Cinryze
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Cinryze
Cinryze Side Effects Center
This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
What is Patient Information in Detail?
Easy-to-read and understand detailed drug information and pill images for the patient or caregiver from Cerner Multum.
Cinryze in Detail - Patient Information: Side Effects
Stop your IV infusion and get emergency medical help if you have any of these signs of an allergic reaction: hives; wheezing or difficult breathing; feeling like you might pass out; or swelling of your face, lips, tongue, or throat.
Call your doctor at once if you have any other serious side effect, such as:
- new or worsening pain;
- sudden numbness or weakness, especially on one side of the body;
- sudden headache, confusion, problems with vision, speech, or balance;
- stomach pain or swelling;
- chest pain, sudden cough, rapid breathing, fast heart rate; or
- pain, swelling, warmth, or redness in one or both legs.
Less serious side effects may include:
- nausea, vomiting, diarrhea, stomach pain;
- cold symptoms such as stuffy nose, sneezing, sore throat;
- mild itching or rash; or
- mild headache.
This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
Read the entire detailed patient monograph for Cinryze (C1 Esterase Inhibitor [Human] Freeze Dried Powder) »
What is Patient Information Overview?
A concise overview of the drug for the patient or caregiver from First DataBank.
Cinryze Overview - Patient Information: Side Effects
Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.
This medication may increase the risk for blood clots, especially when used at high doses. Get medical help right away if you notice any of the following rare but serious side effects: new swelling/pain in the arm/leg/abdomen, chest pain, loss of feeling or ability to move, slurred speech.
A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.
If you notice other effects not listed above, contact your doctor or pharmacist.
In the US -
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.
Read the entire patient information overview for Cinryze (C1 Esterase Inhibitor [Human] Freeze Dried Powder)»
What is Prescribing information?
The FDA package insert formatted in easy-to-find categories for health professionals and clinicians.
Cinryze FDA Prescribing Information: Side Effects
(Adverse Reactions)
SIDE EFFECTS
Adverse Reaction Overview
The most serious adverse events observed in clinical studies of CINRYZE (c1 esterase inhibitor [human] freeze dried powder) 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 infections, 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 (c1 esterase inhibitor [human] freeze dried powder) 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 (c1 esterase inhibitor [human] freeze dried powder) 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.
Read the entire FDA prescribing information for Cinryze (C1 Esterase Inhibitor [Human] Freeze Dried Powder) »
Additional Cinryze Information
Cinryze - User Reviews
Cinryze User Reviews
Now you can gain knowledge and insight about a drug treatment with Patient Discussions.
Here is a collection of user reviews for the medication Cinryze sorted by most helpful.
Report Problems to the Food and Drug Administration
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.
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