Garadacimab

Garadacimab is a prescription medication indicated for prophylaxis to prevent attacks of hereditary angioedema (HAE) in adult and pediatric patients aged 12 years and older.

• Garadacimab is available under the following different brand names: Andembry, garadacimab-gxii.

Common side effects of Garadacimab include:

• injection site reactions
• abdominal pain  
• nasopharyngitis

Serious side effects of Garadacimab include:

• not available

Rare side effects of Garadacimab include:

• none 

Seek medical care or call 911 at once if you have the following serious side effects:

• Severe headache, confusion, slurred speech, arm or leg weakness, trouble walking, coordination loss, unsteady, very stiff muscles, high fever, profuse sweating, or tremors.
• Serious eye symptoms such as sudden vision loss, blurred vision, tunnel vision, eye pain or swelling, or seeing halos around lights.
• Serious heart symptoms include fast, irregular, or pounding heartbeats; fluttering in the chest; shortness of breath; sudden dizziness, lightheadedness, or passing out.

This is not a complete list of side effects and other serious side effects or health problems that may occur because of the use of this drug. Call your doctor for medical advice about serious side effects or adverse reactions. You may report side effects or health problems to FDA at 1-800-FDA-1088.

Adult dosage

Solution for SC injection

• 200 mg/1.2 mL as a single-dose prefilled autoinjector or syringe

Hereditary Angioedema

Adult dosage

• Initial loading: 400 mg (two 200-mg injections) SC, followed by a maintenance dose 1 month later
• Maintenance: 200 mg SC monthly

Pediatric dosage

• Children younger than 12 years: Safety and efficacy not established
• Children aged 12 years and older
• Initial loading: 400 mg (two 200-mg injections) SC, followed by a maintenance dose 1 month later
• Maintenance: 200 mg SC monthly

Dosage Considerations – Should be Given as Follows: 

• See “Dosages”

Tell your doctor or pharmacist about all the products you use. Keep a list of all your medications with you and share this information with your doctor and pharmacist. Visit the RxList Drug Interaction Checker for any drug interactions. Check with your healthcare professional or doctor for additional medical advice, health questions, or concerns.

Contraindications

• None

Effects of drug abuse

• None

Short-Term Effects

• See “What Are Side Effects Associated with Using Garadacimab?”

Long-Term Effects

• See “What Are Side Effects Associated with Using Garadacimab?”

Cautions

• Interference with laboratory coagulation tests
• Can prolong activated partial thromboplastin time (aPTT) due to an interaction with the aPTT assay
• Reagents used in the aPTT laboratory test initiate intrinsic coagulation by activation of FXII in the contact system; therefore, inhibition of plasma FXIIa by garadacimab can prolong aPTT in this assay

Pregnancy and Lactation

• Data are not available regarding use during pregnancy to evaluate for a drug-associated risk of major birth defects, miscarriage, or other adverse maternal or fetal outcomes
• Monoclonal antibodies are transported across the placenta during the
• Third-trimester placental transport of monoclonal antibodies is known; therefore, potential fetal effects would be observed during this stage of pregnancy
• Lactation
  • Data are unavailable on the presence of garadacimab or its metabolite in either human or animal milk, effects on breastfed infants, or effects on milk production
  • Maternal IgG is known to be present in human milk
  • Effects of local gastrointestinal exposure and limited systemic exposure in breastfed infants are unknown