포말리킨캡슐2밀리그램(포말리도마이드)

Pomalidomide capsules are a thalidomide analogue indicated for the treatment of adult patients: in combination with dexamethasone, for patients with multiple myeloma (MM) 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 (1.1). 1.1 Multiple Myeloma Pomalidomide capsules, in combination with dexamethasone, is indicated for adult patients with multiple myeloma (MM) 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.

Pregnancy (4.1) Hypersensitivity (4.2) 4.1 Pregnancy Pomalidomide capsules are contraindicated in females who are pregnant. Pomalidomide capsules can cause fetal harm when administered to a pregnant female [see Warnings and Precautions (5.1) and Use in Specific Populations (8.1)]. Pomalidomide is a thalidomide analogue and is teratogenic in both rats and rabbits when administered during the period of organogenesis. If the patient becomes pregnant while taking this drug, the patient should be apprised of the potential risk to a fetus. 4.2 Hypersensitivity Pomalidomide capsules are contraindicated in patients who have demonstrated severe hypersensitivity (e.g., angioedema, anaphylaxis) to pomalidomide or any of the excipients [see Warnings and Precautions (5.7), Description (11)] .

Increased Mortality: Observed in patients with MM when pembrolizumab was added to dexamethasone and a thalidomide analogue (5.4). Hematologic Toxicity: Neutropenia was the most frequently reported Grade 3/4 adverse event. Monitor patients for hematologic toxicities, especially neutropenia (5.5). Hepatotoxicity: Hepatic failure including fatalities; monitor liver function tests monthly (5.6). Severe Cutaneous Reactions: Discontinue pomalidomide capsules for severe reactions (5.7). Tumor Lysis Syndrome (TLS): Monitor patients at risk of TLS (i.e., those with high tumor burden) and take appropriate precautions (5.11). Hypersensitivity: Monitor patients for potential hypersensitivity. Discontinue pomalidomide capsules for angioedema and anaphylaxis (5.12). 5.1 Embryo-Fetal Toxicity Pomalidomide capsules are 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)] . Pomalidomide capsules are only available through PS-Pomalidomide REMS [see Warnings and Precautions (5.2)]. 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 …

8.1 Pregnancy Pregnancy Exposure Registry There is a pregnancy exposure registry that monitors pregnancy outcomes in females exposed to pomalidomide capsules during pregnancy as well as female partners of male patients who are exposed to pomalidomide capsules. This registry is also used to understand the root cause for the pregnancy. Report any suspected fetal exposure to pomalidomide capsules to the FDA via the MedWatch program at 1-800-FDA-1088 and also to the REMS Call Center at 1-888-423-5436. Risk Summary Based on the mechanism of action [see Clinical Pharmacology (12.1)] and findings from animal studies, pomalidomide capsules can cause embryo-fetal harm when administered to a pregnant …