Vyepti · 4.1 Therapeutic indications · 1

HOS-099442 · has-adverse-reaction-information · PDF-Seite 5

Summary of the safety profile Over 5 900 patients have been treated with VYEPTI in clinical studies. Of these, approximately 3 000 patients have been exposed for at least 6 months and 1 600 exposed for at least 1 year. Common adverse reactions in the placebo-controlled clinical studies for the preventive treatment of migraine were hypersensitivity and infusion-related reactions (see below). Most hypersensitivity reactions occurred during infusion and were not serious. Infusion site related adverse events occurred infrequently and in similar proportions of VYEPTI and placebo patients (< 1%) with no apparent relationship to VYEPTI dose. The most frequently occurring infusion-site related adverse event was infusion site extravasation, which occurred in ≤ 0.5% of VYEPTI and placebo patients. Tabulated list of adverse reactions Adverse reactions from clinical trials and post-marketing experience (table 1) are classified by MedDRA system organ classification and frequency. Frequencies have been evaluated according to the following convention: 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). Table 1: List of Adverse Reactions System organ class Adverse reaction Frequency category preferred term Immune system disorders Hypersensitivity reactions Common Anaphylactic reaction Uncommon General disorders and Infusion-related reaction Common administration site conditions Fatigue Common Description of selected adverse reactions Hypersensitivity and infusion-related reactions Serious hypersensitivity reactions, including anaphylactic reactions, have been reported and may develop within minutes of the infusion (see section 4.4). The reported anaphylactic reactions have included symptoms of hypotension and respiratory difficulties, and have led to discontinuation of VYEPTI. In clinical studies, other hypersensitivity reactions, including angioedema, urticaria, flushing, rash and pruritus, were reported in approximately 4% and 3% of patients on the 300 mg and 100 mg dose, respectively, and 2% of patients on placebo (saline). Other symptoms reported in association with eptinezumab infusion include respiratory symptoms (nasal congestion, rhinorrhea, throat irritation, cough, sneezing, dyspnea) and fatigue (see below). Mos

Auszug; vollständigen Abschnitt im Original lesen.

HOS-099438 · has-contraindication-information · PDF-Seite 3

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

HOS-099437 · has-indication-information · PDF-Seite 2

VYEPTI is indicated for the prophylaxis of migraine in adults who have at least 4 migraine days per month.

HOS-099440 · has-interaction-information · PDF-Seite 4

Eptinezumab is not metabolized by cytochrome P450 enzymes. Therefore, interactions by eptinezumab with concomitant medications that are substrates, inducers, or inhibitors of cytochrome P450 enzymes are considered unlikely.

HOS-099441 · has-pregnancy-information · PDF-Seite 4

Pregnancy There is limited data from the use of eptinezumab in pregnant women. Animal studies with eptinezumab do not indicate direct or indirect harmful effects with respect to reproductive toxicity (see section 5.3). Human IgG is known to cross the placental barrier; therefore, eptinezumab may be transmitted from the mother to the developing fetus. As a precautionary measure, it is preferable to avoid the use of VYEPTI during pregnancy. Breast-feeding There are no data on the presence of eptinezumab in human milk, the effects on the breastfed infant, or the effects on milk production. Human IgG is known to be excreted in breast milk during the first few days after birth, which is decreasing to low concentrations soon afterward; consequently, a risk to the breastfed infant cannot be excluded during this short period. Afterwards, use of eptinezumab could be considered during breast-feeding only if clinically needed. 4 Fertility The effect of eptinezumab on human fertility has not been evaluated. Animal studies with eptinezumab showed no impact on female and male fertility (see section 5.3).

HOS-099439 · has-warning-information · PDF-Seite 3

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. 3 Patients with cardiovascular, neurological or psychiatric diseases Patients with a history of clinical significant cardiovascular disease (e.g. ischemic heart disease, cerebrovascular disease, vascular ischemia or thromboembolic events) were excluded from the clinical studies (see section 5.1). Limited safety data are available in patients with cardiovascular disease and/or cardiovascular risk factors such as diabetes, circulatory diseases and hyperlipidaemia. Patients with a history of neurological diseases or patients with psychiatric conditions that were uncontrolled and/or untreated were excluded from the clinical studies. Limited safety data are available in these patients. Serious hypersensitivity Serious hypersensitivity reactions, including anaphylactic reactions, have been reported and may develop within minutes of the infusion. Most hypersensitivity reactions occurred during infusion and were not serious (see section 4.8). If a serious hypersensitivity reaction occurs, administration of VYEPTI should be discontinued immediately and appropriate therapy initiated. If the hypersensitivity reaction is not serious, continuation of further treatment with VYEPTI is up to the discretion of the treating physician, taking into account the benefit-risk for the individual patient. Excipients VYEPTI contains sorbitol (E420). Patients with hereditary fructose intolerance (HFI) must not be given this medicinal product unless strictly necessary. A detailed history with regard to HFI symptoms has to be taken of each patient prior to being given this medicinal product.