Tesamorelin

Tesamorelin
Black Box Warning
Adult Indications & Dosage
Pediatric Indications & Dosage
Contraindications
Warnings & Precautions
Adverse Reactions
Drug Interactions
Use in Specific Populations
Administration & Monitoring
Overdosage
Pharmacology
Clinical Studies
How Supplied
Images
Patient Counseling Information
Precautions with Alcohol
Brand Names
Look-Alike Names

Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]; Associate Editor(s)-in-Chief: Kiran Singh, M.D. [2]

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Black Box Warning

ConditionName: See full prescribing information for complete Boxed Warning. ConditionName: Content

Overview

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Adult Indications and Dosage

FDA-Labeled Indications and Dosage (Adult)

Indications

• EGRIFTA® (tesamorelin for injection) is indicated for the reduction of excess abdominal fat in HIV-infected patients with lipodystrophy.

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®.

Dosage

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.

DOSAGE FORMS AND STRENGTHS

• EGRIFTA® (tesamorelin for injection) is supplied in a vial containing 2 mg of tesamorelin as a lyophilized powder. The diluent (Sterile Water for Injection, USP 10 mL) is provided in a separate bottle.

Off-Label Use and Dosage (Adult)

Guideline-Supported Use

There is limited information regarding Off-Label Guideline-Supported Use of Tesamorelin in adult patients.

Non–Guideline-Supported Use

There is limited information regarding Off-Label Non–Guideline-Supported Use of Tesamorelin in adult patients.

Pediatric Indications and Dosage

FDA-Labeled Indications and Dosage (Pediatric)

There is limited information regarding FDA-Labeled Use of Tesamorelin in pediatric patients.

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Off-Label Use and Dosage (Pediatric)

Guideline-Supported Use

There is limited information regarding Off-Label Guideline-Supported Use of Tesamorelin in pediatric patients.

Non–Guideline-Supported Use

There is limited information regarding Off-Label Non–Guideline-Supported Use of Tesamorelin in pediatric patients.

Contraindications

Disruption of the Hypothalamic-pituitary Axis

• EGRIFTA® is contraindicated in patients with disruption of the hypothalamic-pituitary axis due to hypophysectomy, hypopituitarism, pituitary tumor/surgery, head irradiation or head trauma.

Active Malignancy

• EGRIFTA® is contraindicated in patients with active malignancy (either newly diagnosed or recurrent). Any preexisting malignancy should be inactive and its treatment complete prior to instituting therapy with EGRIFTA®.

Hypersensitivity

• EGRIFTA® is contraindicated in patients with known hypersensitivity to tesamorelin and/or mannitol (an excipient).

Pregnancy

• EGRIFTA® is contraindicated in pregnant women. During pregnancy, visceral adipose tissue increases due to normal metabolic and hormonal changes. Modifying this physiologic change of pregnancy with EGRIFTA® offers no known benefit and could result in fetal harm. Tesamorelin acetate administration to rats during organogenesis and lactation resulted in hydrocephalus in offspring at a dose approximately two and four times the clinical dose, respectively, based on measured drug exposure (AUC). If pregnancy occurs, discontinue EGRIFTA® therapy. If this drug is used during pregnancy, or if the patient becomes pregnant while taking this drug, the patient should be apprised of the potential hazard to the fetus

Warnings

ConditionName: See full prescribing information for complete Boxed Warning. ConditionName: Content

There is limited information regarding Tesamorelin Warnings' in the drug label.

Adverse Reactions

Clinical Trials Experience

There is limited information regarding Clinical Trial Experience of Tesamorelin in the drug label.

Postmarketing Experience

There is limited information regarding Postmarketing Experience of Tesamorelin in the drug label.

Drug Interactions

There is limited information regarding Tesamorelin Drug Interactions in the drug label.

Use in Specific Populations

Pregnancy

Pregnancy Category (FDA):

• Pregnancy Category

Pregnancy Category (AUS):

• Australian Drug Evaluation Committee (ADEC) Pregnancy Category

There is no Australian Drug Evaluation Committee (ADEC) guidance on usage of Tesamorelin in women who are pregnant.

Labor and Delivery

There is no FDA guidance on use of Tesamorelin during labor and delivery.

Nursing Mothers

There is no FDA guidance on the use of Tesamorelin with respect to nursing mothers.

Pediatric Use

There is no FDA guidance on the use of Tesamorelin with respect to pediatric patients.

Geriatic Use

There is no FDA guidance on the use of Tesamorelin with respect to geriatric patients.

Gender

There is no FDA guidance on the use of Tesamorelin with respect to specific gender populations.

Race

There is no FDA guidance on the use of Tesamorelin with respect to specific racial populations.

Renal Impairment

There is no FDA guidance on the use of Tesamorelin in patients with renal impairment.

Hepatic Impairment

There is no FDA guidance on the use of Tesamorelin in patients with hepatic impairment.

Females of Reproductive Potential and Males

There is no FDA guidance on the use of Tesamorelin in women of reproductive potentials and males.

Immunocompromised Patients

There is no FDA guidance one the use of Tesamorelin in patients who are immunocompromised.

Administration and Monitoring

Administration

• Oral

• Intravenous

Monitoring

There is limited information regarding Monitoring of Tesamorelin in the drug label.

• Description

IV Compatibility

There is limited information regarding IV Compatibility of Tesamorelin in the drug label.

Overdosage

Acute Overdose

Signs and Symptoms

• Description

Management

• Description

Chronic Overdose

There is limited information regarding Chronic Overdose of Tesamorelin in the drug label.

Pharmacology

There is limited information regarding Tesamorelin Pharmacology in the drug label.

Mechanism of Action

Structure

File:Tesamorelin01.png

This image is provided by the National Library of Medicine.

Pharmacodynamics

There is limited information regarding Pharmacodynamics of Tesamorelin in the drug label.

Pharmacokinetics

There is limited information regarding Pharmacokinetics of Tesamorelin in the drug label.

Nonclinical Toxicology

There is limited information regarding Nonclinical Toxicology of Tesamorelin in the drug label.

Clinical Studies

There is limited information regarding Clinical Studies of Tesamorelin in the drug label.

How Supplied

Storage

There is limited information regarding Tesamorelin Storage in the drug label.

Images

Drug Images

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Package and Label Display Panel

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Patient Counseling Information

There is limited information regarding Patient Counseling Information of Tesamorelin in the drug label.

Precautions with Alcohol

• Alcohol-Tesamorelin interaction has not been established. Talk to your doctor about the effects of taking alcohol with this medication.

Brand Names

• ®

Look-Alike Drug Names

• A® — B®

Drug Shortage Status

Price

References

The contents of this FDA label are provided by the National Library of Medicine.

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