Pronunciation:

ep-ti-NEZ-ue-mab - jjmr

Brand Names:

• Vyepti

Dosage Forms:

• Solution

Classifications:

Therapeutic—

Antimigraine

Pharmacologic—

Eptinezumab

Uses of This Medicine:

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

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

Before Using This Medicine:

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies—

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Children—

Appropriate studies on the relationship of age to the effects of eptinezumab-jjmr injection have not been performed in the pediatric population. Safety and efficacy have not been established.

Older adults—

Appropriate studies on the relationship of age to the effects of eptinezumab-jjmr injection have not been performed in the geriatric population. Safety and efficacy have not been established.

Breast-feeding—

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Other medicines—

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. Tell your healthcare professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine.

Other interactions—

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Proper Use of This Medicine:

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.

Precautions While Using This Medicine:

It is very important that your doctor check your progress closely while you are receiving this medicine. This will allow your doctor to see if the medicine is working properly and to decide if you should continue to receive it.

This medicine may cause serious allergic reactions, including anaphylaxis and angioedema, which can be life-threatening and require 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 receiving this medicine.

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

Side Effects of This Medicine:

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.