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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.
DOSAGE AND ADMINISTRATION
The recommended starting dose of POMALYST is 4 mg once daily orally on Days 1-21 of repeated28-day cycles until disease progression. POMALYST should 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 Toxicities
Table 1: Dose Modification Instructions for POMALYST
for Hematologic Toxicities
|ANC, absolute neutrophil count|
To initiate a new cycle of POMALYST, the neutrophil count must be at least 500 per mcL and the platelet count must be at least 50,000 per mcL. If toxicities occur after dose reductions to 1 mg, then discontinue POMALYST.
Permanently discontinue POMALYST for angioedema, skin exfoliation, bullae, or any other severe dermatologic reaction [see WARNINGS AND PRECAUTIONS].
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.
Dose Adjustment For Strong CYP1A2 Inhibitors In The Presence Of Strong CYP3A4 And P-gp Inhibitors
Avoid co-administration of strong inhibitors of CYP1A2. If necessary to co-administer strong inhibitors of CYP1A2 in the presence of strong inhibitors of CYP3A4 and P-gp, reduce POMALYST dose by 50%. No clinical efficacy or safety data exist [see DRUG INTERACTIONS and CLINICAL PHARMACOLOGY].
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 (NDC 59572-501-21)
1 mg bottles of 100 (NDC 59572-501-00)
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 (NDC 59572-502-21)
2 mg bottles of 100 (NDC 59572-502-00)
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 (NDC 59572-503-21)
3 mg bottles of 100 (NDC 59572-503-00)
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 (NDC 59572-504-21)
4 mg bottles of 100 (NDC 59572-504-00)
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.
Follow procedures for proper handling and disposal of anticancer drugs.1
1. OSHA Hazardous Drugs. OSHA. [Accessed on 29 January 2013, from http://www.osha.gov/SLTC/hazardousdrugs/index.html]
Manufactured for: Celgene Corporation, Summit, NJ 07901. Revised: April 2015This monograph has been modified to include the generic and brand name in many instances.
Last reviewed on RxList: 7/18/2016
Additional Pomalyst Information
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