Adult Dosing

HIV-infected patients with abdominal lipodystrophy

• Recommended dose: 2 mg SC daily

Note:

• Recommended injection site is the abdomen. Do not inject into scar tissue, bruises or the navel

Pediatric Dosing

• Safety and effectiveness in pediatric patients have not been established

[Outline]

• Adult Dosing
• Pediatric Dosing

• Reduction of excess abdominal fat in HIV-infected patients with lipodystrophy

• Hypersensitivity to any of the ingredients of the product
• Hypersensitivity to mannitol
• Hypopituitarism
• Hypophysectomy
• Pituitary tumor/surgery
• Head irradiation/trauma
• Malignancy
• Pregnancy

• N/A

Renal Dose Adjustment

• Renal impairment: Dose adjustments not defined

Hepatic Dose Adjustment

• Hepatic impairment: Dose Adjustments not defined

• Avoid use of therapy in patients with active malignancy. For the patients with a history of non-malignant neoplasms and with a history of treated and stable malignancies therapy should be started after careful evaluation of the potential benefit of treatment
• Therapy increases serum IGF-I. Monitor IGF-I levels during therapy. Consider discontinuation of therapy in patients with persistent elevations of IGFI levels
• Fluid retention including edema, arthralgia, and carpal tunnel syndrome have been reported during therapy
• Glucose intolerance may develop with the use of tesamorelin; therefore, glucose status should be carefully examined before starting tesamorelin, and monitored periodically for changes in glucose metabolism worsening of retinopathy. Use cautiously in treating HIV-positive patients with lipodystrophy
• Hypersensitivity reactions including pruritus, erythema, flushing, urticaria, and rash have been reported with tesamorelin use; if this occur advise patient to seek medical attention and discontinue the treatment immediately
• Injection site reactions, including injection site erythema, pruritus, pain, irritation, and bruising have been occurred with therapy, thus advise patients to rotate sites
• Consider discontinuation of the treatment in critically ill patients

Caution: Use cautiously in

• Hx non-malignant neoplasm
• Hx malignancy
• Diabetes mellitus
• Diabetes mellitus risk
• Acute critical illness

Pregnancy Category:X

Breastfeeding: Because of both the potential for HIV-1 infection transmission and serious adverse reactions in nursing infants, mothers receiving tesamorelin should be instructed to avoid breastfeeding.

• CV: Peripheral edema, hypertension
• CNS: Hypoesthesia
• NEURO: Carpal tunnel syndrome, paresthesia
• PSYCHIATRY: Depression
• GI: Nausea, vomiting
• METABOLIC: Hyperglycemia
• DERM: Rash, urticaria, extremity pain, pruritis, irritation, elevated CK
• ENDO: Diabetes mellitus
• MUSC: Arthralgia, musculoskeletal pain, myalgia
• MISC: Pain
• LOCAL: Injection site reactions, swelling, pain in extremity

• Growth hormone-releasing factor; stimulates the synthesis and pulsatile release of endogenous growth hormone by acting on the pituitary somatotroph cells
• Metabolism: Unknown; CYP450: inhibits 11 beta-hydroxysteroid dehydrogenase Type 1
• Excretion: Unknown
• Half-life: 26-38 minutes

US Trade Name(s)

• Egrifta

US Availability

Egrifta

• PWDR for INJ: 2 mg/vial

Canadian Trade Name(s)

• N/A

Canadian Availability

• N/A

UK Trade Name(s)

• N/A

UK Availability

• N/A

Australian Trade Name(s)

• N/A

Australian Availability

• N/A

[Outline]

Endocrine/Metabolic

Growth Hormone-releasing Factor

Pricing data from www.DrugStore.com in U.S.A.

• Egrifta 1 MG SOLR [Vial] (SERONO)
  1 mg = $45.99
  2 mg = $80.97

Warning: This pricing information is subject to change at the sole discretion of DS Pharmacy. For the most current and up-to-date pricing information, please visit drugstore.com.