Norditropin Flexpro 10mg/1.5ml Inj
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 (rhGH)
Pregnancy Category
Category C
FDA Approved
Oct 1987
DEA Schedule
Not Controlled
Overview
What is this medicine?
Somatropin 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 into the fatty part of the skin.
If stored in the refrigerator, allow the medication to come to room temperature before use. 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.
Precautions and Safety Measures
Wash your hands before and after use.
Dispose of 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 or concerns, consult your doctor or pharmacist.
Using Prefilled Syringes or Pens
This product may produce a clicking sound when preparing the dose. Do not rely on the clicks to determine the dose, as this may 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 another person, even if the needle has been changed, as this can transmit 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 Doses
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 into the fatty part of the skin.
If stored in the refrigerator, allow the medication to come to room temperature before use. 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.
Precautions and Safety Measures
Wash your hands before and after use.
Dispose of 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 or concerns, consult your doctor or pharmacist.
Using Prefilled Syringes or Pens
This product may produce a clicking sound when preparing the dose. Do not rely on the clicks to determine the dose, as this may 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 another person, even if the needle has been changed, as this can transmit 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 Doses
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
- Store Norditropin Flexpro in the refrigerator (2°C to 8°C or 36°F to 46°F). Do not freeze. Once in use, it can be stored at room temperature (up to 25°C or 77°F) for up to 3 weeks.
- Always check the expiration date before use.
- Rotate injection sites (e.g., abdomen, thigh, buttocks, upper arm) to prevent skin problems like lipoatrophy or lipohypertrophy.
- Follow your doctor's instructions carefully regarding dose and administration technique.
- Do not share your pen with anyone else, even if the needle is changed, as this carries a risk of transmitting infections.
- Report any new or worsening headaches, vision changes, or severe joint pain to your doctor immediately.
- Maintain regular follow-up appointments and blood tests as advised by your doctor.
Available Forms & Alternatives
Dosing & Administration
Adult Dosing
Standard Dose:
Initial dose 0.2 mg/day (0.6 IU/day) subcutaneously, may be increased gradually based on IGF-1 levels and clinical response.
Dose Range:
0.2 - 0.8 mg
Condition-Specific Dosing:
Adult Growth Hormone Deficiency (GHD):
Initial dose 0.2 mg/day (0.6 IU/day) subcutaneously. Dose may be increased every 1-2 months by increments of 0.1-0.2 mg/day (0.3-0.6 IU/day) based on patient response and IGF-1 levels. Max dose typically 0.8 mg/day (2.4 IU/day).
Transition GHD:
Patients who were treated with growth hormone during childhood and adolescence for GHD and who have attained final height should be re-evaluated for GHD. For those requiring continued treatment, the recommended initial dose is 0.2-0.5 mg/day (0.6-1.5 IU/day).
Pediatric Dosing
Neonatal:
Not established for routine use in neonates, specific indications may exist but require expert consultation.
Infant:
Not established for routine use in infants, specific indications may exist but require expert consultation.
Child:
Dosing is individualized based on weight and indication. For Growth Hormone Deficiency (GHD): 0.024-0.034 mg/kg/day (0.07-0.1 IU/kg/day) subcutaneously. For Turner Syndrome: 0.05 mg/kg/day (0.15 IU/kg/day) subcutaneously. For Prader-Willi Syndrome: 0.034 mg/kg/day (0.1 IU/kg/day) subcutaneously. For Small for Gestational Age (SGA) with no catch-up growth by age 2-4: 0.033-0.067 mg/kg/day (0.1-0.2 IU/kg/day) subcutaneously. For Noonan Syndrome: 0.066 mg/kg/day (0.2 IU/kg/day) subcutaneously. For Idiopathic Short Stature (ISS): 0.034 mg/kg/day (0.1 IU/kg/day) subcutaneously.
Adolescent:
Dosing continues as per child guidelines until final height is achieved or GHD re-evaluation for transition to adult dosing.
Dose Adjustments
Renal Impairment:
Mild:
No specific dose adjustment recommended, but monitor closely.
Moderate:
No specific dose adjustment recommended, but monitor closely.
Severe:
No specific dose adjustment recommended, but monitor closely. Use with caution.
Dialysis:
No specific dose adjustment recommended, but use with caution and monitor closely. Growth hormone is not significantly removed by dialysis.
Hepatic Impairment:
Mild:
No specific dose adjustment recommended, but monitor closely.
Moderate:
No specific dose adjustment recommended, but monitor closely.
Severe:
No specific dose adjustment recommended, but monitor closely. Use with caution.
Pharmacology
Mechanism of Action
Somatropin is a recombinant human growth hormone (rhGH) that binds to specific growth hormone receptors on target cells, including chondrocytes, osteoblasts, hepatocytes, and adipocytes. This binding stimulates linear growth in children and adolescents who have not achieved epiphyseal fusion, and maintains normal body composition in adults. Its primary effects are mediated indirectly through insulin-like growth factor-1 (IGF-1), which is produced predominantly in the liver. IGF-1 stimulates protein synthesis, cell proliferation, and differentiation, leading to increased linear growth, organ growth, and metabolic effects such as increased lipolysis and decreased glucose utilization.
Pharmacokinetics
Absorption:
Bioavailability:
Approximately 80% (subcutaneous)
Tmax:
3-6 hours (subcutaneous)
FoodEffect:
Not applicable for subcutaneous administration.
Distribution:
Vd:
Approximately 0.07-0.1 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 0.15-0.25 L/kg/hr
ExcretionRoute:
Renal (metabolites)
Unchanged:
<0.1%
Pharmacodynamics
OnsetOfAction:
Metabolic effects (e.g., lipolysis) can be observed within hours; growth effects are long-term.
PeakEffect:
Peak IGF-1 levels typically 12-24 hours post-dose; clinical growth effects are observed over months to years.
DurationOfAction:
Effects on IGF-1 last for approximately 24 hours; long-term growth effects are cumulative.
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, difficulty breathing, swallowing, or talking, unusual hoarseness, or swelling of the mouth, face, lips, tongue, or throat.
Signs of high blood sugar: confusion, drowsiness, 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, ear pain, or other unusual symptoms.
Other Possible Side Effects
Like all medications, this drug can cause side effects. While many people may not experience any side effects or only minor ones, it's essential to discuss any concerns with your doctor. If you experience any of the following side effects or any other unusual symptoms, contact your doctor for advice:
Headache, fatigue, or weakness.
Back, muscle, or joint pain, muscle stiffness, or difficulty sleeping.
Diarrhea, stomach pain, nausea, vomiting, or gas.
Irritation at the injection site, common cold symptoms, or flu-like symptoms.
* Hair loss, breast enlargement, or other unusual symptoms.
Reporting Side Effects
This list is not exhaustive, and you may experience other side effects not mentioned here. If you have questions or concerns about side effects, consult 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, difficulty breathing, swallowing, or talking, unusual hoarseness, or swelling of the mouth, face, lips, tongue, or throat.
Signs of high blood sugar: confusion, drowsiness, 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, ear pain, or other unusual symptoms.
Other Possible Side Effects
Like all medications, this drug can cause side effects. While many people may not experience any side effects or only minor ones, it's essential to discuss any concerns with your doctor. If you experience any of the following side effects or any other unusual symptoms, contact your doctor for advice:
Headache, fatigue, or weakness.
Back, muscle, or joint pain, muscle stiffness, or difficulty sleeping.
Diarrhea, stomach pain, nausea, vomiting, or gas.
Irritation at the injection site, common cold symptoms, or flu-like symptoms.
* Hair loss, breast enlargement, or other unusual symptoms.
Reporting Side Effects
This list is not exhaustive, and you may experience other side effects not mentioned here. If you have questions or concerns about side effects, consult 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 or vomiting
- Blurred vision or other vision changes
- Numbness, tingling, or pain in hands or feet (carpal tunnel syndrome)
- Severe or unusual joint pain
- Swelling of hands, feet, or ankles
- Increased thirst or urination, unexplained weight loss (signs of high blood sugar)
- Limping or hip/knee pain (in children, may indicate slipped capital femoral epiphysis)
- Changes in skin moles (size, shape, color)
- Any signs of an allergic reaction (rash, itching, swelling, severe dizziness, trouble breathing)
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 to this medication, its components, or other substances, including foods and drugs. Describe the allergic reaction and its symptoms.
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, experiences breathing difficulties, or has 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 determine if it is safe to take this medication with your other medications and health conditions. Never start, stop, or change the dose of any medication without consulting your doctor.
It is essential to inform your doctor about the following:
Any allergies you have to this medication, its components, or other substances, including foods and drugs. Describe the allergic reaction and its symptoms.
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, experiences breathing difficulties, or has 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 determine if it is safe to take this medication with your other medications and health conditions. Never start, stop, or change the dose of any medication without 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.
High Blood Sugar Risk
This medication can cause high blood sugar levels, including new or worsening diabetes. Monitor your blood sugar levels as directed by your doctor. Regular blood work and eye exams are also crucial, as advised by your doctor.
Lab Test Interference
This medication may affect certain lab 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. This medication may increase the risk of cancer or tumor growth, as well as the development of new tumors in some patients.
Turner Syndrome and Prader-Willi Syndrome
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 brain bleeding. Additionally, patients with Turner syndrome or Prader-Willi syndrome may be at a higher risk of raised pressure in the head, which can occur within the first 8 weeks of treatment. Seek immediate medical attention if you experience changes in vision, severe headaches, nausea, or vomiting.
Age-Related Precautions
If you are 65 or older, use this medication with caution, as you may be more susceptible to side effects.
Pregnancy and Breastfeeding
Inform your doctor if you are pregnant, plan to become pregnant, or are breastfeeding. Your doctor will discuss the benefits and risks of this medication for you and your baby.
Children
In children with Prader-Willi syndrome, this medication can cause severe and potentially life-threatening lung or breathing problems. Monitor your child's condition closely, and seek immediate medical attention if they experience a fever over 100.4°F (38°C), 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 with your doctor, as this medication may worsen the condition in growing children.
In rare cases, children using this medication can develop a bone problem in the hip (slipped growth plate). 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 products with benzyl alcohol in newborns or infants, as it can cause serious side effects, especially when combined with other medications containing benzyl alcohol. Consult with 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.
High Blood Sugar Risk
This medication can cause high blood sugar levels, including new or worsening diabetes. Monitor your blood sugar levels as directed by your doctor. Regular blood work and eye exams are also crucial, as advised by your doctor.
Lab Test Interference
This medication may affect certain lab 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. This medication may increase the risk of cancer or tumor growth, as well as the development of new tumors in some patients.
Turner Syndrome and Prader-Willi Syndrome
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 brain bleeding. Additionally, patients with Turner syndrome or Prader-Willi syndrome may be at a higher risk of raised pressure in the head, which can occur within the first 8 weeks of treatment. Seek immediate medical attention if you experience changes in vision, severe headaches, nausea, or vomiting.
Age-Related Precautions
If you are 65 or older, use this medication with caution, as you may be more susceptible to side effects.
Pregnancy and Breastfeeding
Inform your doctor if you are pregnant, plan to become pregnant, or are breastfeeding. Your doctor will discuss the benefits and risks of this medication for you and your baby.
Children
In children with Prader-Willi syndrome, this medication can cause severe and potentially life-threatening lung or breathing problems. Monitor your child's condition closely, and seek immediate medical attention if they experience a fever over 100.4°F (38°C), 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 with your doctor, as this medication may worsen the condition in growing children.
In rare cases, children using this medication can develop a bone problem in the hip (slipped growth plate). 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 products with benzyl alcohol in newborns or infants, as it can cause serious side effects, especially when combined with other medications containing benzyl alcohol. Consult with your doctor to determine if this product contains benzyl alcohol.
Overdose Information
Overdose Symptoms:
- Acute overdose: Initially, low blood sugar (hypoglycemia) followed by high blood sugar (hyperglycemia).
- Chronic overdose: Signs and symptoms of gigantism (in children) or acromegaly (in adults), such as enlarged hands/feet, joint pain, and other metabolic disturbances.
What to Do:
Seek immediate medical attention. For acute overdose, management may involve monitoring blood glucose and providing glucose if hypoglycemia occurs. For chronic overdose, discontinue somatropin and manage symptoms. Call 1-800-222-1222 (Poison Control Center) for advice.
Drug Interactions
Major Interactions
- Glucocorticoids (may inhibit growth-promoting effects of somatropin)
- Thyroid hormones (untreated hypothyroidism can impair response to somatropin; thyroid hormone replacement may be needed)
- Insulin and/or other antidiabetic agents (somatropin may decrease insulin sensitivity, requiring dose adjustments of antidiabetic agents)
- Oral estrogens (may increase hepatic IGF-1 production, potentially requiring higher somatropin doses in women on oral estrogen replacement)
Moderate Interactions
- Cytochrome P450-metabolized drugs (somatropin may increase the clearance of compounds metabolized by CYP3A4, such as corticosteroids, sex steroids, cyclosporine, and anticonvulsants, potentially requiring dose adjustments of these drugs)
Monitoring
Baseline Monitoring
IGF-1 and IGFBP-3 levels
Rationale: To confirm GHD diagnosis and establish baseline for treatment monitoring.
Timing: Prior to initiation of therapy.
Thyroid function tests (TSH, Free T4)
Rationale: Untreated hypothyroidism can impair response to somatropin. Somatropin may unmask central hypothyroidism.
Timing: Prior to initiation of therapy.
Fasting glucose and HbA1c
Rationale: To assess glucose metabolism, as somatropin can induce insulin resistance.
Timing: Prior to initiation of therapy.
Bone age (pediatric patients)
Rationale: To assess skeletal maturity and monitor growth potential.
Timing: Prior to initiation of therapy.
Fundoscopic examination (pediatric patients)
Rationale: To screen for papilledema, especially in patients with Prader-Willi syndrome or those at risk for intracranial hypertension.
Timing: Prior to initiation of therapy.
Scoliosis screening (pediatric patients)
Rationale: To screen for progression of pre-existing scoliosis or new onset.
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 SD score).
Action Threshold: If IGF-1 levels are consistently above +2 SD, consider dose reduction. If consistently below -2 SD, consider dose increase.
Thyroid function tests (TSH, Free T4)
Frequency: Every 3-6 months, or if clinical signs of hypothyroidism develop.
Target: Normal range.
Action Threshold: If abnormal, initiate or adjust thyroid hormone replacement.
Fasting glucose and HbA1c
Frequency: Every 6-12 months, or if symptoms of hyperglycemia develop.
Target: Normal range.
Action Threshold: If elevated, consider dose adjustment of somatropin or initiation/adjustment of antidiabetic therapy.
Growth velocity (pediatric patients)
Frequency: Every 3-6 months.
Target: Increased growth velocity appropriate for age and condition.
Action Threshold: Suboptimal growth may indicate need for dose adjustment or evaluation for other causes.
Bone age (pediatric patients)
Frequency: Annually.
Target: Progression consistent with chronological age.
Action Threshold: Accelerated bone age may indicate need for dose adjustment.
Fundoscopic examination (pediatric patients)
Frequency: Annually, or if symptoms of intracranial hypertension (e.g., severe headache, visual changes) occur.
Target: No papilledema.
Action Threshold: If papilledema is present, discontinue somatropin and evaluate for idiopathic intracranial hypertension.
Scoliosis screening (pediatric patients)
Frequency: Annually.
Target: No progression or new onset of scoliosis.
Action Threshold: If progression, refer to orthopedics.
Symptom Monitoring
- Headache (especially severe or persistent)
- Visual changes (blurred vision, double vision)
- Nausea/vomiting
- Joint pain or stiffness
- Muscle pain
- Peripheral edema (swelling of hands/feet)
- Numbness or tingling (paresthesias)
- Injection site reactions (pain, redness, swelling)
- Changes in skin moles (for patients with pre-existing nevi)
- Signs of hyperglycemia (increased thirst, urination, fatigue)
- Signs of hypothyroidism (fatigue, weight gain, cold intolerance)
Special Patient Groups
Pregnancy
Category C. There are no adequate and well-controlled studies in pregnant women. Use during pregnancy only if the potential benefit justifies the potential risk to the fetus. Human growth hormone is known to cross the placental barrier.
Trimester-Specific Risks:
First Trimester:
Potential risk not well-established; avoid unless clearly needed.
Second Trimester:
Potential risk not well-established; avoid unless clearly needed.
Third Trimester:
Potential risk not well-established; avoid unless clearly needed.
Lactation
L3 (Moderately safe). It is unknown whether somatropin is excreted in human milk. However, growth hormone is a protein and is likely to be digested in the infant's gastrointestinal tract. Caution should be exercised when somatropin is administered to a nursing mother.
Infant Risk:
Low risk of systemic effects in the infant due to likely digestion of the protein in the infant's GI tract. Monitor infant for any adverse effects.
Pediatric Use
Somatropin is indicated for various growth disorders in pediatric patients. Dosing is weight-based and individualized. Close monitoring of growth velocity, IGF-1, thyroid function, and potential adverse effects (e.g., intracranial hypertension, slipped capital femoral epiphysis, scoliosis) is crucial.
Geriatric Use
Clinical studies have not included sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. 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 peripheral edema and arthralgia. Initial doses should be lower and increased gradually.
Clinical Information
Clinical Pearls
- Norditropin Flexpro is a pre-filled, multi-dose pen, simplifying administration for patients.
- Individualize dosing based on patient's clinical response, IGF-1 levels, and adverse effects. Do not base dose solely on weight.
- Patients with Prader-Willi syndrome who are severely obese or have severe respiratory impairment are contraindicated due to reports of sudden death.
- Monitor for signs of intracranial hypertension (e.g., severe headache, visual changes, nausea/vomiting) and discontinue therapy if suspected.
- Somatropin can decrease insulin sensitivity; monitor glucose levels, especially in patients with diabetes or risk factors for diabetes.
- Untreated hypothyroidism can impair response to somatropin; ensure thyroid function is optimized before and during therapy.
- Slipped capital femoral epiphysis and progression of scoliosis can occur in children receiving somatropin; monitor for limping or back pain.
- Patients with a history of malignancy should be carefully evaluated before starting somatropin, and monitored for recurrence. Somatropin is contraindicated in patients with active malignancy.
Alternative Therapies
- Genotropin (somatropin)
- Humatrope (somatropin)
- Saizen (somatropin)
- Omnitrope (somatropin, biosimilar)
- Zomacton (somatropin)
- Nutropin (somatropin)
Cost & Coverage
Average Cost:
Highly variable, typically several thousand USD per 1.5ml pen (10mg)
Insurance Coverage:
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 promptly. 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.