Thado Special Precautions

Pregnancy category: X (Pregnant women are restricted to use).
THADO is not used to patients hypersensitive to thalidomide. Signs and symptoms include erythematous macular rash, possibly associated with fever, tachycardia and hypotension. If severe, may necessitate interruption of therapy. If the reaction recurs when dosing is resumed, THADO should be discontinued.
Bradycardia in association with thalidomide use has been reported. At present there have been no reports of bradycardia requiring medical or other intervention.
Before dispensing, patients must read and sign the female/male inform consent form for THADO therapy. Only patients are willing to comply with the instructions in the inform consent form are allowed to be prescribed THADO (thalidomide).
Thalidomide is contraindicated in pregnant women, women capable becoming pregnant and nursing mothers. Women may become pregnant are required at least two types of contraception including at least one highly effective method (e.g., IUD, hormonal contraception, tubal ligation, or partner's vasectomy) and one additional effective method (e.g., latex condom, diaphragm, or cervical cap), beginning 1 month prior to initiating treatment with thalidomide, during therapy with thalidomide, and continuing for 1 month discontinuation of thalidomide therapy.
Males receiving thalidomide must always use a latex condom during any sexual contact with women of childbearing potential during thalidomide therapy and 1 month discontinuation of Thalidomide therapy.
Women of childbearing potential should have a pregnancy test performed (sensitivity of at least 50 mIU/mL). The test should be performed within 24 hours prior to beginning therapy and the weekly during the first 4 weeks of Thalidomide therapy, then monthly intervals in women with regular menstrual cycles or every 2 weeks in women with irregular menstrual cycles. Pregnancy testing and counseling should be performed if a patient misses her period or if there is any abnormality in menstrual bleeding.
Thalidomide may cause dizziness and orthostatic hypotension. Therefore, patients should be advised to sit upright for a few minutes prior to standing up from a recumbent position.
Thalidomide therapy should not be initiated with an absolute neutrophil count (ANC) of <750/mm³. White blood cell count and differential should be monitored on an ongoing basis. If AND decreases to below 750/mm³ while on treatment, the patient's medication regimen should be re-evaluated and, if the neutropenia persists, consideration should be given to withholding thalidomide if clinically appropriate.
Patients should be examined at monthly intervals for the first 3 months of thalidomide therapy to enable the clinician to detect early signs of neuropathy. Consideration should be given to electrophysiological testing, consisting of measurement of sensory nerve action potential (SNAP) amplitudes at baselines and thereafter every 6 months in an effort to detect asymptomatic neuropathy. If symptoms of drug-induced neuropathy develop, thalidomide should be discontinued immediately to limit further damage, if clinical appropriate. Usually, treatment with thalidomide should only be reinitiated if the neuropathy returns to baseline status.
Increased HIV-viral load: It has been reported that in an HIV-seropositive patient population, plasma HIV RNA levels were found to increase. The clinical significance of this increase is unknown. Until the clinical significance of this finding is further understood, in HIV-seropositive patients, viral load should be measured after the first and third months of treatment and every 3 months thereafter.
Drug interactions: It has been reported to enhance the sedative activity of barbiturates, alcohol. Chlorpromazine and reserpine. Medications known to be associated peripheral neuropathy should be used with caution in patients receiving thalidomide.
Concomitant use of HIV-protease inhibitors, griseofulvin, rifampicin, rifabutin, phenytoin, or carbamazepine with hormonal contraceptive agents, may reduce the effectiveness of the contraception. Therefore, women requiring treatment with one or more of these drugs must use two OTHER effective or highly effective methods of contraception or abstain from reproductive heterosexual sexual intercourse.
THADO should be prescribed only for the patient and must not be shared with anyone.
Effects on the ability to drive or operate machinery: Thalidomide frequently causes drowsiness and somnolence. Patients should be instructed to avoid driving a car or operating machinery.
Use in Children: THADO must be kept out of the reach of children.