Reslizumab

Reslizumab is a prescription medication given with other asthma medications for the maintenance treatment of severe asthma in patients aged 18 years and older. 

It belongs to a group of drugs called interleukin blocker monoclonal antibodies. Reslizumab reduces severe asthma attacks by reducing the levels of a certain type of white blood cells (eosinophils) that are involved with the development of asthma.

It is available as an injection and is administered into the vein by a healthcare provider every 4 weeks. 

The most common side effect is throat pain. 

Before using reslizumab, tell your healthcare provider if you are breastfeeding or plan to breastfeed. It is not known if this medicine passes into your breast milk.

Before you start treatment with reslizumab, your doctor may perform tests to measure your levels of a certain type of white blood cell (eosinophils).

Reslizumab is given once every 4 weeks and is injected into a vein through an IV. A healthcare provider will give you this injection.

Reslizumab must be given slowly. The IV infusion can take up to 50 minutes to complete.

Some people have had allergic reactions to reslizumab during or shortly after injection. Tell your caregiver right away if you feel nauseated or if you have itching, swelling in your lips, or trouble breathing.

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

Reslizumab is not a rescue medicine. It will not work fast enough to treat an asthma attack. Use only a fast acting inhalation medicine for an asthma attack.

If you also use a steroid medication, do not stop using it suddenly or you may have unpleasant withdrawal symptoms. Talk with your doctor about tapering your steroid dose before stopping completely.

Asthma is often treated with a combination of drugs. Use all medications as directed by your doctor. Read the medication guide or patient instructions provided with each medication. Do not change your doses or medication schedule without your doctor's advice. Tell your doctor if it seems like your asthma medications don't work as well.

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

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

Reslizumab 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.

Reslizumab is used together with other medicines to help control severe asthma in adults.

Reslizumab may also be used for purposes not listed in this medication guide.

Some people have had allergic reactions to reslizumab during or shortly after the injection. Tell your caregiver right away if you feel nauseated or if you have itching, swelling in your lips, or trouble breathing.

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

Asthma

Adjunctive maintenance therapy in patients with severe eosinophilic asthma.1 2 3 4

Reduces asthma exacerbation rate and improves FEV1 from baseline.1 2 3 4

Eosinophilic phenotype (i.e., eosinophilic asthma) generally characterized by blood and sputum eosinophilia, eosinophilic inflammation, recurrent asthma exacerbations, and, frequently, responsiveness to corticosteroids.6 8 9 10

Not indicated for treatment of other eosinophilic conditions.1

Not indicated for relief of acute bronchospasm or status asthmaticus.1

All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:

• Throat pain.

These are not all of the side effects that may occur. If you have questions about side effects, call your doctor. Call your doctor for medical advice about side effects.

You may report side effects to the FDA at 1-800-FDA-1088. You may also report side effects at http://www.fda.gov/medwatch.

Excipient information presented when available (limited, particularly for generics); consult specific product labeling.

Solution, Intravenous [preservative free]:

Cinqair: 100 mg/10 mL (10 mL) [contains mouse (murine) and/or hamster protein]

Store intact vials in refrigerator at 2°C to 8°C (36°F to 46°F). Do not freeze or shake. Protect from light; store in original package. After dilution in NS in infusion bag, administer immediately or store in a refrigerator at 2°C to 8°C (36°F to 46°F) or at room temperature up to 25°C (77°F), protected from light, for up to 16 hours.

Concerns related to adverse effects:

• Anaphylaxis [US Boxed Warning]: Anaphylaxis was reported in 0.3% of asthma patients in placebo-controlled studies; these events were observed during or within 20 minutes after completion of infusion, and may occur as early as the second dose. Observe patients for an appropriate period of time after administration. Manifestations included dyspnea, decreased oxygen saturation, wheezing, vomiting, skin and mucosal involvement, including urticaria. If severe systemic reactions, including anaphylaxis occur, discontinue administration immediately and provide appropriate medical treatment.

• Malignancies: Malignancies were observed during clinical trials with the majority being diagnosed within less than 6 months of drug exposure; neoplasms observed were diverse with no predominant histologic type.

Disease-related concerns:

• Asthma: Not indicated for the treatment of acute asthma symptoms (eg, acute bronchospasm) or acute exacerbations, including status asthmaticus. Appropriate rescue medication should be available. Patients who experience continued uncontrolled asthma or worsening of symptoms following treatment initiation with reslizumab should seek medical attention.

• Helminth infections: It is unknown if administration of reslizumab will influence a patient's immune response against parasitic infections. Therefore, patients with preexisting helminth infections should undergo treatment of the infection prior to initiation of reslizumab therapy. Patients who become infected during reslizumab treatment and do not respond to anti-helminth therapy should discontinue reslizumab until the infection resolves.

Concurrent drug therapy issues:

• Corticosteroids: Do not discontinue systemic or inhaled corticosteroids abruptly upon initiation of reslizumab. Reductions in corticosteroid dose should be gradual, if appropriate. Clinicians should note that a reduction in corticosteroid dose may be associated with withdrawal symptoms and/or unmask conditions previously suppressed by systemic corticosteroid therapy.

Other warnings/precautions:

• Limitation of use: Eosinophilic conditions: Reslizumab is not indicated for the treatment of other eosinophilic conditions.

• Discuss specific use of drug and side effects with patient as it relates to treatment. (HCAHPS: During this hospital stay, were you given any medicine that you had not taken before? Before giving you any new medicine, how often did hospital staff tell you what the medicine was for? How often did hospital staff describe possible side effects in a way you could understand?)

• Patient may experience throat pain. Have patient report immediately to prescriber signs of infusion reaction, shortness of breath, nausea, vomiting, dizziness, passing out, flushing, pale skin, confusion, or tachycardia (HCAHPS).

• Educate patient about signs of a significant reaction (eg, wheezing; chest tightness; fever; itching; bad cough; blue skin color; seizures; or swelling of face, lips, tongue, or throat). Note: This is not a comprehensive list of all side effects. Patient should consult prescriber for additional questions.

Intended Use and Disclaimer: Should not be printed and given to patients. This information is intended to serve as a concise initial reference for health care professionals to use when discussing medications with a patient. You must ultimately rely on your own discretion, experience, and judgment in diagnosing, treating, and advising patients.

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

Data not available

Administration advice:
-This drug is for IV use only. Do not administer as an IV push or bolus.
-This drug should be administered in a healthcare setting by a healthcare professional prepared to manage anaphylaxis.
-If refrigerated prior to administration, allow the diluted solution to reach room temperature before use.
-Use an infusion set with an in-line, low protein-binding filter (pore size of 0.2 micron). This drug is compatible with polyethersulfone (PES), polyvinylidene fluoride (PVDF), nylon, and cellulose acetate in-line infusion filters.
-The infusion time may vary depending on the total volume to be infused as based upon patient weight.
-Do not infuse this drug concomitantly in the same IV line with other agents. No physical or biochemical compatibility studies have been conducted to evaluate the coadministration of this drug with other agents.
-Observe the patient over the infusion and for an appropriate period of time following infusion.

Storage requirements:
-Consult the manufacturer product information.

Reconstitution/preparation techniques:
-Consult the manufacturer product information.

IV compatibility:
-Consult the manufacturer product information.

General:
-This drug is indicated for treatment of asthma of the eosinophilic phenotype but not for other eosinophilic conditions.
-This drug is not indicated for the relief of acute bronchospasm or status asthmaticus.