Serostim (Human Growth Hormone)
Serostim® [somatropin (rDNA origin) for injection] hGH – Human Growth Hormone
Serostim® [somatropin (rDNA origin) for injection] is a human growth hormone used in hormone therapy and is FDA-approved to increase weight and lean body mass improving physical strength and endurance.
Serostim® helps build and maintain weight and lean body mass. It also helps support metabolism, using fat for energy instead of lean body mass. Serostim® is indicated for the treatment of HIV wasting in patients receiving antiretroviral therapy. Talk to a doctor to see if Serono Serostim® is right for you.
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Serostim® [somatropin (rDNA origin) for injection] is a human growth hormone produced by recombinant DNA technology. Serostim has 191 amino acid residues and a molecular weight of 22,125 daltons. Its amino acid sequence and structure are identical to the dominant form of human pituitary growth hormone. Serostim is produced by a mammalian cell line (mouse C127) that has been modified by the addition of the human growth hormone gene. Serostim is secreted directly through the cell membrane into the cell-culture medium for collection and purification.
Serostim® human growth hormone for injection is a highly purified preparation. Biological potency is determined by measuring the increase in the body weight induced in hypophysectomized rats.
Serostim® is available in 5 mg and 6 mg vials for single dose administration. Each 5 mg vial contains 5.0 mg (approximately 15 IU) somatropin, 34.2 mg sucrose and 1.2 mg phosphoric acid. Each 6 mg vial contains 6.0 mg (approximately 18 IU) somatropin, 41.0 mg sucrose and 1.4 mg phosphoric acid. The pH is adjusted with sodium hydroxide or phosphoric acid to give a pH of 7.4 to 8.5 after reconstitution.
HGH INJECTION ADMINISTRATION
Serostim® [somatropin (rDNA origin) for injection] is administered daily by subcutaneous injection under the skin. Serostim growth hormone injections may be administered using a syringe needle injection or through the SeroJet® ‘needle-free’ growth hormone delivery device.
To determine which growth hormone injection delivery method is best for you, consult with your physician or healthcare provider who instructs patients on giving HGH injections and the importance of proper syringe disposal. Never reuse or share needles, syringes or SeroJet’s nozzles and connectors.
Serostim [somatropin (rDNA origin) for injection] is an anabolic and anticatabolic agent which exerts its influence by interacting with specific receptors on a variety of cell types including myocytes, hepatocytes, adipocytes, lymphocytes, and hematopoietic cells. Some, but not all, of its effects are mediated by another class of hormones known as somatomedins (IGF-1 and IGF-2).
AIDS-associated wasting is a metabolic disorder characterized by abnormalities of intermediary metabolism resulting in weight loss, inappropriate depletion of lean body mass (LBM), and paradoxical preservation of body fat. LBM includes primarily skeletal muscle, organ tissue, blood and blood constituents, and both intracellular and extracellular water. Depletion of LBM results in muscle weakness, organ failure, and death. Unlike nutritional intervention for AIDS-associated wasting, in which supplemental calories are converted predominantly to body fat, Serostim treatment resulted in an increase in LBM and a decrease in body fat with a significant increase in body weight due to the dominant effect of LBM gain.
Effects on Protein, Lipid, and Carbohydrate Metabolism: A one-week study in 6 patients with HIV associated wasting has shown that treatment with Serostim improves nitrogen balance, increases protein-sparing lipid oxidation, and has little effect on overall carbohydrate metabolism.
Lean Body Mass Accrual: In the same study, treatment with Serostim resulted in the retention of phosphorous, potassium, nitrogen, and sodium. The ratio of retained potassium and nitrogen during Serostim therapy was consistent with retention of these elements in lean tissue. In clinical studies (12 weeks), Serostim significantly increased lean body mass. There was also a proportionate increase in intracellular and extracellular fluid during Serostim therapy suggesting accretion of normally hydrated lean body tissue.
Physical Performance: Treadmill performance was examined in a 12-week placebo-controlled study. Work output improved significantly in the Serostim- treated group after 12 weeks of therapy and was correlated with LBM. No such correlation was seen with body fat. Isometric muscle performance, as measured by grip strength dynamometry, declined, probably as a result of a transient increase in tissue turgor known to occur with r-hGH therapy.
Growth Hormone Subcutaneous Absorption: The absolute bioavailability of Serostim [somatropin (rDNA origin) for injection] after subcutaneous administration of a formulation not equivalent to the marketed formulation was determined to be 70-90%. The t1/2 (Mean = + or – SD) after subcutaneous administration is significantly longer than that seen after intravenous administration to normal male volunteers, down-regulated with somatostatin (3.94 + or – 3.44 hrs. vs. 0.58 + or – 0.08 hrs.), indicating that the subcutaneous absorption of the clinically tested formulation of the compound is slow and rate-limiting.
Growth Hormone Distribution: The steady-state volume of distribution (Mean + or – SD) following IV administration of Serostim in healthy volunteers is 12.0 + or – 1.08 L.
Growth Homrone Metabolism: Although the liver plays a role in the metabolism of growth hormone, GH is primarily cleaved in the kidney. GH undergoes glomerular filtration and after cleavage within the renal cells, the peptides and amino acids are returned to the systemic circulation.
Growth Hormone Elimination: The t1/2 (Mean + or – SD) in nine patients with AIDS related wasting with an average weight of 56.7 + or – 6.8 kg, given a fixed dose of 6.0 mg r-hGH subcutaneously was 4.28 + or – 2.15 hrs. The renal clearance of r-hGH after subcutaneous administration in nine patients with AIDS related wasting was 0.0015 + or – 0.0037 L/h. No significant accumulation of r-hGH appears to occur after 6 weeks of dosing as indicated.
Pediatric: Available evidence suggests that r-hGH clearances are similar in adults and children, but no clinical studies were conducted in children with acquired immune deficiency syndrome or AIDS-related complex.
Gender: Biomedical literature indicates that a gender related difference in the mean clearance of r-hGH could exist (Clearance of r-hGH in males > Clearance of r-hGH in females). However, no gender-based analysis is available on Serostim in normal volunteers or patients infected with HIV.
Race: No data are available.
Renal insufficiency: It has been reported that individuals with chronic renal failure tend to have decreased hGH clearance compared to normals, but there are no data on Serostim use in the presence of renal insufficiency.
HGH Growth Hormone Therapy for Hormone Replacement Therapy