Product image of Cinryze (C1 esterase inhibitor human) (C1 esterase inhibitor (human)) HUMAN C1-ESTERASE INHIBITOR 500 [iU]/5mL INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION supplied by GNH India

Cinryze (C1 esterase inhibitor human)

Active Ingredient:
C1 esterase inhibitor (human)
Form:
INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Brand:
Cinryze
Origin:
USA

Cinryze (C1 esterase inhibitor human) (C1 esterase inhibitor (human) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION) HUMAN C1-ESTERASE INHIBITOR 500 [iU]/5mL

Cinryze is a C1 esterase inhibitor (human) derived from human plasma, approved by the FDA as an orphan drug for the treatment of hereditary angioedema (HAE). It is administered intravenously and represents a key therapeutic option in the allergy and immunology category for managing acute attacks and preventing recurrent episodes in HAE patients.

Strength

HUMAN C1-ESTERASE INHIBITOR 500 [iU]/5mL

Pack Size

5 mL in 1 VIAL, SINGLE-USE (42227-081-01)

Manufacturer / TM Owner

Takeda Pharmaceuticals U.S.A., Inc.

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Indications & Clinical Uses

  • Cinryze is indicated for the treatment of acute attacks of hereditary angioedema (HAE) in adolescents and adults. HAE is a rare genetic disorder characterized by recurrent episodes of severe swelling affecting the skin, gastrointestinal tract, and potentially life-threatening airway involvement. The drug works by replacing deficient or dysfunctional C1 esterase inhibitor, a key regulatory protein in the contact system and complement cascade. By restoring normal C1 inhibitor levels, Cinryze reduces the excessive bradykinin production that drives angioedema formation. The patient population includes individuals with Type I HAE (C1-INH deficiency), Type II HAE (C1-INH dysfunction), and Type III HAE (normal C1-INH levels). Cinryze is used both for acute attack management and as prophylactic therapy to prevent recurrent episodes, significantly improving quality of life and reducing hospitalizations in this vulnerable orphan disease population.

Side Effects

  • Common side effects of Cinryze include headache, nausea, and mild injection site reactions. Serious adverse events, though rare, include thrombotic complications such as deep vein thrombosis and pulmonary embolism, particularly in patients with underlying risk factors. Hypersensitivity reactions and anaphylaxis have been reported. As a plasma-derived product, there is a theoretical risk of pathogen transmission, though modern manufacturing processes significantly minimize this risk. Patients require baseline and periodic monitoring of coagulation parameters, particularly in those with pre-existing thrombotic risk factors. Regular clinical assessment during and after infusion is essential to evaluate therapeutic response and detect adverse reactions promptly.

Precautions & Warnings

  • Cinryze is contraindicated in patients with known hypersensitivity to C1 esterase inhibitor or any excipients. Caution is warranted in patients with thrombotic risk factors, including immobility, surgery, trauma, or personal/family history of thromboembolism. Use in pregnancy should be carefully evaluated; while HAE management is critical during pregnancy, the risk-benefit profile must be individually assessed. Pediatric use requires dose adjustment and careful monitoring. Patients with renal or hepatic impairment should be monitored closely, though specific dose adjustments are not established. Concurrent use with other hemostatic agents requires careful coordination. Patients should be counseled regarding signs of thrombosis and hypersensitivity reactions, and informed of the plasma-derived nature of the product.

Avoid Interactions

  • Limited specific drug-drug interactions are documented with Cinryze. However, concurrent use with other blood products, anticoagulants, or fibrinolytic agents should be coordinated carefully due to potential effects on hemostasis. Patients receiving angiotensin-converting inhibitor (ACE) inhibitors may experience paradoxical worsening of HAE symptoms and should be monitored closely. No significant food-drug interactions are known. Patients should inform healthcare providers of all medications, supplements, and recent vaccinations before Cinryze administration to ensure safe concurrent use.

Frequently Asked Questions

Cinryze is used to treat acute attacks of hereditary angioedema (HAE) in adolescents and adults. It can also be used as prophylactic therapy to prevent recurrent angioedema episodes. HAE is a rare genetic disorder characterized by unpredictable episodes of severe swelling that can affect the skin, abdomen, and potentially life-threatening airway involvement.

Cinryze is administered as an intravenous infusion. The standard dose for acute attacks is 1000 units (20 mL) infused intravenously over 10-15 minutes. For prophylaxis, dosing may vary based on individual patient needs and clinical response. Administration should occur in a healthcare setting with appropriate monitoring.

Common side effects include headache, nausea, and injection site reactions. Serious but rare adverse events include thrombotic complications such as deep vein thrombosis and pulmonary embolism. Hypersensitivity reactions and anaphylaxis have been reported. Patients should report any unusual symptoms to their healthcare provider immediately.

Cinryze is manufactured by Takeda Pharmaceuticals U.S.A., Inc., a leading global pharmaceutical company specializing in rare disease treatments and other therapeutic areas.

Yes, Cinryze is FDA-approved as an orphan drug for the treatment of hereditary angioedema. Orphan drug designation is granted to medications treating rare diseases affecting fewer than 200,000 people in the United States. This status provides regulatory incentives and market exclusivity to encourage development of treatments for rare conditions like HAE.

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GNH India Pharmaceuticals Limited

Licensed pharmaceutical supplier

Last updated:

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