NUCALA PRE-FILLED AUTO INJECTION

Uses of Nucala Pre-filled Auto Injection

Nucala (mepolizumab) is commonly used for the following conditions.

• Severe asthma, a breathing disorder
• Chronic rhinosinusitis with nasal polyps (CRSwNP), a nasal condition
• Eosinophilic granulomatosis with polyangiitis (EGPA), an immune system disorder
• Hypereosinophilic syndrome (HES), an immune system disorder

Precautions and Warnings

Allergies to Ingredients. People who are allergic to any of the following should not use Nucala.

• Nucala
• Mepolizumab
• Any of the ingredients in the specific product dispensed

Your pharmacist can tell you all of the ingredients in Nucala.

Sudden Asthma Symptoms. Nucala should not be used to treat an asthma attack or a sudden worsening of your asthma symptoms. Get emergency help, follow your asthma action plan, or call your healthcare provider if your asthma gets worse or does not get better while using Nucala.

Do not use Nucala unless it has been prescribed to you by a healthcare provider. Use it as prescribed.

Do not share Nucala with other people, even if they have the same condition as you. It may harm them. Do not share the needle that is attached to Nucala with another person. This practice can risk you or the other person getting an infection.

Keep Nucala out of the reach of children. Because Nucala prefilled syringes and autoinjectors should be kept in a refrigerator, take special precautions to keep them away from children who also use the refrigerator.

Nucala is injected under the skin. Make sure that you or a caregiver understands how to properly prepare and use it. Do not use the medicine if it looks cloudy, discolored, has particles floating in it, or is expired. If you have any questions, talk to your healthcare provider. Ensure that you choose a new injection site each time you use it. Do not inject into moles, scars, bruises, or damaged skin.

Tell your healthcare provider about all of your health conditions and any prescription or over-the-counter (OTC) medicines, vitamins/minerals, herbal products, and other supplements you are using. This will help them determine if Nucala is right for you.

In particular, make sure that you discuss any of the following.

Current and Past Health Conditions. Tell your healthcare provider if you have any of the following.

• A parasitic worm (helminth) infection
• A history of chickenpox or shingles

Corticosteroids. Tell your healthcare provider if you are taking corticosteroid medicines. These medicines could be taken by mouth, such as prednisone, or inhaled, such as fluticasone (Flovent and others) or budesonide (Pulmicort). Do not stop your corticosteroid medicines unless your healthcare provider tells you to. Stopping or lowering the dose of these medicines may cause some of your symptoms to come back.

Vaccines. Review your vaccine history with your healthcare provider before you start Nucala. Because of the chance of a shingles infection, your healthcare provider may recommend a shingles vaccine before starting Nucala.

Pregnancy. It is not known if or how Nucala could affect pregnancy or harm an unborn baby. Tell your healthcare provider if you are or plan to become pregnant.

Breastfeeding. It is not known if Nucala passes into breast milk. Tell your healthcare provider if you are breastfeeding or plan to breastfeed. Your healthcare provider will advise you if you should use Nucala while breastfeeding.

Dosage

Adults and Adolescents Aged 12 Years and Older: The recommended dosage of NUCALA in adults and adolescents aged 12 years and older is 100 mg administered once every 4 weeks by subcutaneous injection into the upper arm, thigh, or abdomen.

Pediatric Patients Aged 6 to 11 Years: The recommended dosage of NUCALA for injection in pediatric patients aged 6 to 11 years is 40 mg administered once every 4 weeks by subcutaneous injection into the upper arm, thigh, or abdomen.

Side Effects

Common side effects:

• headache;
• feeling tired;
• back pain; or
• pain, swelling, redness, burning, or itching where the medicine was injected.