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Anti-factor XIIa monoclonal antibody Pregnancy: No available data on use in pregnant women to evaluate 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, so potential fetal effects are likely to be greater then. No evidence of fetal harm in rabbit embryo-fetal and pre-/post-natal development studies at up to approximately 100 times and 76 times the exposure at the maximum recommended human dose.

Garadacimab

Brand names: Andembry

Garadacimab is a monoclonal antibody used for the long-term prophylaxis of attacks in hereditary angioedema.

Auto-extracted from the source labelling — not yet independently clinician-verified. These values were distilled from the UK SPC (or the US label where noted) but have not had a clinician sign-off. Confirm against the current SmPC before prescribing.

Adult dose

Dose: Initial loading dose of 400 mg (two injections of 200 mg) administered subcutaneously on the first day of treatment, followed by a maintenance dosage of 200 mg administered subcutaneously every month.
Route: Subcutaneous use only - injected into the thigh or abdomen (staying 1 inch / 2 cm away from the navel); the upper arm may also be used if a caregiver administers the injection
Frequency: Loading dose on day 1, then 200 mg once monthly
US labelling for ANDEMBRY (no UK SPC in the fetched bundle) - verify against the UK SPC before publication. Indication in the source label: prophylaxis to prevent attacks of hereditary angioedema (HAE). Missed dose: administer as soon as possible. Available as a 200 mg/1.2 mL single-dose prefilled autoinjector or a 200 mg/1.2 mL (167 mg/mL) single-dose prefilled syringe with needle safety device. Patients/caregivers may self-administer after training; remove from the refrigerator and allow to sit for 30 minutes at room temperature before use; inspect for particulate matter and discoloration (solution is slightly opalescent to clear, brownish-yellow to yellow). PAEDIATRIC: safety and effectiveness have been established in patients aged 12 years and older, who received the same regimen (400 mg loading dose subcutaneously followed by 200 mg subcutaneously every month); no weight-based dose is given. Safety and effectiveness have not been established in patients younger than 12 years of age. Geriatric: no overall differences in safety or effectiveness observed in patients 65 years and older.

Dose auto-extracted from US FDA prescribing information (openFDA / DailyMed) — cross-check; US labelling may differ from UK — not yet clinician-verified. Always confirm against the product SmPC and your local formulary before prescribing.

Contraindications

  • None - the US label states 'None' under Contraindications

Side effects

  • Nasopharyngitis (most common, incidence >= 7%)
  • Abdominal pain (most common, incidence >= 7%)
  • Prolonged activated partial thromboplastin time (aPTT) - laboratory assay interference

Interactions

  • Interference with laboratory tests: garadacimab can prolong activated partial thromboplastin time (aPTT), because aPTT reagents initiate intrinsic coagulation through activation of FXII and garadacimab inhibits plasma FXIIa

Clinical monograph

How it works

It inhibits activated factor XII (factor XIIa), reducing activation of the contact (kallikrein-kinin) system and thereby decreasing bradykinin-mediated angioedema attacks.

Prescribing in practice

  • It is intended for routine prevention of attacks, not for treating an acute attack, so patients must retain access to a recognised acute hereditary angioedema treatment.
  • Use under specialist supervision for confirmed hereditary angioedema and counsel on injection technique where self-administration is used.
  • Consider bleeding risk and refer to the SPC before use in patients on anticoagulants or with bleeding disorders.

Monitoring

Monitor attack frequency and severity and overall treatment response under specialist follow-up.

Counselling the patient

  • Explain that this medicine is taken regularly to prevent angioedema attacks, not to treat one that has started.
  • Stress that on-demand rescue treatment must always be available.
  • Advise reporting any unusual bleeding or bruising.

Evidence & guidelines

Garadacimab is a factor XIIa inhibitor developed for long-term prophylaxis of hereditary angioedema attacks.

Reference: NICE TA1041; SmPC; Drug verified in RxNorm (NLM); confirm dosing against the manufacturer SPC (eMC). Verify against your local formulary and current prescribing references before prescribing. The structured dose values shown have been reviewed by a clinician. Monograph status: clinician-reviewed (2026-07-04).

Related

Curated clinical cross-links plus same-class fallbacks.

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