EGRIFTA Powder for solution fot injection Ref.[10721] Active ingredients: Tesamorelin

Source: Health Products and Food Branch (CA)  Revision Year: 2015 

Indications and clinical use

EGRIFTA is indicated for the treatment of excess visceral adipose tissue (VAT), as assessed by waist circumference ≥95 cm for males and ≥94 cm for females, and confirmed by a VAT level >130 cm² by CT scan, in treatment-experienced adult HIV-infected patients with lipodystrophy.

Limitations of use:

  • EGRIFTA is not indicated for weight loss management (weight neutral effect).
  • Treatment with EGRIFTA should be limited to patients who failed to reduce excess VAT using diet and exercise.
  • 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.
  • There are no data to support improved compliance with anti-retroviral therapies in HIV-positive patients taking EGRIFTA.

Geriatrics (>65 years of age)

There is no information on the use of EGRIFTA in patients greater than 65 years of age with HIV and lipodystrophy.

Pediatrics (<18 years of age)

EGRIFTA is contraindicated in patients under 18 years of age.

Dosage and administration

Recommended Dose and Dosage Adjustment

The recommended dose of EGRIFTA is 2 mg injected subcutaneously (SC) 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.

Missed Dose

If an injection is missed, there should not be a double dose at the next injection. Instead, an injection should be taken at the next dose as normal.

Administration

EGRIFTA is supplied as a lyophilized powder in two strengths: 1 mg per vial or 2 mg per vial.

For the 1 mg/vial, two vials of EGRIFTA should be reconstituted with the diluent provided in the package (Sterile Water for Injection) before use (see Reconstitution subsection).

For the 2 mg/vial, one vial of EGRIFTA should be reconstituted with the diluent provided in the package (Sterile Water for Injection) before use (see Reconstitution subsection).

Reconstitution

Parenteral Products:

Presentation Vial Size Volume of Diluent to be Added to Vial* Approximate Available VolumeFinal Concentration per mL
1 mg vial** 3 mL 2.2 mL 2 mL 1 mg/mL
2 mg vial 3 mL 2.1 mL 2 mL 1 mg/mL

* Refer to Reconstitution subsection.
** For 1mg vial: Two 1 mg vials of EGRIFTA per day are required for a 2 mg dose.

After reconstitution with Sterile Water for Injection, the reconstituted solution should be injected immediately. EGRIFTA vials should be protected from light and be kept in the original box. Non-reconstituted EGRIFTA must be stored at refrigerated temperature, between 2°C and 8°C. Injection material like Sterile Water for Injection, syringes and needles should be stored at room temperature (between 15°C and 30°C).

For full reconstitution instructions, see Part III PATIENT MEDICATION INFORMATION/Proper use of this medication.

Overdosage

No data is available.

For management of a suspected drug overdose, contact your regional Poison Control Centre.

Storage and stability

EGRIFTA vials should be protected from light and be kept in the original box. Nonreconstituted EGRIFTA must be stored under refrigeration at 2°C to 8°C.

Sterile Water for Injection, syringes and needles should be stored at room temperature (between 15°C and 30°C).

Keep in a safe place out of reach of children.

Reconstituted Solutions

EGRIFTA should be administered immediately after reconstitution.

The final concentration of the reconstituted product corresponds to 1 mg/mL.

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