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POMALYST(pomalidomide) capsules, for oral use
These highlights do not include all the information needed to use POMALYST safely and effectively. See full prescribing information for POMALYST.
POMALYST® (pomalidomide) capsules, for oral use
Initial U.S. Approval: 2013
WARNING: EMBRYO-FETAL TOXICITY and VENOUS
THROMBOEMBOLISM
See full prescribing information for complete boxed warning
EMBRYO-FETAL TOXICITY
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POMALYST is contraindicated in pregnancy. POMALYST is a thalidomide analogue. Thalidomide is a known human teratogen that causes severe life-threatening birth defects. (4, 5.1, 8.1).
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For females of reproductive potential: Exclude pregnancy before start of treatment. Prevent pregnancy during treatment by the use of 2 reliable methods of contraception (5.1, 8.6).
POMALYST is available only through a restricted program called POMALYST REMS™ (5.2).
VENOUS THROMBOEMBOLISM
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Deep venous thrombosis (DVT) and pulmonary embolism (PE) occur in patients with multiple myeloma treated with POMALYST (5.3).
RECENT MAJOR CHANGES
Dosage and Administration (2.3) 03/14
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. (1)
DOSAGE AND ADMINISTRATION
4 mg per day taken orally on Days 1-21 of repeated 28-day cycles until disease progression (2)
DOSAGE FORMS AND STRENGTHS
Capsules: 1 mg, 2 mg, 3 mg, and 4 mg (3)
WARNINGS AND PRECAUTIONS
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Hematologic Toxicity: Neutropenia was the most frequently reported Grade 3/4 adverse event. Monitor patients for hematologic toxicities, especially neutropenia (5.4).
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 (6.1).
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.
DRUG INTERACTIONS
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Strong CYP1A2 Inhibitors: Avoid the use of strong CYP1A2 inhibitors unless medically necessary (2.3, 7.1, 12.3).
USE IN SPECIFIC POPULATIONS
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Nursing Mothers: Discontinue drug or nursing taking into consideration importance of drug to mother (8.3).
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Avoid POMALYST in patients with serum creatinine >3.0 mg/dL (8.7).
See 17 for PATIENT COUNSELING INFORMATION and Medication Guide.
Revised: 3/2014
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FULL PRESCRIBING INFORMATION
WARNING: EMBRYO-FETAL TOXICITY and VENOUS THROMBOEMBOLISM
Embryo-Fetal Toxicity
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POMALYST is contraindicated in pregnancy. POMALYST is a thalidomide analogue. Thalidomide is a known human teratogen that causes severe birth defects or embryo-fetal death. In females of reproductive potential, obtain 2 negative pregnancy tests before starting POMALYST treatment.
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Females of reproductive potential must use 2 forms of contraception or continuously abstain from heterosexual sex during and for 4 weeks after stopping POMALYST treatment [see Contraindications (4), Warnings and Precautions (5.1), and Use in Specific Populations (8.1, 8.6)].
POMALYST is only available through a restricted distribution program called POMALYST REMS™ [see Warnings and Precautions (5.2)].
Venous Thromboembolism
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Deep venous thrombosis (DVT) and pulmonary embolism (PE) occur in patients with multiple myeloma treated with POMALYST. Prophylactic anti-thrombotic measures were employed in the clinical trial. Consider prophylactic measures after assessing an individual patient’s underlying risk factors [see Warnings and Precautions (5.3)].
1 INDICATIONS AND USAGE
1.1 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 (14.1)]. Clinical benefit, such as improvement in survival or symptoms, has not been verified.
2 DOSAGE AND ADMINISTRATION
2.1 Multiple Myeloma
Females of reproductive potential must have negative pregnancy testing and use contraception methods before initiating POMALYST [see Warnings and Precautions (5.1) and Use in Specific Populations (8.6)].
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 (14.1)].
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).
2.2 Dose Adjustments for Toxicities
Table 1: Dose Modification Instructions for POMALYST for Hematologic Toxicities
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ANC, absolute neutrophil count. |
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Toxicity |
Dose Modification |
Neutropenia
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ANC <500 per mcL or febrile neutropenia (fever more
than or equal to 38.5°C and ANC <1,000 per mcL)
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ANC return to more than or equal to 500 per mcL
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Interrupt POMALYST treatment, follow CBC weekly
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Resume POMALYST treatment at 3 mg daily
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For each subsequent drop <500 per mcL
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Return to more than or equal to 500 per mcL
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Interrupt POMALYST treatment
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Resume POMALYST treatment at 1 mg less than the previous dose
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Thrombocytopenia
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Platelets <25,000 per mcL
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Platelets return to >50,000 per mcL
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Interrupt POMALYST treatment, follow CBC weekly
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Resume POMALYST treatment at 3 mg daily
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For each subsequent drop <25,000 per mcL
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Return to more than or equal to 50,000 per mcL
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Interrupt POMALYST treatment
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Resume POMALYST treatment at 1 mg less than previous dose
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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 and the platelet count must be at least 50,000 per mcL. If toxicities occur after dose reductions to 1 mg, then discontinue POMALYST.
2.3 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 (7.1) and Clinical Pharmacology (12.3)].
3 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
4 CONTRAINDICATIONS
Pregnancy
POMALYST can cause fetal harm when administered to a pregnant female [see Warnings and Precautions (5.1) and Use in Specific Populations (8.1)]. POMALYST is contraindicated in females who are pregnant. Pomalidomide is a thalidomide analogue and is teratogenic in both rats and rabbits when administered during the period of organogenesis. If this drug is used during pregnancy or if the patient becomes pregnant while taking this drug, the patient should be apprised of the potential hazard to a fetus.
5 WARNINGS AND PRECAUTIONS
5.1 Embryo-Fetal Toxicity
POMALYST is a thalidomide analogue and is contraindicated for use during pregnancy. Thalidomide is a known human teratogen that causes severe birth defects or embryo-fetal death [see Use in Specific Populations (8.1)]. POMALYST is only available through the POMALYST REMS program [see Warnings and Precautions (5.2)].
Females of Reproductive Potential
Females of reproductive potential must avoid pregnancy while taking POMALYST and for at least 4 weeks after completing therapy.
Females must commit either to abstain continuously from heterosexual sexual intercourse or to use 2 methods of reliable birth control, beginning 4 weeks prior to initiating treatment with POMALYST, during therapy, during dose interruptions and continuing for 4 weeks following discontinuation of POMALYST therapy.
Two negative pregnancy tests must be obtained prior to initiating therapy. The first test should be performed within 10-14 days and the second test within 24 hours prior to prescribing POMALYST therapy and then weekly during the first month, then monthly thereafter in women with regular menstrual cycles, or every 2 weeks in women with irregular menstrual cycles [see Use in Specific Populations (8.6)].
Males
Pomalidomide is present in the semen of patients receiving the drug. Therefore, males must always use a latex or synthetic condom during any sexual contact with females of reproductive potential while taking POMALYST and for up to 28 days after discontinuing POMALYST, even if they have undergone a successful vasectomy. Male patients taking POMALYST must not donate sperm [see Use in Specific Populations (8.6)].
Blood Donation
Patients must not donate blood during treatment with POMALYST and for 1 month following discontinuation of the drug because the blood might be given to a pregnant female patient whose fetus must not be exposed to POMALYST.
5.2 POMALYST REMS™ Program
Because of the embryo-fetal risk [see Warnings and Precautions (5.1)], POMALYST is available only through a restricted program under a Risk eva luation and Mitigation Strategy (REMS) called “POMALYST REMS.”
Required components of the POMALYST REMS program include the following:
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Prescribers must be certified with the POMALYST REMS program by enrolling and complying with the REMS requirements.
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Patients must sign a Patient-Prescriber agreement form and comply with the REMS requirements. In particular, female patients of reproductive potential who are not pregnant must comply with the pregnancy testing and contraception requirements [see Use in Specific Populations (8.6)] and males must comply with contraception requirements [see Use in Specific Populations (8.6)].
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Pharmacies must be certified with the POMALYST REMS program, must only dispense to patients who are authorized to receive POMALYST and comply with REMS requirements.
Further information about the POMALYST REMS program is available www.CelgeneRiskManagement.com or by telephone at 1-888-423-5436.
5.3 Venous Thromboembolism
Patients receiving POMALYST have developed venous thromboembolic events (VTEs) (venous thromboembolism) reported as serious adverse reactions. In the trial, all patients were required to receive prophylaxis or anti-thrombotic treatment; 81% used aspirin, 16% warfarin, 21% heparin, and 3% clopidogrel. The rate of deep vein thrombosis or pulmonary embolism was 3%. Consider anti-coagulation prophylaxis after an assessment of each patient’s underlying risk factors.
5.4 Hematologic Toxicity
Neutropenia was the most frequently reported Grade 3/4 adverse reaction, followed by anemia and thrombocytopenia. Neutropenia of any grade was reported in 50% of patients in the trial. The rate of Grade 3/4 neutropenia was 43%. The rate of febrile neutropenia was 3%.
Monitor patients for hematologic toxicities, especially neutropenia. Monitor complete blood counts weekly for the first 8 weeks and monthly thereafter. Patients may require dose interruption and/or modification [see Dosage and Administration (2.2)].
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