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Thalidomide Pregnancy Prevention Programme Information For Thalidomide Healthcare Professional Brochure Celgene Corporation Thalidomide Pregnancy Prevention Programme Information for Healthcare Professionals Prescribing or Dispensing Thalidomide RMP/THA/001/20-07/M 1 Thalidomide Healthcare Professional Brochure Celgene Corporation This brochure is intended for healthcare professionals involved in prescribing or dispensing thalidomide, and contains information about: Preventing harm to unborn babies: If thalidomide is taken during pregnancy it can cause severe birth defects or death to an unborn baby. Other side effects of thalidomide: Ischaemic heart disease including myocardial infarction. Further information and recommended precautions can be found in the thalidomide Summary of Product Characteristics (SmPC). Thalidomide Pregnancy Prevention Programme: This Programme is designed to prevent unborn babies being exposed to thalidomide. It will provide you with information about how to follow the programme and explain your responsibilities. It is a requirement of the Pregnancy Prevention Programme that all healthcare professionals ensure that they have read and understood this brochure To ensure your patients’ safety, please read this brochure carefully. You must ensure that your patients fully understand what you have told them about thalidomide before starting treatment. RMP/THA/001/20-07/M 2 Thalidomide Healthcare Professional Brochure Celgene Corporation CONTENTS Introduction ..................................................................................... 4 Thalidomide ................................................................................................................... 5 Thalidomide and Other Potential Side Effects ............................................................ 6 Healthcare Professionals’ Obligations ........................................................................ 7 Information for Prescribers ............................................................ 8 Introduction ................................................................................................................... 8 Specific advice for female patients .............................................................................. 9 Childbearing and non–childbearing potential ................................................................... 9 Contraceptive methods ................................................................................................. 10 Pregnancy testing ......................................................................................................... 11 Specific Advice for Male Patients .............................................................................. 12 Contraceptive methods ................................................................................................. 12 Advice for all Patients .................................................................................................... 13 Prescribing thalidomide ................................................................................................. 13 Information for Pharmacists ......................................................... 15 Introduction ................................................................................................................. 15 Dispensing thalidomide ................................................................................................. 15 Dispensing advice ......................................................................................................... 15 Patient education .......................................................................................................... 15 Points to consider for handling the medicinal product: for healthcare professionals and caregivers .................................... 16 The Thalidomide Pregnancy Prevention Programme at a Glance ........................................................................................................ 19 RMP/THA/001/20-07/M 3 Thalidomide Healthcare Professional Brochure Celgene Corporation Introduction Thalidomide belongs to a group of medicines known as ‘immunomodulatory’ medicines. As the prescriber or pharmacist, you play a central role in ensuring that thalidomide is used safely and in accordance with the requirements of the Pregnancy Prevention Programme. Thalidomide in combination with melphalan and prednisone is approved across Europe for the following indication: o Thalidomide in combination with melphalan and prednisone as first line treatment of patients with untreated multiple myeloma, aged ≥ 65 years or ineligible for high dose chemotherapy. Thalidomide is prescribed and dispensed according to the thalidomide Pregnancy Prevention Programme. When thalidomide is given in combination with other medicinal products, the corresponding SmPC must be consulted prior to initiation of treatment. The recommended oral dose is 200 mg per day, and a maximum number of 12 cycles of 6 weeks should be used. Thalidomide should be taken as a single dose at bedtime, to reduce the impact of somnolence. Thalidomide can be taken with or without food. This brochure is part of the ‘Thalidomide Pregnancy Prevention Programme’ because if thalidomide is taken during pregnancy it can cause severe birth defects or death to an unborn baby. In the 1950s and 1960s, approximately 12,000 children were born with severe birth defects caused by thalidomide, and approximately 5,000 are alive today. This brochure will describe your responsibilities as a prescriber or a pharmacist, and will summarise the information that you need to tell your patient to ensure they are aware of the risks and their responsibilities. All of the Thalidomide Pregnancy Prevention Programme materials are contained within the ‘Educational Healthcare Professional’s Kit’, and additional copies can be obtained by contacting Celgene. These materials can be used for counselling patients on the risks of thalidomide and the precautions to be taken. You must be sure that your patients fully understand what you have told them about thalidomide before starting treatment. RMP/THA/001/20-07/M 4 Thalidomide Healthcare Professional Brochure Celgene Corporation Special warnings and precautions for use: Teratogenic effects. Thalidomide is a powerful human teratogen, inducing a high frequency of severe and life-threatening birth defects. Thalidomide must never be used by women who are pregnant or by women who could become pregnant unless all the conditions of the Thalidomide Pregnancy Prevention Programme are met. The conditions of the Thalidomide Pregnancy Prevention Programme must be fulfilled for all male and female patients. Thalidomide must never be used by women who are pregnant, as just a single dose (one capsule) can induce a high frequency of severe and life-threatening birth defects. Thalidomide must never be used by women who are able to become pregnant unless they follow the Thalidomide Pregnancy Prevention Programme. Since thalidomide may be present in the seminal fluid of male patients, male patients must also follow contraceptive measures. Requirements in the event of a suspected pregnancy: o Stop treatment immediately, if female patient o Refer patient to a physician specialised or experienced in teratology for evaluation and advice o Notify Celgene and the Medicines Authorityof such occurrences o Pregnancy Reporting Form is included in this pack Call AM Mangion Ltd on + 356 23976333 o o Celgene will wish to follow-up with you on the progress of all pregnancies. RMP/THA/001/20-07/M 5 Thalidomide Healthcare Professional Brochure Celgene Corporation Thalidomide and Other Potential Side Effects In addition to the teratogenic effects of thalidomide, other potential side effects your patients should be aware of include ischaemic heart disease, including myocardial infarction. Please refer to the thalidomide SmPC for full information about the side effects and recommended precautions. Your patient should be encouraged to report any unusual reactions or side effects from their medication to their prescriber. The side effects are also described in the thalidomide product information leaflet, which patients should read thoroughly. RMP/THA/001/20-07/M 6 Thalidomide Healthcare Professional Brochure Celgene Corporation Healthcare Professionals’ Obligations Obligations of healthcare professionals who intend to prescribe or dispense thalidomide are: o The need to provide comprehensive advice and counselling to patients o To ensure their patients are capable of complying with the requirements for the safe use of thalidomide o To provide patients with the appropriate patient educational materials o To report any pregnancy, or adverse events to Celgene and the local health authority (if applicable to a Member State) using the forms provided in the ‘Educational Healthcare Professional’s Kit’ RMP/THA/001/20-07/M 7 Thalidomide Healthcare Professional Brochure Celgene Corporation Information for Prescribers Introduction As the prescriber, you play a central role in ensuring that thalidomide is used safely. Most importantly, you will be helping to ensure that your patients understand the risks involved in taking thalidomide and that they are aware of their responsibilities in preventing foetal exposure to the drug. In addition, you may need to help your patients understand the processes involved in the thalidomide Pregnancy Prevention Programme. If you refer your patient to a fertility expert (e.g. obstetrician or gynaecologist) for further contraceptive advice, it is your responsibility
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