registry there is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to antiepileptic drugs (aeds), such as fintepla, during pregnancy. encourage women who are taking fintepla during pregnancy to enroll in the north american antiepileptic drug (naaed) pregnancy registry by calling the toll-free number 1-888-233-2334 or visiting http://www.aedpregnancyregistry.org. risk summary there are no data on fintepla use in pregnant women. available data from epidemiologic studies with fenfluramine or dexfenfluramine are insufficient to evaluate for a drug-associated risk of major birth defects, miscarriage, or other adverse maternal or fetal outcomes. fintepla can cause decreased appetite and decreased weight [see warnings and precautions (5.3)]; monitor for adequate weight gain during pregnancy. in animal studies, administration of fenfluramine throughout organogenesis (rat and rabbit) or throughout gestation and lactation (rat) resulted in adverse effects on development (fetal malformations, embryofetal and offspring mortality and growth impairment) in the presence of maternal toxicity at clinically relevant maternal plasma levels of fenfluramine and its major active metabolite (see data) . the estimated background risk of major birth defects and miscarriage for the indicated population is unknown. all pregnancies have a background risk of birth defect, loss, or other adverse outcomes. in the u.s. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively. data animal data oral administration of fenfluramine (0, 4.5, 8.6, or 34.6 mg/kg/day) to pregnant rats during organogenesis resulted in decreased fetal body weights and marked increases in fetal malformations (external, visceral, and skeletal) at the highest dose tested, which was associated with maternal toxicity. at the no-effect dose (8.6 mg/kg/day) for adverse effects on embryofetal development in rats, maternal plasma exposures (auc) of fenfluramine and norfenfluramine (the major metabolite) were approximately 2 and 5 times, respectively, those in humans at the maximum recommended human dose (mrhd) of 26 mg/day. oral administration of fenfluramine (0, 4.3, 8.6, 13.0 mg/kg/day) to pregnant rabbits throughout organogenesis resulted in increased embryofetal mortality at all doses and increases in fetal malformations (external and skeletal) at the highest dose tested, which was associated with maternal toxicity. a no-adverse-effect dose for adverse effects on embryofetal development in rabbits was not identified. at the lowest dose tested in rabbits (4.3 mg/kg/day), maternal plasma exposures of fenfluramine and norfenfluramine were lower than those in humans at the mrhd. oral administration of fenfluramine (0, 4.3, 8,6, or 34.6 mg/kg/day) to female rats throughout gestation and lactation resulted in marked increases in stillborn pups and neonatal offspring deaths at the highest dose tested and delayed growth and reflex development during the pre- weaning period at all doses. maternal body weight gain was decreased at all doses during pregnancy and at the two highest doses during lactation. a no-effect dose for adverse effects on pre- and postnatal development in rats was not determined. at the lowest dose tested in rats (4.3 mg/kg/day), maternal plasma exposures of fenfluramine and norfenfluramine were approximately 0.5 and 3 times, respectively, those in humans at the mrhd. risk summary there are no data on the presence of fenfluramine or its metabolites in human milk, the effects on the breastfed infant, or the effects on milk production. the developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for fintepla and any potential adverse effects on the breastfed infant from fintepla or from the underlying maternal condition. infertility in animal studies, oral administration of fenfluramine resulted in adverse reproductive effects in males and females at clinically relevant doses in the presence of parental toxicity [see nonclinical toxicology (13.1)] . the safety and effectiveness of fintepla for the treatment of seizures associated with ds and lgs have been established in patients 2 years of age and older. use of fintepla for the treatment of seizures associated with ds in patients 2 years of age and older is supported by two randomized, double-blind, placebo-controlled trials in 202 patients 2 to 18 years of age. use of fintepla for the treatment of seizures associated with lgs is supported by a randomized, double-blind, placebo-controlled study in 263 patients aged 2 to 35 years, including 187 patients less than 18 years [see boxed warning, warnings and precautions (5), adverse reaction (6.1), and clinical studies (14)]. fintepla can cause decreases in appetite and weight. the growth of pediatric patients treated with fintepla should be carefully monitored. safety and effectiveness in patients less than 2 years of age have not been established. juvenile animal data oral administration of fenfluramine (0, 3.0, 7,8, or 17.3 mg/kg/day) to young rats for 10 weeks starting on postnatal day 7 resulted in reduced body weight and neurobehavioral changes (decreased locomotor activity and learning and memory deficits) at all doses tested. neurobehavioral effects persisted after dosing was discontinued. bone size was decreased at the mid and high doses; brain size was decreased at the highest dose. partial or complete recovery was seen for these endpoints. a no-effect dose for postnatal developmental toxicity was not identified. the lowest dose tested (3.0 mg/kg/day) was associated with plasma fenfluramine exposures (auc) less than that in humans at the maximum recommended human dose (mrhd) of 26 mg/day and norfenfluramine (metabolite) exposures (auc) approximately 2 times that in humans at the mrhd. clinical studies of fintepla for the treatment of ds or lgs did not include patients 65 years of age and over to determine whether they respond differently from younger patients. in general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy. in patients with estimated glomerular filtration rate (egfr) 15 to 29 ml/min/1.73m2 , do not exceed the maximum daily dosage of fintepla of 20 mg. in patients with egfr 15 to 29 ml/min/1.73m2 and concomitant stiripentol use, do not exceed the maximum daily dosage of fintepla of 17 mg [see dosage and administration (2.4) and clinical pharmacology (12.3)]. fintepla has not been studied in patients with egfr < 15 ml/min/1.73m2 . combined molar exposures of fenfluramine and norfenfluramine were increased in subjects with various degrees of hepatic impairment (child-pugh class a, b, and c), necessitating a dosage adjustment in these patients [see dosage and administration (2.5) and clinical pharmacology (12.3)] . be sure that you read, understand, and follow these instructions before you start using fintepla oral solution and each time you get a refill. there may be new information. this instructions for use contains information on how to take fintepla. this information does not take the place of talking to your healthcare provider about your medical condition or treatment. what is included with fintepla? the following items are included to prepare and give an oral dose of fintepla: - 1 bottle of fintepla oral solution (2.2 mg/ml) - 2 reusable oral syringes 1 bottle of fintepla oral solution (2.2 mg/ml)    2 oral syringes call the pharmacist at 1-844-288-5007 if you did not receive the items listed above, or if you need help using them. important information about fintepla - fintepla is an oral medicine (taken by mouth) and is given 2 times each day . follow your healthcare provider's instructions for taking or giving doses of fintepla. - if you have questions about how to prepare or give fintepla, contact your healthcare provider or call your pharmacist. - always use the oral syringes provided with fintepla to make sure the right dose is given. if you need a new syringe contact your pharmacist. do not use a household teaspoon or tablespoon. oral syringes provided with fintepla by the pharmacy. with fintepla you will receive 2 reusable oral syringes. call the pharmacist at 1-844-288-5007 if you have any questions about the syringes provided with fintepla. - the bottle of fintepla oral solution, and - a clean, dry reusable oral syringe that was provided with fintepla. - do not use the medicine if the "throw away" (discard) date has passed. - if the date is near, contact your pharmacy or healthcare provider to get a refill or new prescription. - if the date has passed, dispose of any unused fintepla. - set the cap aside (do not throw away). - if the bottle does not have an adapter, contact the pharmacist. - always leave the adapter in place in the bottle of medicine. - use the other oral syringe provided, or - contact the pharmacist to get a new one. - if you draw out too much medicine: leave the oral syringe in the adapter. push the plunger slowly back into the syringe until you reach the prescribed dose. - leave the oral syringe in the adapter. - push the plunger slowly back into the syringe until you reach the prescribed dose. - if you see air bubbles in the medicine: leave the oral syringe in the adapter. pull the plunger further down. allow the bubbles to rise to the tip of the syringe. push the plunger in all the way. slowly pull the plunger out to the prescribed dose. note: very small bubbles in the liquid are normal. - leave the oral syringe in the adapter. - pull the plunger further down. - allow the bubbles to rise to the tip of the syringe. - push the plunger in all the way. - slowly pull the plunger out to the prescribed dose. note: very small bubbles in the liquid are normal. - put the syringe back into adapter. - see steps 9 to 11 to adjust the dose, as needed. - do not squirt or forcefully push the medicine into the back of the throat. this may cause choking. - always leave the adapter in place in the bottle - the cap will fit over it. - rinse the oral syringe with clean tap water and allow it to air dry after each use. - make sure you rinse the inside of the syringe and the plunger. - pull clean tap water into the syringe with the plunger and push it out several times to clean the syringe. - remove the plunger from the barrel of the oral syringe - rinse both parts under tap water - make sure the syringe and plunger are completely dry before the next use. - the syringe is also safe to clean in the dishwasher. how should i store fintepla? - store fintepla at room temperature between 68°f to 77°f (20°c to 25°c). - do not refrigerate or freeze. - keep the cap tightly closed and the bottle upright. - store the fintepla bottle and syringe together in a clean area. - throw away (discard) any unused fintepla 3 months after first opening the bottle or if the discard after date on the package or bottle has passed. whichever one comes first. - keep fintepla and all medicines out of the reach of children. manufactured for: ucb, inc., smyrna, ga 30080 fintepla® is a registered trademark of the ucb group of companies. ©2023. all rights reserved. this instructions for use has been approved by the u.s. food and drug administration. revised: 9/2023

США - англійська - NLM (National Library of Medicine)

ucb, inc. - zilucoplan (unii: yg391pk0cc) (zilucoplan - unii:yg391pk0cc) - zilbrysq is indicated for the treatment of generalized myasthenia gravis (gmg) in adult patients who are anti-acetylcholine receptor (achr) antibody positive. zilbrysq is contraindicated in patients with unresolved neisseria meningitidis infection [see warnings and precautions (5.1)] . risk summary there are no available data on zilbrysq use in pregnant women to evaluate for a drug-associated risk of major birth defects, miscarriage, or other adverse maternal or fetal outcomes. administration of zilucoplan to pregnant monkeys resulted in increases in embryofetal death at maternal exposures similar to those in humans at therapeutic doses (see animal data) . all pregnancies have a background risk of birth defect, loss, or other adverse outcomes. the background rate of major birth defects and miscarriage in the indicated population is unknown. in the u.s. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively. data animal data subcutaneous administration of zilucoplan (0, 1, 2, or 4 mg/kg/day) to pregnant monkeys throughout gestation resulted in an increase in embryofetal death at all doses, in the absence of maternal toxicity. a no effect dose for adverse developmental effects in monkeys was not identified. the lowest dose tested was associated with maternal exposures (auc) similar to that in humans at the maximum recommended human dose of 32.4 mg/day. data from an ex vivo human placental transfer model demonstrated transfer of zilucoplan into the fetal compartment at a rate of 0.5% at a steady state plasma concentration of 10 µg/ml zilucoplan, which corresponds to a therapeutic dose of 0.3 mg/kg. the clinical significance of these data in human pregnancies is unknown. risk summary there are no data on the presence of zilucoplan in human milk, the effects on the breastfed infant, or the effects on milk production. the developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for zilbrysq and any potential adverse effects on the breastfed infant from zilbrysq or from the underlying maternal condition. safety and effectiveness in pediatric patients have not been established. clinical studies of zilbrysq did not include sufficient numbers of patients aged 65 and older to determine whether they respond differently from younger adult patients. zilbrysq® (zil-brisk) (zilucoplan) injection, for subcutaneous use single-dose prefilled syringe this instructions for use contains information on how to inject zilbrysq. understanding your zilbrysq prefilled syringe read this instructions for use before using the zilbrysq prefilled syringe. this information does not take the place of talking to your healthcare provider about your medical condition or treatment. see the medication guide that comes with zilbrysq for important information. your healthcare provider should show you how to prepare and inject zilbrysq prefilled syringe properly before you use it for the first time. do not inject yourself or someone else until you have been shown how to inject zilbrysq correctly. keep this instructions for use and refer to it as needed until you have used all of the zilbrysq prefilled syringes in the packaging. for general questions or help, please call your healthcare provider or ucbcares at 1-844-599-care (2273). how should i store zilbrysq prefilled syringes? - store zilbrysq prefilled syringes in a refrigerator between 36°f to 46°f (2°c to 8°c) until the expiration date on the carton. do not freeze zilbrysq. - zilbrysq prefilled syringes may be stored at room temperature up to 86°f (30°c) in the original carton for a single period of up to 3 months. write the date you removed the prefilled syringes from the refrigerator in the space provided on the carton. after zilbrysq prefilled syringes have been stored at room temperature, do not place them back in the refrigerator. throw them away if not used within 3 months or if the expiration date has passed, whichever occurs first. - keep the zilbrysq prefilled syringes in the original carton before use. - keep zilbrysq prefilled syringes and all medicines out of the reach of children. important information you need to know before you inject zilbrysq - do not use zilbrysq if the expiration date on the packaging has passed or the carton seals have been broken. - do not reuse the zilbrysq prefilled syringe. the prefilled syringe is for 1-time (single use) only. you may get an infection. - do not inject zilbrysq more than 1 time per day. - do not miss any doses of zilbrysq. if you miss your zilbrysq dose, inject a dose as soon as possible. then, inject the next dose at your scheduled time. do not inject more than 1 dose each day. - do not use the zilbrysq prefilled syringe if it has been dropped. - do not remove the needle cap from the zilbrysq prefilled syringe until you are ready to inject. - do not insert the needle into the skin more than 1 time because this may bend or break the needle, causing trauma to the tissue. - do not pull back on the zilbrysq prefilled syringe plunger head at any time because this can break the prefilled syringe. - do not touch the needle guard activation clips at any time because this can cause the early activation of the needle guard. zilbrysq prefilled syringe guide to parts (figure a): preparing for injection step 1: take out the zilbrysq prefilled syringe if the zilbrysq prefilled syringes are stored in the refrigerator: - take the zilbrysq prefilled syringes carton out of the refrigerator and remove 1 prefilled syringe from the carton. grasp the prefilled syringe body. carefully lift the prefilled syringe straight up out of the tray (figures b.1 and b.2) . put the rest of the prefilled syringes in the carton back in the refrigerator. - before you inject zilbrysq, let the prefilled syringe warm up to room temperature on a clean flat surface for 30 to 45 minutes . this will help to reduce discomfort when injecting. - do not warm the zilbrysq prefilled syringe in any other way (for example in a microwave, in hot water, or in direct sunlight). - do not remove the needle cap from the prefilled syringe until you are ready to inject. if the zilbrysq prefilled syringes are stored at room temperature: - remove 1 zilbrysq prefilled syringe from the carton. grasp the prefilled syringe body. carefully lift the prefilled syringe straight up out of the tray (figures b.1 and b.2 ). any remaining prefilled syringes in the carton should not be placed in the refrigerator after it has been stored at room temperature. figure b.1 figure b.2 step 2: inspect the zilbrysq prefilled syringe - check the prefilled syringe for damage (figure c) . - do not use if any part of the prefilled syringe appears to be cracked, leaking, or broken. - check that the needle cap is not cracked or broken and attached to the prefilled syringe (figure c) . - do not use if the needle cap is missing or not securely attached. - check the expiration date and medicine name (zilbrysq) on the prefilled syringe label (figure c) . - do not use if the expiration date printed on the prefilled syringe has passed. - do not use if the word zilbrysq does not appear on the prefilled syringe. - check the dose appearing on the label (figure c) and make sure it matches your prescribed dose. - do not use if the dose does not match your prescribed dose. - check the medicine inside the prefilled syringe (figure c) . the medicine should be clear to almost clear and colorless. it is normal to see air bubbles in the prefilled syringe. - do not use if the medicine is cloudy, discolored, or contains floating particles. figure c step 3: gather supplies wash your hands with soap and water and dry them with a clean towel. gather the following supplies on a clean, flat surface (figure d) : - 1 zilbrysq prefilled syringe - 1 alcohol wipe (not supplied) - 1 cotton ball or gauze pad (not supplied) - 1 adhesive bandage (not supplied) - 1 sharps disposal or puncture-resistant container (not supplied). see step 12 for instructions on throwing away the syringe. figure d step 4: choose your injection site choose an injection site from the following areas (figures e.1 and e.2) : - the stomach (abdomen), except for the 2-inch area around the belly button (navel) (figure e.1) - the front of the thighs (figure e.1) figure e.1 – abdomen and thighs - the back of the upper arms (only if someone else is giving you the injection) (figure e.2) figure e.2 – upper arms choose a different site each time you give yourself an injection. if you want to use the same injection site, make sure it is at least 1-inch from a spot you used before. do not inject zilbrysq into an area that is red, tender, bruised, swollen, hard or that has scars or stretch marks. step 5: clean your injection site clean the injection site using an alcohol wipe (figure f) . let the skin dry for 10 seconds before injecting. do not touch the injection site again before giving your injection. injecting the medicine step 6: remove the needle cap hold the body of the zilbrysq prefilled syringe with one hand and pull the needle cap straight off with your other hand (figure g) . throw away (discard) the needle cap into your household trash or a sharps disposal container. do not touch the needle or let it touch anything. do not recap the needle at any time to avoid injury. do not try to remove any air bubbles from the zilbrysq prefilled syringe. air bubbles will not affect your dose and will not harm you. this is normal. you can continue to take your injection. step 7: pinch your injection site use your other hand to pinch the area of cleaned skin and hold it firmly (figure h) . step 8: insert the needle insert the entire needle into the pinched skin at a 45° to 90° angle. when the needle is fully inserted, hold the zilbrysq prefilled syringe in place (figure i) . do not pull back on the plunger head at any time because this could break the prefilled syringe. do not touch the needle guard activation clips. step 9: release the pinched skin when the needle is fully inserted, hold the zilbrysq prefilled syringe in place and release the pinched skin (figure j) . do not reinsert the needle into the skin if the needle is pulled out when releasing the skin. if this happens, safely throw away (dispose of) the syringe in a sharps disposal container and get a new zilbrysq prefilled syringe to give the injection. step 10: inject the medicine push the plunger head all the way down while holding onto the finger grip to inject all the medicine (figure k) . step 11: release the plunger head slowly release the plunger head by lifting your thumb. after a complete injection, the needle guard will cover the needle and you may hear a click (figure l) . step 12: throw away (dispose of) the used zilbrysq prefilled syringe throw away (dispose of) the used zilbrysq prefilled syringe into a sharps disposal container (figure m) right away. do not throw away (dispose of) the zilbrysq prefilled syringe in your household trash. if you do not have an fda-cleared sharps disposal container, you may use a household container that is: - made of a heavy-duty plastic, - can be closed with a tight-fitting, puncture-resistant lid, without sharps being able to come out, - upright and stable during use, - leak-resistant, and - properly labelled to warn of hazardous waste inside the container. do not throw away (dispose of) your used sharps disposal container in your household trash unless your community guidelines permit this. do not recycle your used sharps disposal container. always keep the sharps disposal container out of the reach of children. step 13: examine the injection site press a cotton ball or gauze pad over the injection site and hold it for 10 seconds (figure n) . do not rub the injection site. you may have slight bleeding. this is normal. apply an adhesive bandage if needed (figure o). the injection is complete. for more information or help, contact your healthcare provider. if you have any questions, call ucbcares at 1-844-599-care (2273) or visit www.askucbcares.com. manufactured for: ucb, inc. smyrna, ga 30080 this instructions for use has been approved by the u.s. food and drug administration.        issued: 10/2023