What are the dosing, administration, storage, and monitoring instructions for Egrifta (tesamorelin) in an adult with HIV‑associated lipodystrophy?

Egrifta (Tesamorelin) Administration Instructions for HIV-Associated Lipodystrophy

Dosing

Administer tesamorelin 2 mg subcutaneously once daily to reduce excess visceral adipose tissue in adults with HIV-associated lipodystrophy. 1, 2, 3

• The 2 mg daily dose has been consistently validated across multiple phase 3 trials and represents the only FDA-approved dosing regimen for this indication 3, 4, 5
• Treatment must be continuous, as discontinuation results in rapid reaccumulation of visceral fat within weeks 3, 5

Administration Technique

Inject subcutaneously into the abdomen daily, rotating injection sites to minimize local reactions. 1, 2

• Reconstitute the lyophilized powder according to manufacturer instructions immediately before use 1
• Administer at approximately the same time each day to maintain consistent growth hormone stimulation 3
• Injection site reactions (pain, erythema, pruritus) are the most common adverse events, occurring in the majority of patients but rarely leading to discontinuation 1, 2

Storage Requirements

Store at room temperature between 20-25°C (68-77°F) and avoid excessive heat and humidity. 6

• Protect from light exposure 6
• Once reconstituted, use immediately and discard any unused portion 1

Monitoring Parameters

Baseline Assessment (Before Initiation)

Obtain baseline visceral adipose tissue measurement by CT scan, fasting glucose, HbA1c, and IGF-1 levels before starting therapy. 3, 4

• Screen for active malignancy, as tesamorelin is contraindicated in patients with active cancer due to growth hormone effects 1, 2
• Assess for diabetic retinopathy in patients with diabetes, as growth hormone analogs may worsen this condition 2
• Measure baseline liver function tests, particularly if hepatic steatosis is suspected 4

Ongoing Monitoring

Monitor fasting glucose at 2 weeks, then monthly for the first 3 months, as transient glucose elevations occur early in treatment. 3, 4

• Fasting glucose increases by approximately 7-9 mg/dL within the first 2 weeks but typically stabilizes by 6 months without clinically meaningful long-term changes 3, 4
• Check HbA1c every 3 months during the first year of therapy 4
• Measure IGF-1 levels at 1 month and every 3-6 months thereafter, as levels increase by approximately 108 ng/mL on average 3
• Reassess visceral adipose tissue by CT scan at 6 months to document treatment response, with expected reduction of approximately 15-18% 3, 5

Safety Monitoring

Evaluate for arthralgia, peripheral edema, and carpal tunnel symptoms at each visit, as these are common growth hormone-related adverse effects. 1, 2

• Monitor for signs of fluid retention (peripheral edema occurs in a subset of patients) 1, 2
• Assess injection sites at each visit for persistent reactions or lipohypertrophy 1

Expected Outcomes and Treatment Duration

Visceral fat reduction of 15-18% is typically achieved by 6 months and maintained with continued therapy through 12 months. 3, 5

• Improvements in waist circumference (approximately 3-4 cm reduction), trunk fat, and patient-reported belly appearance distress are secondary benefits 3, 5
• Triglycerides decrease by approximately 12-37 mg/dL and cholesterol-to-HDL ratio improves by 7% 3
• Subcutaneous adipose tissue remains unchanged, which is desirable as the goal is selective visceral fat reduction 3, 5

Critical Warnings

Do not initiate tesamorelin in patients with active malignancy, uncontrolled diabetes (HbA1c >7.5%), or diabetic retinopathy. 1, 2

• Discontinue immediately if new malignancy is diagnosed during treatment 2
• The early glucose elevation at 2 weeks requires close monitoring but does not typically necessitate discontinuation unless glucose becomes severely uncontrolled 4
• Reaccumulation of visceral fat occurs rapidly upon discontinuation, so patients must understand the need for indefinite therapy to maintain benefits 3, 5