tesamorelin

Therapeutic Classification: none assigned

Pharmacologic Classification: growth hormone releasing factor analogues

REMS

Reduction of excess abdominal fat (lipodystrophy) seen in HIV-infected patients.

Acts as an analog of human growth hormone-releasing factor (GRF, GHRH), resulting in endogenous production of growth hormone (GH), which has anabolic and lipolytic properties.

Therapeutic effects:

Reduction of abdominal adipose tissue in HIV-infected patients.

Absorption: <4% absorbed following SUBQ administration.

Distribution: Unknown.

Metabolism/Excretion: Unknown.

Half-Life: 26–38 min.

(effect on visceral adipose tissue)

ROUTE	ONSET	PEAK	DURATION
SUBQ	within 3 mos	10–12 mos	3 mos‡

‡Following discontinuation.

Contraindicated in:

Hypersensitivity to tesamorelin or mannitol;
Any pathology that alters the hypothalamic-pituitary axis, including hypophysectomy, hypopituitarism, pituitary surgery/tumor, cranial irradiation/trauma;
OB: Pregnancy (may cause fetal harm);
Lactation: Breast feeding should be avoided in patients with HIV.

Use Cautiously in:

Acute critical illness (may ↑ risk of serious complications; consider discontinuation);
Pre-existing malignancy (disease should be inactive or treatment completed);
Non-malignant neoplasms (carefully consider benefit);
Persistently elevated insulin-like growth factor (IGF-1; may require discontinuation);
Diabetes mellitus (may cause glucose intolerance);
Pedi: Safety and effectiveness not established.

CV: peripheral edema

Endo: glucose intolerance

Local: erythema, hemorrhage, irritation, pain, pruritus

MS: arthralgia, carpal tunnel syndrome, extremity pain, myalgia

Misc: hypersensitivity reactions

Drug-drug:

May alter the clearance and actions of drugs known to be metabolized by the CYPP450 enzyme system including corticosteroids, androgens, estrogens and progestins (including hormonal contraceptives), anticonvulsants, and cyclosporine, careful monitoring for efficacy and/or toxicity recommended.
Inhibits the conversion of cortisone acetate and prednisone to active forms; patients on replacement therapy may need ↑ maintenance/stress doses.

SC (Adults ): Egrifta: 2 mg once daily; Egrifta SV: 1.4 mg once daily.

Lyophilized powder for injection (requires reconstitution) (Egrifta): 1 mg/vial
Lyophilized powder for injection (requires reconstitution) (Egrifta SV): 2 mg/vial

Assess for fluid retention which manifests as ↑ tissue turgor and musculoskeletal discomfort (edema, arthralgia, extremity pain, carpal tunnel syndrome). May be transient or resolve with discontinuation of treatment.

Lab Test Considerations:

Monitor serum IGF-I closely during therapy; tesamorelin stimulates growth hormone production and the effect on progression of malignancies is unknown. Consider discontinuing tesamorelin in patients with persistent elevations of IGF-I levels, especially if efficacy response is not strong.
- May cause glucose intolerance and ↑ risk of developing diabetes. Monitor serum glucose prior to starting and periodically during therapy. Monitor diabetic patients closely for worsening of retinopathy.

SC: Sterile water for injection 10 mL diluent is provided. For 1–mg vial, two vials must be reconstituted for dose. Inject 2.2 mL of sterile water for injection into first 1–mg tesamorelin, angled so that water goes down inside wall to prevent foaming. Roll vial gently between hands for 30 sec to mix; do not shake. Change needle. Withdraw solution and inject into 2nd 1–mg tesamorelin vial with solution against wall of vial. Mix between hands for 30 sec. Withdraw all solution. For 2–mg vial, reconstitute 1 vial with 0.5 mL of diluent (2 mg per 0.5 mL). Mix by rolling the vial gently in your hands for 30 sec. Do not shake. Administer 0.35 mL of immediately following reconstitution and throw away any unused solution and diluent. Solution is clear and colorless; do not administer solution that is discolored or contains particulate matter. Use solution immediately upon reconstitution or discard; do not refrigerate or freeze. Change needle to ½ inch 27 gauge needle. Pinch skin and inject at right angle into abdomen below navel; rotate sites. Remove hand from pinched area and inject slowly. Do not inject into scar, bruises, or the navel. Prior to reconstitution, vials must be refrigerated and protected from light.

Instruct patient on correct technique for administration of tesamorelin. Caution patient never to share needles with others.
Inform patient that tesamorelin may cause symptoms of fluid retention (edema, arthralgia, carpal tunnel syndrome); usually transient or resolve with discontinuation of therapy.
Advise patient to discontinue tesamorelin and notify health care professional promptly if signs and symptoms of hypersensitivity (rash, urticaria, hives, swelling of face or throat, shortness of breath, fast heartbeat, fainting) occur.
Advise female patients to notify health care professional if pregnancy is planned or suspected and to avoid breast feeding.

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

NDC Code

62064- Theratechnologies Inc.
- 62064-241- EGRIFTA SV
  - 62064-241-30- 1 KIT in 1 BOX (62064-241-30) * .5 mL in 1 VIAL * 30 BOTTLE in 1 TRAY / 10 mL in 1 BOTTLE

71052- DARMERICA, LLC
- 71052-520-
  - 71052-520-01- 1 g in 1 CONTAINER (71052-520-01)

71052- DARMERICA, LLC
- 71052-520-
  - 71052-520-05- .5 g in 1 CONTAINER (71052-520-05)

71052- DARMERICA, LLC
- 71052-520-
  - 71052-520-10- .1 g in 1 CONTAINER (71052-520-10)

71052- DARMERICA, LLC
- 71052-520-
  71052-520-25- 5 g in 1 CONTAINER (71052-520-25)

73212- Qingdao Biopeptek Co., Ltd.
- 73212-014-
  73212-014-01- 1 g in 1 BOTTLE (73212-014-01)

73212- Qingdao Biopeptek Co., Ltd.
- 73212-014-
  73212-014-05- 5 g in 1 BOTTLE (73212-014-05)

73212- Qingdao Biopeptek Co., Ltd.
- 73212-014-
  73212-014-10- 10 g in 1 BOTTLE (73212-014-10)

73212- Qingdao Biopeptek Co., Ltd.
- 73212-014-
  73212-014-11- 50 g in 1 BOTTLE (73212-014-11)

73212- Qingdao Biopeptek Co., Ltd.
- 73212-014-
  73212-014-12- 100 g in 1 BOTTLE (73212-014-12)

83589- Nanjing Cuccess Pharmaceutical Co., Ltd.
- 83589-111-
  83589-111-01- 1 g in 1 BAG (83589-111-01)

83589- Nanjing Cuccess Pharmaceutical Co., Ltd.
- 83589-111-
  83589-111-02- 1 g in 1 BOTTLE (83589-111-02)

83589- Nanjing Cuccess Pharmaceutical Co., Ltd.
- 83589-111-
  83589-111-03- 5 g in 1 BAG (83589-111-03)

83589- Nanjing Cuccess Pharmaceutical Co., Ltd.
- 83589-111-
  83589-111-04- 5 g in 1 BOTTLE (83589-111-04)

83589- Nanjing Cuccess Pharmaceutical Co., Ltd.
- 83589-111-
  83589-111-05- 10 g in 1 BAG (83589-111-05)

83589- Nanjing Cuccess Pharmaceutical Co., Ltd.
- 83589-111-
  83589-111-06- 10 g in 1 BOTTLE (83589-111-06)

83589- Nanjing Cuccess Pharmaceutical Co., Ltd.
- 83589-111-
  83589-111-07- 25 g in 1 BAG (83589-111-07)

83589- Nanjing Cuccess Pharmaceutical Co., Ltd.
- 83589-111-
  83589-111-08- 25 g in 1 BOTTLE (83589-111-08)

83589- Nanjing Cuccess Pharmaceutical Co., Ltd.
- 83589-111-
  83589-111-09- 50 g in 1 BAG (83589-111-09)

83589- Nanjing Cuccess Pharmaceutical Co., Ltd.
- 83589-111-
  83589-111-10- 50 g in 1 BOTTLE (83589-111-10)

83589- Nanjing Cuccess Pharmaceutical Co., Ltd.
- 83589-111-
  83589-111-11- 100 g in 1 BAG (83589-111-11)

83589- Nanjing Cuccess Pharmaceutical Co., Ltd.
- 83589-111-
  83589-111-12- 100 g in 1 BOTTLE (83589-111-12)

83589- Nanjing Cuccess Pharmaceutical Co., Ltd.
- 83589-111-
  83589-111-13- 250 g in 1 BAG (83589-111-13)

83589- Nanjing Cuccess Pharmaceutical Co., Ltd.
- 83589-111-
  83589-111-14- 250 g in 1 BOTTLE (83589-111-14)

83589- Nanjing Cuccess Pharmaceutical Co., Ltd.
- 83589-111-
  83589-111-15- 500 g in 1 BAG (83589-111-15)

84347- Shenzhen Alvantis Pharma Co., Ltd.
- 84347-006-
  84347-006-01- 1 g in 1 BOTTLE (84347-006-01)

84347- Shenzhen Alvantis Pharma Co., Ltd.
- 84347-006-
  84347-006-05- 5 g in 1 BOTTLE (84347-006-05)

84347- Shenzhen Alvantis Pharma Co., Ltd.
- 84347-006-
  84347-006-10- 10 g in 1 BOTTLE (84347-006-10)

84347- Shenzhen Alvantis Pharma Co., Ltd.
- 84347-006-
  84347-006-25- 25 g in 1 BOTTLE (84347-006-25)

84347- Shenzhen Alvantis Pharma Co., Ltd.
- 84347-006-
  84347-006-50- 50 g in 1 BOTTLE (84347-006-50)

84347- Shenzhen Alvantis Pharma Co., Ltd.
- 84347-006-
  84347-006-60- 100 g in 1 BOTTLE (84347-006-60)

84347- Shenzhen Alvantis Pharma Co., Ltd.
- 84347-006-
  84347-006-90- 500 g in 1 BOTTLE (84347-006-90)

84789- Hangzhou XinHan Biopharma Co., Ltd.
- 84789-111-
  84789-111-20- 5 g in 1 BOTTLE (84789-111-20)

85139- Hangzhou Yiqi Biotechnology Co., Ltd
- 85139-009-
  85139-009-01- 1 g in 1 BOTTLE (85139-009-01)

85139- Hangzhou Yiqi Biotechnology Co., Ltd
- 85139-009-
  85139-009-02- 5 g in 1 BOTTLE (85139-009-02)

85139- Hangzhou Yiqi Biotechnology Co., Ltd
- 85139-009-
  85139-009-03- 10 g in 1 BOTTLE (85139-009-03)

85139- Hangzhou Yiqi Biotechnology Co., Ltd
- 85139-009-
  85139-009-04- 25 g in 1 BOTTLE (85139-009-04)

85139- Hangzhou Yiqi Biotechnology Co., Ltd
- 85139-009-
  85139-009-05- 50 g in 1 BOTTLE (85139-009-05)

85139- Hangzhou Yiqi Biotechnology Co., Ltd
- 85139-009-
  85139-009-06- 100 g in 1 BOTTLE (85139-009-06)

85526- Shenzhen PK Biotechnology Co., Ltd.
- 85526-015-
  85526-015-01- 1 g in 1 BOTTLE (85526-015-01)

85526- Shenzhen PK Biotechnology Co., Ltd.
- 85526-015-
  85526-015-05- 5 g in 1 BOTTLE (85526-015-05)

85526- Shenzhen PK Biotechnology Co., Ltd.
- 85526-015-
  85526-015-10- 10 g in 1 BOTTLE (85526-015-10)

85526- Shenzhen PK Biotechnology Co., Ltd.
- 85526-015-
  85526-015-25- 25 g in 1 BOTTLE (85526-015-25)

85526- Shenzhen PK Biotechnology Co., Ltd.
- 85526-015-
  85526-015-50- 50 g in 1 BOTTLE (85526-015-50)

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