Cinqair is a monoclonal antibody that affects the actions of the body's immune system. Reslizumab works by reducing levels of a certain type of white blood cell that may contribute to the symptoms of asthma.

Cinqair is a prescription medicin eused together with other medicines to help control severe asthma.

Cinqair is used in people aged 18 years of age and older whose asthma is not controlled by their current asthma medicines.

Some people have had allergic reactions to Cinqair during or shortly after the injection. Tell your caregiver if you feel nauseated, light-headed, itchy, or have swelling in your face or trouble breathing.

You will be watched closely after receiving Cinqair, to make sure you do not have an allergic reaction.

Before taking this medicine

You should not be treated with Cinqair if you are allergic to reslizumab.

To make sure Cinqair is safe for you, tell your doctor if:

• you also use steroid asthma medication; or

• you have ever had a parasite infection (such as roundworms or tapeworms).

Using Cinqair may increase your risk of developing cancer. Ask your doctor about this risk.

Tell your doctor if you are pregnant. It is not known whether reslizumab will harm an unborn baby. However, having uncontrolled asthma during pregnancy may cause premature birth, a low birth weight baby, or complications such as eclampsia (dangerously high blood pressure that can lead to medical problems in both mother and baby). The benefit of treating asthma may outweigh any risks to the baby.

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

Cinqair is given as an infusion into a vein, usually once every 4 weeks. A healthcare provider will give you this injection.

This medicine must be given slowly, and the infusion can take 20 to 50 minutes to complete.

You will be watched closely for a short time after each injection, to make sure you do not have an allergic reaction.

If you also use a steroid medication, you should not stop using it suddenly. Follow your doctor's instructions about tapering your dose.

Before you start treatment with Cinqair, your doctor may perform tests to measure your white blood cells.

Cinqair is not a rescue medicine for asthma attacks. Seek medical attention if your breathing problems get worse quickly, or if you think your asthma medications are not working as well.

Use all asthma medications as directed. Your dose needs may change due to surgery, illness, stress, or a recent asthma attack. Do not change your dose or dosing schedule without your doctor's advice. Tell your doctor if any of your medicines seem to stop working.

Usual Adult Dose for Asthma:

3 mg/kg IV over 20 to 50 minutes every 4 weeks

Comments:
-Do not administer as an IV push or bolus.
-The infusion should be discontinued immediately if the patient experiences a severe systemic reaction, including anaphylaxis.

Use: For the add-on maintenance treatment of patients with severe asthma with an eosinophilic phenotype

You should not be treated with Cinqair if you are allergic to reslizumab.

To make sure Cinqair is safe for you, tell your doctor if:

• you also use steroid asthma medication; or

• you have ever had a parasite infection (such as roundworms or tapeworms).

Using Cinqair may increase your risk of developing cancer. Ask your doctor about this risk.

Tell your doctor if you are pregnant. It is not known whether reslizumab will harm an unborn baby. However, having uncontrolled asthma during pregnancy may cause premature birth, a low birth weight baby, or complications such as eclampsia (dangerously high blood pressure that can lead to medical problems in both mother and baby). The benefit of treating asthma may outweigh any risks to the baby.

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

Call your doctor for instructions if you miss an appointment for your Cinqair injection.

Since this medicine is given by a healthcare professional in a medical setting, an overdose is unlikely to occur.

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

Get emergency medical help if you have signs of an allergic reaction to Cinqair: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Some side effects may occur during or shortly after the injection. Tell your caregiver if you feel dizzy, nauseated, light-headed, itchy, short of breath, or if you have swelling in your face.

Common Cinqair side effects may include:

• sore throat; or

• muscle pain.

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.

Other drugs may interact with reslizumab, 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.