CARBAGLU Dispersible tablet Ref.[6534] Active ingredients: Carglumic acid

Therapeutic monitoring

Plasma levels of ammonia and amino acids should be maintained within normal limits. As very few data on the safety of carglumic acid are available, systematic surveillance of liver, renal, cardiac functions and haematological parameters is recommended.

Nutritional management

Protein restriction and arginine supplementation may be indicated in case of low protein tolerance.

No specific interaction studies have been performed.

Pregnancy

For carglumic acid no clinical data on exposed pregnancies are available. Animal studies have revealed minimal developmental toxicity (see section 5.3). Caution should be exercised when prescribing to pregnant women.

Breast-feeding

Although it is not known whether carglumic acid is secreted into human milk, it has been shown to be present in the milk of lactating rats (see section 5.3). Therefore, breast-feeding during the use of carglumic acid is contraindicated (see section 4.3).

No studies on the effects on the ability to drive and use machines have been performed.

Reported adverse reactions are listed below, by system organ class and by frequency. Frequencies are defined as: 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), not known (cannot be estimated from the available data).

Within each frequency grouping, undesirable effects are presented in order of decreasing seriousness.

Undesirable effects in N-acetylglutamate synthase deficiency

Investigations

Uncommon: increased transaminases

Skin and subcutaneous tissue disorders

Common: increased sweating

Not known: rash

Undesirable effects in organic acidaemia

Cardiac disorders

Uncommon: bradycardia

Gastrointestinal disorders

Uncommon: diarrhoea, vomiting

General disorders and Administration site conditions

Uncommon: pyrexia

Skin and subcutaneous tissue disorders

Not known: rash

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 national reporting system listed in Appendix V.

Not applicable.