Welcome to Dwaey, specifically on Recombinant Somatropin page.
This medicine contains important and useful components, as it consists of
Recombinant Somatropin is available in the market in concentration.
Recombinant Somatropin
Before using Recombinant Somatropin, it is crucial for patients to consult with a healthcare provider. Recombinant Somatropin is a synthetic form of human growth hormone and should be administered under medical supervision. Important precautions include:
- Diabetes: Patients with diabetes or those at risk for diabetes should be monitored regularly, as somatropin may affect glucose metabolism, potentially causing hyperglycemia or making it more difficult to control blood sugar levels.
- Hypothyroidism: Individuals with thyroid disorders, particularly hypothyroidism, should be monitored closely, as somatropin may exacerbate thyroid dysfunction.
- Prader-Willi Syndrome: Patients with Prader-Willi syndrome are at higher risk for complications such as sleep apnea, and the medication may need to be adjusted or avoided in such cases due to the increased risk of severe adverse reactions.
- Cancer or Tumors: Recombinant Somatropin should not be used in patients with active cancer, as it can promote the growth of tumors. This includes individuals with a history of cancer or those with undiagnosed growth hormone deficiency.
- Intracranial Hypertension: There is a risk of increased pressure inside the skull, leading to symptoms like headaches, nausea, and vomiting. Patients should be observed for such signs, particularly in the early stages of therapy.
- Pregnancy and Lactation: There is limited information on the safety of Recombinant Somatropin during pregnancy or lactation, so it should only be used if clearly necessary and prescribed by a healthcare provider.
- Obesity and Sleep Apnea: Recombinant somatropin is contraindicated in severe obesity or sleep apnea due to the risks of worsened conditions or respiratory complications.
Recombinant Somatropin is primarily used to treat growth hormone deficiencies and related conditions. Its therapeutic indications include:
- Growth Hormone Deficiency: Used in both children and adults who have low levels of growth hormone due to congenital or acquired conditions.
- Turner Syndrome: A genetic disorder that leads to short stature and developmental issues, where Recombinant Somatropin helps promote growth and development.
- Prader-Willi Syndrome: This syndrome can cause growth failure and obesity, and recombinant somatropin is used to promote growth and lean body mass.
- Chronic Kidney Disease (CKD): In patients with CKD, Recombinant Somatropin may be used to improve growth and metabolic outcomes in children who experience stunted growth.
- Idiopathic Short Stature: Used in children who have normal growth hormone levels but still fail to achieve expected height due to unknown causes.
- Muscle Wasting in HIV/AIDS: Recombinant Somatropin is used to increase lean body mass in individuals with HIV/AIDS-related muscle wasting.
There are specific situations in which Recombinant Somatropin should not be used, including:
- Active Malignancy: Somatropin is contraindicated in individuals with active cancers (e.g., leukemia, lymphoma, or brain tumors), as it may promote tumor growth.
- Severe Respiratory or Sleep Disorders: In individuals with severe sleep apnea or respiratory conditions, the medication could worsen symptoms and cause complications.
- Diabetic Retinopathy: Somatropin should not be used in patients with diabetic retinopathy or other retinal disorders, as it may exacerbate these conditions.
- Prader-Willi Syndrome with Severe Obesity: Recombinant somatropin should not be used in patients with Prader-Willi syndrome if they have severe obesity, especially in those with respiratory distress or sleep apnea, due to an increased risk of life-threatening complications.
- Hypersensitivity: Patients with known hypersensitivity to Recombinant Somatropin or any of its components should avoid the medication to prevent severe allergic reactions.
Common and serious side effects of Recombinant Somatropin should be carefully monitored. Patients should report any of the following to their healthcare provider:
- Common Side Effects:
- Injection Site Reactions: Pain, redness, or swelling at the injection site is common and usually resolves over time.
- Headaches: Mild headaches can occur as a side effect, especially at the beginning of therapy.
- Muscle and Joint Pain: Some patients may experience discomfort in their muscles or joints.
- Edema (Swelling): Mild swelling in the extremities may occur due to fluid retention.
- Fatigue: Some patients report feeling unusually tired or lethargic.
- Serious Side Effects:
- Increased Intracranial Pressure: Symptoms include headache, nausea, vomiting, and visual disturbances. This requires immediate medical attention.
- Diabetes or Glucose Intolerance: Somatropin may lead to hyperglycemia or diabetes in susceptible individuals, necessitating blood glucose monitoring.
- Slipped Capital Femoral Epiphysis (SCFE): A condition that affects the hip joint in growing children. It may cause hip or knee pain and requires urgent evaluation.
- Scoliosis: In children with growth hormone therapy, there is a potential risk of the development or worsening of scoliosis.
- Pancreatitis: In rare cases, pancreatitis (inflammation of the pancreas) may occur, presenting as severe abdominal pain, nausea, and vomiting.
2
Recombinant Somatropin works by mimicking the natural growth hormone produced by the pituitary gland. It stimulates growth and various metabolic functions through its actions on specific receptors, primarily in bones, cartilage, and muscles. By binding to the growth hormone receptor (GHR), recombinant somatropin activates several signaling pathways that regulate:
- Bone Growth: Increases the length and density of bones, especially in children.
- Protein Synthesis: Stimulates protein synthesis in muscle cells, promoting muscle growth and repair.
- Fat Metabolism: It aids in lipid breakdown, leading to decreased fat accumulation, particularly in areas like the abdomen.
- Carbohydrate Metabolism: Somatropin increases the rate of glucose utilization and promotes the storage of glycogen, though it may also affect insulin sensitivity, leading to changes in glucose metabolism.
- Cell Regeneration: Enhances the regeneration of cells, contributing to the repair of damaged tissues and maintaining tissue function.
The overall effect is an increase in growth, muscle mass, bone density, and improvement in various metabolic processes.
Several drug interactions may affect the safety or efficacy of Recombinant Somatropin. Patients should inform their healthcare provider of any other medications they are taking, including over-the-counter drugs, vitamins, and herbal supplements:
- Glucocorticoids: Concurrent use of glucocorticoids (e.g., prednisone) can reduce the effectiveness of recombinant somatropin. Glucocorticoids can inhibit growth hormone action and impair its therapeutic benefits.
- Estrogen: Estrogen or oral contraceptives may increase the activity of somatropin and could require dosage adjustments, as estrogen can enhance growth hormone secretion and alter hormone metabolism.
- Cyclosporine: Cyclosporine (an immunosuppressive drug) may interact with recombinant somatropin by affecting its pharmacokinetics and potentially requiring careful monitoring and adjustment of dosage.
- Insulin: As recombinant somatropin can affect glucose metabolism, patients using insulin may require adjustments to their insulin dose to maintain proper blood sugar control.
- Other Hormonal Therapy: Any hormonal therapy, including thyroid hormone replacement or estrogen therapy, may interact with somatropin, requiring careful monitoring of hormone levels.
The dose of Recombinant Somatropin for adults varies based on the specific condition being treated:
- Growth Hormone Deficiency: A typical starting dose for adults with growth hormone deficiency is around 0.15 to 0.3 mg per day administered via subcutaneous injection. The dosage may be adjusted based on clinical response and tolerance.
- Muscle Wasting in HIV/AIDS: The usual dose for patients with HIV/AIDS-related muscle wasting is 0.1 to 0.3 mg per day, depending on body weight and clinical response.
- Turner Syndrome: A starting dose of 0.375 mg/kg per week administered in daily or divided doses.
Dosing regimens may vary, and adjustments are made based on clinical response, side effects, and individual needs.
The pediatric dose of Recombinant Somatropin depends on the condition being treated and the age of the child:
- Growth Hormone Deficiency: For children, the typical starting dose is 0.025 to 0.05 mg/kg per day administered via subcutaneous injection.
- Turner Syndrome: The recommended dose for children with Turner syndrome is usually 0.375 mg/kg per week, divided into daily or multiple doses.
- Prader-Willi Syndrome: Dosing is individualized, but typically 0.24 mg/kg per week is given in divided daily doses.
- Idiopathic Short Stature: Doses are generally 0.03 to 0.05 mg/kg per day.
It is essential to adjust the dose based on the child's weight, growth response, and any adverse effects.
For patients with renal impairment, dosing of Recombinant Somatropin may need to be adjusted. It is recommended to use lower starting doses, and renal function should be closely monitored during treatment. Specific adjustments depend on the severity of kidney disease, and renal clearance of the hormone is not significantly affected, but careful monitoring is necessary.
Not available in a medicine form yet