somatrem

Action and Spectrum

Actions and spectrum: 

somatrem is a synthetic form of human growth hormone, also known as recombinant growth hormone. It stimulates the growth, cell reproduction, and regeneration in humans.

It has a wide spectrum of actions, including promoting the growth of bones and tissues, increasing protein synthesis, and influencing metabolism. somatrem is primarily used to treat growth hormone deficiency in children and adults. 

Drug Interaction

Adverse Reaction

Frequency not defined 

Redness 

lumps or lipoatrophy 

muscle and joint pain 

itching 

Headache 

benign intracranial hypertension 

Black Box Warning

Black Box Warning: 

There is no specific black box warning associated with somatrem. 

Contraindication / Caution

Contraindication/Caution: 

Contraindication: 

• Active Malignancy: somatrem is contraindicated in patients with any active malignancy, as growth hormone therapy may promote the growth of certain tumors. 
• Hypersensitivity: somatrem should not be used in patients with a known hypersensitivity or allergy to the drug or any of its components. 
• Prader-Willi Syndrome: Individuals with Prader-Willi syndrome who are severely obese or have respiratory impairment should not receive somatrem. There have been reports of sudden death in such patients. 
• Closed Epiphyses: The presence of closed epiphyses in pediatric patients indicates the end of longitudinal bone growth. somatrem is not indicated for the treatment of short stature in these patients. 
• Children with Prader-Willi Syndrome: In pediatric patients with Prader-Willi syndrome, somatrem is contraindicated in those with severe obesity or respiratory impairment.

Caution: 

• Intracranial Lesions: Caution is advised when prescribing somatrem to patients with preexisting intracranial lesions (e.g., pituitary tumors) due to the potential for increased intracranial pressure. Regular monitoring and evaluation by a healthcare provider, including periodic ophthalmic examinations, may be necessary. 
• Diabetes Mellitus: Patients with diabetes mellitus or impaired glucose tolerance should be monitored closely during somatrem therapy. Dose adjustments of antidiabetic medications may be necessary. 
• Scoliosis: Patients with scoliosis should be monitored for progression of the condition during somatrem therapy. Spinal radiographs may be needed. 
• Fluid Retention: somatrem can cause fluid retention. Patients with a history of fluid retention, cardiovascular disease, or renal dysfunction should be closely monitored during therapy. 
• Pediatric Growth: somatrem should not be used to increase the final height of pediatric patients with closed epiphyses (growth plates). The efficacy and safety of somatrem in patients with closed epiphyses have not been established. 
• Hepatic Function: Patients with hepatic dysfunction should be monitored for potential adverse effects, as the liver plays a role in the metabolism of somatrem. 
• Pregnancy and Lactation: The safety of somatrem in pregnant or breastfeeding women has not been established. Caution should be exercised when considering somatrem therapy in these populations.

Comorbidities: 

• Pituitary Tumors: Growth hormone deficiency can result from pituitary tumors or other structural abnormalities in the brain. The presence of these tumors may require surgical intervention and hormonal replacement therapy, such as somatrem. 
• Hypopituitarism: Growth hormone deficiency often occurs as part of a broader condition known as hypopituitarism, which involves the underproduction of several hormones by the pituitary gland. Other hormonal deficiencies may include TSH, ACTH, LH, and FSH. 
• Turner Syndrome: Girls with Turner syndrome, a genetic disorder that affects female development, may experience short stature and growth hormone deficiency. somatrem can be used to promote growth in these individuals. 
• Idiopathic Short Stature: In some cases, children may exhibit short stature for unknown reasons, referred to as idiopathic short stature. If growth hormone deficiency is identified as a contributing factor, somatrem treatment may be considered. 
• Muscle Wasting Conditions: Growth hormone can also play a role in muscle development and maintenance. Some conditions associated with muscle wasting may benefit from growth hormone therapy, although this is less common. 

Pregnancy / Lactation

Pregnancy consideration: pregnancy category: C 

Lactation: excreted into human milk: unknown  

Pregnancy category: 

• Category A: well-controlled and Satisfactory studies show no risk to the fetus in the first or later trimester. 
• <b>Category B: there was no evidence of risk to the fetus in animal studies, and there were not enough studies on pregnant women. 
• Category C: there was evidence of risk of adverse effects in animal reproduction studies, and no adequate evidence in human studies must take care of potential risks in pregnant women.   
• Category D: adequate data with sufficient evidence of human fetal risk from various platforms, but despite the potential risk, and used only in emergency cases for potential benefits. 
• Category X: Drugs listed in this category outweigh the risks over benefits. Hence these categories of drugs need to be avoided by pregnant women. 
• Category N: There is no data available for the drug under this category. 

Pharmacology

Pharmacology: 

somatrem is a synthetic form of human growth hormone (hGH) designed to mimic the action of naturally occurring hGH in the body. Its pharmacology revolves around stimulating the growth and development of various tissues, primarily by binding to specific receptors on the target cells.

This binding triggers a cascade of intracellular signalling pathways that result in enhanced protein synthesis, tissue growth, and overall development. somatrem is used therapeutically to address growth hormone deficiencies in individuals, promoting linear growth, muscle development, and overall well-being. It is administered via injection and requires careful monitoring to ensure effective and safe treatment outcomes.  

Pharmacodynamics: 

• Binding to hGH Receptors: somatrem binds to specific receptors on the surface of target cells. These receptors are known as growth hormone receptors (GHRs). 
• Activation of Intracellular Signalling: Upon binding to GHRs, somatrem initiates a series of intracellular signalling events. This involves the activation of molecules like JAK2 (Janus kinase 2) and STAT (signal transducer and activator of transcription) proteins. 
• IGF-1 Production: One of the key downstream effects of somatrem’s action is the stimulation of IGF-1 production in the liver and other tissues. IGF-1 is a crucial mediator of the growth-promoting effects of hGH. 
• Stimulation of Growth and Development: IGF-1, in turn, promotes growth and development in various tissues and organs, including bone, cartilage, and muscle. It enhances protein synthesis, cellular proliferation, and tissue growth. 
• Metabolic Effects: somatrem also has metabolic effects, such as increasing the utilization of fats for energy and reducing glucose uptake by cells.  
• Anti-insulin Effects: somatrem can antagonize the effects of insulin, leading to increased blood glucose levels. This can be a concern in individuals with diabetes.

Pharmacokinetics: 

Absorption 

somatrem is typically administered via subcutaneous injection. This route ensures direct absorption into the bloodstream. The absorption rate can vary based on factors like injection site, depth, and individual patient factors. 

Distribution 

Once in the bloodstream, somatrem is expected to distribute throughout the body, like endogenous growth hormone. It interacts with growth hormone receptors on various target tissues and cells. 

Metabolism 

somatrem’s metabolism is not extensively documented, as it is a synthetic analog designed to mimic the action of natural growth hormone. It is unlikely to undergo typical metabolic processes in the liver, as seen with many drugs. 

Elimination and excretion 

The excretion of somatrem from the body is also not well-documented. It is presumed that somatrem is eliminated through normal metabolic and excretory pathways, but specific details may be limited. 

Adminstartion

Administration: 

• Dosage: The dosage of somatrem varies depending on the individual patient’s needs and the specific growth disorder being treated.  
• Injection Site: somatrem is typically injected subcutaneously (under the skin) in areas with a thin layer of fat, such as the abdomen, thigh, or upper arm. Rotate injection sites to prevent lipodystrophy (changes in fat tissue). 
• Timing: somatrem is typically administered once daily. The timing of the injection may vary but is often done in the evening or before bedtime. 
• Storage: Follow the storage instructions provided with the somatrem product. Some formulations may need to be refrigerated, while others can be stored at room temperature. 

Patient Information Leaflet

Patient information leaflet 

Generic Name: somatrem 

Pronounced: (soh-muh-trem)  

Why do we use somatrem? 

• Treatment of Growth Hormone Deficiency (GHD): somatrem is prescribed to individuals, often children, who have insufficient levels of growth hormone. It stimulates linear growth, helping children with GHD to reach a more normal height. 
• Treatment of Short Stature: somatrem may be prescribed to children with idiopathic short stature, which means they are shorter than their peers without an identifiable medical cause. It can help increase their growth rate. 
• Turner Syndrome: Girls with Turner syndrome, a genetic disorder that affects growth and development, may be prescribed somatrem to improve height and overall growth. 
• Chronic Renal Insufficiency: Some children with chronic kidney disease may experience growth delays. somatrem can be used to help promote growth in these individuals. 
• Prader-Willi Syndrome: This rare genetic disorder can cause numerous health issues, including growth hormone deficiency. somatrem may be used to address growth concerns in individuals with Prader-Willi syndrome.