Teva's Acitretin

Teva's Take Action to Prevent Pregnancy (T.A.P.P.) is dedicated to making sure that acitretin is used as safely as possible. The program provides women and their healthcare providers with information about the risk of birth defects associated with Acitretin use. A variety of tools are available through T.A.P.P. to help prevent the occurrence of pregnancy during use of Acitretin and for three years after the last dose.

If you think you've become pregnant while taking Acitretin or within 3 years of stopping:

  • Stop taking Acitretin
  • Call your doctor to tell him/her you might be pregnant
  • Call Teva Pharmaceuticals: 855.850.2138
  • Or call FDA MedWatch: 800.FDA.1088 (800.332.1088)

For 24 hour, toll-free, automated birth control counseling
please call: 855.850.2138

For more information, ask your doctor or call 855.850.2138

Indication

Acitretin are indicated for the treatment of severe psoriasis in adults. Because of significant adverse effects associated with its use, acitretin should be prescribed only by those knowledgeable in the systemic use of retinoids. In females of reproductive potential, acitretin should be reserved for non-pregnant patients who are unresponsive to other therapies or whose clinical condition contraindicates the use of other treatments.

Important Safety Information including Boxed Warning


CONTRAINDICATIONS AND WARNINGS: Acitretin must not be used by females who are pregnant or who may become pregnant during therapy or at any time for at least 3 years after discontinuation of treatment. Acitretin also must not be used by females of reproductive potential who may not use 2 effective forms of contraception (birth control) simultaneously for at least 1 month before, during and for at least 3 years after treatment. Two effective forms of contraception (birth control) are to be used simultaneously, even when one is a hormonal contraceptive. Patients should not self-medicate with St. John's Wort because of possible interaction with hormonal contraceptives. Prescribers must obtain negative results for 2 pregnancy tests before initiating treatment with Acitretin. The first test is a screening test, the second is a confirmation test done during the first 5 days of the menstrual period immediately preceding Acitretin therapy. For patients with amenorrhea, the second test should be done at least 11 days after the last act of unprotected sexual intercourse. Timing of pregnancy testing throughout the treatment course should be monthly or individualized based on the prescriber's clinical judgement. Females must sign a Patient Information/Consent about the risks of birth defects. Acitretin is a metabolite of etretinate and major fetal abnormalities have been reported with both drugs. Acitretin can interact with ethanol to form etretinate. Therefore, females of reproductive potential must not ingest ethanol during treatment and for 2 months after cessation of treatment. Before prescribing, please see complete pregnancy warning in the accompanying complete product information. Females who have undergone treatment with Tegison® (etretinate) must continue to follow the contraception requirements for Tegison.


Common side effects include: cheilitis, rhinitis, dry mouth, arthralgia, spinal hyperostosis, alopecia, skin peeling, dry skin, nail disorder, pruritus, erythematous rash, hyperesthesia, paresthesia, paronychia, skin atrophy, sticky skin, alteration in lipids, rigors, xerophthalmia, and epistaxis.

Less frequent, but potentially serious, adverse events include hepatotoxicity, hyperostosis, alteration in lipids with possible cardiovascular effects, ophthalmologiceffects, pancreatitis, and pseudotumor cerebri.

Common side effects can include: chapped lips; peeling fingertips, palms, and soles; itching; scaly skin all over; weak nails; sticky or fragile (weak) skin; runny or dry nose; nosebleeds; dry mouth; joint pain; tight muscles; hair loss; dry eyes; and rise in blood fats (lipids).

Less frequent, but potentially serious side effects include: bad headaches, nausea, vomiting, blurred vision; decreased vision in the dark; depression; yellowing of your skin or the whites of your eyes, nausea and vomiting, loss of appetite or dark urine; aches or pains in your bones, joints, muscles or back, trouble moving; loss of feeling in your hands or feet; frequent urination, great thirst or hunger. Shortness of breath, dizziness, chest pain, weakness, trouble speaking, or swelling of a leg may be signs of a heart attack, blood clots, or stroke.


You are encouraged to report negative side effects of prescription drugs to the FDA.

Visit www.fda.gov/medwatch, or call 1-800-FDA-1088

More information about safe use of Acitretin may be found in the medication guide.Please see accompanying prescribing information, including Boxed Warnings.