Australia - English - Department of Health (Therapeutic Goods Administration)

pharmaco australia ltd - tretinoin, quantity: 10 mg - capsule, soft - excipient ingredients: purified water; glycerol; yellow beeswax; iron oxide yellow; gelatin; titanium dioxide; iron oxide red; soya oil; partially hydrogenated soya oil; hydrogenated soya oil; maize starch; sorbitol; mannitol - vesanoid should be used for induction of remission in acute promyelocytic leukemia (apl; fab classification aml-m3). previously untreated patients as well as patients who relapse after or are refractory to standard chemotherapy (daunorubicin and cytosine arabinoside (ara-c)or equivalent therapies) may be treated with vesanoid. following complete remission, consolidation full dose chemotherapy should be employed. a loss of responsiveness to vesanoid has been reported among patients maintained on vesanoid. the median time to relapse for patients maintained on vesanoid is 4 to 6 months.

New Zealand - English - Medsafe (Medicines Safety Authority)

pharmaco (nz) ltd - tretinoin 10mg - liquid filled capsule - 10 mg - active: tretinoin 10mg excipient: gelatin glycerol iron oxide red iron oxide yellow karion 83 soya bean oil, hydrogenated soya oil   titanium dioxide yellow beeswax - vesanoid should be used for induction of remission in acute promyelocytic leukaemia (apl; fab classification aml-m3). previously untreated patients as well as patients who relapse after or are refractory to standard chemotherapy (anthracycline and cytosine arabinoside or equivalent therapies) may be treated with tretinoin. following complete remission, consolidation full-dosechemotherapy should be employed. the addition of chemotherapy to tretinoin improves the chance of longer survival as this combination reduces the risk of relapse as compared to chemotherapy alone. maintenance therapy is still under investigation, however a loss of responsiveness to tretinoin has been reported among patients maintained on tretinoin alone.

Australia - English - Department of Health (Therapeutic Goods Administration)

pharmaco australia ltd - tretinoin -

Israel - English - Ministry of Health

tzamal bio-pharma ltd - tretinoin - capsules - tretinoin 10 mg - tretinoin - induction of remission in acute promyelocytic leukemia.

Malaysia - English - NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

dksh malaysia sdn bhd - tretinoin/retinoic acid -

United Kingdom - English - MHRA (Medicines & Healthcare Products Regulatory Agency)

esteve pharmaceuticals ltd - tretinoin - oral capsule - 10mg

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

h2-pharma, llc - tretinoin (unii: 5688utc01r) (tretinoin - unii:5688utc01r) - vesanoid is indicated for the induction of remission in adults and pediatric patients 1 year of age and older with acute promyelocytic leukemia (apl) characterized by the presence of the t(15;17) translocation or pml/rarα gene expression, and who are refractory to or who have relapsed from anthracycline chemotherapy or for whom anthracycline-based chemotherapy is contraindicated. vesanoid is contraindicated in patients with a known hypersensitivity to vesanoid, any of its components, or other retinoids. reactions have included rash, pruritus, face edema, and dyspnea. [see adverse reactions (6.1)]. risk summary based on findings in animals and its mechanism of action [see clinical pharmacology (12.1)], vesanoid can cause embryo-fetal loss and malformations when administered to a pregnant woman. vesanoid is a retinoid and there is an increased risk of major congenital malformations, spontaneous abortions and premature births following exposure to retinoids during pregnancy in humans. tretinoin was teratogenic and embryotoxic in mice, rats, hamsters, rabbits and pigtail monkeys at doses less than the human dose on a mg/m2 basis (see data) . advise pregnant women of the potential risk to a fetus. the estimated background risk of major birth defects and miscarriage for the indicated population(s) 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 human data vesanoid is a retinoid and increased spontaneous abortions and major fetal abnormalities related to the use of retinoids have been documented in humans. reported malformations include abnormalities of the central nervous system, musculoskeletal system, external ear, eye, thymus and great vessels; and facial dysmorphia, cleft palate, and parathyroid hormone deficiency. some of these abnormalities were fatal.   iq scores less than 85, with or without obvious cns abnormalities, have been reported in pediatrics exposed to retinoids in utero. animal data tretinoin causes fetal resorptions and a decrease in live fetuses in all animals studied. gross external, soft tissue and skeletal alterations occurred at doses higher than 0.7 mg/kg/day in mice, 2 mg/kg/day in rats, 7 mg/kg/day in hamsters, and at a dose of 10 mg/kg/day, the only dose tested, in pigtail monkeys (about 1/20, 1/4, and 1/2 and 4 times the human dose, respectively, on a mg/m2 basis). there are no data on the presence of tretinoin in human milk, the effects on the breastfeed child or the effects on milk production. because of the potential for serious adverse reactions from vesanoid in breastfed infants, advise women not to breastfed during treatment with vesanoid and for 1 week after the last dose. vesanoid can cause embryo-fetal loss and malformations when administered to a pregnant woman [see  use in specific populations (8.1 )] . pregnancy testing verify pregnancy status in females of reproductive potential prior to initiating vesanoid. females of reproductive potential must have a negative pregnancy test within 1 week prior to initiating vesanoid with a sensitivity of at least 50 miu/ml. contraception females advise females of reproductive potential to abstain continuously from sexual intercourse or to use two effective methods of contraception. counsel patients to use two effective methods of contraception during treatment with vesanoid and for 1 month after the last dose. two methods of effective contraception is indicated even where there has been a history of infertility, unless due to hysterectomy. refer females of reproductive potential to a qualified provider of contraceptive methods, if needed. males advise males with female partners of reproductive potential to use effective contraception during and after treatment with vesanoid and for 1 week after the last dose. infertility males based on testicular toxicities observed in dogs, vesanoid may impair male fertility [see nonclinical toxicology (13.1)] . the reversibility of effect on fertility is unknown. safety and effectiveness of vesanoid has been established in pediatric patients 1 year of age and older and the information on this use is discussed throughout the labeling. the maximum tolerated dose is lower in pediatric patients compared to adults. some pediatric patients experience severe headache and intracranial hypertension, which required management with an analgesic and a lumbar puncture. dose reduction may be considered for pediatric patients experiencing serious and/or intolerable adverse reactions. safety and effectiveness in pediatric patients less than 1 year of age have not been established. across clinical studies of vesanoid, 21% were 60 years and older. no overall differences in safety or effectiveness were observed between these patients and younger patients.

Ireland - English - HPRA (Health Products Regulatory Authority)

cheplapharm arzneimittel gmbh - tretinoin - capsule, soft - 10 milligram(s) - cytostatic-differentiating agent

Canada - English - Health Canada

cheplapharm arzneimittel gmbh - tretinoin - capsule - 10mg - tretinoin 10mg - antineoplastic agents