Fremanezumab

What is fremanezumab?

Fremanezumab is a prescription medicine that is used to prevent migraine headaches.

Description

Fremanezumab-vfrm is a fully humanized IgG2Δa/kappa monoclonal antibody specific for calcitonin gene-related peptide (CGRP) ligand. Fremanezumab-vfrm is produced by recombinant DNA technology in Chinese hamster ovary (CHO) cells. The antibody consists of 1324 amino acids and has a molecular weight of approximately 148 kDa.

AJOVY (fremanezumab-vfrm) injection is a sterile, preservative-free, clear to opalescent, colorless to slightly yellow solution for subcutaneous injection, supplied in a single-dose 225 mg/1.5 mL prefilled autoinjector and a single-dose 225 mg/1.5 mL prefilled syringe.

Each prefilled autoinjector or prefilled syringe delivers 1.5 mL of solution containing 225 mg fremanezumab-vfrm, disodium ethylenediaminetetraacetic acid dihydrate (EDTA) (0.204 mg), L-histidine (0.815 mg), L-histidine hydrochloride monohydrate (3.93 mg), polysorbate-80 (0.3 mg), sucrose (99 mg), and Water for Injection, and has a pH of 5.5.

 Mechanism of Action

Fremanezumab-vfrm is a humanized monoclonal antibody that binds to calcitonin gene-related peptide (CGRP) ligand and blocks its binding to the receptor.

Before taking fremanezumab, tell your doctor:

• If you are allergic to fremanezumab; any part of this medicine; or any other drugs, foods, or substances. Tell your doctor about the allergy and what signs you had.

This medicine may interact with other drugs or health problems.

Tell your doctor and pharmacist about all of your drugs (prescription or OTC, natural products, vitamins) and health problems. You must check to make sure that it is safe for you to take fremanezumab with all of your drugs and health problems. Do not start, stop, or change the dose of any drug without checking with your doctor.

What are some things I need to know or do while I take fremanezumab?

• Tell all of your health care providers that you take fremanezumab. This includes your doctors, nurses, pharmacists, and dentists.
• Allergic reactions have happened within hours and up to 1 month after fremanezumab was given. Tell your doctor right away about any bad effects after getting fremanezumab.
• Tell your doctor if you are pregnant or plan on getting pregnant. You will need to talk about the benefits and risks of using fremanezumab while you are pregnant.
• Tell your doctor if you are breast-feeding. You will need to talk about any risks to your baby.

How is fremanezumab best taken?

Use fremanezumab as ordered by your doctor. Read all information given to you. Follow all instructions closely.

• It is given as a shot into the fatty part of the skin on the top of the thigh, belly area, or upper arm.
• If you will be giving yourself the shot, your doctor or nurse will teach you how to give the shot.
• Wash your hands before use.
• If stored in a refrigerator, let fremanezumab come to room temperature before using it. Leave it at room temperature for at least 30 minutes. Do not heat fremanezumab.
• Do not shake.
• Do not give into skin that is irritated, bruised, red, infected, or scarred.
• Do not give into the same place as another shot.
• If your dose is more than 1 injection, you may give it in the same body part. Make sure you do not give injections in the same spot you used for the other injections.
• Do not use if the solution is cloudy, leaking, or has particles.
• This medicine is colorless to a faint yellow. Do not use if the solution changes color.
• Each prefilled syringe is for one use only.
• Throw away needles in a needle/sharp disposal box. Do not reuse needles or other items. When the box is full, follow all local rules for getting rid of it. Talk with a doctor or pharmacist if you have any questions.

What do I do if I miss a dose?

• Take a missed dose as soon as you think about it.
• After taking a missed dose, start a new schedule based on when the dose is taken.

What are the side effects of fremanezumab that I need to call my doctor about immediately?

WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:

• Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing, swallowing, or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
• Very bad irritation where the shot was given.

What are some other side effects of fremanezumab?

All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:

• Irritation where the shot is given.

These are not all of the side effects that may occur. If you have questions about side effects, call your doctor. Call your doctor for medical advice about side effects.

You may report side effects to the FDA at 1-800-332-1088. You may also report side effects at https://www.fda.gov/medwatch.

If overdose is suspected:

If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.

How do I store and/or throw out fremanezumab?

• Store in a refrigerator. Do not freeze.
• Store in the original container to protect from light.
• If needed, fremanezumab can be left out at room temperature for up to 24 hours. Throw away drug if left at room temperature for more than 24 hours.
• Protect from heat and sunlight.
• Keep all drugs in a safe place. Keep all drugs out of the reach of children and pets.
• Throw away unused or expired drugs. Do not flush down a toilet or pour down a drain unless you are told to do so. Check with your pharmacist if you have questions about the best way to throw out drugs. There may be drug take-back programs in your area.

Label

PACKAGE/LABEL DISPLAY PANEL,CARTON OF 1 PREFILLED AUTOINJECTOR

• NDC 51759-202-10
  Rx only
  AJOVY (fremanezumab-vfrm) injection 225 mg/1.5 mL
  FOR SUBCUTANEOUS USE ONLY
  One single-dose prefilled autoinjector
  Store in refrigerator at 36°F to 46°F (2° to 8°C) in the original carton to protect from light. DO NOT FREEZE. DO NOT SHAKE. If needed, AJOVY® may be kept at room temperature up to 86°F (30°C) for 7 days. Once stored at room temperature, do not place back in the refrigerator. Discard after 7 days.
• OPEN HERE
  teva

PACKAGE/LABEL DISPLAY PANEL,CARTON OF 3 PREFILLED AUTOINJECTORS

• NDC 51759-202-22
  Rx only
  AJOVY (fremanezumab-vfrm) injection 225 mg/1.5 mL
  FOR SUBCUTANEOUS USE ONLY
  3 x 225 mg/1.5 mL single-dose prefilled autoinjectors
  Store in refrigerator at 36°F to 46°F (2° to 8°C) in the original carton to protect from light. DO NOT FREEZE. DO NOT SHAKE. If needed, AJOVY® may be kept at room temperature up to 86°F (30°C) for 7 days. Once stored at room temperature, do not place back in the refrigerator. Discard after 7 days.
• OPEN HERE
  teva