Advise patient to immediately report signs/symptoms of thromboembolism (shortness of breath, chest pain, arm/leg swelling).

May cause fetal harm. Inform women of reproductive potential that they must use one highly effective method (IUD, hormonal contraceptive, tubal ligation, partner's vasectomy) and one additional method (latex condom, diaphragm, cervical cap) AT THE SAME TIME for ≥4 wk before, during therapy and interruptions of therapy, and for 4 wk following discontinuation of therapy, even with a history of infertility, unless due to a hysterectomy or patient has been postmenopausal naturally for 24 consecutive mo. Advise female patients to avoid breastfeeding during therapy. Men receiving thalidomide with female partners of reproductive potential must always use a latex condom during and for up to 4 wk following discontinuation, even if they have undergone a successful vasectomy. Thalidomide must be discontinued if pregnancy is suspected or confirmed. Suspected fetal exposure must be reported to FDA via MedWatch at 1-800-FDA-1088 and to manufacturer at 1-888-668-2528. Inform women of reproductive potential that there is a Pregnancy Exposure Registry that monitors pregnancy outcomes in women exposed to thalidomide during pregnancy and that they can contact the Pregnancy Exposure Registry by calling 1-888-423-5436. May impair male fertility.