Thalomid Patient, Information, Instructions - Thalidomide

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 [1 CAPSULE (50 mg, 100 mg or 200 TAKEN BY A PREGNANT WOMAN CAN CAUSE SEVERE BIRTH DEFECTS.

· The patient understands that severe birth defects can occur with the use of THALOMIDÒ (thalidomide).

· The patient has been warned by his/her doctor that an unborn baby will almost certainly have severe birth defects and can even die, if a woman is pregnant or becomes pregnant while taking THALOMIDÒ (thalidomide).

· THALOMIDÒ (thalidomide) will be prescribed ONLY for the patient and must NOT be shared with ANYONE, even someone who has similar symptoms.

· THALOMIDÒ (thalidomide) must be kept out of the reach of children and should NEVER be given to women who are able to have children.

· The patient cannot donate blood while taking THALOMIDÒ (thalidomide).

· The patient has read the THALOMIDÒ (thalidomide) patient brochure and/or viewed the videotape, "Important Information for Men and Women Taking THALOMIDÒ (thalidomide)" and understands the contents, including other possible health problems from THALOMIDÒ (thalidomide), "side effects."

· The patient’s doctor has answered any questions the patient has asked.

· The patient must participate in a telephone survey and patient registry, while taking THALOMIDÒ (thalidomide).

· The patient must not take THALOMIDÒ (thalidomide) if she is pregnant, breast-feeding a baby, or able to get pregnant and not using the required two methods of birth control.

· The patient confirms that she is not now pregnant, nor will she try to become pregnant during THALOMIDÒ (thalidomide) therapy and for at least 4 weeks after she has completely finished taking THALOMIDÒ (thalidomide).

· If the patient is able to become pregnant, she 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 beginning THALOMIDÒ (thalidomide) therapy, during THALOMIDÒ (thalidomide) therapy, and for 4 weeks following discontinuation of THALOMIDÒ (thalidomide) therapy.

· The patient must use these birth control methods unless she completely abstains from heterosexual sexual contact.

· If a hormonal method (birth control pills, injections, or implants) or IUD is not medically possible for the patient, she may use another highly effective method or two barrier methods AT THE SAME TIME.

· The patient must have a pregnancy test done by her doctor within the 24 hours prior to starting THALOMIDÒ (thalidomide) therapy, then every week during the first 4 weeks of THALOMIDÒ (thalidomide) therapy.

· Thereafter, the patient must have a pregnancy test every 4 weeks if she has regular menstrual cycles, or every 2 weeks if her cycles are irregular while she is taking THALOMIDÒ (thalidomide).

· The patient must immediately stop taking THALOMIDÒ (thalidomide) and inform her doctor:

If she becomes pregnant while taking the drug

If she misses her menstrual period, or experiences unusual menstrual bleeding

If she stops using birth control

If she thinks FOR ANY REASON that she may be pregnant

The patient understands that if her doctor is not available, she can call 1-888-668-2528 for information on emergency contraception.

· The patient certifies that she is not now pregnant, nor of childbearing potential as she has been postmenopausal for at least 24 months (been through the change of life); or she has had a hysterectomy.

· The patient or guardian certifies that a prepubertal female child is not now pregnant, nor is of childbearing potential as menstruation has not yet begun, and/or the child will not be engaging in heterosexual sexual contact for at least 4 weeks before THALOMIDÒ (thalidomide) therapy, during THALOMIDÒ (thalidomide) therapy, and for at least 4 weeks after stopping therapy.

· The patient has been told by his doctor that he must NEVER have unprotected sexual contact with a woman who can become pregnant.

· Because THALOMIDÒ (thalidomide) is present in semen, his doctor has explained that he must either completely abstain from sexual contact with women who are pregnant or able to become pregnant, or he must use a latex condom EVERY TIME he engages in any sexual contact with women who are pregnant or may become pregnant while he is taking THALOMIDÒ (thalidomide) and for 4 weeks after he stops taking the drug, even if he has had a successful vasectomy.

· The patient must inform his doctor:

If he has had unprotected sexual contact with a woman who can become pregnant

If he thinks FOR ANY REASON, that his sexual partner may be pregnant

The patient understands that if his doctor is not available, he can call 1-888-668-2528 for information on emergency contraception.

· The patient cannot donate semen or sperm while taking THALOMIDÒ (thalidomide).

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 THALOMIDÒ (thalidomide).

I now authorize my doctor to begin my treatment with THALOMIDÒ (thalidomide).

Patient Signature___________________________ Date_________________________

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 he/she has any questions regarding his/her treatment with THALOMIDÒ (thalidomide) and have answered those questions to the best of my ability. I will comply with all of my obligations and responsibilities as a prescriber registered under the S.T.E.P.SÒ restricted distribution program.

Prescriber Name (please type): _____________________________________________

DEA Number: ___________ Social Security Number if PA or NP: ________________

Street Address: __________________________________________________________

City: _____________ State: ____________ Zip: _______________________________

Prescriber Signature _____________________________________________________