POMALYST® (pomalidomide) capsules
Warnings
| WARNING: EMBRYO-FETAL TOXICITY and VENOUS THROMBOEMBOLISM See full prescribing information for complete boxed warning EMBRYO-FETAL TOXICITY For females of reproductive potential: Exclude pregnancy before start of treatment. Prevent pregnancy during treatment by the use of two reliable methods of contraception. POMALYST is available only through a restricted program called the POMALYST REMS program . VENOUS THROMBOEMBOLISM |
Description
| POMALYST® (pomalidomide) capsules, for oral use Initial U.S. Approval: 2013 POMALYST is an immunomodulatory antineoplastic agent. Pomalidomide is a yellow solid powder. It has limited to low solubility into organic solvents and it has low solubility in all pH solutions (about 0.01 mg/mL). Pomalidomide has a chiral carbon atom which exists as a racemic mixture of the R(+) and S(-) enantiomers. POMALYST is available in 1 mg, 2 mg, 3 mg and 4 mg capsules for oral administration. |
Clinical pharmacology
| Mechanism of Action: Pomalidomide, an analogue of thalidomide, is an immunomodulatory agent with antineoplastic activity. In in vitro cellular assays, pomalidomide inhibited proliferation and induced apoptosis of hematopoietic tumor cells. Additionally, pomalidomide inhibited the proliferation of lenalidomide-resistant multiple myeloma cell lines and synergized with dexamethasone in both lenalidomide-sensitive and lenalidomide-resistant cell lines to induce tumor cell apoptosis. Pomalidomide enhanced T cell- and natural killer (NK) cell-mediated immunity and inhibited production of pro-inflammatory cytokines (e.g., TNF-a and IL-6) by monocytes. Pomalidomide demonstrated anti-angiogenic activity in a mouse tumor model and in the in vitro umbilical cord model. |
Indications and usage
| INDICATIONS AND USAGE: POMALYST is a thalidomide analogue indicated for patients with multiple myeloma who have received at least two prior therapies including lenalidomide and bortezomib and have demonstrated disease progression on or within 60 days of completion of the last therapy. Approval is based on response rate. Clinical benefit, such as improvement in survival or symptoms, has not been verified. |
Precautions
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WARNINGS AND PRECAUTIONS:
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Adverse reactions
| ADVERSE REACTIONS Most common adverse reactions (≥30%) included fatigue and asthenia, neutropenia, anemia, constipation, nausea, diarrhea, dyspnea, upper-respiratory tract infections, back pain and pyrexia . To report SUSPECTED ADVERSE REACTIONS, contact Celgene Corporation at 1-888-423-5436 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. USE IN SPECIFIC POPULATIONS See PACKAGE INSERT for PATIENT COUNSELING INFORMATION and Medication Guide. |
Dosage and administration
| DOSAGE AND ADMINISTRATION:
4 mg per day taken orally on days 1-21 of repeated 28-day cycles until disease progression. |
Reference
| Package insert data: [Accessed: Jan 2014].
Issued February 2013 Manufactured for: POMALYST®, REVLIMID®and THALOMID® are registered trademarks of Celgene Corporation. ©2005-2013 Celgene Corporation, All Rights Reserved. |
Reference(s)
National Institutes of Health, U.S. National Library of Medicine, DailyMed Database.
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