Nucala

Indications for Use

Nucala is a prescription medicine used to manage several chronic conditions that involve high levels of eosinophils, a type of white blood cell that can cause inflammation when too many are present. It is used as an add-on treatment, meaning it is taken alongside other medications to improve symptom control.

Severe Asthma

Nucala is used for the long-term treatment of severe asthma in adults and children aged 6 years and older. It is specifically for patients with an eosinophilic phenotype, where high eosinophil levels contribute to airway swelling and breathing difficulties.

Chronic Rhinosinusitis with Nasal Polyps

In adults, Nucala is used to treat chronic rhinosinusitis with nasal polyps (CRSwNP). It is typically prescribed when nasal corticosteroid medicines have not provided adequate relief, helping to shrink polyps and reduce nasal congestion.

Eosinophilic Granulomatosis with Polyangiitis (EGPA)

Nucala is approved for adults with EGPA, a rare condition involving inflammation of the blood vessels. It helps manage the symptoms of this autoimmune disorder by targeting the underlying eosinophilic inflammation.

Hypereosinophilic Syndrome (HES)

This medication is used for adults and children aged 12 years and older with HES. It is intended for patients who have had symptoms for at least six months without a clear non-blood-related cause, helping to prevent flares of the condition.

Chronic Obstructive Pulmonary Disease (COPD)

Nucala is used as a maintenance treatment for adults with COPD who have an eosinophilic phenotype and continue to experience symptoms despite using other standard therapies.

Important: Nucala is not a rescue inhaler. It should not be used to treat sudden breathing problems or an acute asthma attack.

Targeting Inflammation

Nucala (mepolizumab) belongs to a class of medications called monoclonal antibodies. It is specifically designed to target and bind to a protein in the body called interleukin-5 (IL-5).

The Role of IL-5 and Eosinophils

IL-5 is a signaling molecule that plays a key role in the growth, activation, and survival of eosinophils. Eosinophils are a type of white blood cell that helps the immune system fight off certain infections. However, in people with certain conditions, the body produces too many eosinophils or they become overactive.

High levels of eosinophils can lead to significant inflammation in various parts of the body, including:

• The lungs and airways (in severe asthma)
• The nasal passages (in chronic rhinosinusitis with nasal polyps)
• The blood vessels (in eosinophilic granulomatosis with polyangiitis)
• The blood and organs (in hypereosinophilic syndrome)

How Nucala Reduces Symptoms

Nucala works by attaching itself to the IL-5 protein. By doing this, it prevents IL-5 from binding to the receptors on the surface of eosinophils. Without the IL-5 signal, the production and survival of these cells are significantly reduced.

By lowering the number of eosinophils in the blood and tissues, Nucala helps decrease the underlying inflammation. This can lead to fewer flare-ups, improved breathing, and a reduction in other symptoms associated with high eosinophil levels.

Common Side Effects

• Headache
• Injection site reactions, including pain, redness, swelling, itching, or a burning sensation where the shot was given
• Back pain
• Fatigue or feeling tired
• Sore throat
• Runny nose or sinus infection
• Stomach pain

Serious Side Effects

• Allergic reactions: Serious and sometimes life-threatening allergic reactions can occur. Symptoms may include swelling of the face, tongue, or mouth; breathing problems; low blood pressure; dizziness; or hives. These reactions can occur immediately or several days after receiving a dose.
• Shingles: Some people taking Nucala have developed shingles (herpes zoster), which is a painful skin rash caused by the reactivation of the chickenpox virus.

Contact a healthcare provider immediately if you notice signs of an allergic reaction or a new painful skin rash.

Contraindications

Nucala is contraindicated in patients who have a history of hypersensitivity to mepolizumab or any of its inactive ingredients.

Hypersensitivity Reactions

Serious allergic reactions, including anaphylaxis, angioedema, and bronchospasm, have been reported following the use of Nucala. These reactions typically occur within hours of administration, but in some cases, they may be delayed by several days. Symptoms may include swelling of the face or mouth, breathing difficulties, fainting, dizziness, or hives. If a serious reaction occurs, treatment should be discontinued.

Acute Asthma Symptoms

Nucala should not be used to treat acute asthma symptoms, acute bronchospasm, or status asthmaticus. It is a maintenance medication and is not designed to provide immediate relief for sudden breathing problems. Patients should continue to use their rescue inhalers for acute symptoms.

Corticosteroid Reduction

Systemic or inhaled corticosteroids should not be discontinued abruptly upon starting Nucala. If a reduction in steroid dosage is appropriate, it must be performed gradually and under the direct supervision of a healthcare provider to avoid withdrawal symptoms or a return of the underlying condition.

Parasitic Infections

Eosinophils, the white blood cells targeted by Nucala, are involved in the body's immune response to some helminth (parasitic) infections. Patients with pre-existing parasitic infections should be treated before starting Nucala. If a patient becomes infected while receiving treatment and does not respond to anti-parasitic therapy, Nucala may need to be paused until the infection resolves.

Herpes Zoster

Cases of herpes zoster (shingles) have occurred in individuals receiving Nucala. Healthcare providers may consider shingles vaccination if it is medically appropriate for the patient before or during treatment.

Pregnancy

Data on the use of Nucala in pregnant women are insufficient to determine if there is a drug-associated risk for major birth defects, miscarriage, or other adverse outcomes. In animal studies, no evidence of fetal harm was observed in monkeys given mepolizumab at doses significantly higher than the recommended human dose.

Mepolizumab is a monoclonal antibody. These types of proteins are known to cross the placenta, with the amount transferred increasing during the third trimester. Therefore, any potential effects on the fetus are most likely to occur during the later stages of pregnancy.

A pregnancy exposure registry has been established to monitor the health of individuals who use Nucala while pregnant. Healthcare providers may encourage patients to enroll in this registry to help collect more data on the drug's safety during pregnancy.

Breastfeeding

It is not known whether Nucala is present in human breast milk, how it affects milk production, or what effects it may have on a breastfed infant. Because Nucala is a large protein molecule, it is thought that the amount absorbed by a nursing infant would be low.

The decision to use Nucala while breastfeeding should involve a discussion with a healthcare provider. Factors to consider include the mother's clinical need for the medication, the health benefits of breastfeeding for the infant, and any potential adverse effects on the child.

Available Forms

Nucala is administered as a subcutaneous injection. It is available in the following forms:

• Prefilled autoinjector: A single-dose device used to deliver the medication under the skin.
• Prefilled syringe: A single-dose syringe used for subcutaneous administration.
• Vial: A single-dose vial containing a lyophilized powder that must be mixed with a liquid before injection.

FDA Approval and Indications

Nucala (mepolizumab) is approved by the U.S. Food and Drug Administration (FDA) as an interleukin-5 (IL-5) antagonist monoclonal antibody. It works by reducing the levels of eosinophils, which are white blood cells that contribute to inflammation in various diseases.

The FDA has approved Nucala for the following specific uses:

• Severe Eosinophilic Asthma: As an add-on maintenance treatment for patients aged 6 years and older.
• Chronic Rhinosinusitis with Nasal Polyps (CRSwNP): As an add-on maintenance treatment for adults who do not respond adequately to nasal corticosteroids.
• Eosinophilic Granulomatosis with Polyangiitis (EGPA): For the treatment of adult patients with this rare condition.
• Hypereosinophilic Syndrome (HES): For adults and pediatric patients aged 12 years and older who have had the condition for at least six months without a known non-hematologic cause.

Regulatory Status and Safety

Nucala is available only with a prescription from a healthcare provider. It is administered via subcutaneous injection. The FDA has not approved Nucala for the treatment of other eosinophilic conditions or for the relief of acute bronchospasm (sudden breathing problems).

There are currently no boxed warnings or Risk Evaluation and Mitigation Strategy (REMS) requirements associated with Nucala. It is intended for long-term maintenance rather than emergency use.

Factors Influencing Cost

The actual price you pay for Nucala can vary significantly based on several variables:

• Insurance Coverage: Your specific health insurance plan, including your deductible and copay or coinsurance requirements, will determine your out-of-pocket expenses.
• Administration Method: Nucala is available as a prefilled syringe or autoinjector for self-administration, or as a vial that a healthcare professional must administer. Costs may differ depending on whether the drug is billed through your pharmacy benefit or medical benefit.
• Specialty Pharmacy: As a biologic medication, Nucala is often classified as a specialty drug. It may only be available through specific specialty pharmacies, which can influence the final price.

Financial Assistance

There are options available that may help reduce the cost of Nucala for eligible patients:

• Copay Savings Programs: Patients with commercial insurance may be eligible for manufacturer copay cards to help lower their monthly costs.
• Patient Assistance Programs: For individuals who are uninsured or underinsured, programs may exist to provide the medication at a reduced cost or for free, based on financial need and eligibility criteria.

Because Nucala is a long-term maintenance treatment, it is important to verify coverage with your insurance provider and discuss potential financial assistance options with your healthcare team or the manufacturer's support services.