CINQAIR® is an anti-interleukin-5 approved as an add-on treatment for adults (18 years and older) with severe asthma and elevated eosinophil levels.1 CINQAIR® is not used to treat other problems caused by eosinophils or sudden breathing problems.

Want to learn more about CINQAIR®? See the Important Safety Information below, then click the appropriate button below to get started.

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What is the most important information I should know about CINQAIR® (reslizumab) Injection?

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 CINQAIR infusion 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
  • paleness
  • flushing
  • skin rash (hives)
  • itching
  • swelling of your face, lips, mouth, or tongue
  • symptoms of low blood pressure (fainting, dizziness, light headedness, confusion, fast heart beat)
  • 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 ingredients in 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 CINQAIR will harm your unborn baby. Tell your healthcare provider if you become pregnant during your treatment with CINQAIR.
  • are breastfeeding or plan to breastfeed. It is not known if CINQAIR 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.

Do not stop taking your other asthma medicines unless your healthcare provider tells you to.

What are the possible side effects of CINQAIR?

CINQAIR may cause serious side effects, including:

  • See “What is the most important information I should know about CINQAIR?”
  • abnormal growth of cells or tissue in your body that may or may not be cancer (malignancy)

The most common side effects of CINQAIR include throat pain.

These are not all the possible side effects of CINQAIR.

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Please see the accompanying Full Prescribing Information.

REFERENCE:

  1. CINQAIR Injection [prescribing information]. Frazer, PA: Teva Respiratory, LLC; 2016.

IMPORTANT SAFETY INFORMATION

WARNING: ANAPHYLAXIS

  • Anaphylaxis has been observed with CINQAIR infusion in 0.3% of patients in placebo-controlled clinical studies. Anaphylaxis was reported as early as the second dose of CINQAIR.
  • Anaphylaxis can be life-threatening. Patients should be observed for an appropriate period of time after CINQAIR administration by a healthcare professional prepared to manage anaphylaxis. Discontinue CINQAIR immediately if the patient experiences signs or symptoms of anaphylaxis.

INDICATIONS AND USAGE

CINQAIR is 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.

Limitations of Use: CINQAIR is not indicated for:

  • treatment of other eosinophilic conditions
  • relief of acute bronchospasm or status asthmaticus
  • CINQAIR is contraindicated in patients who have known hypersensitivity to reslizumab or any of its excipients.
  • In placebo-controlled clinical studies, 6/1028 (0.6%) patients receiving 3 mg/kg CINQAIR had at least 1 malignant neoplasm reported compared to 2/730 (0.3%) patients in the placebo group.
  • No clinical studies have been conducted to assess reduction of maintenance corticosteroid dosages following administration of CINQAIR. Do not discontinue systemic or inhaled corticosteroids abruptly upon initiation of therapy with CINQAIR. Reductions in corticosteroid dose, if appropriate, should be gradual and performed under the supervision of a physician. Reduction in corticosteroid dose may be associated with systemic withdrawal symptoms and/or unmask conditions previously suppressed by systemic corticosteroid therapy.
  • Eosinophils may be involved in the immunological response to some parasitic (helminth) infections. Treat patients with pre-existing helminth infections before initiating CINQAIR. If patients become infected while receiving treatment with CINQAIR and do not respond to anti-helminth treatment, discontinue treatment with CINQAIR until infection resolves.
  • Adverse reactions that occurred at greater than or equal to 2% incidence and more commonly than in the placebo group included 1 event: oropharyngeal pain (2.6% vs. 2.2%).

Please see accompanying Full Prescribing Information, including Boxed WARNING.

What is the most important information I should know about CINQAIR® (reslizumab) Injection?

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 CINQAIR infusion 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
  • paleness
  • flushing
  • skin rash (hives)
  • itching
  • swelling of your face, lips, mouth, or tongue
  • symptoms of low blood pressure (fainting, dizziness, light headedness, confusion, fast heart beat)
  • 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 ingredients in 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 CINQAIR will harm your unborn baby. Tell your healthcare provider if you become pregnant during your treatment with CINQAIR.
  • are breastfeeding or plan to breastfeed. It is not known if CINQAIR 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.

Do not stop taking your other asthma medicines unless your healthcare provider tells you to.

What are the possible side effects of CINQAIR?

CINQAIR may cause serious side effects, including:

  • See “What is the most important information I should know about CINQAIR?”
  • abnormal growth of cells or tissue in your body that may or may not be cancer (malignancy)

The most common side effects of CINQAIR include throat pain.

These are not all the possible side effects of CINQAIR.

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Please see the accompanying Full Prescribing Information.

REFERENCE:

  1. CINQAIR Injection [prescribing information]. Frazer, PA: Teva Respiratory, LLC; 2016.

IMPORTANT SAFETY INFORMATION

WARNING: ANAPHYLAXIS

  • Anaphylaxis has been observed with CINQAIR infusion in 0.3% of patients in placebo-controlled clinical studies. Anaphylaxis was reported as early as the second dose of CINQAIR.
  • Anaphylaxis can be life-threatening. Patients should be observed for an appropriate period of time after CINQAIR administration by a healthcare professional prepared to manage anaphylaxis. Discontinue CINQAIR immediately if the patient experiences signs or symptoms of anaphylaxis.

INDICATIONS AND USAGE

CINQAIR is 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.

Limitations of Use: CINQAIR is not indicated for:

  • treatment of other eosinophilic conditions
  • relief of acute bronchospasm or status asthmaticus
  • CINQAIR is contraindicated in patients who have known hypersensitivity to reslizumab or any of its excipients.
  • In placebo-controlled clinical studies, 6/1028 (0.6%) patients receiving 3 mg/kg CINQAIR had at least 1 malignant neoplasm reported compared to 2/730 (0.3%) patients in the placebo group.
  • No clinical studies have been conducted to assess reduction of maintenance corticosteroid dosages following administration of CINQAIR. Do not discontinue systemic or inhaled corticosteroids abruptly upon initiation of therapy with CINQAIR. Reductions in corticosteroid dose, if appropriate, should be gradual and performed under the supervision of a physician. Reduction in corticosteroid dose may be associated with systemic withdrawal symptoms and/or unmask conditions previously suppressed by systemic corticosteroid therapy.
  • Eosinophils may be involved in the immunological response to some parasitic (helminth) infections. Treat patients with pre-existing helminth infections before initiating CINQAIR. If patients become infected while receiving treatment with CINQAIR and do not respond to anti-helminth treatment, discontinue treatment with CINQAIR until infection resolves.
  • Adverse reactions that occurred at greater than or equal to 2% incidence and more commonly than in the placebo group included 1 event: oropharyngeal pain (2.6% vs. 2.2%).

Please see accompanying Full Prescribing Information, including Boxed WARNING.