Fremanezumab-vfrm (Subcutaneous)

Fremanezumab-vfrm injection is used to stop migraine headaches.

This medicine is only available with a prescription from your doctor.

It is very important for your doctor to check your progress at regular visits to make sure that this medicine is working properly and to look for any unwanted effects.

This medicine may cause serious allergic reactions, which can be life-threatening and need immediate medical attention. Tell your doctor right away if you have a rash, itching, hoarseness, trouble breathing, trouble swallowing, or any swelling of your hands, face, or mouth after using this medicine.

In deciding to use a medicine, you and your doctor will weigh the risks of taking the medicine against the benefits it may provide. Consider the following for this medicine:

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 other allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Appropriate studies have not been conducted on how age affects the use of fremanezumab-vfrm injection in children. Safety and effectiveness have not been confirmed.

Geriatric

Current studies have not shown any specific problems in older adults that would limit the usefulness of fremanezumab-vfrm injection.

Breast Feeding

There are no adequate studies in women to determine the risk to infants when using this medication while breastfeeding. Consider the potential benefits and risks before using this medication during breastfeeding.

Interactions with Medicines

Some medicines should not be used together, while others may be used together even if an interaction could happen. In such cases, your doctor may adjust the dose or take other precautions. Inform your healthcare professional about any other prescription or nonprescription (over-the-counter [OTC]) medicines you are taking.

Interactions with Food/Tobacco/Alcohol

Some medicines should not be taken around the time of eating food or certain types of food due to possible interactions. Using alcohol or tobacco with certain medicines may also lead to interactions. Talk to 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 immediately if any of the following side effects occur:

More common

• Fast heartbeat
• fever
• hives, itching, skin rash
• hoarseness
• irritation
• joint pain, stiffness, or swelling
• redness of the skin
• swelling of the eyelids, face, lips, hands, or feet
• tightness in the chest
• troubled breathing or swallowing

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

• Bleeding, blistering, burning, coldness, discoloration of 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.

• Ajovy

Available Dosage Forms:

• Solution

Therapeutic Class: Antimigraine

Pharmacologic Class: Fremanezumab

Find detailed information on biosimilars for this medication.

A nurse or other trained health professional will give you this medicine. It is given through a needle given as a shot under your skin, usually in the stomach, thighs, or upper arm. You or your caregiver may be trained to prepare and inject this medicine at home. Be sure that you understand how to use the medicine.

If you use this medicine at home, you will be shown the body areas where this shot can be given. Use a different body area each time you give yourself a shot. Keep track of where you give each shot to make sure you rotate body areas. This will help prevent skin problems from the injections. Do not inject into skin areas that are tender, red, bruised, or hard.

This medicine comes with a patient information leaflet and patient instructions. Read and follow these instructions carefully. Ask your doctor if you have any questions.

Check the liquid in the prefilled syringe or autoinjector. It should be clear and colorless to slightly yellow. Do not use the medicine if the liquid is cloudy, discolored, or has particles in it. Do not shake.

Allow the medicine to warm to room temperature for at least 30 minutes before you use it. Do not warm it in any other way.

Do not remove the needle cap from the prefilled syringe until you are ready to use it.

You might not use all of the medicine in each prefilled syringe or autoinjector. Use each prefilled syringe and autoinjector only one time. Do not save an open syringe or autoinjector.

Dosing

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

• For injection dosage form (solution):For migraine headaches: Adults—225 milligrams (mg) injected under the skin once a month, or 675 mg injected under the skin every 3 months. Children—Use and dose must be determined by your doctor.

Missed Dose

If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Continue to use this medicine each month from the date of your last dose.

Storage

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

Store in the refrigerator. Do not freeze.

Keep the medicine in its original carton. You may store it at room temperature for up to 24 hours. After removing the medicine from the refrigerator, use it within 24 hours. Throw away any unused medicine kept at room temperature after 24 hours.

Throw away used needles in a hard, closed container where the needles cannot poke through. Keep this container away from children and pets.

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