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ALITRETINOIN is a brand name for Alitretinoin. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: Alitretinoin is indicated for use in adults who have severe chronic hand eczema that is unresponsive to treatment with potent topical corticosteroids. Patients in whom the eczema has predominantly hyperkeratotic features are more likely to respond to treatment than in those in whom the eczema predominantly presents as…
Verbatim from this product's MHRA label. Tap a section to expand.
Alitretinoin should only be prescribed by dermatologists, or physicians with experience in the use of systemic retinoids who have full understanding of the risks of systemic retinoid therapy and monitoring requirements. Prescriptions of Alitretinoin for women of childbearing potential should be limited to 30 days of treatment and continuation of treatment requires a new prescription.
Ideally, pregnancy testing, issuing a prescription and dispensing of Alitretinoin should occur on the same day. Dispensing of Alitretinoin should occur within a maximum of 7 days of the prescription. Posology The recommended dose for alitretinoin is 10 mg or 30 mg once daily.
The recommended starting dose for alitretinoin is 30 mg once daily. A dose reduction to 10 mg once daily may be considered in patients with unacceptable adverse reactions to the 30 mg dose. In studies investigating 10 mg and 30 mg daily doses, both doses resulted in clearing of the disease.
The 30 mg dose provided a more rapid response and a higher response rate. 1). Duration of treatment A treatment course of alitretinoin may be given for 12 to 24 weeks depending on response. 1). Discontinuation of therapy should also be considered for patients who still have severe disease after the initial 12 weeks of continuous treatment.
1). 2). Alitretinoin should not be prescribed if the patient's eczema can be adequately controlled by standard measures, including skin protection, avoidance of allergens and irritants, and treatment with potent topical corticosteroids.
Paediatric population Alitretinoin is not recommended for use in patients under 18 years of age. 3). 2). 2). 3). 2).
1). 9%). These reversible ADRs are dose dependent and may therefore be alleviated by dose reduction. • Very common (≥1/10) Common (≥1/100 to <1/10) Uncommon (≥1/1,000 to <1/100) Rare (≥1/10,000 to <1/1,000) Very rare (<1/10,000) Unknown (cannot be estimated from the available data) Blood and lymphatic system disorders Anaemia, increased iron binding capacity, monocytes decreased, thrombocytes increased Immune system disorders Anaphylactic reactions, hypersensitivity Endocrine disorders TSH decreased, free T4 decreased Psychiatric disorders Depression, depression aggravated, aggressive tendencies, anxiety, mood alterations Suicide, suicide attempt, suicidal ideation, psychotic disorder, abnormal behaviour Nervous system disorders Headache Dizziness Benign intracranial hypertension Eye disorders Conjunctivitis, dry eye, eye irritation Blurred vision, cataract Decreased night vision Ear and labyrinth disorders Tinnitus Vascular disorders Flushing, hypertension Vasculitis Respiratory, thoracic and mediastinal disorders Epistaxis Gastrointestinal disorders Nausea, dry mouth, vomiting Dyspepsia Inflammatory bowel disease Hepatobiliary disorders Transaminase increased1) Skin and subcutaneous tissues disorders Dry skin, dry lips, cheilitis, eczema1), dermatitis1), erythema, alopecia Pruritus, rash, skin exfoliation, asteatotic eczema Nail disorders, photosensitivity reaction, hair texture changes Musculoskeletal and connective tissue disorders Arthralgia1), myalgia1) Exostosis (hyperostosis), ankylosing spondylitis General disorders and administration site conditions Fatigue Peripheral oedema Investigations Hypertriglyceridemia, high density lipoprotein decreased, hypercholesterolemia Blood creatinine phosphokinase increased 1) The overall incidence of adverse events was not higher than those observed in the corresponding placebo group.
4). Changes in bone mineralization and extra-osseous calcifications have been associated with systemic retinoid treatment. In clinical studies with alitretinoin, degenerative changes of the spine and ligamentous calcifications were frequent findings in patients with chronic hand eczema before treatment (baseline), with minor progression in a small number of patients during treatment.
Teratogenic effects Alitretinoin is a powerful human teratogen inducing a high frequency of severe and life-threatening birth defects. Alitretinoin is strictly contraindicated in: - Pregnant women - Women of childbearing potential unless all of the conditions of the Pregnancy Prevention Programme are met.
Pregnancy Prevention Programme This medicinal product is TERATOGENIC. 1 “Therapeutic indications”). • The potential for pregnancy must be assessed for all female patients. • She understands the teratogenic risk. • She understands the need for rigorous follow-up, on a monthly basis.
• She understands and accepts the need for effective contraception, without interruption, 1 month before starting treatment, throughout the entire duration of treatment and for 1 month after the end of treatment. e. a user-independent form) or two complementary user-dependent forms of contraception should be used.
• Individual circumstances should be evaluated in each case, when choosing the contraception method, involving the patient in the discussion, to guarantee her engagement and compliance with the chosen measures. • Even if she has amenorrhea she must follow all of the advice on effective contraception.
• She is informed and understands the potential consequences of pregnancy and the need to rapidly consult if there is a risk of pregnancy or if she might be pregnant. • She understands the need and accepts to undergo pregnancy testing before, ideally monthly during treatment and 1 month after stopping treatment.
• She has acknowledged that she has understood the hazards and necessary precautions associated with the use of alitretinoin. These conditions also concern women who are not currently sexually active unless the prescriber considers that there are compelling reasons to indicate that there is no risk of pregnancy.
The prescriber must ensure that: • The patient complies with the conditions for pregnancy prevention as listed above, including confirmation that she has an adequate level of understanding. • The patient has acknowledged the aforementioned conditions.
6). 4). Alitretinoin capsules contain soya oil. Patients who are allergic to peanut or soya should not take this medicine. Alitretinoin is contraindicated in nursing mothers. 5).
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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These observations were consistent with age dependent degenerative changes. Assessments of bone density (DXA) did not indicate a dose dependent effect on bone mineralization. In rare cases soya oil can lead to severe allergic reactions.
Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the Yellow Card Scheme.
uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.
e. a user-independent form) or two complementary user-dependent forms of contraception, for at least 1 month prior to starting treatment and is continuing to use effective contraception throughout the treatment period and for at least 1 month after cessation of treatment.
• Negative pregnancy test results have been obtained before, during and 1 month after the end of treatment. The dates and results of pregnancy tests should be documented. If pregnancy occurs in a woman treated with alitretinoin, treatment must be stopped and the patient should be referred to a physician specialised or experienced in teratology for evaluation and advice.
If pregnancy occurs after stopped treatment there remains a risk of severe and serious malformation of the foetus. This risk persists until the product has been completely eliminated, which is within one month following the end of treatment.
Contraception Female patients must be provided with comprehensive information on pregnancy prevention and should be referred for contraceptive advice if they are not using effective contraception. If the prescribing physician is not in a position to provide such information the patient should be referred to the relevant healthcare professional.
e. a user-independent form), or two complementary user-dependent forms of contraception. Contraception should be used for at least 1 month prior to starting treatment, throughout treatment and continued for at least 1 month after stopping treatment with alitretinoin, even in patients with amenorrhea.
Individual circumstances should be evaluated in each case when choosing the contraception methods, involving the patient in the discussion to guarantee her engagement and compliance with the chosen measures. Pregnancy testing According to local practice, medically supervised pregnancy tests with a minimum sensitivity of 25 mIU/mL are recommended to be performed, as follows: Prior to starting therapy At least one month after the patient has started using contraception, and shortly (preferably a few days) prior to the first prescription, the patient should undergo a medically supervised pregnancy test.
This test should ensure the patient is not pregnant when she starts treatment with alitretinoin. Follow-up visits Follow-up visits should be arranged at regular intervals, ideally monthly. The need for repeated medically supervised pregnancy tests every month should be determined according to local practice including consideration of the patient's sexual activity, recent menstrual history (abnormal menses, missed periods or amenorrhea) and method of contraception.
Where indicated, follow-up pregnancy tests should be performed on the day of the prescribing visit or in the 3 days prior to the visit to the prescriber. End of treatment 1 month after stopping treatment, women should undergo a final pregnancy test.
Prescribing and dispensing restrictions For women of childbearing potential, the prescription duration of Alitretinoin should ideally be limited to 30 days in order to support regular follow-up, including pregnancy testing and monitoring.
Ideally, pregnancy testing, issuing a prescription and dispensing of Alitretinoin should occur on the same day. This monthly follow-up will allow ensuring that regular pregnancy […]