Faced with severe acne, isofair (active ingredient in generics of Roaccutane®) is an effective treatment. But how does this medicine work? What are the prescription conditions? What are the precautions to be taken? … Healthlinerx answers the ten most frequently asked questions.
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What is isofair?
Isotretinoin is the active principle in generics of Isofair®, which was withdrawn from the French market in 2008. Generics are however still marketed (Acnetrait, Contracné, Curacné and Procuta). It has been used in the treatment of severe acne since the early 1980s. This molecule is a derivative of vitamin A, a substance naturally present in our body. This medicine should be prescribed by an experienced doctor, with special monitoring because of its potentially serious side effects.
What is isofair prescribed for?
- The treatment of first-line or attack is local with a single drug for acne very light, topical retinoids (tretinoin 0.025% or 0.05% or 0.1% adapalene) 1 or benzoyle2 peroxide (1x / day ) are recommended as first-line treatment. Treatment for grade 2 and 3 acne is also local but combines two drugs, while that for grade 4 acne can also include an antibiotic (cyclin) by mouth. As for grade 5 acne, the use of oral isotretinoin is recommended from the outset;
- For grade 1 to 4 acne , treatment can be changed if it fails after 3 months of treatment. New to these recommendations, this period may be shorter for grade 4 acne to avoid the risk of scarring. In this case, oral isotretinoin may be offered. Remember that this drug is prescribed only by specialists, the renewal of the prescription can be done by general practitioners;
- A maintenance treatment adjusted if the progressive response is continued until the complete disappearance of lesions.
What is the mode of action of isofair?
Isofair works mainly by causing a reduction in the size of the sebaceous glands and by inhibiting the secretion of sebum. In addition, it limits bacterial development as well as local inflammation.
How is isofair used?
Isofair comes in two forms: oral or topical treatment .
- Your doctor may suggest capsules to swallow, 5 mg, 10 mg or 20 mg depending on your weight;
- Isotretinoin gel is reserved for specific types of acne.
What duration of treatment for what effectiveness?
The general duration of treatment varies between four and six months . If the treatment is well followed, a complete disappearance of acne is observed in more than 85% of cases . The risk of relapse is between 20 and 40%. But in two thirds of cases, a usual treatment – antibiotic or cream – is enough to treat these relapses.
What are the drug interactions?
During treatment, it is generally not advisable to apply any other medicine , in particular a local cream. Isofair should not be combined with tetracyclines (anti-acne antibiotics). Any association with a drug containing vitamin A is also prohibited, because of a risk of intoxication with this one. In any case, always seek medical advice before doing anything.
What precautions should be taken ?
As isotretinoin can cause dry eyes , it is advisable to avoid wearing contact lenses . If you use it, tell your doctor who will prescribe “artificial tears” as a preventive measure.
Isofair can also cause reduced night vision , so be careful if you have to get behind the wheel.
Finally, any use of scrubs, exfoliants and hair removal waxes is strongly discouraged , due to the fragility of the skin during the treatment.
What are the side effects of isofair?
Like all medicines, isofair has side effects . Here, these effects are mainly characterized by dryness of the skin and mucous membranes . Thus, in 80% of cases, patients suffer from chapped lips, dryness and irritation of the skin, itching and nosebleeds. In addition, cases of hepatic toxicity are possible. Finally, it happens that the acne is aggravated at the beginning of treatment, but this reaction is only transient.
What are the risks for women?
The use of isofair is strictly prohibited in pregnant women because of a significant risk (more than 30% risk) of serious malformations, such as abnormalities of the brain, face or heart on the fetus of a child. person on isotretinoin. This is why contraception and monitoring of a potential pregnancy is mandatory to follow the treatment.
In the event of treatment in a woman of childbearing age, it is imperative to ensure that no pregnancy occurs or begins during this treatment. A pregnancy test must be carried out before each prescription and repeated each month during the treatment and 5 weeks after the end of it. This risk is particularly important in adolescent girls.
A care and contraception agreement must be obtained from the patient, it will be included in her patient record. Each prescription is then only valid for one month and must be issued within 7 days.
New neurological risks for the fetus under study
A new study appears to indicate new risks to fetuses that might not necessarily be visible on ultrasound or at birth. The National Medicines Safety Agency (ANSM) warned on February 18 about the potential risk of neurodevelopmental disorders in the event of exposure during pregnancy. “Following the declaration to the national network of pharmacovigilance centers of a suspicion of autistic disorders in a young child exposed during pregnancy to isotretinoin and born without visible malformation,” the risk of neurodevelopmental disorders without visible malformation is now under study announces the ANSM.
After an opinion of the Permanent Scientific Council declaring itself in favor of a potential risk, it was decided that the Scientific Interest Group EPI-PHARE studies “the feasibility of a pharmaco-epidemiology study on insurance data. disease “ .
Pending the results of this new study, to confirm or not the risk of neuro-developmental disorders, prevention remains the same for women of childbearing age: compulsory contraception and pregnancy test by blood sample every month during treatment. then a month after stopping.
What are the links between isofair and the onset of depressive symptoms?
The announcement of teenage suicides under Roaccutane © sparked heated controversy in France and the United States. The occurrence of psychiatric disorders under oral isotretinoin is the subject of particular pharmacovigilance monitoring . This has led to changes in the information on the safety of use of this drug, and to inform health professionals with the help of learned societies, as well as the public.
Adolescents are particularly vulnerable to depression and the risk is higher in those with acne. Experts recommend that any adolescent consulting for acne be screened for depression using appropriate means and that a specialist consultation be sought if necessary. Particular attention should be paid to the risk of suicide in certain adolescents. Although these risks have not been demonstrated in the general population on isotretinoin, exceptional cases have been reported. The doctor must thus communicate with the patient before any start of treatment and inquire about the personal or family history. In case of risk, close monitoring is necessary, especially at the start of treatment.