Benralizumab

Benralizumab is a prescription medication indicated for the add-on maintenance treatment of adult and pediatric patients aged 6 years and older with severe asthma, and with an eosinophilic phenotype. Benralizumab is also indicated for the treatment of adult patients with eosinophilic granulomatosis with polyangiitis (EGPA).

• Benralizumab is available under the following different brand names: Fasenra.

Common side effects of Benralizumab include:

• headache
• sore throat

Serious side effects of Benralizumab include:

• new or worsening asthma symptoms
• allergic reactions include hives, rash, difficulty breathing, feeling light-headed (low blood pressure), and swelling of the face, lips, tongue, or throat.

Rare side effects of Benralizumab include:

• none 

Seek medical care or call 911 at once if you have the following serious side effects:

• Severe headache, confusion, slurred speech, arm or leg weakness, trouble walking, coordination loss, unsteady, very stiff muscles, high fever, profuse sweating, or tremors.
• Serious eye symptoms such as sudden vision loss, blurred vision, tunnel vision, eye pain or swelling, or seeing halos around lights.
• Serious heart symptoms include fast, irregular, or pounding heartbeats; fluttering in the chest; shortness of breath; sudden dizziness, lightheadedness, or passing out.

This is not a complete list of side effects and other serious side effects or health problems that may occur because of the use of this drug. Call your doctor for medical advice about serious side effects or adverse reactions. You may report side effects or health problems to FDA at 1-800-FDA-1088.

Adult and pediatric dosage

Solution for SC injection (single-dose prefilled syringe)

• 10 mg/0.5 mL
• 30 mg/mL

Solution for SC injection (single-dose autoinjector pen)

• 30 mg/mL

Severe asthma

Adult dosage

• 30 mg SC every 4 weeks for the first 3 doses, then every 8 weeks thereafter

Pediatric dosage

• Children younger than 6 years: Safety and efficacy not established
• Children aged between 6 and younger than 12 years:
• Children weighing less than 35 kg: 10 mg (one injection) SC every 4 weeks for the first 3 doses, then every 8 weeks thereafter
• Children weighing 35 kg and more: 30 mg (one injection) SC every 4 weeks for the first 3 doses, then every 8 weeks thereafter
• Children aged 12 years and older: 30 mg SC every 4 weeks for the first 3 doses, then every 8 weeks thereafter

Eosinophilic granulomatosis with polyangiitis (EGPA)

Adult dosage

• 30 mg SC every 4 weeks

Dosage Considerations – Should be Given as Follows: 

• See “Dosages”

If your medical doctor is using this medicine to treat your pain, your doctor or pharmacist may already be aware of any possible drug interactions and may be monitoring you for them. Do not start, stop, or change the dosage of any medicine before checking with your doctor, health care provider, or pharmacist first.

• Benralizumab has no noted severe interactions with any other drugs
• Benralizumab has no noted serious interactions with any other drugs
• Benralizumab has no noted moderate interactions with any other drugs
• Benralizumab has no noted minor interactions with any other drugs

This information does not contain all possible interactions or adverse effects. Visit the RxList Drug Interaction Checker for any drug interactions. Therefore, before using this product, tell your doctor or pharmacist about all the products you use. Keep a list of all your medications with you and share this information with your doctor and pharmacist. Check with your healthcare professional or doctor for additional medical advice, health questions, or concerns.

Contraindications

• Hypersensitivity to benralizumab or any of its excipients

Effects of drug abuse

• None

Short-Term Effects

• See “What Are Side Effects Associated with Using Benralizumab?”

Long-Term Effects

• See “What Are Side Effects Associated with Using Benralizumab?”

Cautions

• Hypersensitivity
  • Hypersensitivity reactions (e.g., anaphylaxis, angioedema, urticaria, rash) reported
  • These reactions generally occur within hours of administration, but in some instances have a delayed onset (ie, days)
  • Discontinue if hypersensitivity occurs
• Acute asthma or deteriorating disease
  • Do not use to treat acute asthma symptoms or acute exacerbations
  • Do not use for acute bronchospasm or status asthmaticus
  • Instruct patients to seek medical advice if their asthma remains uncontrolled or worsens after initiating
• Reduction of corticosteroid dosage
  • Do not discontinue systemic or inhaled corticosteroids abruptly upon initiating benralizumab
  • Corticosteroid dose reductions, if appropriate, should be gradual and performed under the direct supervision of a physician
  • Monitor for systemic withdrawal symptoms and/or unmasking of conditions previously suppressed by systemic corticosteroid therapy
• Parasitic (helminth) infection
  • Eosinophils may be involved in the immunological response to some helminth infections
  • Unknown if Benralizumab influences immunologic response against helminth infections
  • Treat patients with preexisting helminth infections before initiating therapy
  • If parasitic infection occurs while receiving treatment and does not respond to antihelminth treatment, discontinue Benralizumab until the infection resolves

Pregnancy and Lactation

• No data are available regarding use in pregnant women; a pregnancy exposure registry monitors pregnancy outcomes in women exposed to drugs during pregnancy; healthcare providers can enroll patients or encourage patients to enroll themselves by calling 1-877-311-8972 or visiting mothertobaby.org/Fasenra
• Monoclonal antibodies are transported across the placenta during the third trimester of pregnancy; therefore, potential effects on a fetus are likely to be greater during the third trimester of pregnancy
• In women with poorly or moderately controlled asthma, evidence demonstrates an increased risk of preeclampsia in the mother and prematurity, low birth weight, and small for gestational age in the neonate; closely monitor in pregnant women and adjust treatment as necessary
• Lactation
  • No information is available regarding the presence of benralizumab in human or animal milk, and the effects of benralizumab on the breastfed infant and milk production are not known
  • Humanized monoclonal antibodies and immunoglobulin G are present in human milk in small amounts
  • The development and health benefits of breastfeeding should be considered along with the mother’s clinical need for the drug and any potential adverse effects on the breastfed child or from the underlying maternal condition