Source: Health Products and Food Branch (CA) Revision Year: 2015
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:
There is no information on the use of EGRIFTA in patients greater than 65 years of age with HIV and lipodystrophy.
EGRIFTA is contraindicated in patients under 18 years of age.
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.
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.
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).
Parenteral Products:
Presentation | Vial Size | Volume of Diluent to be Added to Vial* | Approximate Available Volume | Final 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.
No data is available.
For management of a suspected drug overdose, contact your regional Poison Control Centre.
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.
EGRIFTA should be administered immediately after reconstitution.
The final concentration of the reconstituted product corresponds to 1 mg/mL.
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