LuciXaz

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.