ACH-MYCOPHENOLATE POWDER FOR SUSPENSION Canada - English - Health Canada

ach-mycophenolate powder for suspension

accord healthcare inc - mycophenolate mofetil - powder for suspension - 200mg - mycophenolate mofetil 200mg

PROLEUKIN- aldesleukin injection, powder, lyophilized, for solution United States - English - NLM (National Library of Medicine)

proleukin- aldesleukin injection, powder, lyophilized, for solution

iovance biotherapeutics, inc - aldesleukin (unii: m89n0q7eqr) (aldesleukin - unii:m89n0q7eqr) - proleukin is indicated for the treatment of adults with metastatic renal cell carcinoma (rcc). proleukin is indicated for the treatment of adults with metastatic melanoma. - severe hypersensitivity reactions proleukin is contraindicated in patients with a known history of severe hypersensitivity to aldesleukin or any component of the proleukin formulation [see adverse reactions (6.2)]. - organ allografts proleukin is contraindicated in patients with organ allografts [see warnings and precautions (5.5)] . - significant organ impairment proleukin is contraindicated in patients with significant cardiac (including those with an abnormal cardiac ejection fraction, impaired wall motion, or significant coronary artery disease), pulmonary (including those with an fev1 ≤ 2 liters or < 75% predicted for height and age), renal, hepatic, or cns impairment [see warnings and precautions (5.1, 5.2, 5.4)] . risk summary based on findings in an animal study and its mechanism of action, proleukin may cause fetal harm or loss of pregnancy when administered to a pregnant woman [see clinical pharmacology (12.1)]. data on the use of proleukin in pregnant women are limited and insufficient to assess the drug-associated risk of major birth defects, miscarriage, or other adverse maternal or fetal outcomes; however, development of capillary leak syndrome during pregnancy can lead to adverse fetal outcomes (see clinical considerations) . intravenous administration of aldesleukin to pregnant rats during the period of organogenesis resulted in embryo lethality at doses 27 times and maternal toxicities at doses 2.1 times the human exposure at the recommended clinical 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%–4% and 15–20%, respectively. clinical considerations fetal/neonatal adverse reactions capillary leak syndrome in women who are exposed to proleukin during pregnancy may result in maternal hypotension and decreased placental perfusion. severe or prolonged maternal hypotension and decreased placental perfusion can lead to intrauterine growth restriction, perinatal asphyxia, or fetal/neonatal demise. monitor fetal and neonatal status in pregnant women who develop capillary leak syndrome associated with proleukin. data animal data aldesleukin has been shown to have embryolethal effects in rats when given in doses at 27 to 36 times the human dose (scaled by body weight). significant maternal toxicities were observed in pregnant rats administered aldesleukin by iv injection at doses 2.1 to 36 times higher than the human dose during critical period of organogenesis. risk summary there are no data on the presence of aldesleukin in either human or animal milk, the effects on the breastfed child, or the effects on milk production. maternal cytokines are known to be present in human breast milk. because of the potential for serious adverse reactions from proleukin in a breastfed child, such as impaired immune function, advise women not to breastfeed during treatment. based on animal data and mechanism of action, proleukin may cause embryo-fetal harm [see use in specific populations (8.1)]. pregnancy testing verify pregnancy status of females of reproductive potential prior to initiating proleukin [see use in specific populations (8.1)]. contraception females advise females of reproductive potential to use effective contraception during treatment with proleukin. the safety and effectiveness of proleukin have not been established in pediatric patients. clinical studies of proleukin did not include sufficient numbers of patients 65 years of age and older to determine whether they respond differently from younger adult patients.