Drug Action
Thalidomide has immunomodulatory and anti-inflammatory activity.
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Drug reference
Thalidomide has immunomodulatory and anti-inflammatory activity.
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First-line treatment for untreated multiple myeloma, in patients aged 65 years and over, or for those not eligible for high-dose chemotherapy (for example, patients with significant co-morbidity such as cardiac risk factors) in combination with melphalan and prednisolone ▶BY MOUTH ▶Adult 18–75 years: 200 mg once daily for 6–week cycle for a maximum of 12 cycles, dose to be taken at bedtime ▶Adult 76 years and over: 100 mg once daily for 6–week cycle for a maximum of 12 cycles, dose to be taken at bedtime
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High tumour burden—risk of tumour lysis syndrome. patients aged 76 years and over—increased risk of serious side-effects CAUTIONS, FURTHER INFORMATION ▶Thromboembolism Risk factors for thromboembolism (such as smoking, hypertension, hyperlipidaemia) should be minimised. Thromboprophylaxis is recommended for at least the first 5 months of treatment, especially in patients with additional thrombotic risk factors. ▶Second primary malignancy Patients should be carefully evaluated before and during treatment with thalidomide using routine cancer screening for occurrence of second primary malignancy and treatment should be instituted as indicated. ▶Peripheral neuropathy Patients with pre-existing peripheral neuropathy should not be treated with thalidomide unless the potential clinical benefits outweigh the risk.
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Patient, prescriber, and supplying pharmacy must comply with a pregnancy prevention programme. Every prescription must be accompanied by a complete Prescription Authorisation Form.
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NICE decisions ▶Bortezomib and thalidomide for the first-line treatment of multiple myeloma (July 2011) NICE TA228 Thalidomide (Thalidomide Celgene ®) in combination with an alkylating drug and a corticosteroid is recommended as an option for the first-line treatment of multiple myeloma in people for whom high-dose chemotherapy with stem cell transplantation is considered inappropriate. www.nice.org.uk/guidance/ta228
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→Appendix 1: thalidomide
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▶Common or very common Anaemia. arrhythmias. asthenia . confusion. constipation. decreased leucocytes. depression. dizziness. drowsiness. dry mouth. dyspnoea. embolism and thrombosis. fever. heart failure. increased risk of infection. malaise. movement disorders. neutropenia. peripheral neuropathy. peripheral oedema. respiratory disorders. sensation abnormal. skin reactions. thrombocytopenia. tremor. vomiting ▶Frequency not known Atrioventricular block. gastrointestinal disorders. gastrointestinal haemorrhage. hearing impairment. hypothyroidism. liver disorder. menstrual cycle irregularities. myocardial infarction. neoplasms. pancreatitis. pancytopenia. posterior reversible encephalopathy syndrome (PRES). pulmonary hypertension. reactivation of infections. renal failure. seizure. sexual dysfunction. toxic epidermal necrolysis. tumour lysis syndrome SIDE-EFFECTS, FURTHER INFORMATION Rash If rash occurs, treatment should be discontinued and only restarted following appropriate clinical evaluation. Peripheral neuropathy If symptoms suggestive of peripheral neuropathy develop (such as paraesthesia, abnormal coordination, or weakness) dose reduction, dose interruption, or treatment discontinuation may be necessary—consult product literature.
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For women of child- bearing potential, pregnancy must be excluded before starting treatment with thalidomide (perform pregnancy test on initiation or within 3 days prior to initiation). Women must practise effective contraception at least 1 month before, during, and for at least 1 month after treatment, including during dose interruptions (oral combined hormonal contraceptives and copper-releasing intra-uterine devices not recommended) and men should use condoms during treatment, during dose interruption, and for at least 1 week after stopping if their partner is pregnant or is of childbearing potential and not using effective contraception. Patients, prescribers and pharmacists must comply with pregnancy prevention measures as specified in the manufacturer’s Pregnancy Prevention Programme.
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Important: teratogenic risk.
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Avoid—present in milk in animal studies.
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Manufacturer advises caution in severe impairment (no information available).
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Caution in severe impairment—no information available.
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▶Monitor white blood cell count (including differential count) and platelet count (reduce dose or interrupt treatment if neutropenia or thrombocytopenia develop— consult product literature). ▶Monitor for arterial or venous thromboembolism. ▶Monitor patients for signs and symptoms of peripheral neuropathy. ▶Hepatic disorder Liver function should be monitored, particularly when there is history of, or concurrent viral liver infection, or when thalidomide is combined with drugs known to be associated with liver dysfunction (e.g. paracetamol).
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There can be variation in the licensing of different medicines containing the same drug. Forms available from special-order manufacturers include: tablet, oral suspension, oral solution Tablet ▶Talidex (Alan Pharmaceuticals) Thalidomide 25 mg Talidex 25mg tablets | 30 tablet £1,075.00 Capsule CAUTIONARY AND ADVISORY LABELS 2 ▶Thalidomide (Non-proprietary) Thalidomide 50 mg Thalidomide Celgene 50mg capsules | 28 capsule P £298.48 Photodynamic therapy responsive malignancy PHOTOSENSITISERS
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Patients and their carers should be made aware of the symptoms of thromboembolism and advised to report sudden breathlessness, chest pain, or swelling of a limb. Patients and their carers should be made aware of the symptoms of neutropenia and advised to seek medical advice if symptoms suggestive of neutropenia (such as fever, sore throat) or of thrombocytopenia (such as bleeding) develop. Patients and their carers should be advised to seek medical advice if symptoms of peripheral neuropathy such as paraesthesia, abnormal coordination, or weakness develop. Immune system and malignant disease Conception and contraception Patient counselling advised for thalidomide capsules (pregnancy and contraception).
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200 mg once daily for 6–week cycle
First-line fragment. Read the complete Indications and Dose section above.
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100 mg once daily for 6–week
First-line fragment. Read the complete Indications and Dose section above.
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