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CINRYZE(c1 esterase inhibitor (human)) injection, powder, ly

2014-06-20 14:12:01 来源: 作者: 【大中小】浏览:328次评论:0条

HIGHLIGHTS OF PRESCRIBING INFORMATION

These highlights do not include all the information needed to use CINRYZE™ safely and effectively. See full prescribing information for CINRYZE.
CINRYZE™ (C1 Esterase Inhibitor [Human])
For Intravenous Use, Freeze-Dried Powder for Reconstitution
Initial U.S. Approval: 2008

RECENT MAJOR CHANGES

Warnings and Precautions, Thrombotic Events (5.2)
11/2010
Adverse Reactions, Postmarketing Experience (6.2)
11/2010

INDICATIONS AND USAGE

CINRYZE is a C1 esterase inhibitor indicated for routine prophylaxis against angioedema attacks in adolescent and adult patients with Hereditary Angioedema (HAE).

DOSAGE AND ADMINISTRATION

Intravenous Use Only
Prior to reconstitution, protect from light.
Store at 2 °C - 25 °C (36 °F - 77 °F). Do not freeze.
To obtain the required dose, reconstitute 2 CINRYZE vials with 2 vials Sterile Water for Injection, USP (5 mL each) using aseptic sterile technique.
Administer at room temperature within 3 hours of reconstitution.

Routine Prophylaxis Dosing
Indication	Dose	Initial Infusion rate	Maintenance infusion rate (if tolerated)
Routine prophylaxis against HAE attacks	1,000 Units Intravenous every 3 or 4 days	1 mL/min (10 min)	1 mL/min (10 min)

DOSAGE FORMS AND STRENGTHS

Approximately 500 Units (lyophilized) in an 8 mL vial.

CONTRAINDICATIONS

Patients who have manifested life-threatening immediate hypersensitivity reactions, including anaphylaxis, to the product (4).

WARNINGS AND PRECAUTIONS

Hypersensitivity reactions may occur. Epinephrine should be immediately available to treat any acute severe hypersensitivity reactions (5.1).
Thrombotic events have been reported in patients receiving Cinryze for routine prophylaxis. Thrombotic events also have been reported in patients receiving off-label high dose C1 esterase inhibitor therapy (5.2). Monitor patients with known risk factors for thrombotic events.
CINRYZE is made from human plasma and may contain infectious agents e.g. viruses and, theoretically, the Creutzfeldt-Jakob disease agent. (5.3)

ADVERSE REACTIONS

In the clinical trial, the most common adverse reactions observed by ≥ 5% of subjects after receiving CINRYZE were upper respiratory tract infection, sinusitis, rash, and headache. (5.1, 6.1)

To report SUSPECTED ADVERSE REACTIONS, contact ViroPharma Biologics, Inc. at (877) 945-1000 or FDA at 1-800-FDA-1088 orwww.fda.gov/medwatch.

DRUG INTERACTIONS

No drug interaction studies have been conducted.

USE IN SPECIFIC POPULATIONS

Pregnancy: No human or animal data. Use only if clearly needed. (8.1)

See 17 for PATIENT COUNSELING INFORMATION and the FDA-approved Medication Guide

Revised: 11/2010

Back to Highlights and Tabs

FULL PRESCRIBING INFORMATION: CONTENTS*

*Sections or subsections omitted from the full prescribing information are not listed

1 INDICATIONS AND USAGE

2 DOSAGE AND ADMINISTRATION

2.1 Routine prophylaxis against HAE Attacks

2.2 Instructions for Use

2.3 Preparation and Handling

2.4 Administration

3. DOSAGE FORMS AND STRENGTHS

4 CONTRAINDICATIONS

5 WARNINGS AND PRECAUTIONS

5.1 Sensitivity

5.2 Thrombotic Events

5.3 Transmissible Infectious Agents

6 ADVERSE REACTIONS

6.1 Clinical Trials Experience

6.2 Postmarketing Experience

7 DRUG INTERACTIONS

8 USE IN SPECIFIC POPULATIONS

8.1 Pregnancy

8.2 Labor and Delivery

8.3 Nursing Mothers

8.4 Pediatric Use

8.5 Geriatric Use

10 OVERDOSAGE

11 DESCRIPTION

12 CLINICAL PHARMACOLOGY

12.1 Mechanism of Action

12.2 Pharmacodynamics

12.3 Pharmacokinetics

13 NONCLINICAL TOXICOLOGY

13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility

13.2 Animal Toxicology and/or Pharmacology

14 CLINICAL STUDIES

14.1 Routine Prophylaxis Trial LEVP2005-1/B

15 REFERENCES

16 HOW SUPPLIED/STORAGE AND HANDLING

17 PATIENT COUNSELING INFORMATION

17.1 Allergic-type Hypersensitivity Reactions

17.2 Pregnancy

17.3 Nursing

17.4 Usage While Traveling

17.5 Transmissible Infectious Agents

FULL PRESCRIBING INFORMATION

CINRYZE™(C1 Esterase Inhibitor [Human])

Freeze dried powder

1 INDICATIONS AND USAGE

CINRYZE is a C1 esterase inhibitor indicated for routine prophylaxis against angioedema attacks in adolescent and adult patients with Hereditary Angioedema (HAE).

2 DOSAGE AND ADMINISTRATION

For Intravenous Use, Freeze-Dried powder for Reconstitution.

2.1 Routine prophylaxis against HAE Attacks

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 is administered at an injection rate of 1 mL per minute.

Table 1 Routine Prophylaxis Dosing
Indication	Dose	Initial Infusion rate	Maintenance infusion rate (if tolerated)
Routine prophylaxis against HAE attacks	1,000 Units Intravenous every 3 or 4 days	1 mL/min (10 min)	1 mL/min (10 min)

2.2 Instructions for Use

The procedures below are provided as general guidelines for the reconstitution and administration of CINRYZE. Use either the Mix2Vial® transfer device or a commercially available double-ended needle.

CINRYZE IS A LYOPHILIZED POWDER THAT IS SUPPLIED IN A VACUUM-SEALED VIAL.

Always work on a clean surface and wash your hands before performing the following procedures.

Reconstitution, product administration, and handling of the administration set and needles must be done with caution. Percutaneous puncture with a needle contaminated with blood can transmit infectious viruses including HIV (AIDS) and hepatitis. Obtain immediate medical attention if injury occurs. Place needles in a sharps container after single use. Discard all equipment, including any reconstituted CINRYZE in an appropriate container.

2.3 Preparation and Handling

Prior to reconstitution, CINRYZE should be protected from light.
CINRYZE should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. The reconstituted solution should be colorless to slightly blue, and free from visible particles. Do not use if turbid or discolored.
The CINRYZE vial is for single use only. CINRYZE contains no preservative. Any vial that has been entered should be used promptly. Partially used vials should be discarded in accordance with biohazard procedures.
Do not mix CINRYZE with other materials.
Do not use if frozen.
Do not use after expiration date.

Reconstitution:

Two vials of reconstituted CINRYZE are combined for a single dose. Sterile Water for Injection, USP, is required and not supplied with CINRYZE.

Aseptic technique should be used during the reconstitution procedure.
Bring the CINRYZE (powder) and Sterile Water for Injection, USP (diluent) (not supplied) to room temperature if refrigerated.
Remove caps from the CINRYZE and diluent vials.
Cleanse stoppers with an alcohol wipe or swab, and allow them to dry prior to use.
Remove protective covering from the top of the Mix2Vial transfer device package. Do not remove the device from the package.
Note: Diluent vial must be accessed prior to CINRYZE vial to prevent loss of vacuum. Place diluent on a flat surface and insert the blue end of the device into the diluent vial, pushing down until the spike penetrates through the center of the diluent vial stopper and the device snaps in place (Figure 1). The Mix2Vial transfer device must be positioned completely vertical prior to penetrating the stopper closure.
Remove the plastic package and discard it (Figure 2). Take care not to touch the exposed end of the device.
Place vial of CINRYZE on a flat surface. Invert diluent vial containing 5 mL Sterile Water for Injection, USP, and insert the clear end into the CINRYZE vial, pushing down until the spike penetrates the rubber stopper and the device snaps into place. The Mix2Vial transfer device must be positioned completely vertical prior to penetrating the stopper closure. The Sterile Water for Injection, USP will automatically flow into the vial of CINRYZE (Figure 3), because the vacuum in the vial will draw in the diluent. If there is no vacuum in the vial, do not use the product.
Gently swirl (do not shake) the CINRYZE vial until all powder is dissolved. Be sure that CINRYZE is completely dissolved (Figure 4). Disconnect the Sterile Water for Injection, USP vial by turning it counterclockwise (Figure 5). Do not remove the clear end of the Mix2Vial transfer device from the vial of CINRYZE.

One vial of reconstituted CINRYZE contains 5 mL of C1 esterase inhibitor at a concentration of 100 Units/mL. Reconstitute two vials of CINRYZE for one dose. Repeat steps 1 to 9 above using an additional package containing a Mix2Vial transfer device to reconstitute the second of two vials of CINRYZE. Do not reuse the Mix2Vial transfer device.