Vyepti^® (Concentrate) Instructions for Use

Marketing Authorization Holder

H. Lundbeck, A/S (Denmark)

Manufactured By

Vetter Pharma-Fertigung, GmbH & Co. KG (Germany)

ATC Code

N02CD05 (Eptinezumab)

Active Substance

Eptinezumab (Group Name)

Dosage Form

Vyepti®

Concentrate for solution for infusion 100 mg/1 ml: fl. 1 ml 1 pc.

Dosage Form, Packaging, and Composition

Concentrate for solution for infusion as a clear or slightly opalescent liquid from colorless to brownish-yellow.

1 ml of concentrate contains 40.5 mg of sorbitol.

After dilution in 100 ml of 0.9% sodium chloride solution, the concentration of eptinezumab is:

For a dose of 100 mg (the contents of one vial – 1 ml is diluted) – 1 mg/ml;

For a dose of 300 mg (the contents of three vials – 3 ml is diluted) – 3 mg/ml.

PH from 5.5 to 6.1.

Osmolality: from 290 to 350 mOsm/kg.

Excipients : sorbitol (E420), L-histidine, L-histidine hydrochloride monohydrate, polysorbate 80, water for injections.

1 ml – colorless glass vials (1) – cardboard packs.

Clinical-Pharmacological Group

Monoclonal antibody for the preventive treatment of migraine

Pharmacotherapeutic Group

Analgesics; antimigraine preparations; CGRP (calcitonin gene-related peptide) antagonists

Pharmacological Action

Antimigraine agent. Blocks the activity of a substance that is naturally produced in the body and whose levels may be elevated in patients with migraine.

This medicinal product is subject to additional monitoring, which facilitates the rapid identification of new safety information.

Indications

For the prevention of migraine, if attacks are observed for at least 4 days per month.

ICD codes

Dosage Regimen

Administer the recommended dose of 100 mg as a single intravenous infusion every 12 weeks.

Consider a dose of 300 mg as a single intravenous infusion every 12 weeks for patients who may derive additional benefit.

Select the appropriate dose based on individual patient presentation and response.

Dilute the 100 mg dose (1 ml vial) in 100 ml of 0.9% sodium chloride solution prior to administration.

Dilute the 300 mg dose (three 1 ml vials) in 100 ml of 0.9% sodium chloride solution prior to administration.

Infuse the diluted solution intravenously over approximately 30 minutes.

Do not mix with other medicinal products.

Do not administer as an intravenous push or bolus.

Inspect the solution visually for particulate matter and discoloration before administration.

Discard any unused portion left in the vial.

No dose adjustment is required for elderly patients (65 years and older).

No dose adjustment is required for patients with hepatic impairment or renal impairment.

Adverse Reactions

Common allergic reactions, incl. hives, flushing, itching, rash, respiratory symptoms (such as nasal congestion or runny nose, throat irritation, cough, sneezing, shortness of breath), increased fatigue.

Uncommon serious allergic reactions – difficulty breathing, fast or weak pulse, sharp decrease in blood pressure, leading to dizziness or loss of consciousness; swelling of the lips or tongue, severe itching, rash.

Contraindications

Hypersensitivity to eptinezumab, children and adolescents under 18 years of age.

Use in Pregnancy and Lactation

Contraindicated for use during pregnancy and breastfeeding.

Use in Hepatic Impairment

No dose adjustment is required for patients with hepatic impairment.

Use in Renal Impairment

No dose adjustment is required for patients with renal impairment.

Pediatric Use

Contraindicated for use in children and adolescents under 18 years of age.

Geriatric Use

No dose adjustment is required for elderly patients.

Special Precautions

The safety of eptinezumab has not been sufficiently studied in patients with arterial hypertension, coronary artery disease; in the presence of risk factors for the development of cardiovascular diseases, for example, diabetes mellitus, diseases of the circulatory system, lipid metabolism disorders; in patients with neurological diseases or mental disorders.

Severe allergic reactions may develop as early as during the first administration of eptinezumab.

Drug Interactions

Cytochrome P450 isoenzymes are not involved in the metabolism of eptinezumab. Thus, interactions of eptinezumab with concomitant drugs that are substrates, inducers, or inhibitors of cytochrome P450 enzymes are considered unlikely.

Storage Conditions

Store at 2°C (36°F) to 8°C (46°F). Keep in original packaging, protected from light. Keep out of reach of children.

Dispensing Status

Rx Only

Important Safety Information

This information is for educational purposes only and does not replace professional medical advice. Always consult your doctor before use. Dosage and side effects may vary. Use only as prescribed.