Drug Guide
Tesamorelin Acetate
Classification
Therapeutic: HIV-associated lipodystrophy, specifically abdominal fat reduction
Pharmacological: Ghrelin analogue, growth hormone-releasing hormone (GHRH) analog
FDA Approved Indications
- Reduction of excess visceral adipose tissue in HIV-infected patients with lipodystrophy
Mechanism of Action
Tesamorelin stimulates the pituitary gland to increase the secretion of endogenous growth hormone, which in turn reduces visceral adipose tissue and improves lipid profiles.
Dosage and Administration
Adult: For HIV-associated lipodystrophy, the recommended dose is 2 mg subcutaneously once daily.
Pediatric: Not approved for pediatric use.
Geriatric: No specific adjustments; monitor for side effects.
Renal Impairment: No specific dosage adjustment recommended.
Hepatic Impairment: No specific dosage adjustment recommended.
Pharmacokinetics
Absorption: Rapidly absorbed following subcutaneous administration.
Distribution: Wide distribution; specific volume not well established.
Metabolism: Metabolized via proteolytic enzymes; not extensively studied.
Excretion: Excreted primarily in urine as metabolites.
Half Life: Approximately 26 minutes (short half-life, but biological effects last longer).
Contraindications
- Hypersensitivity to tesamorelin or any component of the product.
Precautions
- Use with caution in patients with a history of active malignancy, allergy to growth hormone therapies, or those at risk for increased intracranial pressure.
Adverse Reactions - Common
- Injection site reactions (erythema, swelling) (Common)
- Nausea (Less common)
Adverse Reactions - Serious
- Increased risk of neoplasia or active malignancy (Rare)
- Hypersensitivity reactions (Rare)
Drug-Drug Interactions
- Insulin or insulin-like growth factors (may increase blood glucose levels)
- Medications that affect growth hormone levels
Drug-Food Interactions
- No major interactions reported
Drug-Herb Interactions
- Limited data; caution advised with herbal supplements affecting hormone levels
Nursing Implications
Assessment: Monitor for side effects, including hyperglycemia, injection site reactions, and symptoms of malignancy.
Diagnoses:
- Risk for hyperglycemia related to growth hormone increase
- Impaired skin integrity due to injection site reactions
Implementation: Administer subcutaneously once daily, rotating injection sites. Educate patient on proper injection techniques.
Evaluation: Assess reduction in visceral adipose tissue, monitor blood glucose levels, and evaluate for any adverse reactions.
Patient/Family Teaching
- Instruct on proper subcutaneous injection technique.
- Report any signs of allergic reactions, new lumps, or rapid weight gain.
- Emphasize importance of adherence to prescribed daily schedule.
Special Considerations
Black Box Warnings:
- No specific black box warnings for tesamorelin.
Genetic Factors: Limited data; no specific genetic considerations.
Lab Test Interference: May affect glucose metabolism tests and tumor screening results.
Overdose Management
Signs/Symptoms: Unusually elevated blood glucose levels, hypersensitivity reactions.
Treatment: Discontinue medication; provide supportive care. Manage hyperglycemia with antidiabetic medications if necessary.
Storage and Handling
Storage: Store in a refrigerator at 2°C to 8°C (36°F to 46°F). Protect from light.
Stability: Stable for up to 14 days at room temperature; discard opened vials after 14 days.