September 2, 2015
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Pomalyst

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Pomalyst

Indications
Dosage
How Supplied

INDICATIONS

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.

DOSAGE AND ADMINISTRATION

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 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

Toxicity Dose Modification
Neutropenia
  • ANC < 500 per mcL or febrile neutropenia (fever more than or equal to 38.5°C and ANC < 1,000 per mcL)
  • Interrupt POMALYST treatment, follow CBC weekly
  • ANC return to more than or equal to 500 per mcL
  • Resume POMALYST treatment at 3 mg daily
  • For each subsequent drop < 500 per mcL
  • Interrupt POMALYST treatment
  • Return to more than or equal to 500 per mcL
  • Resume POMALYST treatment at 1 mg less than the previous dose
Thrombocytopenia
  • Platelets < 25,000 per mcL
  • Interrupt POMALYST treatment, follow CBC weekly
  • Platelets return to > 50,000 per mcL
  • Resume POMALYST treatment at 3 mg daily
  • For each subsequent drop < 25,000 per mcL
  • Interrupt POMALYST treatment
  • Return to more than or equal to 50,000 per mcL
  • Resume POMALYST treatment at 1 mg less than previous dose
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].

HOW SUPPLIED

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)

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.

Follow procedures for proper handling and disposal of anticancer drugs. 1

REFERENCES

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 2015

Last reviewed on RxList: 5/12/2015
This monograph has been modified to include the generic and brand name in many instances.

Indications
Dosage
How Supplied

Report Problems to the Food and Drug Administration

 

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.


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