Active ingredients: Thalidomide 50 mg.
HARD CAPSULE: 28. Dosage: Multiple myeloma (adult dosage): Should be initiated at 200 mg daily orally and increased by 100 mg at weekly intervals to a maximum dose of 800 mg daily according to tolerance and toxicity. Depending on tolerance and observed toxicity, lower maintenance doses can be used. Erythema Nodosum Leprosum (adult dosage): Dosing should be initiated at 100 mg daily orally and, only where symptoms remain uncontrolled, increased by 100 mg at weekly intervals according to tolerance and toxicity. The maximum recommended dose is 400 mg daily. Depending on tolerance and observed toxicity, lower maintenance doses can be used than those used to control the active reaction. In patients with moderate to severe neuritis (due to leprosy) or other serious complications (e.g. uveitis), corticosteroids and other appropriate therapy may be started concomitantly and tapered/discontinued when neuritis etc. has improved. There have been no well-controlled studies of thalidomide as maintenance therapy to prevent ENL relapse to provide maintenance dosing recommendations. In study E-003P only 1 of 23 patients was tapered from treatment successfully using a 3-7 week tapering regimen. Given the risks associated with ongoing thalidomide treatment, it is suggested that tapering (with the aim of discontinuation) be attempted every 3-6 months, in decrements of 50 mg every 2 to 4 weeks.
To reduce central nervous system effects (e.g. drowsiness, somnolence, sedation) during the day, this dose is normally taken as a single dose in the evening. Should be taken at least one hour after food. Prescribing Restrictions:
Treatment of multiple myeloma after failure of standard therapies. Acute treatment of the cutaneous manifestations of moderate to severe erythema nodosum leprosum (ENL). Thalidomide is not indicated as monotherapy for ENL treatment in the presence of moderate to severe neuritis. Also indicated as maintenance therapy for prevention and suppression of the cutaneous manifestations of ENL recurrence. Contra-Indications:
Known hypersensitivity to thalidomide or to any of the excipients. Patients below 12 years of age. Pregnancy and lactation. Women of child bearing potential who are not using, not willing or not able to use adequate contraceptive measures to prevent pregnancy. Women of childbearing potential where there is an alternative treatment of non-inferior efficacy available. Males who are not able or willing to comply with adequate contraceptive measures. Severe neutropenia (absolute neutrophil count (ANC) of <750/mm3 (0.75 x 109/l)) Special Precautions:
Only leprosy specialists, with experience in the treatment of ENL, or oncology or hematology specialists, with experience in the treatment of relapsing or refractory multiple myeloma, should initiate treatment.
Patients (or their legal guardians) should give written, fully informed consent for the use of thalidomide. Patients should be counseled monthly regarding risks and precautions to be taken. Can cause severe birth defects or death to an unborn baby if taken during pregnancy. Patients should be instructed to take thalidomide only as prescribed and not to share medication with anyone else.
The physician must obtain a negative result of a blood pregnancy test that was performed within 36 hours before delivering the first, and each monthly prescription. In the case of a woman who reports having undergone hysterectomy, or who is not post-menopausal for more than 24 months, the physician must confirm hysterectomy status and take sufficient measures to exclude existing pregnancy. It is strongly recommended that pregnancy testing be carried out weekly in the first month of treatment, then monthly in women with regular menstrual cycles or fortnightly if irregular menstrual cycles.
Women of childbearing potential must use reliable contraceptive methods for at least one month before starting treatment, during treatment, and for one month following termination of treatment. Reliable contraception in these patients means that she uses at the same time at least one highly effective method of contraception (IUD, hormonal contraception, tubal ligation or partner’s vasectomy) and at least one additional effective method (diaphragm, cervical cap or latex/polyurethane condom by her male partner).
Males receiving thalidomide must always use a latex or polyurethane condom when engaging in sexual activity with women of childbearing potential. Thyroid activity should be monitored during ongoing treatment as cases of hypothyroidism have been reported. Patients must not donate blood or semen during therapy. See prescribing information for full details. Side Effects:
Drowsiness, somnolence and sedation. Peripheral neuropathy. Seizures. Neutropenia. Dermatological reactions. Impaired wound healing. Thrombogenicity. Sensory peripheral neuropathy. Orthostatic hypotension, neutropenia. Severe skin reactions including Stevens-Johnson Syndrome and toxic epidermal necrolysis, headache, rash, eosinophilia, peripheral edema, dyspnea, dizziness, hypotension, bradycardia, symptomatic hypothyroidism. Increase or decrease in platelet count, anemia. An increase in HIV viral load in HIV patients. See prescribing information for full details. Drug Interactions:
Specific drug interactions have not been studied. Can enhance sedative activity of barbiturates, alcohol, chlorpromazine, and reserpine. Increases effects of morphine derivatives, benzodiazipines and other anxiolytics. Medications known to cause peripheral neuropathy. Doxorubicin.