Cinryze Side Effects

Please note - some side effects for Cinryze may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

Side Effects of Cinryze - for the Consumer

Cinryze

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome when using Cinryze:

Headache; stuffy or runny nose.

Seek medical attention right away if any of these SEVERE side effects occur when using Cinryze:

Severe allergic reactions (rash; hives; itching; difficulty breathing or shortness of breath; tightness in the chest; fast heartbeat; severe dizziness or lightheadedness; fainting; swelling of the mouth, face, lips, or tongue; blue lips or gums; wheezing); symptoms of infection (eg, fever, sore throat, cough).

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

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Cinryze Side Effects - for the Professional

Cinryze

The most serious adverse events observed in clinical studies of Cinryze have been death due to non-catheter related foreign body embolus, pre-eclampsia resulting in emergency C-section, stroke, and exacerbation of HAE attacks, none of which have been considered drug related.

The most common drug related adverse reactions observed at a rate ≥ 5% were upper respiratory tract infection, sinusitis, rash, and headache.

Clinical Trials Experience

Because clinical studies are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.

Routine Prophylaxis

Twenty-four subjects were evaluated in study LEVP2005-1/B for routine prophylaxis.

There were no treatment-emergent serious adverse reactions in study LEVP2005-1/B.

Adverse reactions in trial LEVP2005-1/B that occurred in at least two subjects during Cinryze prophylaxis, irrespective of the causality assessment, are given in the following table:

Table 2 Adverse Reactions in Routine Prophylaxis Study LEVP2005-1/B Irrespective of Causality

Adverse Reaction	Number of Adverse Events	Number of Subjects (N = 24)
Sinusitis	8	5
Rash	7	5
Headache	4	4
Upper respiratory tract infection	3	3
Viral upper respiratory tract infection	5	3
Bronchitis	2	2
Limb injury	2	2
Back pain	2	2
Pain in extremity	2	2
Pruritus	2	2

More than 9000 doses of Cinryze have been administered to over 180 patients in all controlled and open label clinical studies. All patients were evaluated and found negative for seroconversion to parvovirus B19, Hepatitis B, Hepatitis C and HIV.

No clinically relevant antibody formation was seen in clinical trials of prophylaxis.

Postmarketing Experience

Because postmarketing reporting of adverse reactions is voluntary and from a population of uncertain size, it is not always possible to reliably estimate the frequency of these reactions or establish a causal relationship to product exposure.

Postmarketing adverse reactions include local infusion site reactions (including pain, rash, erythema, inflammation or hematoma at the infusion site).

Postmarketing thrombotic events have been reported, including catheter-related and deep venous thromboses, transient ischemic attack, and stroke. Patients with known risk factors for thrombotic events should be monitored closely.

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Side Effects by Body System - for Healthcare Professionals

Respiratory

Respiratory side effects have included sinusitis, bronchitis, upper respiratory tract infection, and viral upper respiratory tract infection.

Nervous system

Nervous system side effects have included headache.

Musculoskeletal

Musculoskeletal side effects have included limb injury, back pain, and pain in extremity.

Dermatologic

Dermatologic side effects have included pruritus.

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