Neotigason Special Precautions

Full patient information about the teratogenic risk and the strict pregnancy prevention measures should be given by the physician to all patients, both male and female.
Clinical evidence has shown that etretinate can be formed with concurrent ingestion of Neotigason and alcohol. Etretinate is highly teratogenic and has a longer half-life (approximately 120 days) than acitretin. Women of childbearing age must not consume alcohol (in drinks, food or medicines) during treatment with Neotigason and for 2 months after cessation of Neotigason therapy. Contraceptive measures and pregnancy tests must also be taken for 3 years after completion of Neotigason treatment (see Warnings and Pharmacology: Pharmacokinetics under Actions).
Woman of childbearing potential must not receive blood from patient being treated with Neotigason. Therefore donation of blood by a patient being treated with Neotigason is prohibited during and for three years after completion of treatment with Neotigason.
Due to the risk of foetal malformations, the medicine must not be passed on the other people.
Hepatic function should be checked before starting treatment with Neotigason, every 1-2 weeks for the first 2 months after commencement and then every 3 months during treatment. If abnormal results are obtained, weekly checks should be instituted. If hepatic function fails to return to normal or deteriorates further, Neotigason must be withdrawn. In such cases it is advisable to continue monitoring hepatic function for at least 3 months (see Adverse Reactions).
Serum cholesterol and serum triglycerides (fasting values) must be monitored, one month after the commencement and then every 3 months during treatment.
Decreased night vision has been reported with Neotigason therapy. Patients should be advised of this potential problem and warned to be cautious when driving or operating any vehicle at night. Visual problems should be carefully monitored (see Adverse Reactions).
There has been rare reports of benign intracranial hypertension. Patients with severe headache, nausea, vomiting, and visual disturbances should discontinue Neotigson immediately and be referred for neurologic evaluation and care.
In adults receiving long-term treatment with Neotigason, appropriate examinations should be periodically performed in view of possible ossification abnormalities (see Adverse Reactions). If such disorders arise, the continuation of therapy should be discussed with the patient on the basis of a careful risk/benefit analysis. In children, growth parameters and bone development must be closely monitored.
It should be emphasized that, at the present time, not all the consequences of life-long administration of Neotigason are known.
The effect of UV light are enhanced by retinoid therapy, therefore patients should avoid excess exposure to sunlight and the unsupervised use of sun lamps. Where necessary a sun-protection product with a high protection factor of at least SPF 15 should be used.
Effects on ability to drive and use machines: Decreased night vision has been report with Neotigason therapy. Patient should be advised of this potential problem and warned to be cautions when driving or operating any vehicle at night. Visual problems should be carefully monitored (see Adverse Reactions).
Use in Children: Since there have been occasional reports of bone changes in children, including premature epiphyseal closure, skeletal hyperostosis and extraosseous calcification after long-term treatment with etretinate, these effects may be expected with Neotigason. Neotigason therapy in children is not therefore recommended. If, in exceptional circumstances, such therapy is undertaken the child should be carefully monitored for any abnormalities of musculo-skeletal development and growth parameters and bone development must be closely monitored.