Pomalyst 4 mg/1
pomalidomide · CAPSULE · Celgene Corporation
Pomalyst is a capsule containing pomalidomide at 4 mg/1, taken oral. Manufactured by Celgene Corporation.
Key Facts
- Brand Name
- Pomalyst
- Generic Name
- pomalidomide
- NDC Code (Product)
59572-504- Manufacturer
- Celgene Corporation
- Strength
- 4 mg/1
- Dosage Form
- CAPSULE
- Route
- ORAL
- Marketing Status
- Application #
- NDA204026
- Drug Class
- Thalidomide Analog [EPC]
- Marketing Start
- 02/18/2013
Recall History
Kroger Specialty Pharmacy, Inc.
Lack of Processing Controls.
Side Effects Reported to FDA
FDA FAERS database · These are reported events, not confirmed side effects
Full Prescribing Information
Indications & Usage
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 ). 1.1 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. 1.2 Kaposi Sarcoma POMALYST is indicated for the treatment of: • Adult patients with AIDS-related Kaposi sarcoma …
Dosage & 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 ). • 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 POMALYST [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 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) ] . 2.3 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 …
Contraindications
4 CONTRAINDICATIONS • Pregnancy ( 4.1 ) • Hypersensitivity ( 4.2 ) 4.1 Pregnancy POMALYST is contraindicated in females who are pregnant. POMALYST 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. 4.2 Hypersensitivity POMALYST 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) ] .
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 POMALYST 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 POMALYST dose [see Dosage and Administration (2.6) ] .
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 ). • KS: Most common adverse reactions including laboratory …
Frequently Asked Questions
What is Pomalyst used for?
Pomalyst contains pomalidomide. It is a capsule taken oral. Consult your doctor for specific uses.
Is Pomalyst a controlled substance?
Pomalyst is not classified as a controlled substance by the DEA.
What is the generic name for Pomalyst?
The generic name for Pomalyst is pomalidomide. There are 10 other brand versions of pomalidomide.
What is the NDC code for Pomalyst 4 mg/1?
The NDC (National Drug Code) for Pomalyst 4 mg/1 is 59572-504, listed by Celgene Corporation.