For: Multiple Myeloma
Ninlaro (ixazomib) is an oral proteasome inhibitor indicated for use in combination with lenalidomide and dexamethasone for the treatment of patients with multiple myeloma who have received at least one prior therapy.
NINLARO is supplied as:
4 mg gelatin capsule: Light orange, size 3, imprinted with "Takeda" on the cap and "4.0 mg" on the body in black ink. NINLARO 4 mg capsules contain 4 mg of ixazomib equivalent to 5.7 mg of ixazomib citrate.
One 4 mg capsule in a single blister pack (NDC 63020-080-01)
Three 4 mg single packs in a carton (NDC 63020-080-02)
3.0 mg gelatin capsule: Light grey, size 4, imprinted with "Takeda" on the cap and "3.0 mg" on the body in black ink. NINLARO 3 mg capsules contain 3 mg of ixazomib equivalent to 4.3 mg of ixazomib citrate.
One 3 mg capsule in a single blister pack (NDC 63020-079-01)
Three 3 mg single packs in a carton (NDC 63020-079-02)
2.3 mg gelatin capsule: Light pink, size 4, imprinted with "Takeda" on the cap and "2.3 mg" on the body in black ink. NINLARO 2.3 mg capsules contain 2.3 mg of ixazomib equivalent to 3.3 mg of ixazomib citrate.
One 2.3 mg capsule in a single blister pack (NDC 63020-078-01)
Three 2.3 mg single packs in a carton (NDC 63020-078-02)
Capsules are individually packaged in a PVC-Aluminum/Aluminum blister.
16.2 Storage
NINLARO may be stored at room temperature. Do not store above 30°C (86°F). Do not freeze.
Store capsules in original packaging until immediately prior to use.
These highlights do not include all the information needed to use NINLARO safely and effectively. See full prescribing information for NINLARO.
NINLARO® (ixazomib) capsules, for oral use
Initial U.S. Approval: 2015
INDICATIONS AND USAGE
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)
DOSAGE FORMS AND STRENGTHS
Capsules: 4 mg, 3 mg, and 2.3 mg (3)
CONTRAINDICATIONS
None. (4)
WARNINGS AND PRECAUTIONS
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)
ADVERSE REACTIONS
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.
DRUG INTERACTIONS
Strong CYP3A inducers: Avoid concomitant use with NINLARO. (7.1, 12.3)
USE IN SPECIFIC POPULATIONS
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)
See 17 for PATIENT COUNSELING INFORMATION and FDA-approved patient labeling.
Revised: 11/2015