Thado Patient Counseling Information

For Prescribers: Major human fetal abnormalities related to thalidomide administration during pregnancy have been documented: Amelia (absent of limbs), phocomelia (short limbs), hypoplasticity of the bones, absent of bones, external ear abnormalities (including anotia, micro pinna, small or absent external auditory canals), and congenital heart defects. Alimentary tract, urinary tract, and genital malformations have also been documented. Mortality at shortly after birth has been repeated at about 40%.
Before prescribing, patients must read and sign the informed consent forms for female/male patients for thalidomide treatment. Only patients willing to comply with the constructions are qualified for thalidomide treatment.
Effective contraception must be used 1 month before beginning thalidomide therapy, during thalidomide therapy. Two reliable forms of contraception must be used simultaneousely unless continuous unless due to hysterectomy or because the patient has been postmenopausal for at least 2 years. Women of childbearing potential should be referred to a qualified provider of contraceptive method.
Before starting treatment: women of childbearing potential should have a pregnancy test (sensitivity of at least 50 mIU/mL). The test should be performed within 24 hours prior to beginning therapy. A prescription for thalidomide for a woman of childbearing potential must not be issued by the prescriber until a written report of a negative pregnancy test has been obtained by the presenter.
Once treatment has started: pregnancy test should occur weekly during the first month of use, then monthly thereafter in women with regular menstrual cycles. If menstrual cycles are irregular, the pregnancy testing should occur every two weeks. Pregnancy testing and counseling should be performed if a patient misses her period or if there is any abnormality in menstrual bleeding.
If pregnancy does occur during thalidomide treatment, thalidomide must be discontinued immediately. The patient must be reported immediately to number at and also to TTY Biopharm Co., Ltd. The patient should be referred to an obstetrician/gynecologist experienced in reproductive toxicity for further evaluation and counseling.
For Female Patients: Thalidomide is contraindicated in WOMEN of childbearing potential. Female patients should sign the female consent form for THADO and comply with the constructions in the female informed consent form for THADO therapy before starting the treatment.
For Male Patients: Male patients should completely comply with the contents in and sign the male patient informed consent form for THADO therapy before starting thalidomide treatment.