Dosing & Uses
Dosage Forms & Strengths
solution for SC injection (single-dose prefilled syringe)
- 30mg/mL (single-dose prefilled syringe or autoinjector pen)
Severe Asthma
Add-on maintenance treatment in patients with an eosinophilic phenotype
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
Eosinophilic esophagitis
Sponsor
- AstraZeneca; P.O. Box 8355; 1800 Concord Pike; Wilmington, Delaware 19803
Dosage Forms & Strengths
solution for SC injection (single-dose prefilled syringe)
- 30mg/mL (single-dose prefilled syringe or autoinjector pen)
Severe Asthma
Add-on maintenance treatment in patients with an eosinophilic phenotype
<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
Adverse Effects
1-10%
Headache (8%)
Pharyngitis (5%)
Pyrexia (3%)
Hypersensitivity reactions (3%)
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
Pregnancy & Lactation
Pregnancy
No data are available regarding use in pregnant women; a pregnancy exposure registry monitors pregnancy outcomes in women exposed to drug 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 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.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: ~3.5 days
Absolute bioavailability: ~59% (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: 15.5 days
Systemic clearance: 0.29 L/day
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 if given by care giver or clinician, or in thigh or abdomen by self-injection with autoinjector
Discard used syringe into a sharps container
Storage
All formulations
- Refrigerate at 2-8°C (36-46°F)
- Store in the original carton to protect from light
- Do not freeze
- Do not shake
Images
| BRAND | FORM. | UNIT PRICE | PILL IMAGE |
|---|---|---|---|
| Fasenra subcutaneous - | 30 mg/mL solution |  |
Copyright © 2010 First DataBank, Inc.
Formulary
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