Cinryze for routine prevention of hereditary angioedema attacks

Cinryze is a human plasma-derived C1 esterase inhibitor supplied as a freeze-dried powder for intravenous use. It is approved for routine prophylaxis to prevent angioedema attacks in adults, adolescents, and children aged 6 years and older with hereditary angioedema (HAE).

Cinryze is indicated for routine prevention of angioedema attacks in patients with hereditary angioedema (HAE) aged 6 years and above, including adults, adolescents, and pediatric patients.

C1 esterase inhibitor (human)

Cinryze provides C1 esterase inhibitor proteins that replace the deficient or dysfunctional inhibitor in patients with hereditary angioedema. By restoring normal levels of this inhibitor, it helps prevent the episodes of swelling characteristic of HAE.

Administration and Preparation

• For intravenous use only after reconstitution with 5 mL of Sterile Water for Injection per vial.
• Use aseptic technique and protect the powder from light before reconstitution.
• A silicone-free syringe is recommended for reconstitution and administration.
• The reconstituted solution must be clear and colorless to slightly blue; do not use if turbid or contains particles.
• Administer at room temperature within 3 hours of reconstitution.

Routine Prophylaxis Dosing

Cinryze is contraindicated in patients who have had life-threatening immediate hypersensitivity reactions, including anaphylaxis, to Cinryze or its components.

Serious Warnings and Precautions

• Hypersensitivity reactions: Severe allergic reactions including anaphylaxis may occur. Symptoms include hives, chest tightness, wheezing, hypotension, and anaphylaxis during or after infusion. Discontinue Cinryze immediately and have epinephrine available for emergency treatment.
• Thromboembolic events: Serious arterial and venous blood clots have been reported with C1 esterase inhibitor products, including Cinryze. Risk factors include indwelling venous catheters, prior thrombosis, atherosclerosis, oral contraceptive or androgen use, obesity, and immobility. Monitor patients with risk factors carefully during and after treatment.
• Infection risk: As a human plasma-derived product, Cinryze carries a risk of transmitting infectious agents, including viruses and theoretically Creutzfeldt-Jakob disease. Physicians should discuss these risks with patients.

Common Side Effects

• Injection site reactions
• Headache
• Rash
• Fatigue

Serious Side Effects

• Severe hypersensitivity (anaphylaxis)
• Thromboembolic events such as deep vein thrombosis, pulmonary embolism, myocardial infarction, stroke

No specific drug interaction data listed in the provided label.

Store Cinryze powder protected from light at 36°F to 77°F (2°C to 25°C). Do not freeze.

Reconstituted solution should be used within 3 hours and stored at room temperature. Do not use after expiration date.