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Medical Disclaimer: This information is for educational purposes only and is not a substitute for professional medical advice.
Glandula Suprarenalis Suis, Thyroidinum (bovine), Hgh
Brand Name
Somaderm Awe
Generic Name
Glandula Suprarenalis Suis, Thyroidinum (bovine), Hgh
Active Ingredient
SomatropinCategory
Non-Standardized Food Allergenic Extract [EPC]
Variants
1
Different strengths and dosage forms
| Strength | Form | Route | NDC |
|---|---|---|---|
| 30 [hp_X]/g | GEL | TOPICAL | 61877-0008 |
Detailed information about Somaderm Awe
This page is for informational purposes only and does not replace medical advice. Before using any prescription or over-the-counter medication for Somaderm Awe, you must consult a qualified healthcare professional.
Somatropin is a recombinant human growth hormone (rhGH) used to treat growth failure in children and growth hormone deficiency in adults. It mimics the natural hormone produced by the pituitary gland to stimulate tissue growth, protein synthesis, and metabolism.
For Adult Growth Hormone Deficiency (AGHD), dosing is highly individualized and is not typically based on body weight, but rather on clinical response and serum IGF-1 levels.
In children, dosing is almost always based on body weight or body surface area and varies significantly by the condition being treated.
No specific dosage adjustment is generally required for patients with renal impairment, though growth response may be decreased in children with chronic kidney disease. Monitoring for fluid retention is essential.
No specific dosage adjustment is required for patients with liver disease, but the production of IGF-1 (which occurs in the liver) may be impaired, potentially requiring higher doses to achieve clinical effects.
Patients over age 65 are often more sensitive to the effects of somatropin and are more likely to experience side effects like fluid retention and joint pain. Healthcare providers typically start with lower doses (e.g., 0.1 mg/day) and titrate more slowly.
If you miss a dose, take it as soon as you remember unless it is almost time for your next dose. Do not "double up" or take two doses at once to make up for a missed one. If you miss more than three doses in a row, contact your healthcare provider for guidance.
Acute overdose may lead to initial hypoglycemia (low blood sugar) followed by hyperglycemia (high blood sugar). Long-term overdose (chronic over-exposure) can lead to acromegaly, a condition characterized by the overgrowth of bones in the face, hands, and feet, as well as organ enlargement.
> Important: Follow your healthcare provider's dosing instructions exactly. Do not adjust your dose or stop treatment without medical guidance, as this can affect the success of the therapy.
These side effects occur frequently, especially when starting therapy or after a dose increase. They are often related to the drug's effect on fluid balance.
> Warning: Stop taking Somatropin and call your doctor immediately if you experience any of these serious symptoms.
There is no universal "Black Box Warning" for all somatropin products; however, specific brands carry contraindications for use in patients with Prader-Willi Syndrome who are severely obese or have severe respiratory impairment. There have been reports of sudden death in these patients when starting somatropin therapy, likely due to sleep apnea or airway obstruction.
Report any unusual symptoms to your healthcare provider. Monitoring through regular blood tests and physical exams is a standard part of somatropin therapy.
Somatropin is a potent hormone that affects almost every system in the body. It should only be prescribed by specialists, such as pediatric or adult endocrinologists. Patients must be monitored regularly to ensure the dose is effective and safe. It is vital to disclose your full medical history, including any history of cancer, diabetes, or kidney disease, before starting treatment.
While not a formal "Black Box" on all labels, the FDA issues a high-level warning regarding Prader-Willi Syndrome (PWS). Somatropin is contraindicated in pediatric patients with PWS who are severely obese, have a history of upper airway obstruction or sleep apnea, or have severe respiratory impairment. Sudden deaths have been reported in these specific populations. All PWS patients should be evaluated for sleep apnea before starting therapy and monitored for respiratory infections during treatment.
To ensure safety, your doctor will require the following tests:
Somatropin generally does not affect the ability to drive or operate machinery. However, if you experience visual changes or severe headaches (symptoms of intracranial hypertension), you should avoid these activities until cleared by a doctor.
There is no direct contraindication between alcohol and somatropin. However, alcohol can affect blood sugar levels and growth hormone secretion. It is best to limit alcohol consumption to maintain the metabolic benefits of the medication.
In children, somatropin is typically discontinued once the epiphyses (growth plates) have closed or when a satisfactory height has been reached. In adults, therapy may be lifelong. Stopping somatropin suddenly does not typically cause a withdrawal syndrome, but the metabolic benefits (such as improved energy and body composition) will gradually disappear.
> Important: Discuss all your medical conditions and any family history of cancer with your healthcare provider before starting Somatropin.
> Important: Tell your doctor about ALL medications, supplements, and herbal products you are taking, as somatropin can alter how your body processes other substances.
Somatropin must NEVER be used in the following circumstances:
These conditions require a careful risk-benefit analysis by a specialist:
Patients who are allergic to E. coli-derived products should be cautious, as many somatropin brands are produced using E. coli expression systems. Additionally, some liquid formulations contain benzyl alcohol; these should be avoided in newborns (due to "gasping syndrome") and used with caution in patients with known alcohol sensitivities.
> Important: Your healthcare provider will evaluate your complete medical history, including family history and previous lab results, before prescribing Somatropin.
Somatropin is generally classified as Pregnancy Category C (under the older FDA system). There are no adequate and well-controlled studies in pregnant women. Animal reproduction studies have not shown evidence of fetal harm, but human data is limited. Somatropin should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. It is typically discontinued during pregnancy unless the mother has severe, symptomatic growth hormone deficiency.
It is not known whether somatropin is excreted in human milk. However, because somatropin is a large protein molecule, it is unlikely that significant amounts would be absorbed intact by the nursing infant's digestive system. Caution should be exercised, and the decision to breastfeed while taking somatropin should be made in consultation with a healthcare provider.
Somatropin is most commonly used in the pediatric population. It is approved for use in infants, children, and adolescents, depending on the specific condition.
Clinical studies of somatropin did not include sufficient numbers of subjects aged 65 and over to determine if they respond differently than younger subjects. However, elderly patients are known to be more prone to the side effects of somatropin, particularly fluid retention, joint pain, and impaired glucose tolerance. Dosing for geriatric patients should be conservative, starting at the lowest possible dose.
In children with chronic kidney disease (CKD), somatropin is used to treat growth failure. Treatment should be discontinued at the time of renal transplantation. In adults with renal failure, the clearance of somatropin is reduced, which may theoretically increase the risk of side effects, though specific dose adjustments are not standardized.
Patients with severe liver disease (Child-Pugh Class C) may have a reduced ability to produce IGF-1 in response to somatropin. This can lead to "growth hormone resistance," where higher doses are needed to achieve a clinical response. Close monitoring of serum IGF-1 levels is essential in these patients.
> Important: Special populations require individualized medical assessment and more frequent laboratory monitoring.
Somatropin is a potent metabolic hormone that acts by binding to the Growth Hormone Receptor (GHR), a member of the class I cytokine receptor family. Upon binding, the GHR undergoes dimerization, activating the intracellular signaling protein Janus kinase 2 (JAK2). This triggers the phosphorylation of STAT5 (Signal Transducers and Activators of Transcription) proteins, which then migrate to the nucleus to regulate gene expression. The most significant result of this pathway is the synthesis of Insulin-like Growth Factor-1 (IGF-1). IGF-1 then acts on its own receptors (IGF-1R) to stimulate systemic cell growth, particularly in skeletal muscle and bone.
| Parameter | Value |
|---|---|
| Bioavailability | 70% - 90% (Subcutaneous) |
| Protein Binding | Minimal (GH-binding proteins exist but are not traditional albumin binding) |
| Half-life | 2 - 5 hours (Subcutaneous) |
| Tmax | 3 - 6 hours |
| Metabolism | Hepatic and Renal (proteolysis) |
| Excretion | Renal <1% (unchanged) |
Somatropin is classified as a Recombinant Human Growth Hormone [EPC]. It is a member of the somatotropin agonist class. Related medications include various brands of somatropin and long-acting (pegylated) growth hormones like lonapegsomatropin.
Common questions about Somaderm Awe
Somatropin is primarily used to treat growth failure in children who have conditions such as growth hormone deficiency, Turner syndrome, Prader-Willi syndrome, or chronic kidney disease. In adults, it is used to treat growth hormone deficiency that began in childhood or resulted from pituitary damage in adulthood. It is also FDA-approved for specific conditions like HIV-associated wasting and short bowel syndrome. The medication works by replacing the natural growth hormone the body is failing to produce. It helps increase height in children and improves body composition, bone density, and energy levels in adults. Always consult a specialist to see if somatropin is appropriate for your specific medical needs.
The most common side effects of somatropin are related to fluid retention and include swelling in the hands and feet (edema), joint pain, and muscle aches. Some patients may also experience headaches or tingling sensations in the skin (paresthesia). In children, injection site reactions like redness or itching are frequently reported. These side effects are often temporary and may improve as the body adjusts to the medication or if the doctor reduces the dose. However, if side effects become severe or persistent, you must contact your healthcare provider. Monitoring for more serious risks, such as high blood sugar or increased pressure in the brain, is a standard part of treatment.
There is no known direct dangerous interaction between alcohol and somatropin. However, alcohol can interfere with the metabolic processes that somatropin is trying to improve, such as blood sugar regulation and fat metabolism. Excessive alcohol consumption can also suppress the natural secretion of growth hormone and potentially worsen side effects like headaches. For patients with growth hormone deficiency, maintaining a healthy lifestyle is key to the success of the therapy. It is generally advised to consume alcohol only in moderation, if at all. Always discuss your lifestyle habits with your doctor to ensure the best results from your treatment.
Somatropin is classified as Pregnancy Category C, meaning there is limited data on its safety in human pregnancy. Animal studies have not shown direct harm to the fetus, but because human growth hormone is a complex protein, its effects on a developing baby are not fully understood. In most cases, healthcare providers recommend discontinuing somatropin during pregnancy unless the mother's growth hormone deficiency is so severe that it poses a health risk to her. If you become pregnant while taking somatropin, you should notify your doctor immediately. They will perform a risk-benefit analysis to determine if you should continue the medication. Breastfeeding while on somatropin is also generally approached with caution.
The time it takes to see results from somatropin depends on the condition being treated. In children, an increase in growth rate is often noticeable within 3 to 6 months of starting therapy, though the full effect on final adult height takes years of consistent use. In adults with growth hormone deficiency, improvements in energy levels and mood may be felt within a few weeks, while changes in body composition—such as increased muscle mass and decreased body fat—typically take 3 to 6 months to become apparent. Bone density improvements take the longest, often requiring a year or more of treatment. Regular follow-ups with an endocrinologist are necessary to track these changes. Consistency with daily injections is the most important factor in seeing results.
Stopping somatropin suddenly does not typically cause life-threatening withdrawal symptoms, but it will cause the benefits of the medication to reverse over time. In children, stopping treatment before the growth plates have closed will result in a significant slowdown or cessation of growth, preventing them from reaching their full height potential. In adults, stopping therapy will lead to a gradual return of symptoms like fatigue, increased body fat, and decreased muscle strength. If you need to stop somatropin due to side effects or financial reasons, you should always do so under a doctor's supervision. They can help you manage the transition and monitor your hormone levels. Never stop a prescribed hormone therapy without medical guidance.
If you miss a dose of somatropin, you should take it as soon as you remember. However, if it is almost time for your next scheduled dose, skip the missed dose and return to your regular injection schedule. Do not take two doses at the same time to make up for the one you missed, as this could increase the risk of side effects like fluid retention or high blood sugar. It is helpful to set a daily alarm or use a medication tracking app to stay consistent, as the drug is most effective when taken every day. If you miss more than three doses in a row, it is a good idea to call your doctor's office. They can advise you on how to get back on track and ensure your progress isn't stalled.
Somatropin typically causes changes in body composition rather than simple weight gain. It is known to increase lean muscle mass and decrease body fat, particularly abdominal fat. However, because muscle is denser than fat, some patients may see a slight increase in their total body weight even as they look leaner and their clothes fit better. Additionally, somatropin can cause temporary weight gain due to fluid retention (edema) when first starting the drug or after a dose increase. This type of weight gain usually presents as swelling in the ankles or hands. If you experience rapid or excessive weight gain, you should consult your doctor to check for fluid retention or other metabolic changes.
Somatropin can interact with several other types of medications, so a full review of your current prescriptions is necessary. It most commonly interacts with glucocorticoids (like prednisone), which can block the growth-promoting effects of somatropin. It also interacts with insulin and oral diabetes medications, as somatropin can raise blood sugar levels, requiring a dose adjustment of the diabetes drugs. Women taking oral estrogen may find that they need higher doses of somatropin because oral estrogen interferes with growth hormone action in the liver. Always tell your doctor about all vitamins, herbal supplements, and over-the-counter drugs you are using. This ensures that your somatropin dose is calculated accurately for your specific needs.
Somatropin is a complex biologic medication, so it does not have 'generics' in the same way that simple drugs like aspirin do. Instead, it has 'biosimilars.' A biosimilar is a biological product that is highly similar to an already approved biological 'reference' product and has no clinically meaningful differences in safety or effectiveness. Omnitrope was the first somatropin product to be approved through a pathway similar to generics in the U.S. Today, there are several brands available, and your insurance company may require you to use a specific one based on their formulary. While the active ingredient is the same, the injection devices and the way the medicine is stored can vary between brands.
Other drugs with the same active ingredient (Somatropin)