INDICATIONS AND USAGE（适应症）

Multiple Myeloma

POMALYST, 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.

Kaposi Sarcoma

POMALYST is indicated for the treatment of:

Adult patients with AIDS-related Kaposi sarcoma (KS) after failure of highly active antiretroviral therapy (HAART).

Kaposi sarcoma (KS) in adult patients who are HIV-negative.

This indication is approved under accelerated approval based on overall response rate. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s).

DOSAGE（服用剂量）

Pregnancy Testing Prior to Administration

Females of reproductive potential must have negative pregnancy testing and use contraception methods before initiating POMALYST.

Recommended Dosage for Multiple Myeloma

The recommended dosage of POMALYST is 4 mg once daily orally with or without food on Days 1 through 21 of each 28-day cycle until disease progression. Give POMALYST in combination with dexamethasone.

Recommended Dosage for Kaposi Sarcoma

The recommended dosage of POMALYST is 5 mg once daily taken orally with or without food on Days 1 through 21 of each 28-day cycle until disease progression or unacceptable toxicity. Continue HAART as HIV treatment in patients with AIDS-related Kaposi sarcoma (KS).

ADVERSE REACTIONS（不良反应）

Embryo-Fetal Toxicity

Venous and Arterial Thromboembolism

Increased Mortality in Patients with Multiple Myeloma When Pembrolizumab Is Added to a Thalidomide Analogue and Dexamethasone

Hematologic Toxicity

Hepatotoxicity

Severe Cutaneous Reactions

Dizziness and Confusional State

Neuropathy

Risk of Second Primary Malignancies

Tumor Lysis Syndrome

Hypersensitivity

For full information, please refer to:

https://nctr-crs.fda.gov/fdalabel/services/spl/set-ids/2b25ef01-5c9e-11e1-b86c-0800200c9a66/spl-doc?hl=Pomalidomide

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