Important Information and Warnings for All Patients Taking THALOMID (thalidomide)

WARNING: SERIOUS HUMAN BIRTH DEFECTS IF THALIDOMIDE IS TAKEN DURING PREGNANCY, IT CAN CAUSE SEVERE BIRTH DEFECTS OR DEATH TO AN UNBORN BABY. THALIDOMIDE SHOULD NEVER BE USED BY WOMEN WHO ARE PREGNANT OR WHO COULD BECOME PREGNANT WHILE TAKING THE DRUG. EVEN A SINGLE DOSE [I CAPSULE (50 mg)] TAKEN BY A PREGNANT WOMAN CAN CAUSE SEVERE BIRTH DEFECTS.
INIT ____ 10 I understand that I must participate in a survey and patient registry while I am on THALOMID (thalidomide), which will require completing additional forms.
CONSENT FOR WOMEN:
INIT ____ 1 I understand that I must not take THALOMID (thalidomide) if I am pregnant, breast-feeding a baby, or able to get pregnant and not using the required two methods of birth control.
INIT ____ 2 I understand that severe birth defects can occur with the use of THALOMID (thalidomide). I have been warned by my doctor that my unborn baby will almost certainly have serious birth defects or maybe even die if I am pregnant or become pregnant while taking THALOMIDTM (thalidomide).
INIT ____ 3 I understand that it I am able to become pregnant, I must use at least one highly effective method and one additional effective method of birth control contraception AT THE SAME TIME:
At least one highly effective method AND One additional effective method
IUD Latex condom
Hormonal (birth control pills, injections, or implants) Diaphragm
Tubal ligation Cervical cap
Partner's vasectomy

These birth control methods must be used for at least 4 weeks before starting THALOMID (thalidomide) therapy, all during THALOMID (thalidomide) therapy, and for at least 4 weeks after THALOMID (thalidomide) therapy has stopped. I must use these methods even if I am infertile, unless I have had a hysterectomy or because I have been postmenopausal for at least 24 months (been through the changes of life). The only exception is if I completely avoid heterosexual sexual intercourse. If a hormonal (birth control pills, injections, or implants) or IUD method is riot medically possible for me, I may use another highly effective method or two barrier methods AT THE SAME TIME

INIT ____ 4 I know that I must have a pregnancy test done by my doctor within) the 24 hours prior to starting THALOMID (thalidomide) therapy, then every week during the first 4 weeks of THALOMID (thalidomide) therapy. I will then have a pregnancy test every 4 weeks if I have regular menstrual cycles, or every 2 weeks if my cycles are irregular while I am taking THALOMID (thalidomide).
INIT ____ 5 I know that I must immediately stop taking THALOMID (thalidomide) and inform my doctor if I become pregnant while taking the drug; if I miss my menstrual period, or experience unusual menstrual bleeding; stop using birth control; or think, FOR ANY REASON, that I may be pregnant. If my doctor is not available, I can call 1-888-668-2528 for information on emergency contraception.
INIT ____ 6 1 am not now pregnant, nor will I try to become pregnant for at least 4 weeks after I have completely finished taking THALOMID thalidomide).
INIT ____ 7 I understand that THALOMID (thalidomide) will be prescribed ONLY for me. I must NOT share it with ANYONE, even someone who has symptoms similar to mine. It must be kept out of the reach of children and should never be given to women who are able to have children.
INIT ____ 8 I have read the THALOMID (thalidomide) patient brochure and/or viewed the videotape, "Important Information for Men and Women Taking THALOMID (thalidomide)"" I understand the contents, including other possible health problems from THALOMID (thalidomide), so-called "side effects.' I know that I cannot donate blood while taking THALOMID (thalidomide).
INIT ____ 9 My doctor has answered any questions I have asked.
CONSENT FOR MEN:
INIT ____ 1 I understand that I must not take THALOMID (thalidomide) if I cannot avoid unprotected sex with a woman, even if I have had a successful vasectomy.
INIT ____ 2 I understand that severe birth defects or death to an unborn baby have occurred when women took thalidomide during pregnancy.
INIT ____ 3 1 have been told by my doctor that I must NEVER have unprotected sex with a woman because it is hot known if the drug is present in semen or sperm. My doctor has explained that I must either completely avoid heterosexual sexual intercourse or I must use a latex condom EVERY TIME I have sexual intercourse with a female partner while I am taking THALOMID (thalidomide) and for 4 weeks after I stop taking the drug, even if I have had a successful vasectomy.
INIT ____ 4 I also know that I must inform my doctor if I have had unprotected sex with a woman or if I think, FOR ANY REASON, that my sexual partner may be pregnant. If my doctor is not available, I can call 1-888-668-2528 for information on emergency contraception.
INIT ____ 5 I understand that THALOMID (thalidomide) will be prescribed ONLY for me. I must NOT share it with ANYONE, even someone who has symptoms similar to mine. It must be kept out of the reach of children and should never be given to women who are able to have children.
INIT ____ 6 I have read the THALOMID (thalidomide) patient brochure and/or viewed the videotape, "Important Information for Men and Women Taking THALOMID (thalidomide)" I understand the contents, including other possible health problems from THALOMID (thalidomide), so-called "side effects". I know that I cannot donate blood or semen while taking THALOMID (thalidomide).
INIT ____ 7 My doctor has answered any questions I have asked.
INIT ____ 8 I understand that I must participate in a survey and patient registry while I am on THALOMID (thalidomide), which will require completing additional forms.
Authorization:
This information has been read aloud to me in the language of my choice. I understand that if I do not follow all of my doctor's instructions, I will not be able to receive THALOMID (thalidomide). I now authorize. my doctor to begin my treatment with THALOMID (thalidomide).
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I have fully explained to the patient the nature, purpose, and risks of the treatment described above, especially the risks to women of childbearing potential. I have asked the patient if she/he has any questions regarding her/his treatment with THALOMID (thalidomide) and have answered those questions to the best of my ability. I will ensure that the appropriate components of the patient consent form are completed. In addition, I will comply with all of my obligations and responsibilities as a prescriber registered under the STEPS. restricted distribution program.
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