Pomalidomide 1 mg Capsule, 100-count
🆔 Identity & classification
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🏷️ RxNorm drug class
This medicine belongs to the Thalidomide Analog class.
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🏭 Manufacturer & labeler
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🩺 Clinical
Pomalidomide is used in combination with dexamethasone to treat multiple myeloma (a type of cancer of the bone marrow) that has not improved during or within 60 days of treatment with at least two other medications, including lenalidomide (Revlimid) and a proteasome inhibitor such as bortezomib (Velcade) or carfilzomib (Kyprolis). It is also used to treat Kaposi's sarcoma (a type of cancer that causes abnormal tissue to grow on different parts of the body) related to acquired immunodeficiency syndrome (AIDS) after unsuccessful treatment with other medications or in people with Kaposi's sarcoma...
Read the full MedlinePlus article ↗- Pomalidomide is closely related to thalidomide — a drug that caused devastating birth defects in thousands of children decades ago. Because of that history, the FDA requires a spec...
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🧪 Inactive Ingredients / Excipients
Inactive ingredients, also called excipients, are components of the drug product other than the active ingredient. They may include fillers, dyes, coatings, preservatives, flavors, or other formulation ingredients.
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UNII 5138Q19F1X
Ammonia is a colorless gas made from nitrogen and hydrogen. It's used in medicines as a pH buffer to maintain the correct acidity level and help keep the product stable.
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UNII XM0M87F357
A dark iron oxide compound that gives medicines their black or dark color. It's used as a colorant in tablets and capsules to help identify the product and make it visually distinctive.
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UNII 2G86QN327L
Gelatin is a protein derived from animal collagen, commonly used in medicines as a gelling agent and capsule material. It helps create soft or hard capsule shells that hold and release medication, and can also thicken liquid formulations.
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UNII 3OWL53L36A
A natural sugar alcohol derived from seaweed or synthesized in the lab. It's used as a filler to add bulk, a sweetener in sugar-free formulas, and a disintegrant to help tablets break apart in the stomach.
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UNII 7T9FYH5QMK
A plant-derived powder that serves as a binder and filler in tablets and capsules. It helps hold ingredients together, adds bulk, and aids in smooth tablet disintegration when swallowed.
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Potassium hydroxide is a strong alkaline chemical used in medicines to adjust and maintain the pH level of liquid formulations, helping keep the product stable and the active ingredients effective.
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UNII 6DC9Q167V3
Propylene glycol is a clear liquid derived from petroleum or vegetable sources. It acts as a solvent, humectant, and preservative in medicines, helping dissolve active ingredients and maintain product stability.
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UNII 46N107B71O
Shellac is a natural resin secreted by the lac beetle. It's used as a coating on tablets and capsules to control how quickly the medicine dissolves and to improve appearance and stability.
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UNII 7CV7WJK4UI
Sodium stearyl fumarate is a synthetic compound made from stearyl alcohol and fumaric acid. It acts as a lubricant and glidant in tablets and capsules, helping ingredients flow smoothly during manufacturing and preventing sticking.
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UNII O8232NY3SJ
A plant-based carbohydrate derived from corn kernels. It acts as a filler to add bulk, a binder to hold ingredients together, and a disintegrant to help the tablet break apart in your stomach for absorption.
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UNII 15FIX9V2JP
Titanium dioxide is a bright white mineral powder commonly used as a colorant and opacifying agent. It makes pills and tablets white or lighter in color and helps make coatings non-transparent.
11 inactive ingredients listed in the exact product block matched to this NDC.
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ingredient classCode="IACT" elements from the exact product block matched by this NDC. Label-section narrative from DailyMed / the openFDA label index is shown separately when available.Inactive ingredient FAQ
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💲 Pricing
A drug doesn't have one price. Each row is a different public payment system, and none is what you'd pay at the counter — that depends on your insurance. The ⓘ on each row explains what it measures.
| Price system | Per each | Per package |
|---|---|---|
| Retail pharmacies payNADAC · weekly | Not in the retail survey — common for institutional, discontinued, or low-volume packs. | |
| Medicaid paysCMS SDUD · 12 mo | No recent Medicaid claims on file for this NDC — rare and low-volume NDCs are suppressed in the public data. | |
| Medicare drug plans payPart D · Q2 2026 | $536.29 | $53,628.98 / 100 capsules |
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🔁 Therapeutic equivalents
| Product | Labeler | Pack | NADAC/unit | TE | Status | Price vs. this |
|---|---|---|---|---|---|---|
| Pomalidomide 1 mg 00480-4018-21 | Teva | 21 capsules | — | AB | FDA listed | — |
| Pomalidomide 1 mgthis 31722-0770-01 | Camber | 100 capsules | — | AB | FDA listed | — |
| Pomalidomide 1 mg 51991-0342-21 | Breckenridge | 21 capsules | — | AB | FDA listed | — |
| Pomalyst 1 mg 59572-0501-00 | Celgene | 100 capsules | — | AB | FDA listed | — |
| Pomalidomide 1 mg 59651-0194-01 | Aurobindo | 100 capsules | — | AB | FDA listed | — |
| Pomalidomide 1 mg 60505-4497-02 | Apotex | 21 capsules | — | AB | FDA listed | — |
| Pomalidomide 1 mg 63850-0131-01 | Natco | 21 capsules | — | AB | FDA listed | — |
| Pomalidomide 1 mg 69097-0036-07 | Cipla | 100 capsules | — | — | FDA listed | — |
| pomalidomide 1 mg 43598-0520-01 | Dr. | 100 capsules | — | — | FDA listed | — |
| Pomalidomide 1 mg 00781-2354-27 | Sandoz | 21 capsules | — | — | FDA listed | — |
| Pomalidomide 1 mg 70095-0057-01 | Sun | 21 capsules | — | — | FDA listed | — |
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⏳ Availability & generic status
This product is an FDA-approved generic. Other versions of the same drug are listed under Therapeutic equivalents, least expensive first.
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📊 Medicare Part D spend CMS · PART D · 2026 (Q1)
🔬 Reported adverse events (FAERS)
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📦 Packaging — all sizes for this product
| Package NDC | Description | Marketing start | Status |
|---|---|---|---|
| 31722-0770-01 You're viewing this | 100 CAPSULE in 1 BOTTLE (31722-770-01) | 2026-02-28 | Active |
| 31722-0770-21 | 21 CAPSULE in 1 BOTTLE (31722-770-21) | 2026-02-28 | Active |
| 31722-0770-32 | 6 BLISTER PACK in 1 CARTON (31722-770-32) / 10 CAPSULE in 1 BLISTER PACK | 2026-02-28 | Active |
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| NDC identity (package / product / labeler codes) | ✓ Available |
| Labeler | ✓ Available |
| Product & package description | ✓ Available |
| Marketing category & status | ✓ Available |
| Active ingredient / dosage form / route | ✓ Available |
| FDA label (SPL via DailyMed) | ✓ Available |
| Package photos | ✓ Available |
| Inactive ingredients (structured) | ✓ Available |
| NADAC pharmacy acquisition price (CMS) | — Not published for this NDC CMS publishes NADAC only for NDCs reported in its retail-pharmacy survey. |
| Orange Book / therapeutic-equivalence data | ✓ Available |
| HCPCS J-code billing crosswalk | — Not published for this NDC Most self-administered / retail products have no J-code — that is normal. |
| Medicaid utilization (CMS SDUD) | — Not published for this NDC CMS reports utilization only for NDCs with Medicaid claims above its privacy threshold. |
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📄 Full prescribing information FDA SPL
🚨 Boxed Warning ▾
WARNING: EMBRYO-FETAL TOXICITY and VENOUS AND ARTERIAL THROMBOEMBOLISM WARNING: EMBRYO-FETAL TOXICITY and VENOUS AND ARTERIAL THROMBOEMBOLISM Embryo-Fetal Toxicity • Pomalidomideis contraindicated in pregnancy. Pomalidomide is 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 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 treatment [see Contraindications (4), Warnings and Precautions (5.1) and Use in Specific Populations (8.1, 8.3) ]. Pomalidomide is only available through a restricted distribution program called PS-Pomalidomide REMS [see Warnings and Precautions (5.2) ] .
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. 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 (5.3) ]. See full prescribing information for complete boxed warning EMBRYO-FETAL TOXICITY • Pomalidomide is contraindicated in pregnancy. Pomalidomide is a thalidomide analogue.
Thalidomide is a known human teratogen that causes severe life-threatening birth defects ( 4 , 5.1 , 8.1 ). • For females of reproductive potential: Exclude pregnancy before start of treatment. Prevent pregnancy during treatment by the use of 2 reliable methods of contraception ( 5.1 , 8.3 ). Pomalidomide is available only through a restricted program called PS-Pomalidomide REMS ( 5.2 ).
VENOUS AND ARTERIAL THROMBOEMBOLISM • Deep venous thrombosis (DVT), pulmonary embolism (PE), myocardial infarction, and stroke occur in patients with multiple myeloma treated with pomalidomide. Antithrombotic prophylaxis is recommended ( 5.3 ).
🎯 Indications and Usage ▾
1 INDICATIONS AND USAGE Pomalidomide 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 ).
1.1Multiple 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.
⏱️ Dosage and Administration ▾
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 ). • 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 pomalidomide capsules [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 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) ].
2.4Dosage Modifications for Hematologic Adverse Reactions Multiple Myeloma: Dosage Modifications for Hematologic Adverse Reactions Initiate a new cycle of pomalidomide capsules 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 pomalidomide capsules for hematologic adverse reactions in patients with MM are summarized in Table 1. Table 1: Dosage Modifications for Pomalidomide Capsules for Hematologic in MM Adverse Reaction Severity Dosage Modification 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 pomalidomide capsules until ANC is greater than or equal to 500 per mcL; follow CBC weekly.
Resume pomalidomide capsules dose at 1 mg less than the previous dose.* For each subsequent drop of ANC less than 500 per mcL Withhold pomalidomide capsules until ANC is greater than or equal to 500 mcL. Resume pomalidomide capsules dose at 1 mg less than the previous dose.* Thrombocytopenia [see Warnings and Precautions (5.5) ] Platelets less than 25,000 per mcL Withhold pomalidomide capsules until platelets are greater than or equal to 50,000 per mcL; follow CBC weekly. Resume pomalidomide capsules dose at 1 mg less than the previous dose.* For each subsequent drop of platelets less than 25,000 per mcL Withhold pomalidomide capsules until platelets are greater than or equal to 50,000 per mcL.
Resume pomalidomide capsules at 1 mg less than the previous dose.* * Permanently discontinue pomalidomide capsules if unable to tolerate 1 mg once daily. ANC= absolute neutrophil count
2.5Dosage Modifications for Non-Hematologic Adverse Reactions Permanently discontinue pomalidomide capsules for angioedema, anaphylaxis, Grade 4 rash, skin exfoliation, bullae, or any other severe dermatologic reaction [See Warnings and Precautions (5.7 , 5.12) ]. For other Grade 3 or 4 toxicities, hold treatment and restart treatment at 1 mg less than the previous dose when toxicity has resolved to less than or equal to Grade 2 at the physician’s discretion.
2.6Dosage Modifications for Strong CYP1A2 Inhibitors Avoid concomitant use of pomalidomide capsules with strong CYP1A2 inhibitors. If concomitant use of a strong CYP1A2 inhibitor is unavoidable, reduce pomalidomide capsules dose to 2 mg [see Drug Interactions (7.1) and Clinical Pharmacology (12.3) ].
2.7Dosage Modification for Severe Renal Impairment on Hemodialysis Take pomalidomide capsules after completion of dialysis procedure on hemodialysis days [see Use in Specific Populations (8.6) and Clinical Pharmacology (12.3) ]. • For patients with MM with severe renal impairment requiring dialysis, reduce the recommended dosage to 3 mg orally daily.
2.8Dosage Modification for Hepatic Impairment Multiple Myeloma For patients with MM with mild or moderate hepatic impairment (Child-Pugh A or B), reduce the recommended dosage to 3 mg orally daily. For patients with MM with severe hepatic impairment (Child-Pugh C),…
💊 Dosage Forms and Strengths ▾
3 DOSAGE FORMS AND STRENGTHS Pomalidomide capsules are available in the following capsule strengths: • 1 mg: Opaque, white cap and opaque white body, hard gelatin capsules imprinted with 'H' on cap and 'P1' on body, filled with pale yellow to yellowish color powder. • 2 mg: Opaque, white cap and opaque brown body, hard gelatin capsules imprinted with 'H' on cap and 'P2' on body, filled with pale yellow to yellowish color powder. • 3 mg: Opaque, white cap and opaque pink body, hard gelatin capsules imprinted with 'H' on cap and 'P3' on body, filled with pale yellow to yellowish color powder. • 4 mg: Opaque, white cap and opaque white body, hard gelatin capsules imprinted with 'H' on cap and 'P4' on body, filled with pale yellow to yellowish color powder.
Capsules: 1 mg, 2 mg, 3 mg, and 4 mg ( 3 )
⛔ Contraindications ▾
4 CONTRAINDICATIONS • Pregnancy (4.1 ) • Hypersensitivity ( 4.2 )
4.1Pregnancy Pomalidomide is contraindicated in females who are pregnant. Pomalidomide 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.
4.2Hypersensitivity Pomalidomide is 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) ].
⚠️ Warnings and Cautions ▾
5 WARNINGS AND PRECAUTIONS • 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 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 for angioedema and anaphylaxis ( 5.12 ).
5.1Embryo-Fetal Toxicity Pomalidomide is 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 is only available through the PS-Pomalidomide REMS program [see Warnings and Precautions ( 5.2 )].
Females of Reproductive Potential Females of reproductive potential must avoid pregnancy for at least 4weeksbefore beginning pomalidomide 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, during therapy, during dose interruptions, and continuing for 4 weeks following discontinuation of pomalidomide therapy.
Two negative pregnancy tests must be obtained prior to initiating therapy. The first test should be performed within 10 to 14 days and the second test within 24 hours prior to prescribing pomalidomide 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 ( 8.3)]. 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 and for up to 4 weeks after discontinuing pomalidomide, even if they have undergone a successful vasectomy. Male patients taking pomalidomide must not donate sperm [see Use in Specific Populations ( 8.3)]. Blood Donation Patients must not donate blood during treatment with pomalidomide 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.
5.2PS-Pomalidomide REMS Because of the embryo-fetal risk [see Warnings and Precautions (5.1) ] , pomalidomide is available only through a restricted program under a Risk Evaluationand Mitigation Strategy (REMS), “PS-Pomalidomide REMS”. Required componentsof PS-Pomalidomide REMS include the following: • Prescribers must be certified with PS-Pomalidomide REMS by enrolling and complying with the REMS requirements. • Patients must signaPatient-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 (8.3) ] and males must comply with contraception requirements [see Use in Specific Populations (8.3) ]. • Pharmacies mustbe certified with PS-Pomalidomide REMS , must only dispense to patients who are authorized to receive pomalidomide and comply with REMS requirements.
Further information about PS-Pomalidomide REMS is availableat www.PS-PomalidomideREMS.com or by telephone at 1-888-423-5436.
5.3Venous and Arterial Thromboembolism Venous thromboembolic events (deep venous thrombosis and…
🤒 Adverse Reactions ▾
6 ADVERSE REACTIONS 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 ).
To report SUSPECTED ADVERSE REACTIONS, contact Hetero Labs Limited at 1-866-495-1995 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
6.1Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. Multiple Myeloma (MM) In Trial 1, data were evaluated from 219 patients (safety population) who received treatment with pomalidomide + Low-dose Dex (112 patients) or pomalidomide alone (107 patients). Median number of treatment cycles was 5.
Sixty-seven percent of patients in the study had a dose interruption of either drug due to adverse reactions. Forty-two percent of patients in the study had a dose reduction of either drug due to adverse reactions. The discontinuation rate due to adverse reactions was 11%.
In Trial 2, data were evaluated from 450 patients (safety population) who received treatment with pomalidomide + Low-dose Dex (300 patients) or High-dose Dexamethasone (High-dose Dex) (150 patients). The median number of treatment cycles for the pomalidomide + Low-dose Dex arm was 5. In the pomalidomide + Low-dose Dex arm, 67% of patients had a dose interruption of pomalidomide, the median time to the first dose interruption of pomalidomide was 4.1 weeks.
Twenty-seven percent of patients had a dose reduction of pomalidomide, the median time to the first dose reduction of pomalidomide was 4.5 weeks. Eight percent of patients discontinued pomalidomide due to adverse reactions. Tables 3 and 4 summarize the adverse reactions reported in Trials 1 and 2, respectively.
Table 3: Adverse Reactions in Any Pomalidomide Treatment Arm in Trial 1* *Regardless of attribution of relatedness to pomalidomide. a Pomalidomide alone arm includes all patients randomized to the pomalidomide alone arm who took study drug; 61 of the 107 patients had dexamethasone added during the treatment period. b Serious adverse reactions were reported in at least 2 patients in any pomalidomide treatment arm. Data cutoff: 01 March 2013 Table 4: Adverse Reactions in Trial 2 a Percentage did not meet the criteria to be considered as an adverse reaction for pomalidomide for that category of event (i.e., all adverse events or Grade 3 or 4 adverse events). b Serious adverse reactions were reported in at least 3 patients in the POM + Low-dose Dex arm, AND at least 1% higher than the High-dose-Dex arm percentage.
Data cutoff: 01 March 2013 Other Adverse Reactions Other adverse reactions of pomalidomide in patients with MM, not described above, and considered important: Cardiac Disorders: Myocardial infarction, Atrial fibrillation, Angina pectoris, Cardiac failure congestive Ear and Labyrinth Disorders: Vertigo Gastr…
🔄 Drug Interactions ▾
7 DRUG INTERACTIONS Strong CYP1A2 Inhibitors: Avoid concomitant use of strong CYP1A2 inhibitors. If concomitant use of a strong CYP1A2 inhibitor is unavoidable, reduce pomalidomide dose to 2 mg ( 2.6, 7.1, 12.3 ).
7.1Drugs That Affect Pomalidomide Plasma Concentrations CYP1A2 inhibitors: In healthy subjects, co-administration of fluvoxamine, a strong CYP1A2 inhibitor, increased C max and AUC of pomalidomide by 24% and 125% respectively [see Clinical Pharmacology (12.3) ]. Increased pomalidomide exposure may increase the risk of exposure related toxicities. Avoid co-administration of strong CYP1A2 inhibitors (e.g. ciprofloxacin and fluvoxamine).
If co-administration is unavoidable, reduce the pomalidomide dose [see Dosage and Administration (2.6) ].
👥 Use in Specific Populations ▾
8 USE IN SPECIFIC POPULATIONS • Lactation: Advise women not to breastfeed ( 8.2 ).
8.1Pregnancy Pregnancy Exposure Registry There is a pregnancy exposure registry that monitors pregnancy outcomes in females exposed to pomalidomide during pregnancy as well as female partners of male patients who are exposed to pomalidomide. This registry is also used to understand the root cause for the pregnancy. Report any suspected fetal exposure to pomalidomide 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 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 is 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.
Alimentary tract, urinary tract, and genital malformations have also been documented, and mortality at or shortly after birth has been reported in about 40% of infants. Pomalidomide was teratogenic in both rats and rabbits when administered during the period of organogenesis. Pomalidomide crossed the placenta after administration to pregnant rabbits (see Data) .
If this drug is used during pregnancy or if the patient becomes pregnant while taking this drug, the patient should be apprised of the potential risk to a fetus. If pregnancy does occur during treatment, immediately discontinue the drug. Under these conditions, refer patient to an obstetrician/gynecologist experienced in reproductive toxicity for further evaluation and counseling.
Report any suspected fetal exposure to pomalidomide to the FDA via the MedWatch program at 1-800-FDA-1088 and also to the REMS Call Center at 1-888-423-5436. The estimated background risk of major birth defects and miscarriage for the indicated population is unknown. The estimated background risk in the U.S. general population of major birth defects is 2% to 4% and of miscarriage is 15% to 20% of clinically recognized pregnancies.
Data Animal Data Pomalidomide was teratogenic in both rats and rabbits in the embryo-fetal developmental studies when administered during the period of organogenesis. In rats, pomalidomide was administered orally to pregnant animals at doses of 25 to 1000 mg/kg/day. Malformations or absence of urinary bladder, absence of thyroid gland, and fusion and misalignment of lumbar and thoracic vertebral elements (vertebral, central, and/or neural arches) were observed at all dose levels.
There was no maternal toxicity observed in this study. The lowest dose in rats resulted in an exposure (AUC) approximately 85-fold of the human exposure at the recommended dose of 4 mg/day. Other embryo-fetal toxicities included increased resorptions leading to decreased number of viable fetuses.
In rabbits, pomalidomide was administered orally to pregnant animals at doses of 10 to 250 mg/kg/day. Increased cardiac malformations such as interventricular septal defect were seen at all doses with significant increases at 250 mg/kg/day. Additional malformations observed at 250 mg/kg/day included anomalies in limbs (flexed and/or rotated fore - and/or hindlimbs, unattached or absent digit) and associated skeletal malformations (not ossified metacarpal, misaligned phalanx and metacarpal, absent digit, not ossified phalanx, and short not ossified or bent tibia), moderate dilation of the lateral ventricle in the brain, abnormal placement of the right subclavian artery, absent intermediate lobe in the lungs, low-s…
🤰 Pregnancy ▾
8.1Pregnancy Pregnancy Exposure Registry There is a pregnancy exposure registry that monitors pregnancy outcomes in females exposed to pomalidomide during pregnancy as well as female partners of male patients who are exposed to pomalidomide. This registry is also used to understand the root cause for the pregnancy. Report any suspected fetal exposure to pomalidomide 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 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 is 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.
Alimentary tract, urinary tract, and genital malformations have also been documented, and mortality at or shortly after birth has been reported in about 40% of infants. Pomalidomide was teratogenic in both rats and rabbits when administered during the period of organogenesis. Pomalidomide crossed the placenta after administration to pregnant rabbits (see Data) .
If this drug is used during pregnancy or if the patient becomes pregnant while taking this drug, the patient should be apprised of the potential risk to a fetus. If pregnancy does occur during treatment, immediately discontinue the drug. Under these conditions, refer patient to an obstetrician/gynecologist experienced in reproductive toxicity for further evaluation and counseling.
Report any suspected fetal exposure to pomalidomide to the FDA via the MedWatch program at 1-800-FDA-1088 and also to the REMS Call Center at 1-888-423-5436. The estimated background risk of major birth defects and miscarriage for the indicated population is unknown. The estimated background risk in the U.S. general population of major birth defects is 2% to 4% and of miscarriage is 15% to 20% of clinically recognized pregnancies.
Data Animal Data Pomalidomide was teratogenic in both rats and rabbits in the embryo-fetal developmental studies when administered during the period of organogenesis. In rats, pomalidomide was administered orally to pregnant animals at doses of 25 to 1000 mg/kg/day. Malformations or absence of urinary bladder, absence of thyroid gland, and fusion and misalignment of lumbar and thoracic vertebral elements (vertebral, central, and/or neural arches) were observed at all dose levels.
There was no maternal toxicity observed in this study. The lowest dose in rats resulted in an exposure (AUC) approximately 85-fold of the human exposure at the recommended dose of 4 mg/day. Other embryo-fetal toxicities included increased resorptions leading to decreased number of viable fetuses.
In rabbits, pomalidomide was administered orally to pregnant animals at doses of 10 to 250 mg/kg/day. Increased cardiac malformations such as interventricular septal defect were seen at all doses with significant increases at 250 mg/kg/day. Additional malformations observed at 250 mg/kg/day included anomalies in limbs (flexed and/or rotated fore - and/or hindlimbs, unattached or absent digit) and associated skeletal malformations (not ossified metacarpal, misaligned phalanx and metacarpal, absent digit, not ossified phalanx, and short not ossified or bent tibia), moderate dilation of the lateral ventricle in the brain, abnormal placement of the right subclavian artery, absent intermediate lobe in the lungs, low-set kidney, altered liver morphology, incompletely or not ossified pelvis, an increa…
🧒 Pediatric Use ▾
8.4Pediatric Use The safety and effectiveness of pomalidomide have not been established in pediatric patients. The safety and effectiveness were assessed but not established in two open-label studies: a dose escalation study in 25 pediatric patients aged 5 to <17 with recurrent, progressive or refractory CNS tumors [NCT02415153] and a parallel-group study conducted in 47 pediatric patients aged 4 to <17 years with recurrent or progressive high-grade glioma, medulloblastoma, ependymoma, or diffuse intrinsic pontine glioma (DIPG) [NCT03257631].
No new safety signals were observed in pediatric patients across these studies. At the same dose by body surface area, pomalidomide exposure in 55 pediatric patients aged 4 to < 17 years old was within the range observed in adult patients with MM but higher than the exposure observed in adult patients with KS [see Clinical Pharmacology (12.3) ].
🧓 Geriatric Use ▾
8.5Geriatric Use Multiple Myeloma Of the total number of patients in clinical studies of pomalidomide, 44% were aged older than 65 years, while 10% were aged older than 75 years. No overall differences in effectiveness were observed between these patients and younger patients. In these studies, patients older than 65 years were more likely than patients less than or equal to 65 years of age to experience pneumonia.
🆘 Overdosage ▾
10 OVERDOSAGE Hemodialysis can remove pomalidomide from circulation.
🧬 Clinical Pharmacology ▾
12 CLINICAL PHARMACOLOGY
12.1Mechanism of Action 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. In vitro , in the presence of drug, substrate proteins (including Aiolos and Ikaros) are targeted for ubiquitination and subsequent degradation leading to direct cytotoxic and immunomodulatory effects.
In in vitro cellular assays, pomalidomide inhibited proliferation and induced apoptosis of hematopoietic tumor cells. Additionally, pomalidomide inhibited the proliferation of lenalidomide-resistant multiple myeloma (MM) cell lines and synergized with dexamethasone in both lenalidomide-sensitive and lenalidomide-resistant cell lines to induce tumor cell apoptosis. Pomalidomide enhanced T cell- and natural killer (NK) cell-mediated immunity and inhibited production of pro-inflammatory cytokines (e.g., TNF-α and IL-6) by monocytes.
Pomalidomide demonstrated anti-angiogenic activity in a mouse tumor model and in the in vitro umbilical cord model.
12.2Pharmacodynamics Pomalidomide exposure-response analyses showed that there was no relationship between systemic pomalidomide exposure level and efficacy or safety following pomalidomide dose of 4 mg. Cardiac Electrophysiology The QTc prolongation potential of pomalidomide was evaluated in a single center, randomized, double-blind crossover study (N=72) using 4 mg pomalidomide, 20 mg pomalidomide, placebo, and 400 mg moxifloxacin (positive control). No significant QTc prolongation effect of pomalidomide was observed following pomalidomide doses of 4 and 20 mg.
12.3Pharmacokinetics 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. Absorption Following administration of single oral doses of pomalidomide, the maximum plasma concentration (C max ) for pomalidomide occurs at 2 to 3 hours postdose in patients with MM. Effect of Food Co-administration of pomalidomide with a high-fat meal (approximately 50% of the total caloric content) and high-calorie meal (approximately 800 to 1000 calories) (the meal contained approximately 150, 250, and 500 to 600 calories from protein, carbohydrates, and fat, respectively) delays the T max by 2.5 hours, decreased mean plasma C max and AUC in healthy subjects by about 27% and 8%, respectively.
Distribution Pomalidomide has a mean apparent volume of distribution (Vd/F) between 62 and 138 L at steady state in patients with MM. Pomalidomide is distributed in semen of healthy subjects at a concentration of approximately 67% of plasma level at 4 hours postdose (~T max ) after 4 days of 2 mg once-daily dosing. Human plasma protein binding of pomalidomide ranges from 12% to 44% and is not concentration dependent.
Pomalidomide is a substrate for P-gp. Elimination Pomalidomide has a mean total body clearance (CL/F) of 7 to 10 L/h in patients with MM. Pomalidomide is eliminated with a median plasma half-life of 9.5 hours in healthy subjects and 7.5 hours in patients with MM.
Metabolism Pomalidomide is primarily metabolized in the liver by CYP1A2 and CYP3A4. Minor contributions from CYP2C19 and CYP2D6 were also observed in vitro. Excretion Following a single oral administration of [ 14 C]-pomalidomide to healthy subjects, approximately 73% and 15% of the radioactive dose was eliminated in urine and feces, respectively, with approximately 2% and 8% of the radiolabeled dose eliminated unchanged as pomalidomide in urine and feces.
Specific Populations Age (61 to 85 years old), sex and race have no clinically significant effect on the systemic exposure of pomalidomide. Patients with Renal Impairment Pomalidomide pharmacokinetic parameters were not significantly affected in patients with moderat…
🧬 Mechanism of Action ▾
12.1Mechanism of Action 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. In vitro , in the presence of drug, substrate proteins (including Aiolos and Ikaros) are targeted for ubiquitination and subsequent degradation leading to direct cytotoxic and immunomodulatory effects.
In in vitro cellular assays, pomalidomide inhibited proliferation and induced apoptosis of hematopoietic tumor cells. Additionally, pomalidomide inhibited the proliferation of lenalidomide-resistant multiple myeloma (MM) cell lines and synergized with dexamethasone in both lenalidomide-sensitive and lenalidomide-resistant cell lines to induce tumor cell apoptosis. Pomalidomide enhanced T cell- and natural killer (NK) cell-mediated immunity and inhibited production of pro-inflammatory cytokines (e.g., TNF-α and IL-6) by monocytes.
Pomalidomide demonstrated anti-angiogenic activity in a mouse tumor model and in the in vitro umbilical cord model.
📦 How Supplied / Storage and Handling ▾
16 HOW SUPPLIED/STORAGE AND HANDLING Pomalidomide Capsules, 1 mg are opaque, white cap and opaque white body, hard gelatin capsules imprinted with 'H' on cap and 'P1' on body, filled with pale yellow to yellowish color powder. They are supplied as follows: Bottles of 21 Capsules NDC 31722-770-21 Bottles of 100 Capsules NDC 31722-770-01 Carton of 60 capsules (6 x 10 unit-dose) NDC 31722-770-32 Pomalidomide Capsules, 2 mg are opaque, white cap and opaque brown body, hard gelatin capsules imprinted with 'H' on cap and 'P2' on body, filled with pale yellow to yellowish color powder.
They are supplied as follows: Bottles of 21 Capsules NDC 31722-771-21 Bottles of 100 Capsules NDC 31722-771-01 Carton of 60 capsules (6 x 10 unit-dose) NDC 31722-771-32 Pomalidomide Capsules, 3 mg are opaque, white cap and opaque pink body, hard gelatin capsules imprinted with 'H' on cap and 'P3' on body, filled with pale yellow to yellowish color powder. They are supplied as follows: Bottles of 21 Capsules NDC 31722-772-21 Bottles of 100 Capsules NDC 31722-772-01 Carton of 60 capsules (6 x 10 unit-dose) NDC 31722-772-32 Pomalidomide Capsules, 4 mg are opaque, white cap and opaque white body, hard gelatin capsules imprinted with 'H' on cap and 'P4' on body, filled with pale yellow to yellowish color powder.
They are supplied as follows: Bottles of 21 Capsules NDC 31722-773-21 Bottles of 100 Capsules NDC 31722-773-01 Carton of 60 capsules (6 x 10 unit-dose) NDC 31722-773-32 Store at 20°C to 25°C (68°F to 77°F); excursions permitted to 15°C to 30°C (59°F to 86°F). [see USP Controlled Room Temperature]. Care should be exercised in handling of pomalidomide. Do not open or crush pomalidomide capsules.
If powder from pomalidomide capsules contacts the skin, wash the skin immediately and thoroughly with soap and water. If pomalidomide contacts the mucous membranes, flush thoroughly with water. Follow procedures for proper handling and disposal of hazardous drugs.1
📋 Description ▾
11 DESCRIPTION Pomalidomide is a thalidomide analog. The chemical name is (RS)-4-Amino-2-(2,6-dioxo-piperidin-3-yl)-1H-isoindoline-1,3-dione and it has the following chemical structure: The molecular formula for pomalidomide is C 13 H 11 N 3 O 4 and the gram molecular weight is 273.24. Pomalidomide is a pale yellow to yellow color powder.
Soluble in dimethylformamide and in dimethylsulfoxide. Pomalidomide has a chiral carbon atom which exists as a racemic mixture of the R(+) and S(-) enantiomers. Pomalidomide is available in 1 mg, 2 mg, 3 mg, and 4 mg capsules for oral administration.
Each capsule contains pomalidomide as the active ingredient and the following inactive ingredients: black iron oxide, gelatin, mannitol, microcrystalline cellulose, potassium hydroxide, pregelatinized starch, propylene glycol, shellac, sodium stearyl fumarate, strong ammonia solution and titanium dioxide. In addition, the 2 mg and 3 mg capsules also contain iron oxide red. The 2 mg capsule also contains iron oxide yellow.
The botanical source for pregelatinized starch is corn starch. chemical-structure
💬 Information for Patients ▾
17 PATIENT COUNSELING INFORMATION Advise the patient to read the FDA-approved patient labeling ( Medication Guide ). Embryo-Fetal Toxicity Advise patients that pomalidomide is contraindicated in pregnancy [see Contraindications (4 )]. Pomalidomide 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 pomalidomide capsules and for at least 4 weeks after completing therapy. • Initiate pomalidomide 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 pomalidomide therapy, during dose interruptions, and for 4 weeks after she has completely finished taking pomalidomide capsules.
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 pomalidomide capsules 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 pomalidomide capsules and for up to 4 weeks after discontinuing pomalidomide capsules, even if they have undergone a successful vasectomy. • Advise male patients taking pomalidomide capsules 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 pomalidomide capsules and for 4 weeks following discontinuation of pomalidomide capsules [see Warnings and Precautions (5.1) ].
PS-Pomalidomide REMS Because of the risk of embryo-fetal toxicity, pomalidomide 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 pomalidomide capsules. 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) ]. • Pomalidomide capsules are 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 pomalidomide 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…
💬 Medication Guide ▾
MEDICATION GUIDE Pomalidomide (poe” ma lid' oh mide) capsules What is the most important information I should know about pomalidomide capsules? Before you begin taking pomalidomide capsules, 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 pomalidomide capsules, your healthcare provider will explain PS-Pomalidomide REMS to you and have you sign the Patient-Physician Agreement Form. Pomalidomide capsules 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 pomalidomide capsules.
Pomalidomide capsules are similar to the medicine thalidomide (THALOMID). We know thalidomide can cause severe life-threatening birth defects. Pomalidomide capsules have not been tested in pregnant females.
Pomalidomide capsules have harmed unborn animals in animal testing. Females must not get pregnant: o For at least 4 weeks before starting pomalidomide capsules o While taking pomalidomide capsules o During any breaks (interruptions) in your treatment with pomalidomide capsules o For at least 4 weeks after stopping pomalidomide capsules Females who can become pregnant: o 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. o 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 pomalidomide capsules. o 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 pomalidomide capsules.
If you become pregnant while taking pomalidomide capsules, 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: o FDA MedWatch at 1-800-FDA-1088, and o REMS Call Center at 1-888-423-5436 There is a pregnancy exposure registry that monitors the outcomes of females who take pomalidomide capsules during pregnancy, or if their male partner takes pomalidomide capsules and they are exposed during pregnancy.
You can enroll in this registry by calling the REMS Call Center at the phone number listed above. Pomalidomide can pass into human semen: o 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 pomalidomide capsules, during any breaks (interruptions) in your treatment with pomalidomide capsules, and for 4 weeks after stopping pomalidomide capsules. o 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. o Do not donate sperm while taking pomalidomide capsules, during any breaks (interruptions) in your treatment, and for 4 weeks after stopping pomalidomide capsules. If a female becomes pregnant with your sperm, the baby may be exposed to pomalidomide 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 pomalidomide capsules.
Most people who take pomalidomide capsules will also take a blood thinner medicine to help prevent blood clots. Before taking pomalidomide capsules, tell your healthcare provider: o If…