Midostaurin

The Basics

What is Midostaurin?

Midostaurin is a targeted anti-cancer therapy.

Brand names for Midostaurin

Rydapt

How Midostaurin is classified

Antineoplastic Agents, Enzyme Inhibitors, Protein Kinase Inhibitors

Midostaurin During Pregnancy

Midostaurin pregnancy category

Category Not AssignedNote that the FDA has deprecated the use of pregnancy categories, so for some medications, this information isn’t available. We still think it’s useful to list historical info, however, given what a common proxy this has been in the past.

What we know about taking Midostaurin while pregnant

Based on mechanism of action and findings in animal reproduction studies, RYDAPT may cause fetal harm when administered to a pregnant woman [see CLINICAL PHARMACOLOGY]. There are no available data on RYDAPT use in pregnant women to inform a drug-associated risk of major birth defects and miscarriage. In animal reproduction studies, oral administration of midostaurin to pregnant rats and rabbits during organogenesis caused embryo-fetal toxicities, including late embryo-fetal death and reduced fetal birth weight, with delays in fetal growth at doses lower than the recommended human dose . Advise pregnant women of the potential risk to a fetus. The background risk of major birth defects and miscarriage for the indicated population are unknown. Adverse outcomes in pregnancy occur regardless of the health of the mother or the use of medications. 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 Animal Data When midostaurin was administered to female rats prior to mating and through the first week of pregnancy at a dose of 60 mg/kg/day (approximately 0.1 times the human exposure at the recommended dose based on AUC), there were increases in pre- and post-implantation loss, including total litter loss, resulting in a reduction in the number of live embryos. During organogenesis, midostaurin administered at oral doses greater than or equal to 3 mg/kg/day (approximately 0.004 times the human exposure at the recommended dose by AUC) to pregnant female rats caused late embryo-fetal death. Dilated lateral brain ventricles were observed in offspring of rats given doses greater than or equal to 3 mg/kg/day. Extra rib and reduced fetal birth weight with effects on fetal growth (severe renal pelvic cavitation and widened anterior fontanelle) were observed in the absence of maternal toxicity at the highest dose of 30 mg/kg/day (approximately 0.05 times the human exposure at the recommended dose by AUC). Midostaurin administered orally to pregnant rabbits during organogenesis led to maternal toxicity with spontaneous abortions and some delay in fetal growth (reduced fetal birth weight) at doses greater than or equal to 10 mg/kg/day (approximately 0.01 times the human exposure at the recommended dose by AUC). In an oral pre- and postnatal development study in the rat, adverse effects upon maternal performance included dams with signs of dystocia and a lower live litter size at 30 mg/kg/day (approximately 0.05 times the human exposure at the recommended dose by AUC). For the F1 offspring, lower body weights, accelerated complete eye opening and delayed auricular startle ontogeny were noted at 30 mg/kg/day.

Taking Midostaurin While Breastfeeding

What are recommendations for lactation if you're taking Midostaurin?

No information is available on the clinical use of midostaurin during breastfeeding. Because midostaurin and its active metabolites are 99.8% bound to plasma proteins, the amount in milk is likely to be low. The manufacturer recommends that breastfeeding be discontinued during midostaurin therapy and for at least 4 months after the last dose. Avoiding breastfeeding is particularly important when midostaurin is given with other cancer chemotherapy agents.

Maternal / infant drug levels

No information is available on the clinical use of midostaurin during breastfeeding. Because midostaurin and its active metabolites are 99.8% bound to plasma proteins, the amount in milk is likely to be low. The manufacturer recommends that breastfeeding be discontinued during midostaurin therapy and for at least 4 months after the last dose. Avoiding breastfeeding is particularly important when midostaurin is given with other cancer chemotherapy agents.

Possible effects of Midostaurin on milk supply

Relevant published information was not found as of the revision date.

Possible alternatives to Midostaurin

None listed