Pomalidomide
Generic Name: pomalidomide
Brand Names:
Pomalidomide
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.
Overview
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.
Uses
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 ). 1.1 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.
Dosage
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 ). 2.1 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.
Side Effects
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...
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 ). 7.1 Drugs 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) ].
Warnings
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. 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 ). 4 CONTRAINDICATIONS • Pregnancy (4.1 ) • Hypersensitivity ( 4.2 ) 4.1 Pregnancy 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) ] .
Pregnancy
8.1 Pregnancy 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.
Storage
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.
Frequently Asked Questions
What is Pomalidomide used for?▼
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 ). 1.1 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.
What are the side effects of Pomalidomide?▼
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...
Can I take Pomalidomide during pregnancy?▼
8.1 Pregnancy 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.
What are the important warnings for Pomalidomide?▼
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. 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 ). 4 CONTRAINDICATIONS • Pregnancy (4.1 ) • Hypersensitivity ( 4.2 ) 4.1 Pregnancy 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) ] .
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Medical Disclaimer
This drug information is for educational purposes only and should not replace professional medical advice. Drug information is sourced from the FDA National Drug Code Directory and Structured Product Labeling. Always consult with a healthcare provider before starting, stopping, or changing any medication.