Rx Item-Pomalyst 4Mg Cap 100 By Celgene

POMALYST- pomalidomide capsule
Celgene Corporation

WARNING: EMBRYO-FETAL TOXICITY and VENOUS AND ARTERIAL THROMBOEMBOLISM

Embryo-Fetal Toxicity

POMALYST is contraindicated in pregnancy. POMALYST is a thalidomide analogue. Thalidomide is a known human teratogen that causes severe birth defects or embryo-fetal death. In females of reproductive potential, obtain 2 negative pregnancy tests before starting POMALYST treatment.
Females of reproductive potential must use 2 forms of contraception or continuously abstain from heterosexual sex during and for 4 weeks after stopping POMALYST treatment [see Contraindications (4), Warnings and Precautions (5.1), and Use in Specific Populations (8.1, 8.3)].


POMALYST is only available through a restricted distribution program called POMALYST REMS [see Warnings and Precautions (5.2) ].

Venous and Arterial Thromboembolism

Deep venous thrombosis (DVT), pulmonary embolism (PE), myocardial infarction, and stroke occur in patients with multiple myeloma treated with POMALYST. Prophylactic antithrombotic measures were employed in clinical trials. Thromboprophylaxis is recommended, and the choice of regimen should be based on assessment of the patient�s underlying risk factors [see Warnings and Precautions (5.3) ].
1 INDICATIONS AND USAGE

1.1 Multiple Myeloma
POMALYST, in combination with dexamethasone, is indicated for patients with multiple myeloma 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.

2 DOSAGE AND ADMINISTRATION

2.1 Multiple Myeloma
Females of reproductive potential must have negative pregnancy testing and use contraception methods before initiating POMALYST [see Warnings and Precautions (5.1) and Use in Specific Populations (8.3)].

The recommended starting dose of POMALYST is 4 mg once daily orally on Days 1-21 of repeated 28-day cycles until disease progression. POMALYST should be given in combination with dexamethasone [see Clinical Studies (14.1) ].

? POMALYST may be taken with water. Inform patients not to break, chew, or open the capsules. POMALYST may be taken with or without food.

RX ITEM-Pomalyst 4Mg Cap 100 By Celgene
NDC 59572-0504-00 UPC/GTIN No.3-59572-50400-4 Mfg.Part No.50400

Pomalyst 4Mg Cap 100 By Celgene
BRAND: POMALYST NDC: 59572-0504-00,59572050400 UPC: 3-59572-50400-4,359572504004 Celgene Corporation

POMALIDOMIDE ORAL CAPSULE
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