Leukemias, lymphomas, and other hematologic cancers:

Indications for: NINLARO

In combination with lenalidomide and dexamethasone for the treatment of patients with multiple myeloma who have received at least 1 prior therapy.

Limitations of Use:

Not recommended for use in the maintenance setting or in newly diagnosed multiple myeloma in combination with lenalidomide and dexamethasone outside of controlled clinical trials.

Adult Dosage:

Swallow whole. Take ≥1hr before or ≥2hrs after food. Initially 4mg once weekly on Days 1, 8, and 15 of a 28-day cycle (in combination with lenalidomide 25mg daily on Days 1–21 and dexamethasone 40mg on Days 1, 8, 15, and 22). Continue until disease progression or unacceptable toxicity. Moderate or severe hepatic impairment, severe renal impairment, or ESRD on dialysis: initially 3mg. Prior to new cycle, ensure ANC ≥1,000/mm3, platelets ≥75,000/mm3, recovery of non-hematologic toxicities to baseline or Grade ≤1. Consider antiviral prophylaxis to decrease risk of herpes zoster reactivation. Dose modifications: see full labeling.

Children Dosage:

Not established.

NINLARO Warnings/Precautions:

Thrombocytopenia: monitor platelets at least monthly during treatment; consider more frequently for first 3 cycles. Adjust dose for Grade 3/4 GI symptoms or Grade ≥2 rash. Monitor for peripheral neuropathy; adjust dose if worsens. Adjust dosing of dexamethasone or ixazomib if Grade 3/4 peripheral edema symptoms occur. Discontinue if cutaneous reactions occur (eg, Stevens-Johnson syndrome). Thrombotic microangiopathy (including TTP/HUS). Hepatic impairment; monitor enzymes regularly and adjust for Grade 3/4 symptoms. Severe renal impairment or ESRD. Embryo-fetal toxicity. Advise to use effective non-hormonal contraception (females of reproductive potential) or effective contraception (males w. female partners) during and for 90 days after the last dose. Pregnancy: exclude status prior to initiation. Nursing mothers: not recommended (during and for 90 days after the last dose).

NINLARO Classification:

Proteasome inhibitor.

NINLARO Interactions:

Avoid concomitant strong CYP3A inducers (eg, rifampin, phenytoin, carbamazepine, St. John's Wort). Risk of reduced hormonal contraceptives efficacy with concomitant dexamethasone.

Adverse Reactions:

Diarrhea, constipation, thrombocytopenia, peripheral neuropathy, nausea, peripheral edema, vomiting, back pain; rash, hepatotoxicity, herpes zoster, eye disorders.

Generic Drug Availability:


How Supplied:

Caps—1, 3