Generic Name: reslizumab
Date of Approval: March 23, 2016
Company: Teva Pharmaceutical Industries Ltd.
Treatment for: Severe Asthma
FDA Approves Cinqair
The U.S. Food and Drug Administration (FDA) has approved Cinqair (reslizumab) Injection, an interleukin 5 antagonist monoclonal antibody (IgG4 kappa) indicated for add-on maintenance treatment of patients with severe asthma aged 18 years and older, and with an eosinophilic phenotype.
Read this Patient Information before you start treatment, and each time you receive treatment. There may be new information. This information does not take the place of talking with your healthcare provider about your medical condition or treatment.
Cinqair can cause serious side effects, including:
Serious allergic reactions (anaphylaxis). Serious allergic reactions can happen right after you receive your Cinqair infusion. These reactions can cause death. Allergic reactions sometimes do not happen right away. Your healthcare provider will watch you during and after you receive your treatment for any signs of a reaction. Tell your healthcare provider right away if you have any of the following symptoms that may be associated with an allergic reaction:
- breathing problems
- symptoms of low blood pressure (fainting, dizziness, light headedness, confusion, fast heart beat)
- skin rash (hives)
- swelling of your face, lips, mouth, or tongue
- nausea or abdominal discomfort
What is Cinqair?
Cinqair is a prescription medicine used with other asthma medicines for the maintenance treatment of asthma in people aged 18 years of age and older whose asthma is not controlled with the current asthma medicines. When added to other medicines for asthma, Cinqair helps prevent severe asthma attacks (exacerbations) and can improve your breathing.
Medicines such as Cinqair reduce blood eosinophils. Eosinophils are a type of white blood cell that may contribute to your asthma.
- Cinqair is not used to treat other problems caused by eosinophils.
- Cinqair is not used to treat sudden breathing problems.
It is not known if Cinqair is safe and effective in children less than 18 years of age.
Do not receive Cinqair if you are allergic to reslizumab or any of the other ingredients. See the end of this leaflet for a complete list of ingredients.
Before receiving Cinqair
Before receiving Cinqair, tell your healthcare provider about all of your medical conditions, including if you:
- are taking oral or inhaled corticosteroid medicines. Do not stop taking your corticosteroid unless your healthcare provider tells you to stop. This may cause other symptoms that were controlled by the corticosteroid medicine to come back.
- have or have had cancer (malignancy).
- have a parasitic (helminth) infection.
- are pregnant or plan to become pregnant. It is not known if this medicine will harm your unborn baby. Tell your healthcare provider if you become pregnant during treatment.
- are breastfeeding or plan to breastfeed. It is not known if this medicine passes into your breast milk. You and your healthcare provider should decide if you will receive Cinqair and breastfeed. Talk to your healthcare provider about the best way to feed your baby if you receive Cinqair.
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 your healthcare provider tells you to.
How will I receive Cinqair?
- You will be given Cinqair by a healthcare provider using a needle placed in a vein (intravenous infusion) one time every four weeks. It will take about 20 to 50 minutes to receive the full dose of Cinqair.
Cinqair side effects
Cinqair may cause serious side effects, including:
- See Important information.
- abnormal growth of cells or tissue in your body that may or may not be cancer (malignancy)
The most common side effects include throat pain.
These are not all the possible side effects. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
General information about the safe and effective use of Cinqair.
Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. Do not use this medicine for a condition for which it was not prescribed. You can ask your pharmacist or healthcare provider for information that is written for healthcare professionals.
What are the ingredients in Cinqair?
Active ingredient: reslizumab
Inactive ingredients: sodium acetate, acetic acid, sucrose