Nucala

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

Nucala, 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.

Nucala 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 Nucala include headache, pain, redness, swelling, itching, or a burning feeling at the injection site, back pain, and weakness.

Nucala 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. Nucala helps prevent severe asthma attacks (exacerbations). Nucala reduces blood eosinophils. Eosinophils are a type of white blood cells that may contribute to your asthma.

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

It is not known if Nucala 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.

• Glaxo SmithKline Pharmaceuticals

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

The most common side effects of Nucala 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 Nucala.

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

No Nucala 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.

Nucala can cause serious side effects, including:

• allergic (hypersensitivity) reactions. Serious allergic reactions can happen after you get your Nucala injection. Allergic reactions can sometimes happen hours or days after you get a dose of Nucala. 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 Nucala.

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

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 Nucala, there are no specific foods that you must exclude from your diet while receiving this medication.

Before receiving Nucala, 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 Nucala may harm your unborn baby. There is a pregnancy registry for women who receive Nucala 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 Nucala 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 Nucala may harm your unborn baby.

• Pregnancy Registry. There is a pregnancy registry for women who receive Nucala 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 Nucala and breastfeed. You should not do both without talking with your doctor first.

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

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

Nucala 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.