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Details for: CINQAIR

Company: TEVA CANADA LIMITED

DIN DIN name Active Ingredient(s) Strength Dosage Form Route of Administration
02456419CINQAIRRESLIZUMAB10 MG / MLSOLUTIONINTRAVENOUS
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Summary Reports

Summary Basis of Decision
Regulatory Decision Summary

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.

In case of drug overdose, contact your healthcare professional, hospital emergency department, or regional Poison Control Centre immediately, even if there are no symptoms.

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
    Postage paid labels and the Patient Side Effect Reporting Form are available at MedEffect.

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.

Date modified: