C1 Inhibitor, Human
Pronunciation: (in-HIB-a-tor)Class: Protein C1 inhibitor
Trade Names:
Cinryze
- Injection, lyophilized powder for solution 500 units
Pharmacology
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Regulates the activation of the complement and intrinsic coagulation (contact system) pathway and regulates the fibrinolytic system.
Pharmacokinetics
Absorption
C max is 0.68 units/mL. T max is 3.9 h.
Elimination
Half-life is 56 h.
Onset
Increases plasma levels of C1 inhibitor within approximately 1 h or less of IV administration.
Special Populations
Renal Function ImpairmentPharmacokinetic studies have not been conducted.
Hepatic Function ImpairmentPharmacokinetic studies have not been conducted.
Indications and Usage
Routine prophylaxis against angioedema attacks in adolescent and adult patients with hereditary angioedema.
Contraindications
Life-threatening immediate hypersensitivity reactions, including anaphylaxis, to this product.
Dosage and Administration
AdultsIV 1,000 units every 3 or 4 days.
General Advice
- Initial and maintenance infusion rates are 1 mL/min.
- Product is for single use only; partially used vials should be discarded.
- Do not mix with other materials.
Storage/Stability
Store at 36° to 77°F. Do not freeze. Protect from light. Use reconstituted solution within 3 h of reconstitution.
Drug Interactions
None well documented.
Laboratory Test Interactions
None well documented.
Adverse Reactions
CNS
Headache (at least 5%).
Dermatologic
Rash (at least 5%); pruritus.
Musculoskeletal
Back pain, limb injury, pain in extremities.
Respiratory
Sinusitis, upper respiratory tract infections (at least 5%); bronchitis, viral upper respiratory tract infection.
Precautions
Pregnancy
Category C .
Lactation
Undetermined.
Children
Safety and efficacy not established.
Hypersensitivity
Severe hypersensitivity reactions may occur.
Infections
Because C1 inhibitor is prepared from human blood, there is a risk of transmitting infectious agents (eg, viruses), including Creutzfeldt-Jakob disease.
Thrombotic events
Have been reported when used off-label at high doses.
Overdosage
Symptoms
Overdosage has not been reported.
Patient Information
- Instruct patients to immediately report the following to their health care provider: signs and symptoms of allergic hypersensitivity reactions, such as hives, urticaria, tightness of the chest, wheezing, hypotension, and anaphylaxis, or signs and symptoms of thrombosis, such as new onset of swelling and pain in the limbs or abdomen, new-onset chest pain, shortness of breath, loss of sensation or motor power, or altered consciousness or speech.
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C1 Inhibitor, Human Side Effects
