entrectinib 200 mg tvrdé tobolky k otevření f1 - search results

United States - English - NLM (National Library of Medicine)

rozlytrek- entrectinib capsule rozlytrek- entrectinib pellet

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

New Zealand - English - Medsafe (Medicines Safety Authority)

rozlytrek

roche products (nz) ltd - entrectinib 100mg; - capsule - 100 mg - active: entrectinib 100mg excipient: colloidal silicon dioxide crospovidone hypromellose iron oxide yellow lactose magnesium stearate microcrystalline cellulose tartaric acid tekprint blue sb-6018 titanium dioxide - solid tumours rozlytrek is indicated for the treatment of adult and paediatric patients 12 years of age and older, with neurotrophic tyrosine receptor kinase (ntrk) fusion-positive locally advanced or metastatic solid tumours, who have progressed following prior therapies, or as initial therapy when there are no acceptable standard therapies. this indication was approved based on objective response rate and response duration in single-arm trials. continued approval for this indication depends on verification and description of clinical benefit in the confirmatory trials. non-small cell lung cancer (nsclc) rozlytrek is indicated for the treatment of adult patients with ros1-positive, locally advanced or metastatic nsclc.

New Zealand - English - Medsafe (Medicines Safety Authority)

rozlytrek

roche products (nz) ltd - entrectinib 200mg; - capsule - 200 mg - active: entrectinib 200mg excipient: colloidal silicon dioxide crospovidone hypromellose lactose magnesium stearate microcrystalline cellulose sunset yellow aluminium lake tartaric acid tekprint blue sb-6018 titanium dioxide - solid tumours rozlytrek is indicated for the treatment of adult and paediatric patients 12 years of age and older, with neurotrophic tyrosine receptor kinase (ntrk) fusion-positive locally advanced or metastatic solid tumours, who have progressed following prior therapies, or as initial therapy when there are no acceptable standard therapies. this indication was approved based on objective response rate and response duration in single-arm trials. continued approval for this indication depends on verification and description of clinical benefit in the confirmatory trials. non-small cell lung cancer (nsclc) rozlytrek is indicated for the treatment of adult patients with ros1-positive, locally advanced or metastatic nsclc.