Multiple Myeloma

POMALYST is 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 [see Clinical Studies]. Clinical benefit, such as improvement in survival or symptoms, has not been verified.

Multiple Myeloma

Females of reproductive potential must have negative pregnancy testing and use contraception methods before initiating POMALYST [see WARNINGS AND PRECAUTIONS and Use in Specific Populations].

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 may be given in combination with dexamethasone [see Clinical Studies].

POMALYST may be taken with water. Inform patients not to break, chew or open the capsules. POMALYST should be taken without food (at least 2 hours before or 2 hours after a meal).

Dose Adjustments for Toxicity

Table 1: Dose Modification Instructions for POMALYST for Hematologic Toxicities

For other Grade 3 or 4 toxicities hold treatment and restart treatment at 1 mg less than the previous dose when toxicity has resolved to less than or equal to Grade 2 at the physician's discretion.

To initiate a new cycle of POMALYST, the neutrophil count must be at least 500 per mcL, the platelet count must be at least 50,000 per mcL. If toxicities occur after dose reductions to 1 mg, then discontinue POMALYST.

Dosage Forms And Strengths

POMALYST is available in the following capsule strengths:

1 mg: Dark blue opaque cap and yellow opaque body imprinted “POML” on the cap in white ink and “1 mg” on the body in black ink

2 mg: Dark blue opaque cap and orange opaque body imprinted “POML” on the cap and “2 mg” on the body in white ink

3 mg: Dark blue opaque cap and green opaque body, imprinted, “POML” on the cap and “3 mg” on the body in white ink

4 mg: Dark blue opaque cap and blue opaque body, imprinted “POML” on the cap and “4 mg” on the body in white ink

Storage And Handling

Dark blue opaque cap and yellow opaque body imprinted “POML” on the cap in white ink and “1 mg” on the body in black ink

1 mg bottles of 21
1 mg bottles of 100

Dark blue opaque cap and orange opaque body imprinted “POML” on the cap and “2 mg” on the body in white ink

2 mg bottles of 21
2 mg bottles of 100

Dark blue opaque cap and green opaque body imprinted “POML” on the cap and “3 mg” on the body in white ink

3 mg bottles of 21
3 mg bottles of 100

Dark blue opaque cap and blue opaque body imprinted “POML” on the cap and “4 mg” on the body in white ink

4 mg bottles of 21
4 mg bottles of 100

Storage

Store at 20°C -25°C (68°F -77°F); excursions permitted to 15°C-30°C (59°F-86°F). [See USP Controlled Room Temperature].

Handling and Disposal

Care should be exercised in handling of POMALYST. POMALYST capsules should not be opened or crushed. If powder from POMALYST contacts the skin, wash the skin immediately and thoroughly with soap and water. If POMALYST contacts the mucous membranes, flush thoroughly with water.

Procedures for proper handling and disposal of anticancer drugs should be considered. Several guidelines on the subject have been published¹.

Manufactured for: Celgene Corporation, Summit, NJ 07901. Revised 02/2013

Last reviewed on RxList: 2/21/2013
This monograph has been modified to include the generic and brand name in many instances.