HIGHLIGHTS OF PRESCRIBING INFORMATION

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

INDICATIONS AND USAGE

LuciPoma is a thalidomide analogue indicated, for the treatment of adult patients:

• in combination with dexamethasone, for patients with multiple myeloma (MM) who have received at least two prior therapies including lenalidomide and a proteasome inhibitor and have demonstrated disease progression on or within 60 days of completion of the last therapy .

• with AIDS-related Kaposi sarcoma (KS) after failure of highly active antiretroviral therapy (HAART) or in patients with KS who are HIV-negative. This indication is approved under accelerated approval based on overall response rate. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s) .

DOSAGE AND ADMINISTRATION

• MM: 4 mg per day taken orally on Days 1 through 21 of repeated 28-day cycles until disease progression .

• KS: 5 mg per day taken orally on Days 1 through 21 of repeated 28-day cycles until disease progression or unacceptable toxicity.

• Modify the dosage for certain patients with renal impairment or hepatic impairment.

DOSAGE FORMS AND STRENGTHS

Capsules: 4 mg×21 capsules

CONTRAINDICATIONS

• Pregnancy

• Hypersensitivity

WARNINGS AND PRECAUTIONS

• Increased Mortality: Observed in patients with MM when pembrolizumab was added to dexamethasone and a thalidomide analogue.

• Hematologic Toxicity: Neutropenia was the most frequently reported Grade 3/4 adverse event. Monitor patients for hematologic toxicities, especially neutropenia.

• Hepatotoxicity: Hepatic failure including fatalities; monitor liver function tests monthly.

• Severe Cutaneous Reactions: Discontinue LuciPoma (pomalidomide) for severe reactions.

• Tumor Lysis Syndrome (TLS): Monitor patients at risk of TLS (i.e., those with high tumor burden) and take appropriate precautions.

• Hypersensitivity: Monitor patients for potential hypersensitivity. Discontinue LuciPoma for angioedema and anaphylaxis.

ADVERSE REACTIONS

• MM: Most common adverse reactions (≥30%) included fatigue and asthenia, neutropenia, anemia, constipation, nausea, diarrhea, dyspnea, upper-respiratory tract infections, back pain, and pyrexia.

• KS: Most common adverse reactions including laboratory abnormalities (≥30%) are decreased absolute neutrophil count or white blood cells, elevated creatinine or glucose, rash, constipation, fatigue, decreased hemoglobin, platelets, phosphate, albumin, or calcium, increased ALT, nausea, and diarrhea.

DRUG INTERACTIONS

Strong CYP1A2 Inhibitors: Avoid concomitant use of strong CYP1A2 inhibitors. If concomitant use of a strong CYP1A2 inhibitor is unavoidable, reduce LuciPoma dose to 2 mg.

USE IN SPECIFIC POPULATIONS

• Lactation: Advise women 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.