Eptinezumab-jjmr (Intravenous)

Eptinezumab-jjmr injection is used to prevent migraine headaches in adults.

This medicine is to be given only by your doctor or under their direct supervision.

It is very important that your doctor checks your progress closely while you are using this medicine. This will help your doctor see if the medicine is working properly and decide if you should keep using it.

This medicine may cause serious allergic reactions, including anaphylaxis and angioedema, which can be life-threatening and need immediate medical attention. Tell your doctor right away if you have chest tightness, cough, rash, itching, redness of the face, trouble breathing or swallowing, large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs, or unusual tiredness or weakness while you are using this medicine.

Tell your doctor right away if you are pregnant or planning to become pregnant before using this medicine.

In deciding to use a medicine, you and your doctor will consider the risks against the benefits. For this medicine, keep the following in mind:

Allergies

Inform your doctor if you have ever had any unusual or allergic reactions to this medicine or any other medicines. Also, let your healthcare professional know if you have allergies to foods, dyes, preservatives, or animals. For non-prescription products, carefully read the label or package ingredients.

Pediatric

Studies on the effects of eptinezumab-jjmr injection in children have not been conducted. Safety and effectiveness are not known.

Geriatric

Studies on the effects of eptinezumab-jjmr injection in older adults have not been conducted. Safety and effectiveness are not known.

Breast Feeding

There are no sufficient studies on the risks to infants when women use this medication while breastfeeding. Consider the potential benefits and risks before taking this medication during breastfeeding.

Interactions with Medicines

Some medicines should not be used together. In some cases, two different medicines can be used together even if an interaction might happen. In these situations, your doctor may adjust the dose or take other precautions. Inform your healthcare professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicines.

Interactions with Food/Tobacco/Alcohol

Some medicines should not be taken around mealtime or with certain foods, as interactions may occur. Using alcohol or tobacco with certain medicines can also lead to interactions. Discuss with your healthcare professional about using your medicine with food, alcohol, or tobacco.

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor or nurse immediately if any of the following side effects occur:

Less common

• Chest tightness
• fast heartbeat
• feeling of warmth
• fever
• hives, itching, skin rash
• hoarseness
• irritation
• joint pain, stiffness or swelling
• large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, sex organs
• redness of the skin
• redness of the face, neck, arms and occasionally, upper chest
• swelling of the eyelids, face, lips, hands, or feet
• trouble breathing or swallowing

Incidence not known

• Cough
• dizziness
• unusual tiredness or weakness

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common

• Headache
• muscle aches
• sore throat
• stuffy or runny nose

Incidence not known

• Bleeding, blistering, burning, coldness, discoloration of the skin, feeling of pressure, hives, infection, inflammation, itching, lumps, numbness, pain, rash, redness, scarring, soreness, stinging, swelling, tenderness, tingling, ulceration, or warmth at the injection site

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

In the U.S.

• Vyepti

Available Dosage Forms:

• Solution

Therapeutic Class: Antimigraine

Pharmacologic Class: Eptinezumab

Find detailed information on biosimilars for this medication.

A nurse or other healthcare professional will give you this medicine in a hospital. This medicine is given through a needle placed in one of your veins. It must be given slowly, so the needle should remain in place for at least 30 minutes every 3 months.

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