TM Owner Celgene
Thalomid 100mg Capsule
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Indications & Clinical Uses
- Thalomid (thalidomide) 100 mg capsules are an immunomodulatory, anti-angiogenic agent approved in the United States for two separate uses: in combination with dexamethasone for newly diagnosed multiple myeloma in adults, and for acute treatment and maintenance of the skin manifestations of erythema nodosum leprosum (ENL), a painful inflammatory complication of leprosy.
- Thalomid is manufactured by Celgene, now part of Bristol Myers Squibb.
- The same molecule is marketed in the European Union under other brand names, including Thalidomide Lipomed, with a licence limited to first-line multiple myeloma in patients aged 65 or over or unfit for high-dose chemotherapy.
- Thalomid is taken by mouth at home, once daily, and dispensed only through the mandatory THALOMID REMS programme.
Side Effects
- Thalomid very commonly causes drowsiness and somnolence, fatigue, constipation, peripheral neuropathy (numbness, tingling or pain in the hands or feet, which may be irreversible), dizziness, tremor, rash and swelling of the limbs.
- Thalomid carries a boxed warning for two serious risks: taken during pregnancy it can cause severe birth defects or death of the unborn child, and in multiple myeloma it increases the risk of venous thromboembolism, including deep vein thrombosis and pulmonary embolism, particularly when combined with dexamethasone.
- Low white blood cell counts and increased infection risk also occur.
- Seek urgent medical attention for sudden leg swelling or pain, chest pain, breathlessness, coughing blood, fainting, or new numbness or weakness, rather than waiting for your next appointment.
Precautions & Warnings
- Thalomid is available only through the THALOMID REMS programme: prescribers, pharmacies and patients must be certified, women of childbearing potential need two negative pregnancy tests before starting and monthly tests during treatment, and effective contraception is mandatory for both sexes because thalidomide is present in semen.
- It is contraindicated in pregnancy.
- Nerve conduction is often checked at baseline and periodically, since peripheral neuropathy may require dose reduction or discontinuation, and blood counts are monitored regularly.
- Thromboprophylaxis is usually given alongside Thalomid, especially with dexamethasone, because of the clot risk.
- Use caution in significant hepatic or renal impairment, and avoid driving or hazardous tasks if you feel drowsy or dizzy.
- Capsules must not be opened, broken or chewed; contact with the powder should be avoided.
Avoid Interactions
- Tell your healthcare provider about every prescription and over-the-counter medicine, herbal product and supplement you take before starting Thalomid.
- Other sedating medicines, including benzodiazepines, sleep aids, alcohol and certain antihistamines, add to Thalomid's own strong drowsiness and should be used cautiously.
- Combining Thalomid with dexamethasone or with oestrogen-containing hormonal contraceptives further raises the risk of dangerous blood clots, so this combination requires close monitoring and often preventive anticoagulation.
- Other neuropathy-causing drugs, such as certain chemotherapy agents, can add to Thalomid's nerve side effects.
- Live vaccines should be discussed with your healthcare provider first because immune response may be reduced during treatment.
References
Frequently Asked Questions
Thalomid (thalidomide) treats newly diagnosed multiple myeloma in adults, given with dexamethasone, and also treats erythema nodosum leprosum, a painful skin complication of leprosy. It works by blocking new blood vessel growth that tumours need and by calming abnormal immune activity. It is a controlled-distribution medicine.
You take Thalomid as a capsule by mouth once daily, usually at bedtime, with water, and swallow it whole without opening or chewing it. It is combined with dexamethasone for myeloma. Never share your capsules, and avoid contact with the powder inside a damaged capsule.
Common effects include drowsiness, constipation, tremor and tingling or numbness in the hands or feet. Thalomid carries a boxed warning for severe birth defects if taken in pregnancy and for a higher risk of blood clots. Get urgent help for leg swelling, chest pain, breathlessness or sudden weakness.
Avoid alcohol and other sedating medicines, which add to Thalomid's drowsiness. Pregnancy must never occur during treatment: Thalomid causes severe birth defects, so it is only dispensed through the THALOMID REMS programme with mandatory contraception and pregnancy testing for women and condom use for men.
If you miss a dose, skip it and take your next dose at the usual time; do not double up to make up for it. Take Thalomid at roughly the same time each day, and call your healthcare provider or REMS-certified pharmacy if you are unsure what to do.
No. Thalomid (thalidomide) is strictly contraindicated in pregnancy because it causes severe, irreversible birth defects or death of the unborn child. Women of childbearing potential need two negative pregnancy tests before starting and monthly tests during treatment, and effective contraception is required throughout, under the mandatory REMS programme.
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