Becker's Hospital Review

FASENRA ® (benralizumab) injection, for subcutaneous use Initial U.S. Approval: 2017 Brief Summary of Prescribing Information. For complete prescribing information consult official package insert. INDICATIONS AND USAGE FASENRA is indicated for the add-on maintenance treatment of patients with severe asthma aged 12 years and older, and with an eosinophilic phenotype [see Clinical Studies (14) in the full Prescribing Information]. Limitations of use: • FASENRA is not indicated for treatment of other eosinophilic conditions. • FASENRA is not indicated for the relief of acute bronchospasm or status asthmaticus. DOSAGE AND ADMINISTRATION Recommended Dose FASENRA is for subcutaneous use only. The recommended dose of FASENRA is 30 mg administered once every 4 weeks for the first 3 doses, and then once every 8 weeks thereafter by subcutaneous injection into the upper arm, thigh, or abdomen. General Administration Instructions FASENRA is intended for use under the guidance of a healthcare provider. In line with clinical practice, monitoring of patients after administration of biologic agents is recommended [see Warnings and Precautions (5.1) in the full Prescribing Information]. Administer FASENRA into the thigh or abdomen. The upper arm can also be used if a healthcare provider or caregiver administers the injection. Prior to administration, warm FASENRA by leaving carton at room temperature for about 30 minutes. Visually inspect FASENRA for particulate matter and discoloration prior to administration. FASENRA is clear to opalescent, colorless to slightly yellow, and may contain a few translucent or white to off-white particles. Do not use FASENRA if the liquid is cloudy, discolored, or if it contains large particles or foreign particulate matter. Prefilled Syringe The prefilled syringe is for administration by a healthcare provider. Autoinjector (FASENRA PEN™) FASENRA PEN is intended for administration by patients/caregivers. Patients/caregivers may inject after proper training in subcutaneous injection technique, and after the healthcare provider determines it is appropriate. Instructions for Administration of FASENRA Prefilled Syringe (Healthcare Providers) Refer to Figure 1 to identify the prefilled syringe components for use in the administration steps. Figure 1 Needle guard activation clips Syringe body Label with expiration date Needle cover Plunger head Plunger Finger flange Viewing window Needle NEEDLE GUARD WINGS Do not touch the needle guard activation clips to prevent premature activation of the needle safety guard. 1 Grasp the syringe body, not the plunger, to remove prefilled syringe from the tray. Check the expiration date on the syringe. The syringe may contain small air bubbles; this is normal. Do not expel the air bubbles prior to administration. 2 Do not remove needle cover until ready to inject. Hold the syringe body and remove the needle cover by pulling straight off. Do not hold the plunger or plunger head while removing the needle cover or the plunger may move. If the prefilled syringe is damaged or contaminated (for example, dropped without needle cover in place), discard and use a new prefilled syringe. 3 Gently pinch the skin and insert the needle at the recommended injection site (i.e., upper arm, thigh, or abdomen). 4 Inject all of the medication by pushing in the plunger all the way until the plunger head is completely between the needle guard activation clips. This is necessary to activate the needle guard. 5 After injection, maintain pressure on the plunger head and remove the needle from the skin. Release pressure on the plunger head to allow the needle guard to cover the needle. Do not re-cap the prefilled syringe. 6 Discard the used syringe into a sharps container. Instructions for Administration of FASENRA PEN Refer to the FASENRA PEN 'Instructions for Use' for more detailed instructions on the preparation and administration of FASENRA PEN [See Instructions for Use in the full Prescribing Information]. A patient may self-inject or the patient caregiver may administer FASENRA PEN subcutaneously after the healthcare provider determines it is appropriate. CONTRAINDICATIONS FASENRA is contraindicated in patients who have known hypersensitivity to benralizumab or any of its excipients [see Warnings and Precautions (5.1) in the full Prescribing Information]. WARNINGS AND PRECAUTIONS Hypersensitivity Reactions Hypersensitivity reactions (e.g., anaphylaxis, angioedema, urticaria, rash) have occurred following administration of FASENRA. These reactions generally occur within hours of administration, but in some instances have a delayed onset (i.e., days). In the event of a hypersensitivity reaction, FASENRA should be discontinued [see Contraindications (4) in the full Prescribing Information]. Acute Asthma Symptoms or Deteriorating Disease FASENRA should not be used to treat acute asthma symptoms or acute exacerbations. Do not use FASENRA to treat acute bronchospasm or status asthmaticus. Patients should seek medical advice if their asthma remains uncontrolled or worsens after initiation of treatment with FASENRA. Reduction of Corticosteroid Dosage Do not discontinue systemic or inhaled corticosteroids abruptly upon initiation of therapy with FASENRA. Reductions in corticosteroid dose, if appropriate, should be gradual and performed under the direct supervision of a physician. Reduction in corticosteroid dose may be associated with systemic withdrawal symptoms and/or unmask conditions previously suppressed by systemic corticosteroid therapy. Parasitic (Helminth) Infection Eosinophils may be involved in the immunological response to some helminth infections. Patients with known helminth infections were excluded from participation in clinical trials. It is unknown if FASENRA will influence a patient's response against helminth infections. Treat patients with pre-existing helminth infections before initiating therapy with FASENRA. If patients become infected while receiving treatment with FASENRA and do not respond to anti-helminth treatment, discontinue treatment with FASENRA until infection resolves. ADVERSE REACTIONS The following adverse reactions are described in greater detail in other sections: • Hypersensitivity Reactions [see Warnings and Precautions (5.1) in the full Prescribing Information] Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. Across Trials 1, 2, and 3, 1,808 patients received at least 1 dose of FASENRA [see Clinical Studies (14) in the full Prescribing Information]. The data described below reflect exposure to FASENRA in 1,663 patients, including 1,556 exposed for at least 24 weeks and 1,387 exposed for at least 48 weeks. The safety exposure for FASENRA is derived from two Phase 3 placebo-controlled studies (Trials 1 and 2) from 48 weeks duration [FASENRA every 4 weeks (n=841), FASENRA every 4 weeks for 3 doses, then every 8 weeks (n=822), and placebo (n=847)]. While a dosing regimen of FASENRA every 4 weeks was included in clinical trials, FASENRA administered every 4 weeks for 3 doses, then every 8 weeks thereafter is the recom- mended dose [see Dosage and Administration (2.1) in the full Prescribing Information]. The population studied was 12 to 75 years of age, of which 64% were female and 79% were white. Adverse reactions that occurred at greater than or equal to 3% incidence are shown in Table 1. Table 1. Adverse Reactions with FASENRA with Greater than or Equal to 3% Incidence in Patients with Asthma (Trials 1 and 2) Adverse Reactions FASENRA (N=822) % Placebo (N=847) % Headache 8 6 Pyrexia 3 2 Pharyngitis* 5 3 Hypersensitivity reactions † 3 3 * Pharyngitis was defined by the following terms: 'Pharyngitis', 'Pharyngitis bacterial', 'Viral pharyngitis', 'Pharyngitis streptococcal'. † Hypersensitivity Reactions were defined by the following terms: 'Urticaria', 'Urticaria papular', and 'Rash' [see Warnings and Precautions (5.1) in the full Prescribing Information].

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