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POMALYST® (pomalidomide) capsules, for oral use

DESCRIPTION CLINICAL PHARMACOLOGY INDICATIONS AND USAGE
CONTRAINDICATIONS PRECAUTIONS ADVERSE REACTIONS
DOSAGE AND ADMINISTRATION HOW SUPPLIED WARNINGS
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Drug Updates:  POMALYST® (pomalidomide) capsules, for oral use
[Drug information  /  PDF]  
Dosing:  Click (+) next to Dosage and Administration section (drug info link)

Initial U.S. Approval:  2013

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.

WARNINGS  top of page

 WARNING: EMBRYO-FETAL TOXICITY and VENOUS
THROMBOEMBOLISM


See full prescribing information for complete boxed warning

EMBRYO-FETAL TOXICITY
POMALYST is contraindicated in pregnancy. POMALYST is a thalidomide analogue. Thalidomide is a known human teratogen that causes severe life-threatening birth defects.

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
Deep Venous Thrombosis (DVT) and Pulmonary Embolism (PE) occur in patients with multiple myeloma treated with POMALYST.

DESCRIPTION  top of page

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: top of page

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  top of page

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.

CONTRAINDICATIONS top of page

Pregnancy

PRECAUTIONS top of page

WARNINGS AND PRECAUTIONS:

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

ADVERSE REACTIONS top of page

ADVERSE REACTIONS
Most common adverse reactions (geq30%) 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
Nursing Mothers: Discontinue drug or nursing taking into consideration importance of drug to mother.
Avoid POMALYST in patients with serum creatinine >3.0 mg/d.

See PACKAGE INSERT for PATIENT COUNSELING INFORMATION and Medication Guide.

DOSAGE AND ADMINISTRATION  top of page

DOSAGE AND ADMINISTRATION:

4 mg per day taken orally on days 1-21 of repeated 28-day cycles until disease progression.

HOW SUPPLIED top of page

DOSAGE FORMS AND STRENGTHS

Capsules: 1 mg, 2 mg, 3 mg and 4 mg

REFERENCE

Package insert data:   [Accessed: Jan 2014].

Issued February 2013

Manufactured for:
Celgene Corporation
Summit, NJ 07901

POMALYST®, REVLIMID®and THALOMID® are registered trademarks of Celgene Corporation.
POMALYST REMS™ is a trademark of Celgene Corporation.
U.S. Pat. Nos. 5,635,517; 6,045,501; 6,315,720; 6,316,471; 6,476,052; 6,561,976; 6,561,977; 6,755,784; 6,908,432; 8,158,653; 8,198,262; 8,204,763; 8,315,886.

©2005-2013 Celgene Corporation, All Rights Reserved.
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