Alitretinoin Orifarm: Uses, Dosage & Side Effects

What Is Alitretinoin Orifarm and What Is It Used For?

Quick Answer: Alitretinoin Orifarm is an oral retinoid (vitamin A-related medicine) prescribed by dermatologists for severe chronic hand eczema in adults that has not responded to potent topical treatments. It works by reducing inflammation and normalizing skin cell growth.

The active substance in Alitretinoin Orifarm is alitretinoin, also known as 9-cis-retinoic acid. It belongs to a group of medicines called retinoids, which are chemically related to vitamin A. Retinoids play a critical role in regulating cell differentiation, immune responses, and inflammation throughout the body. Unlike topical retinoids that are applied directly to the skin, alitretinoin is taken orally as a soft capsule, allowing it to exert its effects systemically.

Alitretinoin Orifarm is specifically indicated for the treatment of severe chronic hand eczema (also called hand dermatitis) in adult patients whose condition has not improved adequately with other topical treatments, including potent topical corticosteroids. Chronic hand eczema is a debilitating condition that can significantly impair quality of life, making everyday tasks painful and difficult. It affects approximately 2–10% of the general population at some point in their lifetime, with prevalence higher among certain occupational groups such as healthcare workers, hairdressers, food handlers, and construction workers.

The mechanism of action of alitretinoin is unique among dermatological agents. It is an endogenous retinoid that binds to and activates both retinoic acid receptors (RARs) and retinoid X receptors (RXRs). This dual receptor binding modulates multiple pathways involved in inflammation, immune cell function, and epidermal differentiation. By downregulating inflammatory mediators and promoting normal keratinization, alitretinoin can significantly improve the signs and symptoms of chronic hand eczema, including vesicles, scaling, fissuring, and erythema.

Treatment with Alitretinoin Orifarm must be initiated and supervised by a dermatologist experienced in the use of systemic retinoids. This is essential because the medication carries significant risks, particularly regarding teratogenicity (the potential to cause birth defects), and requires careful monitoring through regular blood tests and clinical assessments throughout the treatment course.

What Should You Know Before Taking Alitretinoin Orifarm?

Quick Answer: Alitretinoin Orifarm is contraindicated during pregnancy and breastfeeding, in patients with liver disease, severe kidney disease, uncontrolled high blood lipids, untreated thyroid disease, or hypervitaminosis A. It must not be taken with tetracycline antibiotics or alongside other retinoids.

Contraindications

You must not take Alitretinoin Orifarm if any of the following apply to you:

• Allergy to alitretinoin, other retinoids (such as isotretinoin), peanuts, soya, or any of the other ingredients in the capsules.
• Pregnancy or breastfeeding. Alitretinoin is highly teratogenic and can cause severe birth defects.
• Possibility of becoming pregnant without following the required pregnancy prevention programme (see below).
• Liver disease. The medication is metabolized in the liver and may worsen hepatic impairment.
• Severe kidney disease. Alitretinoin is not recommended for patients with severe renal impairment.
• High blood lipids (elevated cholesterol or triglycerides) that are not adequately controlled.
• Untreated thyroid disease. Alitretinoin can further affect thyroid hormone levels.
• Hypervitaminosis A (excessively high vitamin A levels in the body).
• Concurrent use of tetracycline antibiotics, as the combination increases the risk of a serious condition called intracranial hypertension (raised pressure inside the skull).

Pregnancy Prevention Programme

Because of the extreme risk of birth defects, women of childbearing potential are subject to a strict pregnancy prevention programme before, during, and after treatment. The requirements include:

• Education about risks: Your dermatologist must explain in full the risk of harm to an unborn child. You must understand why you must not become pregnant and what steps are necessary to prevent pregnancy.
• Contraception counselling: You must discuss contraception with your doctor, who may refer you to a specialist for advice. You must agree to use at least one highly reliable method of contraception (such as an intrauterine device or contraceptive implant) or two effective methods that work in different ways (such as the contraceptive pill and a condom).
• Contraception timing: Effective contraception must be in place for at least one month before starting treatment, throughout the entire treatment period, and for one month after stopping Alitretinoin Orifarm.
• Pregnancy testing: A medically supervised pregnancy test (with a minimum sensitivity of 25 mIU/mL) must be negative before starting treatment. Regular pregnancy tests are required—ideally monthly during treatment and one month after stopping the medication.
• Monthly follow-up visits: You must attend regular appointments with your dermatologist, ideally every month.
• If you become pregnant: Stop taking Alitretinoin Orifarm immediately and contact your doctor, who can refer you to a specialist for advice.

Contraception must be used even if you do not currently have menstrual periods or are not sexually active, unless your doctor decides this is not necessary based on your individual circumstances.

Warnings and Precautions

Before and during treatment with Alitretinoin Orifarm, discuss the following with your dermatologist:

• Mental health history: If you have ever experienced depression, aggressive behaviour, mood changes, or thoughts of self-harm or suicide, inform your doctor. Your mood may be affected while taking alitretinoin. Tell friends and family that you are taking this medication so they can help identify mood or behavioural changes.
• Kidney disease: If you have moderate kidney impairment, discuss whether alitretinoin is appropriate for you, as the medication is not recommended for this group.
• High blood lipids: Alitretinoin frequently increases levels of cholesterol and triglycerides. You may need more frequent blood tests to monitor lipid levels. If they remain elevated, your doctor may reduce the dose or discontinue treatment.
• Diabetes: If you have diabetes, your blood glucose levels may need more frequent monitoring, and your doctor may initiate treatment at a lower dose.
• Thyroid disease: Alitretinoin can reduce thyroid hormone levels. If thyroid hormone levels drop, your doctor may prescribe thyroid hormone supplementation.

Sun sensitivity: Your skin may become more sensitive to sunlight while taking alitretinoin. Use sunscreen with an SPF of at least 15 and avoid prolonged sun exposure and sunbeds. Dry skin and lips: Use moisturising creams or ointments and lip balm regularly to manage dryness. Dry eyes: Lubricating eye drops or ointments can help. If you wear contact lenses, you may need to use glasses during treatment. Exercise: Reduce intense physical activity, as alitretinoin may cause muscle pain and joint discomfort.

Mental Health Considerations

Retinoids, including alitretinoin, have been associated with mood changes and psychiatric effects in some patients. Although a direct causal relationship has not been definitively established, depression, anxiety, mood swings, aggressive behaviour, and in very rare cases suicidal thoughts have been reported during treatment. It is important that you, your family, and your friends remain vigilant for any changes in mood or behaviour. If you experience depressive symptoms, mood changes, or thoughts of self-harm, stop taking Alitretinoin Orifarm immediately and contact your doctor as soon as possible. Stopping the medication may not be sufficient to resolve symptoms, and your doctor may arrange further support.

Children and Adolescents

Alitretinoin Orifarm is not recommended for use in children and adolescents under 18 years of age. The efficacy and safety of alitretinoin have not been established in this age group.

Blood Donation

You must not donate blood during treatment with Alitretinoin Orifarm or for one month after stopping treatment. If a pregnant woman were to receive your donated blood, the medication could harm their unborn child.

How Does Alitretinoin Orifarm Interact with Other Drugs?

Quick Answer: Alitretinoin Orifarm has clinically significant interactions with tetracycline antibiotics, other retinoids, vitamin A supplements, certain antifungal medications, simvastatin, gemfibrozil, amiodarone, and several other drugs. Always inform your doctor of all medications you are taking.

Drug interactions can alter how alitretinoin works or increase the risk of side effects. The following table summarises the key drug interactions. Always tell your dermatologist about all prescription medications, over-the-counter drugs, and supplements you are taking.

Major Interactions

The most critical interactions involve tetracycline antibiotics and other retinoids. Combining alitretinoin with tetracyclines (such as doxycycline, minocycline, or tetracycline) can cause a dangerous condition called intracranial hypertension (pseudotumor cerebri), characterised by severe headaches, visual disturbances, nausea, and vomiting. This condition can lead to permanent vision loss if not treated promptly. Similarly, using two or more retinoid medications simultaneously increases the risk of all retinoid-related side effects, including severe dryness of the skin and mucous membranes, elevated blood lipids, and liver toxicity.

Moderate Interactions

CYP3A4 enzyme inhibitors such as ketoconazole, fluconazole, and miconazole can significantly increase the blood concentration of alitretinoin, potentially enhancing its side effects. If concurrent use is necessary, your dermatologist may choose to reduce the alitretinoin dose. Conversely, alitretinoin can affect the metabolism of simvastatin, potentially reducing its cholesterol-lowering efficacy. Gemfibrozil and oxandrolone may increase alitretinoin exposure, and your doctor may need to adjust your dose accordingly. Amiodarone, used to treat heart rhythm disorders, is not recommended for use with alitretinoin due to potential additive effects on thyroid function and lipid metabolism.

What Is the Correct Dosage of Alitretinoin Orifarm?

Quick Answer: The recommended dose is 30 mg once daily taken with a main meal. If the 30 mg dose is not tolerated, it may be reduced to 10 mg once daily. A treatment course usually lasts 12 to 24 weeks.

Always take Alitretinoin Orifarm exactly as your dermatologist has told you. Do not change the dose or stop treatment without consulting your doctor first. The capsules should be swallowed whole with a glass of water during a main meal—preferably at the same time each day. Do not chew or open the capsules. Taking the medication with food significantly improves its absorption from the gastrointestinal tract.

Adults

Treatment Duration

A single treatment course typically lasts between 12 and 24 weeks, depending on how well your hand eczema responds to the medication. Treatment should be stopped once the condition has cleared or shown significant improvement. Clinical studies have demonstrated that the majority of patients who respond to alitretinoin do so within the first 12 weeks of treatment. If there is no meaningful improvement after 12 weeks at 30 mg daily, your dermatologist will reassess whether to continue treatment.

If your hand eczema returns after a successful course of treatment, your doctor may prescribe a second course. The same treatment rules, monitoring requirements, and pregnancy prevention measures apply to subsequent courses.

Elderly Patients

There is limited experience with alitretinoin in patients over 65 years of age. No specific dose adjustment is recommended based on age alone, but your dermatologist will consider your overall health, kidney function, and other medications before prescribing alitretinoin.

Missed Dose

Overdose

If you take more Alitretinoin Orifarm than prescribed, or if a child accidentally ingests the medication, contact your doctor, go to the nearest hospital emergency department, or call your national poison control centre immediately. Symptoms of retinoid overdose may include severe headache, nausea, vomiting, drowsiness, and irritability. Bring the medication packaging with you so medical professionals can identify what was taken.

What Are the Side Effects of Alitretinoin Orifarm?

Quick Answer: The most common side effects are headache and elevated blood lipids (triglycerides and cholesterol). Other frequently reported effects include dry skin, dry and inflamed lips, dry eyes, nausea, flushing, dizziness, and joint or muscle pain. Rare but serious side effects include intracranial hypertension, vision problems, and psychiatric effects.

Like all medicines, Alitretinoin Orifarm can cause side effects, although not everybody gets them. Most side effects are dose-related and tend to improve with dose reduction or after treatment is stopped. Your dermatologist will monitor you regularly throughout treatment with blood tests and clinical assessments.

Psychiatric Side Effects

Psychiatric side effects have been reported with alitretinoin and other retinoids, though they are rare. Depression and related mood disturbances may occur in up to 1 in 1,000 patients. Very rarely (up to 1 in 10,000 patients), thoughts of self-harm or suicide, unusual behaviour, and psychotic symptoms (such as hearing voices or seeing things that are not there) have been reported. It is important to note that patients experiencing these symptoms may not appear outwardly depressed. If you or those around you notice any changes in mood, thinking, or behaviour, contact your doctor immediately. Your doctor may advise you to stop treatment, and additional medical or psychological support may be needed.

Side Effects Reported with Other Retinoids

Although not observed specifically with alitretinoin to date, the following very rare side effects have been reported with other medications in the retinoid class and therefore cannot be entirely excluded:

• Diabetes (excessive thirst, frequent urination, elevated blood sugar)
• Colour blindness or impaired colour vision
• Intolerance to contact lenses
• Arthritis, bone disease (delayed growth, changes in bone density), and premature closure of growth plates in adolescents

Can You Drive While Taking Alitretinoin Orifarm?

Quick Answer: Alitretinoin may impair night vision. Exercise caution when driving in the dark or in tunnels, and when operating machinery in low-light conditions.

Night vision (dark adaptation) may be reduced during treatment with Alitretinoin Orifarm. This effect typically resolves after treatment is stopped. You should be particularly careful when driving at night, entering tunnels, or working with machinery in dim lighting. If you experience any visual changes, discuss them with your dermatologist and avoid driving until the issue is resolved. Your ability to drive or operate machinery may also be affected by other side effects such as dizziness; assess your own fitness to drive responsibly.

How Should You Store Alitretinoin Orifarm?

Quick Answer: Store in the original packaging to protect from moisture. Keep out of the sight and reach of children. Do not use after the expiry date on the carton. Return unused capsules to a pharmacy for safe disposal.

Proper storage of Alitretinoin Orifarm is essential to ensure the medication remains effective and safe throughout your treatment. Follow these guidelines:

• Keep out of the sight and reach of children. Accidental ingestion by a child is a medical emergency.
• Store in the original blister packaging to protect the capsules from moisture.
• Do not use after the expiry date printed on the carton and blister pack after “EXP.” The expiry date refers to the last day of the stated month.
• Store at room temperature. No special temperature requirements.
• Do not dispose of medicines in household waste or down the drain. Return any unused capsules to your pharmacist for environmentally safe disposal.

What Does Alitretinoin Orifarm Contain?

Quick Answer: Each capsule contains 10 mg or 30 mg of alitretinoin as the active ingredient, along with soybean oil, hydrogenated vegetable oils, glycerol monostearate, medium-chain triglycerides, and tocopherol. The capsule shells contain gelatin, glycerol, sorbitol, and colouring agents.

Active Substance

The active ingredient is alitretinoin (9-cis-retinoic acid). Each soft capsule contains either 10 mg or 30 mg of alitretinoin.

Other Ingredients

Capsule filling: Refined soybean oil, partially hydrogenated soybean oil, hydrogenated vegetable oil, glycerol monostearate, medium-chain triglycerides, and all-rac-alpha-tocopherol (vitamin E).

10 mg capsule shell: Gelatin, glycerol, sorbitol (13 mg per capsule), titanium dioxide (E 171), red iron oxide (E 172), yellow iron oxide (E 172), black iron oxide (E 172), and water. These capsules are light brown, oval, approximately 10 mm long and 6 mm wide, filled with a yellow to orange opaque viscous solution.

30 mg capsule shell: Gelatin, glycerol, sorbitol (26 mg per capsule), titanium dioxide (E 171), yellow iron oxide (E 172), and water. These capsules are yellow, oval, approximately 13 mm long and 8 mm wide, filled with a yellow to orange opaque viscous solution.

Alitretinoin Orifarm is available in blister packs containing 30, 40, 60, 90, or 100 soft capsules. Not all pack sizes may be marketed in your country.