Details for: CINQAIR
Company: TEVA CANADA LIMITED
| DIN | DIN name | Active Ingredient(s) | Strength | Dosage Form | Route of Administration |
|---|---|---|---|---|---|
| 02456419 | CINQAIR | RESLIZUMAB | 10 MG / ML | SOLUTION | INTRAVENOUS |
Summary Reports
Consumer Information
This information was provided by the drug’s manufacturer when this drug product was approved for sale in Canada. It is designed for consumers and care givers. It is a summary of information about the drug and will not tell you everything about the drug. Contact your doctor or pharmacist if you have any questions about the drug.
What the medication is used for
CINQAIR™ is a prescription medicine used in addition to other asthma medicines for adult patients with severe eosinophilic asthma, whose symptoms are not controlled with their current asthma medicines such as medium-to-high-dose inhaled corticosteroids (ICS).
Severe eosinophilic asthma is a type of asthma in which there is a presence of eosinophils (a type of white blood cells). When added to other medicines for asthma, CINQAIR™ reduces the frequency of asthma attacks.
CINQAIR™ is not used to treat other problems caused by eosinophils. CINQAIR™ is not used to treat a sudden breathing problem.
What it does
CINQAIR™ contains the active substance, reslizumab, a monoclonal antibody that blocks specific protein called interleukin-5. By blocking the action of interleukin-5, CINQAIR™ limits the production of more eosinophils from the bone marrow and lowers the number of eosinophils in the blood and lungs.
When it should not be used
You are allergic to reslizumab or any of the ingredients in CINQAIR™. Check with your doctor if this may apply to you.
What the medicinal ingredient is
Reslizumab
What the non-medicinal ingredients are
acetic acid, sodium acetate, sucrose, and water.
What dosage form it comes in
Single use vials of reslizumab (10 mg/mL) for intravenous administration.
Warnings and precautions
Serious allergic reactions (anaphylaxis) can happen right after you receive CINQAIR™ infusion. These reactions can be life-threatening. Allergic reactions sometimes do not happen right away. Your healthcare provider will watch you during and after you receive your CINQAIR™ infusion for any signs of reaction. Tell your healthcare provider right away if you have any of the following symptoms that may be associated with an allergic reaction: skin rash, redness, itching or swelling, fever, shivering, headache, trouble breathing, wheezing, changes in blood pressure, nausea, vomiting, and abdominal discomfort (see What are possible side effects from using CINQAIR™?)
To help avoid side effects and ensure proper use, talk to your healthcare professional before receiving CINQAIR™. Talk about any health conditions or problems you may have, including if you:
- are allergic to other medicines or have other allergies (such as food allergy or seasonal allergies).
- have had similar reactions to medications of this type (monoclonal antibodies) as they can cause severe allergic reactions when injected into the body (see What are possible side effects from using CINQAIR™?). Serious allergic reactions have occurred in patients receiving CINQAIR™.
- are taking oral or inhaled corticosteroid medicines. Do not suddenly stop taking your corticosteroids once you have started CINQAIR™. Corticosteroids must be stopped gradually, under the supervision of your doctor.
- have or have had a parasitic infection, live in a region where infections caused by parasites are common, or if you are travelling to such a region. It is important to talk to your doctor before using CINQAIR™, as CINQAIR™ may weaken your resistance to such infections. Parasitic infections should be treated prior to starting treatment with CINQAIR™.
- feel that your asthma symptoms get worse while receiving CINQAIR™ treatment.
- have recently received a vaccination or if you think you may need a vaccination.
- are receiving other medicines that affect your immune system.
- have any other medical conditions.
Pregnancy and breastfeeding
- If you are pregnant, think you may be pregnant, or are planning to have a baby, ask your doctor for advice before using this medicine. You should not use this medicine if you are pregnant, unless this is considered necessary by your doctor.
- If you become pregnant while being treated with CINQAIR™ or within 5 months of stopping treatment with CINQAIR™, tell your doctor immediately.
- It is not known if CINQAIR™ passes into your breast milk. If you are breastfeeding or plan to breastfeed, you must check with your doctor before being treated with CINQAIR™.
Other warnings you should know about:
CINQAIR™ should not be given to children and adolescents under 18 years old.
Interactions with this medication
Tell your healthcare professional about all the medicines you take, including any drugs, vitamins, minerals, natural supplements, or alternative medicines.
Know the medicines you take. Keep a list of your medicines with you to show to your healthcare provider and pharmacist when you get a new medicine.
You and your healthcare provider will discuss whether it is appropriate for you to receive CINQAIR™.
Proper use of this medication
- You will be given CINQAIR™ by a healthcare professional using a needle placed in a vein (intravenous infusion). It will take about 20 to 50 minutes to receive the full dose of CINQAIR™.
- You will receive additional doses of CINQAIR™ about every 4 weeks. It may take more than one dose before you see improvements in your asthma symptoms.
- Your healthcare provider will watch you closely while you are receiving CINQAIR™ and after your infusion for signs of a reaction.
- Your healthcare provider may have you continue to use other medicines that help treat your condition.
Usual dose
CINQAIR™ is for intravenous infusion only.
The recommended dosage regimen is 3 mg/kg every 4 weeks.
Missed Dose
- If you miss a scheduled dose of CINQAIR™, ask your healthcare provider when to schedule your next treatment.
Side effects and what to do about them
These are not all the possible side effects you may experience when taking CINQAIR™. If you experience any side effects not listed here, contact your healthcare professional.
Uncommon Side Effects (may affect up to 1 in 100 people):
Allergic or Infusion-related reactions
Serious allergic or infusion-related reactions can happen on the day of receiving CINQAIR™. Your healthcare provider will watch you closely while you are receiving CINQAIR™ and after your infusion for signs of a reaction. Tell your healthcare provider right away if you experience an allergic reaction or any of the following symptoms:
- skin rash, redness, itching, or swelling
- trouble breathing, wheezing
- fever, shivering
- changes in blood pressure
- headache
- nausea, vomiting, abdominal discomfort
Muscle Pain
If you have a troublesome symptom or side effect that is not listed here or becomes bad enough to interfere with your daily activities, talk to your healthcare professional.
How to store
Store vials of CINQAIR™ refrigerated at 2ºC to 8ºC. Do not freeze.
Vials should be protected from light and stored in the original package until time of use.
Keep out of reach and sight of children.
Reporting side effects
You can help improve the safe use of health products for Canadians by reporting serious and unexpected side effects to Health Canada. Your report may help to identify new side effects and change the product safety information.
3 ways to report:
- Online at MedEffect;
- By calling 1-866-234-2345 (toll-free);
- By completing a Patient Side Effect Reporting Form and sending it by:
- Fax toll-free to 1-866-678-6789, or
- Mail to: Canada Vigilance Program
Health Canada, Postal Locator 0701E
Ottawa, ON
K1A 0K9
NOTE: Contact your health professional if you need information about how to manage your side effects. The Canada Vigilance Program does not provide medical advice.
More information
- Talk to your healthcare professional Find the full product monograph that is prepared for healthcare professionals and includes this Patient Medication Information by visiting the Health Canada website; Teva Canada Innovation site at http://www.tevacanadainnovation.ca or by contacting the sponsor, Teva Canada Innovation at 1-855-514-8382 through the Teva Support Solutions™ program.
This leaflet was prepared by Teva Canada Innovation.
Last Revised: January 16, 2017
CINQAIR™ is a trademark of Cephalon Inc., a member of the Teva Group; used under license.