Pomalidomide - Warnings and Precautions
The following warnings and precautions are taken directly from the US FDA-approved drug label for Pomalidomide. This is the same information dispensing pharmacists read.
\u26a0\ufe0f Boxed Warning (Highest FDA Alert)
BOXED WARNING WARNING: EMBRYO-FETAL TOXICITY and VENOUS AND ARTERIAL THROMBOEMBOLISM Embryo-Fetal Toxicity Pomalidomide capsules are contraindicated in pregnancy. Pomalidomide capsules are 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 pomalidomide capsules treatment. Females of reproductive potential must use 2 forms of contraception or continuously abstain from heterosexual sex during and for 4 weeks after stopping pomalidomide capsules treatment [see Contraindications , Warnings and Precautions and Use in Specific Populations (8.1, 8.3 )]. Pomalidomide capsules are only available through a restricted distribution program called PS-Pomalidomide REMS [see Warnings and Precautions ]. Information about PS-Pomalidomide REMS is available at www.PS-PomalidomideREMS.com or by calling the REMS Call Center at 1-888-423-5436. Venous and Arterial Thromboembolism Deep venous thrombosis (DVT), pulmonary embolism (PE), myocardial infarction, and stroke occur in patients with multiple myeloma treated with pomalidomide capsules. Prophylactic antithrombotic measures were employed in clinical trials. Thromboprophylaxis is recommended, and the choice of regimen should be based on assessment of the patient's underlying risk factors [see Warnings and Precautions ]. WARNING: EMBRYO-FETAL TOXICITY and VENOUS AND ARTERIAL THROMBOEMBOLISM Se
5 WARNINGS AND PRECAUTIONS Increased Mortality: Observed in patients with MM when pembrolizumab was added to dexamethasone and a thalidomide analogue .
Hematologic Toxicity: Neutropenia was the most frequently reported Grade 3/4 adverse event.
Monitor patients for hematologic toxicities, especially neutropenia .
Hepatotoxicity: Hepatic failure including fatalities; monitor liver function tests monthly .
Severe Cutaneous Reactions: Discontinue pomalidomide capsules for severe reactions .
Tumor Lysis Syndrome (TLS): Monitor patients at risk of TLS (i.e., those with high tumor burden) and take appropriate precautions .
Hypersensitivity: Monitor patients for potential hypersensitivity.
Discontinue pomalidomide capsules for angioedema and anaphylaxis .
5.1 Embryo-Fetal Toxicity Pomalidomide capsules are a thalidomide analogue and are 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 ].
Pomalidomide capsules are only available through PS-Pomalidomide REMS [see Warnings and Precautions ].
Females of Reproductive Potential Females of reproductive potential must avoid pregnancy for at least 4 weeks before beginning Pomalidomide Capsules therapy, during therapy, during dose interruptions 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 pomalidomide capsules, during therapy, during dose interruptions, and continuing for 4 weeks following discontinuation of pomalidomide capsules 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 pomalidomide capsules therapy and then weekly during the first month, then monthly thereafter in females with regular menstrual cycles, or every 2 weeks in females with irregular menstrual cycles [see Use in Specific Populations ].
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 pomalidomide capsules and for up to 4 weeks after discontinuing pomalidomide capsules, even if they have undergone a successful vasectomy.
Male patients taking pomalidomide capsules must not donate sperm [see Use in Specific Populations ].
Blood Donation Patients must not donate blood during treatment with pomalidomide capsules and for 4 weeks following discontinuation of the drug because the blood might be given to a pregnant female patient whose fetus must not be exposed to pomalidomide capsules.
5.2 PS-Pomalidomide REMS Because of the embryo-fetal risk [see Warnings and Precautions ], pomalidomide capsules are available only through a restricted program under a Risk Evaluation and Mitigation Strategy (REMS), “PS-Pomalidomide REMS”.
Required components of PS-Pomalidomide REMS include the following: Prescribers must be certified with PS-Pomalidomide REMS by enrolling and complying with the REMS requirements.
Patients must sign a Patient-Physician 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 ] and males must comply with contraception requirements [see Use in Specific Populations ].
Pharmacies must be certified with PS-Pomalidomide REMS, must only dispense to patients who are authorized to receive pomalidomide capsules and comply with REMS requirements.
Further information about PS-Pomalidomide REMS is available at www.PS-PomalidomideREMS.com or by telephone at 1-888-423-5436.
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