FREQUENTLY ASKED QUESTIONS CONCERNING Thalidomide

If you have other questions concerning Thalidomide or any other human drug products, please feel free to call Drug Information Branch (301) 827-4573.

1. What is thalidomide?

Thalidomide is a drug that was marketed outside of the United States in the late 1950’s and early 1960’s. It was used as a sleeping pill, and to treat morning sickness during pregnancy. However, its use by pregnant women resulted in the birth of thousands of deformed babies.

2. Is thalidomide approved in any other countries? If so, what countries?

Yes, thalidomide is approved in Brazil and Mexico.

3. What is thalidomide approved for in the United States?

Thalomid (thalidomide) is approved to treat the painful, disfiguring skin sores associated with leprosy, and to prevent and control the return of these skin sores.

4. Can children take Thalomid (thalidomide)?

Safety and effectiveness have not been demonstrated in pediatric patients below the age of 12.

5. Can thalidomide be used to treat other diseases such as AIDS or cancer?

Adequate and well-controlled studies are needed to determine if thalidomide is effective in treating other diseases.

6. Is Thalomid (thalidomide) use safe during pregnancy, or if I plan to get pregnant?

NO. A pregnant woman or any woman thinking about becoming pregnant must not take Thalomid (thalidomide), because it is known to cause severe birth defects or death to an unborn baby, even after taking just one dose. When a woman of child-bearing age has no other appropriate treatment choice and must take Thalomid (thalidomide), there are many precautions that must be taken to avoid pregnancy. Some of these precautions include:

• A pregnancy test 24 hours before taking Thalomid (thalidomide) and then weekly during the first month of use; then monthly in women with regular menstrual cycles, or every 2 weeks if menstrual cycles are irregular as long as you are taking Thalomid (thalidomide).
• Committing to either not having heterosexual sexual intercourse, or to using two methods of birth control starting 4 weeks before your first dose of Thalomid (thalidomide) and continuing for 4 weeks after your last dose of Thalomid (thalidomide).

7. What methods of birth control should men and women use?

Women: You must use one highly effective method:

• Birth control pills
• Implantable hormone capsules
• Injectable contraception
• Intrauterine device (IUD)

• Plus one additional effective method:
• Condoms
• Cervical cap
• Diaphragm

8. How long must I use birth control?

Women: You must use two methods of birth control beginning 4 weeks before starting treatment with Thalomid (thalidomide) and continuing for 4 weeks after stopping Thalomid (thalidomide).

Men: You must use a latex condom every time you have heterosexual sexual intercourse while you are taking Thalomid (thalidomide) and for 4 weeks after you take the last dose.

9. Can I breast-feed while taking Thalomid (thalidomide)?

NO. You must not breast-feed a baby while taking Thalomid (thalidomide) because of possible side effects to the infant.

10. Can I donate blood or sperm while being treated with Thalomid (thalidomide)?

NO. You must not donate blood or sperm while you are taking Thalomid (thalidomide).

11. Are there any side effects with Thalomid (thalidomide)?

The most serious side effect known with Thalomid (thalidomide) is its risk of severe birth defects or death to an unborn baby, even after taking one dose. Therefore, if you are pregnant or trying to get pregnant, you must not take Thalomid (thalidomide).

Thalomid (thalidomide) is also associated with the following adverse events:

• Nerve damage that can be severe and permanent. If you notice any numbness, tingling, or pain or a burning sensation in your hands and feet, stop taking Thalomid (thalidomide) and call your health care provider.
• Allergic reactions --signs may include rash, fever, a fast heart beat, or very low blood pressure. Call your health care provider if you have any of these symptoms.
• Increase in viral load for HIV positive patients
• Drowsiness -- use caution when driving or operating other heavy machinery
• Dizziness or a drop in blood pressure -- sit upright for a few minutes before standing up from a lying down or seated position to avoid falling
• Rash
• Low white blood count

12. Can I take other medications with Thalomid (thalidomide)?

Thalomid (thalidomide) can interact with certain other medications. Therefore, it is important to review all medications that you are taking with your health care provider, including those that you take without a prescription.

• Thalidomide has been reported to increase the sedative effect of barbiturates, alcohol, chlorpromazine, and reserpine.
• Medications that are known to cause numbness, tingling or nerve pain should be used cautiously with Thalomid (thalidomide).
• Some drugs may reduce the effectiveness of birth control pills (e.g., HIV-protease inhibitors, griseofulvin, rifampin, rifabutin, phenytoin, and carbamazepine). Therefore, women that need treatment with one or more of these drugs should use two barrier methods of birth control, or abstain from having heterosexual sexual intercourse.

13. How do I take Thalomid (thalidomide)?

Depending on your medical condition, your doctor may prescribe Thalomid (thalidomide) at a dose between 100 mg and 300 mg to be taken once a day with water. It is recommended that the dose be taken at bedtime at least 1 hour after the evening meal.

14. How will Thalomid (thalidomide) be supplied?

Thalomid (thalidomide) will be available as a 50mg oral capsule. Thalomid (thalidomide) will be limited to a maximum of a 1-month supply.

15. Will Thalomid (thalidomide) be prescription only or available over-the-counter?

Thalomid (thalidomide) will be available by prescription only from physicians and pharmacies registered in the System for Thalidomide Education and Prescribing Safety (S.T.E.P.S.) program.

16. What is the S.T.E.P.S. program?

The S.T.E.P.S. program is a restricted distribution program designed to prevent fetal exposure. The program involves:

• required pregnancy testing
• required birth control measures
• physician education
• patient education
• registration
• patient informed consent forms

17. How do physicians/pharmacies enroll in the S.T.E.P.S. program?

Physicians and pharmacies will receive a mailing from Celgene, which will include instructions on how to register in the program.

18. How much will Thalomid (thalidomide) cost?

The FDA has no input into or legal control over the pricing of any drug product. FDA is presently unaware of the price that Thalomid (thalidomide) will have when it becomes available in U.S. pharmacies.

19. Will insurance companies pay for Thalomid (thalidomide)?

The FDA has no input into or legal control over whether an insurance company does or does not cover the cost of drugs. Please call your insurance company if you have questions abut whether your particular insurance provider will cover the cost of Thalomid (thalidomide).

20. What do I do with unused Thalomid (thalidomide)?

NEVER share Thalomid (thalidomide) with anyone. Return any unused Thalomid (thalidomide) to your pharmacy. Your pharmacy will accept all unused Thalomid (thalidomide) as part of the controlled distribution system.

21. What is the FDA going to do if there is a fetal exposure to Thalomid (thalidomide)?

The FDA has set up additional safeguards for the use of Thalomid (thalidomide) by men and women. The Agency has worked closely with the manufacturer, the Canadian Thalidomide Victims Association, and others to develop a program to ensure the safe and effective use of Thalomid (thalidomide). If there is even ONE fetal exposure to Thalomid (thalidomide), the Agency will re-evaluate the entire distribution system and take the necessary steps to ensure that all deficiencies are corrected.

22. What is FDA’s post-marketing strategy?

Any suspected fetal exposure to Thalomid (thalidomide) or any serious adverse drug event must be reported to the FDA via the Medwatch report form and also to the Celgene Corporation. The Agency will continue to evaluate the S.T.E.P.S. program, which will include inspections of pharmacies, and reviewing the data from and the procedures associated with the national physician/patient registry.

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