NINLARO is a proteasome inhibitor indicated in combination with lenalidomide and dexamethasone for the treatment of patients with multiple myeloma who have received at least one prior therapy. (1)
DOSAGE AND ADMINISTRATION

• Recommended starting dose of 4 mg taken orally on Days 1, 8, and 15 of a 28-day cycle. (2.1)
• Dose should be taken at least one hour before or at least two hours after food. (2.1)

• Thrombocytopenia: Monitor platelet counts at least monthly during treatment and adjust dosing, as needed. (2.2, 5.1)
• Gastrointestinal Toxicities: Adjust dosing for severe diarrhea, constipation, nausea, and vomiting, as needed. (2.2, 5.2)
• Peripheral Neuropathy: Monitor patients for symptoms of peripheral neuropathy and adjust dosing, as needed. (2.2, 5.3)
• Peripheral Edema: Monitor for fluid retention. Investigate for underlying causes, when appropriate. Adjust dosing, as needed. (2.2, 5.4)
• Cutaneous Reactions: Monitor patients for rash and adjust dosing, as needed. (2.2, 5.5)
• Hepatotoxicity: Monitor hepatic enzymes during treatment. (5.6)
• Embryo-Fetal Toxicity: NINLARO can cause fetal harm. Advise females of reproductive potential of the potential risk to a fetus and to use effective contraception. (5.7, 8.1)

The most common adverse reactions (≥ 20%) are diarrhea, constipation, thrombocytopenia, peripheral neuropathy, nausea, peripheral edema, vomiting, and back pain. (6.1)
To report SUSPECTED ADVERSE REACTIONS, contact Takeda Pharmaceuticals America, Inc. at 1-844-617-6468 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

Strong CYP3A inducers: Avoid concomitant use with NINLARO. (7.1, 12.3)

• Hepatic Impairment: Reduce the NINLARO starting dose to 3 mg in patients with moderate or severe hepatic impairment. (2.3, 8.6)
• Renal Impairment: Reduce the NINLARO starting dose to 3 mg in patients with severe renal impairment or end-stage renal disease requiring dialysis. (2.4, 8.7)
• Lactation: Discontinue nursing. (8.2)