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Generic name: C1 Esterase Inhibitor (Human)
Dosage form: injection, powder, lyophilized

Cinryze Freeze Dried Powder (C1 Esterase Inhibitor - Human) (Freeze-Dried powder for restructuring) is a sterile, stable, lyophilized (by freezing in high vacuum) preparation of C1 esterase inhibitor found in human plasma. CINRYZE is produced from human plasma purified by a combination of filtration and chromatographic procedures. Cinryze Freeze Dried Powder (C1 Esterase Inhibitor - Human) is the first and only Food and Drug Administration (FDA)-approved C1 esterase avoidance therapy for routine stoppage of HAE attacks in infants and adults. Integrated C1 esterase inhibitor is used in people suffering from hereditary angioedema. The Cinryze brand is used to inhibit attacks of angioedema. This drug works by helping to control inflammation and parts of the immune system. It also helps to prevent the swelling and painful attacks that occur with HAE.

Drug Description:

The specific enterprise of CINRYZE is 4.0 – 9.0 units/mg protein. The purity is ≥ 90% human C1 esterase inhibitor. Following restructuring with 5 mL of Sterile Water for Injection, 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 resembles to the mean quantity of C1 esterase inhibitor present in 1 mL of normal fresh plasma.

CINRYZE, when altered with 5 mL of Sterile Water for Injection, It contains the following diluents: 2.0 mg/mL L-Valine, 21 mg/mL sucrose, 2.6 mg/mL trisodium citrate, 4.1 mg/mL sodium chloride, 1.2 mg/mL LAlanine, and 4.5 mg/mL L-Threonine.

Drug Product Composition:

Ingredient

Amount per ml (w/v), Reconstituted in 5 ml

Function of ingredient

C1-inhibitor (U/ml)

100

Active ingredient

Trisodium citrate (mg/ml)

2.58

Buffer

Sodium Chloride (mg/ml)

4.09

Tonicity

Sucrose (mg/ml)

20.54

 

Valine (mg/ml)

1.99

 

Alanine (mg/ml)

1.16

 

Threonine (mg/ml)

4.53

 

 

Indications:

CINRYZE is a C1 esterase inhibitor which is indicated for daily measure taken to prevent diseases against angioedema offense violate in teenager and adult patients with Hereditary Angioedema (HAE)

Dosage:

  • The drug is recommendable for injecting directly into the vein only.
  • A dosage of 1,000 Units CINRYZE is to be executed every 3 or 4 days for routine prevention against angioedema attacks in HAE patients.
  • Administered CINRYZE at an injection rate of 1 mL per minute.

Dosage Forms and Strengths:

  • CINRYZE (Freeze-Dried powder for Reconstitution) is a lyophilized (dried by freezing in high vacuum) formation available in a single-use vial that contains 500 Units (U) human C1 esterase inhibitor.
  • Two transformed vials are supposed to use for making a single, 1,000 Units dose.
  • Reconstruction of each vial should be with 5 mL Sterile Water for Injection, (diluent).

Over dosage:

The maximum dose directed in clinical studies are 4000 Units which are given over nearly 5 hours (an average dose of 57 Units/kg) and 9000 Units dosage are given over a 7 day period. There is hardly any over dosage of CINRYZE administrated during clinical studies.

Using Guide for CINRYZE:

  • A guidance patient leaflet is available with CINRYZE drug. Refer to the pharmacist in case of questions about the drug.
  • CINRYZE is found in injection form at your doctor's clinic or hospital. In case of consuming CINRYZE at home, a health care provider will teach you how to consume it. Be sure you follow the instructions and understand how to use CINRYZE. Follow the procedures taught to you while consuming a dose. In case of any queries contact your health care provider.
  • The result after mixing this drug, CINRYZE should be colorless to lightly blue. Avoid using CINRYZE drug if it contains particles, is opaque, discolored, or if the package is broken or damaged.
  • CINRYZE should be mixed before its use. The mixed solution is suggested to be used within 3 hours post mixing.
  • Keep this drug/mixture, as well as syringes and needles, away from children and pets. Avoid reusing needles, syringes, or other materials. Follow the guide book for disposal of the used material. Follow all local rules for disposal.
  • If you miss a dose of CINRYZE, intake it as soon as possible. If the time period of your next dosage is near skip the missed drug and follow the routine intake dosage.

Storage:

  • Store CINRYZE drug in a refrigerator or at room temperature between 36° to 77°F (2° to 25°C).
  • Keep CINRYZE in the original carton (original package) to protect it from light.
  • Avoid using CINRYZE after the expiration date on the vial.

Side Effects:

  • All medications have their side effects, but many people have none or minor side effects by the same drug consumption. Side effects like: Headache; stuffy or runny nose are very common after injection of CINRYZE drug.
  • Some may seek SEVERE side effects which consist of: Severe allergic reactions (rash; itching; difficulty breathing or restlessness of breath; chocking in the chest; rising heartbeat; severe dizziness ; fainting; swelling of the mouth, face, lips, or tongue; blue lips or gums; uneasy breathing); symptoms of infection could include:  fever, sore throat, cough.
  • Some of the side effects that occur after the consumption of C1 esterase inhibitor (human) may not need any special medical attention. As and when your body adjusts to the medication during treatment these side effects may vanish.

Warning and Precautions

Sensitivity:

  • During or after injection of CINRYZE the patient may seek the signs and symptoms of hypersensitivity reactions which may include - appearance of hives, urticaria, chocking in the chest, wheezing, hypotension and/or anaphylaxis.
  • As hypersensitivity reactions may include symptoms similar to HAE attacks, treatment manner should be taken care off.
  • In higher case of hypersensitivity, CINRYZE immersion should be discontinued and appropriate treatment instituted. Epinephrine should be quickly available for treatment of subtle acute severe hypersensitivity reaction. 

Thrombotic Events:

  • Thrombotic events have been observed in relation with C1 esterase inhibitor products when used at high rate of consumption.

Transmissible Infectious Agents:

CINRYZE may carry risk of transmitting infectious agents, as it is made from human blood eg. Viruses. Any physical infection is to be reported to healthcare provider.