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EGRIFTA(tesamorelin)kit

2015-01-12 18:35:19 来源: 作者: 【大中小】浏览:621次评论:0条

HIGHLIGHTS OF PRESCRIBING INFORMATION
Egrifta (tesamorelin for injection) These highlights do not include all the information needed to use Egrifta safely and effectively. see full prescribing information for Egrifta. Egrifta (tesamorelin) KIT for SUBCUTANEOUS use. Initial U.S. Approval: 2010
INDICATIONS AND USAGE
EGRIFTA® is a growth hormone releasing factor (GRF) analog indicated for the reduction of excess abdominal fat in HIV-infected patients with lipodystrophy. (1) Limitations of use (1): Long-term cardiovascular benefit and safety of EGRIFTA® have not been studied. Not indicated for weight loss management (weight neutral effect). There are no data to support improved compliance with anti-retroviral therapies in HIV-positive patients taking EGRIFTA®.
DOSAGE AND ADMINISTRATION
Recommended dose of EGRIFTA® is 2 mg injected subcutaneously once daily. (2.1)
DOSAGE FORMS AND STRENGTHS
Each vial of EGRIFTA® contains 1 mg of tesamorelin (3). Another vial contains the reconstitution diluent, Sterile Water for Injection. (3)
CONTRAINDICATIONS
Disruption of the hypothalamic-pituitary axis due to hypophysectomy, hypopituitarism or pituitary tumor/surgery, head irradiation or head trauma (4.1) Active malignancy (4.2) Known hypersensitivity to tesamorelin and/or mannitol (4.3) Pregnancy (4.4)
WARNINGS AND PRECAUTIONS
Neoplasms: Preexisting malignancy should be inactive and its treatment complete prior to starting EGRIFTA® therapy. (5.1) Elevated IGF-1: Monitor regularly in all patients. Consider discontinuation in patients with persistent elevations. (5.2) Fluid retention: May include edema, arthralgia, and carpal tunnel syndrome. (5.3) Glucose intolerance: May develop with EGRIFTA® use. eva luate glucose status prior to and during therapy with EGRIFTA®. (5.4) Hypersensitivity reactions (e.g., rash, urticaria): Advise patients to seek immediate medical attention if suspected. (5.5) Injection site reactions: Advise patients to rotate sites. (5.6) Acute critical illness: Consider discontinuation. (5.7)
ADVERSE REACTIONS
Most commonly reported adverse reactions (>5% and more frequent than placebo): Arthralgia, injection site erythema, injection site pruritis, pain in extremity, peripheral edema, and myalgia. (6.1) To report SUSPECTED ADVERSE REACTIONS, contact at or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
DRUG INTERACTIONS
Cytochrome P450-metabolized drugs: Monitor carefully if used with EGRIFTA®. (7.1)
USE IN SPECIFIC POPULATIONS
Nursing mothers: HIV-l infected mothers should not human milk-feed to avoid potential postnatal transmission of HIV-1. (8.2) Pediatric use: Safety and efficacy not established. (8.3)
See 17 for PATIENT COUNSELING INFORMATION and FDA-approved patient labeling
Revised: 07/2011

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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 General Dosing Information

2.2 Reconstitution Instructions

3 DOSAGE FORMS AND STRENGTHS

4 CONTRAINDICATIONS

4.1 Disruption of the Hypothalamic-pituitary Axis

4.2 Active Malignancy

4.3 Hypersensitivity

4.4Pregnancy

5 WARNINGS AND PRECAUTIONS

5.1 Neoplasms

5.2 Elevated IGF-1

5.3 Fluid Retention

5.4 Glucose Intolerance

5.5Hypersensitivity Reactions

5.6 Injection Site Reactions

5.7Acute Critical Illness

6 ADVERSE REACTIONS

6.1 Clinical Trial Experience

6.2Immunogenicity

7 DRUG INTERACTIONS

7.1Cytochrome P450-Metabolized Drugs

7.2 11β-Hydroxysteroid Dehydrogenase Type 1 (11βHSD-1)

8 USE IN SPECIFIC POPULATIONS

8.1 Pregnancy

8.2 Nursing Mothers

8.3 Pediatric Use

8.4 Geriatric Use

8.5 Renal and Hepatic Impairment

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

14 CLINICAL STUDIES

16 HOW SUPPLIED/STORAGE AND HANDLING

17 PATIENT COUNSELING INFORMATION

PATIENT INFORMATION

PATIENT INSTRUCTIONS FOR USE

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

FULL PRESCRIBING INFORMATION

1 INDICATIONS AND USAGE

EGRIFTA® (tesamorelin for injection) is indicated for the reduction of excess abdominal fat in HIV-infected patients with lipodystrophy [see Clinical Studies (14)].

Limitations of Use:

Since the long-term cardiovascular safety and potential long-term cardiovascular benefit of EGRIFTA® treatment have not been studied and are not known, careful consideration should be given whether to continue EGRIFTA® treatment in patients who do not show a clear efficacy response as judged by the degree of reduction in visceral adipose tissue measured by waist circumference or CT scan.
EGRIFTA® is not indicated for weight loss management (weight neutral effect).
There are no data to support improved compliance with anti-retroviral therapies in HIV-positive patients taking EGRIFTA®.

2 DOSAGE AND ADMINISTRATION

2.1 General Dosing Information

The recommended dose of EGRIFTA® is 2 mg injected subcutaneously once a day.

The recommended injection site is the abdomen. Injection sites should be rotated to different areas of the abdomen. Do not inject into scar tissue, bruises or the navel.

2.2 Reconstitution Instructions

Instructions for reconstituting EGRIFTA® are provided in the INSTRUCTIONS FOR USE leaflet enclosed in the EGRIFTA® medication box and in the injection box.

If not used immediately, the reconstituted EGRIFTA® solution should be discarded. Do not freeze or refrigerate the reconstituted EGRIFTA® solution.

Reconstituted EGRIFTA® solution should always be inspected visually for particulate matter and discoloration prior to administration. EGRIFTA® must be injected only if the solution is clear, colorless and without particulate matter.

3 DOSAGE FORMS AND STRENGTHS

EGRIFTA® (tesamorelin for injection) is supplied in a vial containing 1 mg of tesamorelin as a lyophilized powder. The diluent (Sterile Water for Injection, 10 mL) is provided in a separate vial.