Product Name: SEROSTIM® (somatropin for injection) 6 mg, 126 IU HGH Kit
Active Ingredient: Somatropin (recombinant human growth hormone, r-hGH)
Dosage Strength: 6 milligrams (mg) per vial, equivalent to approximately 126 International Units (IU)
Presentation: Single-patient-use kit containing one lyophilized powder vial of somatropin, one vial of sterile diluent, and syringes/needles for reconstitution and administration.
Important Note: This product requires a prescription. The information below is for educational and professional reference only and does not constitute medical advice.
SEROSTIM® (somatropin for injection) represents a specific, prescription-only formulation of recombinant human growth hormone (HGH) engineered to address a critical metabolic complication of advanced HIV infection: wasting or cachexia. Unlike generalized growth hormone formulations, SEROSTIM® is uniquely indicated to increase lean body mass and body weight, improve physical endurance, and enhance overall functional status in patients with HIV-associated wasting or cachexia. Each 6 mg vial, containing approximately 126 IU of bioactive somatropin, is part of a comprehensive kit designed for precise, aseptic reconstitution and subcutaneous administration.
SEROSTIM® is explicitly indicated for the treatment of HIV-associated wasting or cachexia. This condition, characterized by the progressive, involuntary loss of lean body mass (LBM) despite adequate caloric intake, was a major contributor to morbidity and mortality before the advent of effective antiretroviral therapy (ART). It remains a concern in some patient populations.
The therapeutic action of SEROSTIM® is anabolic and anti-catabolic. It works by:
Stimulating Protein Synthesis: Directly promoting the uptake of amino acids into muscle cells, facilitating the building of new proteins.
Promoting Lipolysis: Enhancing the breakdown of stored fat for energy, helping to spare protein and redirect metabolic resources toward muscle preservation.
Counteracting Catabolic Pathways: Mitigating the effects of inflammatory cytokines and other metabolic disturbances that drive muscle breakdown in chronic illness.
This results in a net gain of lean body mass, not simply weight from fluid retention or fat accumulation.
The approval of SEROSTIM® was based on robust, randomized, placebo-controlled clinical trials. Key findings in patients with HIV-associated wasting demonstrated that SEROSTIM®, in conjunction with optimized antiretroviral therapy, led to:
Significant Increase in Lean Body Mass: Measured via dual-energy x-ray absorptiometry (DEXA) scans, patients showed statistically significant gains in LBM compared to placebo.
Improved Body Weight: Weight gain was primarily attributed to the increase in lean tissue.
Enhanced Physical Function and Endurance: Patients reported and demonstrated improved ability to perform daily activities and measured increases in treadmill work output.
Positive Trends in Quality of Life: Associated improvements in perceived well-being and functional status were noted.
These outcomes underscore SEROSTIM®'s role not as a primary antiviral, but as a specialized adjuvant therapy to reverse a specific debilitating complication of HIV disease.
Each SEROSTIM® 6mg (126 IU) Kit is a complete, single-patient system:
One Vial of Lyophilized SEROSTIM® Powder: 6 mg somatropin (approximately 126 IU), under vacuum.
One Vial of Sterile Diluent: Bacteriostatic Water for Injection, USP, preserved with 0.9% benzyl alcohol (1.0 mL).
Administration Components: Typically includes one or two sterile syringes and needles for reconstitution and subcutaneous injection.
Product Information Leaflet: Detailed prescribing information and handling instructions.
Expiration Dating: This specific kit features an extended shelf life, with an expiration date of 2027. Always check the date on the individual carton and vials prior to use. Do not use beyond the expiration date.
Crucial Note: Administration must be under the guidance of a qualified healthcare provider. The following is a general overview.
Reconstitution: Using aseptic technique, slowly inject the supplied 1.0 mL of diluent into the SEROSTIM® vial. Direct the stream against the glass wall. Gently swirl (do not shake) until the powder is fully dissolved. The resulting solution should be clear. Inspect for particulate matter or discoloration before use.
Dosage: The recommended adult dosage is 0.7 mg (approximately 0.1 mL or 12.6 IU) administered subcutaneously once daily. Dosing is based on milligrams (mg), not IU. The provided diluent allows for accurate measurement of this standard dose.
Administration: Administer via subcutaneous injection, typically in the abdomen, thigh, or upper arm, rotating sites daily to avoid tissue irritation.
Storage: Unreconstituted vials must be refrigerated at 2°C to 8°C (36°F to 46°F). Do not freeze. After reconstitution, the solution is stable for up to 14 days when refrigerated at 2°C to 8°C. Protect from light.
SEROSTIM® is a potent biologic agent with a defined safety profile. Prescribers must be aware of the following:
Contraindications: SEROSTIM® is contraindicated in patients with active malignancy, acute critical illness due to complications after open heart or abdominal surgery, multiple accidental trauma, or acute respiratory failure; patients with Prader-Willi syndrome who are severely obese or have severe respiratory impairment; and those with known hypersensitivity to somatropin or any component of the formulation.
Warnings and Precautions:
Fluid Retention/Edema: May occur, particularly at initiation, and may manifest as edema, arthralgia, carpal tunnel syndrome. Usually transient but may require dose adjustment.
Glucose Intolerance: May decrease insulin sensitivity. Monitor glucose levels regularly, especially in patients with diabetes or risk factors.
Neoplasia: As with all growth hormone products, there is a theoretical risk. Monitor patients with a history of malignancy.
Intracranial Hypertension (IH): Rare cases of IH (pseudotumor cerebri) have been reported. Monitor for headache, papilledema, visual changes.
Hypothyroidism: May unmask or worsen underlying hypothyroidism. Monitor thyroid function.
Common Adverse Reactions: The most frequently reported side effects include arthralgia (joint pain), myalgia (muscle pain), peripheral edema, hypersensitivity reactions (rash, itching), and paresthesias (tingling/numbness).
The SEROSTIM® 6mg (126 IU) HGH Kit remains a vital, FDA-approved therapeutic option specifically designed to counteract the catabolic state of HIV-associated wasting. Its proven ability to increase lean body mass, improve physical function, and enhance patient well-being positions it as a unique adjunctive therapy within a modern, multifaceted HIV treatment regimen. The extended expiration date (2027) of this lot ensures long-term stability when stored correctly.
Disclaimer: This description is for informational purposes only. SEROSTIM® is a prescription medication with serious potential risks. Patients must be managed by a physician experienced in the treatment of HIV and metabolic disorders. Treatment decisions must be based on the official Prescribing Information, individual patient assessment, and professional medical judgment.
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