Stati Uniti - inglese - NLM (National Library of Medicine)

genentech, inc. - tocilizumab (unii: i031v2h011) (tocilizumab - unii:i031v2h011) - tocilizumab 20 mg in 1 ml - actemra® (tocilizumab) is indicated for the treatment of adult patients with moderately to severely active rheumatoid arthritis who have had an inadequate response to one or more disease-modifying anti-rheumatic drugs (dmards). actemra® (tocilizumab) is indicated for the treatment of giant cell arteritis (gca) in adult patients. actemra® (tocilizumab) is indicated for slowing the rate of decline in pulmonary function in adult patients with systemic sclerosis-associated interstitial lung disease. actemra® (tocilizumab) is indicated for the treatment of active polyarticular juvenile idiopathic arthritis in patients 2 years of age and older. actemra® (tocilizumab) is indicated for the treatment of active systemic juvenile idiopathic arthritis in patients 2 years of age and older. actemra® (tocilizumab) is indicated for the treatment of chimeric antigen receptor (car) t cell-induced severe or life-threatening cytokine release syndrome in adults and pediatric patients 2 years of age and older. actemra® (toci

Stati Uniti - inglese - NLM (National Library of Medicine)

genentech, inc. - valganciclovir hydrochloride (unii: 4p3t9qf9nz) (ganciclovir - unii:p9g3ckz4p5) - valganciclovir 450 mg - treatment of cytomegalovirus (cmv) retinitis: valcyte is indicated for the treatment of cmv retinitis in patients with acquired immunodeficiency syndrome (aids) [see clinical studies (14.1)] . prevention of cmv disease: valcyte is indicated for the prevention of cmv disease in kidney, heart, and kidney-pancreas transplant patients at high risk (donor cmv seropositive/recipient cmv seronegative [d+/r-]) [see clinical studies (14.1)] . prevention of cmv disease: valcyte is indicated for the prevention of cmv disease in kidney transplant patients (4 months to 16 years of age) and heart transplant patients (1 month to 16 years of age) at high risk [see clinical studies (14.2)] . valcyte is contraindicated in patients who have had a demonstrated clinically significant hypersensitivity reaction (e.g., anaphylaxis) to valganciclovir, ganciclovir, or any component of the formulation [see adverse reactions (6.1)]. risk summary after oral administration, valganciclovir (prodrug) is converted to ganciclovir (active drug) and, therefore, valcyte is expected to have reproductive toxicity effects similar to ganciclovir. in animal studies, ganciclovir caused maternal and fetal toxicity and embryo-fetal mortality in pregnant mice and rabbits as well as teratogenicity in rabbits at exposures two-times the human exposure. there are no available human data on use of valcyte or ganciclovir in pregnant women to establish the presence or absence of drug-associated risk. the background risk of major birth defects and miscarriage for the indicated populations is unknown. however, the background risk in the u.s. general population of major birth defects is 2–4% and the risk of miscarriage is 15–20% of clinically recognized pregnancies. advise pregnant women of the potential risk to the fetus [see warnings and precautions (5.3), use in specific populations (8.3)]. clinical considerations disease-associated maternal and/or embryo/fetal risk most maternal cmv infections are asymptomatic or they may be associated with a self-limited mononucleosis-like syndrome. however, in immunocompromised patients (i.e., transplant patients or patients with aids) cmv infections may be symptomatic and may result in significant maternal morbidity and mortality. the transmission of cmv to the fetus is a result of maternal viremia and transplacental infection. perinatal infection can also occur from exposure of the neonate to cmv shedding in the genital tract. approximately 10% of children with congenital cmv infection are symptomatic at birth. mortality in these infants is about 10% and approximately 50–90% of symptomatic surviving newborns experience significant morbidity, including mental retardation, sensorineural hearing loss, microcephaly, seizures, and other medical problems. the risk of congenital cmv infection resulting from primary maternal cmv infection may be higher and of greater severity than that resulting from maternal reactivation of cmv infection. data animal data doses resulting in two-times the human exposure of ganciclovir (based on the human auc following a single intravenous infusion of 5 mg per kg of ganciclovir) resulted in maternal and embryo-fetal toxicity in pregnant mice and rabbits as well as teratogenicity in the rabbits. fetal resorptions were present in at least 85% of rabbits and mice. rabbits showed increased embryo-fetal mortality, growth retardation of the fetuses and structural abnormalities of multiple organs of the fetuses including the palate (cleft palate), eyes (anophthalmia/microphthalmia), brain (hydrocephalus), jaw (brachygnathia), kidneys and pancreas (aplastic organs). increased embryo-fetal mortality was also seen in mice. daily intravenous doses of approximately 1.7 times the human exposure (based on auc) administered to female mice prior to mating, during gestation, and during lactation caused hypoplasia of the testes and seminal vesicles in the male offspring, as well as pathologic changes in the nonglandular region of the stomach. data from an ex-vivo human placental model showed that ganciclovir crosses the human placenta. the transfer occurred by passive diffusion and was not saturable over a concentration range of 1 to 10 mg/ml. risk summary no data are available regarding the presence of valganciclovir (prodrug) or ganciclovir (active drug) in human milk, the effects on the breastfed infant, or the effects on milk production. animal data indicate that ganciclovir is excreted in the milk of lactating rats. the centers for disease control and prevention recommend that hiv-infected mothers not breastfeed their infants to avoid risking postnatal transmission of hiv. advise nursing mothers that breastfeeding is not recommended during treatment with valcyte because of the potential for serious adverse events in nursing infants and because of the potential for transmission of hiv [see boxed warning, warnings and precautions (5.1, 5.3, 5.4, 5.5), nonclinical toxicology (13.1)] . pregnancy testing females of reproductive potential should undergo pregnancy testing before initiation of valcyte [see use in specific populations (8.1)] . contraception females because of the mutagenic and teratogenic potential of valcyte, females of reproductive potential should be advised to use effective contraception during treatment and for at least 30 days following treatment with valcyte [see dosage and administration (2.6), warnings and precautions (5.4, 5.5), nonclinical toxicology (13.1)] . males because of its mutagenic potential, males should be advised to use condoms during and for at least 90 days following, treatment with valcyte [see dosage and administration (2.6), warnings and precautions (5.3, 5.5), nonclinical toxicology (13.1)]. infertility valcyte at the recommended doses may cause temporary or permanent female and male infertility [see warnings and precautions (5.3), nonclinical toxicology (13.1)]. data human data in a small, open-label, non-randomized clinical study, adult male renal transplant patients receiving valcyte for cmv prophylaxis for up to 200 days post-transplantation were compared to an untreated control group. patients were followed-up for six months after valcyte discontinuation. among 24 evaluable patients in the valcyte group, the mean sperm density at the end of treatment visit decreased by 11 million/ml from baseline; whereas, among 14 evaluable patients in the control group the mean sperm density increased by 33 million/ml. however, at the follow-up visit among 20 evaluable patients in the valcyte group the mean sperm density was comparable to that observed among 10 evaluable patients in the untreated control group (the mean sperm density at the end of follow-up visit increased by 41 million/ml from baseline in the valcyte group and by 43 million/ml in the untreated group). valcyte for oral solution and tablets are indicated for the prevention of cmv disease in pediatric kidney transplant patients 4 months to 16 years of age and in pediatric heart transplant patients 1 month to 16 years of age at risk for developing cmv disease [see indications and usage (1.2), dosage and administration (2.3)]. the use of valcyte for oral solution and tablets for the prevention of cmv disease in pediatric kidney transplant patients 4 months to 16 years of age is based on two single-arm, open-label, non-comparative studies in patients 4 months to 16 years of age. study 1 was a safety and pharmacokinetic study in pediatric solid organ transplant patients (kidney, liver, heart, and kidney/pancreas). valcyte was administered once daily within 10 days of transplantation for a maximum of 100 days post-transplantation. study 2 was a safety and tolerability study where valcyte was administered once daily within 10 days of transplantation for a maximum of 200 days post-transplantation in pediatric kidney transplant patients. the results of these studies were supported by previous demonstration of efficacy in adult patients [see adverse reactions (6.1), clinical pharmacology (12.3), clinical studies (14.2)]. the use of valcyte for oral solution and tablets for the prevention of cmv disease in pediatric heart transplant patients 1 month to 16 years of age is based on two studies (study 1 described above and study 3) and was supported by previous demonstration of efficacy in adult patients [see clinical pharmacology (12.3), clinical studies (14.2)] . study 3 was a pharmacokinetic and safety study of valcyte in pediatric heart transplant patients less than 4 months of age who received a single dose of valcyte oral solution on each of two consecutive days. a physiologically based pharmacokinetic (pbpk) model was developed based on the available pharmacokinetic data from pediatric and adult patients to support dosing in heart transplant patients less than 1 month of age. however, due to uncertainty in model predictions for neonates, valcyte is not indicated for prophylaxis in this age group. the safety and efficacy of valcyte for oral solution and tablets have not been established in children for prevention of cmv disease in pediatric liver transplant patients, in kidney transplant patients less than 4 months of age, in heart transplant patients less than 1 month of age, in pediatric aids patients with cmv retinitis, and in infants with congenital cmv infection. a pharmacokinetic and pharmacodynamic evaluation of valcyte for oral solution was performed in 24 neonates with congenital cmv infection involving the central nervous system. all patients were treated for 6 weeks with a combination of intravenous ganciclovir 6 mg per kg twice daily or valcyte for oral solution at doses ranging from 14 mg per kg to 20 mg per kg twice daily. the pharmacokinetic results showed that in infants greater than 7 days to 3 months of age, a dose of 16 mg per kg twice daily of valcyte for oral solution provided ganciclovir systemic exposures (median auc0-12h =23.6 [range 16.8–35.5] mcg∙ h/ml; n=6) comparable to those obtained in infants up to 3 months of age from a 6 mg per kg dose of intravenous ganciclovir twice daily (auc0-12h =25.3 [range 2.4–89.7] mcg∙ h/ml; n=18) or to the ganciclovir systemic exposures obtained in adults from a 900 mg dose of valcyte tablets twice daily. however, the efficacy and safety of intravenous ganciclovir and of valcyte have not been established for the treatment of congenital cmv infection in infants and no similar disease occurs in adults; therefore, efficacy cannot be extrapolated from intravenous ganciclovir use in adults. studies of valcyte for oral solution or tablets have not been conducted in adults older than 65 years of age. clinical studies of valcyte did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. 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. valcyte is known to be substantially excreted by the kidneys, and the risk of toxic reactions to this drug may be greater in patients with impaired renal function. because renal clearance decreases with age, valcyte should be administered with consideration of their renal status. renal function should be monitored and dosage adjustments should be made accordingly [see dosage and administration (2.5), warnings and precautions (5.2), use in specific populations (8.6), clinical pharmacology (12.3)]. dose reduction is recommended when administering valcyte to patients with renal impairment [see dosage and administration (2.5), warnings and precautions (5.2), clinical pharmacology (12.3)] . for adult patients on hemodialysis (crcl less than 10 ml/min), valcyte tablets should not be used. adult hemodialysis patients should use ganciclovir in accordance with the dose-reduction algorithm cited in the cytovene® -iv complete product information section on dosage and administration: renal impairment [see dosage and administration (2.5) and clinical pharmacology (12.3)]. the safety and efficacy of valcyte have not been studied in patients with hepatic impairment. be sure that you read, and that you understand and follow these instructions carefully to ensure proper dosing of the oral solution. important: - avoid contact with your skin or eyes. if you come in contact with the contents of the oral solution, wash your skin well with soap and water or rinse your eyes well with plain water. - do not use valcyte for oral solution after the discard date on the bottle. - always use the oral dispenser provided to give or take a dose of valcyte for oral solution. - call your pharmacist if your oral dispenser is lost or damaged, and they will tell you how to continue to give or take a dose of valcyte for oral solution. - ask your healthcare provider or pharmacist to show you how to measure your prescribed dose. to take a dose of valcyte for oral solution, you will need the bottle of medicine and an oral dispenser provided with the medicine (see figure 1) . your pharmacist inserts the bottle adapter in the valcyte for oral solution bottle. - place the tip of the oral dispenser in the mouth. - slowly push down the oral dispenser plunger until the oral dispenser is empty. - remove the plunger from the oral dispenser barrel by pulling the plunger all the way out of the barrel. - rinse the oral dispenser barrel and plunger with water and let them air dry. - when the oral dispenser barrel and plunger are dry, put the plunger back into the oral dispenser barrel for the next use. how should i store valcyte for oral solution? - store solution in the refrigerator at 36°f to 46°f (2°c to 8°c) for no longer than 49 days. - do not freeze. this patient information and instructions for use have been approved by the u.s. food and drug administration. valcyte is a registered trademark of hoffmann-la roche inc. distributed by: genentech usa, inc. a member of the roche group 1 dna way south san francisco, ca 94080-4990 revised: 10/2020 for more information, go to www.valcyte.com or call 1-888-835-2555. © 2020 genentech, inc. all rights reserved.

Stati Uniti - inglese - NLM (National Library of Medicine)

genentech, inc. - entrectinib (unii: l5orf0an1i) (entrectinib - unii:l5orf0an1i) - rozlytrek is indicated for the treatment of adult patients with ros1- positive metastatic non-small cell lung cancer (nsclc), as detected by an fda-approved test. rozlytrek is indicated for the treatment of adult and pediatric patients older than 1 month of age with solid tumors that: - have a neurotrophic tyrosine receptor kinase (ntrk) gene fusion, as detected by an fda-approved test without a known acquired resistance mutation, - are metastatic or where surgical resection is likely to result in severe morbidity, and - have progressed following treatment or have no satisfactory alternative therapy. this indication is approved under accelerated approval based on tumor response rate and durability of response [see clinical studies (14.2)] . continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trials. none. risk summary based on literature reports in humans with congenital mutations leading to changes in trk signaling, findings from animal studies, and its mechanism of action [see clinical pharmacology (12.1)] , rozlytrek can cause fetal harm when administered to a pregnant woman. there are no available data on rozlytrek use in pregnant women. administration of entrectinib to pregnant rats during the period of organogenesis resulted in malformations at maternal exposures approximately 2.7 times the human exposure at the 600 mg dose (see data) . advise pregnant women of the potential risk to a fetus. 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 human data published reports of individuals with congenital mutations in trk pathway proteins suggest that decreases in trk-mediated signaling are correlated with obesity, developmental delays, cognitive impairment, insensitivity to pain, and anhidrosis. animal data entrectinib administration to pregnant rats during the period of organogenesis at a dose of 200 mg/kg [resulting in exposures up to 2.7 times the human exposure (auc) at the 600 mg dose] resulted in maternal toxicity and fetal malformations including body closure defects (omphalocele and gastroschisis) and malformations of the vertebrae, ribs, and limbs (micromelia and adactyly), but not embryolethality. lower fetal weights and reduced skeletal ossification occurred at doses ≥ 12.5 and 50 mg/kg [approximately 0.2 and 0.9 times the human exposure (auc) at the 600 mg dose], respectively. risk summary there are no data on the presence of entrectinib or its metabolites in human milk or their effects on either the breastfed child or on milk production. because of the potential serious adverse reactions in breastfed children from rozlytrek, advise a lactating woman to discontinue breastfeeding during treatment with rozlytrek and for 7 days after the last dose. pregnancy testing verify the pregnancy status of females of reproductive potential prior to initiating rozlytrek [see use in specific populations (8.1)] . contraception rozlytrek can cause embryo-fetal harm when administered to a pregnant woman [see use in specific populations (8.1)]. females advise female patients of reproductive potential to use effective contraception during treatment with rozlytrek and for at least 5 weeks following the last dose [see use in specific populations (8.1)] . males advise male patients with female partners of reproductive potential to use effective contraception during treatment with rozlytrek and for 3 months following the last dose [see nonclinical toxicology (13.1)]. the safety and effectiveness of rozlytrek have been established in pediatric patients older than 1 month of age [clinical studies (14.2)]. use of rozlytrek in these age groups is supported by evidence from adequate and well-controlled studies of rozlytrek in adults and pediatric patients with additional population pharmacokinetic data demonstrating that the exposure of drug substance in pediatric patients greater than 1 month of age is expected to be in the adult range, and that the course of disease is sufficiently similar in adult and pediatric patients to allow extrapolation of data in adults to pediatric patients. the safety and effectiveness of rozlytrek have not been established in pediatric patients with ros1 -positive nsclc. juvenile animal toxicity data in a 13-week juvenile rat toxicology study, animals were dosed daily from post-natal day 7 to day 97 (approximately equivalent to neonate to adulthood). entrectinib resulted in: - decreased body weight gain and delayed sexual maturation at doses ≥ 4 mg/kg/day (approximately 0.06 times the human exposure (auc) at the 600 mg dose), - deficits in neurobehavioral assessments including functional observational battery and learning and memory (at doses ≥ 8 mg/kg/day, approximately 0.14 times the human exposure at the 600 mg dose), and - decreased femur length at doses ≥ 16 mg/kg/day (approximately 0.18 times the human exposure at the 600 mg dose). of the 355 patients who received rozlytrek across clinical trials, 25% were 65 years or older, and 5% were 75 years of age or older. clinical studies of rozlytrek did not include sufficient numbers of geriatric patients to determine whether they respond differently from younger patients. no dose adjustment is recommended for patients with mild or moderate renal impairment (clcr 30 to < 90 ml/min calculated by cockcroft-gault equation). rozlytrek has not been studied in patients with severe renal impairment (clcr < 30 ml/min) [see clinical pharmacology (12.3)]. the effect of moderate hepatic impairment (total bilirubin > 1.5 – 3.0 times uln with any aspartate aminotransferase) or severe hepatic impairment (total bilirubin >3.0 times uln with any aspartate aminotransferase) on the safety of rozlytrek at the recommended dosage is unknown. consider the risk-benefit profile of rozlytrek prior to determining whether to administer rozlytrek to patients with moderate to severe hepatic impairment. monitor for rozlytrek adverse reactions in patients with hepatic impairment more frequently since these patients may be at increased risk for adverse reactions [see clinical pharmacology (12.3)]. instructions for use rozlytrek® [roz lye trek] (entrectinib) capsules, for oral use this instructions for use contains information on how to prepare and take or give rozlytrek capsules. read this instructions for use before giving rozlytrek capsules for the first time and each time you get a refill. there may be new information. rozlytrek capsules can be swallowed whole or prepared as a suspension and taken or given by mouth or through a nasogastric tube (ng tube) or gastrostomy tube (g tube) feeding tube. - your healthcare provider or pharmacist should show you how to correctly prepare and take or give a dose of rozlytrek capsules. always take or give rozlytrek capsules exactly as your healthcare provider tells you. - do not take or give rozlytrek to someone else until you have been shown how to properly prepare and take or give rozlytrek. - wash your hands before and after preparing, taking, or giving rozlytrek. - check the expiration date and check the product for damage before use. do not use if expired or damaged. - your healthcare provider will decide the right dose of rozlytrek for you or your child. - your healthcare provider will tell you what your daily dose of rozlytrek is. - swallow rozlytrek capsules whole, with or without food. - swallow whole capsules with drinking water, as directed by your healthcare provider. - do not crush or chew the capsules. if you or your child cannot swallow capsules whole, rozlytrek capsules can be prepared as a suspension and taken or given by mouth or through a feeding tube. for doses of 3 ml or higher, a ng or g feeding tube size 8 french or larger should be used. your healthcare provider or pharmacist will show you how to prepare and take or give a dose of rozlytrek capsules prepared as a suspension. table 1 shows the prescribed dose, the number and strength of capsules needed, the amount of water or milk needed to mix the capsules, and the amount of suspension needed to give for the prescribed dose. your healthcare provider will tell you the number of capsules to use, the amount of liquid needed to mix the capsules, and the amount of suspension (ml) to take or give to get the correct dose of rozlytrek. you may need to measure a smaller amount of suspension than you prepared to take or give the correct prescribed dose of rozlytrek. supplies needed to prepare and take or give rozlytrek as a suspension : - the number of capsules needed for your prescribed dose - a clean empty cup - a paper towel - a cup of room temperature drinking water or milk - an oral syringe (provided by your healthcare provider or pharmacist) - if the medicine is spilled outside of the cup, go to step d1 for clean-up instructions, then start over at step 1. - you have withdrawn the correct amount (ml) - there are no large bubbles (figure l ) - put the syringe into the cup again - push the suspension back into the cup - then draw up the suspension again (start at step 12). - wash your hands and all the items used to give rozlytrek. - remove the syringe plunger from the syringe barrel. - use only clean water to rinse the syringe parts and the cup used to prepare the suspension. let all items dry before the next use. - put the syringe plunger back into the syringe barrel when dry. - throw away (discard of) the disposable items in your household trash. - store rozlytrek capsules at room temperature between 68°f to 77°f (20°c to 25°c). - do not store rozlytrek prepared as a suspension for more than 2 hours at room temperature below 86°f (30°c). throw away any unused suspension if it is not used within 2 hours of preparation. - store rozlytrek capsules in the original container and keep the bottle tightly closed to protect from moisture. distributed by: genentech usa, inc. a member of the roche group 1 dna way south san francisco, ca 94080-4990 rozlytrek® is a registered trademark of genentech, inc. ©2023 genentech, inc. for more information, go to www.rozlytrek.com or call 1-877-436-3683. this instructions for use has been approved by the u.s. food and drug administration. issued: 10/2023 instructions for use rozlytrek® [roz lye trek] (entrectinib) oral pellets this instructions for use contains information on how to prepare and take or give rozlytrek oral pellets. read this instructions for use before giving rozlytrek oral pellets for the first time and each time you get a refill. there may be new information. sprinkle rozlytrek oral pellets on 1 or more spoonfuls of a soft food before taking or giving. do not use rozlytrek oral pellets to prepare a suspension. do not give or take rozyltrek oral pellets through a gastrostomy tube (g tube) or nasogastric tube (ng tube) because the pellets may clog the feeding tube. - your healthcare provider should show you how to properly prepare and take or give a daily dose of rozlytrek oral pellets. always take or give rozlytrek oral pellets exactly as your healthcare provider tells you. - do not take rozlytrek oral pellets or give it to someone else until you have been shown how to properly prepare and take or give rozlytrek. - wash your hands before and after preparing, taking, or giving rozlytrek. - check the expiration date and check the product for damage before use. do not use if expired or damaged. - your healthcare provider will decide the right dose of rozlytrek for you or your child. - rozlytrek oral pellets come in a carton with 42 packets. each packet contains 50 mg of rozlytrek. - use the whole packet of pellets. do not use part of the packet to try to prepare a dose. - sprinkle the prescribed number of packets on 1 or more spoonfuls of soft food and take or give within 20 minutes of sprinkling the pellets on the soft food. - do not crush or chew the pellets to avoid a bitter taste. supplies needed to prepare and take or give rozlytrek oral pellets: - the number of packets needed for your prescribed dose - a clean spoon - a paper towel or clean plate - soft food like applesauce, yogurt, or pudding - tap the packets to make sure that the pellets are on one side of the packet. - hold the side of the packet where the pellets are tapped and open the other side of the packet with your other hand or with scissors (figure a ). note: make sure that you do not cut the pellets with scissors. - sprinkle the prescribed number of packets on the spoonful of soft food (figure b ). - tap the packets to make sure all pellets are sprinkled on the food. - wash your hands and all the items used to give rozlytrek. - throw away (discard of) the disposable items in your household trash. - store rozlytrek oral pellets at room temperature between 68°f to 77°f (20°c to 25°c) - store rozlytrek oral pellets in the original container to protect from moisture. distributed by: genentech usa, inc. a member of the roche group 1 dna way south san francisco, ca 94080-4990 rozlytrek® is a registered trademark of genentech, inc. ©2023 genentech, inc. for more information, go to www.rozlytrek.com or call 1-877-436-3683. this instructions for use has been approved by the u.s. food and drug administration. issued: 10/2023

Stati Uniti - inglese - NLM (National Library of Medicine)

genentech, inc. - glofitamab (unii: 06p3klk2j8) (glofitamab - unii:06p3klk2j8) - columvi is indicated for the treatment of adult patients with relapsed or refractory diffuse large b-cell lymphoma, not otherwise specified (dlbcl, nos) or large b-cell lymphoma (lbcl) arising from follicular lymphoma, after two or more lines of systemic therapy. this indication is approved under accelerated approval based on response rate and durability of response [see clinical studies (14.1)] . continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s). none. risk summary based on its mechanism of action columvi may cause fetal harm when administered to a pregnant woman [see clinical pharmacology (12.1)] . there are no available data on the use of columvi in pregnant women to evaluate for a drug-associated risk. no animal reproductive and developmental toxicity studies have been conducted with glofitamab-gxbm. glofitamab-gxbm causes t-cell activation and cytokine release; immune activation may compromise pregnancy maintenance. i

Stati Uniti - inglese - NLM (National Library of Medicine)

genentech, inc. - dornase alfa (unii: 953a26oa1y) (dornase alfa - unii:953a26oa1y) - dornase alfa 1 mg in 1 ml - pulmozyme® is indicated, in conjunction with standard therapies, for the management of pediatric and adult patients with cystic fibrosis (cf) to improve pulmonary function. in cf patients with an fvc ≥ 40% of predicted, daily administration of pulmozyme has also been shown to reduce the risk of respiratory tract infections requiring parenteral antibiotics. pulmozyme is contraindicated in patients with known hypersensitivity to dornase alfa, chinese hamster ovary cell products, or any component of the product. risk summary there are no adequate and well-controlled studies with pulmozyme in pregnant women. however, animal reproduction studies have been conducted with dornase alfa. in these studies, no evidence of fetal harm was observed in rats and rabbits at doses of dornase alfa up to approximately 600 times the maximum recommended human dose (mrhd). the background risk of major birth defects and miscarriage for the cystic fibrosis population is unknown. however, the background risk in the u.s. general population of major birth defects is 2-4% and of miscarriage is 15-20% of clinically recognized pregnancies. data animal data reproductive studies have been performed in rats and rabbits at intravenous doses of dornase alfa up to 10 mg/kg/day (approximately 600 times the mrhd in adults). in a combined embryo-fetal development and pre- and post-natal development study, no evidence of maternal toxicity, embryotoxicity, or teratogenicity was observed when dornase alfa was administered to dams throughout organogenesis (gestation days 6 to 17). dornase alfa did not elicit adverse effects on fetal or neonatal growth when administered to dams throughout most of gestation and delivery (gestation days 6 to 25) and nursing (post-partum days 6 to 21). a pharmacokinetic study in cynomolgus monkeys found no detectable levels of dornase alfa in fetal blood or amniotic fluid on gestation day 150 (end of gestation) from mothers that were administered an intravenous bolus dose (0.1 mg/kg) followed by an intravenous infusion dose (0.080 mg/kg) over a 6-hour period during pregnancy. risk summary it is not known whether pulmozyme is present in human milk. in a pharmacokinetic study in cynomolgus monkeys, levels of dornase alfa detected in milk were less than 0.1% of the maternal serum concentration at 24 hours after dosing [intravenous bolus dose (0.1 mg/kg) of dornase alfa followed by an intravenous infusion (0.080 mg/kg/hr) over a 6-hour period] on post-partum day 14. the developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for pulmozyme and any potential adverse effects on the breastfed child from pulmozyme or from the underlying maternal condition. the safety and effectiveness of pulmozyme in conjunction with standard therapies for cystic fibrosis have been established in pediatric patients. use of pulmozyme in pediatric patients is supported by evidence in the following age groups: - patients 5 to 17 years of age: use of pulmozyme in patients 5 to 17 years of age is supported by evidence from a randomized, placebo-controlled trial of 303 of clinically stable cystic fibrosis patients 5 to 17 years of age who received pulmozyme [see clinical studies (14)]. - patients less than 5 years : use of pulmozyme in patients less than 5 years of age is supported by extrapolation of efficacy data in patients 5 years of age and older with additional safety data in 65 pediatric patients aged 3 months to less than 5 years who received pulmozyme 2.5 mg daily by inhalation for 2 weeks [see adverse reactions (6.1) and clinical studies (14)] . cystic fibrosis is primarily a disease of children and young adults. clinical studies of pulmozyme did not include sufficient numbers of subjects aged 65 or older to determine whether they respond differently from younger subjects. pulmozyme® (pull-muh-zyme) (dornase alfa) inhalation solution this instructions for use contains information on how to use pulmozyme with jet nebulizers and compressors see the other side of this instructions for use for information on use of pulmozyme with the recommended vibrating mesh nebulizers read and understand this instructions for use and the nebulizer manufacturer's instruction manual before you start taking pulmozyme and each time you get a refill. there may be new information. this information does not take the place of talking to your doctor about your medical condition or your treatment. a nebulizer and a compressor are used together to give a dose of pulmozyme. a nebulizer changes the pulmozyme liquid medicine into a fine mist you inhale by breathing through a mouthpiece. a compressor gives the nebulizer power and makes the nebulizer work. pulmozyme should only be used with the approved nebulizers and appropriate compressors as recommended below, or with the recommended vibrating mesh nebulizers (see other side of this instructions for use). read and follow the manufacturer's instruction manual. do not use any other inhaled medicines in the nebulizer at the same time. keep all other inhaled medicine systems completely separate from pulmozyme. use the mouthpiece or face mask provided with the nebulizer kit. if your child cannot breathe in or breathe out by mouth, you may use the pari baby reusable nebulizer, but you should discuss it with your doctor first. the pari baby nebulizer is the same as the pari lc plus jet system, except the mouthpiece is replaced by a tight-fitting face mask connected to an elbow piece. follow the steps on this side of the instructions for use to give pulmozyme using the following jet nebulizer systems - approximate air flow of 3.5 l/min to 12 l/min at approximately 20 psi to 45 psi pressure for additional information on an appropriate compressor to use with pulmozyme, read the manufacturer's instruction manual for the recommended nebulizer. important information you need to know before using pulmozyme read and follow the nebulizer manufacturer's instruction manual for correct use and maintenance: - to clean the nebulizer before first use and after each use as recommended. - to disinfect the nebulizer parts by using the disinfecting method recommended. - to replace nebulizer parts as recommended. supplies you will need to give a dose of pulmozyme (see figure a): - 1 pulmozyme ampule - compressor - nebulizer cup and cap (screw-on or snap-on) - plastic t (not needed for sidestream nebulizer or pari baby) - flexible aerosol tube (not needed for sidestream nebulizer or pari baby) - mouthpiece (clean) or pari baby facemask - long connecting tube - nose clip (optional, not needed for pari baby) - clean a flat table surface. - wash your hands well with soap and water before using the pulmozyme ampule and nebulizer. this helps prevent infection (see figure b) . - place the nebulizer parts on a clean, flat table surface within reach. - test the compressor by turning it on and putting your finger in front of the "air out" or "air" port to feel air flowing. turn off the compressor (see figure c) . - remove 1 foil pouch of pulmozyme from the refrigerator. open the foil pouch and remove 1 ampule of pulmozyme. put the remaining ampules back in the foil pouch and return them to the refrigerator. - check the expiration (exp.) date printed on the ampule (see figure d) . - do not use the pulmozyme ampule if the expiration date has passed. - check the ampule for leaks by turning it upside down and gently squeezing (see figure e) . do not use the ampule if it is leaking. throw it away and get a new one. - check the pulmozyme liquid in the ampule and make sure it is clear and free of particles. - do not use pulmozyme if the liquid is cloudy or discolored. take the pulmozyme back to the pharmacy, hospital, or clinic that gave you the medicine. - attach the long connecting tube to the "air out" or "air" port on the compressor (see figure f) . - skip to step 7 if you use the sidestream nebulizer or the pari baby nebulizer. - push the mouthpiece into the wider end of the plastic t. attach the flexible aerosol tube to the other end of the t (see figure g) . - unscrew or unsnap the cap from the nebulizer cup (see figure h) . - put the nebulizer cup on the table face up and place the cap upside down on a clean surface (see figure i) . - hold the tab at the bottom of the pulmozyme ampule firmly. twist off the top. do not squeeze the body of the ampule (see figure j) . - turn the ampule upside down and squeeze gently to empty the medicine into the nebulizer cup. keep squeezing until the ampule is empty. it is very important you squeeze all of the medicine out of the ampule (see figure k) . - screw or snap the cap onto the nebulizer cup (see figure l) . - connect the plastic t to the nebulizer cap (see figure m) . - if you are using the sidestream nebulizer, attach the mouthpiece to the top of the nebulizer (see figure n). - if you are using the pari baby nebulizer, connect the elbow piece and mask to the nebulizer outlet (see figure o). - connect the open end of the long connecting tube to the port on the bottom of the nebulizer cup by pushing up firmly (see figure p) . - turn on the compressor and check to see that mist is coming out of the nebulizer (see figure q) . - skip to step 14 if you are using the pari baby to give pulmozyme to your child. - place the mouthpiece between your teeth and on top of your tongue (see figure r) . - breathe slowly in and out through your mouth. do not block the airflow with your tongue. - do not breathe through your nose. if you have problems breathing only through your mouth, use a nose clip (see figure s) . - do not be concerned if liquid droplets form in the long connecting tube during treatment. when the nebulizer begins spitting, gently tap the nebulizer cup and continue breathing until the nebulizer cup is empty or stops making mist (see figure t) . - if you need to stop treatment before you are finished, or you begin coughing, turn off the compressor and do not spill any of the medicine. - to start treatment again, turn on the compressor and continue breathing slowly in and out through your mouth. - the complete treatment usually takes from 10 to 15 minutes for most nebulizers. - if you are using the sidestream nebulizer, treatment usually takes from 2 to 6 minutes. - it is important to inhale the full dose of pulmozyme. if you find a leak or feel any moisture coming from the nebulizer during treatment, turn off the compressor and check to make sure the nebulizer cap is sealed correctly before continuing (see figure u) . - during the treatment your child may sit, lie down or stand. - place the facemask gently but firmly over your child's nose and mouth (see figure v) . - make sure there are no air gaps between the mask and your child's face. this will help make sure that your child will get the full dose of pulmozyme. - it is important that you try to keep the body of the nebulizer upright during the entire treatment (see figure v) . the elbow piece will allow you to move the mask for a good fit while keeping the nebulizer body upright. - when the nebulizer begins "spitting," gently tap the nebulizer cup and continue treatment until the nebulizer is empty or stops making a mist (see figure w) . - if you need to stop the treatment or your child begins to cough during treatment, turn the compressor off. do not spill any pulmozyme. - if you have not removed the mask and you want to begin the treatment again, turn on the compressor. - if you have removed the mask, repeat the steps above to replace the mask on your child's face and restart the compressor. - the complete treatment usually takes from 10 to 15 minutes. - turn off the compressor and take apart the nebulizer system. set aside the flexible aerosol tube and the long connecting tube. note: the sidestream nebulizer does not use a flexible aerosol tube. - throw away the pulmozyme ampule in your household trash. - follow the manufacturer's recommendations for care of your nebulizer and compressor. - store pulmozyme ampules at a refrigerated temperature between 36°f to 46°f (2°c to 8°c) in their protective foil pouch to protect from light and heat until you are ready to use them. when the protective foil pouch is opened, the unused ampules must be kept refrigerated in the protective foil pouch to protect from light and heat. - when traveling, pulmozyme ampules should be kept refrigerated in their protective foil pouch to protect from light and heat. - protect pulmozyme from excessive heat and light. - do not use pulmozyme if the ampules have been exposed to room temperature 72°f to 82°f (22°c to 28°c) for more than a total of 60 hours or if the solution has turned cloudy or discolored. - do not use pulmozyme past the expiration date printed on the ampule. genentech, inc. a member of the roche group 1 dna way south san francisco, ca 94080-4990 us license no. 1048 this instructions for use has been approved by the u.s. food and drug administration. revised: 02/2024 pulmozyme® (pull-muh-zyme) (dornase alfa) inhalation solution this instructions for use contains information on how to use pulmozyme with the following recommended vibrating mesh nebulizers: see the other side of this instructions for use for information on use with jet nebulizers and compressors read and understand this instructions for use and the nebulizer manufacturer's instruction manual before you start taking pulmozyme and each time you get a refill. there may be new information. this information does not take the place of talking to your healthcare provider about your medical condition or your treatment. this information does not take the place of the manufacturer's instruction manual for the vibrating mesh nebulizer. the vibrating mesh nebulizer changes the pulmozyme liquid medicine into a fine mist you inhale by breathing through a mouthpiece. do not use any other inhaled medicines in the nebulizer at the same time. keep all other inhaled medication systems completely separate from pulmozyme. the erapid nebulizer system should only be used by adults and children who can use a mouthpiece, and not by younger children who need a mask to take pulmozyme. follow the instructions on this side of the instructions for use to give pulmozyme using a vibrating mesh nebulizer. important information you need to know before using pulmozyme read and follow the nebulizer manufacturer's instruction manual for correct use and maintenance: - to clean the nebulizer before first use and after each use as recommended - to disinfect the nebulizer parts by using the disinfecting method recommended - to replace nebulizer parts as recommended supplies you will need to give a dose of pulmozyme: - 1 pulmozyme ampule (see figure a) - vibrating mesh nebulizer and its parts - manufacturer's instruction manual for the vibrating mesh nebulizer - nose clip (optional) (see figure b) - clean a flat table surface. - wash your hands well with soap and water before using the pulmozyme ampule and nebulizer. this helps prevent infection (see figure c) . - place the vibrating mesh nebulizer on a clean, flat table surface within reach. make sure you have followed the manufacturer's instruction manual to make sure that the nebulizer is charged and ready for use. - remove 1 foil pouch of pulmozyme from the refrigerator. open the foil pouch and remove 1 ampule of pulmozyme. put the remaining ampules back in the foil pouch and return them to the refrigerator. - check the expiration (exp.) date printed on the ampule (see figure d) . do not use the pulmozyme ampule if the expiration date has passed. - check the ampule for leaks by turning it upside down and gently squeezing (see figure e) . do not use the ampule if it is leaking. throw it away and get a new one. - check the pulmozyme liquid in the ampule and make sure it is clear and free of particles. do not use pulmozyme if the liquid is cloudy or discolored. take the pulmozyme back to the pharmacy, hospital, or clinic that gave you the medicine. - put the nebulizer together according to the step-by-step manufacturer's instruction manual. - follow the manufacturer's instruction manual on how to add the pulmozyme medicine to the nebulizer. - open the pulmozyme ampule. - hold the tab at the bottom of the pulmozyme ampule firmly. twist off the top. do not squeeze the body of the ampule (see figure f) . - turn the ampule upside down and squeeze gently to empty the medicine into the medicine cup. keep squeezing until the ampule is empty. it is very important that you squeeze out all the medicine in the ampule. - read the manufacturer's instruction manual on how to turn the nebulizer on and off and follow the steps for how to: take your nebulized treatment, breathe through the mouthpiece or facemask, restart treatment if you need to stop before you are finished, and confirm that your treatment is complete. - take your nebulized treatment, - breathe through the mouthpiece or facemask, - restart treatment if you need to stop before you are finished, and - confirm that your treatment is complete. - skip to step 8 if you are using a facemask to take your dose of pulmozyme. - place the mouthpiece between your teeth and on top of your tongue. breathe slowly in and out through your mouth when using a mouthpiece. do not block medicine flow with your tongue. do not breathe through your nose when using a mouthpiece. if you have problems breathing only through your mouth, use a nose clip (see figure b) . - breathe slowly in and out through your mouth when using a mouthpiece. do not block medicine flow with your tongue. - do not breathe through your nose when using a mouthpiece. if you have problems breathing only through your mouth, use a nose clip (see figure b) . - place the facemask gently but firmly over the nose and mouth. - make sure there are no air gaps between the mask and the face. this will help make sure that you will get the full dose of pulmozyme. - throw away the empty pulmozyme ampule in your household trash. - clean the nebulizer thoroughly after each use. follow the manufacturer's instruction manual for cleaning the nebulizer. - all nebulizer parts must be cleaned after each use and disinfected after each day of use as recommended in the manufacturer's instruction manual. - replace the handset as recommended in the manufacturer's instruction manual. how should i store pulmozyme? - store pulmozyme ampules at a refrigerated temperature between 36°f to 46°f (2°c to 8°c) in their protective foil pouch to protect from light and heat until you are ready to use them. when the protective foil pouch is opened, the unused ampules must be kept refrigerated in the protective foil pouch to protect from light and heat. - when traveling, pulmozyme ampules should be kept refrigerated in their protective foil pouch to protect from light and heat. - protect pulmozyme from excessive heat and light. - do not use pulmozyme if the ampules have been exposed to room temperature at 72°f to 82°f (22°c to 28°c) for more than a total of 60 hours or if the solution has turned cloudy or discolored. - do not use pulmozyme past the expiration date printed on the ampule. genentech, inc. a member of the roche group 1 dna way south san francisco, ca 94080-4990 us license no. 1048 this instructions for use has been approved by the u.s. food and drug administration. revised: 02/2024 representative sample of labeling (see the how supplied section for complete listing):

Cuba - spagnolo - CECMED (Autoridad Reguladora de Medicamentos, Equipos y Dispositivos Médicos)

genentech inc - polatuzumab vedotina - polvo concentrado para solución para infusión iv - 140 mg

Cuba - spagnolo - CECMED (Autoridad Reguladora de Medicamentos, Equipos y Dispositivos Médicos)

genentech inc - polatuzumab (eq. a 38 mg de polatuzumab vedotina) - polvo concentrado para solución para infusión iv - 30 mg

Stati Uniti - inglese - NLM (National Library of Medicine)

genentech, inc. - orlistat (unii: 95m8r751w8) (orlistat - unii:95m8r751w8) - orlistat 120 mg - xenical is indicated for obesity management including weight loss and weight maintenance when used in conjunction with a reduced-calorie diet. xenical is also indicated to reduce the risk for weight regain after prior weight loss. xenical is indicated for obese patients with an initial body mass index (bmi) ≥30 kg/m2 or ≥27 kg/m2 in the presence of other risk factors (e.g., hypertension, diabetes, dyslipidemia). table 1 illustrates body mass index (bmi) according to a variety of weights and heights. the bmi is calculated by dividing weight in kilograms by height in meters squared. for example, a person who weighs 180 lbs and is 5' 5" would have a bmi of 30. xenical is contraindicated in: - pregnancy [see use in specific populations (8.1)] - patients with chronic malabsorption syndrome - patients with cholestasis - patients with known hypersensitivity to xenical or to any component of this product pregnancy category x xenical is contraindicated during pregnancy, because weight loss offers no potential be

Stati Uniti - inglese - NLM (National Library of Medicine)

genentech, inc. - ganciclovir sodium (unii: 02l083w284) (ganciclovir - unii:p9g3ckz4p5) - ganciclovir 500 mg in 10 ml - cytovene-iv is indicated for the treatment of cytomegalovirus (cmv) retinitis in immunocompromised adult patients, including patients with acquired immunodeficiency syndrome (aids) [see clinical studies (14.1)] . cytovene-iv is indicated for the prevention of cmv disease in adult transplant recipients at risk for cmv disease [see clinical studies (14.2)]. cytovene-iv is contraindicated in patients who have experienced a clinically significant hypersensitivity reaction (e.g., anaphylaxis) to ganciclovir, valganciclovir, or any component of the formulation. risk summary in animal studies, ganciclovir caused maternal and fetal toxicity and embryo-fetal mortality in pregnant mice and rabbits as well as teratogenicity in rabbits at exposures two times the exposure at the recommended human dose (rhd) [see data] . although placental transfer of ganciclovir has been shown to occur based on ex vivo experiments with human placenta and in at least one case report in a pregnant woman, no adequate human data are available

Stati Uniti - inglese - NLM (National Library of Medicine)

genentech, inc. - faricimab (unii: qc4f7fkk7i) (faricimab - unii:qc4f7fkk7i) - vabysmo is a vascular endothelial growth factor (vegf) and angiopoietin 2 (ang-2) inhibitor indicated for the treatment of patients with: vabysmo is contraindicated in patients with ocular or periocular infections. vabysmo is contraindicated in patients with active intraocular inflammation. vabysmo is contraindicated in patients with known hypersensitivity to faricimab or any of the excipients in vabysmo. hypersensitivity reactions may manifest as rash, pruritus, urticaria, erythema, or severe intraocular inflammation. risk summary there are no adequate and well-controlled studies of vabysmo administration in pregnant women. administration of vabysmo to pregnant monkeys throughout the period of organogenesis resulted in an increased incidence of abortions at intravenous (iv) doses 158 times the human exposure (based on cmax ) of the maximum recommended human dose [see animal data] . based on the mechanism of action of vegf and ang-2 inhibitors, there is a potential risk to female reproductive capacity, and t