TOCTINO

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. Dispensing of Toctino should occur within a maximum of 7 days of the prescription. 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).

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 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 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 Respirat ory, thoracic and mediasti nal disorder s Epistaxis Gastroin testinal Nausea, dry mouth, Dyspepsi a Inflammatory bowel 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 disorder s vomiting 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 lipoprote in decrease d, hypercho lesterol aemia Blood creatinine phosphokin ase increased 1) The overall incidence of adverse events was not higher than those observed in the corresponding placebo group.

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.

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).