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Cinryze

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Cinryze

Cinryze Side Effects Center

Medical Editor: John P. Cunha, DO, FACOEP

Cinryze (c1 esterase inhibitor [human]) Freeze Dried Powder is a man-made form of a protein that occurs naturally in the bloodstream and helps control inflammation in the body and is used in people with hereditary angioedema. The Berinert brand of this medication is used to treat attacks of angioedema. The Cinryze brand is used to prevent attacks of angioedema. Common side effects include headache.

A dose of 1,000 Units Cinryze can be administered every 3 or 4 days for routine prophylaxis against angioedema attacks in HAE patients. Cinryze may interact with other drugs. Tell your doctor all medications and supplements you use. During pregnancy, Cinryze should be used only if prescribed. It is unknown if this drug passes into breast milk. Consult your doctor before breastfeeding.

Our Cinryze (c1 esterase inhibitor [human]) Freeze Dried Powder Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

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 severe 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, stomach pain;
  • altered sense of taste;
  • 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

SIDE EFFECTS: Headache may occur. Other side effects are uncommon. If you notice any unusual side effects, tell your doctor or pharmacist promptly.

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

The only serious adverse reaction observed in clinical studies of CINRYZE was cerebrovascular accident.

The most common adverse reactions observed were headache, nausea, rash, and vomiting.

Because CINRYZE is a therapeutic protein, there is potential for immunogenicity. Using a validated assay there was no evidence of antibody development following administration of CINRYZE. The detection of antibody formation is highly dependent on the sensitivity and specificity of the assay. Additionally, the observed incidence of anti-C1 Esterase Inhibitor antibody positivity in an assay may be influenced by several factors including assay methodology, sample handling, timing of sample collection, concomitant medications, and underlying disease. For these reasons, comparison of the incidence of antibody development across products cannot be made.

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 the randomized, placebo-controlled, crossover, routine prophylaxis trial.

There were no serious adverse reactions in the randomized, placebo-controlled, crossover, routine prophylaxis trial.

Adverse reactions in the randomized, placebo-controlled, crossover, routine prophylaxis trial (n=24) that occurred in at least two subjects ( ≥ 8%) receiving CINRYZE are given in the following table:

Table 2: Adverse Reactions in the Randomized, Placebo-Controlled, Crossover, Routine Prophylaxis Trial

Adverse Reaction Number of Adverse Reactions Number of Subjects
(N = 24)
Rash 8 5
Headache 4 4
Pruritus 2 2
Vomiting 2 2

In an open-label follow-on trial, 146 patients received a median of 243.5 days of CINRYZE (maximum = 959 days).

The most common adverse reaction observed was headache. No patients were discontinued due to an adverse reaction.

Adverse reactions in the open-label follow-on trial (n=146) that occurred in at least three subjects ( ≥ 2%) receiving CINRYZE, are given in the following table:

Table 3 : Adverse Reactions in the Open-Label Follow-On Trial

Adverse Reaction Number (%) of Subjects
(N=146) with Adverse Reaction
Number (%) of Infusion Days
(N=11,435) with Adverse Reaction
Headache 28 (19) 62 (0.5)
Nausea 26 (18) 29 (0.3)
Rash 15 (10) 30 (0.3)
Vomiting 15 (10) 17 (0.1)
Pyrexia 7 (5) 7 ( < 0.1)
Catheter Site Pain 4 (3) 5 ( < 0.1)
Dizziness 3 (2) 4 ( < 0.1)
Erythema 3 (2) 3 ( < 0.1)
Pruritus 3 (2) 4 ( < 0.1)

More than 14,000 doses of CINRYZE have been administered to over 260 different patients in all completed, controlled and open-label clinical studies. All patients who were evaluated were found negative for seroconversion to parvovirus B19, Hepatitis B, Hepatitis C and HIV. (See WARNINGS AND PRECAUTIONS, Transmissible Infectious Agents)

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 inflammation or hematoma at the infusion site) and hypersensitivity.

Postmarketing thromboembolic events have been reported, including catheter-related and deep venous thromboses, transient ischemic attack, and stroke.

Read the entire FDA prescribing information for Cinryze (C1 Esterase Inhibitor [Human] Freeze Dried Powder) »

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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. Patient Discussions FAQs

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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