Mepolizumab

Mepolizumab is a prescription medication used for the treatment of severe eosinophilic asthma in patients age 12 years and older. Mepolizumab is approved for patients who have a history of severe asthma attacks (exacerbations) despite receiving their current asthma medicines.

Mepolizumab, a monoclonal antibody, reduces severe asthma attacks by reducing the levels of blood eosinophils — a type of white blood cell that contributes to the development of asthma.

Mepolizumab is administered once every four weeks by subcutaneous injection by a health care professional into the upper arm, thigh, or abdomen.

The most common side effects of mepolizumab include headache, pain, redness, swelling, itching, or a burning feeling at the injection site, back pain, and weakness.

Mepolizumab is a prescription medicine used with other asthma medicines for the maintenance treatment of asthma in people aged 12 years and older whose asthma is not controlled with their current asthma medicines. Mepolizumab helps prevent severe asthma attacks (exacerbations). Mepolizumab reduces blood eosinophils. Eosinophils are a type of white blood cells that may contribute to your asthma.

Mepolizumab is not used to treat other problems caused by eosinophils. Mepolizumab is not used to treat sudden breathing problems.

It is not known if mepolizumab is safe and effective in children under 12 years of age.

This medication may be prescribed for other uses. Ask your doctor or pharmacist for more information.

Mepolizumab may be found in some form under the following brand names:

• Nucala

Mepolizumab can cause serious side effects. See "Mepolizumab Precautions" section.

The most common side effects include: headache, injection site reactions (pain, redness, swelling, itching, or a burning feeling at the injection site), back pain, and weakness (fatigue).

These are not all the possible side effects of mepolizumab.

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

No drug interactions have been studied by the manufacturer. However, you should tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Not all drug interactions are known or reported and new interactions are continually being reported.

Mepolizumab can cause serious side effects, including:

• allergic (hypersensitivity) reactions. Serious allergic reactions can happen after you get your injection. Allergic reactions can sometimes happen hours or days after you get a dose of mepolizumab. Tell your healthcare provider or get emergency help right away if you have any of the following symptoms of an allergic reaction:
  • swelling of your face, mouth, and tongue  
  • breathing problems
  • fainting, dizziness, feeling lightheaded (low blood pressure)      
  • rash
  • hives

Herpes zoster infections that can cause shingles have happened in people who received mepolizumab.

Do not use this medication if you are allergic to mepolizumab or any of the ingredients in it.

Medications can interact with certain foods. In some cases, this may be harmful and your doctor may advise you to avoid certain foods. In the case of mepolizumab, there are no specific foods that you must exclude from your diet while receiving this medication.

Before receiving mepolizumab, tell your healthcare provider about all of your medical conditions, including if you:

• have a parasitic (helminth) infection
• have not had chickenpox (varicella) or the chickenpox vaccine
• are taking oral or inhaled corticosteroid medicines. Do not stop taking your corticosteroid medicines unless instructed by your healthcare provider. This may cause other symptoms that were controlled by the corticosteroid medicine to come back.
• are pregnant or plan to become pregnant. It is not known if mepolizumab may harm your unborn baby. There is a pregnancy registry for women who receive this medication while pregnant. The purpose of the registry is to collect information about the health of you and your baby. You can talk to your healthcare provider about how to take part in this registry or you can get more information and register by calling 1-877-311-8972 or go to www.mothertobaby.org/asthma.
• are breastfeeding or plan to breastfeed. You and your healthcare provider should decide if you will use mepolizumab and breastfeed. You should not do both without talking with your healthcare provider first.

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Do not stop taking your other asthma medicines unless instructed to do so by your healthcare provider.

Tell your doctor if you are pregnant or plan to become pregnant. It is not known if mepolizumab may harm your unborn baby.

• Pregnancy Registry. There is a pregnancy registry for women who receive mepolizumab while pregnant. The purpose of the registry is to collect information about the health of you and your baby. You can talk to your healthcare provider about how to take part in this registry or you can get more information and register by calling 1-877-311-8972 or go to www.mothertobaby.org/asthma.

Tell your doctor if you are breastfeeding or plan to breastfeed. You and your doctor should decide if you will use mepolizumab and breastfeed. You should not do both without talking with your doctor first.

A healthcare provider will inject mepolizumab under your skin (subcutaneously) 1 time every 4 weeks.

The recommended dose of mepolizumab is 100 mg administered once every 4 weeks by subcutaneous injection into the upper arm, thigh, or abdomen.

Mepolizumab is administered by a healthcare provider in a medical setting. It is unlikely that an overdose will occur. However, if overdose is suspected, 

Store below 25°C (77°F). Do not freeze. Store in the original package to protect from light.