Cinryze

DRUG DESCRIPTION

CINRYZE (c1 esterase inhibitor human freeze dried powder) (C1 esterase inhibitor [Human]) is a sterile, stable, lyophilized preparation of C1 esterase inhibitor derived from human plasma. CINRYZE (c1 esterase inhibitor human freeze dried powder) is manufactured from human plasma purified by a combination of filtration and chromatographic procedures. The specific activity of CINRYZE (c1 esterase inhibitor human freeze dried powder) is 4.0 9.0 units/mg protein. The purity is ? 90% human C1 esterase inhibitor. Following reconstitution with 5 mL of Sterile Water for Injection, USP, each vial contains approximately 500 units of functionally active C1 esterase inhibitor, pH 6.6 - 7.4, and an osmolality between 200 400 mosmol/kg. One unit (U) of CINRYZE (c1 esterase inhibitor human freeze dried powder) corresponds to the mean quantity of C1 esterase inhibitor present in 1 ml of normal fresh plasma.

CINRYZE (c1 esterase inhibitor human freeze dried powder) , when reconstituted with 5 mL of Sterile Water for Injection contains the following excipients: 4.1 mg/mL sodium chloride, 21 mg/mL sucrose, 2.6 mg/mL trisodium citrate, 2.0 mg/mL L-Valine, 1.2 mg/mL L-Alanine, and 4.5 mg/mL L-Threonine.

The following manufacturing steps are designed to reduce the risk of viral transmission:

  • Screening donors at U.S. licensed blood collection centers to rule out infection with Human Immunodeficiency Virus (HIV-1/HIV-2), Hepatitis B Virus, or Hepatitis C Virus.
  • Testing plasma pools by in-process NAT for parvovirus B19 via minipool testing and the limit of B19 in the manufacturing pool is set not to exceed 104 IU of B19 DNA per mL.
  • Use of two independent viral reduction steps in the manufacture of CINRYZE (c1 esterase inhibitor human freeze dried powder) : pasteurization (heat treatment at 60C for 10 hours in solution with stabilizers) and nanofiltration through two sequential 15 nm Planova filters.

These viral reduction steps, along with a step in the manufacturing process, PEG precipitation, have been validated in a series of in vitro experiments for their capacity to inactivate/remove a wide range of viruses of diverse physicochemical characteristics including: Human Immunodeficiency Virus (HIV), Hepatitis A Virus (HAV), and the following model viruses: Bovine Viral Diarrhea Virus (BVDV) as a model virus for HCV, Canine Parvovirus (CPV) as a model virus for Parvovirus B19, Pseudorabies Virus (PRV) as a model virus for large enveloped DNA viruses (e.g. herpes virus). Total mean log10 reductions are shown in Table 3.

Table 3: Log10 Virus Reduction Factor for Selected Viruses

Process step Log10 Virus Reduction
Enveloped viruses Non-enveloped viruses
HIV BVDV PRV HAV CPV
PEG precipitation 5.1 0.2 4.5 0.3 6.0 0.3 2.8 0.2 4.2 0.2
Pasteurization > 6.1 0.2 > 6.7 0.3 > 6.7 0.2 2.8 0.3 0.1 0.3
Nanofiltration > 5.6 0.2 > 5.5 0.2 > 6.4 0.3 > 4.9 0.2 > 4.5 0.3
Total reduction > 16.8 > 16.7 > 19.1 > 10.5 > 8.7

What are the possible side effects of complement C1 esterase inhibitor (Berinert, Cinryze)?

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:

  • sudden numbness or weakness, especially on one side of the body;
  • sudden headache, confusion, problems with vision, speech, or balance;
  • stomach pain or...

Read All Potential Side Effects and See Pictures of Cinryze

What are the precautions when taking c1 esterase inhibitor [human] freeze dried powder (Cinryze)?

Before using C1-inhibitor, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: blood clots (such as in the lungs, legs).

This medication is made from human blood. Even though the blood is carefully tested and this medication goes through a special manufacturing process, there is an extremely small chance that you may get infections from the medication (for example, virus infections such as hepatitis). Consult your doctor or pharmacist for more information.

Before having surgery, tell your...

Read All Potential Precautions of Cinryze


Cinryze Consumer (continued)

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.

PRECAUTIONS: Before using C1-inhibitor, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: blood clots (such as in the lungs, legs).

This medication is made from human blood. Even though the blood is carefully tested and this medication goes through a special manufacturing process, there is an extremely small chance that you may get infections from the medication (for example, virus infections such as hepatitis). Consult your doctor or pharmacist for more information.

Before having surgery, tell your doctor or dentist that you are using this medication.

During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor.

It is not known whether this drug passes into breast milk. Consult your doctor before breast-feeding.


Cinryze Patient Information Including Side Effects

Brand Names: Berinert, Cinryze

Generic Name: complement C1 esterase inhibitor (Pronunciation: KOM ple ment C1 ES ter ase in HIB it or)

  • What is complement C1 esterase inhibitor (Cinryze)?
  • What are the possible side effects of complement C1 esterase inhibitor (Cinryze)?
  • What is the most important information I should know about complement C1 esterase inhibitor (Cinryze)?
  • What should I discuss with my health care provider before using complement C1 esterase inhibitor (Cinryze)?
  • How should I use complement C1 esterase inhibitor (Cinryze)?
  • What happens if I miss a dose (Cinryze)?
  • What happens if I overdose (Cinryze)?
  • What should I avoid while using complement C1 esterase inhibitor (Cinryze)?
  • What other drugs will affect complement C1 esterase inhibitor (Cinryze)?
  • Where can I get more information?

What is complement C1 esterase inhibitor (Cinryze)?

Complement C1 esterase inhibitor is a man-made form of a protein that occurs naturally in the bloodstream and helps control inflammation in the body. In people with hereditary angioedema, complement C1 esterase inhibitor does not function properly or occurs in low levels.

Complement C1 esterase inhibitor is used to prevent attacks of angioedema in people with hereditary angioedema.

Complement C1 esterase inhibitor may also be used for other purposes not listed in this medication guide.

What are the possible side effects of complement C1 esterase inhibitor (Cinryze)?

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:

  • 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 or swelling in one or both legs.

Less serious side effects may include:

  • cold symptoms such as stuffy nose, sneezing, sore throat;
  • mild itching or rash;
  • mild headache; or
  • back pain.

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 the most important information I should know about complement C1 esterase inhibitor (Cinryze)?

You should not use this medication if you have ever had an allergic reaction to it, or if you have ever had any life-threatening allergic reaction.

If you have certain conditions, you may need a dose adjustment or special tests to safely use this medication. Before using complement C1 esterase inhibitor, tell your doctor if you have a history of stroke or blood clot.

Do not self-inject this medicine if you do not fully understand how to give the injection and properly dispose of needles, IV tubing, and other items used in giving the medicine. This medication comes with patient instructions for safe and effective use. Follow these directions carefully. Ask your doctor or pharmacist if you have any questions.

If you are using the injections at home, be sure you understand how to properly mix and store the medication. Do not mix the medicine until you are ready to give the injection.

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.

Other serious side effects may include sudden numbness or weakness, chest pain, confusion, pain or swelling, and problems with vision, speech, or balance.

Complement C1 esterase inhibitor is made from human plasma (part of the blood) and may contain viruses and other infectious agents that can cause disease. Although donated human plasma is screened, tested, and treated to reduce the risk of it containing anything that could cause disease, there is still a small possibility it could transmit disease. Talk with your doctor about the risks and benefits of using this medication.

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