Genotropin (Somatropin) – Complete Product Information

Genotropin (somatropin) represents the gold standard in recombinant human growth hormone therapy, providing bioidentical hormone replacement for patients with growth hormone deficiency and specific growth disorders. As a 191-amino acid polypeptide with a molecular weight of 22,124 daltons, Genotropin is structurally identical to natural human growth hormone, ensuring optimal therapeutic efficacy with minimal immunogenicity risk.

Human growth hormone plays essential roles throughout life, regulating linear growth in children and maintaining proper body composition, bone density, muscle mass, and metabolic function in adults. Growth hormone deficiency can result from genetic conditions, pituitary tumors, trauma, surgery, radiation therapy, or idiopathic causes, leading to significant health consequences requiring hormone replacement therapy.

Comprehensive Therapeutic Applications: Genotropin addresses multiple growth-related conditions across different age groups. In pediatric patients, the medication treats growth hormone deficiency, Prader-Willi syndrome, Turner syndrome, children born small for gestational age who fail to achieve catch-up growth, and idiopathic short stature. Each indication requires specific dosing regimens tailored to the underlying condition and patient characteristics.

For adult patients, Genotropin replaces deficient growth hormone in those with either childhood-onset or adult-onset growth hormone deficiency. Adult growth hormone deficiency often manifests as increased body fat, decreased lean muscle mass, reduced bone density, impaired quality of life, and metabolic abnormalities that significantly improve with replacement therapy.

Advanced Delivery Systems and Patient Convenience: Genotropin utilizes sophisticated delivery technology designed to enhance patient compliance and treatment outcomes. The medication is available in color-coded cartridge systems (5mg green tip, 12mg purple tip) used with corresponding GENOTROPIN PEN devices, and single-use GENOTROPIN MINIQUICK devices available in multiple dose strengths from 0.2mg to 2.0mg.

These delivery systems incorporate two-chamber cartridges that keep the lyophilized growth hormone powder separate from the diluent until injection time, ensuring medication stability and potency. The reconstitution process occurs automatically when the pen device components are assembled, providing consistent dosing accuracy and reducing preparation errors.

Mechanism of Action and Physiological Effects: Somatropin exerts its effects through binding to growth hormone receptors throughout the body, initiating complex signaling cascades that promote growth and metabolic regulation. The hormone stimulates production of insulin-like growth factor-I (IGF-I), which mediates many of growth hormone’s effects on linear growth, protein synthesis, and metabolic processes.

In growing children, Genotropin primarily affects the epiphyseal plates of long bones, stimulating chondrocyte proliferation and matrix production that results in increased linear growth. The medication also increases muscle cell number and size, enhances protein synthesis, promotes lipolysis, and affects carbohydrate metabolism by improving insulin sensitivity in some patients while potentially causing glucose intolerance in others.

Pharmacokinetic Profile and Dosing Considerations: Following subcutaneous administration, Genotropin demonstrates approximately 80% bioavailability compared to intravenous dosing. Peak serum concentrations occur around 6 hours after injection, with a half-life of approximately 3 hours. The medication undergoes classical protein catabolism in the liver and kidneys, with metabolic products partially returning to systemic circulation.

Dosing varies significantly based on indication, patient weight, age, and individual response. Pediatric dosing ranges from 0.16-0.48 mg/kg/week depending on the specific condition, while adult dosing can follow either weight-based (0.04-0.08 mg/kg/week) or non-weight-based (0.15-0.30 mg/day) regimens with dose adjustments based on clinical response and IGF-I levels.

Safety Profile and Critical Warnings: Genotropin carries several important safety warnings, including contraindications for acute critical illness due to increased mortality risk demonstrated in intensive care unit studies. The medication is contraindicated in patients with active malignancy, and childhood cancer survivors treated with cranial radiation face increased risk of secondary neoplasms, particularly meningiomas.

Special precautions apply to patients with Prader-Willi syndrome, where fatal respiratory complications have occurred in severely obese patients or those with respiratory impairment. The medication can unmask or worsen diabetes mellitus, cause intracranial hypertension, and lead to slipped capital femoral epiphysis in pediatric patients, requiring careful monitoring and prompt intervention when complications arise.

Monitoring Requirements and Laboratory Surveillance: Successful Genotropin therapy requires comprehensive monitoring including growth velocity assessment in children, body composition changes in adults, IGF-I levels, glucose tolerance, thyroid function, and monitoring for potential complications. Regular funduscopic examinations help detect intracranial hypertension, while bone age assessments guide treatment duration in pediatric patients.

Laboratory monitoring includes serum IGF-I concentrations to guide dose adjustments, glucose levels to detect diabetes development, and thyroid function tests since hypothyroidism can impair growth hormone effectiveness. Patients also require monitoring for potential antibody development, though clinically significant antibodies are rare with recombinant somatropin.

Long-term Outcomes and Quality of Life Benefits: Genotropin therapy can dramatically improve quality of life for patients with growth hormone deficiency. Children often achieve normal or near-normal adult height when treatment is initiated early and continued appropriately. Adults typically experience improved body composition, increased muscle mass, reduced fat mass, enhanced exercise capacity, and improved psychological well-being.

However, patients and families must understand that growth hormone therapy requires long-term commitment, regular monitoring, and ongoing medical supervision. Treatment success depends on adherence to injection schedules, proper injection technique, regular follow-up appointments, and prompt reporting of potential side effects or complications.

For patients with growth hormone deficiency or related conditions, Genotropin offers significant therapeutic potential when used appropriately under endocrinologic supervision. Those exploring growth hormone therapy should work with experienced pediatric or adult endocrinologists who can coordinate comprehensive care including growth monitoring, metabolic assessment, and management of treatment-related complications. Patients seeking affordable hormone therapy options should understand that while Genotropin represents advanced treatment, the medication requires extensive medical monitoring and should never be used without appropriate specialist oversight and regular safety assessments, as the benefits and risks of growth hormone replacement require specialized expertise for optimal patient outcomes and safety management throughout the treatment journey.

Brand	Genotropin GoQuick Pre-Filled Pen Brand
Form	5.3mg 16IU 1 pen, 12mg 36IU 1 pen, 12mg 36IU 5 pen

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Genotropin can cause significant side effects ranging from common injection site reactions to life-threatening complications in critically ill patients. Understanding these potential effects is crucial for safe treatment, as many require immediate medical attention or treatment modifications to prevent serious complications.

Life-Threatening Side Effects (Black Box Level Warnings):

Increased mortality in acute critical illness: 42% vs 19% mortality in ICU patients with complications from surgery, trauma, or respiratory failure
Sudden death in Prader-Willi syndrome: Fatal respiratory complications in severely obese patients or those with sleep apnea
Upper airway obstruction: Fatal breathing complications, particularly in PWS patients
Respiratory failure: Acute breathing difficulties requiring immediate intervention
Sleep apnea complications: Worsening breathing problems during sleep

Serious Malignancy Risks:

Second neoplasms in childhood cancer survivors: Increased risk, particularly meningiomas in patients treated with cranial radiation
Intracranial tumors: Brain tumors, especially meningiomas, in high-risk populations
Leukemia: Rare cases reported in GHD children, though causality unclear
Progression of preexisting malignancies: Tumor growth or recurrence
Malignant changes in nevi: Changes in existing moles requiring monitoring

Serious Metabolic and Endocrine Effects:

New-onset Type 2 diabetes: Development of diabetes mellitus requiring treatment
Impaired glucose tolerance: Prediabetic glucose abnormalities
Diabetic ketoacidosis: Severe metabolic complications in diabetic patients
Severe hypoglycemia: Dangerous low blood sugar episodes
Hypothyroidism: Central hypothyroidism requiring hormone replacement
Hypoadrenalism: Adrenal insufficiency requiring glucocorticoid replacement

Serious Neurological Complications:

Intracranial hypertension: Increased brain pressure with papilledema, visual changes, headache, nausea/vomiting
Papilledema: Optic nerve swelling potentially causing permanent vision loss
Visual field defects: Permanent vision problems from increased intracranial pressure
Severe headaches: Persistent, severe head pain requiring evaluation
Seizures: New-onset seizure activity

Serious Musculoskeletal Complications in Children:

Slipped capital femoral epiphysis (SCFE): Hip joint displacement requiring surgery
Legg-Calve-Perthes disease: Hip bone death/avascular necrosis
Progressive scoliosis: Worsening spinal curvature requiring intervention
Severe joint pain: Debilitating arthralgia affecting mobility
Growth plate abnormalities: Complications affecting bone development

Serious Cardiovascular Effects:

Severe fluid retention: Dangerous edema requiring hospitalization
Congestive heart failure: Heart failure exacerbation in predisposed patients
Severe hypertension: Dangerously elevated blood pressure
Cardiovascular collapse: Severe cardiovascular compromise

Common Side Effects (>5% of patients):

Injection site reactions: Pain, swelling, redness, nodules, fibrosis affecting 37% of rheumatology patients
Headaches: Frequent head pain affecting daily activities
Upper respiratory infections: Colds, flu, sinusitis, tonsillitis
Arthralgia (joint pain): Affecting multiple joints, particularly in adults
Peripheral edema: Swelling in hands, feet, or ankles
Extremity pain: Arm and leg discomfort
Fatigue: Persistent tiredness affecting daily function

Adult-Specific Side Effects (Dose-Dependent):

Peripheral swelling - 17.5% vs 5.1% placebo: Fluid retention requiring dose reduction
Arthralgia - 17.3% vs 4.2% placebo: Joint pain affecting mobility
Extremity pain - 14.7% vs 5.9% placebo: Arm and leg discomfort
Paresthesia - 9.6% vs 1.9% placebo: Numbness and tingling sensations
Extremity stiffness - 7.9% vs 1.6% placebo: Joint and muscle stiffness
Carpal tunnel syndrome - 2% of patients: Nerve compression requiring surgery in some cases

Pediatric-Specific Side Effects:

Growth-related complications: Rapid growth causing joint or bone problems
Precocious puberty: Early onset of puberty requiring monitoring
Jaw prominence: Facial bone changes affecting appearance
Progression of pigmented nevi: Changes in moles requiring dermatologic evaluation
Behavioral changes: Aggressiveness, mood alterations
Increased appetite: Significant weight gain in some patients

Condition-Specific Side Effects:

Prader-Willi Syndrome Patients:

Respiratory complications: Upper airway obstruction, sleep apnea worsening
Sudden death: Fatal outcomes in high-risk patients
Aggressive behavior: Behavioral changes requiring management
Fluid retention: Edema potentially affecting breathing

Turner Syndrome Patients:

Otitis media: Increased ear infections requiring treatment
Cardiovascular disorders: Stroke, aortic aneurysm/dissection, hypertension
Hearing problems: Progressive hearing loss
Increased infection risk: Various respiratory and urinary tract infections

Gastrointestinal Side Effects:

Pancreatitis: Severe abdominal pain, particularly in Turner syndrome girls
Severe abdominal pain: Requiring emergency evaluation
Nausea and vomiting: Digestive system upset
Gastroenteritis: Digestive tract inflammation

Dermatologic Side Effects:

Lipoatrophy: Fat tissue loss at injection sites
Injection site fibrosis: Scar tissue formation at injection sites
Skin pigmentation changes: Color changes at injection sites
Hair loss: Temporary or permanent alopecia
Rash and inflammation: Various skin reactions

Severe Hypersensitivity Reactions:

Anaphylactic reactions: Life-threatening allergic responses
Angioedema: Severe swelling of face, lips, tongue, throat
Systemic hypersensitivity: Whole-body allergic reactions
Severe urticaria: Widespread hives requiring treatment

Laboratory Abnormalities:

Elevated IGF-I levels: Above normal ranges requiring dose adjustment
Elevated alkaline phosphatase: Bone enzyme increases
Increased inorganic phosphorus: Mineral metabolism changes
Hematuria: Blood in urine requiring investigation
Anti-growth hormone antibodies: Immune reactions (rare but significant when >2 mg/mL)

Drug Interaction-Related Side Effects:

Glucocorticoid insufficiency: Need for increased steroid doses
Insulin resistance: Requiring diabetes medication adjustments
Altered drug metabolism: Changes in other medication effectiveness
Thyroid hormone interactions: Need for thyroid medication adjustments

Long-term Treatment Complications:

Gigantism/acromegaly: From chronic overdosage
Progressive glucose intolerance: Development of diabetes over time
Cardiovascular complications: Long-term heart and blood vessel effects
Joint problems: Arthritis-like symptoms from prolonged use

Age-Related Side Effect Patterns:

Elderly patients: Higher sensitivity to fluid retention and cardiovascular effects
Adolescents: Increased risk of slipped capital femoral epiphysis
Young children: Growth-related complications and injection site issues

Emergency Warning Signs Requiring Immediate Medical Attention:

Breathing difficulties: Shortness of breath, stridor, sleep apnea worsening
Severe headache with vision changes: Signs of intracranial hypertension
Sudden onset hip or knee pain: Possible slipped capital femoral epiphysis
Signs of diabetes: Excessive thirst, urination, fatigue
Severe allergic reactions: Difficulty breathing, facial swelling
Persistent severe abdominal pain: Possible pancreatitis
Rapid weight gain with swelling: Severe fluid retention

Critical Safety Warning: The most serious risks with Genotropin involve increased mortality in critically ill patients and fatal respiratory complications in Prader-Willi syndrome patients. All patients require comprehensive screening before treatment and ongoing monitoring for malignancy development, metabolic complications, and growth-related problems. Any signs of respiratory distress, severe headache, or metabolic abnormalities require immediate medical attention.

Genotropin (somatropin) has comprehensive FDA-approved indications for growth hormone replacement therapy across multiple age groups and conditions, representing the most versatile growth hormone treatment available based on extensive clinical research demonstrating significant benefits in growth promotion and metabolic normalization:

Pediatric Indications:

Growth Hormone Deficiency (GHD) in Children:

Congenital GHD: Genetic or developmental abnormalities affecting growth hormone production
Acquired GHD: Secondary to tumors, surgery, radiation, trauma, or infection
Idiopathic GHD: Unknown cause of growth hormone deficiency
Multiple pituitary hormone deficiencies: GHD as part of hypopituitarism
Dosing: 0.16 to 0.24 mg/kg/week divided into 6-7 daily injections

Prader-Willi Syndrome (PWS):

Genetic confirmation required: Appropriate genetic testing must confirm PWS diagnosis
Growth failure treatment: Improving linear growth and body composition
Dosing: 0.24 mg/kg/week with careful respiratory monitoring
Safety requirements: Exclude severe obesity, sleep apnea, or respiratory impairment
Monitoring: Continuous assessment for respiratory complications

Small for Gestational Age (SGA):

Birth criteria: Children born small for gestational age
Catch-up failure: Fail to manifest catch-up growth by age 2 years
Dosing: Up to 0.48 mg/kg/week, with recent recommendations for individualized dosing
Age considerations: Younger children (<4 years) may start with lower doses (0.24 mg/kg/week)
Severe short stature: Very short children (height SDS <-3) may benefit from higher initial doses

Turner Syndrome:

Chromosomal condition: X-chromosome abnormalities causing short stature
Growth failure treatment: Addressing characteristic growth patterns
Dosing: 0.33 mg/kg/week
Special monitoring: Cardiovascular and otologic complications
Combination therapy: May be used with adjunctive hormonal therapy

How long does it take for Genotropin to start working?

Growth response to Genotropin varies by condition and age. In children with growth hormone deficiency, increased growth velocity typically becomes apparent within 3-6 months of treatment, with most dramatic effects in the first year. Adult patients may notice improvements in body composition, energy levels, and exercise capacity within 3-6 months. However, failure to show increased growth rate in the first year of pediatric treatment indicates need for compliance assessment and evaluation for other causes of growth failure.

Do children need to take Genotropin until adulthood?

Treatment duration depends on the underlying condition and individual response. Children with growth hormone deficiency typically continue treatment until they reach adult height potential and epiphyses close, usually during late adolescence. Some conditions like Turner syndrome may benefit from treatment into early adulthood. Patients who were treated as children and whose epiphyses are closed should be reevaluated for adult growth hormone deficiency before continuing therapy at adult doses.

What are the most serious risks of Genotropin treatment?

The most serious risks include increased mortality in critically ill patients, sudden death in Prader-Willi syndrome patients with respiratory complications, secondary malignancies (especially in childhood cancer survivors), and acute critical illness complications. Other serious risks include intracranial hypertension, slipped capital femoral epiphysis, diabetes development, and severe hypersensitivity reactions. All patients require comprehensive screening and ongoing monitoring for these complications.

How do I properly inject Genotropin?

Genotropin is administered subcutaneously using either the color-coded GENOTROPIN PEN devices or single-use MINIQUICK devices. Injection sites should be rotated daily between thigh, buttocks, and abdomen to prevent lipoatrophy. Follow device-specific instructions for reconstitution and injection, never shake the medication, and ensure the solution is clear before injection. Proper training from healthcare providers is essential before self-administration.

Can Genotropin cause diabetes?

Yes, Genotropin can decrease insulin sensitivity and unmask previously undiagnosed impaired glucose tolerance or diabetes mellitus. New-onset Type 2 diabetes has been reported, particularly in patients with risk factors like obesity, Turner syndrome, or family history of diabetes. All patients require periodic glucose monitoring, and those with existing diabetes may need antihyperglycemic medication adjustments when starting Genotropin treatment.

What monitoring do I need while taking Genotropin?

Comprehensive monitoring includes growth velocity and bone age assessment in children, IGF-I levels for dose adjustment, glucose tolerance testing, thyroid function, funduscopic examinations for intracranial hypertension, and regular evaluation for side effects. Children require monitoring for slipped capital femoral epiphysis, scoliosis progression, and signs of precocious puberty. Adults need body composition assessment and cardiovascular monitoring.

Why might Genotropin treatment be stopped?

Treatment may be discontinued for serious adverse effects (respiratory complications, intracranial hypertension, severe diabetes), malignancy development, lack of growth response in children, epiphyseal closure in pediatric patients, or development of neutralizing antibodies affecting efficacy. In Prader-Willi syndrome, treatment must be stopped immediately if upper airway obstruction or sleep apnea develops. Some patients may require temporary treatment interruptions for surgery or illness.

Can adults with growth hormone deficiency use Genotropin?

Yes, Genotropin is indicated for adult growth hormone deficiency in both childhood-onset and adult-onset patients. Adult dosing uses either weight-based (0.04-0.08 mg/kg/week) or non-weight-based (0.15-0.30 mg/day) regimens, with doses adjusted based on clinical response and IGF-I levels. Adults typically require lower starting doses and smaller increments than children, especially elderly patients who are more sensitive to side effects.

What should I do if I miss doses of Genotropin?

If you miss a dose, take it as soon as you remember, then continue with your regular schedule. Don't double doses to make up for missed injections. Consistent daily dosing is important for maintaining steady growth hormone levels and therapeutic effectiveness. If you frequently miss doses, discuss strategies with your healthcare team to improve adherence, such as setting reminders or adjusting injection timing.

How should Genotropin be stored?

Store unreconstituted Genotropin in the refrigerator at 36-46°F (2-8°C), protecting from light and never freezing. After reconstitution, cartridges with preservative can be stored refrigerated for up to 28 days, while MINIQUICK devices without preservative must be used within 24 hours. MINIQUICK can be stored at room temperature for up to 3 months before reconstitution. Always check expiration dates and discard outdated medication.

Can Genotropin interact with other medications?

Yes, Genotropin can interact with several medications. It inhibits 11β-hydroxysteroid dehydrogenase, potentially requiring glucocorticoid dose increases in patients on steroid replacement. The medication may alter cytochrome P450 enzyme activity, affecting metabolism of other drugs. Oral estrogen may increase Genotropin dose requirements in women, and diabetes medications may need adjustment due to effects on glucose tolerance.

What special precautions apply to children with specific conditions?

Children with Prader-Willi syndrome require evaluation for sleep apnea and respiratory problems before starting treatment, with immediate discontinuation if breathing problems develop. Turner syndrome patients need cardiovascular monitoring and evaluation for ear problems. All children require monitoring for rapid growth complications like slipped capital femoral epiphysis and scoliosis progression. Bone health monitoring is essential in all pediatric patients.

How do I know if Genotropin is working effectively?

Effectiveness is measured differently by age and condition. In children, growth velocity should increase significantly in the first year, typically doubling or tripling from baseline. Height standard deviation scores should improve over time. In adults, body composition changes (decreased fat mass, increased lean mass), improved exercise capacity, and normalized IGF-I levels indicate effectiveness. Regular monitoring by your endocrinologist helps assess treatment response and adjust dosing as needed.

Are there any activities I should avoid while taking Genotropin?

No specific activity restrictions apply to most patients, though children should be monitored for joint pain or limping that might indicate slipped capital femoral epiphysis. Patients with intracranial hypertension may need to avoid activities that increase intracranial pressure. Maintain good injection site hygiene and rotation practices. Contact sports may require evaluation if joint problems develop. Always inform healthcare providers about Genotropin use before surgeries or medical procedures.

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