ALLUZIENCE Solution for injection Ref.[50428] Active ingredients: Botulinum toxin type A

Care should be taken to ensure that Alluzience is not injected into a blood vessel.

Injection of Alluzienceis not recommended in patients with a history of dysphagia and aspiration. Adverse reactions possibly related to the spread of toxin effect distant from the site of administration have been reported very rarely with botulinum toxin. Swallowing and breathing difficulties are serious and can result in death.

Very rare cases of death, occasionally in the context of dysphagia, pneumopathy (including but not limited to dyspnoea, respiratory failure, respiratory arrest) and/or in patients with significant asthenia have been reported following treatment with botulinum toxin A or B.

Patients should be advised to seek immediate medical care if swallowing, speech or respiratory difficulties arise.

Alluzience should be used with caution in patients with a risk of, or clinical evidence of, marked defective neuro-muscular transmission. These patients may have an increased sensitivity to agents such as botulinum toxin, and excessive muscle weakness may follow treatment.

It is essential to study the patient’s facial anatomy prior to administering Alluzience. Facial asymmetry, ptosis, excessive dermatochalasis, scarring and any alterations to this anatomy, as a result of previous surgical interventions, should be taken into consideration.

Dry eyes have been reported with use of Alluzience in periocular regions (see section 4.8). Attention to this side effect is important since dry eyes may predispose to corneal disorders. Protective drops, ointment, closure of the eye by patching or other means may be required to prevent corneal disorders.

The recommended dose and frequency of administration for Alluzience must not be exceeded.

Patients treated with the recommended dose may experience exaggerated muscle weakness.

Caution should be taken when Alluzience is used in the presence of inflammation at the proposed injection sites or when the targeted muscle(s) show excessive weakness or atrophy.

As with all intramuscular injections, use of Alluzience is not recommended in patients who have a prolonged bleeding time.

Each vial of Alluzience must be used for a single patient treatment during a single session.

Any excess of unused product must be disposed of as detailed in Section 6.6. Specific precautions must be taken for the inactivation and disposal of any unused solution (see Section 6.6).

Antibody formation

Injections at more frequent intervals or at higher doses may increase the risk of neutralising antibody formation to botulinum toxin. Clinically, the formation of neutralising antibodies may reduce the effectiveness of subsequent treatment.

Traceability

In order to improve the traceability of biological medicinal products, the name and the batch number of the administered product should be clearly recorded.

Sodium content

This medicine contains less than 1 mmol sodium (23 mg) per 125U vial, that is to say essentially ‘sodium-free’.

Concomitant treatment with Alluzience and aminoglycosides or other agents interfering with neuromuscular transmission (e.g. curare-like agents) should only be used with caution since the effect of botulinum toxin may be potentiated.

No interaction studies have been performed.

Pregnancy

There are only limited data from the use of botulinum toxin type A in pregnant women. Animals studies do not indicate direct or indirect harmful effects with respect to reproductive toxicity (see Section 5.3). As a precautionary measure Alluzience should not be used during pregnancy.

Breastfeeding

It is unknown if Alluzience is excreted in human milk. Alluzience should not be used during breast-feeding.

Fertility

There are no clinical data examining the effect of Alluzience on fertility. There is no evidence of direct effect of Alluzience on fertility in animal studies (see section 5.3).

Alluzience has a minor or moderate influence on the ability to drive and use machines. There is a potential risk of localised muscle weakness or visual disturbances linked with the use of this medicinal product which may temporarily impair the ability to drive or operate machinery.

Summary of the safety profile

A majority of adverse reactions reported with Alluzience in clinical trials were of mild to moderate intensity and reversible. The most frequently reported adverse reactions were headache and injection site reactions. The incidence of adverse reactions tended to decrease with repeated treatments.

Adverse effects related to the spread of toxin effect distant from the site of administration have been very rarely reported with botulinum toxin (excessive muscle weakness, dysphagia, aspiration pneumonia with fatal outcomes in some cases) (see section 4.4).

The adverse reactions are presented from pivotal placebo-controlled clinical trials with Alluzience and also the pivotal placebo-controlled studies with the powder formulation of the same active substance, and organised according to primary system organ class (SOC) for each preferred term in MedDRA (Table 1).

Tabulated summary of adverse reactions

The frequency of undesirable effects is classified as follows: 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).

Table 1. Adverse Drug Reactions Observed in Clinical Studies:

^* additional adverse drug reactions only observed with powder formulation of the same active substance in clinical trials

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 HPRA Pharmacovigilance Website: www.hpra.ie.

This medicinal product must not be mixed with other medicinal products.