benralizumab (Rx)

Brand and Other Names:Fasenra
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Dosing & Uses

AdultPediatric

Dosage Forms & Strengths

solution for SC injection

  • 30mg/mL in single-dose prefilled syringe

Asthma

Indicated for add-on maintenance treatment of severe asthma in patients with an eosinophilic phenotype aged ≥12 years

30 mg SC q4weeks for the first 3 doses, THEN q8weeks thereafter

Dosage Modifications

Hepatic impairment: IgG monoclonal antibodies are not primarily cleared via hepatic pathway; changes in hepatic function are not expected to influence benralizumab clearance

Renal impairment

  • Based on population pharmacokinetic analysis, clearance was comparable with CrCl of 30-80 mL/min and patients with normal renal function
  • Data are limited with CrCl <30 mL/min; however, benralizumab is not cleared renally

Dosing Considerations

Limitations of use

  • Not indicated for treatment of other eosinophilic conditions
  • Not indicated for relief of acute bronchospasm or status asthmaticus

Orphan Designations

Hypereosinophilic syndrome

Eosinophilic granulomatosis with polyangiitis

Sponsor

  • AstraZeneca; P.O. Box 8355; 1800 Concord Pike; Wilmington, Delaware 19803

Dosage Forms & Strengths

solution for SC injection

  • 30mg/mL in single-dose prefilled syringe

Asthma

Indicated for add-on maintenance treatment of severe asthma in patients with an eosinophilic phenotype aged ≥12 years

<12 years: Safety and efficacy not established

≥12 years: 30 mg SC q4weeks for the first 3 doses, THEN q8weeks thereafter

Dosage Modifications

Hepatic impairment: IgG monoclonal antibodies are not primarily cleared via hepatic pathway; changes in hepatic function are not expected to influence benralizumab clearance

Renal impairment

  • Based on population pharmacokinetic analysis, clearance was comparable with CrCl of 30-80 mL/min and patients with normal renal function
  • Data are limited with CrCl <30 mL/min; however, benralizumab is not cleared renally

Dosing Considerations

Limitations of use

  • Not indicated for treatment of other eosinophilic conditions
  • Not indicated for relief of acute bronchospasm or status asthmaticus
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Adverse Effects

1-10%

Headache (8%)

Pharyngitis (5%)

Pyrexia (3%)

Hypersensitivity reactions (3%)

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Warnings

Contraindications

Hypersensitivity to benralizumab or any of its excipients

Cautions

Hypersensitivity reactions (eg, 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

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

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 infection resolves

Avoid use in acute asthma symptoms or acute exacerbations; do not use to treat acute bronchospasm or status asthmaticus

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Pregnancy & Lactation

Pregnancy

No data are available regarding use in pregnant women

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 on 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

Pregnancy Categories

A: Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.

B: May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.

C: Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.

D: Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk.

X: Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist.

NA: Information not available.

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Pharmacology

Mechanism of Action

Interleukin (IL)-5 receptor alpha-directed cytolytic monoclonal antibody (IgG1, kappa); the IL-5 receptor is expressed on the surface of eosinophils and basophils; reduces eosinophils and basophils through antibody-dependent cell-mediated cytotoxicity (ADCC)

Absorption

Absorption half-life: 3.6 days

Absolute bioavailability: 58% (no difference between injection sites)

Distribution

Vd: 3.2 L (central); 2.5 L (peripheral)

Metabolism

IgG1 monoclonal antibody that is degraded by proteolytic enzymes widely distributed in the body and not restricted to hepatic tissue

Elimination

Elimination half-life: 15 days

Systemic clearance: 0.29 L/day

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Administration

SC Preparation

Instruct patients regarding SC injection technique and proper disposal of syringe and needles

Prior to administration, warm by leaving carton at room temperature for about 30 minutes

Once removed from refrigerator, administer within 24 hr or discard into sharps container

Visually inspect; solution should appear clear to opalescent, colorless to slightly yellow, and may contain a few translucent or white to off-white particles Do not use if solution is cloudy, discolored, or if it contains large particles or foreign particulate matter

SC Administration

For subcutaneous use only

Administer SC in upper arm, thigh, or abdomen

Discard the used syringe into a sharps container

Storage

Refrigerate at 2-8°C (36-46°F)

Store in the original carton to protect from light

Do not freeze

Do not shake

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Formulary

FormularyPatient Discounts

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The above information is provided for general informational and educational purposes only. Individual plans may vary and formulary information changes. Contact the applicable plan provider for the most current information.

Tier Description
1 This drug is available at the lowest co-pay. Most commonly, these are generic drugs.
2 This drug is available at a middle level co-pay. Most commonly, these are "preferred" (on formulary) brand drugs.
3 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs.
4 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
5 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
6 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
NC NOT COVERED – Drugs that are not covered by the plan.
Code Definition
PA Prior Authorization
Drugs that require prior authorization. This restriction requires that specific clinical criteria be met prior to the approval of the prescription.
QL Quantity Limits
Drugs that have quantity limits associated with each prescription. This restriction typically limits the quantity of the drug that will be covered.
ST Step Therapy
Drugs that have step therapy associated with each prescription. This restriction typically requires that certain criteria be met prior to approval for the prescription.
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Drugs that have restrictions other than prior authorization, quantity limits, and step therapy associated with each prescription.
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Medscape prescription drug monographs are based on FDA-approved labeling information, unless otherwise noted, combined with additional data derived from primary medical literature.