Therapeutic Indications

Alitretinoin is indicated for:

Severe chronic hand eczema

No gender/age discrimination

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 pompholyx.

For this indication, the medical literature mentions below treatments (click for details):

Treatment 1: Oral - 30mg once daily

AIDS related Kaposi’s sarcoma

Men inly, only Adults (18 - 65 years old)

Alitretinoin is indicated for the topical treatment of cutaneous lesions in patients with AIDS related Kaposi’s sarcoma (KS) when:
- lesions are not ulcerated or lymphoedematous
- treatment of visceral KS is not required
- lesions are not responding to systemic antiretroviral therapy
- radiotherapy or chemotherapy are not appropriate

For this indication, the medical literature mentions below treatments (click for details):

Treatment 1: Cutaneous - 2-4 shifts per day

Contraindications

Active ingredient Alitretinoin is contraindicated in the following cases:

Breast-feeding

No gender/age discrimination

It is not known whether this medicinal product is excreted in human milk. Based on the plasma concentrations observed in patients, milk concentrations of 9-cis-retinoic acid probably pose a low risk for the infant. However, because of the potential for undesirable effects from alitretinoin gel in infants being breast-fed, mothers must discontinue breast-feeding prior to using the medicinal product and not initiate breast-feeding while using the medicinal product.

Care should be taken not to bring the neonate into skin contact with areas to which alitretinoin has been recently applied. It is recommended that HIV-infected mothers do not breast-feed their children to exclude the risk of transmission of the virus.

Pregnancy

No gender/age discrimination

Orally administered retinoids have been associated with congenital abnormalities. When used in accordance with the prescribing information topically administered retinoids are generally assumed to result in low systemic exposure due to minimal dermal absorption. However there could be individual factors (e.g. damaged skin barrier, excessive use) that contribute to an increased systemic exposure.

In rabbits, alitretinoin was shown to be teratogenic at a dose which resulted in plasma concentrations about 60 times the highest observed plasma concentration in male patients with KS following topical application of the gel. However, it is not currently certain to what extent topical treatment with alitretinoin gel would increase 9-cis-retinoic acid plasma concentrations, in women with KS above naturally occurring levels; therefore, alitretinoin is contraindicated in pregnancy, or in women planning a pregnancy. If the product is used during pregnancy, or if the patient becomes pregnant while taking this drug, treatment should be discontinued.