Usual Adult Dose for Asthma - Maintenance

100 mg subcutaneously every 4 weeks

Comments:

• This drug should be administered in the upper arm, thigh, or abdomen.

Use: Add-on maintenance treatment for severe asthma with an eosinophilic phenotype

Usual Adult Dose for Wegener's Granulomatosis

300 mg (as 3 separate 100 mg injections) subcutaneously every 4 weeks

Comments:

• This drug should be administered in the upper arm, thigh, or abdomen as 3 separate 100 mg injections at least 5 cm (approximately 2 inches) apart if more than 1 injection is administered at the same site.

Use: For eosinophilic granulomatosis with polyangiitis (EGPA)

Usual Adult Dose for Sinusitis

100 mg subcutaneously every 4 weeks

Comments:

• This drug should be administered in the upper arm, thigh, or abdomen

Use: Adult patients with chronic rhinosinusitis with nasal polyps

Usual Adult Dose for Nasal Polyps

100 mg subcutaneously every 4 weeks

Comments:

• This drug should be administered in the upper arm, thigh, or abdomen

Use: Adult patients with chronic rhinosinusitis with nasal polyps

Usual Adult Dose for Rhinitis

100 mg subcutaneously every 4 weeks

Comments:

• This drug should be administered in the upper arm, thigh, or abdomen

Use: Adult patients with chronic rhinosinusitis with nasal polyps

Usual Adult Dose for Hypereosinophilic Syndrome

300 mg (as 3 separate 100 mg injections) subcutaneously every 4 weeks

Comments:

• This drug should be administered in the upper arm, thigh, or abdomen as 3 separate 100 mg injections at least 5 cm (approximately 2 inches) apart.

Use: Adult patients with hypereosinophilic syndrome

Usual Pediatric Dose for Asthma - Maintenance

6 to 12 years:
40 mg subcutaneously every 4 weeks

12 years or older:
100 mg subcutaneously every 4 weeks

Comments:

• This drug should be administered in the upper arm, thigh, or abdomen.

Use: Add-on maintenance therapy for severe asthma with an eosinophilic phenotype in children 6 years and older

Usual Pediatric Dose for Hypereosinophilic Syndrome

300 mg (as 3 separate 100 mg injections) subcutaneously every 4 weeks

Comments:

• This drug should be administered in the upper arm, thigh, or abdomen as 3 separate 100 mg injections at least 5 cm (approximately 2 inches) apart.

Use: Patients 12 years and older with hypereosinophilic syndrome without an identifiable non-hematologic secondary cause

Renal Dose Adjustments

No adjustment recommended.

Liver Dose Adjustments

No adjustment recommended.

Precautions

US FDA requires a medication guide to assure safe use. For additional information: www.fda.gov/drugs/drug-safety-and-availability/medication-guides

CONTRAINDICATIONS:

• Hypersensitivity to the active component or any of the ingredients

• Asthma: Safety and efficacy have not been established in patients younger than 6 years old.
• Rhinosinusitis with nasal polyps and EGPA: Safety and efficacy have not been established in patients under 18 years old.
• Hypereosinophilic syndrome: Safety and efficacy have not been established in patients under 12 years old.

Consult WARNINGS section for additional precautions.

Dialysis

Data not available

Other Comments

Administration advice:

• This drug should be reconstituted and administered by a health care provider.
• Discard if cloudy, milky, or particulate matter remains in solution after reconstitution.
• This drug is for subcutaneous use only. Administration in upper arm, thigh, or abdomen is preferred.

Storage requirements:

• Lyophilized powder: Protect from light; do not freeze.
• Reconstituted solution: Do not freeze; discard if not used within 6 to 8 hours of reconstitution.

Reconstitution/preparation techniques:

• The manufacturer product information should be consulted.

General:

• This drug should not be used to treat other eosinophilic conditions, acute asthma, bronchospasm, or status asthmaticus.
• Avoid decreasing or discontinuing corticosteroids during initiation of this drug.
• This drug may interfere with helminth infections.
• Hypersensitivity reactions may occur up to days after administration.
• This drug should be prescribed by healthcare professionals experienced in the diagnosis and treatment of severe asthma.

Monitoring:

• Signs and symptoms of uncontrolled or worsening asthma
• Signs and symptoms of an allergic reaction (e.g., facial swelling, rash, hypotension, hives)

Patient advice:

• Read the Patient Information and Instructions for Use.
• Warn patients to avoid interruptions or abrupt discontinuation of corticosteroids.
• Instruct patients to notify their healthcare provider upon signs and symptoms of worsening asthma or allergic reaction.
• Patients should be advised to speak to their healthcare provider if pregnant, intend to become pregnant, or are breastfeeding.

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