Inotuzumab Ozogamicin

The Basics

What is Inotuzumab Ozogamicin?

Used to treat relapsed or refractory B-cell precursor acute lymphoblastic leukemia.

Brand names for Inotuzumab Ozogamicin

Besponsa

How Inotuzumab Ozogamicin is classified

Antibodies – Monoclonal (Humanized), Antineoplastic Agents

Inotuzumab Ozogamicin During Pregnancy

Inotuzumab Ozogamicin 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 Inotuzumab Ozogamicin while pregnant

Based on its mechanism of action and findings from animal studies [see Nonclinical Toxicology], BESPONSA can cause embryo-fetal harm when administered to a pregnant woman. There are no available data on BESPONSA use in pregnant women to inform a drug-associated risk of major birth defects and miscarriage. In rat embryo-fetal development studies, inotuzumab ozogamicin caused embryo-fetal toxicity at maternal systemic exposures that were ‚â• 0.4 times the exposure in patients at the maximum recommended dose, based on AUC . If this drug is used during pregnancy, or if the patient becomes pregnant while taking this drug, advise the patient of the potential risk to a fetus. Adverse outcomes in pregnancy occur regardless of the health of the mother or the use of medications. The estimated background risk of major birth defects and miscarriage for the indicated population is unknown. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies are 2-4% and 15-20%, respectively. Data Animal Data In embryo-fetal development studies in rats, pregnant animals received daily intravenous doses of inotuzumab ozogamicin up to 0.36 mg/m2 during the period of organogenesis. Embryo-fetal toxicities including increased resorptions and fetal growth retardation as evidenced by decreased live fetal weights and delayed skeletal ossification were observed at ‚â• 0.11 mg/m2 (approximately 2 times the exposure in patients at the maximum recommended dose, based on AUC). Fetal growth retardation also occurred at 0.04 mg/m2 (approximately 0.4 times the exposure in patients at the maximum recommended dose, based on AUC). In an embryo-fetal development study in rabbits, pregnant animals received daily intravenous doses up to 0.15 mg/m2 (approximately 3 times the exposure in patients at the maximum recommended dose, based on AUC) during the period of organogenesis. At a dose of 0.15 mg/m2, slight maternal toxicity was observed in the absence of any effects on embryo-fetal development.

Taking Inotuzumab Ozogamicin While Breastfeeding

What are recommendations for lactation if you're taking Inotuzumab Ozogamicin?

No information is available on the clinical use of inotuzumab oxogamicin during breastfeeding. Because inotuzumab oxogamicin is a large protein molecule with a molecular weight of 168,000 and its active metabolite is 97% plasma protein bound, the amount in milk is likely to be very low. However, the half-life of inotuzumab oxogamicin is about 12.3 days and it might accumulate in the infant. Until more data become available, inotuzumab oxogamicin should be used with caution during breastfeeding, especially while nursing a newborn or preterm infant. The manufacturer recommends that breastfeeding be discontinued during inotuzumab oxogamicin therapy for at least 2 months after the last dose.

Maternal / infant drug levels

No information is available on the clinical use of inotuzumab oxogamicin during breastfeeding. Because inotuzumab oxogamicin is a large protein molecule with a molecular weight of 168,000 and its active metabolite is 97% plasma protein bound, the amount in milk is likely to be very low. However, the half-life of inotuzumab oxogamicin is about 12.3 days and it might accumulate in the infant. Until more data become available, inotuzumab oxogamicin should be used with caution during breastfeeding, especially while nursing a newborn or preterm infant. The manufacturer recommends that breastfeeding be discontinued during inotuzumab oxogamicin therapy for at least 2 months after the last dose.

Possible effects of Inotuzumab Ozogamicin on milk supply

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

Possible alternatives to Inotuzumab Ozogamicin

None listed