Acitretin Orifarm

What Is Acitretin Orifarm and What Is It Used For?

Acitretin belongs to a group of medicines known as retinoids, which are synthetic compounds derived from vitamin A. Unlike topical retinoids that are applied directly to the skin, acitretin is taken orally as a capsule, allowing it to exert its effects systemically throughout the body. The drug was first approved for clinical use in the 1980s and has since become an established second-line therapy for several severe dermatological conditions.

The primary mechanism of action of acitretin involves the normalisation of keratinocyte differentiation — the process by which skin cells in the epidermis mature and eventually form the protective outermost layer of the skin. In conditions such as psoriasis, this process is dysregulated, leading to excessively rapid cell turnover and the characteristic thickened, scaly plaques. Acitretin binds to nuclear retinoid receptors (RAR and RXR), modulating gene expression to slow down abnormal cell proliferation and promote more orderly cell differentiation.

Acitretin Orifarm is primarily indicated for:

• Severe plaque psoriasis — particularly erythrodermic and generalised pustular psoriasis that has not responded adequately to other systemic treatments or phototherapy
• Darier's disease (keratosis follicularis) — a rare genetic skin disorder characterised by greasy, warty-like skin lesions, predominantly in adults
• Severe ichthyosis and other disorders of keratinisation — where abnormal skin thickening and scaling significantly impair quality of life
• Palmoplantar pustulosis — a chronic condition causing recurring outbreaks of sterile pustules on the palms and soles

In clinical practice, acitretin is often used in combination with other treatments. It can be combined with topical therapies (such as calcipotriol or corticosteroids) or with phototherapy (PUVA or narrowband UVB) to enhance efficacy while potentially allowing lower doses of each individual treatment. The European Academy of Dermatology and Venereology (EADV) and the British Association of Dermatologists (BAD) both recognise acitretin as a valuable option in the management of moderate-to-severe psoriasis, particularly when biologic therapies are contraindicated or unavailable.

It is important to note that acitretin is not a cure for these conditions. The medicine controls symptoms and reduces disease severity while it is being taken. Symptoms typically return after treatment is stopped, though some patients maintain improvements for a period of time. Treatment duration and approach are always determined by a specialist dermatologist based on individual patient response and tolerability.

What Should You Know Before Taking Acitretin Orifarm?

Contraindications

Acitretin Orifarm must not be taken in the following circumstances:

• Pregnancy or planned pregnancy — acitretin is classified as Pregnancy Category X and is a known human teratogen
• Breastfeeding — acitretin passes into breast milk and can harm the nursing infant
• Allergy to acitretin, other retinoids (e.g. isotretinoin, tretinoin), or any excipient in the formulation
• Severe hepatic (liver) impairment — the drug is extensively metabolised by the liver
• Severe renal (kidney) impairment
• Severe hyperlipidaemia — pre-existing very high levels of cholesterol or triglycerides in the blood
• Concurrent use of other retinoids or high-dose vitamin A supplements, which can cause hypervitaminosis A
• Concurrent use of tetracycline antibiotics — risk of benign intracranial hypertension (pseudotumour cerebri)
• Concurrent use of methotrexate — the combination increases the risk of hepatotoxicity

Pregnancy Prevention Programme

Women of childbearing potential may only be prescribed acitretin under a strict pregnancy prevention programme. The requirements are comprehensive and legally mandated in many countries:

• The prescribing physician must fully explain the teratogenic risk and ensure the patient understands the consequences
• A negative pregnancy test must be confirmed before starting treatment
• At least one highly effective method of contraception (e.g. intrauterine device or implant) or two complementary methods (e.g. hormonal contraceptive plus barrier method) must be used continuously
• Contraception must begin 1 month before starting treatment and continue for 3 years after stopping
• Regular pregnancy testing — ideally monthly during treatment and every 1–3 months for 3 years after discontinuation
• Progestogen-only contraceptives (“mini-pills”) must not be used as acitretin may reduce their effectiveness
• The patient must sign an informed consent form acknowledging the risks and commitments

The unusually long 3-year post-treatment contraception period exists because acitretin can be converted in the body to etretinate, a related compound with an extremely long half-life. Etretinate is stored in adipose (fat) tissue and can be released slowly over many months or even years. This conversion is particularly accelerated by alcohol consumption, which is one reason alcohol must be strictly avoided.

Warnings and Precautions

Before starting and during treatment with acitretin, several important precautions must be observed:

• Blood donation — you must not donate blood during treatment or for 3 years after stopping, as your blood could potentially harm an unborn child if transfused to a pregnant woman
• Diabetes mellitus — acitretin can affect blood glucose control. If you have diabetes, monitor blood sugar levels more frequently, particularly when starting treatment
• Night vision — night vision may be impaired, sometimes suddenly. This can affect driving and operating machinery, especially at night or in tunnels. In rare cases, impairment has persisted after stopping treatment
• Contact lenses — acitretin causes eye dryness that may make contact lens wear uncomfortable. Consider using glasses throughout treatment
• Sun exposure — the skin becomes more sensitive to sunlight. Use broad-spectrum sunscreen with at least SPF 15 and avoid sunbeds and prolonged sun exposure
• Children — use in children is only considered under special circumstances. Growth and bone development must be monitored regularly if treatment is necessary
• Elderly patients — bone changes must be assessed periodically during long-term treatment
• Mental health — acitretin may affect mood and mental health. Report any changes in mood, depression, aggression, irritability, or signs of psychosis (altered perception of reality) to your doctor
• Intracranial hypertension — seek immediate medical attention if you experience severe headache, nausea, vomiting and visual disturbances, which could indicate raised intracranial pressure
• Pancreatitis risk — acitretin typically raises blood lipids (cholesterol and triglycerides), which are associated with pancreatitis. Report severe abdominal and back pain to your doctor immediately

Pregnancy and Breastfeeding

Acitretin is absolutely contraindicated during pregnancy and breastfeeding. The teratogenic effects are well-documented and include major malformations of the central nervous system, craniofacial structures, cardiovascular system and skeletal system. There is no safe dose of acitretin during pregnancy.

Women must use effective contraception without interruption for 4 weeks before treatment, throughout the entire treatment period, and for 3 full years after the last dose. Even women who do not have regular menstrual periods or are not sexually active must use contraception unless their physician has determined it is not necessary.

If pregnancy occurs during treatment or within 3 years of stopping, the medicine must be stopped immediately and specialist advice sought urgently. The physician should refer the patient to a specialist experienced in teratology for counselling and assessment.

Driving and Using Machines

Your ability to drive or operate machinery may be affected by acitretin. Night vision can be impaired, sometimes with sudden onset. In rare cases, this impairment has continued after treatment was stopped. Exercise particular caution when driving at night or in poorly lit conditions such as tunnels. Assess your own fitness to drive and discuss any concerns with your doctor.

How Does Acitretin Orifarm Interact with Other Drugs?

Drug interactions with acitretin can be serious and potentially life-threatening. Always inform your prescriber and pharmacist of all medicines you are taking, including over-the-counter products, herbal remedies and vitamin supplements. The following table summarises the most important interactions:

Major Interactions (Do Not Combine)

Moderate Interactions (Use with Caution)

Beyond these specific interactions, always exercise caution with hepatotoxic drugs (medicines that can damage the liver), as acitretin itself places a burden on liver function. Inform your healthcare provider about all medications and supplements, including seemingly harmless ones like multivitamins that may contain vitamin A.

What Is the Correct Dosage of Acitretin Orifarm?

Acitretin dosage is always individualised by a specialist dermatologist and adjusted according to clinical response and tolerability. The capsules should be swallowed whole with food or milk to maximise absorption, as acitretin is a fat-soluble compound and its bioavailability is significantly enhanced when taken with a meal containing fat.

Adults and Elderly

The dose-response relationship of acitretin means that both efficacy and side effects increase with higher doses. Most dermatologists aim for the lowest effective dose to minimise adverse effects while maintaining adequate disease control. Starting at a lower dose and gradually increasing allows the body to adapt, which can improve tolerance of common mucocutaneous side effects such as dry lips and skin.

Combination therapy with topical agents (emollients, corticosteroids, vitamin D analogues) or phototherapy is common in clinical practice. When combined with PUVA phototherapy, lower doses of acitretin (10–25 mg/day) may be sufficient, reducing the risk of dose-dependent side effects while potentially improving overall psoriasis clearance rates. The European Medicines Agency (EMA) and British Association of Dermatologists (BAD) guidelines both support this combination approach.

Children and Adolescents

In paediatric patients, the dermatologist must carefully weigh the severity of the skin condition against the potential risks of systemic retinoid therapy. Regular monitoring of growth parameters, bone development and skeletal radiographs is mandatory during treatment. Premature epiphyseal closure has been reported with long-term retinoid use in children, making periodic assessment essential.

Missed Dose

If you forget to take a dose, take it as soon as you remember, unless it is almost time for your next scheduled dose. In that case, skip the missed dose and continue with your regular dosing schedule. Do not take a double dose to make up for the one you missed.

Overdose

If you take too much acitretin, you may experience symptoms of acute vitamin A toxicity including headache, dizziness, nausea, vomiting, drowsiness, irritability and itching. Stop taking the medicine and contact your doctor, emergency department or poison control centre immediately. Treatment is generally supportive, as there is no specific antidote for acitretin overdose.

Stopping Treatment

Do not stop taking acitretin without consulting your doctor. Your dermatologist is best placed to advise on whether and how to discontinue treatment, taking into account your disease activity, treatment response, and the need for ongoing monitoring. Abrupt discontinuation does not typically cause withdrawal effects, but your skin condition may gradually return.

What Are the Side Effects of Acitretin Orifarm?

Like all medicines, acitretin can cause side effects, although not everyone experiences them. Because acitretin is a vitamin A derivative, most of its side effects resemble the symptoms of hypervitaminosis A (vitamin A excess). The side effects are generally dose-dependent — they are more likely at higher doses and often improve when the dose is reduced. Many patients experience a temporary worsening of their skin condition during the first few weeks of treatment before improvement occurs.

Mental Health Effects

Acitretin, like other retinoids, may affect mood and mental health. High-dose retinoid treatment has been associated with mood swings, irritability, aggression and depression. In some cases, signs of psychosis (altered perception of reality, such as hearing voices or seeing things that are not there) have been reported. It is very important that patients, family members and friends are aware that this medicine can affect mood and behaviour. Changes may be subtle and not noticed by the patient themselves, so trusted people around the patient play an important role in identifying any concerning changes early.

Monitoring During Treatment

Your doctor will perform regular blood tests before and during treatment to monitor:

• Liver function tests — measured before treatment, every 1–2 weeks for the first 2 months, then every 3 months
• Blood lipid profile (cholesterol and triglycerides) — particularly important in patients with diabetes, obesity, high alcohol intake, or pre-existing dyslipidaemia
• Blood glucose — in patients with diabetes, as acitretin may affect glucose tolerance
• Bone monitoring — skeletal radiographs at intervals during long-term treatment in adults and regularly in children

How Should You Store Acitretin Orifarm?

Proper storage of acitretin is particularly important given the drug's teratogenic potential. Accidental ingestion by a pregnant woman or a woman of childbearing potential could have devastating consequences. Therefore:

• Keep out of sight and reach of children at all times
• Do not use after the expiry date printed on the carton (the expiry date refers to the last day of that month)
• Store in the original packaging to protect from light and moisture
• Return any unused capsules to a pharmacy when treatment is complete — never share this medicine with anyone
• Do not dispose of via wastewater or household waste — medicines should be returned to a pharmacy to protect the environment

What Does Acitretin Orifarm Contain?

Active Substance

Each hard capsule contains either 10 mg or 25 mg of acitretin.

Excipients (Inactive Ingredients)

Capsule contents: Maltodextrin, microcrystalline cellulose, sodium ascorbate, disodium edetate (EDTA), poloxamer.

Capsule shell: Gelatin, titanium dioxide (E171), red iron oxide (E172), yellow iron oxide (E172), black iron oxide (E172).

Printing ink: Shellac, titanium dioxide (E171), propylene glycol.

Appearance and Pack Sizes

Not all pack sizes may be marketed in every country.