Pomalyst pomalidomide 1 mg Capsule, 100-count

1 INDICATIONS AND USAGE POMALYST is 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 ). • with AIDS-related Kaposi sarcoma (KS) after failure of highly active antiretroviral therapy (HAART) or in patients with KS 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) ( 1.2 ).

1.1Multiple 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.

1.2Kaposi 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 [see Clinical Studies (14.2) ] . Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s).

2 DOSAGE AND ADMINISTRATION • MM: 4 mg per day taken orally on Days 1 through 21 of repeated 28-day cycles until disease progression ( 2.2 ). Refer to section 14.1 for dexamethasone dosing ( 14.1 ). • KS: 5 mg per day taken orally on Days 1 through 21 of repeated 28-day cycles until disease progression or unacceptable toxicity ( 2.3 ). • Modify the dosage for certain patients with renal impairment ( 2.7 , 8.6 ) or hepatic impairment ( 2.8 , 8.7 ).

2.1Pregnancy Testing Prior to Administration 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 (8.1 , 8.3) ] .

2.2Recommended 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 [see Clinical Studies (14.1) ] .

2.3Recommended 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) [see Clinical Studies (14.2) ] .

2.4Dosage Modifications for Hematologic Adverse Reactions Multiple Myeloma: Dosage Modifications for Hematologic Adverse Reactions Initiate a new cycle of POMALYST in patients with multiple myeloma (MM) when the neutrophil count is at least 500 per mcL and the platelet count is at least 50,000 per mcL. Dosage modification for POMALYST for hematologic adverse reactions in patients with MM are summarized in Table 1. Table 1: Dosage Modifications for POMALYST for Hematologic in MM Adverse Reaction Severity Dosage Modification * Permanently discontinue POMALYST if unable to tolerate 1 mg once daily.

ANC= absolute neutrophil count Neutropenia [see Warnings and Precautions (5.5) ] • ANC less than 500 per mcL or febrile neutropenia (fever greater than or equal to 38.5°C and ANC less than 1,000 per mcL) • Withhold POMALYST until ANC is greater than or equal to 500 per mcL; follow CBC weekly. • Resume POMALYST dose at 1 mg less than the previous dose.* • For each subsequent drop of ANC less than 500 per mcL • Withhold POMALYST until ANC is greater than or equal to 500 mcL. • Resume POMALYST dose at 1 mg less than the previous dose.* Thrombocytopenia [see Warnings and Precautions (5.5) ] • Platelets less than 25,000 per mcL • Withhold POMALYST until platelets are greater than or equal to 50,000 per mcL; follow CBC weekly. • Resume POMALYST dose at 1 mg less than the previous dose* • For each subsequent drop of platelets less than 25,000 per mcL • Withhold POMALYST until platelets are greater than or equal to 50,000 per mcL. • Resume POMALYST at 1 mg less than the previous dose* Kaposi Sarcoma: Dosage Modifications for Hematologic Adverse Reactions Initiate a new cycle of POMALYST in patients with KS when the neutrophil count is at least 1000 per mcL and the platelet count is at least 75,000 per mcL.

Dose modifications for POMALYST for hematologic adverse reactions in patients with KS are summarized in Table 2. Table 2: Dosage Modifications for POMALYST for Hematologic Adverse Reactions in KS Adverse Reaction Severity Dosage Modification * Permanently discontinue POMALYST if unable to tolerate 1mg once daily. ANC= absolute neutrophil count Neutropenia [see Warnings and Precautions (5.5) ] ANC 500 to less than 1,000 per mcL Day 1 of cycle • Withhold POMALYST until ANC is greater than or equal to 1,000 per mcL. • Resume POMALYST at the same dose.

During cycle • Continue POMALYST at the current dose. ANC less than 500 per mcL • Withhold POMALYST until ANC is greater than or equal to 1,000 per mcL. • Resume POMALYST at the same dose. Febrile Neutropenia [see Warnings and Precautions (5.5) ] ANC less than 1,000 per mcL and single temperature…

3 DOSAGE FORMS AND STRENGTHS • Capsules: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 Capsules: 1 mg, 2 mg, 3 mg, and 4 mg ( 3 )

17 PATIENT COUNSELING INFORMATION Advise the patient to read the FDA-approved patient labeling (Medication Guide). Embryo-Fetal Toxicity Advise patients that POMALYST is contraindicated in pregnancy [see Contraindications (4) ] . POMALYST is a thalidomide analogue and may cause serious birth defects or death to a developing baby [see Warnings and Precautions (5.1) and Use in Specific Populations (8.1) ] . • Advise females of reproductive potential that they must avoid pregnancy while taking POMALYST and for at least 4 weeks after completing therapy. • Initiate POMALYST treatment in females of reproductive potential only following a negative pregnancy test. • Advise females of reproductive potential of the importance of monthly pregnancy tests and the need to use 2 different forms of contraception, including at least 1 highly effective form, simultaneously during POMALYST therapy, during dose interruptions, and for 4 weeks after she has completely finished taking POMALYST.

Highly effective forms of contraception other than tubal ligation include IUD and hormonal (birth control pills, injections, patch, or implants) and a partner's vasectomy. Additional effective contraceptive methods include latex or synthetic condom, diaphragm, and cervical cap. • Instruct patient to immediately stop taking POMALYST and contact her healthcare provider if she becomes pregnant while taking this drug, if she misses her menstrual period or experiences unusual menstrual bleeding, if she stops taking birth control, or if she thinks FOR ANY REASON that she may be pregnant. • Advise patient that if her healthcare provider is not available, she should call the REMS Call Center at 1-888-423-5436 [see Warnings and Precautions (5.1) and Use in Specific Populations (8.3) ]. • Advise males to always use a latex or synthetic condom during any sexual contact with females of reproductive potential while taking POMALYST and for up to 4 weeks after discontinuing POMALYST, even if they have undergone a successful vasectomy. • Advise male patients taking POMALYST that they must not donate sperm [see Warnings and Precautions (5.1) and Use in Specific Populations (8.3) ] . • All patients must be instructed to not donate blood while taking POMALYST and for 4 weeks following discontinuation of POMALYST [see Warnings and Precautions (5.1) ] .

PS-Pomalidomide REMS Because of the risk of embryo-fetal toxicity, POMALYST is only available through a restricted program called PS-Pomalidomide REMS [see Warnings and Precautions (5.2) ] . • Patients must sign a Patient-Physician Agreement Form and comply with the requirements to receive POMALYST. In particular, females of reproductive potential must comply with the pregnancy testing, contraception requirements, and participate in monthly telephone surveys. Males must comply with the contraception requirements [see Use in Specific Populations (8.3) ] . • POMALYST is available only from pharmacies that are certified in PS-Pomalidomide REMS.

Provide patients with the telephone number and website for information on how to obtain the product. Pregnancy Exposure Registry Inform females that there is a Pregnancy Exposure Registry that monitors pregnancy outcomes in females exposed to POMALYST during pregnancy and that they can contact the Pregnancy Exposure Registry by calling 1-888-423-5436 [see Use in Specific Populations (8.1) ] . Venous and Arterial Thromboembolism Inform patients of the risk of developing DVT, PE, MI, and stroke and to report immediately any signs and symptoms suggestive of these events for evaluation [see Warnings and Precautions (5.3) ] .

Hematologic Toxicities Inform patients on the risks of developing neutropenia, thrombocytopenia, and anemia and the need to report signs and symptoms associated with these events to their healthcare provider for further evaluation [see Warnings and Precautions (5.5) ] . Hepatotoxicity Inform patients on the risks of developing hepatotoxicity, including hepatic failure and deat…

This Medication Guide has been approved by the U.S. Food and Drug Administration. Revised: Feb 2025 MEDICATION GUIDE POMALYST ® (POM-uh-list) (pomalidomide) capsules What is the most important information I should know about POMALYST?

Before you begin taking POMALYST, you must read and agree to all of the instructions in PS-Pomalidomide REMS. For more information, call 1-888-423-5436 or go to www.PS-PomalidomideREMS.com. Before prescribing POMALYST, your healthcare provider will explain PS-Pomalidomide REMS to you and have you sign the Patient-Physician Agreement Form.

POMALYST can cause serious side effects including: • Possible birth defects (deformed babies) or death of an unborn baby. Females who are pregnant or who plan to become pregnant must not take POMALYST. POMALYST is similar to the medicine thalidomide (THALOMID).

We know thalidomide can cause severe life-threatening birth defects. POMALYST has not been tested in pregnant females. POMALYST has harmed unborn animals in animal testing.

Females must not get pregnant: ∘ For at least 4 weeks before starting POMALYST ∘ While taking POMALYST ∘ During any breaks (interruptions) in your treatment with POMALYST ∘ For at least 4 weeks after stopping POMALYST Females who can become pregnant: ∘ Will have pregnancy tests weekly for 4 weeks, then every 4 weeks if your menstrual cycle is regular, or every 2 weeks if your menstrual cycle is irregular. If you miss your period or have unusual bleeding, you will need to have a pregnancy test and receive counseling. ∘ Must agree to use two acceptable forms of birth control at the same time, for at least 4 weeks before, while taking, during any breaks (interruptions) in your treatment, and for at least 4 weeks after stopping POMALYST. ∘ Talk with your healthcare provider to find out about options for acceptable forms of birth control that you may use to prevent pregnancy before, during, and after treatment with POMALYST.

If you become pregnant while taking POMALYST, stop taking it right away and call your healthcare provider. If your healthcare provider is not available, you can call the REMS Call Center at 1-888-423-5436. Healthcare providers and patients should report all cases of pregnancy to: ∘ FDA MedWatch at 1-800-FDA-1088, and ∘ REMS Call Center at 1-888-423-5436 There is a pregnancy exposure registry that monitors the outcomes of females who take POMALYST during pregnancy, or if their male partner takes POMALYST and they are exposed during pregnancy.

You can enroll in this registry by calling the REMS Call Center at the phone number listed above. POMALYST can pass into human semen: ∘ Males, including those who have had a vasectomy, must always use a latex or synthetic condom during any sexual contact with a pregnant female or a female that can become pregnant while taking POMALYST, during any breaks (interruptions) in your treatment with POMALYST, and for 4 weeks after stopping POMALYST. ∘ Do not have unprotected sexual contact with a female who is or could become pregnant.

Tell your healthcare provider if you do have unprotected sexual contact with a female who is or could become pregnant. ∘ Do not donate sperm while taking POMALYST, during any breaks (interruptions) in your treatment, and for 4 weeks after stopping POMALYST. If a female becomes pregnant with your sperm, the baby may be exposed to POMALYST and may be born with birth defects. Men, if your female partner becomes pregnant, you should call your healthcare provider right away. • Blood clots in your arteries, veins, and lungs, heart attack, and stroke can happen if you take POMALYST.

Most people who take POMALYST will also take a blood thinner medicine to help prevent blood clots. Before taking POMALYST, tell your healthcare provider: ∘ If you have had a blood clot in the past ∘ If you have high blood pressure, smoke, or if you have been told you have a high level of fat in your blood (hyperlipidemia) ∘ About all the medicines you take. Certain other medicines can al…