Alitretinoin is an active pharmaceutical ingredient in the Retinoids For Cancer Treatment group (L01XF). The information below is compiled per regulator from the product labels on record, with direct links to the original documents.
GBOfficial regulatory label· revised January 16, 2026[1]
Toctino is indicated for use in adults who have severe chronic hand eczema that is unresponsive to treatment with potent topical corticosteroids. 1).
How to take
GB
CACanada· Health Canada
2 products
Uses
CAOfficial regulatory label· revised March 22, 2025[2]
AND CLINICAL USE ....................................................................... 3 CONTRAINDICATIONS ......................................................................................... 4 WARNINGS AND PRECAUTIONS ..........................................................................
5 ADVERSE REACTIONS........................................................................................ 12 DRUG INTERACTIONS ........................................................................................ 15 DOSAGE AND ADMINISTRATION.......................................................................
18 OVERDOSAGE .................................................................................................... 19 ACTION AND CLINICAL PHARMACOLOGY ........................................................ 19 STORAGE AND STABILITY .................................................................................
22 SPECIAL HANDLING INSTRUCTIONS ................................................................. 22 DOSAGE FORMS, COMPOSITION AND PACKAGING ........................................... 22 PART II: SCIENTIFIC INFORMATION.......................................................................
Drug interactions
Known interactions involving Alitretinoin. Select one for details. This list is informational and not a complete interaction checker.
Interaction data compiled from DDInter (academic, CC-BY). Severity classification only - this is not a complete interaction checker and not medical advice.
[1]MHRA (UK) · PL194940252 · revised January 16, 2026
[2]Health Canada (DPD) · 02477432 · revised March 22, 2025
Information on this page is compiled from public regulatory records. Drugvu is not affiliated with any regulator or pharmaceutical manufacturer. This is not medical advice. Always consult a qualified healthcare professional.
Toctino 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 Toctino 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 Toctino should occur on the same day. The recommended dose for Toctino is 10 mg or 30 mg once daily. The recommended starting dose for Toctino 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 Toctino 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). Toctino 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 Toctino is not recommended for use in patients under 18 years of age. 3). 2). 2). 3). 2).
This is not medical advice. Consult a qualified healthcare professional.
Side effects & warnings
GBOfficial regulatory label· Adverse reactions· revised January 16, 2026[1]
1). 9%). These reversible ADRs are dose dependent and may therefore be alleviated by dose reduction. Very common (≥ 1/10) Common (≥ 1/100 < 1/10) Uncom mon (≥ 1/1000, < 1/100) Rare (≥ 1/10,000 < 1/1000) Very Rare (<1/10000 ) Unknown Blood and lymphati c system disorder s Anaemia, increased iron binding capacity, monocytes decreased; thrombocyt es increased Immune system disorder s Anaphylactic reactions, hypersensitiv ity Endocri ne Disorder s TSH decreased, free T4 decreased Psychiat ric disorder s Depressio n, depression aggravate d, aggressive tendencies , anxiety, mood alterations Suicide, suicide attempt, suicidal ideation, psychotic disorder, abnormal behaviour Nervous system disorder s Headach e Dizziness Benign intracrania l hypertensi on Eye disorder s Conjunctivi tis, dry eye, eye irritation Blurred vision, cataract Decreased night vision Ear and labyrint h disorder s Tinnitus Vascular disorder s Flushing, hypertensio n Vasculitis Very common (≥ 1/10) Common (≥ 1/100 < 1/10) Uncom mon (≥ 1/1000, < 1/100) Rare (≥ 1/10,000 < 1/1000) Very Rare (<1/10000 ) Unknown Respirat ory, thoracic and mediasti nal disorder s Epistaxis Gastroin testinal disorder s Nausea, dry mouth, vomiting Dyspepsi a Inflammatory bowel disease Hepatobi liary disorder s Transamina se increased1) Skin and subcutan eous tissues disorder s Dry skin, dry lips, cheileitis, eczema1), dermatitis1) , erythema, alopecia Pruritus, rash, skin exfoliatio n, asteatotic eczema Nail disorders, photosensi tivity reaction, hair texture changes Musculo -skeletal and connecti ve tissue disorder s Arthralgia1) , myalgia1) Exostosis , (hyperost osis), ankylosi ng spondylit is General disorder s and administ ration site conditio ns Fatigue Peripheral oedema Investiga tions Hypertri glyceride mia, high density Blood creatinine phosphokin ase increased Very common (≥ 1/10) Common (≥ 1/100 < 1/10) Uncom mon (≥ 1/1000, < 1/100) Rare (≥ 1/10,000 < 1/1000) Very Rare (<1/10000 ) Unknown lipoprote in decrease d, hypercho lesterol aemia 1) The overall incidence of adverse events was not higher than those observed in the corresponding placebo group.
4). Changes in bone mineralisation 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.
These observations were consistent with age dependent degenerative changes. Assessments of bone density (DXA) did not indicate a dose dependent effect on bone mineralisation. 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. uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.
GBOfficial regulatory label· Warnings and precautions· revised January 16, 2026[1]
4 Special warnings and precautions for use Teratogenic effects Toctino is a powerful human teratogen inducing a high frequency of severe and life threatening birth defects. Toctino 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). • The potential for pregnancy must be assed 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 amenorrhoea 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 regular 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. 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.
This is not medical advice. Consult a qualified healthcare professional.
Who should not take it
GBOfficial regulatory label· Contraindications· revised January 16, 2026[1]
6). 4). Toctino contains soya oil. Patients who are allergic to peanut, soya or with rare hereditary fructose intolerance should not take this medicine. Toctino is contraindicated in nursing mothers. 5).
This is not medical advice. Consult a qualified healthcare professional.
33 PART III: CONSUMER INFORMATION ..................................................................... 36 Page 3 of 40HANZEMA HANZEMA Alitretinoin capsules 10 mg and 30 mg PART I: HEALTH PROFESSIONAL INFORMATION SUMMARY PRODUCT INFORMATION Route of Administration Dosage Form / Strength Clinically Relevant Nonmedicinal Ingredients Oral Capsule / 10 mg DL-α-tocopherol, Gelatin, Glycerin, Medium chain triglycerides, Glyceryl distearate, Glyceryl Monooleate, Non crystallising sorbitol solution, Soybean oil, Water, iron oxide red, iron oxide black.
The imprinting Opacode® S-1-7085 white contains shellac, titanium dioxide, ammonium hydroxide, propylene glycol and simethicone. Oral Capsule / 30 mg DL-α-tocopherol, Gelatin, Glycerin, Medium chain triglycerides, Glyceryl distearate, Glyceryl Monooleate, Sorbitol, Soybean oil, Water, iron oxide red, iron oxide yellow.
The imprinting Opacode® S-1-7085 white contains shellac, titanium dioxide, ammonium hydroxide, propylene glycol and simethicone. INDICATIONS AND CLINICAL USE HANZEMA (alitretinoin) is indicated for the treatment of severe chronic hand eczema refractory to high potency topical corticosteroids in adults.
HANZEMA should only be prescribed by physicians knowledgeable in the use and monitoring requirements of systemic retinoids, who understand the risk of teratogenicity in females of child bearing potential (see CONTRAINDICATIONS and WARNINGS AND PRECAUTIONS: Serious Warnings and Precautions and Special Populations, Women of Child Bearing Potential).
Geriatrics (> 65 years of age):
Clinical trial experience has not identified differences in responses between elderly and other patients. However clinical studies of alitretinoin did not include sufficient numbers of subjects aged 65 years and over to determine with certainty whether they respond differently from younger subjects (ACTION AND CLINICAL PHARMACOLOGY, Special Populations and Conditions, Pharmacokinetics in special populations).
Page 4 of 40HANZEMA Pediatrics (< 18 years of age):
HANZEMA is not recommended for use in patients under 18 years of age. CONTRAINDICATIONS HANZEMA (alitretinoin) is contraindicated in pregnancy. Females must not become pregnant while taking HANZEMA and for at least one month after its discontinuation.
HANZEMA can cause severe birth defects in infants born to women who become pregnant during treatment with HANZEMA in any amount, even for a short period of time. Potentially any exposed fetus can be affected. There are no accurate means of determining whether an exposed fetus has been affected (see WARNINGS AND PRECAUTIONS: Special populations, Women of child bearing potential).
If pregnancy does occur during treatment with HANZEMA or within one month after its discontinuation, HANZEMA treatment must be immediately stopped and a physician and the patient should discuss the desirability of continuing the pregnancy.
HANZEMA should only be prescribed by physicians knowledgeable in the use of systemic retinoids, who have full understanding of the risks of systemic retinoid therapy and the monitoring requirements (see INDICATIONS AND CLINICAL USE).
HANZEMA is contraindicated in females of childbearing potential unless all of the conditions of the Pregnancy Prevention Program are met (see WARNINGS AND PRECAUTIONS, Pregnancy Prevention Program for women of childbearing potential).
HANZEMA is contraindicated in breastfeeding women. HANZEMA is also contraindicated in patients: With hepatic insufficiency With severe renal insufficiency With uncontrolled hypercholesterolemia With uncontrolled hypertriglyceridemia With uncontrolled hypothyroidism With hypervitaminosis A With hypersensitivity either to alitretinoin, to other retinoids or to any of the excipients, in particular in case of allergies to peanut or soya.
For a complete listing see the Dosage Forms, Composition and Packaging section of the product monograph. Page 5 of 40HANZEMA With rare hereditary problems of fructose intolerance Receiving concomitant treatment with tetracyclines (see WARNINGS AND PRECAUTIONS and DRUG INTERACTIONS) WARNINGS AND PRECAUTIONS Serious Warnings and Precautions Pregnancy Prevention: HANZEMA (alitretinoin) is a known […]
• 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 Toctino, 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 stopping treatment there remains a risk of severe and serious malformation of the foetus. The 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 continue for at least 1 month after stopping treatment with Toctino, even in patients with amenorrhoea.
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. 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 amenorrhoea) 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 […]