Voxzogo · 4.5 Interaction with other medicinal products and other forms of interaction · 1

HOS-099717 · has-adverse-reaction-information · PDF-Seite 5

Summary of the safety profile The most common adverse reactions to vosoritide were injection site reactions (85%), vomiting (27%), and decreased blood pressure (13%). Tabulated list of adverse reactions Adverse reactions in patients treated with vosoritide are tabulated below. Adverse reactions are listed below by MedDRA 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 available data). Within each frequency grouping, adverse reactions are presented in order of decreasing seriousness. Table 2: Adverse reactions in patients treated with Voxzogo System organ class Very common Common Nervous system disorders Syncope Pre-syncope Dizziness Vascular disorders Hypotensiona Gastrointestinal disorders Vomiting Nausea Skin and subcutaneous tissue disorders Hypertrichosis General disorders and administration Injection site reactionb Fatigue site conditions 5  Investigations Increased alkaline phosphatase a. Hypotension includes both asymptomatic and symptomatic adverse reactions. b. Injection site reactions include the preferred terms; injection site erythema, injection site reaction, injection site swelling, injection site urticaria, injection site pain, injection site bruising, injection site pruritus, injection site haemorrhage, injection site discolouration, and injection site induration. Description of selected adverse reactions Hypotension In ACH study 111-301, patients aged ≥ 5 years, 13% of patients treated with vosoritide compared to 5% of patients treated with placebo, experienced events of decreases in blood pressure which were transient and resolved without intervention. The median time to onset from injection was 31 (18 to 120) minutes with resolutio

Auszug; vollständigen Abschnitt im Original lesen.

HOS-099713 · has-contraindication-information · PDF-Seite 4

Hypersensitivity to the active substance(s) or to any of the excipients listed in section 6.1.

HOS-099712 · has-indication-information · PDF-Seite 2

Voxzogo is indicated for the treatment of achondroplasia in patients 4 months of age and older whose epiphyses are not closed. The diagnosis of achondroplasia should be confirmed by appropriate genetic testing.

HOS-099715 · has-interaction-information · PDF-Seite 4

In vitro cytochrome P450 (CYP) inhibition and induction studies and in vitro transporter inhibition studies have been performed. Results suggested that vosoritide is unlikely to cause CYP- or transporter-mediated drug-drug interactions in humans when the medicinal product is administered concomitantly with other medicinal products. No other interaction studies have been performed. Because it is a recombinant human protein, vosoritide is an unlikely candidate for drug-drug interactions. 4

HOS-099716 · has-pregnancy-information · PDF-Seite 5

Pregnancy There are no or limited amount of data from the use of vosoritide in pregnant women. Animal studies do not indicate direct or indirect harmful effects with respect to reproductive toxicity (see section 5.3). As a precautionary measure, it is preferable to avoid the use of vosoritide during pregnancy. Breast-feeding Available pharmacodynamic/toxicological data in animals have shown excretion of vosoritide in milk (see section 5.3). A risk to newborns/infants cannot be excluded. Vosoritide should not be used during breast-feeding. Fertility No impairment of male or female fertility has been observed in nonclinical studies (see section 5.3).

HOS-099714 · has-warning-information · PDF-Seite 4

Traceability In order to improve the traceability of biological medicinal products, the name and the batch number of the administered medicinal product should be clearly recorded. Blood pressure effects Patients with significant cardiac or vascular disease and patients on anti-hypertensive medicinal products were excluded from participation in premarketing clinical trials. To reduce the risk of a potential decrease in blood pressure and associated symptoms (dizziness, fatigue and/or nausea), patients should be well hydrated at the time of injection (see sections 4.2 and 4.8). Sodium This medicinal product contains less than 1 mmol sodium (23 mg) per unit volume, that is to say essentially ‘sodium-free’.