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Garadacimab, sold under the brand name Andembry, is a human monoclonal antibody used for the treatment of hereditary angioedema. Garadacimab is a monoclonal antibody against the activated coagulation factor XIIa (FXIIa), with potential anti-inflammatory and anticoagulant activities.
Read the full article on WikipediaChronic treatment of hereditary angioedema Types 1 or 2 Clinical criteria: Treatment Phase: Initial 1: New patient (commencing with no previous treatment with C1-INH for routine prophylaxis), Initial 2: New patient (commencing from National Blood Authority-funded C1-INH) or Initial 3: New patient (transitioning from PBS-subsidised lanadelumab) - balance of supply Patient must have received insufficient therapy with this drug for this condition under the Initial 1: New patient (commencing with no previous treatment with C1-INH for routine prophylaxis) restriction to complete 24 weeks treatment; OR Patient must have received insufficient therapy with this drug for this condition under the Initial 2: New patient (commencing from National Blood Authority-funded C1-INH) restriction to complete 24 weeks treatment; OR Patient must have received insufficient therapy with this drug for this condition under the Initial 3: New patient (transitioning from PBS-subsidised lanadelumab) restriction to complete 24 weeks treatment, AND The treatment must provide no more than the balance of up to 24 weeks treatment available under the above restriction, AND The treatment must not be used in combination with either: (i) a C1-esterase inhibitor concentrate, or (ii) lanadelumab. Treatment criteria: Must be treated by a clinical immunologist or a specialist allergist. For the purposes of administering this restriction, an adequate response is a reduction of the baseline number of acute attacks of hereditary angioedema of a severity necessitating immediate medical intervention with either (i) icatibant, or (ii) C1-esterase inhibitor concentrate. The details of the reduction must be documented in the patient's medical records for auditing purposes.
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