Acitretin for Severe Psoriasis: A Guide to Use and Critical Warnings

MEDICAL INFORMATION: This is a potent medication with significant risks. It must only be used under the strict supervision of a dermatologist experienced in the use of systemic retinoids. This information is for educational purposes and is not a substitute for professional medical advice.

Acitretin® (Kahira / Sabaa)

Summary

Acitretin is a systemic retinoid, a synthetic derivative of Vitamin A, used to treat severe and resistant forms of psoriasis and other skin keratinization disorders. It is a potent medication reserved for cases that have not responded to other treatments. Acitretin works by normalizing the excessive growth and differentiation of skin cells. Due to its significant risk of causing severe birth defects, its use is strictly controlled.

BLACK BOX WARNING: EXTREME RISK OF SEVERE BIRTH DEFECTS

Acitretin is a potent human teratogen and is absolutely contraindicated in pregnancy. There is an extremely high risk that a severely deformed infant will result if pregnancy occurs while taking this drug in any amount, even for a short period.

• Female patients of childbearing potential must use at least two effective forms of contraception simultaneously for at least 1 month before, during, and for at least 3 years after discontinuing treatment.
• They must have negative pregnancy tests before, during, and periodically after therapy.
• Alcohol is strictly forbidden during treatment and for 2 months after stopping, as it can convert Acitretin into Etretinate, a substance with a much longer half-life, extending the risk period for birth defects.
• Patients must not donate blood during therapy and for at least 3 years after stopping treatment to prevent a pregnant woman from receiving a transfusion with their blood.

Manufacturer & Marketer

• Manufactured by: Kahira Pharmaceuticals and Chemical Industries Co.
• Marketed by: Sabaa International Company for Pharmaceuticals and Chemical Industries.

Category & Active Ingredient

• Category: Systemic Retinoid (for Psoriasis).
• Active Ingredient: Acitretin.

Available Forms & Strengths in Egypt

Acitretin is available as oral capsules:

• Acitretin 10 mg Capsules
• Acitretin 25 mg Capsules

Indications for Acitretin

Acitretin is indicated for the treatment of:

• Severe, extensive, and resistant psoriasis, including erythrodermic psoriasis and pustular psoriasis.
• Other severe disorders of keratinization (e.g., ichthyosis, Darier's disease) that are unresponsive to standard therapies.

Dosage and Administration

Dosage is highly individualized by a dermatologist. Treatment is usually initiated at a low dose (e.g., 25 mg/day) and adjusted as needed. Capsules should be taken once daily with a main meal to improve absorption.

Side Effects

Side effects are common and often dose-related, resembling symptoms of hypervitaminosis A.

• Very Common: Dryness of the skin and mucous membranes (lips, nose, eyes), leading to chapped lips (cheilitis), nosebleeds, and dry eyes. Peeling skin on palms and soles, hair thinning.
• Common: Increased liver enzymes, elevated triglycerides and cholesterol, headache, muscle or joint pain.
• Serious: Hepatotoxicity (liver damage), pancreatitis, pseudotumor cerebri (increased pressure in the brain), and mood changes. Regular blood tests are mandatory to monitor for these effects.

Contraindications

Besides pregnancy, Acitretin is contraindicated in:

• Women who are breastfeeding.
• Patients with severe liver or kidney impairment.
• Patients with chronically high levels of blood fats (uncontrolled hyperlipidemia).

Drug Interactions

Acitretin has several critical drug interactions:

• Tetracyclines: Must not be used together. This combination increases the risk of increased pressure in the brain (pseudotumor cerebri).
• Methotrexate: Must not be used together. This combination increases the risk of liver damage (hepatitis).
• Vitamin A Supplements: Must be avoided to prevent additive toxicity and symptoms of hypervitaminosis A.
• Phenytoin: Acitretin can decrease the protein binding of phenytoin.
• Progestin-only mini-pills: May not be a reliable form of contraception in patients taking Acitretin.

Frequently Asked Questions (FAQ)

Why is alcohol strictly forbidden with Acitretin?
Consuming alcohol causes the body to convert Acitretin into another substance called Etretinate. Etretinate is also highly teratogenic but is stored in the body for a much longer time, which would extend the risk period for birth defects for many more years.

How long must I wait to get pregnant after stopping Acitretin?
The mandatory waiting period is at least 3 years after the last dose. This is to ensure the drug and its byproducts are completely cleared from the body.

What should I do about the severe dryness?
Liberal use of emollients (moisturizers) for the skin and lip balm for the lips is essential. Artificial tears can help with eye dryness. Consult your dermatologist for product recommendations.

References

1. U.S. National Library of Medicine (MedlinePlus): For patient-friendly information on Acitretin. Acitretin - MedlinePlus
2. DrugBank Database: For detailed technical and pharmacological information. DrugBank – Acitretin Profile
3. Product Information: Sourced from the manufacturer/marketer (Kahira/Sabaa).