somatrogon-ghla

Action and Spectrum

Actions and Spectrum: 

somatrogon is a synthetic form of human growth hormone (HGH) that is being developed to treat growth hormone deficiency (GHD) in children. It is designed to provide a long-acting effect, reducing the frequency of injections required compared to traditional growth hormone therapies. 

somatrogon stimulates the growth-promoting effects of human growth hormone in the body. The pituitary gland naturally produces the human growth hormone and plays a crucial role in growth, cell reproduction, and regeneration.

somatrogon aims to mimic the effects of endogenous growth hormone by binding to specific receptors and stimulating growth-related processes. 

Drug Interaction

Adverse Reaction

Frequency defined 

>10% 

Injection site reactions (42.2%) 

Headache (16.5%) 

Nasopharyngitis (33%) 

Elevated eosinophil levels (29%) 

Pyrexia (16.5%) 

1-10% 

Hypothyroidism (6.4%) 

Otitis media (4.6%) 

Rash (5.5%) 

Anemia (8.3%) 

Bronchitis (2.8%) 

Abdominal pain (6.4%) 

Oropharyngeal pain (5.5%) 

Cough (8.3%) 

Arthralgia (4.6%) 

Vomiting (7.3%) 

Black Box Warning

Black Box Warning: 

None 

Contraindication / Caution

Contraindication/Caution: 

Contraindication 

• Allergy or hypersensitivity: Individuals with a known allergy or hypersensitivity to somatrogon or its components should not use the medication. 
• Active malignancy: Growth hormone therapies are generally contraindicated in individuals with an active malignancy or a history of certain types of cancers, such as leukemia or tumors of the brain. 
• Closed epiphyses: The epiphyses are the ends of long bones, and their closure signifies the end of linear growth. Growth hormone therapy is not typically recommended for individuals with closed epiphyses, as it may not provide significant growth benefits. 
• Acute critical illness: Growth hormone therapy is generally not recommended for individuals with acute critical illness, as it may interfere with the body’s response to the illness or complicate the treatment. 
• Intracranial hypertension: Growth hormone therapy should be used cautiously in individuals with a history of or current intracranial hypertension (increased pressure within the skull). 

Caution 

• Underlying medical conditions: Individuals with certain medical conditions, such as diabetes, hypertension, thyroid disorders, or kidney or liver problems, may require careful monitoring and adjustment of their medication regimen when using growth hormone therapies. Close medical supervision is crucial in these cases. 
• Intracranial lesions: Growth hormone therapy should be used cautiously in individuals with a history of or current intracranial lesions, as it may worsen the condition. Regular monitoring, including periodic imaging studies, may be necessary. 
• Scoliosis: Growth hormone therapy may exacerbate pre-existing scoliosis (abnormal spine curvature). Regular monitoring of spinal health and careful assessment of the benefits versus risks are important considerations. 
• Fluid retention: Growth hormone therapy may cause fluid retention, leading to peripheral edema (swelling in the extremities). Individuals with a cardiac or renal impairment history may be more susceptible to these effects and require close monitoring. 
• Interactions with other medications: Growth hormone therapies may interact with certain medications, such as glucocorticoids or sex hormones. It’s essential to inform the healthcare provider about all medications, supplements, or herbal products being taken to ensure proper monitoring and potential dosage adjustments. 

Pregnancy / Lactation

Pregnancy consideration:  

US FDA pregnancy category: Not assigned. 

Lactation:   

Excreted into human milk: Not known. 

Pregnancy category: 

• Category A: well-controlled and Satisfactory studies show no risk to the fetus in the first or later trimester. 
• 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: 

Growth hormone therapies, including somatrogon, aim to mimic the effects of endogenous human growth hormone (HGH) in the body. The pituitary gland naturally produces the human growth hormone and plays a vital role in growth, cell reproduction, and regeneration. It exerts its effects by binding to specific receptors in various tissues and stimulating the production of insulin-like growth factor 1 (IGF-1). IGF-1, in turn, mediates the growth-promoting actions of growth hormone. 

Pharmacodynamics: 

Mechanism of action: The action of somatrogon is expected to be similar to that of endogenous human growth hormone (hGH). Human growth hormone plays a crucial role in stimulating growth, cell reproduction, and regeneration in the body. It exerts its effects by binding to specific receptors, primarily the growth hormone receptor (GHR), in various tissues and cells. 

When somatrogon is administered, the growth hormone component of the fusion protein binds to the GHR, initiating a signaling cascade. This activates multiple downstream signaling pathways, such as the Janus kinase or signal transducer and activator of transcription (JAK/STAT) pathway. 

The activated signaling pathways result in various biological effects, including: 

• Stimulation of linear growth: Growth hormone therapies promote longitudinal bone growth in children by stimulating the proliferation of chondrocytes (cartilage cells) in the growth plates of long bones. 
• Protein synthesis: Growth hormone promotes the synthesis of proteins in various tissues, including skeletal muscle. This can result in increased muscle mass and strength. 
• Lipolysis: Growth hormone stimulates the breakdown of stored fat (lipolysis), releasing free fatty acids into the bloodstream. 
• Carbohydrate metabolism: Growth hormone regulates carbohydrate metabolism by reducing insulin sensitivity and promoting glucose production in the liver. 

Pharmacokinetics: 

Absorption 

Growth hormone therapies are typically administered via subcutaneous injection. After injection, the medication is absorbed slowly through the subcutaneous tissue and enters the systemic circulation. The rate and extent of absorption can vary depending on the formulation and specific characteristics of the medication. 

Distribution 

Once in the bloodstream, growth hormone therapies are distributed throughout the body. Human growth hormone and its synthetic forms, like somatrogon, can bind to specific receptors on target tissues, like skeletal muscle, adipose tissue, and liver. The distribution may be influenced by factors such as protein binding and tissue perfusion. 

Metabolism 

Human growth hormone, including synthetic forms like somatrogon, undergoes metabolism in various tissues, including the liver and kidneys. The exact metabolic pathways and enzymes involved can vary. Metabolism may involve processes such as proteolysis and enzymatic modifications. 

Elimination and Excretion 

Metabolites of growth hormone therapies, including somatrogon, are primarily excreted in the urine. The exact excretion mechanisms and elimination half-life can vary depending on the specific formulation and characteristics of the medication. 

Adminstartion

Administration: 

Subcutaneous administration 

• Route of administration: somatrogon is typically administered via subcutaneous injection, which involves injecting the medication into the fatty tissue beneath the skin. The exact technique and injection site may vary depending on the specific medication and individual patient factors. It’s crucial to receive proper training from a healthcare professional on the correct administration technique. 
• Injection frequency: The frequency of injections may vary depending on the specific growth hormone therapy used. Some therapies require daily injections, while others may be administered a few times weekly. It’s essential to follow the prescribed dosing schedule and instructions the healthcare professional provides. 
• Injection sites: Common injection sites for growth hormone therapies include the thighs, abdomen, or buttocks. It’s generally recommended to rotate injection sites to minimize discomfort or skin-related issues arising from repeated injections in the same area. 
• Preparation and storage: Proper preparation and instructions may vary depending on the specific growth hormone therapy used. It’s important to carefully read and follow the instruction provided by the manufacturer or healthcare professional regarding reconstitution (if applicable), storage temperature, and expiration dates. 
• Monitoring and follow-up: Regular monitoring of growth, therapy response, and potential side effects is essential when administering growth hormone therapies. The healthcare professional will typically schedule follow-up visits to assess the progress and make any necessary adjustments to the treatment plan. 

Patient Information Leaflet

Patient information leaflet 

Generic Name: somatrogon-ghla 

Why do we use somatrogon-ghla? 

The primary intended use of somatrogon is for treating growth hormone deficiency (GHD) in children. Growth hormone deficiency is characterized by inadequate production or secretion of growth hormone from the pituitary gland. It can result in stunted growth and development in children.

somatrogon, a synthetic form of human growth hormone (HGH), is being developed as a treatment option for children with GHD. It is designed to provide a long-acting effect, reducing the frequency of injections required compared to traditional growth hormone therapies.