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EGRIFTA SV

TESAMORELIN

Standard Dose

2 DOSAGE AND ADMINISTRATION The recommendations in this prescribing information only apply to EGRIFTA SV (tesamorelin) for injection 2 mg per vial formulation. For recommendations for tesamorelin for injection 1 mg per vial formulation, see the EGRIFTA prescribing information. These two formulations and strengths have differences in the dosage, the number of vials required to prepare a dose, reconstitution instructions, and storage requirements. ( 2.1 ). The dose of EGRIFTA SV is 1.4 mg (0.35 mL of the reconstituted solution) injected subcutaneously once daily. ( 2.1 ) Inject EGRIFTA SV into the abdomen, rotating injection sites. ( 2.1 , 5.6 ) Use only the diluent provided, Sterile Water for Injection, to reconstitute EGRIFTA SV. ( 2.2 ) Reconstitute one vial of lyophilized powder with 0.5 mL of diluent. Mix by rolling the vial gently in your hands for 30 seconds. Do not shake. ( 2.2 ) Inspect the reconstituted vial visually for particulate matter and discoloration. Use only if the solution is clear, colorless and without particulate matter. ( 2.2 ) Administer 0.35 mL of EGRIFTA SV immediately following reconstitution and throw away any unused solution and diluent. ( 2.2 ) 2.1 Dosage and Administration • The dosage and administration recommendations in this prescribing information only apply to EGRIFTA SV (tesamorelin) for injection 2 mg per vial formulation. For dosage and administration recommendations for tesamorelin for injection 1 mg per vial formulation, see the EGRIFTA prescribing information. These two formulations and strengths have differences in the dosage, the number of vials required to prepare a dose, reconstitution instructions, and storage requirements. • The dose of EGRIFTA SV is 1.4 mg, 0.35 mL of the reconstituted solution [see Dosage and Administration ( 2.2 )] , injected subcutaneously once daily. • Inject EGRIFTA SV into the abdomen. Rotate injection sites to different areas of the abdomen [see Warnings and Precautions ( 5.5 )] . Do not inject into scar tissue, bruises or the navel. 2.2 Reconstitution Procedure • Instruct patients to read the Instructions for Use enclosed in the EGRIFTA SV Medication Box. • Use only the diluent provided, Sterile Water for Injection, to reconstitute EGRIFTA SV. • Reconstitute 1 vial of EGRIFTA SV lyophilized powder with 0.5 mL of diluent (2 mg per 0.5 mL). Mix by rolling the vial gently in your hands for 30 seconds. Do not shake. • Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. Use only if the solution is clear, colorless and without particulate matter. • Administer 0.35 mL of EGRIFTA SV immediately following reconstitution and throw away any unused solution and diluent. If not used immediately, discard the reconstituted solution. Do not freeze or refrigerate the reconstituted solution.

Max Dose

See official label

Primary Use

1 INDICATIONS AND USAGE EGRIFTA SV is indicated for the reduction of excess abdominal fat in HIV-infected adult patients with lipodystrophy.

Summary

Indications and usage 1 INDICATIONS AND USAGE EGRIFTA SV is indicated for the reduction of excess abdominal fat in HIV-infected adult patients with lipodystrophy.

Limitations of Use: Long-term cardiovascular safety of EGRIFTA SV has not been established.

Structured Monograph

Clinical summary

Indications and usage 1 INDICATIONS AND USAGE EGRIFTA SV is indicated for the reduction of excess abdominal fat in HIV-infected adult patients with lipodystrophy. Limitations of Use: Long-term cardiovascular safety of EGRIFTA SV has not been established. Consider risk/benefit of continuation of treatment in patients who have not had a reduction in visceral adipose tissue. EGRIFTA SV is not indicated for weight loss management as it has a weight neutral effect. There are no data to support improved compliance with anti-retroviral therapies in HIV-positive patients taking EGRIFTA SV. EGRIFTA SV is a growth hormone-releasing factor (GHRF) analog indicated for the reduction of excess abdominal fat in HIV-infected adult patients with lipodystrophy. ( 1 ) Limitations of use: Long-term cardiovascular safety of EGRIFTA SV has not been established. ( 1 ) Not indicated for weight loss management. ( 1 ) There are no data to support improved compliance with anti-retroviral therapies in HIV-positive patients taking EGRIFTA SV. ( 1 ) Dosage and administration 2 DOSAGE AND ADMINISTRATION The recommendations in this prescribing information only apply to EGRIFTA SV (tesamorelin) for injection 2 mg per vial formulation. For recommendations for tesamorelin for injection 1 mg per vial formulation, see the EGRIFTA prescribing information. These two formulations and strengths have differences in the dosage, the number of vials required to prepare a dose, reconstitution instructions, and storage requirements. ( 2.1 ). The dose of EGRIFTA SV is 1.4 mg (0.35 mL of the reconstituted solution) injected subcutaneously once daily. ( 2.1 ) Inject EGRIFTA SV into the abdomen, rotating injection sites. ( 2.1 , 5.6 ) Use only the diluent provided, Sterile Water for Injection, to reconstitute EGRIFTA SV. ( 2.2 ) Reconstitute one vial of lyophilized powder with 0.5 mL of diluent. Mix by rolling the vial gently in your hands for 30 seconds. Do not shake. ( 2.2 ) Inspect the reconstituted vial visually for particulate matter and discoloration. Use only if the solution is clear, colorless and without particulate matter. ( 2.2 ) Administer 0.35 mL of EGRIFTA SV immediately following reconstitution and throw away any unused solution and diluent. ( 2.2 ) 2.1 Dosage and Administration • The dosage and administration recommendations in this prescribing information only apply to EGRIFTA SV (tesamorelin) for injection 2 mg per vial formulation. For dosage and administration recommendations for tesamorelin for injection 1 mg per vial formulation, see the EGRIFTA prescribing information. These two formulations and strengths have differences in the dosage, the number of vials required to prepare a dose, reconstitution instructions, and storage requirements. • The dose of EGRIFTA SV is 1.4 mg, 0.35 mL of the reconstituted solution [see Dosage and Administration ( 2.2 )] , injected subcutaneously once daily. • Inject EGRIFTA SV into the abdomen. Rotate injection sites to different areas of the abdomen [see Warnings and Precautions ( 5.5 )] . Do not inject into scar tissue, bruises or the navel. 2.2 Reconstitution Procedure • Instruct patients to read the Instructions for Use enclosed in the EGRIFTA SV Medication Box. • Use only the diluent provided, Sterile Water for Injection, to reconstitute EGRIFTA SV. • Reconstitute 1 vial of EGRIFTA SV lyophilized powder with 0.5 mL of diluent (2 mg per 0.5 mL). Mix by rolling the vial gently in your hands for 30 seconds. Do not shake. • Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. Use only if the solution is clear, colorless and without particulate matter. • Administer 0.35 mL of EGRIFTA SV immediately following reconstitution and throw away any unused solution and diluent. If not used immediately, discard the reconstituted solution. Do not freeze or refrigerate the reconstituted solution. Warnings and cautions 5 WARNINGS AND PRECAUTIONS Increased risk of neoplasms: Preexisting malignancy should be inactive and its treatment complete prior to starting EGRIFTA SV . Discontinue EGRIFTA SV if there is any evidence of recurrent malignancy. ( 5.1 ) Elevated IGF-1: EGRIFTA SV stimulates GH production and increases serum IGF-1, a growth factor. The effects of prolonged elevations in IGF-1 levels are unknown. Monitor IGF-1 levels during EGRIFTA SV therapy. Consider discontinuing in patients with persistent elevations. ( 5.2 ) Fluid retention: May occur with EGRIFTA SV and may include edema, arthralgia, and carpal tunnel syndrome. ( 5.3 ) Glucose intolerance or diabetes mellitus: May develop with EGRIFTA SV use. Evaluate glucose prior to and during therapy. ( 5.4 ) Hypersensitivity reactions: Have occurred in clinical trials. Advise patients to seek immediate medical attention and discontinue treatment if suspected. ( 5.5 ) Increased mortality in patients with acute critical illness: Consider discontinuation in

Monitoring

• 5 WARNINGS AND PRECAUTIONS Increased risk of neoplasms: Preexisting malignancy should be inactive and its treatment complete prior to starting EGRIFTA SV .
• Discontinue EGRIFTA SV if there is any evidence of recurrent malignancy.
• ( 5.1 ) Elevated IGF-1: EGRIFTA SV stimulates GH production and increases serum IGF-1, a growth factor.
• The effects of prolonged elevations in IGF-1 levels are unknown.

Interaction Notes

• 7 DRUG INTERACTIONS Cytochrome P450-metabolized drugs : Monitor patients for potential interactions when administering with EGRIFTA SV .
• ( 7.1 ) Glucocorticoids : Patients receiving glucocorticoid replacement for previously diagnosed hypoadrenalism may require an increase in maintenance or stress doses following initiation of EGRIFTA SV.
• ( 7.2 ) 7.1 Cytochrome P450-Metabolized Drugs Co-administration of tesamorelin with simvastatin, a CYP3A substrate had no significant impact on the pharmacokinetics profiles of simvastatin in healthy subjects [see Clinical Pharmacology ( 12.3 )] .
• EGRIFTA SV stimulates GH production.