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

mylan institutional inc. - bexarotene (unii: a61rxm4375) (bexarotene - unii:a61rxm4375) - bexarotene 75 mg - bexarotene capsules are indicated for the treatment of cutaneous manifestations of cutaneous t-cell lymphoma in patients who are refractory to at least one prior systemic therapy. bexarotene can cause fetal harm when administered to a pregnant female. bexarotene is a member of the retinoid class of drugs that is associated with birth defects in humans and is contraindicated in females who are pregnant. bexarotene was also teratogenic and caused developmental mortality when administered orally to pregnant rats. if this drug is used during pregnancy or if the patient becomes pregnant while taking this drug, the patient should be advised of the potential risk to a fetus. bexarotene capsules are contraindicated in patients with a known serious hypersensitivity to bexarotene or other components of the product. bexarotene, a retinoid, can cause fetal harm based on findings from animal studies when administered to a pregnant female and is contraindicated during pregnancy. bexarotene was teratogenic and caused develo

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

oceanside pharmaceuticals - bexarotene (unii: a61rxm4375) (bexarotene - unii:a61rxm4375) - bexarotene 1 g in 100 g - bexarotene gel 1% is indicated for the topical treatment of cutaneous lesions in patients with ctcl (stage ia and ib) who have refractory or persistent disease after other therapies or who have not tolerated other therapies. bexarotene gel 1% is contraindicated in patients with a known hypersensitivity to bexarotene or other components of the product. bexarotene gel 1% may cause fetal harm when administered to a pregnant woman. bexarotene gel must not be given to a pregnant woman or a woman who intends to become pregnant. if a woman becomes pregnant while taking bexarotene gel, bexarotene gel must be stopped immediately and the woman given appropriate counseling. bexarotene caused malformations when administered orally to pregnant rats during days 7-17 of gestation. developmental abnormalities included incomplete ossification at 4 mg/kg/day and cleft palate, depressed eye bulge/microphthalmia, and small ears at 16 mg/kg/day. at doses greater than 10 mg/kg/day, bexarotene caused developmental mortality. the no

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

mylan pharmaceuticals inc. - bexarotene (unii: a61rxm4375) (bexarotene - unii:a61rxm4375) - bexarotene 75 mg - bexarotene capsules are indicated for the treatment of cutaneous manifestations of cutaneous t-cell lymphoma in patients who are refractory to at least one prior systemic therapy. bexarotene can cause fetal harm when administered to a pregnant female. bexarotene is a member of the retinoid class of drugs that is associated with birth defects in humans and is contraindicated in females who are pregnant. bexarotene was also teratogenic and caused developmental mortality when administered orally to pregnant rats. if this drug is used during pregnancy or if the patient becomes pregnant while taking this drug, the patient should be advised of the potential risk to a fetus. bexarotene capsules are contraindicated in patients with a known serious hypersensitivity to bexarotene or other components of the product. bexarotene, a retinoid, can cause fetal harm based on findings from animal studies when administered to a pregnant female and is contraindicated during pregnancy. bexarotene was teratogenic and caused develo

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

oceanside pharmaceuticals - bexarotene (unii: a61rxm4375) (bexarotene - unii:a61rxm4375) - bexarotene 75 mg - bexarotene capsules are indicated for the treatment of cutaneous manifestations of cutaneous t-cell lymphoma in patients who are refractory to at least one prior systemic therapy. bexarotene capsules can cause fetal harm when administered to a pregnant female. bexarotene capsule is a member of the retinoid class of drugs that is associated with birth defects in humans and is contraindicated in females who are pregnant. bexarotene was also teratogenic and caused developmental mortality when administered orally to pregnant rats. if this drug is used during pregnancy or if the patient becomes pregnant while taking this drug, the patient should be advised of the potential risk to a fetus. bexarotene capsules are contraindicated in patients with a known serious hypersensitivity to bexarotene or other components of the product. risk summary bexarotene capsule, a retinoid, can cause fetal harm based on findings from animal studies when administered to a pregnant female and is contraindicated during pregnancy. be

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

amneal pharmaceuticals ny llc - bexarotene (unii: a61rxm4375) (bexarotene - unii:a61rxm4375) - bexarotene gel, 1% is indicated for the topical treatment of cutaneous lesions in patients with ctcl (stage ia and ib) who have refractory or persistent disease after other therapies or who have not tolerated other therapies. bexarotene gel, 1% is contraindicated in patients with a known hypersensitivity to bexarotene or other components of the product. bexarotene gel, 1% may cause fetal harm when administered to a pregnant woman. bexarotene gel must not be given to a pregnant woman or a woman who intends to become pregnant. if a woman becomes pregnant while taking bexarotene gel, bexarotene gel must be stopped immediately and the woman given appropriate counseling. bexarotene caused malformations when administered orally to pregnant rats during days 7 to 17 of gestation. developmental abnormalities included incomplete ossification at 4 mg/kg/day and cleft palate, depressed eye bulge/microphthalmia, and small ears at 16 mg/kg/day. at doses greater than 10 mg/kg/day, bexarotene caused developmental mortality. the no-effect oral dose in rats was 1 mg/kg/day. plasma bexarotene concentrations in patients with ctcl applying bexarotene gel, 1% were generally less than one hundredth the cmax  associated with dysmorphogenesis in rats, although some patients had cmax  levels that were approximately one eighth the concentration associated with dysmorphogenesis in rats. women of child-bearing potential should be advised to avoid becoming pregnant when bexarotene gel is used. the possibility that a woman of child-bearing potential is pregnant at the time therapy is instituted should be considered. a negative pregnancy test (e.g., serum beta-human chorionic gonadotropin, beta-hcg) with a sensitivity of at least 50 miu/l should be obtained within one week prior to bexarotene gel therapy, and the pregnancy test must be repeated at monthly intervals while the patient remains on bexarotene gel. effective contraception must be used for one month prior to the initiation of therapy, during therapy and for at least one month following discontinuation of therapy; it is recommended that two reliable forms of contraception be used simultaneously unless abstinence is the chosen method. male patients with sexual partners who are pregnant, possibly pregnant, or who could become pregnant must use condoms during sexual intercourse while applying bexarotene gel and for at least one month after the last dose of drug. bexarotene gel therapy should be initiated on the second or third day of a normal menstrual period. no more than a one month supply of bexarotene gel should be given to the patient so that the results of pregnancy testing can be assessed and counseling regarding avoidance of pregnancy and birth defects can be reinforced.

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

amneal pharmaceuticals ny llc - bexarotene (unii: a61rxm4375) (bexarotene - unii:a61rxm4375) - bexarotene capsules are indicated for the treatment of cutaneous manifestations of cutaneous t-cell lymphoma in patients who are refractory to at least one prior systemic therapy. bexarotene can cause fetal harm when administered to a pregnant female. bexarotene is a member of the retinoid class of drugs that is associated with birth defects in humans and is contraindicated in females who are pregnant. bexarotene was also teratogenic and caused developmental mortality when administered orally to pregnant rats. if this drug is used during pregnancy or if the patient becomes pregnant while taking this drug, the patient should be advised of the potential risk to a fetus. bexarotene capsules are contraindicated in patients with a known serious hypersensitivity to bexarotene or other components of the product. risk summary  bexarotene, a retinoid, can cause fetal harm based on findings from animal studies when administered to a pregnant female and is contraindicated during pregnancy. bexarotene was teratogenic and

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

upsher-smith laboratories, inc. - bexarotene (unii: a61rxm4375) (bexarotene - unii:a61rxm4375) - bexarotene capsules are indicated for the treatment of cutaneous manifestations of cutaneous t-cell lymphoma in patients who are refractory to at least one prior systemic therapy. bexarotene can cause fetal harm when administered to a pregnant female. bexarotene is a member of the retinoid class of drugs that is associated with birth defects in humans and is contraindicated in females who are pregnant. bexarotene was also teratogenic and caused developmental mortality when administered orally to pregnant rats. if this drug is used during pregnancy or if the patient becomes pregnant while taking this drug, the patient should be advised of the potential risk to a fetus. bexarotene capsules are contraindicated in patients with a known serious hypersensitivity to bexarotene or other components of the product. risk summary bexarotene, a retinoid, can cause fetal harm based on findings from animal studies when administered to a pregnant female and is contraindicated during pregnancy. bexarotene was teratogenic and

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

ani pharmaceuticals, inc. - bexarotene (unii: a61rxm4375) (bexarotene - unii:a61rxm4375) - bexarotene capsules are indicated for the treatment of cutaneous manifestations of cutaneous t-cell lymphoma in patients who are refractory to at least one prior systemic therapy. bexarotene can cause fetal harm when administered to a pregnant female. bexarotene is a member of the retinoid class of drugs that is associated with birth defects in humans and is contraindicated in females who are pregnant. bexarotene was also teratogenic and caused developmental mortality when administered orally to pregnant rats. if this drug is used during pregnancy or if the patient becomes pregnant while taking this drug, the patient should be advised of the potential risk to a fetus. bexarotene capsules are contraindicated in patients with a known serious hypersensitivity to bexarotene or other components of the product. risk summary bexarotene, a retinoid, can cause fetal harm based on findings from animal studies when administered to a pregnant female and is contraindicated during pregnancy. bexarotene was teratogenic and

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

hikma pharmaceuticals usa inc. - bexarotene (unii: a61rxm4375) (bexarotene - unii:a61rxm4375) - bexarotene capsules are indicated for the treatment of cutaneous manifestations of cutaneous t-cell lymphoma in patients who are refractory to at least one prior systemic therapy. bexarotene capsules can cause fetal harm when administered to a pregnant female. bexarotene capsules are a member of the retinoid class of drugs that is associated with birth defects in humans and is contraindicated in females who are pregnant. bexarotene was also teratogenic and caused developmental mortality when administered orally to pregnant rats. if this drug is used during pregnancy or if the patient becomes pregnant while taking this drug, the patient should be advised of the potential risk to a fetus. bexarotene capsules are contraindicated in patients with a known serious hypersensitivity to bexarotene or other components of the product. risk summary bexarotene capsules, a retinoid, can cause fetal harm based on findings from animal studies when administered to a pregnant female and is contraindicated during pregnancy. bexarotene was teratogenic and caused developmental mortality in rats following oral administration during organogenesis [see data] . bexarotene capsules must not be given to a pregnant female or a female who intends to become pregnant. if pregnancy does occur during treatment with bexarotene capsules, immediately discontinue the drug and advise the pregnant female of the potential risk to a fetus. the background risk of major birth defects and miscarriage for the indicated populations are 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 : bexarotene caused malformations when administered orally to pregnant rats during days 7-17 of gestation. developmental abnormalities included incomplete ossification at 4 mg/kg/day and cleft palate, depressed eye bulge/microphthalmia, and small ears at 16 mg/kg/day. the plasma auc of bexarotene in rats at 4 mg/kg/day is approximately one third the auc in humans at the recommended daily dose. at doses greater than 10 mg/kg/day, bexarotene caused developmental mortality. the no effect dose for fetal effects in rats was 1 mg/kg/day (producing an auc approximately one sixth of the auc at the recommended human daily dose). risk summary there is no information regarding the presence of bexarotene capsules in human milk, the effects on the breast fed infant, or the effects on milk production. because many drugs are excreted in human milk and because of the potential for serious adverse reactions in nursing infants from bexarotene capsules, discontinue breastfeeding during treatment with bexarotene capsules. pregnancy testing obtain a negative serum pregnancy test (e.g., serum beta-human chorionic gonadotropin [beta-hcg]) with a sensitivity of at least 50 miu/l within one week prior to bexarotene capsules therapy. obtain another pregnancy test at monthly intervals while the patient remains on bexarotene capsules. contraception : females: bexarotene capsules can cause fetal harm when administered to a pregnant female [see use in specific populations (8.1) ]. females of reproductive potential should be advised to avoid becoming pregnant when bexarotene capsules are used. effective contraception must be used for one month prior to the initiation of therapy, during therapy and for at least one month following discontinuation of therapy; it is recommended that two reliable forms of contraception be used simultaneously unless abstinence is the chosen method. bexarotene can potentially induce metabolic enzymes and thereby theoretically reduce the plasma concentrations of oral or other systemic hormonal contraceptives [see drug interactions (7) ]. thus, if treatment with bexarotene capsules is intended in a female with reproductive potential, it is strongly recommended that one of the two reliable forms of contraception should be non-hormonal. bexarotene capsules therapy should be initiated on the second or third day of a normal menstrual period. no more than a one-month supply of bexarotene capsules should be given to the patient so that the results of pregnancy testing can be assessed and counseling regarding avoidance of pregnancy and birth defects can be reinforced. males : male patients with sexual partners who are pregnant, possibly pregnant, or who could become pregnant must use condoms during sexual intercourse while taking bexarotene capsules and for at least one month after the last dose of drug. safety and effectiveness of bexarotene capsules in pediatric patients have not been established. of the total patients with ctcl in clinical trials of bexarotene capsules, 64% were 60 years or older, while 33% were 70 years or older. no overall differences in safety were observed between patients 70 years or older and younger patients, but greater sensitivity of some older individuals to bexarotene capsules cannot be ruled out. responses to bexarotene capsules were observed across all age group decades, without preference for any individual age group decade. no specific studies have been conducted with bexarotene capsules in subjects with hepatic impairment. hepatic impairment is expected to lead to decreased clearance [see clinical pharmacology (12.3) ]. if bexarotene capsules are used in patients with hepatic impairment, monitor for signs of toxicity that may be due to increased exposure.

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

actavis pharma, inc. - bexarotene (unii: a61rxm4375) (bexarotene - unii:a61rxm4375) - bexarotene capsules are indicated for the treatment of cutaneous manifestations of cutaneous t-cell lymphoma in patients who are refractory to at least one prior systemic therapy. bexarotene can cause fetal harm when administered to a pregnant female. bexarotene is a member of the retinoid class of drugs that is associated with birth defects in humans and is contraindicated in females who are pregnant. bexarotene was also teratogenic and caused developmental mortality when administered orally to pregnant rats. if this drug is used during pregnancy or if the patient becomes pregnant while taking this drug, the patient should be advised of the potential risk to a fetus. bexarotene capsules are contraindicated in patients with a known serious hypersensitivity to bexarotene or other components of the product. risk summary bexarotene, a retinoid, can cause fetal harm based on findings from animal studies when administered to a pregnant female and is contraindicated during pregnancy. bexarotene was teratogenic and