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Cinryze

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Cinryze

Warnings
Precautions

WARNINGS

Included as part of the PRECAUTIONS section.

PRECAUTIONS

Hypersensitivity Reactions

Severe hypersensitivity reactions may occur. The signs and symptoms of hypersensitivity reactions may include the appearance of hives, urticaria, tightness of the chest, wheezing, hypotension and/or anaphylaxis experienced during or after injection of CINRYZE.

Consider treatment methods carefully, because hypersensitivity reactions may have symptoms similar to HAE attacks.

In case of hypersensitivity, discontinue CINRYZE infusion and institute appropriate treatment. Have epinephrine immediately available for treatment of acute severe hypersensitivity reaction. (See PATIENT INFORMATION)

Thromboembolic Events

Serious arterial and venous thromboembolic (TE) events have been reported at the recommended dose of C1 Esterase Inhibitor (Human) products, including CINRYZE, following administration in patients with HAE. Risk factors may include presence of an indwelling venous catheter/access device, prior history of thrombosis, underlying atherosclerosis, use of oral contraceptives, certain androgens, morbid obesity, and immobility. Benefits of CINRYZE for routine prophylaxis of HAE attacks should be weighed against the risks of TE events in patients with underlying risk factors. Monitor patients with known risk factors for TE events during and after CINRYZE administration.

TE events have been reported following administration of a C1 Esterase Inhibitor (Human) product when used offlabel at higher than labeled doses2,3. (see Section titled Animal Toxicology and/or Pharmacology)

In an open-label trial further investigating the use of CINRYZE for prevention (n=146) of HAE attacks, 5 serious thromboembolic events (including myocardial infarction, deep vein thrombosis, pulmonary embolism and 2 events of cerebrovascular accident) occurred. Subjects had underlying risk factors for thromboembolic events.

Transmissible Infectious Agents

Because CINRYZE is made from human blood, it may carry a risk of transmitting infectious agents, e.g. viruses, and, theoretically, the Creutzfeldt-Jakob disease (CJD) agent [11]. ALL infections thought by a physician possibly to have been transmitted by CINRYZE should be reported by the physician or other healthcare provider to Shire Medical Information. [1-866-888-0660]. The physician should discuss the risks and benefits of this product with the patient, before prescribing or administering it to the patient. (See PATIENT INFORMATION)

REFERENCES

2. Arzneimittelkommission der Deutschen Aertzteschaft. Schwerwiegende Thrombenbildung nach Berinert HS. Dtsch Aerztebl. 2000; 97:B-864

3. Horstick, G et al, 2001. Circulation 104:3125-3131

Patient Counseling Information

See FDA-approved patient labeling (Information for the Patient).

  • Inform patients to immediately report the following to their physician:
    • Signs of allergic-type hypersensitivity reactions including hives (itchy white elevated patches), tightness of the chest, wheezing, hypotension and anaphylaxis. Advise patients to discontinue use of CINRYZE and contact their physicians if these symptoms occur.
    • Signs of a thromboembolic event including pain and/or swelling of an arm or leg with warmth over the affected area, discoloration of an arm or leg, unexplained shortness of breath, chest pain or discomfort that worsens on deep breathing, unexplained rapid pulse, numbness or weakness on one side of the body.
  • Advise patients with known risk factors for thromboembolic events that they may be at increased risk for these events.
  • Advise female patients to notify their physician if they become pregnant or intend to become pregnant during their routine prevention with CINRYZE.
  • Advise patients to notify their physician if they are breastfeeding or plan to breastfeed.
  • Based on their current regimen, advise patients to bring an adequate supply of CINRYZE for routine prevention when traveling.
  • Advise patient that, because CINRYZE is made from human blood, it may carry a risk of transmitting infectious agents, e.g. viruses, and, theoretically, the Creutzfeldt-Jakob disease (CJD) agent. The risk of transmitting disease has been reduced, but not eliminated, by carefully selecting blood donors, testing donors for infections, and inactivating or removing most viruses during the manufacturing process.
  • Inform patients of the risks and benefits of CINRYZE before prescribing or administering to the patient.

Nonclinical Toxicology

Carcinogenesis, Mutagenesis, Impairment Of Fertility

No animal studies have been completed to evaluate the effects of CINRYZE on carcinogenesis, mutagenesis, and impairment of fertility.

Use In Specific Populations

Pregnancy

Pregnancy Category C

No animal data are available. No adequate and well-controlled studies were conducted in pregnant women. It is not known whether CINRYZE can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. CINRYZE should be given to a pregnant woman only if clearly needed.

Labor And Delivery

The safety and effectiveness of CINRYZE administration prior to or during labor and delivery have not been established. Use only if clearly needed.

Nursing Mothers

It is not known whether CINRYZE is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when CINRYZE is administered to a nursing woman.

Pediatric Use

The safety and effectiveness of CINRYZE have not been established in neonates, infants, or children. Three of the 24 subjects in the randomized, placebo-controlled, crossover, routine prophylaxis trial, were under the age of 18 years (9, 14, and 16 years of age).

Geriatric Use

The randomized, placebo-controlled, crossover, routine prophylaxis trial did not include sufficient numbers of subjects 65 years of age and older to determine whether they respond differently from younger subjects.

Last reviewed on RxList: 12/2/2014
This monograph has been modified to include the generic and brand name in many instances.

Warnings
Precautions
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