Q: What is Fasenra used for?

Fasenra is used to treat severe eosinophilic asthma .

Q: How does Fasenra work?

Targeting Eosinophils Fasenra belongs to a class of medications known as monoclonal antibodies. It is specifically designed to target eosinophils, which are a type of white blood cell. While these cells are a normal part of the immune system, having too many of them can cause the airways to become inflamed and swollen, making it difficult to breathe. How It Works in the Body The medication works by identifying and helping the body remove excess eosinophils through the following steps: Binding: Fasenra attaches to a specific protein called the interleukin-5 (IL-5) receptor alpha, which is located on the surface of eosinophils. Immune Activation: By binding to this receptor, the drug attracts natural killer cells, a type of immune cell that destroys targeted cells. Depletion: This process leads to a rapid and near-total reduction of eosinophils in the blood and the lungs. By reducing the number of these inflammatory cells, Fasenra helps to decrease airway swelling and mucus production. This helps prevent severe asthma attacks and improves overall lung function over time. It does not work immediately and is not intended to replace a rescue inhaler for sudden symptoms.

Q: What are the active ingredients in Fasenra?

The active ingredient in Fasenra is benralizumab .

Q: What are the side effects of Fasenra?

Common side effects of Fasenra may include: headache sore throat injection site reactions Always consult with a healthcare professional about potential side effects.

Q: What is the dosage of Fasenra and how do I take it?

Administration Fasenra is administered as a subcutaneous injection, which is an injection into the fatty tissue just under the skin. Common injection sites include the abdomen, thigh, or the outer area of the upper arm. The medication may be given by a healthcare professional in a medical office. It is also available in forms that allow for self-administration by a patient or caregiver at home, provided they have received instruction and training on the correct technique from a healthcare provider. Dosing Pattern The treatment typically starts with an initial phase where doses are given more frequently. Once this phase is complete, the medication is moved to a maintenance schedule where doses are spaced further apart. Preparation Before use, the medication should be taken out of the refrigerator and allowed to reach room temperature naturally. The liquid should not be shaken. The solution should be inspected for particles or discoloration before administration. It should generally appear clear to opalescent and colorless to slightly yellow. Each prefilled syringe or autoinjector is for a single use only. Missed Dose If a dose is missed, it should be administered as soon as possible. Afterward, the regular dosing schedule should be resumed as directed by a healthcare provider.

Q: Is Fasenra safe during pregnancy and breastfeeding?

Pregnancy There are no adequate and well-controlled studies of Fasenra in pregnant women. While animal studies in monkeys did not show evidence of harm to the fetus, human data are insufficient to confirm safety. Monoclonal antibodies like Fasenra are known to cross the placenta, particularly during the second and third trimesters, which could potentially affect the fetus. It is important to manage asthma effectively during pregnancy, as poorly controlled asthma can increase the risk of complications for both the mother and the baby, such as preeclampsia and low birth weight. Patients are encouraged to discuss their treatment plan with their doctor if they are pregnant or planning to become pregnant. Breastfeeding It is currently unknown if Fasenra is excreted in human breast milk. Although many antibodies are present in milk, the effects on a nursing infant are not well understood. The decision to breastfeed while using Fasenra should involve a discussion with a healthcare provider to consider the health benefits of breastfeeding alongside the mother's clinical need for the medication.

Q: What forms and strengths does Fasenra come in?

Available Forms Fasenra is supplied as a sterile, preservative-free liquid solution for injection. It is available in the following formats: Single-dose prefilled syringe: A syringe containing the medication for injection under the skin. Single-dose autoinjector: A device, also known as the Fasenra Pen, designed for subcutaneous administration. The medication is a clear to opalescent, colorless to slightly yellow liquid intended for subcutaneous use only.

Q: What is the FDA approval status of Fasenra?

FDA Approval History The U.S. Food and Drug Administration (FDA) first approved Fasenra in November 2017. It was initially authorized as an add-on maintenance treatment for patients aged 12 years and older with severe asthma who have an eosinophilic phenotype. In April 2024, the FDA expanded this approval to include children aged 6 to 11 years with the same condition. In September 2024, the FDA granted further approval for Fasenra to treat adults with eosinophilic granulomatosis with polyangiitis (EGPA), a rare autoimmune condition characterized by inflammation of small and medium-sized blood vessels. Regulatory Status and Safety Fasenra is classified as a biologic drug and is available only by prescription. It is not intended for the treatment of other eosinophilic conditions or for the relief of acute breathing emergencies, such as acute bronchospasm or status asthmaticus. There are currently no boxed warnings or Risk Evaluation and Mitigation Strategies (REMS) required for this medication. However, the FDA has monitored and updated labeling regarding potential serious risks, including: Hypersensitivity Reactions: Serious allergic reactions, including anaphylaxis, have been reported. These reactions can occur within hours of administration or may have a delayed onset of several days. Helminth Infection: Because eosinophils are involved in the body's response to parasite infections, patients with pre-existing helminth infections should be treated for the infection before starting Fasenra. The FDA continues to monitor the safety profile of Fasenra through the FDA Adverse Event Reporting System (FAERS). In 2019, the FDA identified a potential signal of serious risk for hypersensitivity, which resulted in updated safety information in the drug's labeling.

Question 1

What is Fasenra?

Accepted Answer

Fasenra is a humanized monoclonal antibody that works by binding to the interleukin-5 receptor on the surface of certain white blood cells. By targeting these receptors, the medication helps to decrease the levels of eosinophils in the body.

Eosinophils are a type of white blood cell that can contribute to inflammation when present in high amounts. This medication is classified as an interleukin-5 receptor antagonist.

Question 2

What is Fasenra used for?

Accepted Answer

Fasenra is used to treat severe eosinophilic asthma.

Question 3

How does Fasenra work?

Accepted Answer

Targeting Eosinophils

Fasenra belongs to a class of medications known as monoclonal antibodies. It is specifically designed to target eosinophils, which are a type of white blood cell. While these cells are a normal part of the immune system, having too many of them can cause the airways to become inflamed and swollen, making it difficult to breathe.

How It Works in the Body

The medication works by identifying and helping the body remove excess eosinophils through the following steps:

Binding: Fasenra attaches to a specific protein called the interleukin-5 (IL-5) receptor alpha, which is located on the surface of eosinophils.
Immune Activation: By binding to this receptor, the drug attracts natural killer cells, a type of immune cell that destroys targeted cells.
Depletion: This process leads to a rapid and near-total reduction of eosinophils in the blood and the lungs.

By reducing the number of these inflammatory cells, Fasenra helps to decrease airway swelling and mucus production. This helps prevent severe asthma attacks and improves overall lung function over time. It does not work immediately and is not intended to replace a rescue inhaler for sudden symptoms.

Question 4

What are the active ingredients in Fasenra?

Accepted Answer

The active ingredient in Fasenra is benralizumab.

Question 5

What are the side effects of Fasenra?

Accepted Answer

Common side effects of Fasenra may include:

headache
sore throat
injection site reactions

Always consult with a healthcare professional about potential side effects.

Question 6

What drug class is Fasenra?

Accepted Answer

Fasenra belongs to the monoclonal antibody for eosinophilic asthma drug class.

Question 7

What is the dosage of Fasenra and how do I take it?

Accepted Answer

Administration

Fasenra is administered as a subcutaneous injection, which is an injection into the fatty tissue just under the skin. Common injection sites include the abdomen, thigh, or the outer area of the upper arm.

The medication may be given by a healthcare professional in a medical office. It is also available in forms that allow for self-administration by a patient or caregiver at home, provided they have received instruction and training on the correct technique from a healthcare provider.

Dosing Pattern

The treatment typically starts with an initial phase where doses are given more frequently. Once this phase is complete, the medication is moved to a maintenance schedule where doses are spaced further apart.

Preparation

Before use, the medication should be taken out of the refrigerator and allowed to reach room temperature naturally.
The liquid should not be shaken.
The solution should be inspected for particles or discoloration before administration. It should generally appear clear to opalescent and colorless to slightly yellow.
Each prefilled syringe or autoinjector is for a single use only.

Missed Dose

If a dose is missed, it should be administered as soon as possible. Afterward, the regular dosing schedule should be resumed as directed by a healthcare provider.

Question 8

Is Fasenra safe during pregnancy and breastfeeding?

Accepted Answer

Pregnancy

There are no adequate and well-controlled studies of Fasenra in pregnant women. While animal studies in monkeys did not show evidence of harm to the fetus, human data are insufficient to confirm safety. Monoclonal antibodies like Fasenra are known to cross the placenta, particularly during the second and third trimesters, which could potentially affect the fetus.

It is important to manage asthma effectively during pregnancy, as poorly controlled asthma can increase the risk of complications for both the mother and the baby, such as preeclampsia and low birth weight. Patients are encouraged to discuss their treatment plan with their doctor if they are pregnant or planning to become pregnant.

Breastfeeding

It is currently unknown if Fasenra is excreted in human breast milk. Although many antibodies are present in milk, the effects on a nursing infant are not well understood. The decision to breastfeed while using Fasenra should involve a discussion with a healthcare provider to consider the health benefits of breastfeeding alongside the mother's clinical need for the medication.

Question 9

What forms and strengths does Fasenra come in?

Accepted Answer

Available Forms

Fasenra is supplied as a sterile, preservative-free liquid solution for injection. It is available in the following formats:

Single-dose prefilled syringe: A syringe containing the medication for injection under the skin.
Single-dose autoinjector: A device, also known as the Fasenra Pen, designed for subcutaneous administration.

The medication is a clear to opalescent, colorless to slightly yellow liquid intended for subcutaneous use only.

Question 10

What is the FDA approval status of Fasenra?

Accepted Answer

FDA Approval History

The U.S. Food and Drug Administration (FDA) first approved Fasenra in November 2017. It was initially authorized as an add-on maintenance treatment for patients aged 12 years and older with severe asthma who have an eosinophilic phenotype. In April 2024, the FDA expanded this approval to include children aged 6 to 11 years with the same condition.

In September 2024, the FDA granted further approval for Fasenra to treat adults with eosinophilic granulomatosis with polyangiitis (EGPA), a rare autoimmune condition characterized by inflammation of small and medium-sized blood vessels.

Regulatory Status and Safety

Fasenra is classified as a biologic drug and is available only by prescription. It is not intended for the treatment of other eosinophilic conditions or for the relief of acute breathing emergencies, such as acute bronchospasm or status asthmaticus.

There are currently no boxed warnings or Risk Evaluation and Mitigation Strategies (REMS) required for this medication. However, the FDA has monitored and updated labeling regarding potential serious risks, including:

Hypersensitivity Reactions: Serious allergic reactions, including anaphylaxis, have been reported. These reactions can occur within hours of administration or may have a delayed onset of several days.
Helminth Infection: Because eosinophils are involved in the body's response to parasite infections, patients with pre-existing helminth infections should be treated for the infection before starting Fasenra.

The FDA continues to monitor the safety profile of Fasenra through the FDA Adverse Event Reporting System (FAERS). In 2019, the FDA identified a potential signal of serious risk for hypersensitivity, which resulted in updated safety information in the drug's labeling.

Question 11

What should I know about Fasenra and cost?

Accepted Answer

Insurance and Coverage

Fasenra is a biologic medication, and its cost is primarily determined by your insurance provider. Coverage can vary significantly between private insurance, Medicare, and Medicaid. Your out-of-pocket expenses will depend on your plan's specific deductibles and co-pay structures.

Administration and Pharmacy Factors

Several logistical factors can influence the final price of the medication:

Administration Site: Costs may vary depending on whether the injection is given by a healthcare professional in a clinical setting or self-administered at home.
Specialty Pharmacy: Because it is a complex biologic, Fasenra is typically dispensed through specialty pharmacies rather than standard retail locations.

Financial Assistance Programs

Support options are often available to help patients manage the cost of treatment:

Co-pay Savings: Patients with commercial insurance may be eligible for programs that lower their monthly out-of-pocket costs.
Patient Assistance: For those without insurance or with limited financial means, manufacturer programs may provide the medication at a reduced cost or for free.

Fasenra

📋Overview

How It Works

Uses

Active Ingredients

Common Side Effects

Warnings & Precautions

Dosage

Pregnancy & Breastfeeding

Frequently Asked Questions

📚References

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