Pomalidomide

Pomalidomide is an analogue of thalidomide with immunomodulatory, antiangiogenic, and antineoplastic properties. Cellular activities of pomalidomide are mediated through its target cereblon, a component of a cullin ring E3 ubiquitin ligase enzyme complex.

• 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 ). with AIDS-related Kaposi sarcoma (KS) after failure of highly active antiretroviral therapy (HAART) or in patients with KS who are HIV-negative.ICD-10: B20, C90.00

• 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 )].contraindicated

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 ). 2.1 Pregnancy Testing Prior to Administration Females of reproductive potential must have negative pregnancy testing and use contraception methods before initiating pomalidomide capsules [see Warnings and Precautions (5.1) and Use in Specific Populations (8.1, 8.3 )]. 2.2 Recommended Dosage for Multiple Myeloma The recommended dosage of pomalidomide capsules is 4 mg once daily orally with or without food on Days 1 through 21 of each 28-day cycle until disease progression. Give pomalidomide capsules in combination with dexamethasone [see Clinical Studies (14.1 )]. 2.3 Recommended Dosage for Kaposi Sarcoma The recommended dosage of pomalidomide capsules 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)].

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 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 (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.

The following clinically significant adverse reactions are described in detail in other labeling sections: Embryo-Fetal Toxicity [see Warnings and Precautions (5.1, 5.2 )] Venous and Arterial Thromboembolism [ see Warnings and Precautions (5.3) ] Increased Mortality in Patients with Multiple Myeloma When Pembrolizumab Is Added to a Thalidomide Analogue and Dexamethasone [see Warnings and Precautions (5.4) ] Hematologic Toxicity [see Warnings and Precautions (5.5) ] Hepatotoxicity [see Warnings and Precautions (5.6) ] Severe Cutaneous Reactions [see Warnings and Precautions (5.7)] Dizziness and Confusional State [see Warnings and Precautions (5.8 )] Neuropathy [see Warnings and Precautions (5.9 )] Risk of Second Primary Malignancies [see Warnings and Precautions (5.10 )] Tumor Lysis Syndrome [see Warnings and Precautions (5.11 )] Hypersensitivity [see Warnings and Precautions (5.12 )]. MM: 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 ). KS: Most common adverse reactions including laboratory abnormalities (≥30%) are decreased absolute neutrophil count or white blood cells, elevated creatinine or glucose, rash, constipation, fatigue, decreased hemoglobin, platelets, phosphate, albumin, or calcium, increased ALT, nausea, and diarrhea ( 6.1 ). To report SUSPECTED ADVERSE REACTIONS, contact Breckenridge Pharmaceutical Inc. at 1-800-367-3395 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

Lactation: Advise women not to breastfeed ( 8.2 ). 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 female and is contraindicated during pregnancy [see Contraindications (4), and Warnings and Precautions (5.1 )]. Pomalidomide capsules are a thalidomide analogue. Thalidomide is a human teratogen, inducing a high frequency of severe and life-threatening birth defects such as amelia (absence of limbs), phocomelia (short limbs), hypoplasticity of the bones, absence of bones, external ear abnormalities (including anotia, micropinna, small or absent external auditory canals), facial palsy, eye abnormalities (anophthalmos, microphthalmos), and congenital heart defects.

Metabolism

In patients with MM who received pomalidomide 4 mg daily alone or in combination with dexamethasone, pomalidomide steady-state drug exposure was characterized by AUC (CV%) of 860 (37%) ng∙h/mL and C max (CV%) of 75 (32%) ng/mL. In patients with Kaposi sarcoma (KS) who received pomalidomide 5 mg daily, pomalidomide steady-state drug exposure was characterized by AUC of 462.3 ng∙h/mL (82%) and C max of 53.1 ng/mL (50%).

Hemodialysis can remove pomalidomide from circulation.

• Feb 8, 2013NDANDA204026Bristol
• Oct 30, 2020ANDAANDA210249Eugia Pharma
• Oct 30, 2020ANDAANDA210111Breckenridge
• May 4, 2022ANDAANDA209956Teva Pharms Usa
• Jun 11, 2024ANDAANDA210164Apotex
• Sep 26, 2024ANDAANDA210236Hetero Labs Ltd V

1. 1Plasma Cell Myeloma7,9427.9%
2. 2Death7,6027.6%
3. 3Fatigue7,3737.3%
4. 4Pneumonia6,2216.2%
5. 5Off Label Use4,4814.5%
6. 6Diarrhoea3,8293.8%
7. 7White Blood Cell Count Decreased3,6183.6%
8. 8Neutropenia3,2703.3%
9. 9Rash3,0023.0%
10. 10Dyspnoea2,8122.8%
11. 11Neuropathy Peripheral2,6412.6%
12. 12Asthenia2,6402.6%
13. 13Constipation2,6292.6%
14. 14Nausea2,5142.5%
15. 15Product Dose Omission Issue2,2262.2%

The 10 most recently updated of 318 ClinicalTrials.gov registrations naming Pomalidomide as an intervention. Registration is not evidence of efficacy or safety — reference crosswalk only.

• All Japanese Population: Belantamab Mafodotin Plus Pomalidomide and Dexamethasone (Pd) Versus Bortezomib Plus Pd in Relapsed/Refractory Multiple Myeloma
  Active not recruiting · Phase 3 · Interventional · 21 enrolled · GlaxoSmithKline
  NCT06956170updated 2026-06-12
• Belantamab Mafodotin Plus Pomalidomide and Dexamethasone (Pd) Versus Bortezomib Plus Pd in Relapsed/Refractory Multiple Myeloma
  Active not recruiting · Phase 3 · Interventional · 302 enrolled · GlaxoSmithKline
  NCT04484623updated 2026-06-12
• Study Assessing Activity of Intravenous (IV) Etentamig Monotherapy Versus Standard Available Therapies in Adult Participants With Relapsed or Refractory Multiple Myeloma
  Recruiting · Phase 3 · Interventional · 380 enrolled · AbbVie
  NCT06158841updated 2026-06-12
• A Study Comparing AZD0120, a Dual-targeted CAR-T Against B-cell Maturation Antigen (BCMA) and CD19, Versus Standard Regimens in Participants With Relapsed Refractory Multiple Myeloma (DURGA-4)
  Recruiting · Phase 3 · Interventional · 508 enrolled · AstraZeneca
  NCT07391657updated 2026-06-11
• A Study to Evaluate the Efficacy and Safety of Belantamab Mafodotin in Combination With Standard of Care in Participants With Relapsed-Refractory Multiple Myeloma (RRMM)
  Recruiting · Phase 2 · Interventional · 200 enrolled · GlaxoSmithKline
  NCT07227311updated 2026-06-10
• A Study to Evaluate Mezigdomide, Bortezomib and Dexamethasone (MEZIVd) Versus Pomalidomide, Bortezomib and Dexamethasone (PVd) in Participants With Relapsed or Refractory Multiple Myeloma (RRMM)
  Recruiting · Phase 3 · Interventional · 810 enrolled · Celgene
  NCT05519085updated 2026-06-10
• Study to Evaluate Efficacy and Safety of Belantamab-based Combinations for Relapsed Multiple Myeloma
  Not yet recruiting · Observational · 100 enrolled · PETHEMA Foundation
  NCT07637526updated 2026-06-09
• Isa-Pom-Dex in Elderly/Frail Subjects With RRMM
  Active not recruiting · Phase 2 · Interventional · 6 enrolled · UNC Lineberger Comprehensive Cancer Center
  NCT05911321updated 2026-06-09
• A Study Comparing Talquetamab in Combination With Daratumumab or in Combination With Daratumumab and Pomalidomide Versus Daratumumab in Combination With Pomalidomide and Dexamethasone in Participants With Multiple Myeloma That Returns After Treatment or is Resistant to Treatment
  Active not recruiting · Phase 3 · Interventional · 864 enrolled · Janssen Research & Development, LLC
  NCT05455320updated 2026-06-09
• Pomalidomide After CAR T-cell Therapy for the Treatment of Relapsed or Refractory CD19+ B-cell Leukemia or Lymphoma
  Recruiting · Phase 1 · Interventional · 12 enrolled · University of Michigan Rogel Cancer Center
  NCT07532525updated 2026-06-09

Frequently asked questions

How does Pomalidomide work?

Pomalidomide is an analogue of thalidomide with immunomodulatory, antiangiogenic, and antineoplastic properties. Cellular activities of pomalidomide are mediated through its target cereblon, a component of a cullin ring E3 ubiquitin ligase enzyme complex.

What is Pomalidomide used for?

According to FDA labeling, Pomalidomide carries indications including: 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 ). with AIDS-related Kaposi sarcoma (KS) after failure of highly active antiretroviral therapy (HAART) or in patients with KS who are HIV-negative.. This is a reference summary of labeled uses, not medical advice or a treatment recommendation.

What class of drug is Pomalidomide?

Pomalidomide is classified as Other immunosuppressants, Thalidomide Analog, E3 Ubiquitin Ligase Inhibitors, Cellular Growth Phase Reduction, Cellular Proliferation Alteration, Increased Cellular Death, Vascular Growth Decrease.

What are the brand names for Pomalidomide?

Pomalidomide is marketed under brand names including Pomalyst.

What are the contraindications for Pomalidomide?

Pomalidomide labeling lists contraindications including: 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 )].. Always consult the full prescribing information and a clinician.