Consumer medicine information

1. Why am I using THALOMID?

THALOMID contains the active ingredient thalidomide. THALOMID is used to treat multiple myeloma, a cancer of the bone marrow. THALOMID is also used for the treatment of the skin symptoms associated with moderate to severe erythema nodosum leprosum (ENL) which can occur if you have leprosy.
For more information, see Section 1. Why am I using THALOMID? in the full CMI.

2. What should I know before I use THALOMID?

Do not use if you have ever had an allergic reaction to THALOMID or any of the ingredients listed at the end of the CMI.
Talk to your doctor if you have any other medical conditions, take any other medicines, or are pregnant or plan to become pregnant or are breastfeeding.
For more information, see Section 2. What should I know before I use THALOMID? in the full CMI.

3. What if I am taking other medicines?

Some medicines may interfere with THALOMID and affect how it works.
A list of these medicines is in Section 3. What if I am taking other medicines? in the full CMI.

4. How do I use THALOMID?

• Your doctor will choose the dose for you, monitor your progress and may adjust your dose. Your doctor will tell you how much THALOMID to take and for how long you will need to take it.

• Swallow the capsules whole with a full glass of water. Do not crush or chew the capsule.

5. What should I know while using THALOMID?

6. Are there any side effects?

Like all medicines, THALOMID can have side effects. Sometimes they may be serious, most of the time they are not. You may need medical attention if you get some of the side effects.
For more information, including what to do if you have any side effects, see Section 6. Are there any side effects? in the full CMI.

Boxed Warnings

Teratogenic effects. Thalidomide has caused severe birth defects when taken during pregnancy. Thalidomide should never be used by women who are pregnant or who could become pregnant whilst taking the medicine or could become pregnant within 4 weeks after stopping the medicine. Even a single dose can cause birth defects.

1 Name of Medicine

Thalidomide.

2 Qualitative and Quantitative Composition

Each 50 mg capsule contains 50 mg of thalidomide.
Each 100 mg capsule contains 100 mg of thalidomide.
For the full list of excipients, see Section 6.1 List of Excipients.

3 Pharmaceutical Form

Thalomid 50 mg capsules. White, opaque capsule shells imprinted with "BMS" and "50 mg" on the body, with a "Do not get pregnant" symbol in black ink (SW-9008/SW-9009) on the cap. The capsule shell contains gelatin and titanium dioxide (E171).
Thalomid 100 mg capsules. Tan, opaque capsule shells imprinted with "BMS" and "100 mg" on the body with a "Do not get pregnant" symbol in black ink (SW-9008/SW-9009) on the cap. The capsule shell contains gelatin, titanium dioxide (E171) and colourants black iron oxide and yellow iron oxide.
Description. Thalidomide has an empirical formula of C₁₃H₁₀N₂O₄ and a relative molecular mass of 258.23. It is a white to off-white powder. Thalidomide is practically insoluble in water, more soluble in ethanol and acetonitrile, and very soluble in DMF and DMSO. It has a partition coefficient in octanol/water at room temperature of about 5.
Thalidomide contains one single asymmetric carbon atom, alpha to the phthalimido nitrogen. The molecule can, therefore, exist in either of two complementary optically active forms. Thalidomide used in the Thalomid capsules formulation is a racemic mixture containing an equal amount of the S(-) and R(+) forms and therefore has a net optical rotation of zero.

4 Clinical Particulars

4.9 Overdose

Eighteen cases of overdose have been reported in the literature concerning doses up to 14.4 g. No fatalities have been reported and all overdose patients recovered without sequelae. There is no specific antidote for a thalidomide overdose. In the event of an overdose, the patient's vital signs should be monitored and appropriate supportive care given to maintain blood pressure and respiratory status.
In Australia, contact the Poisons Information Centre on 13 11 26 for advice on management of overdose.
In New Zealand, contact the National Poison Centre on 0800 POISON or 0800 764 766 for advice on management of overdose.

5 Pharmacological Properties

5.3 Preclinical Safety Data

Genotoxicity. Thalidomide was negative in tests for mutagenicity in Salmonella typhimurium, Escherichia coli and Chinese hamster ovary cells in vitro, and did not induce micronuclei in the bone marrow of mice.
Carcinogenicity. Thalidomide showed no evidence of carcinogenicity in 104 week oral gavage studies in mice administered 0, 100, 1000 or 3000 mg/kg/day (respective systemic exposures up to approximately 4 times the estimated clinical AUC at the maximum dose of 800 mg/day), male rats administered 0, 20, 160 or 300 mg/kg/day (respective exposures up to approximately 4 times the estimated clinical AUC at the maximum dose) or female rats administered 0, 30, 300 or 3000 mg/kg/day (respective exposures up to approximately 11 times the estimated clinical AUC at the maximum dose).

6 Pharmaceutical Particulars

6.7 Physicochemical Properties

Chemical structure.
https://stagingapi.mims.com/au/public/v2/images/fullchemgif/CSTHALID.gif Molecular formula: C₁₃H₁₀N₂O₄.
Molecular weight: 258.23.
Chemical name: 2-(2,6-dioxo-3-piperidinyl)- 1H-iso-indole-1,3(2H)-dione.

7 Medicine Schedule (Poisons Standard)

Schedule 4 (Prescription Only Medicine).

Summary Table of Changes

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