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Biologics in Asthma – The Basics

In clinical practice, I don’t see biologics in asthma very often, but it is something that I think is important to remember. The most commonly used agent over the years that I have seen is omalizumab (Xolair).

According to the GINA guidelines, patients that have difficult to treat asthma and have been diagnosed with Type 2 airway inflammation may need a Type 2 biologic added to their current therapy. Eligible patients include those experiencing exacerbations or poor symptom control while on high-dose ICS-LABA who have eosinophilic biomarkers, allergic biomarkers, or need maintenance OCS. There are currently five biologics that are FDA approved to treat asthma. Here’s a list of those common biologics in asthma.

Xolair (omalizumab) is an anti-IgE monoclonal antibody. It is indicated for severe asthma in patients 6 years and older who have a positive skin test to a perennial aeroallergen. This medication is given once or twice a month. It comes in two forms: prefilled syringes and vials. The vial comes as a powder that needs to be reconstituted and should only be administered by a healthcare professional The prefilled syringe caps contain a natural rubber latex and should not be handled by individuals who are allergic. This medication is a clear solution that must be kept in the fridge but taken out 15-30 minutes before use. Keep the syringe in the box until ready to inject to protect it from light. Pinch the skin before injecting to make sure the needle reaches under the skin but doesn’t go into the muscle. The needle should be angled between 45 degrees and 90 degrees. Adverse effects include local injection site reactions, headaches, peripheral edema, and arthralgia. Cerebrovascular events of transient ischemic attack and ischemic stroke have been reported. Use with caution in patients at increased risk. Hypersensitivity/anaphylactoid reactions have been reported. 60% to 70% of these cases occurred within the first 3 doses. Patients with a history of anaphylaxis to foods, medications, or other causes are at an increased risk. An epinephrine autoinjector should be prescribed to all patients on this medication.

Nucala (mepolizumab) is an interleukin-5 antagonist monoclonal antibody. It is indicated for severe asthma in patients 6 years and older with an eosinophilic phenotype. Nucala is given once a month and comes as an auto-injector, prefilled syringe, and vial. The autoinjector and prefilled syringe are the only forms available to be used at home for ages 12 and older. It must be stored in the fridge and taken out 30 minutes before use. Inject at a 90-degree angle by pushing the autoinjector all the way down against the skin. After pressing down, there should be one click to signify the injection has started. A yellow plunger will start to move into the inspection window. Continue to hold the autoinjector down until there is a second click and the inspection window is filled with a yellow indicator. This means the injection is done. Adverse reactions include local injection site reactions, fatigue, arthralgia, oropharyngeal pain, and back pain. Hypersensitivity reactions may occur. These typically are seen hours after administration but can happen days later.

Fasenra (benralizumab) is an interleukin-5 receptor antagonist monoclonal antibody. It is indicated for severe asthma in patients 12 years and older with an eosinophilic phenotype. The first three doses are given every 4 weeks, and then once every 8 weeks. It comes as an auto-injector and a prefilled syringe. It must be kept in the fridge until 30 minutes prior to giving the injection. When giving the injection you can pinch at the injection site or give the injection without pinching. The pen should be placed at a 90-degree angle and pressed down firmly. An initial click will indicate the injection has started and a second click occurs when the injection is done. A green plunger will move into the viewing window as the medication is being given. After the second click, it should fill the whole window. Adverse effects include headaches, pharyngitis, anaphylaxis, and angioedema. Do not abruptly discontinue corticosteroids when initiating this medication. Reductions should be gradual as withdrawal symptoms can occur.

Dupixent (dupilumab) is an interleukin-4 receptor antagonist monoclonal antibody. It is indicated for severe asthma with eosinophilic phenotype in patients 12 years and older. The medication requires a loading dose and is given every other week. It comes in a prefilled syringe or autoinjector. It needs to be stored in the fridge and taken out 30 minutes before use. Place the pen at a 90-degree angle, then press it down firmly against the skin to start the injection. A click will indicate the injection has started and a plunger will start to enter the window. A second click will indicate the injection is finished and the plunger should fill the window completely. Adverse effects include local injection site reaction, conjunctivitis, herpes simplex infection, and arthralgia. In rare cases, patients may develop serious systemic eosinophilia.

All the biologics approved for use at home have the same injection site. They can be injected into the thigh or abdomen two inches away from the belly button. The outer upper area of the arm can be used as an injection site if someone else is giving it to the patient. Avoid injecting into scar tissue, bruises, breaks in the skin, and tender skin. If injecting more than one injection is needed, make sure the second injection is at least 2 inches away from the first.

Cinqair (reslizumab) is an interleukin-5 antagonist monoclonal antibody indicated for severe asthma in patients 18 years and older with an eosinophilic phenotype. It is available as an intravenous infusion given every four weeks. The solution must be kept in the fridge and diluted into 0.9% NS. The diluted solution should be at room temperature before administration. Infusion time is from 20-50 minutes depending on the total volume infused. Adverse effects include an increased creatine kinase level, myalgia, pain in the throat, anaphylaxis, and cancer.

Which biologics have you seen used in asthma?

This article was written by Madison Bonn PharmD Candidate in collaboration with Eric Christianson, PharmD, BCPS, BCGP

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