4.1. Therapeutic indications

Treatment of facial hirsutism in women.

4.2. Posology and method of administration

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.

4.3. Contraindications

Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.

4.4. Special warnings and precautions for use

Excessive hair growth can result from serious underlying disorders (e.g. polycystic ovary syndrome, androgen secreting neoplasm) or certain active substances (e.g. cyclosporin, glucocorticoids, minoxidil, phenobarbitone, phenytoin, combined oestrogen-androgen hormone replacement therapy). These factors should be considered in the overall medical treatment of patients who might be prescribed Vaniqa.

Vaniqa is for cutaneous use only. Contact with eyes or mucous membranes (e.g. nose or mouth) should be avoided. Transient stinging or burning may occur when the cream is applied to abraded or broken skin.

If skin irritation or intolerance develops, the frequency of application should be reduced temporarily to once a day. If irritation continues, treatment should be discontinued and the physician consulted.

This medicinal product contains cetostearyl alcohol and stearyl alcohol which may cause local skin reactions (e.g. contact dermatitis) as well as methyl parahydroxybenzoate and propyl parahydroxybenzoate which may cause allergic reactions (possibly delayed).

4.5. Interaction with other medicinal products and other forms of interaction

No interaction studies have been performed.

4.6. Fertility, pregnancy and lactation

Pregnancy

Throughout clinical trials data from a limited number of exposed pregnancies (22) indicate that there is no clinical evidence that treatment with Vaniqa adversely affects mothers or foetuses. Among the 22 pregnancies that occurred during the trials, only 19 pregnancies occurred while the patient was using Vaniqa. Of these 19 pregnancies, there were 9 healthy infants, 5 elective abortions, 4 spontaneous abortions and 1 birth defect (Down's Syndrome to a 35 year old). To date, no other relevant epidemiological data are available. Animal studies have shown reproductive toxicity (see section 5.3). The potential risk to humans is unknown. Therefore, women who are pregnant or planning pregnancy should use an alternative means to manage facial hair.

Breast-feeding

It is not known whether eflornithine/metabolites are excreted in human milk. Women should not use Vaniqa whilst breastfeeding.

Fertility

There are no data available.

4.7. Effects on ability to drive and use machines

Vaniqa has no or negligible influence on the ability to drive and use machines.

4.8. Undesirable effects

The mostly skin related adverse reactions reported were primarily mild in intensity and resolved without discontinuation of Vaniqa or initiation of medical treatment. The most frequently reported adverse reaction was acne, which was generally mild. In the vehicle-controlled trials (n= 596), acne was observed in 41% of patients at baseline; 7% of patients treated with Vaniqa and 8% treated with vehicle experienced a worsening of their condition. Of those with no acne at baseline, similar percentages (14%) reported acne following treatment with Vaniqa or vehicle.

The following listing notes the frequency of adverse skin reactions seen in clinical trials, according to MedDRA convention. MedDRA conventions for frequency are very common (≥1/10), common (≥1/100 to <1/10), uncommon (≥1/1,000 to <1/100), rare (≥1/10,000 to <1/1,000), very rare (<1/10,000), or not known (cannot be estimated from the available data) including isolated reports. Note that over 1350 patients were treated with Vaniqa in these trials for 6 months to one year, while only slightly more than 200 patients were treated with vehicle for 6 months. Most events were reported at similar rates between Vaniqa and vehicle. The skin effects of burning, stinging, tingling, rash and erythema were reported at higher levels in Vaniqa treated patients compared to vehicle, as indicated by the asterisk (*).

Frequency of adverse skin reactions seen in Vaniqa clinical trials, (according to MedDRA frequency convention).

Skin and subcutaneous tissue disorders

Very common

(≥1/10)

Acne

Common

(≥1/100 to <1/10)

Pseudofolliculitis barbae, alopecia, stinging skin*, burning skin*, dry skin, pruritus, erythema*, tingling skin*, irritated skin, rash*, folliculitis

Uncommon

(≥1/1,000 to <1/100)

Ingrown hair, oedema face, dermatitis, oedema mouth, papular rash, bleeding skin, herpes simplex, eczema, cheilitis, furunculosis, contact dermatitis, abnormal hair texture and abnormal hair growth, hypopigmentation, flushing skin, lip numbness, skin soreness

Rare

(≥1/10,000 to <1/1,000)

Rosacea, seborrheic dermatitis, skin neoplasm, maculopapular rash, skin cysts, vesiculobullous rash, skin disorder, hirsutism, skin tightness

Paediatric population

The adverse reactions observed in adolescents are similar to the ones observed in adults.

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. Healthcare professionals are asked to report any suspected adverse reactions via the Yellow Card Scheme, Website: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.

4.9. Overdose

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.