S.T.E.P.S. Program - Thalidomide

S.TE.P.S.

System for Thalidomide Education and Prescribing Safety

PRESCRIBER INFORMATION

INSTRUCTIONS FOR PRESCRIBERS

• All prescribers must register in the S.T.E.P.S. Prescriber Registry via the Prescriber Registration Card that is located in every S.T.E.P.S. folder. Only licensed prescribers may register.
• Complete, sign, and return the Prescriber Registration Card. By doing so, you agree to prescribe THALOMID(TM) (thalidomide) in accordance with all the terms listed on the card.
• Wait for confirmation of your registration prior to prescribing THALOMID(TM) (thalidomide).

  S.T.E.P.S. PROGRAM MATERIALS

• All materials that are necessary to comply with S.T.E.P.S. program requirements are contained in the S.T.E.P.S. folder.
• The contents of ONE FOLDER should be used with ONE PATIENT, and kept with the patient's medical record.
• Additional S.T.E.P.S. folders can be obtained from your Celgene Immunology Specialist or by calling 1-888-4-CELGENE.

  S.T.E.P.S. FOLDER CONTENTS

• The S.T.E.P.S. folder contains the following information and materials to help ensure that fetal exposure to THALOMID(TM) (thalidomide) does not occur:
  • Prescriber Registration Card: All prescribers must register.
  • Thalidomide Victims Association of Canada letter: A cautionary message to the prescriber and patient from thalidomide victims.
  • Important Information for Men and Women Taking THALOMID(TM) (thalidomide): Use this brochure for patient counseling regarding the teratogenic risks as well as other side effects and precautions associated with THALOMID(TM) (thalidomide) therapy. A video presentation of this information will be provided to your office upon registration.
  • Your Contraceptive Choices: This brochure is provided to assist in counseling patients on the selection of two appropriate contraceptive methods.
  • Emergency Contraception: Use this brochure to assist patients in the event they have unprotected heterosexual intercourse while taking THALOMID(TM) (thalidomide).
  • Patient Referral Form: A form that must be used if you choose to have another health care professional provide contraceptive counseling for your patient.
  • Patient Quiz: The quiz is provided to verify patient understanding of risks and requirements of therapy.
  • Consent Form: This informed consent document must be understood and signed before your patient can receive THALOMID(TM) (thalidomide).
  • Thalidomide Survey Forms: These mandatory and confidential enrollment and follow-up surveys must be completed by the patient and prescriber. Men must participate, as well as women, because fetal exposure to THALOMID(TM) (thalidomide) could occur as a result of the presence of the drug in semen or through sharing of the medication. Included are forms for patients aged 18 or older. Forms for patients under 18 years of age are available by calling 1-888-4-CELGENE.
• Important Information for Men and Women Taking THALOMID(TM) (thalidomide), the Consent Form, the Patient Quiz, and the Survey Forms are available in 14 languages and can be obtained through your Celgene Immunology Specialist or by calling 1-888-4-CELGENE.

  PLEASE REFER TO THE FOLLOWING STEP-BY-STEP GUIDELINES FOR PRESCRIBING THALOMID(TM) (thalidomide) TO MALE AND FEMALE PATIENTS.

  PRESCRIBING THALOMID(TM) (thalidomide) FOR FEMALE PATIENTS

  INITIAL VISIT

• Establish appropriateness of THALOMID(TM) (thalidomide) therapy versus therapeutic alternatives.
  • THALOMID(TM) (thalidomide) is indicated for the acute treatment of the cutaneous manifestations of moderate to severe erythema nodosum leprosum (ENL). THALOMID(TM) (thalidomide) is not indicated as monotherapy for such ENL treatment in the presence of moderate to severe neuritis. THALOMID(TM) (thalidomide) is also indicated as maintenance therapy for prevention and suppression of the cutaneous manifestations of ENL recurrence.
• Provide comprehensive counseling on the risks and benefits of THALOMID(TM) (thalidomide) therapy.
  • Patients must be counseled on the risk of birth defects, other side effects, and important precautions associated with THALOMID(TM) (thalidomide) therapy.
  • Utilize the patient education materials provided.
• Determine if patient has childbearing potential.
  • If patient has undergone a hysterectomy, or has been postmenopausal or had no menses for at least 24 consecutive months, continue with the instructions provided in the INITIATING THALOMID(TM) (thalidomide) THERAPY section below.
  • If patient is sexually mature and does not meet the above criteria, provide contraceptive counseling, including counseling on emergency contraception.
    • Female patients must thoroughly understand the need for two forms of contraception to be used AT THE SAME TIME, beginning at least 4 weeks before therapy, all during therapy, and for at least 4 weeks after stopping therapy with THALOMID(TM) (thalidomide).
    • Contraceptive methods must include at least one highly effective method (e.g., intrauterine device [IUD], hormonal [birth control pills, injections, or implants], tubal ligation, or partner's vasectomy) and one additional effective method (e.g., latex condom, diaphragm, or cervical cap).
    • If hormonal or IUD contraception is medically contraindicated, another highly effective method or two barrier methods must be used AT THE SAME TIME.
    • Utilize the patient education materials provided.
  • Prescribers may refer patients to another health care professional for contraceptive counseling using the Patient Referral Form.
• Continue selected birth control options for at least 4 weeks prior to initiating THALOMID(TM) (thalidomide).

  INITIATING THALOMID(TM) (thalidomide) THERAPY

• Repeat patient counseling.
• Perform pregnancy test, even if continuous abstinence is the chosen method of birth control.
  • Pregnancy test must be performed with a sensitivity of at least 50 mIU/mL.
  • Pregnancy test must be performed on women of childbearing potential, with negative results in written form, within the 24 hours before beginning THALOMID(TM) (thalidomide) therapy.
  • Women of childbearing potential must also receive a pregnancy test every week for the first 4 weeks, then every 4 weeks thereafter if their menstrual cycles are regular.
  • If the menstrual cycle is irregular, they must receive a pregnancy test every 2 weeks thereafter.
  • 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 treatment, the drug must be immediately discontinued. Any suspected fetal exposure to THALOMID(TM) (thalidomide) must be reported immediately to the FDA via the MedWATCH number at 1-800-FDA- 1088 and also to Celgene Corporation. The patient should be referred to an obstetrician/gynecologist experienced in reproductive toxicity for further evaluation and counseling.
• Administer the THALOMID(TM) (thalidomide) patient quiz.
  • Gauge patient understanding of the requirements for taking the drug.
  • if the patient cannot answer all of the questions correctly, review the material that she does not understand.
  • Readminister patient quiz. Repeat until the patient satisfactorily understands all risks and correctly answers all questions or reconsider the appropriateness of THALOMID(TM) (thalidomide) therapy.
• Complete the informed consent form.
  • The consent form must be read to the patient, and/or parent/legal guardian in the language of their choice. Each statement must be initialed by the patient and/or parent/legal guardian to indicate understanding, and the form must be completed and signed by both prescriber and patient and/or parent/legal guardian.
  • If the patient is under 18 years of age, her parent or legal guardian must read this material, sign the form, and agree to ensure compliance.
  • Retain "Prescriber" copy with patient record.
  • Mail "Survey Coordinators" copy (via self-mailing format).
  • Instruct patient to retain "Patient" copy and to present "Pharmacist" copy with prescription to pharmacist.
• Complete the mandatory and confidential survey enrollment form.
  • Instruct patients to complete the confidential patient section, seal the survey, and return it to you.
  • Complete the prescriber section and return in the envelope provided to the Slone Epidemiology Unit of Boston University School of Public Health.
• Provide prescription.
  • Prescriptions cannot be issued by telephone.
  • Prescribe no more than 4 weeks (28 days) of therapy, with no automatic refills.
  • Inform patient that all prescriptions must be filled within 7 days.
  • It is recommended that female patients initially receive no more than a 1 -week supply for each of the first 4 weeks to coincide with weekly pregnancy testing requirements.
• PATIENT MONITORING DURING FIRST 4 WEEKS OF THERAPY
• Repeat patient counseling.
• Perform pregnancy tests every week for the first 4 weeks of therapy.
  • It is recommended that pregnancy tests be performed within the 24 hours before providing subsequent prescriptions.
  • Pregnancy tests must be performed even if continuous abstinence is the chosen method of birth control.
• If pregnancy test is negative, provide prescription for a 1 -week supply of THALOMID(TM) (thalidomide).

  SUBSEQUENT PATIENT VISITS (after the first 4-week period)

• Repeat patient counseling.
• Perform pregnancy test every 4 weeks if patient's menstrual cycles are regular, every 2 weeks if cycles are irregular.
  • It is recommended that pregnancy tests be performed within the 24 hours before providing subsequent prescriptions.
  • Pregnancy tests must be performed even if continuous abstinence is the chosen method of birth control.
• Complete the follow-up survey form.
  • Forms are included in the S.T.E.P.S. folder.
  • Female patients must complete the form every month.
• If pregnancy test is negative, provide prescription for no more than a 4-week (28-day) supply of THALOMID(TM) (thalidomide) therapy. Telephone prescriptions are not permitted.

  PRESCRIBING THALIDOMID (thalidomide) FOR MALE PATIENTS

  INITIAL VISIT

• Establish appropriateness of THALOMID(TM) (thalidomide) therapy versus therapeutic alternatives.
  • THALOMID(TM) (thalidomide) is indicated for the acute treatment of the cutaneous manifestations of moderate to severe erythema nodosum leprosum (ENL). THALOMID(TM) (thalidomide) is not indicated as monotherapy for such ENL treatment in the presence of moderate to severe neuritis. THALOMID(TM) (thalidomide) is also indicated as maintenance therapy for prevention and suppression of the cutaneous manifestations of ENL recurrence.
• Provide comprehensive counseling on the risks and benefits of THALOMID(TM) (thalidomide) therapy.
  • - Patients must be counseled on the risk of birth defects, other side effects, and important precautions associated with THALOMID(TM) (thalidomide) therapy.
  • Utilize the patient education materials provided.
• Provide contraceptive counseling, including counseling on emergency contraception.
  • Male patients must be instructed to use a latex condom every time they have sexual intercourse with a woman, even if they have undergone successful vasectomy.
  • Utilize patient education materials provided.
• Administer the THALOMID(TM) (thalidomide) patient quiz.
  • Gauge patient understanding of the requirements for taking the drug.
  • If the patient cannot answer all of the questions correctly, review the material that he does not understand.
  • Readminister patient quiz. Repeat until the patient satisfactorily understands all risks and correctly answers all questions or reconsider the appropriateness of THALOMID(TM) (thalidomide) therapy.
• Complete the informed consent form.
  • The consent form must be read to the patient, and/or parent/legal guardian in the language of their choice. Each statement must be initialed by the patient and/or parent/legal guardian to indicate understanding, and the form must be completed and signed by both prescriber and patient and/or parent/legal guardian.
  • If the patient is under 18 years of age, his parent or legal guardian must read this material, sign the form, and agree to ensure compliance.
  • Retain "Prescriber" copy with patient record.
  • Mail "Survey Coordinators" copy (via self-mailing format).
  • Instruct patient to retain "Patient" copy and to present "Pharmacist" copy with prescription to pharmacist.
• Complete the mandatory and confidential survey enrollment form.
  • Instruct patients to complete the confidential patient section, seal the survey, and return it to you.
  • Complete the prescriber section and return in the envelope provided to the Slone Epidemiology Unit of Boston University School of Public Health.
• Provide prescription.
  • Prescriptions cannot be issued by telephone.
  • Prescribe no more than 4 weeks (28 days) of therapy, with no automatic refills.
  • Inform patient that all prescriptions must be filled within 7 days.

SUBSEQUENT PATIENT VISITS

• Repeat patient counseling.
• Complete the follow-up survey form.
  • Forms are included in the S.T.E.P.S. folder.
  • Male patients must complete the form at each visit or at least once every 3 months.
• Provide a prescription for no more than a 4-week (28-day) supply of THALOMID(TM) (thalidomide) therapy.
• Telephone prescriptions are not permitted. 1998 Celgene Corporation Printed in the U.S.A. 7/98 CGI 14

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