Consumer medicine information

Boxed Warnings

Teratogenic effects. Pomalyst (pomalidomide) is a thalidomide analogue. Thalidomide is a known human teratogen that causes severe life threatening human birth defects. If pomalidomide is taken during pregnancy, it may cause birth defects or death to an unborn baby. Women should be advised to avoid pregnancy whilst taking Pomalyst (pomalidomide), during dose interruptions, and for 4 weeks after stopping the medicine.

1 Name of Medicine

Pomalidomide.

2 Qualitative and Quantitative Composition

Each 1 mg capsule contains 1 mg pomalidomide.
Each 2 mg capsule contains 2 mg pomalidomide.
Each 3 mg capsule contains 3 mg pomalidomide.
Each 4 mg capsule contains 4 mg pomalidomide.
For the full list of excipients, see Section 6.1 List of Excipients.
Description. Pomalidomide is a yellow solid powder. It is practically insoluble in water over the pH range 1.2-6.8 and is slightly soluble (e.g. acetone, methylene chloride) to practically insoluble (e.g. heptanes, ethanol) in organic solvents. Pomalidomide has a chiral carbon atom and exists as a racemic mixture of the R(+) and S(-) enantiomers.

3 Pharmaceutical Form

Pomalyst (pomalidomide) 1 mg capsules: dark blue/yellow size 3 gelatin capsules marked "POML" in white ink and "1 mg" in black ink. Each 1 mg capsule contains 1 mg of pomalidomide.
Pomalyst (pomalidomide) 2 mg capsules: dark blue/orange size 1 gelatin capsules marked "POML 2 mg" in white ink. Each 2 mg capsule contains 2 mg of pomalidomide.
Pomalyst (pomalidomide) 3 mg capsules: dark blue/green size 1 gelatin capsules marked "POML 3 mg" in white ink. Each 3 mg capsule contains 3 mg of pomalidomide.
Pomalyst (pomalidomide) 4 mg capsules: dark blue/blue size 1 gelatin capsules marked "POML 4 mg" in white ink. Each 4 mg capsule contains 4 mg of pomalidomide.

4 Clinical Particulars

4.9 Overdose

Pomalidomide doses as high as 50 mg as a single dose in healthy volunteers and 10 mg as once daily multiple doses in multiple myeloma patients have been studied without reported serious adverse events related to overdose. Pomalidomide was removed by haemodialysis. No specific information is available on the treatment of overdose with pomalidomide.
In the event of overdose, supportive care is advised. In Australia, for information on the management of overdose, contact the Poisons Information Centre on 13 11 26. In New Zealand, contact the National Poisons Centre on 0800 POISON or 0800 764 766 for advice on management.

5 Pharmacological Properties

5.3 Preclinical Safety Data

Genotoxicity. Pomalidomide was not mutagenic in bacterial and mammalian mutation assays, and did not induce chromosomal aberrations in human peripheral blood lymphocytes or micronuclei formation in polychromatic erythrocytes in bone marrow of rats administered doses up to 2000 mg/kg/day.
Carcinogenicity. Carcinogenicity studies have not been conducted.

6 Pharmaceutical Particulars

6.7 Physicochemical Properties

Chemical Name: (RS)-4-Amino-2-(2,6-dioxo-piperidin-3-yl)- isoindoline-1,3-dione.
Chemical structure.
https://stagingapi.mims.com/au/public/v2/images/fullchemgif/CSPOMALI.gif CAS number. 19171-19-8.
Molecular Formula: C₁₃H₁₁N₃O₄.
Molecular Weight: 273.24.

7 Medicine Schedule (Poisons Standard)

Schedule 4 (Prescription Only Medicine).

Summary Table of Changes

https://stagingapi.mims.com/au/public/v2/images/fulltablegif/POMALYST.gif