VANIQA Cream Ref.[9693] Active ingredients: Eflornithine

Posology

Vaniqa cream should be applied to the affected area twice daily, at least eight hours apart. Efficacy has only been demonstrated for affected areas of the face and under the chin. Application should be limited to these areas. Maximal applied doses used safely in clinical trials were up to 30 grams per month.

Improvement in the condition may be noticed within eight weeks of starting treatment.

Continued treatment may result in further improvement and is necessary to maintain beneficial effects.

The condition may return to pre-treatment levels within eight weeks following discontinuation of treatment.

Use should be discontinued if no beneficial effects are noticed within four months of commencing therapy.

Patients may need to continue to use a hair removal method (e.g. shaving or plucking) in conjunction with Vaniqa. In that case, the cream should be applied no sooner than five minutes after shaving or use of other hair removal methods, as increased stinging or burning may otherwise occur.

Special population

Elderly (>65 years)

No dosage adjustment is necessary.

Paediatric population

The safety and efficacy of Vaniqa in children aged 0 to 18 years has not been established. There is no data available to support use in this age group.

Hepatic/renal impairment

The safety and efficacy of Vaniqa in women with hepatic or renal impairment have not been established. As the safety of Vaniqa has not been studied in patients with severe renal impairment, caution should be used when prescribing Vaniqa for these patients. No data are available.

Method of administration

A thin layer of the cream should be applied to clean and dry affected areas. The cream should be rubbed in thoroughly. The medicinal product should be applied such that no visual residual product remains on the treated areas after rub-in. Hands should be washed after applying this medicinal product. For maximal efficacy, the treated area should not be cleansed within four hours of application. Cosmetics (including sunscreens) can be applied over the treated areas, but no sooner than five minutes after application.

Given the minimal cutaneous penetration of eflornithine (see section 5.2), overdose is highly unlikely. However, should very high dose cutaneous administration or accidental oral ingestion occur, attention should be paid to the effects seen with therapeutic doses of intravenous eflornithine (400 mg/kg/day or approximately 24 g/day) used in the treatment of Trypanosoma brucei gambiense infection (African sleeping sickness): hair loss, facial swelling, seizures, hearing impairment, gastrointestinal disturbance, loss of appetite, headache, weakness, dizziness, anaemia, thrombocytopenia and leucopenia.

If symptoms of overdose occur the use of the medicinal product should be stopped.

Shelf life: 3 years.

Shelf-life after first opening: 6 months.

Do not store above 25°C.

High density polyethylene tube with a polypropylene screw cap containing 15 g, 30 g or 60 g of cream. Not all pack sizes may be marketed.

Any unused medicinal product or waste material should be disposed of in accordance with local requirements.