Intuniv - Guanfacina

What is Intuniv and Guanfacina used for?

Intuniv is indicated for the treatment of attention deficit / hyperactivity disorder (ADHD) in children and adolescents aged 6 to 17 for whom stimulants are not suitable or do not provide adequate control of symptoms.

Intuniv is used in the context of a comprehensive treatment program, which generally includes psychological, educational and other measures.

The active substance in Intuniv is guanfacine

How is Intuniv - Guanfacina used?

Intuniv treatment should be started under the supervision of a doctor who specializes in behavioral disorders in childhood and / or adolescence. Before starting the therapy, the doctor must assess whether the patient is at risk of side effects, particularly drowsiness, changes in heart rate and blood pressure, and weight gain).

Careful determination of the dose of Intuniv is required, which takes into account the side effects and benefits seen in the patient. At the beginning of the treatment the patient must be monitored weekly and during the first year he must continue to be monitored at least every 3 months.

The medicine is available as tablets (1, 2, 3 and 4 mg). The recommended starting dose for all patients is 1 mg taken by mouth once a day. For information on dose adjustments and necessary medical checks, see the summary of product characteristics (SPC).

The medicine can only be obtained with a prescription.

How does Intuniv - Guanfacina work?

The modes of action of Intuniv in ADHD are not known. It is believed that the active ingredient of the drug, guanfacine, can influence the way signals are transmitted between cells in brain areas called prefrontal cortex and basal ganglia, by binding to certain receptors that are particularly concentrated in these areas.

What benefit has Intuniv - Guanfacine shown during the studies?

Several studies have shown that Intuniv improves the scores for ADHD symptoms (ADHD-RS-IV) in children and adolescents.

In a study involving 337 children aged 6 to 17 years, the reduction in ADHD symptoms in Intuniv treatment after 10-13 weeks was 24 points compared to the 15-point reduction seen with placebo (one treatment fictitious) and 19 points registered in treatment with atomoxetine (a medicine used in the treatment of ADHD). In another study involving 312 adolescents aged 13 to 17 years, the reduction in ADHD symptom scores after 13 weeks of treatment was 25 points with Intuniv and 19 points with placebo. Two other short-term studies involving 631 patients also showed that Intuniv, administered in various doses, improves the relative scores of ADHD symptoms compared to placebo.

Intuniv was also evaluated in terms of therapeutic failure (understood as worsening of ADHD symptoms or interruption of therapy by patients). In a long-term maintenance study conducted on 301 children and adolescents aged 6 to 17 years, therapeutic failure was observed in 49% of Intuniv-treated patients compared to 65% of placebo-treated patients.

What is the risk associated with Intuniv - Guanfacina?

The most common side effects of Intuniv are drowsiness (seen in almost half of the patients), headache (more than a quarter), tiredness (about 1 in 5 patients) and upper abdominal pain and sedation (which may affect 1 in 10 patients both ). Drowsiness usually occurs at the beginning of treatment and lasts for 2-3 weeks.

The most serious side effects are less common and include lowering of blood pressure and weight gain (both observed in about 1 patient in 30), slow heart rate (1 patient in 60) and fainting (affecting less than 1 in 100 patients) .

For the full list of side effects and limitations, see the package leaflet.

Why has Intuniv - Guanfacine been approved?

The Agency's Committee for Medicinal Products for Human Use (CHMP) noted that stimulants are first-line ADHD therapies and that these medicines result in greater and more marked improvement in ADHD symptoms within a comprehensive therapeutic program. However, considering the benefits observed with Intuniv, the committee concluded that the medicine can be used as an alternative in patients who cannot take stimulants or in patients for whom stimulants do not provide adequate control of symptoms.

The most important safety risks are slow heart rate, lowering of blood pressure, fainting, drowsiness and sedation. To keep these risks under control, the CHMP recommended some measures, including periodic patient monitoring.

The Committee therefore decided that Intuniv's benefits are greater than its risks and recommended that it be approved for use in the EU.

What measures are being taken to ensure the safe and effective use of Intuniv - Guanfacine?

A risk management plan has been developed to ensure that Intuniv is used as safely as possible. Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Intuniv, including the appropriate precautions to be followed by healthcare professionals and patients.

Furthermore, before placing the medicine on the market, the company that markets Intuniv must provide healthcare professionals with information material nationally agreed upon. The material must contain information on undesirable effects, a checklist useful for identifying children at risk, and a checklist and table for monitoring pediatric patients during therapy.

Further information is available in the summary of the risk management plan.