NINLARO® (ixazomib) is an oral prescription medicine used to treat in combination with the medicines Revlimid® (lenalidomide) and dexamethasone, in people who have received at least one prior treatment. It belongs to a class of drugs known as proteasome inhibitors. Ixazomib was granted orphan drug designation for in both the U.S. and Europe in 2011, and for light-chain (AL) in both the U.S. and Europe in 2012.
How Does It Work?
Ninlaro is the first and only oral proteasome inhibitor. Both normal cells and cancer cells contain proteasomes, enzyme complexes that break down damaged and unwanted proteins into smaller components. These smaller components are then used to create new proteins required by the cell. Proteasomes can be thought of as crucial to the cell’s “recycling” of proteins. Myeloma cells are particularly sensitive to proteasome inhibition. When their protein recycling system is shut down, myeloma cells die.
How Is Ninlaro Given?
Ninlaro is available in 4 mg, 3 mg, and 2.3 mg capsules. The recommended starting dose is 4 mg taken orally on Days 1, 8, and 15 of a 28-day cycle. Ninlaro should be taken at least one hour before or at least two hours after food.
Important Safety Information
Based on findings with animals, Ninlaro can cause fetal harm when administered to a pregnant woman. There are no adequate or well-controlled studies in pregnant women, but studies in rats and rabbits that were exposed to the medication at slightly higher levels than those observed in patients caused embryo-fetal toxicity. Women of childbearing potential should not become pregnant while taking Ninlaro. Animal studies indicated that there were no effects due to Ninlaro on male or female reproductive organs.
Women are advised not to breastfeed during treatment with Ninlaro, and for 90 days after the last dose.
Warnings and Precautions
The most common adverse reactions (≥ 20%) are diarrhea, constipation, thrombocytopenia, , nausea, peripheral edema, vomiting, and back pain.
Thrombocytopenia: Monitor platelet counts at least monthly during treatment and adjust dosing, as needed.
Gastrointestinal Toxicities: Adjust dosing for severe diarrhea, constipation, nausea, and vomiting, as needed.
: Monitor patients for symptoms of and adjust dosing, as needed.
Peripheral Edema: Monitor for fluid retention. Investigate for underlying causes, when appropriate. Adjust dosing, as needed
Cutaneous Reactions: Monitor patients for rash and adjust dosing, as needed.
Thrombotic Microangiopathy: Monitor for signs and symptoms. Discontinue Ninlaro if suspected.
Hepatotoxicity: Monitor hepatic enzymes during treatment.
Embryo-Fetal Toxicity: Ninlaro can cause fetal harm. Advise patients of the potential risk to a fetus and to use effective non-hormonal contraception.
Takeda Oncology is committed to helping you get access to Ninlaro whenever possible. Here2Assist offers comprehensive programs that can help with coverage, financial, and educational resource needs.