FASENRA

FASENRA- benralizumab injection, solution
AstraZeneca Pharmaceuticals LP

1 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)].

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.

2 DOSAGE AND ADMINISTRATION

2.1 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.

2.2 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)].

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.

2.3 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

Figure 1 prefilled syringe components
(click image for full-size original)

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

Step 2 needle cover image

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

Step 3
(click image for full-size original)

Gently pinch the skin and insert the needle at the recommended injection site (i.e., upper arm, thigh, or abdomen).

4

Step 4
(click image for full-size original)

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

Step 5
(click image for full-size original)

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.

2.4 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]. A patient may self-inject or the patient caregiver may administer FASENRA PEN subcutaneously after the healthcare provider determines it is appropriate.

3 DOSAGE FORMS AND STRENGTHS

FASENRA is a clear to opalescent, colorless to slightly yellow solution and may contain a few translucent or white to off‑white particles.

Injection: 30 mg/mL solution in a single-dose prefilled syringe.
Injection: 30 mg/mL solution in a single-dose autoinjector FASENRA PEN.

4 CONTRAINDICATIONS

FASENRA is contraindicated in patients who have known hypersensitivity to benralizumab or any of its excipients [see Warnings and Precautions (5.1)].

5 WARNINGS AND PRECAUTIONS

5.1 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)].

5.2 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.

5.3 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.

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