Tesamorelin Initial Dose
The recommended initial dose of tesamorelin is 2 mg administered subcutaneously once daily. 1, 2
Dosing Protocol
- Start with 2 mg subcutaneously once daily, which is the FDA-approved starting dose used in all pivotal clinical trials 1, 2
- This dose does not require titration or dose escalation—patients begin and remain at 2 mg daily 1, 2
- The medication should be administered via subcutaneous injection 1, 2
Administration Timing
- The injection can be given at any consistent time of day, though bedtime administration may be preferred to align with physiological growth hormone secretion patterns 1
- No dose adjustment is needed based on body weight, age, or baseline visceral adipose tissue levels 3
Expected Timeline for Response
- Significant reductions in visceral adipose tissue (VAT) are typically observed by 6 months of continuous therapy, with mean reductions of approximately 15-18% 1, 2
- Early assessment at 3 months may not reliably predict treatment response 4
- Patients should continue the 2 mg daily dose for at least 6 months before determining treatment efficacy 1, 2
Patient Selection Considerations
- Patients with metabolic syndrome (NCEP criteria), elevated triglycerides >1.7 mmol/L, or white race demonstrate higher likelihood of VAT reduction response 4
- The medication has been studied specifically in HIV-infected patients with excess abdominal fat on antiretroviral therapy, including those on integrase inhibitor-based regimens 1, 5
Important Safety Notes
- No dose reduction is required for renal or hepatic impairment based on available pharmacokinetic data 3
- The 2 mg dose was well-tolerated without clinically meaningful changes in glucose parameters in clinical trials 1, 2
- IGF-1 levels increase significantly (mean +108 ng/mL) but this is an expected pharmacodynamic effect 1