Omnitrope 5mg/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 helps children grow taller and helps adults and children with growth hormone deficiency maintain healthy body composition and metabolism. It is 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 use 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.
Check the solution for cloudiness, leakage, or particles before use. If you notice any of these issues, do not use the medication.
Check the solution for any changes in color before use. If you notice any changes, do not use the medication.
Wash your hands before and after use.
Dispose of needles and other sharp objects in a designated disposal box. Do not reuse needles or other items. Follow local regulations for disposing of the full box.
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 rely on the clicks to determine the dose, as this could lead to an incorrect dose.
Remove all pen needle covers before injecting a dose (there may be two covers).
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 others, even if the needle has been changed, as this can spread infections.
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, as 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 use 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.
Check the solution for cloudiness, leakage, or particles before use. If you notice any of these issues, do not use the medication.
Check the solution for any changes in color before use. If you notice any changes, do not use the medication.
Wash your hands before and after use.
Dispose of needles and other sharp objects in a designated disposal box. Do not reuse needles or other items. Follow local regulations for disposing of the full box.
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 rely on the clicks to determine the dose, as this could lead to an incorrect dose.
Remove all pen needle covers before injecting a dose (there may be two covers).
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 others, even if the needle has been changed, as this can spread infections.
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, as 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
- Administer injections subcutaneously as directed by your healthcare provider, usually once daily in the evening.
- Rotate injection sites to prevent skin problems.
- Store Omnitrope pens/cartridges in the refrigerator (2°C to 8°C / 36°F to 46°F). Do not freeze. Once opened, store refrigerated and use within 28 days.
- Do not shake the solution.
- Report any new or worsening headaches, vision changes, limping, or hip/knee pain immediately.
- Maintain regular follow-up appointments for monitoring growth, blood tests, and overall health.
- Discuss any other medications, supplements, or herbal products with your doctor, as they may interact with Omnitrope.
Available Forms & Alternatives
Available Strengths:
Dosing & Administration
Adult Dosing
Standard Dose:
Highly individualized based on indication and patient response. Initial dose for adult GHD: 0.2 mg/day (0.006 mg/kg/day) subcutaneously, titrated up to a maximum of 0.8 mg/day (0.024 mg/kg/day).
Dose Range:
0.2 - 0.8 mg
Condition-Specific Dosing:
Adult Growth Hormone Deficiency (GHD):
Initial dose 0.2 mg/day (0.006 mg/kg/day) subcutaneously, increased gradually every 1-2 months based on clinical response and IGF-1 levels. Max 0.8 mg/day (0.024 mg/kg/day).
Transition GHD (from pediatric GHD):
Initial dose 0.2-0.5 mg/day (0.006-0.015 mg/kg/day) subcutaneously, adjusted based on IGF-1 levels and clinical response.
Pediatric Dosing
Neonatal:
Not established for routine neonatal use, except for specific conditions like SGA without catch-up growth (typically initiated later in infancy/childhood).
Infant:
Dosing for Small for Gestational Age (SGA) without catch-up growth: 0.033 mg/kg/day subcutaneously.
Child:
Growth Hormone Deficiency (GHD): 0.025-0.035 mg/kg/day subcutaneously. Turner Syndrome: 0.05 mg/kg/day subcutaneously. Prader-Willi Syndrome: 0.035 mg/kg/day subcutaneously. Idiopathic Short Stature (ISS): 0.034 mg/kg/day subcutaneously. Chronic Kidney Disease (CKD): 0.05 mg/kg/day subcutaneously.
Adolescent:
Dosing continues as per child indications until epiphyseal fusion. For GHD, transition to adult dosing may occur after epiphyseal fusion.
Dose Adjustments
Renal Impairment:
Mild:
No specific dose adjustment recommended.
Moderate:
No specific dose adjustment recommended.
Severe:
No specific dose adjustment recommended, but close monitoring is advised, especially in CKD patients where it is an approved indication.
Dialysis:
No specific dose adjustment recommended. Somatropin is indicated for growth failure in children with CKD, including those on dialysis. Close monitoring of growth and IGF-1 levels is crucial.
Hepatic Impairment:
Mild:
No specific dose adjustment recommended.
Moderate:
No specific dose adjustment recommended.
Severe:
No specific dose adjustment recommended, but caution and close monitoring are advised due to potential altered metabolism.
Pharmacology
Mechanism of Action
Somatropin is a recombinant human growth hormone (rhGH) that is identical to naturally occurring human growth hormone. It exerts its anabolic and metabolic effects through interaction with specific growth hormone receptors on target cells. It stimulates linear growth in children and adolescents who have not achieved epiphyseal fusion, and it maintains normal body composition in adults. Many of its effects are mediated by insulin-like growth factor-1 (IGF-1), which is produced primarily in the liver and other tissues.
Pharmacokinetics
Absorption:
Bioavailability:
Approximately 80% (subcutaneous)
Tmax:
3-6 hours (subcutaneous)
FoodEffect:
Not applicable (parenteral administration)
Distribution:
Vd:
Approximately 50 mL/kg
ProteinBinding:
Low (binds to growth hormone binding protein, but not extensively to plasma proteins)
CnssPenetration:
Limited
Elimination:
HalfLife:
Approximately 2-3 hours (intravenous); 3-5 hours (subcutaneous)
Clearance:
Approximately 15 L/hour (adults)
ExcretionRoute:
Metabolites excreted via urine and feces
Unchanged:
Less than 0.1%
Pharmacodynamics
OnsetOfAction:
Growth effects are gradual, observed over weeks to months. Metabolic effects (e.g., lipolysis, protein synthesis) can be seen within hours.
PeakEffect:
Peak growth velocity typically observed within the first year of treatment.
DurationOfAction:
Effects persist as long as treatment continues; metabolic effects are transient after each dose.
Safety & Warnings
BLACK BOX WARNING
Increased mortality in patients with Prader-Willi Syndrome who are severely obese or have severe respiratory impairment. Omnitrope is contraindicated in patients with Prader-Willi Syndrome who are severely obese or have severe respiratory impairment due to reports of sudden death. A comprehensive sleep study should be performed in all patients with Prader-Willi Syndrome prior to initiation of somatropin treatment and regularly during treatment.
Side Effects
Serious 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 experience 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 insufficiency (weak adrenal gland): severe nausea and vomiting, severe dizziness or fainting, muscle weakness, extreme fatigue, mood changes, decreased appetite, or weight loss
Signs of hypothyroidism (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 urination, 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, difficulty 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 or ear pain
Other Possible Side Effects
Like all medications, this drug can cause side effects. However, many people experience no side effects or only mild ones. If you experience any of the following side effects or any other unusual symptoms, contact your doctor or seek medical attention:
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
Breast enlargement
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 experience 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 insufficiency (weak adrenal gland): severe nausea and vomiting, severe dizziness or fainting, muscle weakness, extreme fatigue, mood changes, decreased appetite, or weight loss
Signs of hypothyroidism (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 urination, 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, difficulty 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 or ear pain
Other Possible Side Effects
Like all medications, this drug can cause side effects. However, many people experience no side effects or only mild ones. If you experience any of the following side effects or any other unusual symptoms, contact your doctor or seek medical attention:
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
Breast enlargement
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
- Blurred vision or other vision changes
- Nausea or vomiting
- Limping or new hip/knee pain (in children)
- Increased thirst or frequent urination
- Swelling of hands or feet
- Numbness or tingling in the hands (carpal tunnel syndrome)
- Changes in skin moles or lesions
- Difficulty breathing or increased snoring (especially in Prader-Willi Syndrome patients)
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:
Any allergies you have, including allergies to this medication, its components, or other substances, such as foods or drugs. Be sure to describe the symptoms you 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
If you are a parent or guardian, it is crucial to discuss the following with your doctor if your child is taking this medication:
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 vital to inform your doctor and pharmacist about all your medications, including prescription and over-the-counter drugs, natural products, and vitamins, as well as any health problems you may have. This will help ensure your safety while taking this medication. Never start, stop, or change the dose of any medication without first consulting your doctor.
It is essential to inform your doctor about the following:
Any allergies you have, including allergies to this medication, its components, or other substances, such as foods or drugs. Be sure to describe the symptoms you 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
If you are a parent or guardian, it is crucial to discuss the following with your doctor if your child is taking this medication:
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 vital to inform your doctor and pharmacist about all your medications, including prescription and over-the-counter drugs, natural products, and vitamins, as well as any health problems you may have. This will help ensure your safety while taking this medication. Never start, stop, or change the dose of any medication without first consulting your doctor.
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. Regularly check your blood sugar levels as directed by your doctor.
Follow your doctor's instructions for regular blood work and eye exams to monitor your condition.
Interference with Lab Tests
This medication may affect certain laboratory tests. Inform all your healthcare providers and lab personnel that you are taking this medication to ensure accurate test results.
Cancer and Tumor Risk
If you have a history of cancer or tumors, discuss your treatment with your doctor, as this medication may increase the risk of cancer or tumor growth. Additionally, the risk of new tumors may be higher in some patients.
Special Considerations
If you have Turner syndrome, consult your doctor, as this medication may increase the 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 (intracranial hypertension) has rarely occurred in patients taking this medication, with a higher risk in those with Turner syndrome or Prader-Willi syndrome. Seek medical attention immediately if you experience changes in vision, severe headaches, nausea, or vomiting, especially within the first 8 weeks of treatment.
Age-Related Considerations
If you are 65 or older, use this medication with caution, as you may be more susceptible to side effects.
If you are pregnant, plan to become pregnant, or are breastfeeding, discuss the benefits and risks of this medication with your doctor.
Pediatric Considerations
Children with Prader-Willi syndrome are at risk of severe and potentially life-threatening lung and breathing problems. Monitor your child's condition closely, and seek medical attention immediately if they experience fever (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.
If your child has scoliosis (an abnormal curvature of the spine), consult your doctor, as this medication may worsen the condition in growing children.
* Children using this medication are at risk of a rare bone problem in the hip (slipped capital femoral epiphysis). Seek medical attention immediately if your child experiences hip or knee pain or a limp.
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 with certain doses of benzyl alcohol, 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. Regularly check your blood sugar levels as directed by your doctor.
Follow your doctor's instructions for regular blood work and eye exams to monitor your condition.
Interference with Lab Tests
This medication may affect certain laboratory tests. Inform all your healthcare providers and lab personnel that you are taking this medication to ensure accurate test results.
Cancer and Tumor Risk
If you have a history of cancer or tumors, discuss your treatment with your doctor, as this medication may increase the risk of cancer or tumor growth. Additionally, the risk of new tumors may be higher in some patients.
Special Considerations
If you have Turner syndrome, consult your doctor, as this medication may increase the 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 (intracranial hypertension) has rarely occurred in patients taking this medication, with a higher risk in those with Turner syndrome or Prader-Willi syndrome. Seek medical attention immediately if you experience changes in vision, severe headaches, nausea, or vomiting, especially within the first 8 weeks of treatment.
Age-Related Considerations
If you are 65 or older, use this medication with caution, as you may be more susceptible to side effects.
If you are pregnant, plan to become pregnant, or are breastfeeding, discuss the benefits and risks of this medication with your doctor.
Pediatric Considerations
Children with Prader-Willi syndrome are at risk of severe and potentially life-threatening lung and breathing problems. Monitor your child's condition closely, and seek medical attention immediately if they experience fever (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.
If your child has scoliosis (an abnormal curvature of the spine), consult your doctor, as this medication may worsen the condition in growing children.
* Children using this medication are at risk of a rare bone problem in the hip (slipped capital femoral epiphysis). Seek medical attention immediately if your child experiences hip or knee pain or a limp.
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 with certain doses of benzyl alcohol, 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 and symptoms of acromegaly (e.g., enlarged hands/feet, joint pain, carpal tunnel syndrome, glucose intolerance).
What to Do:
Seek immediate medical attention. For acute overdose, manage hypoglycemia if present. For chronic overdose, discontinue Omnitrope and monitor for resolution of symptoms. Call 1-800-222-1222 (Poison Control).
Drug Interactions
Major Interactions
- Glucocorticoids (may inhibit growth-promoting effects of somatropin)
- Oral Estrogens (may require higher somatropin doses in women on oral estrogen replacement)
- Insulin and/or Oral Hypoglycemic Agents (somatropin may decrease insulin sensitivity, requiring dose adjustments of antidiabetic agents)
- Cytochrome P450-Metabolized Drugs (somatropin may increase clearance of drugs metabolized by CYP3A4, such as corticosteroids, sex steroids, cyclosporine, anticonvulsants)
Moderate Interactions
- Thyroid Hormone (may need dose adjustment of thyroid hormone in patients with concomitant hypothyroidism)
Confidence Interactions
Monitoring
Baseline Monitoring
Height and Weight
Rationale: To establish baseline growth parameters and calculate dose.
Timing: Prior to initiation of therapy.
IGF-1 and IGFBP-3 levels
Rationale: To assess growth hormone status and guide dosing.
Timing: Prior to initiation of therapy.
Thyroid Function Tests (TSH, Free T4)
Rationale: To rule out hypothyroidism, which can impair growth response.
Timing: Prior to initiation of therapy.
Fasting Glucose and HbA1c
Rationale: To assess glucose metabolism and screen for diabetes.
Timing: Prior to initiation of therapy.
Bone Age (pediatric)
Rationale: To assess skeletal maturity and predict growth potential.
Timing: Prior to initiation of therapy.
Fundoscopic Exam
Rationale: To screen for papilledema (sign of intracranial hypertension).
Timing: Prior to initiation of therapy, especially in patients with risk factors.
Scoliosis screening (pediatric)
Rationale: To screen for pre-existing scoliosis, which may progress with rapid growth.
Timing: Prior to initiation of therapy.
Routine Monitoring
Height and Weight
Frequency: Every 3-6 months (pediatric); annually (adult)
Target: Normal growth velocity for age/sex (pediatric); stable weight/body composition (adult)
Action Threshold: Lack of expected growth response (pediatric); significant changes in body composition (adult)
IGF-1 levels
Frequency: Every 3-6 months (pediatric); every 1-2 months initially, then every 6-12 months (adult)
Target: Age- and sex-adjusted normal range (typically 0 to +2 SD)
Action Threshold: Levels significantly above or below target range, requiring dose adjustment.
Thyroid Function Tests (TSH, Free T4)
Frequency: Every 6-12 months, or if clinical signs of hypothyroidism develop.
Target: Normal range
Action Threshold: Abnormal levels requiring thyroid hormone replacement or adjustment.
Fasting Glucose and HbA1c
Frequency: Annually, or more frequently if risk factors for diabetes are present.
Target: Normal range
Action Threshold: Elevated levels requiring intervention or dose adjustment of somatropin.
Fundoscopic Exam
Frequency: Periodically, or if symptoms of intracranial hypertension (e.g., severe headache, visual changes) occur.
Target: No papilledema
Action Threshold: Presence of papilledema requiring temporary cessation of somatropin.
Scoliosis screening (pediatric)
Frequency: Periodically during rapid growth phases.
Target: No significant progression
Action Threshold: Significant progression requiring orthopedic evaluation.
Symptom Monitoring
- Headache (especially severe or persistent)
- Visual changes (blurred vision, double vision)
- Nausea/vomiting
- Limping or hip/knee pain (pediatric, for slipped capital femoral epiphysis)
- Increased thirst or urination (signs of hyperglycemia)
- Swelling of hands/feet (edema)
- Joint or muscle pain
- Numbness/tingling in hands (carpal tunnel syndrome)
- Changes in skin lesions (for malignancy concerns)
Special Patient Groups
Pregnancy
Use during pregnancy should be avoided unless clearly needed. Human data are limited, but animal studies have not shown evidence of harm. The decision to use should weigh potential benefits against risks.
Trimester-Specific Risks:
First Trimester:
Limited human data; animal studies show no teratogenicity.
Second Trimester:
Limited human data; animal studies show no teratogenicity.
Third Trimester:
Limited human data; animal studies show no teratogenicity.
Lactation
Caution is advised. It is unknown if somatropin is excreted in human milk. Due to the potential for serious adverse reactions in the breastfed infant, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.
Infant Risk:
Risk cannot be excluded (L3).
Pediatric Use
Omnitrope is indicated for various growth disorders in pediatric patients. Dosing is weight-based and adjusted according to growth response and IGF-1 levels. Close monitoring for adverse effects such as slipped capital femoral epiphysis, scoliosis progression, and intracranial hypertension is crucial. Contraindicated in Prader-Willi Syndrome patients who are severely obese or have severe respiratory impairment.
Geriatric Use
Experience in patients over 65 years of age is limited. Elderly patients may be more sensitive to the effects of somatropin and may require lower doses. They may also be at increased risk for adverse effects such as edema, arthralgia, and carpal tunnel syndrome. Close monitoring is recommended.
Clinical Information
Clinical Pearls
- Somatropin therapy requires consistent daily administration for optimal results.
- Patient education on proper injection technique and site rotation is critical to prevent lipoatrophy or lipohypertrophy.
- Regular monitoring of IGF-1 levels is essential for dose titration, aiming for levels within the age- and sex-adjusted normal range (0 to +2 SD).
- Hypothyroidism can blunt the growth response to somatropin; ensure thyroid function is optimized before and during therapy.
- Patients with Prader-Willi Syndrome require careful screening for respiratory issues and sleep apnea before and during somatropin treatment due to increased risk of sudden death.
- Report any new or worsening headaches or visual disturbances immediately, as these could indicate benign intracranial hypertension, a rare but serious side effect.
Alternative Therapies
- Other somatropin brands (e.g., Genotropin, Humatrope, Norditropin)
- Long-acting somatropin formulations (e.g., Skytrofa, Ngenla)
- For specific indications, other treatments may exist (e.g., GnRH analogs for central precocious puberty, specific therapies for underlying genetic conditions causing short stature).
Cost & Coverage
Average Cost:
Varies widely, typically several thousand dollars per month (depending on dose and formulation)
Generic Available:
Yes
Insurance Coverage:
Specialty Tier (requires prior authorization and often step therapy)
General Drug Facts
If your symptoms or health issues persist or worsen, it's 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 be sure to check with your pharmacist for more information. If you have any questions or concerns about this medication, don't hesitate to reach out to 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 reporting the incident, be prepared to provide details about the medication taken, the amount, and the time it occurred.