Garadacimab Dosage

Usual Adult Dose for Hereditary Angioedema

Initial loading dose: 400 mg subcutaneously on day 1
Maintenance dose: 200 mg subcutaneously once a month

Use: For prophylaxis to prevent attacks of hereditary angioedema (HAE)

Usual Pediatric Dose for Hereditary Angioedema

12 years and older:
Initial loading dose: 400 mg subcutaneously on day 1
Maintenance dose: 200 mg subcutaneously once a month

Use: For prophylaxis to prevent attacks of HAE

Renal Dose Adjustments

Renal dysfunction: Data not available

Comment:

• The effects of severe renal dysfunction are unknown; there were no clinically significant differences in exposure in patients with mild to moderate renal dysfunction.

Liver Dose Adjustments

Liver dysfunction: Data not available

Precautions

CONTRAINDICATIONS: None

Safety and efficacy have not been established in patients younger than 12 years.

Dialysis

Data not available

Other Comments

Administration advice:

• This drug is intended for self-administration by the patient or a caregiver after appropriate training.
• Administer subcutaneously into the thigh or abdomen; avoid injection within 1 inch (2 cm) of the navel; may administer in the upper arm if given by a caregiver.
• The initial loading dose of 400 mg is given as two subcutaneous injections of 200 mg.
• If a dose is missed, administer the dose as soon as possible.

• Store the prefilled autoinjector or prefilled syringe refrigerated at 36F to 46F (2C to 8C).
• Product should remain in original carton to protect from light; do not freeze or shake.

• The manufacturer product information, including Instructions for Use, should be consulted prior to preparation and administration.
• Allow product to come to room temperature 30 minutes prior to use; do not return to refrigeration thereafter.
• Inspect solution for particulate matter and discoloration during preparation.

• This drug is supplied as a prefilled autoinjector or as a prefilled syringe with needle safety device.
• Report adverse reactions by contacting CSL Behring at 1-866-915-6958 or the US FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

• Read the US FDA-approved patient labeling (Patient Information and Instructions for Use).
• Speak to a healthcare provider if you are pregnant, intend to become pregnant, or are breastfeeding.

See also:

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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