INDICATIONS
FDA
Reduction of excess abdominal fat secondary to lipodystrophy in HIV-infected pts.
FORMS![[Top]](images/m/top.gif)
brand | preparation | manufacturer | route | form | dosage^ | cost* |
Egrifta | Tesamorelin | Theratechnologies, Inc | SQ | vial | 1 mg | $39 |
*Costs (rounded to the nearest dollar) are based on usual adult dosing per day, are representative of "Average Wholesale Price" (AWP), and are current within the prior three months.
^Dosage is indicated in mg unless otherwise noted.
USUAL ADULT DOSING
RENAL DOSING
DOSING FOR GLOMERULAR FILTRATION OF 50-80
No data; usual dose likely
DOSING FOR GLOMERULAR FILTRATION OF 10-50
No data; usual dose likely
DOSING FOR GLOMERULAR FILTRATION OF <10 ML/MIN
No data; usual dose likely
DOSING IN HEMODIALYSIS
No data
DOSING IN PERITONEAL DIALYSIS
No data
DOSING IN HEMOFILTRATION
No data
ADVERSE DRUG REACTIONS
GENERAL
Discontinuations due to adverse reactions occurred in 9.6% treated with tesamorelin (vs. 6.8% with placebo).
COMMON
- Arthralgia (13%) and myalgia (6%)
- Injection site erythema and pruritis (8-9%)
- Pain in extremity (6 %)
- Peripheral edema (6.1% vs. 2.3% in placebo)
OCCASIONAL
- Paresthesia (4.8% vs 2.3% in placebo)
- Musculoskeletal pain and stiffness (2%)
- Carpal tunnel syndrome (1.5%)
- Nausea and Vomiting (3-4%)
- Pruritis and rash (3-4%)
- Hyperglycemia (4.5%)
DRUG INTERACTIONS
Does not inhibit CYP450 3A4
- Glucocorticoid: higher glucocorticoid dose may be needed with tesamorelin co-administration.
- Anticonvulsants (e.g phenytoin, phenobarbital, carbamazepine): monitor anticonvulsants concentrations closely with co-administration.
- Cyclosporine: monitor cyclosporine concentrations with co-administration.
- Ritonavir: no significant drug-drug interaction.
PHARMACOLOGY
MECHANISM
Tesamoralin, a synthetic analogue of human hypothalamic growth hormone-releasing factor (hGRF), acts on the pituitary cells to stimulate synthesis and release of endogenous growth hormone.
DOSING FOR DECREASED HEPATIC FUNCTION
No data
PREGNANCY RISK
Category X: contraindicated
BREAST FEEDING COMPATIBILITY
Not recommended
COMMENTS
Tesamorelin decreases abdominal fat by a modest 14-18% in HIV pts with lipodystrophy. Musculoskeletal adverse effects, local injection site reactions, and cost may prevent routine use of tesamorelin. Reversal of benefits seen with discontinuation of drug. With currently used ARV regimens, most weight gain is due to increased subcutaneous fat rather than lipodystrophy.
Basis for recommendation
