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Included as part of the PRECAUTIONS section.

Sensitivity

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 (c1 esterase inhibitor [human] freeze dried powder) .

Because hypersensitivity reactions may have symptoms similar to HAE attacks, treatment methods should be carefully considered.

In case of hypersensitivity, CINRYZE (c1 esterase inhibitor [human] freeze dried powder) infusion should be discontinued and appropriate treatment instituted. Epinephrine should be immediately available for treatment of acute severe hypersensitivity reaction. (See Patient Counseling Information)

Thrombotic Events

Thrombotic events have been reported in association with C1 esterase inhibitor products when used off-label at high doses.⁶ Animal studies have supported a concern about the risk of thrombosis from intravenous administration of C1 esterase inhibitor products.⁷ (see OVERDOSAGE and Animal Toxicology and/or Pharmacology)

Transmissible Infectious Agents

Because CINRYZE (c1 esterase inhibitor [human] freeze dried powder) is made from human blood, it may carry a risk of transmitting infectious agents, e.g. viruses, and, theoretically, the Creutzfeldt-Jakob (CJD) agent. ALL infections thought by a physician possibly to have been transmitted by CINRYZE (c1 esterase inhibitor [human] freeze dried powder) should be reported by the physician or other healthcare provider to Lev Pharmaceuticals, Inc [(877) 945-1000]. The physician should discuss the risks and benefits of this product with the patient, before prescribing or administering it to the patient (See Patient Counseling Information).

Patient Counseling Information

Allergic-type Hypersensitivity Reactions

Allergic-type hypersensitivity reactions are possible. Inform patients of the early signs of hypersensitivity reactions [including hives (itchy white elevated patches), tightness of the chest, wheezing, hypotension] and anaphylaxis. Advise patients to discontinue use of CINRYZE (c1 esterase inhibitor [human] freeze dried powder) and contact their physicians if these symptoms occur.

Pregnancy

Advise female patients to notify their physician if they become pregnant or intend to become pregnant during their routine prevention with CINRYZE (c1 esterase inhibitor [human] freeze dried powder) .

Nursing

Advise patients to notify their physician if they are breastfeeding or plan to breastfeed.

Usage While Traveling

Based on their current regimen, advise patients to bring an adequate supply of CINRYZE (c1 esterase inhibitor [human] freeze dried powder) for routine prevention when traveling. Advise patients to consult with their healthcare professional prior to travel.

Transmissible Infectious Agents

Advise patient that, because CINRYZE (c1 esterase inhibitor [human] freeze dried powder) is made from human blood, it may carry a risk of transmitting infectious agents, e.g. viruses, and , theoretically, the Creutzfeldt-Jakob (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 (c1 esterase inhibitor [human] freeze dried powder) 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 (c1 esterase inhibitor [human] freeze dried powder) 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 (c1 esterase inhibitor [human] freeze dried powder) can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. CINRYZE (c1 esterase inhibitor [human] freeze dried powder) should be given to a pregnant woman only if clearly needed.

Labor and Delivery

The safety and effectiveness of CINRYZE (c1 esterase inhibitor [human] freeze dried powder) 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 (c1 esterase inhibitor [human] freeze dried powder) is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when CINRYZE (c1 esterase inhibitor [human] freeze dried powder) is administered to a nursing woman.

Pediatric Use

The safety and effectiveness of CINRYZE (c1 esterase inhibitor [human] freeze dried powder) have not been established in neonates, infants, or children. Three of the 24 subjects in Study LEVP2005-1/B were under the age of 18 years (9, 14, and 16 years of age).

Geriatric Use

The clinical study LEVP2005-1/B did not include sufficient numbers of subject 65 years of age and older to determine whether they respond differently from younger subjects.

REFERENCES

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

7. Horstick, G et al, 2002. Circulation 104:3125-3131

Last reviewed on RxList: 10/2/2009
This monograph has been modified to include the generic and brand name in many instances.