User Guide for lenalidomide models including: REMS Risk Evaluation and Mitigation Strategy, REMS, Risk Evaluation and Mitigation Strategy
Pharmacy Guide to Risk Evaluation and Mitigation Strategy (REMS) Important information about lenalidomide and Lenalidomide REMS · Lenalidomide is contraindicated in pregnant females and females capable of becoming pregnant. Females of reproductive potential may be treated with lenalidomide provided adequate precautions are taken to avoid pregnancy · To avoid embryo-fetal exposure, lenalidomide is only available under a restricted distribution program called "Lenalidomide REMS" (Risk Evaluation and Mitigation Strategy) · Only prescribers and pharmacies certified with Lenalidomide REMS can prescribe and dispense the product to patients who are enrolled and meet the conditions of Lenalidomide REMS · Dispensing pharmacists must be educated on Lenalidomide REMS and on dispensing procedures for lenalidomide · Information about lenalidomide and Lenalidomide REMS can be obtained by visiting www.LenalidomideREMS.com pp,A e l iboMSMER enegl eC eht gni ssecca, or calling Lenalidomide REMS toll-free at 1-888-423-5436 The Lenalidomide REMS includes both REVLIMID® (lenalidomide) and generic lenalidomide products. The Lenalidomide Manufacturers have a contractual agreement under which Celgene Corporation administers the REMS on behalf of the Lenalidomide Manufacturers. All manufacturers retain responsibility for the actions described in the REMS. Reference ID: 481397615060 Table of contents Guidelines for ordering, counseling, and dispensing lenalidomide ................................. 3 Lenalidomide Risk Evaluation and Mitigation Strategy (REMS) Education and Counseling Checklist for Pharmacies ..................................................... 6 Rules for dispensing and shipping..................................................................................... 6 Suspected pregnancy reporting procedure for healthcare professionals........................ 7 2 Reference ID: 481397615060 Guidelines for ordering, counseling, and dispensing lenalidomide Dispensing pharmacies must be certified in Lenalidomide REMS and must be educated in the following dispensing procedures. Step 1. Review incoming lenalidomide prescriptions A. Only accept prescriptions with an authorization number and patient risk category written on them. Authorization numbers are valid for 7 days from the date of last pregnancy test for female patients of reproductive potential and 30 days from the date it is issued for all other patients. No automatic refills or telephone prescriptions are permitted Faxed prescriptions are permissible depending on state laws B. Make sure the prescription is signed and dated. C. Confirm the prescription is written for a 4-week (28-day) supply or less. D. For subsequent prescriptions, verify there are 7 days or less remaining of therapy on the existing prescription. Step 2. Counsel patients A. Make sure a certified Lenalidomide REMS counselor counsels the patient. B. Complete the corresponding section (based on the patient risk category) of the Education and Counseling Checklist and ensure the form is signed and dated. Ensure the appropriate boxes are checked off. Retain a copy of the checklist and record of the associated prescription. C. If the patient mentions adverse drug experiences that are suspected to be associated with the use of lenalidomide and any suspected pregnancy occurring during the treatment with lenalidomide, make sure to document these experiences using acceptable documentation as noted on the checklist. Acceptable documentation examples: 1. Adverse Drug Event form and fax confirmation 2. Pharmacy log D. Report all suspected pregnancies to Lenalidomide REMS within 24 hours. See the Suspected Pregnancy Reporting Procedure on page 7 for more information. 3 Reference ID: 481397615060 Guidelines for ordering, counseling, and dispensing lenalidomide (continued) Step 3. Obtain confirmation number from Lenalidomide REMS A. Prior to each prescription, contact Lenalidomide REMS at 1-888-423-5436. Enter the pharmacy NABP number or DEA number Enter the authorization number written on the prescription Enter the number of capsules and milligram strength being dispensed B. Write the confirmation number and the date of receipt on the prescription. The confirmation number is only valid for 24 hours. C. If you do not obtain a confirmation number, do not dispense lenalidomide. Step 4. Dispensing A. No Refills. A new prescription is required for each dispense. Dispense subsequent prescriptions only if there are 7 days or less remaining of therapy on the existing prescription. B. Ensure the confirmation number has not expired, ie, dispense within 24 hours from confirmation number receipt. If more than 24 hours have elapsed, Do Not Dispense. You must call Lenalidomide REMS at 1-888-423-5436 to cancel the first confirmation number and obtain a new confirmation number. For female patients of reproductive potential, ship the same day or hand to the patient within 24 hours. C. Dispense each prescription with a Medication Guide and maintain a record on acceptable documentation. Acceptable documentation examples: 1. Signed Education and Counseling Checklist (if counseling pharmacist and dispensing pharmacist are the same) 2. Pharmacy log 4 Reference ID: 481397615060 Guidelines for ordering, counseling, and dispensing lenalidomide (continued) D. Document the dispense date and maintain a record on acceptable documentation. Acceptable documentation examples: 1. Shipping receipt 2. Pharmacy dispensing log E. Dispense no more than a 4-week (28-day) supply. A new prescription is required for each dispense. No automatic refills or telephone prescriptions are permitted. F. A signature is required for all shipping and dispense if picked up by patient. Step 5. Perform drug accountability A. Pharmacy shall keep an inventory log for lenalidomide, by strength, reflecting its on-hand inventory at all times. B. Do not transfer lenalidomide to another pharmacy without prior authorization from Lenalidomide REMS. C. Accept unused lenalidomide (previously dispensed) from a patient or patient caregiver and return the capsules to Lenalidomide REMS for proper disposal. 5 Reference ID: 481397615060 Lenalidomide Risk Evaluation and Mitigation Strategy (REMS) Education and Counseling Checklist for Pharmacies Ensure your patients know the risks Before you are able to fill a prescription for lenalidomide, a checklist for each patient must be completed based on the patient risk category (written on the front of the Patient Prescription Form). When completing the checklist, be sure all the appropriate boxes are checked off () and the form is signed and dated. All boxes and spaces must be marked or filled in during counseling with the patient for every prescription. Retain a copy of the checklist and record of the associated prescription. Education and Counseling Checklist for Pharmacies Lenalidomide Risk Evaluation and Mitigation Strategy (REMS) education and prescribing safety Authorization No.: Pharmacy Name: Pharmacy Address: Counselor Name: Patient Name: Risk Category: Confirmation No.: Confirmation Date: Work Phone: Ext.: Date of Birth: Checklist for female patients of reproductive potential I will make sure that patients are aware that they will receive the Medication Guide along with their prescription I COUNSELED ADULTS AND CHILDREN ON: q Potential embryo-fetal toxicity q Not taking lenalidomide if pregnant or breastfeeding q Using at the same time at least 1 highly effective method--tubal ligation, IUD, hormonal (birth control pills, hormonal patches, injections, vaginal rings, or implants), or partner's vasectomy--and at least 1 additional effective method of birth control--male latex or synthetic condom, diaphragm, or cervical cap--every time they have sex with a male, or abstaining from sex with a male q Unacceptable methods of birth control are progesterone-only "mini-pills," IUD Progesterone T, female condoms, natural family planning (rhythm method) or breastfeeding, fertility awareness, withdrawal, and cervical shield (a cervical shield should not be confused with a cervical cap, which is an effective secondary form of contraception) q Continuing to use at the same time at least 1 highly effective method and at least 1 additional effective method of birth control beginning at least 4 weeks before taking lenalidomide, while taking lenalidomide, during dose interruptions, and for at least 4 weeks after stopping lenalidomide every time they have sex with a male, or abstaining from sex with a male q Obtaining a pregnancy test--performed by their healthcare provider--weekly during the first 4 weeks of use. Thereafter, pregnancy testing should be repeated every 4 weeks during the rest of their treatment in females with regular menstrual cycles or no cycle at all. If menstrual cycles are irregular, the pregnancy testing should occur every 2 weeks q The need to stop taking lenalidomide right away in the event of becoming pregnant, or if they think for any reason they may be pregnant, and to call their healthcare provider immediately q Possible side effects include neutropenia, thrombocytopenia, deep vein thrombosis, and pulmonary embolism as well as risk of myocardial infarction and stroke q The need for del 5q MDS patients to schedule a blood test every week for the first 8 weeks and monthly thereafter to monitor blood counts while taking lenalidomide q Not sharing lenalidomide capsules with anyone--especially with females who can get pregnant q Not donating blood while taking lenalidomide (including dose interruptions) and for 4 weeks after stopping lenalidomide q Not breaking, chewing, or opening lenalidomide capsules q Instructions on lenalidomide dose and administration Milligram (mg) Strength Number of Capsules Dispensed FEMALE CHILDREN (<18 YEARS OF AGE): q Parent or legal guardian must have read the Lenalidomide REMS education material and agreed to ensure compliance Checklist for female patients not of reproductive potential (natural menopause for at least 24 consecutive months, a hysterectomy, and/or bilateral oophorectomy) q I will make sure that patients are aware that they will receive the Medication Guide along with their prescription I COUNSELED ADULTS AND CHILDREN ON: q Possible side effects include neutropenia, thrombocytopenia, deep vein thrombosis, and pulmonary embolism as well as risk of myocardial infarction and stroke q The need for del 5q MDS patients to schedule a blood test every week for the first 8 weeks and monthly thereafter to monitor blood counts while taking lenalidomide q Not sharing lenalidomide capsules with anyone--especially with females who can get pregnant q Not donating blood while taking lenalidomide (including dose interruptions) and for 4 weeks after stopping lenalidomide q Not breaking, chewing, or opening lenalidomide capsules q Instructions on lenalidomide dose and administration Milligram (mg) Strength Number of Capsules Dispensed FEMALE CHILDREN (<18 YEARS OF AGE): q Parent or legal guardian must have read the Lenalidomide REMS education material and agreed to ensure compliance q Parent or legal guardian must inform the child's healthcare provider when the child begins menses 1 of 2 (continued on next page) Be prepared to provide the following information for each checklist: Authorization Number Confirmation Number Counselor Name Work Phone Number Patient Name Patient Date of Birth Pharmacy Address (including City, State, ZIP Code) Confirmation Date Extension Pharmacy Name Rules for dispensing and shipping Making sure before you release lenalidomide DO NOT DISPENSE OR SHIP LENALIDOMIDE TO A PATIENT UNLESS ALL OF THE FOLLOWING ARE DONE: · Prescription has an authorization number and patient risk category written on it · You have obtained a confirmation number and a confirmation date · You are shipping the product within 24 hours of obtaining the confirmation number and requesting confirmation of receipt. For females of reproductive potential, the product must be shipped the same day the confirmation number is obtained · The Medication Guide is included with the prescription · You confirm the prescription is no more than a 4-week (28-day) supply and there are 7 days or less remaining on the existing lenalidomide prescription For further information about lenalidomide, please refer to the relevant full Prescribing Information at www.LenalidomideREMS.com. 6 Reference ID: 481397615060 Suspected pregnancy reporting procedure for healthcare professionals Please report any suspected pregnancy occurring during the treatment with lenalidomide to Lenalidomide REMS using any of the following methods. REPORTING TO LENALIDOMIDE REMS · Online: www.celgene.com/contact-us/ · Email: drugsafety@celgene.com · Telephone: 1-908-673-9667 · Toll-free: 1-800-640-7854 (Global Drug Safety & Risk Management) or 1-888-423-5436 (Lenalidomide REMS) · Fax: 1-908-673-9115 · Mail to: Global Drug Safety & Risk Management, Celgene Corporation, 86 Morris Avenue, Summit, NJ 07901 REPORTING TO THE FDA Adverse drug experiences that are suspected to be associated with the use of lenalidomide and any suspected pregnancy occurring during the treatment with lenalidomide may also be reported to the FDA MedWatch Reporting System using any of the following methods: · Online at: https://www.accessdata.fda.gov/scripts/medwatch/medwatch-online.htm · Telephone: 1-800-FDA-1088 · Fax: 1-800-FDA-0178 · Mail to: MedWatch, 5600 Fishers Lane, Rockville, MD 20852-9787 7 Reference ID: 481397615060 For more information about lenalidomide and Lenalidomide REMS, please visit www.LenalidomideREMS.com, or call Lenalidomide REMS at 1-888-423-5436. Lenalidomide REMS 86 Morris Ave Summit, NJ 07901 Lenalidomide is only available under a restricted distribution program, Lenalidomide REMS. Please see relevant full Prescribing Information, including Boxed WARNINGS, CONTRAINDICATIONS, WARNINGS AND PRECAUTIONS, and ADVERSE REACTIONS at www.LenalidomideREMS.com. XX/19 Reference ID: 481397615060 US-REMS-LEN190007Adobe PDF Library 11.0