Hgh Serostim 4mg 12IU
Serostim® [somatropin (rDNA origin) for injection] is a human growth hormone (hGH) 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 GH
What is Hgh Serostim 4mg 12IU ?
SEROSTIM – somatropin
somatropin (rDNA origin) for injection
Hgh Serostim 4mg 12IU (rDNA origin) for injection] is a human growth hormone (hGH) 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 GH. Serostim® is produced by a mammalian cell line (mouse C127) that has been modified by the addition of the hGH gene. Serostim® is secreted directly through the cell membrane into the cell-culture medium for collection and purification.
HGH SEROSTIM 4MG 12IU is a highly purified preparation. Biological potency is determined by measuring the increase in the body weight induced in hypophysectomized rats.
Hgh Serostim 4mg 12IU is available in 5 mg and 6 mg vials for single dose administration. Serostim® is also available in 4 mg and 8.8 mg vials for multi-dose administration. Each 4 mg vial contains 4.0 mg (approximately 12 IU) somatropin, 27.3 mg sucrose, 0.9 mg phosphoric acid. 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. Each 8.8 mg vial contains 8.8 mg (approximately 26.4 IU) somatropin, 60.19 mg sucrose and 2.05 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 with Water for Injection, USP. The pH is adjusted with sodium hydroxide or phosphoric acid to give a pH of 6.5 to 8.5 after reconstitution with Bacteriostatic Water for Injection, USP (0.9% Benzyl Alcohol).
Hgh Serostim 4mg 12IU
HGH SEROSTIM 4MG 12IU [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 insulin-like growth factor-I (IGF-I).
Human immunodeficiency virus (HIV)-associated wasting or cachexia, which commonly involves involuntary loss of lean body mass or body weight, 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 HIV-associated wasting, in which supplemental calories are converted predominantly to body fat, Serostim® treatment resulted in a significant increase in LBM and a decrease in fat mass with a significant increase in body weight due to the dominant effect of LBM gain.
HIV-associated adipose redistribution syndrome (HARS) is characterized by abnormal accumulation of trunk fat, including visceral adipose tissue (VAT), in patients infected with HIV/acquired immune deficiency disorder (AIDS), the vast majority of whom have been treated with highly active antiretroviral therapy (HAART). VAT is comprised of the deep fat in the abdomen in the omental-mesenteric and retroperitoneal compartments. HARS, a subset of HIV lipodystrophy, is more specifically defined as maldistribution of body fat characterized by central fat accumulation (lipohypertrophy) with or without lipoatrophy (subcutaneous fat depletion primarily in the face and limbs). In HARS patients, fat may additionally accumulate in the upper body subcutaneous area such as the dorsocervical area (i.e., “buffalo hump”). These changes may be accompanied by metabolic disturbances including insulin resistance, glucose intolerance, and dyslipidemia, as well as belly image distress. Initial 12-week treatment with Serostim® resulted in decreases in VAT, trunk fat, and patient-reported belly appearance distress . The clinical significance of these changes with respect to improved cardiovascular risk profile or compliance with HAART has not been studied.
Effects on Protein, Lipid, and Carbohydrate Metabolism:Hgh Serostim 4mg 12IU
A one-week study in 6 patients with HIV-associated wasting has shown that treatment with Serostim® 0.1 mg/kg/day improved nitrogen balance, increased protein-sparing lipid oxidation, and had little effect on overall carbohydrate metabolism.
Decreases in trunk fat and total body fat, and increases in lean body mass were observed during two double-blind, placebo-controlled studies wherein Serostim® vs. placebo were administered daily for 12 weeks to patients with HARS.
Effects on Nitrogen and Mineral Retention:
In the one-week study in 6 patients with HIV-associated wasting, treatment with Hgh Serostim 4mg 12IU 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.
Physical Performance:Hgh Serostim 4mg 12IU
Cycle ergometry work output and treadmill performance were examined in separate 12-week, placebo-controlled trials . In both studies, work output improved significantly in the group receiving Hgh Serostim 4mg 12IU 0.1 mg/kg/day subcutaneously vs placebo. 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 Hgh Serostim 4mg 12IU therapy.
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 t½ (Mean ± SD) after subcutaneous administration is significantly longer than that seen after intravenous administration in normal male volunteers down-regulated with somatostatin (3.94 ± 3.44 hrs. vs. 0.58 ± 0.08 hrs.), indicating that the subcutaneous absorption of the clinically tested formulation of the compound is slow and rate-limiting.
Distribution: The steady-state volume of distribution (Mean ± SD) following IV administration of Serostim® in healthy volunteers is 12.0 ± 1.08 L.
Metabolism: Although the liver plays a role in the metabolism of GH, 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.
Elimination: The t½ (Mean ± SD) in nine patients with HIV-associated wasting with an average weight of 56.7 ± 6.8 kg, given a fixed dose omilar in adults and children, but no pharmacokinetic studies have been conducted in children with HIV.
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 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 r-hGH clearance compared to normals, but there are no data on Hgh Serostim 4mg 12IU use in the presence of renal insufficiency.
Hepatic Insufficiency: A reduction in r-hGH clearance has been noted in patients with severe liver dysfunction. However, the clinical significance of this in HIV+ patients is unknown.
HIV-Associated Wasting or Cachexia
The clinical efficacy of Hgh Serostim 4mg 12IU [somatropin (rDNA origin) for injection] in HIV-associated wasting or cachexia was assessed in two placebo-controlled trials. All study subjects received concomitant antiretroviral therapy.
Hgh Serostim 4mg 12IU Clinical Trial 1: A 12-week, randomized, double-blind, placebo-controlled study followed by an open-label extension phase enrolled 178 patients with severe AIDS wasting taking nucleoside analogue therapy (pre-HAART era). The primary endpoint was body weight. Body composition was assessed using dual energy X-ray absorptiometry (DXA) and physical function was assessed by treadmill exercise testing. Patients meeting the inclusion/exclusion criteria were treated with either placebo or Hgh Serostim 4mg 12IU 0.1 mg/kg daily. Ninety-six percent (96%) were male. The average baseline CD4 count/µL was 85. The results from one hundred forty (140) evaluable patients were analyzed (those completing the 12-week course of treatment and who were at least 80% compliant with study drug). After 12 weeks of therapy, the mean difference in weight increase between the Serostim®-treated group and the placebo-treated group was 1.6 kg (3.5 lb). Mean difference in lean body mass (LBM) change between the Serostim®-treated group and the placebo-treated group was 3.1 kg (6.8 lbs) as measured by DXA. Mean increase in weight and LBM, and mean decrease in body fat, were significantly greater in the Serostim®-treated group than in the placebo group (p=0.011, p<0.001, p<0.001, respectively) after 12 weeks of treatment (Figure 1). There were no significant changes with continued treatment beyond 12 weeks suggesting that the original gains of weight and LBM were maintained
THgh Serostim 4mg 12IUreatment with Hgh Serostim 4mg 12IU resulted in a significant increase in physical function as assessed by treadmill exercise testing. The median treadmill work output increased by 13% (p=0.039) at 12 weeks in the group receiving Hgh Serostim 4mg 12IU . There was no improvement in the placebo-treated group at 12 weeks. Changes in treadmill performance were significantly correlated with changes in LBM.