Fremanezumab

Fremanezumab is used to help stop migraine headaches in adults.

Fremanezumab may also be used for reasons not mentioned in this medication guide.

Follow all directions on your prescription label and read all medication guides or instruction sheets. Use the medicine exactly as directed.

Fremanezumab is injected under the skin. A healthcare provider may teach you how to properly use the medication by yourself.

Fremanezumab is usually given as 1 injection once a month, or as 3 injections (in separate syringes) once every 3 months.

Read and carefully follow any Instructions for Use provided with your medicine. Do not use fremanezumab if you don't understand all instructions for proper use. Ask your doctor or pharmacist if you have questions.

Prepare your injection only when you are ready to give it. Do not use if the medicine looks cloudy, has changed colors, is frozen, or has particles in it. Call your pharmacist for new medicine.

Store fremanezumab in the original carton in a refrigerator, protected from light. Do not freeze or shake this medicine.

Take the medicine out of the refrigerator and let it reach room temperature for 30 minutes before injecting your dose. Do not warm the medicine with hot water, sunlight, or a microwave.

You may also store fremanezumab in the original carton at room temperature for up to 7 days. Throw the medicine away if it has been at room temperature for 7 days or longer.

Each prefilled autoinjector or syringe is for one use only. Throw it away after one use, even if there is still medicine left inside.

Use a needle and syringe only once and then place them in a puncture-proof "sharps" container. Follow state or local laws about how to dispose of this container. Keep it out of the reach of children and pets.

Follow all instructions on your medicine label and package. Inform each of your healthcare providers about all your medical conditions, allergies, and all medicines you are using.

You should not use fremanezumab if you are allergic to it.

Fremanezumab is not approved for use by anyone younger than 18 years old.

Tell your doctor if you are pregnant. It is not known whether fremanezumab will harm an unborn baby. However, having migraines during pregnancy may cause complications such as preeclampsia (which can lead to medical problems in both mother and baby). The benefit of preventing migraines may outweigh any risks to the baby.

It may not be safe to breast-feed while using this medicine. Ask your doctor about any risk.

Serious side effects

Fremanezumab may cause serious side effects, including:

• Allergic reactions. Allergic reactions, including itching, rash, and hives, can happen within hours and up to 1 month after receiving fremanezumab. Call your healthcare provider or get emergency medical help right away if you have any of the following symptoms of an allergic reaction: swelling of your face, mouth, tongue, or throat trouble breathing.
• Constipation with serious complications. Severe constipation can happen after receiving fremanezumab. In some cases, people have been hospitalized or needed surgery. Contact your healthcare provider if you have severe constipation or constipation associated with symptoms such as severe or constant belly pain, vomiting, swelling of your belly, or bloating.
• High blood pressure. High blood pressure or worsening of high blood pressure can happen after receiving fremanezumab. Contact your healthcare provider if you have an increase in blood pressure.
• Raynaud's phenomenon. A type of circulation problem can happen or worsen after receiving fremanezumab. Symptoms may include: fingers or toes may feel numb, cool, or painful fingers and toes may change color from pale to blue to red.

Stop taking fremanezumab and contact your healthcare provider if these symptoms occur.

Common side effects of fremanezumab may include:

• pain, redness, or a hard lump where the medicine was injected.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Usual Adult Dose for Migraine Prophylaxis:

225 mg subcutaneously once a month -Alternatively, 675 mg subcutaneously may be administered once every 3 months Comments:-To administer 675 mg subcutaneously, 3 consecutive subcutaneous injections of 225 mg are given. -If switching dosage options, administer the first dose of the new regimen on the next scheduled date of administration. Use: For the preventive treatment of migraine.

Use the medicine as soon as you remember, and then start your regular injection schedule again 1 month or 3 months later.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

Follow your doctor's instructions about any restrictions on food, beverages, or activity.

Other drugs may affect fremanezumab, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell your doctor about all your current medicines and any medicine you start or stop using.