Somatropin is generally used to help manage symptoms related to growth failure caused by hormone deficiency and to support key systemic function. The medication is commonly used to help with conditions associated with significant symptomatic burden, including Growth Hormone Deficiency (GHD) in children and adults, Turner syndrome, Prader-Willi syndrome, Short Bowel Syndrome (SBS), and specialized support for HIV-associated wasting. It assists with the objective of promoting linear growth in children and maintaining functional stability and body composition in adults.

“The supportive relief provided helps ease the overall symptom burden linked to chronic hormonal insufficiency and diminished tissue integrity.”

The therapeutic support is relevant across domains where additional symptomatic support is needed, addressing symptom clusters that include short stature, poor bone density, and severe wasting (cachexia). This provides supportive relief when symptoms interfere with routine activities.

Quick Fact: Relief for Growth Failure and Diminished Lean Body Mass

Regulatory References

1. NIH MedlinePlus Drug Information

The eligibility for using Растан (Somatropin) is strictly determined by official regulatory guidelines, which define populations who can use the medicine and those who must not.

Approved Populations and Restrictions

Растан is approved for use in children and adults with confirmed Growth Hormone Deficiency (GHD), as well as specific pediatric groups with short stature due to conditions like Turner Syndrome or Chronic Kidney Disease. For growth promotion, use is strictly limited to children whose growth plates (epiphyses are open); treatment is contraindicated if epiphyses have closed.

Contraindicated Populations (Must Not Use)	Conditional Eligibility (Requires Monitoring/Treatment)
Active malignancy or cancer	Preexisting Hypothyroidism (must be adequately treated)
Acute critical illness (post-surgery/trauma)	Diabetes Mellitus (requires strict glucose control)
Severe respiratory impairment in PWS	History of Intracranial Neoplasms
Severe non-proliferative diabetic retinopathy	Geriatric Patients (requires lower starting dose)

The medicine is contraindicated in patients with an active malignancy or those recovering from acute critical illness, and in children with Prader-Willi Syndrome who are severely obese or have severe respiratory impairment. Use during pregnancy is generally not recommended, and a decision to discontinue the drug or nursing is necessary for breastfeeding women.

Interactions with other medicines and products

Official regulatory documentation details several clinically significant interactions for Somatropin (Растан) based on its metabolic and hormonal effects. These interactions necessitate careful monitoring and potential dosage adjustments for co-administered medicinal products, as described in drug labels from authorities such as the FDA and EMA.

Documented Interaction Patterns

Somatropin may reduce insulin sensitivity, a pharmacodynamic effect that requires potential dose adjustment for concurrent Antihyperglycemic Agents, including insulin and oral agents. A separate metabolic interaction involves Somatropin's inhibition of the 11beta-Hydroxysteroid Dehydrogenase Type 1 (11beta-HSD-1) enzyme. This effect may necessitate an increase in the replacement dose of glucocorticoids to ensure adequate therapeutic levels.

Furthermore, the labels document that Somatropin can increase the clearance of various compounds metabolized by CYP450 liver enzymes, such as corticosteroids, sex steroids, and certain anticonvulsants. This pharmacokinetic change requires close monitoring, particularly for co-administered drugs with a narrow therapeutic range.

Restrictions and Special Considerations

The regulatory profile specifies a mandatory timing restriction for the diagnostic test drug macimorelin, requiring Somatropin to be discontinued for at least 1 week prior to its administration. Additionally, Oral Estrogen-Containing Products may increase the required dose of Somatropin in women to maintain target IGF-1 levels. For pediatric patients receiving glucocorticoid treatment, careful dosing is necessary to prevent growth attenuation.

Растан (Somatropin) is a polypeptide agonist that binds to the human growth hormone receptor (GHR), a dimeric receptor expressed on the surface of target cells, particularly in the liver and cartilage. Ligand binding induces GHR dimerization and subsequent conformational changes, leading to the recruitment and activation of Janus Kinase 2 (JAK2).

The activation of JAK2 initiates the downstream signal transducer and activator of transcription (STAT) pathway, primarily involving the tyrosine phosphorylation of STAT5. Phosphorylated STAT5 proteins translocate to the nucleus, where they act as transcription factors, stimulating the expression of target genes, including Insulin-like Growth Factor-1 (IGF-1).

Circulating IGF-1, predominantly produced by the liver, subsequently binds to the Type 1 IGF Receptor on peripheral tissues like the growth plate. This interaction promotes the differentiation of pre-chondrocytes and the proliferation of osteoblasts. System-level consequences include the modulation of protein synthesis, lipolysis, and glucose metabolism.

Растан is a pharmaceutical preparation that must be administered as a subcutaneous injection (SC) and is explicitly not for intravenous use. Due to its formulation, the medicine is typically supplied as a sterile solution or a lyophilized powder, with the latter requiring reconstitution with the provided diluent before injection. The site of injection—such as the abdomen, thigh, or upper arm—must be regularly rotated to prevent localized tissue changes.

The treatment protocol mandates a once-daily injection schedule, and the total weekly dose is often divided into six or seven equal daily amounts. Administration is frequently recommended in the evening. Dosing is highly individualized and must be supervised by a physician experienced in growth hormone therapy, as the amount is based on patient weight or a standardized non-weight-based regimen and is adjusted over time.

For Adult Growth Hormone Deficiency (GHD), therapy begins with a low, conservative starting dose, such as 0.15 mg to 0.3 mg per day, which is then gradually adjusted every one to two months based on clinical response and serum IGF-I levels. Specific instructions apply to certain populations: older adults typically require a lower starting dose and slower titration, and obese patients are generally not managed using a weight-based dosing approach.

Treatment duration is defined by physiological criteria. For children, Somatropin is discontinued when epiphyseal growth plates are fused. For adults, the therapy is generally considered long-term replacement. If a dose is missed, patients should administer it as soon as possible that day, but must not double the dose to compensate.

Recent Clinical Evidence

The clinical evidence for Растан (recombinant human growth hormone) primarily centers on its use in patients with Growth Hormone Deficiency (GHD) and Turner's Syndrome (TS). The research focuses on monitoring longitudinal growth, bone health, and the medication's overall safety profile.

Efficacy and Growth Outcomes

Studies have assessed the impact of the drug on growth velocity and height progression in pediatric populations.

• Growth Hormone Deficiency: Clinical trials reported that the drug was studied in children with GHD. Outcomes recorded included statistically significant increases in height velocity and height Standard Deviation Score (SDS) over the treatment period.
• Turner's Syndrome: Similar studies in children with TS noted an increase in height velocity and height SDS. These trials monitored changes over approximately six months, with further observation in long-term extension phases.

Biochemical Markers

Changes in specific biomarkers were key secondary endpoints in the clinical programs:

• IGF-1 and IGFBP-3: Trial data showed significant increases in serum levels of Insulin-like Growth Factor-1 (IGF-1) and Insulin-like Growth Factor-Binding Protein-3 (IGFBP-3), particularly in participants whose levels were initially low. These markers are used to evaluate the body's response to growth hormone treatment.

Safety and Tolerability

The safety profile was comprehensively evaluated across the clinical trials. The most frequently reported adverse events (AEs) were generally described as mild. Trial data on discontinuation rates due to AEs were collected, and these rates were reported to be low, indicating that the majority of participants were able to continue treatment throughout the study periods.

Common questions about Растан (FAQ)

Q: What are the most common side effects or adverse reactions for children?

Official studies indicate that side effects commonly reported in children with Growth Hormone Deficiency (GHD) included reactions at the injection site, such as pain, redness, or swelling. Other reported effects included headache and changes in thyroid function, such as hypothyroidism (low thyroid activity). Additionally, some children have experienced a localized loss of fat or a mild increase in blood sugar levels.

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Q: What conditions or diseases is this drug approved to treat?

The medicine is indicated for use in children and adults diagnosed with Growth Hormone Deficiency (GHD). Regulatory documents also approve its use for children who have short stature due to specific underlying medical conditions, such as Turner Syndrome or Chronic Kidney Disease, among other defined pediatric causes.

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Q: Does taking this medicine require any special blood monitoring?

Official labeling mandates close monitoring, which often includes regular measurement of serum levels of Insulin-like Growth Factor-I (IGF-I) to help assess treatment response. Monitoring of thyroid function and blood sugar levels is also necessary, particularly in patients with diabetes.

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Q: Is it necessary to mix the drug before injection, and if so, how is it done?

If the medicine is supplied as a lyophilized powder (a dry preparation), official labeling states that it must be mixed, or reconstituted, with a liquid diluent before use. The mixing process involves gentle swirling to combine the components, and vigorous shaking must be avoided, as this action can irreversibly damage the medicine.

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Q: Can this drug be injected directly into a vein (IV)?

Official regulatory documents confirm that this medicine is for subcutaneous injection (under the skin) only. The product information explicitly states that it is not for intravenous (IV) use and must not be injected directly into a vein.

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Q: What do I do if I accidentally froze my drug supply?

Official labeling strongly warns that the drug must not be frozen in any form, as freezing can cause irreversible damage to the sensitive protein structure. If the medicine has been frozen, official guidance suggests consulting a healthcare provider or pharmacist for information on handling and disposal, as the product is likely damaged.

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Q: What happens if I accidentally inject the drug into the same spot many times?

The regulatory guidance requires the rotation of injection sites (using a different area each time) to help prevent localized tissue changes. Repeated injection into the exact same location may lead to skin issues, such as a localized loss of fat (lipoatrophy) or a thickening of the tissue at the site.

How to Store and Dispose of Растан

Storing and disposing of this medication must strictly follow regulatory guidelines to maintain the drug's stability and ensure safety. Растан's active ingredient, Somatropin, is a sensitive protein that requires cold-chain management.

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Mandatory Storage and Stability

Condition	Requirement
Temperature	Unmixed and in-use solution must be refrigerated at 36 F to 46 F (2 C to 8 C).
Freezing	Do not freeze the product in any form, as this causes irreversible damage.
Handling	Do not shake the solution vigorously. Protect the product from light by storing it in its original package.
In-Use Stability	The reconstituted solution must be discarded after 28 days, even if continuously refrigerated.

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Disposal and Safety Rules

Used needles and syringes must be placed immediately into an FDA-cleared sharps disposal container. Disposal of all unused or expired medication, as well as the sharps container, must adhere to state and local regulations for medical waste. Always store the drug out of the sight and reach of children.