HIGHLIGHTS OF PRESCRIBING INFORMATION

These highlights do not include all the information needed to use LUCIXAZ safely and effectively. See full prescribing information for LUCIXAZ.

INDICATIONS AND USAGE

LUCIXAZ 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.

DOSAGE AND ADMINISTRATION

· Recommended starting dose of 4 mg taken orally on Days 1, 8, and 15 of a 28-day cycle.

· Dose should be taken at least one hour before or at least two hours after food.

DOSAGE FORMS AND STRENGTHS

Capsules: 4 mg×3 capsules

CONTRAINDICATIONS

None.

WARNINGS AND PRECAUTIONS

· 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.

· Peripheral Neuropathy: Monitor patients for symptoms of peripheral neuropathy 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 LUCIXAZ if suspected.

· Hepatotoxicity: Monitor hepatic enzymes during treatment.

· Embryo-Fetal Toxicity: LUCIXAZ can cause fetal harm. Advise patients of the potential risk to a fetus and to use effective non-hormonal contraception.

ADVERSE REACTIONS

The most common adverse reactions (≥20%) are diarrhea, constipation, thrombocytopenia, peripheral neuropathy, nausea, peripheral edema, vomiting, and back pain.

DRUG INTERACTIONS

Strong CYP3A inducers: Avoid concomitant use with LUCIXAZ.

USE IN SPECIFIC POPULATIONS

· Hepatic Impairment: Reduce the LUCIXAZ starting dose to 3 mg in patients with moderate or severe hepatic impairment.

· Renal Impairment: Reduce the LUCIXAZ starting dose to 3 mg in patients with severe renal impairment or end-stage renal disease requiring dialysis.

· Lactation: Advise not to breastfeed.

Storage

Store at 20℃ to 25℃ (68℉ to 77℉), excursions permitted between 15℃ and 30℃ (59℉ and 86℉) [see USP Controlled Room Temperature]. Protect from moisture.