What is Serostim?
Serostim is the brand name of Serono; a drug prescription and a form of a synthetic growth hormone that is marketed for wasting syndrome associated with AIDS. Specifically, Serostim is basically indicated or used for the HIV patient’s treatment with cachexia or wasting syndrome in order to increase body weight and body mass & also to improve the physical endurance. Along with it, the therapy of concomitant antiretroviral is necessary. The molecular weight of Serostim is 22,125 daltons. Check the full product composition here.
Serostim in Bodybuilding
Also known as somatropin, the HGH is actually an injectable drug for growth hormone that is available only through prescriptions. Like many other growth hormones’ synthetic form, Serostim is created by utilizing the recombinant DNA technologies. The FDA has also approved Serostim for the treatment of the muscle-wasting disease known as cachexia. Actually, the Serostim comprises of residues of the 191 amino acid & its structure and sequence are similarly identical to the endogenous growth hormone. Its structure and sequence confirm that it can do the same job as that of the natural growth hormone. If someone is suffering from lack of growth hormone then he could be seriously benefited from this compound.
The product was also studied in the regard to its capabilities to improve the mass of lean muscle and weight gain for individuals who were diagnosed with HIV. For that purpose, Serostim is used in bodybuilding, though it is illegal to use in bodybuilding.
Benefits and side effects in bodybuilding
According to one source, the treatment of the 0.1 mg/kg per every alternate day is seen to have fewer or fewer side effects. The product is also recommended as the initial dosage for patients who have been diagnosed with a risk of the glucose intolerance. However, it is worthwhile to note that there is actually minimal information regarding long-term or short-term benefits or side effects is accessible from the controlled studies or researchers after the use of it (Serostim) for 48 weeks or more.
Some adverse or negative reactions that may develop are as follows.
• Diabetic ketoacidosis.
• Worsening of diabetes mellitus that was pre-existing.
• A new outbreak of the diabetes mellitus (type 2)
• A new outbreak of the impaired intolerance of glucose.
• Diabetic coma.
Administration and Dosage
Serostim is usually administered by injecting subcutaneously. It should also be remembered that Serostim therapy is carried out best under the capable and regular guidance of at least one physician or doctor who is an expert & experienced in management and diagnosis of the HIV infection.
Cachexia or wasting syndrome associated with HIV
The product common starting dose is 0.1mg/kg, given subcutaneously once every day, which is up to a complete dose of six mg. Serostim must be administered by subcutaneous injection once every day as per the following recommendations of dosage based on the body-weight.
- If the body weight is more than 55 kg or 121 lb then the dosage will be 6 mg given subcutaneously daily.
- If the body weight is between 45 to 55 kg or 99 to 121 lb then the dosage will be 5 mg given subcutaneously daily.
- If the body weight is between 35 to 45 kg or 75 to 99 lb then the dosage will be 4 mg given subcutaneously daily.
- If the body weight is less than 35 kg or 75 lb then the dosage will be 0.1 mg per kg given subcutaneously daily.
Serostim Side effects
Treatment with the product given 0.1 mg per kg every alternate day consorted with some side effects which further resulted in one similar improvement or development in the work output, compared to the Serostim dosage of 0.1 mg per kg daily. Therefore, an initial Serostim dosage of 0.1 mg per kg every alternate day must be taken into consideration for patients who are at the increased or elevated risk for negative or adverse effects associated with the therapy of the growth hormone that is recombinant.
The majority of the effects of the Serostim on the mass of a lean body and work output was obvious post the treatment of 12 weeks. These effects were maintained during the therapy of an extra 12 weeks. There are actually no available data on efficacy or safety from the controlled studies, where the patients were actually treated with the Serostim for over 48 weeks. There are also no data available on efficacy or safety from the trials where patients with wasting syndrome or cachexia associated with HIV infection were observed to be treated sporadically with the Serostim.
Administration and preparation
Each and every product’s vial of 6 mg or 5 mg is transformed with the 0.5 ml to 1 ml of sterile water for the injection, USP.
Each and every Serostim’s vial of 4 mg is transformed in 0.5 ml to 1 ml (bacteriostatic water) for the injection, USP (preserved 0.9 percent of Benzyl Alcohol). For Benzyl Alcohol-sensitive patients, Serostim may be transformed with the help of sterile water for the injection, USP.
When the Serostim is transformed for injection, USP, with the help of sterile water, the transformed solution must be used promptly and immediately. Any unused or extra portion must be discarded. If the injection is not used quickly after it has been made then not only the efficiency of the injection decreases to a great extent but also there could be some serious side effects.
When the product is transformed for injection, USP (preserved 0.9 percent of benzyl alcohol), using bacteriostatic water, the transformed solution can be put in a freezer or refrigerator, maintaining a temperature of 2 to 8-degree celsius or 36 to 46-degree Fahrenheit, for 2 weeks.
Mechanical loss of approximately 10 percent can be related to the administration and reconstitution from the multidose vials.
To recreate the liquid, one has to inject first, into the vial of Serostim, the diluent; aiming that liquid against the vial’s glass wall. Then one will have to start swirling that vial gently with a rotary motion till the contents are completely dissolved. It must not be shaken. The drug products that are parental must be inspected, always, visually for grainy matter & any discoloration before administration, whenever the container and solution permit. The product should not be injected in case the solution is found to contain grainy or particulate matter or appears cloudy. It should only be used if the solution is colorless and clear.
The following should be used while administering the product.
• A needle, standard sterile and disposable syringe.
• A Serostim injection device that is needle-free.
• A device of needle injection that is compatible to Serostim.
Strengths and dosage forms
The single-use administration, which is to be transformed into the sterile water:
• 5 mg of Serostim, per vial.
• 6 mg of Serostim, per vial.
Multi-use administration, which is to be transformed using bacteriostatic water:
• 4 mg of Serostim, per vial.
These are the following contraindications related to the use of Serostim.
• Acute and critical illness
• The therapy of growth hormone should never be initiated or started in those patients who are suffering from acute and critical illness, as a result of complications following abdominal or open heart surgery, failure of acute respiratory or accidental trauma.
• Active Malignancy
• Generally, somatropin or Serostim is often contraindicated in active malignancy’s presence. Any pre-existing active malignancy must be inactive & treatment of it should be complete before starting therapy with the somatropin. The somatropin must be discontinued or stopped if any evidence of such recurrent activity is found.
• Serostim is also contraindicated in those patients who are known to have hypersensitivity to Serostim or somatropin or its excipients. There are reports of systematic hypersensitivity with the post-marketing use of the Serostim or somatropin products.
• Diabetes Retinopathy
• Somatropin or Serostim is also known to have contradictions with severe non-proliferative or active proliferative diabetic retinopathy.
Precautions and Warnings
- Acute and critical illness
There is an increased mortality observed in patients suffering from acute and critical illness because of complications post abdominal or open heart surgery or accidental trauma or patients with reported respiratory failure after the treatment with somatropin or serostim.
- Concomitant or adjuvant antiretroviral therapy
In few experimental systems, the somatropin was shown to increase the HIV replication (in vitro) at concentrations starting from 50 to 250 ng per ml. No increase was seen in the production of the virus when the zidovudine, lamivudine, didanosine or other antiretroviral agents were included to the culture medium. Additionally, studies (in vitro) reveal that somatropin or Serostim doesn’t any way interfere with antiviral activities of stavudine or zalcitabine. Furthermore, it was observed that there was no considerable somatropin or serostim-associated increase in the viral burden. However, that protocol needed all the participants on the concomitant or adjuvant antiretroviral therapy during the entire study. Keeping in view the potential and possible acceleration of the virus replication, it is advised that the HIV infected patients be kept and maintained on the antiretroviral therapy during the treatment of Serostim.
Reason being malignancies are usual in patients who are HIV positive, the benefits and risks of starting serostim or somatropin in those patients of HIV positive must be cautiously taken into consideration prior to the treatment of Serostim & the patients must be carefully monitored for the neoplasms development, once somatropin treatment is started. One should monitor all the patients with a history of neoplasm on a routine basis while on the therapy of Serostim or somatropin, for recurrence or progression of the tumor. Also, one must monitor those on the somatropin therapy cautiously for increased or elevated growth or pre-existing nevi’s possible malignant changes.
- Diabetes/compromised glucose tolerance
Hyperglycaemia is likely to occur in individuals who are HIV infected because of many reasons. In the wasting patients, serostim treatment of 0.1 mg per kg every alternate day & 0.1 mg per kg daily for almost 3 months was related with approximately 6 mg per dL and 10 mg per dL increases in the concentrations of the mean fasting glucose in the blood, respectively. The increases were seen early and initially in treatment. Individuals with some other risk factor related to glucose intolerance must be observed closely during the therapy of serostim.
- Intracranial hypertension
Intracranial hypertension or IH with a headache, nausea, papilledema, and/or vomiting is commonly reported in small number of patients under the somatropin treatment. The symptoms normally occur within first eight weeks after starting the therapy of serostim or somatropin. In all the reported cases, intracranial hypertension related symptoms and signs were seen rapidly resolving after stopping of therapy or reduction of doses of the somatropin. One should perform routinely the fundoscopic examination, during the entire course of the therapy of serostim. In case, papilledema is seen by the fundoscopy during treatment of somatropin or serostim, one should stop the treatment. One can restart the treatment at lower doses if somatropin-induced intracranial hypertension is diagnosed, the treatment with serostim or somatropin, soon after the IH-associated symptoms and signs have resolved.
- Severe hypersensitivity
Serious and severe reactions to systemic hypersensitivity including angioedema and anaphylactic reactions were reported with the somatropin product’s postmarketing use. Caregivers and patients have to be informed about the possibility of such reactions. They should also be advised that they must seek prompt attention if they experience an allergic reaction.
- Fluid retention
Increased or elevated tissue turgor such as swelling especially in the feet and hands, and discomfort in the musculoskeletal like swelling, pain and/or stiffness, may be experienced during serostim treatment, but may be managed with the analgesic therapy or reducing the dosing’s frequency.
When somatropin or serostim is injected subcutaneously at the same site for a longer time, there may be the occurrence of tissue atrophy. This can be prevented by changing or rotating the site of the injection.
- Clinical Pharmacology
Serostim is actually an anticatabolic and anabolic agent that exerts influence by interacting or collaborating with some specific receptors on various cell types, which includes lymphocytes, hepatocytes, myocytes, adipocytes and hematopoietic cells. Few but not all of Serostim’s effects are mediated or arbitrated by IGF-1 (insulin-like growth-factor-1)
- Information on Patient Counselling
Patients who are being treated with the Serostim should be educated on the risks as well as the potential benefits related to the treatment. Patients must be instructed or advised to contact a physician if they experience or feel any discomfort or side effects during the Serostim treatment.
It is advised as well as recommended that the product should be administered or injected using sterile needles and disposable syringes. Patients must be instructed thoroughly the necessity of the proper disposal & should also be cautioned against reuse of syringes and needles. A container must be employed where the used needles and syringes will be disposed.