1. Name Of The Medicinal Product
Vaniqa 11.5% cream
2. Qualitative And Quantitative Composition
Each gram of Vaniqa 11.5% w/w cream contains 115 mg eflornithine (as hydrochloride monohydrate).
Excipients:
Cetostearyl alcohol
Stearyl alcohol.
For a full list of excipients, see section 6.1.
3. Pharmaceutical Form
Cream.
White to off white cream
4. Clinical Particulars
4.1 Therapeutic Indications
Treatment of facial hirsutism in women.
4.2 Posology And Method Of Administration
A thin layer of the cream should be applied to clean and dry affected areas twice daily, at least eight hours apart. The cream should be rubbed in thoroughly. Hands should be washed after applying this medicine. 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.
Efficacy has only been demonstrated for affected areas of the face and under the chin. Application should be limited to these areas. The product should be applied such that no visual residual product remains on the treated areas after rub-in. 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.
Elderly: (> 65 years) no dosage adjustment is necessary.
Children and Adolescents: (< 12 years) safety and efficacy of Vaniqa have not been established.
Hepatic/renal impairment: the safety and efficacy of Vaniqa in women with hepatic or renal impairment have not been established.
4.3 Contraindications
Hypersensitivity to eflornithine or to any of the excipients (see 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 medications (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.
It is recommended that hands are washed following use.
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.
This product contains cetostearyl alcohol and stearyl alcohol which may cause local skin reactions (e.g. contact dermatitis).
4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction
No interaction studies have been performed.
4.6 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.
Lactation: it is not known if eflornithine is excreted in human milk. Women should not use Vaniqa whilst breast-feeding.
4.7 Effects On Ability To Drive And Use Machines
No studies on the effects on the ability to drive and use machines have been performed. No effect is expected.
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 undesirable effect was acne, which was generally mild. In the vehicle controlled trials (n= 594), 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 (> 10%), common (> 1% to < 10%), uncommon (> 0.1% to < 1%), rare (> 0.01% to < 0.1%), or very rare (< 0.01%), 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
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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.
5. Pharmacological Properties
5.1 Pharmacodynamic Properties
Pharmacotherapeutic group: other dermatologicals, ATC code: D11A X.
Eflornithine irreversibly inhibits ornithine decarboxylase, an enzyme involved in the production of the hair shaft by the hair follicle. Vaniqa has been shown to reduce the rate of hair growth.
The safety and efficacy of Vaniqa was evaluated in two double-blind, randomised, vehicle-controlled clinical trials involving 594 women of skin types I
The combined results of these two trials are presented below:
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* At end of therapy (Week 24). For patients who discontinued therapy during the trial last observations were carried forward to Week 24.
Statistically significant (p
Patient self-assessments demonstrated a significantly reduced psychological discomfort with the condition, as measured by responses to 6 questions on a visual analogue scale. Vaniqa significantly reduced how bothered patients felt by their facial hair and by the time spent removing, treating, or concealing facial hair. Patient comfort in various social and work settings was also improved. Patient self
The condition returned to pre
5.2 Pharmacokinetic Properties
Steady state cutaneous penetration of eflornithine in women from Vaniqa on facial skin of shaving women was 0.8%.
The steady state plasma half-life of eflornithine was approximately 8 hours. Steady state was reached within four days. The steady state peak and trough plasma concentrations of eflornithine were approximately 10 ng/ml and 5 ng/ml, respectively. The steady state 12
Eflornithine is not known to be metabolised and is eliminated primarily in the urine.
5.3 Preclinical Safety Data
Non-clinical data reveal no special hazard for humans based on conventional studies of repeat dose toxicity, genotoxicity and carcinogenic potential, including one photocarcinogenicity study in mice.
In a dermal fertility study in rats, no adverse effects on fertility were observed at up to 180 times the human dose. In dermal teratology studies, no teratogenic effects were observed in rats and rabbits at doses up to 180 and 36 times the human dose, respectively. Higher doses resulted in maternal and foetal toxicity without evidence of teratogenicity.
6. Pharmaceutical Particulars
6.1 List Of Excipients
Cetostearyl alcohol;
Macrogol cetostearyl ether;
Dimeticone;
Glyceryl stearate;
Macrogol stearate;
Methyl parahydroxybenzoate (E218);
Liquid paraffin;
Phenoxyethanol;
Propyl parahydroxybenzoate (E216);
Purified water
Stearyl alcohol
Sodium hydroxide (E524) (to adjust pH)
6.2 Incompatibilities
Not applicable.
6.3 Shelf Life
3 years.
6.4 Special Precautions For Storage
Do not store above 25°C.
6.5 Nature And Contents Of Container
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.
6.6 Special Precautions For Disposal And Other Handling
No special requirements.
7. Marketing Authorisation Holder
Almirall, S.A.
Ronda General Mitre, 151,
08022 Barcelona,
Spain.
8. Marketing Authorisation Number(S)
EU/1/01/173/001
9. Date Of First Authorisation/Renewal Of The Authorisation
20 March 2001 / 20 March 2006
10. Date Of Revision Of The Text
September 2010
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