Omnitrope 10mg/1.5ml Inj, 1.5ml
It is used to help with growth and to treat growth hormone deficiency.It is used to treat some patients who have problems growing normally.It may be given to you for other reasons. Talk with the doctor.
Drug Class
Growth Hormone
Pharmacologic Class
Recombinant Human Growth Hormone
Pregnancy Category
Category B
FDA Approved
Jan 2006
DEA Schedule
Not Controlled
Overview
What is this medicine?
Omnitrope is a man-made version of human growth hormone. It's used to help children grow taller if they have certain medical conditions that cause short stature, and to help adults with growth hormone deficiency. It's given as an injection under the skin.
How to Use This Medicine
Proper Use of This Medication
To use this medication correctly, follow your doctor's instructions and read all the information provided. Your doctor or nurse will teach you how to administer the injection if you will be giving it to yourself.
Administration Instructions
This medication is given as a subcutaneous injection, which means it is injected into the fatty part of the skin.
If the medication has been stored in the refrigerator, allow it to come to room temperature before using it. Be sure to follow the recommended time for leaving it at room temperature.
Do not heat the medication.
Rotate the injection site with each dose to avoid irritation.
Avoid injecting into skin that is irritated, bruised, red, infected, hard, or scarred.
Do not inject near the belly button or waistline.
Do not shake the solution before injecting.
Check the solution for cloudiness, leakage, or particles before using. If you notice any of these issues, do not use the medication.
Check the solution for any changes in color before using. If you notice any changes, do not use the medication.
Handling and Disposal
Wash your hands before and after handling the medication.
Dispose of used needles and syringes in a puncture-proof container. Do not reuse needles or other items.
Follow local regulations for disposing of the container when it is full.
If you have any questions, consult your doctor or pharmacist.
Special Instructions for Prefilled Syringes or Pens
You may hear a clicking sound when preparing the dose. Do not prepare the dose by counting the clicks, as this may result in an incorrect dose.
Remove all pen needle covers before injecting a dose. If you are unsure about the type of pen needle or how to use it, consult your doctor.
Do not share pen or cartridge devices with another person, even if the needle has been changed. Sharing these devices can transmit infections from one person to another.
Cartridge Injection Devices (Pens)
Not all injection devices are compatible with all strengths of this medication. Ensure you have the correct pen for your prescribed dose. Using the wrong pen may result in an incorrect dose.
Storage and Disposal
Store Saizen at room temperature.
After mixing, store the medication in the refrigerator. Consult your doctor or pharmacist if you have questions about the storage duration after mixing.
Missed Dose
If you miss a dose, take it as soon as you remember.
If it is close to the time for your next dose, skip the missed dose and resume your regular schedule.
Do not take two doses at the same time or extra doses.
To use this medication correctly, follow your doctor's instructions and read all the information provided. Your doctor or nurse will teach you how to administer the injection if you will be giving it to yourself.
Administration Instructions
This medication is given as a subcutaneous injection, which means it is injected into the fatty part of the skin.
If the medication has been stored in the refrigerator, allow it to come to room temperature before using it. Be sure to follow the recommended time for leaving it at room temperature.
Do not heat the medication.
Rotate the injection site with each dose to avoid irritation.
Avoid injecting into skin that is irritated, bruised, red, infected, hard, or scarred.
Do not inject near the belly button or waistline.
Do not shake the solution before injecting.
Check the solution for cloudiness, leakage, or particles before using. If you notice any of these issues, do not use the medication.
Check the solution for any changes in color before using. If you notice any changes, do not use the medication.
Handling and Disposal
Wash your hands before and after handling the medication.
Dispose of used needles and syringes in a puncture-proof container. Do not reuse needles or other items.
Follow local regulations for disposing of the container when it is full.
If you have any questions, consult your doctor or pharmacist.
Special Instructions for Prefilled Syringes or Pens
You may hear a clicking sound when preparing the dose. Do not prepare the dose by counting the clicks, as this may result in an incorrect dose.
Remove all pen needle covers before injecting a dose. If you are unsure about the type of pen needle or how to use it, consult your doctor.
Do not share pen or cartridge devices with another person, even if the needle has been changed. Sharing these devices can transmit infections from one person to another.
Cartridge Injection Devices (Pens)
Not all injection devices are compatible with all strengths of this medication. Ensure you have the correct pen for your prescribed dose. Using the wrong pen may result in an incorrect dose.
Storage and Disposal
Store Saizen at room temperature.
After mixing, store the medication in the refrigerator. Consult your doctor or pharmacist if you have questions about the storage duration after mixing.
Missed Dose
If you miss a dose, take it as soon as you remember.
If it is close to the time for your next dose, skip the missed dose and resume your regular schedule.
Do not take two doses at the same time or extra doses.
Lifestyle & Tips
- Maintain a balanced diet and regular exercise as advised by your doctor.
- Follow proper injection technique and rotate injection sites to prevent skin problems.
- Store Omnitrope in the refrigerator (2°C to 8°C or 36°F to 46°F). Do not freeze. Protect from light.
- Do not shake the cartridge.
- Discard unused portion after 28 days of first use.
- Keep all appointments for blood tests and doctor visits to monitor your treatment.
Available Forms & Alternatives
Available Strengths:
Dosing & Administration
Adult Dosing
Standard Dose:
Initial dose 0.2 mg/day (non-GHD) or 0.4 mg/day (GHD), adjusted based on IGF-1 levels and clinical response, typically 0.4-0.8 mg/day. Administered subcutaneously.
Dose Range:
0.2 - 0.8 mg
Condition-Specific Dosing:
Adult Growth Hormone Deficiency (GHD):
Initial 0.4 mg/day, adjusted based on IGF-1 and clinical response, max 1.0 mg/day. Older or obese patients may start lower (0.1-0.2 mg/day).
Non-GHD indications (e.g., short bowel syndrome):
Not an approved indication for Omnitrope, but other somatropin products may have specific dosing.
Pediatric Dosing
Neonatal:
Not established for routine use in neonates, except for specific conditions like SGA. Dosing for SGA: 0.033 mg/kg/day subcutaneously.
Infant:
Dosing varies by indication. For GHD: 0.025-0.035 mg/kg/day. For Turner Syndrome: 0.05 mg/kg/day. For Prader-Willi Syndrome: 0.035 mg/kg/day. For Chronic Kidney Disease: 0.05 mg/kg/day.
Child:
Dosing varies by indication. For GHD: 0.025-0.035 mg/kg/day. For Turner Syndrome: 0.05 mg/kg/day. For Prader-Willi Syndrome: 0.035 mg/kg/day. For Chronic Kidney Disease: 0.05 mg/kg/day. For Idiopathic Short Stature: 0.034-0.067 mg/kg/day.
Adolescent:
Dosing varies by indication. For GHD: 0.025-0.035 mg/kg/day. For Turner Syndrome: 0.05 mg/kg/day. For Prader-Willi Syndrome: 0.035 mg/kg/day. For Chronic Kidney Disease: 0.05 mg/kg/day. For Idiopathic Short Stature: 0.034-0.067 mg/kg/day. Dosing may be reduced or discontinued once epiphyseal fusion occurs.
Dose Adjustments
Renal Impairment:
Mild:
No specific dose adjustment recommended.
Moderate:
No specific dose adjustment recommended.
Severe:
No specific dose adjustment recommended, but caution is advised. Patients with chronic kidney disease are an approved indication, with specific dosing (0.05 mg/kg/day).
Dialysis:
Not specifically studied in dialysis patients beyond CKD. Use with caution and monitor IGF-1 levels.
Hepatic Impairment:
Mild:
No specific dose adjustment recommended.
Moderate:
No specific dose adjustment recommended.
Severe:
No specific dose adjustment recommended, but caution is advised due to hepatic metabolism of growth hormone.
Pharmacology
Mechanism of Action
Somatropin is a recombinant human growth hormone (rhGH) that binds to specific growth hormone receptors on target cells, including hepatocytes, adipocytes, and muscle cells. This binding initiates intracellular signal transduction pathways, leading to a wide range of anabolic and metabolic effects. Its primary mechanism of action involves stimulating the production of insulin-like growth factor-1 (IGF-1) in the liver and other tissues, which mediates many of the growth-promoting effects of growth hormone, including linear growth, protein synthesis, and carbohydrate and lipid metabolism.
Pharmacokinetics
Absorption:
Bioavailability:
Approximately 80% (subcutaneous)
Tmax:
3-6 hours (subcutaneous)
FoodEffect:
Not applicable for subcutaneous injection.
Distribution:
Vd:
Approximately 0.07 L/kg
ProteinBinding:
Low (binds to growth hormone binding protein, but not extensively to plasma proteins)
CnssPenetration:
Limited
Elimination:
HalfLife:
Approximately 2-3 hours (subcutaneous)
Clearance:
Approximately 15 L/hour (adults)
ExcretionRoute:
Renal (metabolites)
Unchanged:
Less than 0.1%
Pharmacodynamics
OnsetOfAction:
Biochemical effects (e.g., IGF-1 increase) within hours; clinical growth effects over months to years.
PeakEffect:
IGF-1 levels peak within 12-24 hours after a dose; clinical growth effects are cumulative.
DurationOfAction:
IGF-1 levels remain elevated for approximately 24 hours after a single dose; clinical effects persist with continued therapy.
Safety & Warnings
Side Effects
Urgent Side Effects: Seek Medical Help Right Away
Although rare, some people may experience severe and potentially life-threatening side effects while taking this medication. If you notice any of the following symptoms, contact your doctor or seek medical attention immediately:
Signs of an allergic reaction: rash, hives, itching, red, swollen, blistered, or peeling skin (with or without fever), wheezing, tightness in the chest or throat, trouble breathing, swallowing, or talking, unusual hoarseness, or swelling of the mouth, face, lips, tongue, or throat
Signs of high blood sugar: confusion, feeling sleepy, unusual thirst or hunger, frequent urination, flushing, rapid breathing, or fruity-smelling breath
Signs of pancreatitis (pancreas problem): severe stomach pain, severe back pain, or severe nausea and vomiting
Signs of adrenal gland problems: severe nausea and vomiting, severe dizziness or fainting, muscle weakness, extreme fatigue, mood changes, decreased appetite, or weight loss
Signs of low thyroid levels: constipation, sensitivity to cold, memory problems, mood changes, or abnormal burning, numbness, or tingling sensations
Signs of a urinary tract infection (UTI): blood in the urine, painful or burning urination, frequent or urgent need to urinate, fever, lower abdominal pain, or pelvic pain
Signs of high blood pressure: severe headache or dizziness, fainting, or changes in vision
Weakness on one side of the body, trouble speaking or thinking, balance problems, drooping on one side of the face, or blurred vision
Shortness of breath, significant weight gain, or swelling in the arms or legs
Chest pain or pressure, rapid heartbeat, or excessive sweating
Depression or other mood changes, changes in behavior, or changes in skin color
Burning, numbness, pain, or tingling in the hands, arms, wrists, legs, or feet
Bone pain, changes in mole color or size, or redness and swelling at the injection site
Skin breakdown at the injection site, ear pain
Other Possible Side Effects
Like all medications, this drug can cause side effects. Many people may not experience any side effects or may only have mild ones. If you notice any of the following side effects or any other unusual symptoms, contact your doctor or seek medical attention if they bother you or do not go away:
Headache
Fatigue or weakness
Back, muscle, or joint pain
Muscle stiffness
Sleep disturbances
Diarrhea, stomach pain, nausea, or vomiting
Gas
Irritation at the injection site
Common cold symptoms
Flu-like symptoms
Hair loss
Enlarged breasts
Reporting Side Effects
This is not an exhaustive list of possible side effects. If you have questions or concerns about side effects, contact your doctor. You can also report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch.
Although rare, some people may experience severe and potentially life-threatening side effects while taking this medication. If you notice any of the following symptoms, contact your doctor or seek medical attention immediately:
Signs of an allergic reaction: rash, hives, itching, red, swollen, blistered, or peeling skin (with or without fever), wheezing, tightness in the chest or throat, trouble breathing, swallowing, or talking, unusual hoarseness, or swelling of the mouth, face, lips, tongue, or throat
Signs of high blood sugar: confusion, feeling sleepy, unusual thirst or hunger, frequent urination, flushing, rapid breathing, or fruity-smelling breath
Signs of pancreatitis (pancreas problem): severe stomach pain, severe back pain, or severe nausea and vomiting
Signs of adrenal gland problems: severe nausea and vomiting, severe dizziness or fainting, muscle weakness, extreme fatigue, mood changes, decreased appetite, or weight loss
Signs of low thyroid levels: constipation, sensitivity to cold, memory problems, mood changes, or abnormal burning, numbness, or tingling sensations
Signs of a urinary tract infection (UTI): blood in the urine, painful or burning urination, frequent or urgent need to urinate, fever, lower abdominal pain, or pelvic pain
Signs of high blood pressure: severe headache or dizziness, fainting, or changes in vision
Weakness on one side of the body, trouble speaking or thinking, balance problems, drooping on one side of the face, or blurred vision
Shortness of breath, significant weight gain, or swelling in the arms or legs
Chest pain or pressure, rapid heartbeat, or excessive sweating
Depression or other mood changes, changes in behavior, or changes in skin color
Burning, numbness, pain, or tingling in the hands, arms, wrists, legs, or feet
Bone pain, changes in mole color or size, or redness and swelling at the injection site
Skin breakdown at the injection site, ear pain
Other Possible Side Effects
Like all medications, this drug can cause side effects. Many people may not experience any side effects or may only have mild ones. If you notice any of the following side effects or any other unusual symptoms, contact your doctor or seek medical attention if they bother you or do not go away:
Headache
Fatigue or weakness
Back, muscle, or joint pain
Muscle stiffness
Sleep disturbances
Diarrhea, stomach pain, nausea, or vomiting
Gas
Irritation at the injection site
Common cold symptoms
Flu-like symptoms
Hair loss
Enlarged breasts
Reporting Side Effects
This is not an exhaustive list of possible side effects. If you have questions or concerns about side effects, contact your doctor. You can also report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch.
Seek Immediate Medical Attention If You Experience:
- Severe or persistent headache, especially with nausea/vomiting or vision changes (could indicate increased pressure in the brain)
- Limping or new hip/knee pain (in children, could be a slipped growth plate)
- Increased thirst or frequent urination (signs of high blood sugar)
- Changes in moles or skin lesions (report any new or changing skin growths)
- Signs of an allergic reaction (rash, itching, swelling, severe dizziness, trouble breathing)
- Swelling in hands or feet, joint pain, muscle pain (common side effects, but report if severe or persistent)
Before Using This Medicine
Before Taking This Medication: Important Information to Share with Your Doctor
It is essential to inform your doctor about the following conditions to ensure safe treatment:
Any allergies you have, including allergies to this medication, its components, or other substances, such as foods or drugs. Describe the allergic reactions you have experienced.
Certain health conditions, including:
+ Breathing problems, such as sleep apnea
+ Cancer or other tumors, including brain tumors
+ Diabetic eye disease
+ Recent illness after open heart surgery, stomach surgery, or accidental injury
For Children:
If your child has Prader-Willi syndrome and is severely overweight, has breathing difficulties, or sleep apnea
If your child's bones have stopped growing (closed epiphyses)
This list is not exhaustive, and it is crucial to discuss all your medications (prescription, over-the-counter, natural products, and vitamins) and health problems with your doctor and pharmacist. They will help you determine if it is safe to take this medication with your other treatments. Never start, stop, or adjust the dose of any medication without consulting your doctor first.
It is essential to inform your doctor about the following conditions to ensure safe treatment:
Any allergies you have, including allergies to this medication, its components, or other substances, such as foods or drugs. Describe the allergic reactions you have experienced.
Certain health conditions, including:
+ Breathing problems, such as sleep apnea
+ Cancer or other tumors, including brain tumors
+ Diabetic eye disease
+ Recent illness after open heart surgery, stomach surgery, or accidental injury
For Children:
If your child has Prader-Willi syndrome and is severely overweight, has breathing difficulties, or sleep apnea
If your child's bones have stopped growing (closed epiphyses)
This list is not exhaustive, and it is crucial to discuss all your medications (prescription, over-the-counter, natural products, and vitamins) and health problems with your doctor and pharmacist. They will help you determine if it is safe to take this medication with your other treatments. Never start, stop, or adjust the dose of any medication without consulting your doctor first.
Precautions & Cautions
Important Warnings and Cautions for Patients Taking This Medication
If you are taking this medication, it is essential to inform all your healthcare providers, including doctors, nurses, pharmacists, and dentists, about your treatment.
Monitoring and Testing
High blood sugar levels, including new or worsening diabetes, have been reported in patients taking this medication. To monitor your condition, follow your doctor's instructions for checking your blood sugar levels. Additionally, have your blood work and eye exams performed as recommended by your doctor. This medication may affect certain laboratory tests, so be sure to inform all your healthcare providers and lab workers that you are taking this medication.
Cancer and Tumor Risk
If you have a history of cancer or tumors, or are currently being treated for cancer, discuss the potential risks and benefits of this medication with your doctor. This medication may increase the risk of cancer or tumor growth, and in some cases, may also increase the risk of new tumors.
Special Considerations
If you have Turner syndrome, talk to your doctor about the potential increased risk of ear infections, high blood pressure, and severe blood vessel problems, such as stroke and bleeding in the brain.
Raised Pressure in the Head
In rare cases, this medication has been associated with raised pressure in the head, which may be more likely to occur in patients with Turner syndrome or Prader-Willi syndrome. Signs of raised pressure in the head typically appear within the first 8 weeks of treatment and may include changes in vision, severe headaches, nausea, or vomiting. If you experience any of these symptoms, contact your doctor immediately.
Age-Related Considerations
If you are 65 years or older, use this medication with caution, as you may be more susceptible to side effects.
Pregnancy and Breastfeeding
If you are pregnant, planning to become pregnant, or breastfeeding, discuss the potential benefits and risks of this medication with your doctor.
Children
Prader-Willi Syndrome: In children with Prader-Willi syndrome, this medication has been associated with severe and potentially life-threatening lung and breathing problems. The risk may be higher in children with sleep apnea, lung or airway infections, airway blockages, or obesity. If your child has a fever of 100.4°F (38°C) or higher, cough, sore throat, shortness of breath, chest pain or discomfort, new or worsening snoring, or abnormal breathing during sleep, contact your doctor immediately.
Scoliosis: If your child has an abnormal curvature of the spine (scoliosis), discuss the potential risks of this medication with your doctor, as it may worsen the condition in growing children.
Bone Problems: In rare cases, children taking this medication may experience a bone problem in the hip (slipped growth plate). If your child experiences hip or knee pain, or a limp, contact your doctor immediately.
Benzyl Alcohol Warning: Some products containing this medication may include benzyl alcohol. If possible, avoid using products with benzyl alcohol in newborns or infants, as serious side effects can occur in these children, especially when combined with other medications containing benzyl alcohol. Consult your doctor to determine if this product contains benzyl alcohol.
If you are taking this medication, it is essential to inform all your healthcare providers, including doctors, nurses, pharmacists, and dentists, about your treatment.
Monitoring and Testing
High blood sugar levels, including new or worsening diabetes, have been reported in patients taking this medication. To monitor your condition, follow your doctor's instructions for checking your blood sugar levels. Additionally, have your blood work and eye exams performed as recommended by your doctor. This medication may affect certain laboratory tests, so be sure to inform all your healthcare providers and lab workers that you are taking this medication.
Cancer and Tumor Risk
If you have a history of cancer or tumors, or are currently being treated for cancer, discuss the potential risks and benefits of this medication with your doctor. This medication may increase the risk of cancer or tumor growth, and in some cases, may also increase the risk of new tumors.
Special Considerations
If you have Turner syndrome, talk to your doctor about the potential increased risk of ear infections, high blood pressure, and severe blood vessel problems, such as stroke and bleeding in the brain.
Raised Pressure in the Head
In rare cases, this medication has been associated with raised pressure in the head, which may be more likely to occur in patients with Turner syndrome or Prader-Willi syndrome. Signs of raised pressure in the head typically appear within the first 8 weeks of treatment and may include changes in vision, severe headaches, nausea, or vomiting. If you experience any of these symptoms, contact your doctor immediately.
Age-Related Considerations
If you are 65 years or older, use this medication with caution, as you may be more susceptible to side effects.
Pregnancy and Breastfeeding
If you are pregnant, planning to become pregnant, or breastfeeding, discuss the potential benefits and risks of this medication with your doctor.
Children
Prader-Willi Syndrome: In children with Prader-Willi syndrome, this medication has been associated with severe and potentially life-threatening lung and breathing problems. The risk may be higher in children with sleep apnea, lung or airway infections, airway blockages, or obesity. If your child has a fever of 100.4°F (38°C) or higher, cough, sore throat, shortness of breath, chest pain or discomfort, new or worsening snoring, or abnormal breathing during sleep, contact your doctor immediately.
Scoliosis: If your child has an abnormal curvature of the spine (scoliosis), discuss the potential risks of this medication with your doctor, as it may worsen the condition in growing children.
Bone Problems: In rare cases, children taking this medication may experience a bone problem in the hip (slipped growth plate). If your child experiences hip or knee pain, or a limp, contact your doctor immediately.
Benzyl Alcohol Warning: Some products containing this medication may include benzyl alcohol. If possible, avoid using products with benzyl alcohol in newborns or infants, as serious side effects can occur in these children, especially when combined with other medications containing benzyl alcohol. Consult your doctor to determine if this product contains benzyl alcohol.
Overdose Information
Overdose Symptoms:
- Acute overdose: Hypoglycemia (low blood sugar) initially, followed by hyperglycemia (high blood sugar).
- Chronic overdose: Signs of gigantism (in children) or acromegaly (in adults), such as enlarged hands/feet, joint pain, carpal tunnel syndrome, facial changes.
What to Do:
Seek immediate medical attention. Call 911 or your local emergency number. For poison control, call 1-800-222-1222.
Drug Interactions
Major Interactions
- Glucocorticoids: May inhibit the growth-promoting effects of somatropin. Higher doses of somatropin may be required. Monitor growth parameters and IGF-1 levels.
- Insulin and/or Oral Hypoglycemic Agents: Somatropin may decrease insulin sensitivity, requiring dose adjustments of antidiabetic medications. Monitor blood glucose closely.
Moderate Interactions
- Thyroid Hormone: Hypothyroidism can interfere with response to somatropin. Patients should be euthyroid before starting somatropin. Somatropin may accelerate the peripheral conversion of T4 to T3, potentially unmasking central hypothyroidism. Monitor thyroid function.
- CYP450 Metabolized Drugs (especially CYP3A4 substrates): Somatropin may induce CYP3A4 activity, potentially altering the metabolism of drugs cleared by this pathway (e.g., oral contraceptives, corticosteroids, cyclosporine, anticonvulsants). Monitor for altered drug effects.
Confidence Interactions
Monitoring
Baseline Monitoring
IGF-1 and IGFBP-3 levels
Rationale: To establish baseline and guide initial dosing, and to confirm growth hormone deficiency.
Timing: Prior to initiation of therapy.
Thyroid function tests (TSH, free T4)
Rationale: Hypothyroidism can impair response to somatropin. Ensure euthyroid state.
Timing: Prior to initiation of therapy.
Fasting glucose and HbA1c
Rationale: To assess baseline glucose metabolism, as somatropin can affect insulin sensitivity.
Timing: Prior to initiation of therapy.
Fundoscopic examination
Rationale: To rule out papilledema, especially in patients with Prader-Willi syndrome or those at risk for intracranial hypertension.
Timing: Prior to initiation of therapy.
Bone age (pediatric patients)
Rationale: To assess skeletal maturity and predict adult height potential.
Timing: Prior to initiation of therapy.
Scoliosis screening (pediatric patients, especially Turner/Prader-Willi)
Rationale: To detect or monitor for progression of scoliosis.
Timing: Prior to initiation of therapy.
Lipid profile
Rationale: To assess baseline lipid status, as somatropin can influence lipid metabolism.
Timing: Prior to initiation of therapy.
Routine Monitoring
IGF-1 levels
Frequency: Every 4-8 weeks initially, then every 3-6 months once stable
Target: Age- and sex-adjusted normal range (0 to +2 SDS)
Action Threshold: If consistently above target range, reduce dose; if consistently below, consider dose increase.
Growth velocity (pediatric patients)
Frequency: Every 3-6 months
Target: Increased growth rate appropriate for age and condition
Action Threshold: Lack of expected growth response may indicate need for dose adjustment or re-evaluation of diagnosis/compliance.
Thyroid function tests (TSH, free T4)
Frequency: Every 6-12 months, or if clinical signs of hypothyroidism develop
Target: Normal range
Action Threshold: Treat hypothyroidism if detected; adjust somatropin dose if needed.
Fasting glucose and HbA1c
Frequency: Every 6-12 months
Target: Normal range
Action Threshold: If elevated, consider dose reduction or initiation/adjustment of antidiabetic therapy.
Fundoscopic examination
Frequency: Annually, or if symptoms of intracranial hypertension (e.g., severe headache, visual changes) occur
Target: No papilledema
Action Threshold: If papilledema detected, discontinue somatropin and refer to neurology/ophthalmology.
Scoliosis screening (pediatric patients)
Frequency: Annually
Target: No significant progression
Action Threshold: Refer to orthopedics if progression noted.
Lipid profile
Frequency: Annually
Target: Normal range
Action Threshold: Manage dyslipidemia as per standard guidelines.
Symptom Monitoring
- Headache (especially severe or persistent)
- Visual changes (blurred vision, double vision)
- Nausea/vomiting
- Limping or hip/knee pain (Slipped Capital Femoral Epiphysis in pediatric patients)
- Increased thirst or urination (hyperglycemia)
- Fatigue, cold intolerance, weight gain (hypothyroidism)
- Injection site reactions (pain, redness, swelling)
- Peripheral edema, arthralgia, myalgia (especially in adults, often dose-related)
Special Patient Groups
Pregnancy
Use during pregnancy only if clearly needed and the potential benefit justifies the potential risk to the fetus. Human data are limited.
Trimester-Specific Risks:
First Trimester:
Limited human data. Animal studies have not shown teratogenicity.
Second Trimester:
Limited human data.
Third Trimester:
Limited human data.
Lactation
Caution should be exercised when somatropin is administered to a nursing mother. It is unknown if somatropin is excreted in human milk. The decision to discontinue nursing or discontinue the drug should take into account the importance of the drug to the mother.
Infant Risk:
Low to moderate risk. Growth hormone is a protein and likely to be digested in the infant's GI tract. However, potential effects on infant growth or metabolism are unknown.
Pediatric Use
Somatropin is primarily used in pediatric patients for various growth disorders. Dosing is weight-based and adjusted based on IGF-1 levels and growth response. Close monitoring for adverse effects like intracranial hypertension, slipped capital femoral epiphysis, and scoliosis is crucial.
Geriatric Use
Lower initial doses and slower titration are recommended for older adult patients due to increased sensitivity to somatropin and a higher incidence of adverse effects (e.g., peripheral edema, arthralgia, carpal tunnel syndrome). Monitor closely for adverse reactions and IGF-1 levels.
Clinical Information
Clinical Pearls
- Somatropin therapy requires long-term commitment and adherence for optimal results, especially in pediatric patients.
- Patients and caregivers must be thoroughly trained on proper subcutaneous injection technique and rotation of injection sites.
- Monitor IGF-1 levels closely to ensure dosing is within the appropriate range, avoiding both under-dosing (ineffective) and over-dosing (increased side effects).
- Always check for active malignancy before initiating somatropin, as it is contraindicated in such cases.
- Patients with Prader-Willi syndrome should be screened for upper airway obstruction and sleep apnea prior to initiation and monitored closely during therapy due to increased risk of sudden death.
- Hypothyroidism must be corrected or adequately treated before and during somatropin therapy, as it can impair response.
- Adult patients may experience more fluid retention, arthralgia, and carpal tunnel syndrome, especially at higher doses. These often resolve with dose reduction.
Alternative Therapies
- Other recombinant human growth hormone products (e.g., Genotropin, Humatrope, Norditropin, Nutropin, Saizen)
- Mecasermin (Increlex) for severe primary IGF-1 deficiency (not GHD)
- For specific conditions, other treatments may exist (e.g., GnRH analogs for central precocious puberty, aromatase inhibitors for short stature in boys with constitutional delay, but these are not direct alternatives for GHD).
Cost & Coverage
Average Cost:
Highly variable, typically several thousand dollars per month per 1.5ml cartridge (10mg)
Generic Available:
Yes
Insurance Coverage:
Tier 3 or Specialty Tier (requires prior authorization and often step therapy)
General Drug Facts
If your symptoms or health issues persist or worsen, it is essential to contact your doctor for further guidance. To ensure your safety, never share your medication with others or take someone else's medication. Some medications may come with an additional patient information leaflet, so it's a good idea to check with your pharmacist. If you have any questions or concerns about this medication, don't hesitate to discuss them with your doctor, nurse, pharmacist, or other healthcare provider. In the event of a suspected overdose, immediately call your local poison control center or seek emergency medical attention. When seeking help, be prepared to provide detailed information about the overdose, including the medication taken, the amount, and the time it occurred.