Prescribers’ Program Guide

Background

Acitretin is a highly-teratogenic drug that is associated with a high risk of severe birth defects when taken by pregnant women, or by women who have taken the drug during the month before pregnancy, or up to three years prior to becoming pregnant.

Congenital abnormalities commonly associated with Taro-Acitretin use during pregnancy include:

• External ear abnormalities (e.g., low-set ears)
• Eye abnormalities (e.g., wide-set eyes)
• High palate
• Absence of fingers and/or toes
• Enlarged head, small chin
• Malformation of bones (hip, ankle, forearm, skull)
• Meningoencephalocele
• Multiple synostosis
• Cardiovascular malformations

The Taro-Acitretin Pregnancy Prevention Program has been developed to ensure that female patients are not pregnant when starting treatment with Taro-Acitretin and do not become pregnant during treatment and for at least three years after treatment has been stopped.

Taro-Acitretin must not be prescribed to any woman of childbearing potential unless she meets all of the criteria for treatment listed in the “Taro-Acitretin Product Monograph” and until all components of the Taro-Acitretin Pregnancy Prevention Program have been completed (see “Prescribing Checklist”) and the “Informed Consent Form for Patients” has been signed.

Per the product monograph, Taro-Acitretin is contraindicated in every female of childbearing potential unless all of the following apply:

1. The patient has severe psoriasis or other severe disorder of keratinization, which is resistant to standard therapies.
2. The patient is reliable in understanding and carrying out the physician’s instructions.
3. The patient is able to comply with mandatory contraceptive measures reliably and without fail.
4. Before treatment with Taro-Acitretin, the patient has received from the physician, and acknowledged understanding of, a detailed and careful oral and printed explanation of the precautions to be taken, the risk of very severe fetal malformation, and the possible consequences if pregnancy occurs during the course of treatment with acitretin or within three years of discontinuing.
5. It is absolutely essential that every female of childbearing potential who is to undergo treatment with Taro-Acitretin use two complementary methods of effective contraception (i.e., one primary and one secondary method) without interruption for at least four weeks before, during, and for three years after the discontinuation of treatment with Taro-Acitretin. The patient should be instructed to immediately contact a doctor or pharmacist in case of suspected pregnancy.
6. At the start of treatment, the patient has two negative serum or urine pregnancy tests (with a minimum sensitivity of 25 mIU/mL) from a licensed laboratory. The first test (with a negative result) is obtained at screening when Taro-Acitretin treatment is under consideration and the second confirmatory test must be obtained not more than three days before the first dose is given. During treatment, pregnancy tests should be arranged at 28-day intervals. A negative pregnancy test, not older than three days, is mandatory before a renewal prescription is provided at these visits. After stopping Taro-Acitretin treatment, pregnancy tests must be performed at one-to-three monthly intervals for a period of at least three years after the last dose is given. Pregnancy tests serve to reinforce to the patient the necessity of avoiding pregnancy and, in the event of pregnancy, provide the physician and patient an immediate opportunity to discuss the serious risk to the fetus from this exposure to Taro-Acitretin and the desirability of continuing the pregnancy.
7. Treatment should not begin until the second or third day of the next menstrual period, unless the patient is using treatment that prevents her from having periods (e.g., extended hormonal contraception, progesterone intrauterine device).
8. The same effective and uninterrupted contraceptive measures described above must be taken every time a course of Taro-Acitretin treatment is repeated, however long the intervening period may have been, and must be continued for three years after the last dose.
9. Should pregnancy occur, in spite of these precautions, there is a high risk of severe malformation of the fetus (e.g., craniofacial defects, cardiac and vascular or CNS malformations, skeletal and thymic defects) and the incidence of spontaneous abortion is increased. This risk applies especially during treatment with acitretin and two months after treatment. For three years after acitretin discontinuation, the risk is lower (particularly in females who have not consumed alcohol) but cannot be entirely excluded due to possible formation of etretinate.
10. The patient must avoid alcohol consumption during treatment and for two months after stopping treatment.

Taro-Acitretin Pregnancy Prevention Program Components 

The Taro-Acitretin Pregnancy Prevention Program consists of the following components:

• Prescribers’ Program Guide (this document)
• General Medication Guide for Patients
• Preventing Pregnancy and Precautions Guide for Patients
• Patient Knowledge Test – Understanding the Importance of Preventing Pregnancy
• Prescribing Checklist
• Informed Consent Form for Patients

Before Prescribing Taro-Acitretin:

• You must ensure that your patient has read and understood the “General Medication Guide for Patients” and the “Preventing Pregnancy and Precautions Guide for Patients.”
• The patient must complete the “Patient Knowledge Test – Understanding the Importance of Preventing Pregnancy” document.
• You must discuss treatment options and risks associated with Taro-Acitretin use with the patient to ensure that Taro-Acitretin is the most appropriate management strategy.
• You must discuss any concerns or questions that the patient might have about his/her treatment before asking for his/her signature on the “Informed Consent Form for Patients.”
  • The “Prescribing Checklist” has been developed to help you to determine the suitability and eligibility of female patients for receiving Taro-Acitretin treatment in a step-wise and documented approach. It is strongly recommended that you use this document and keep it in the patient’s file along with the signed “Informed Consent Form for Patients.”

Important safety information about Taro-Acitretin and the Pregnancy Prevention Program is available from Taro-acitretin.ca.

To speak to a customer service representative or to report an adverse reaction, please contact the Taro Pharmaceutical Industries Ltd. Customer Service Department at 1-800-268-1975.