Norditropin Flexpro 30mg/3ml Pf Pen
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
C
FDA Approved
Oct 1987
DEA Schedule
Not Controlled
Overview
What is this medicine?
Norditropin Flexpro is a medicine that contains 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
Taking Your Medication Correctly
To ensure you get the most out of your treatment, it's essential to use this medication exactly as directed by your doctor. Carefully read all the information provided to you and follow the instructions closely.
Administration
This medication is administered via injection into the fatty tissue under the skin. If you'll be self-administering the injection, your doctor or nurse will provide guidance on the proper technique.
Before using the medication, make sure to:
Remove it from the refrigerator and let it come to room temperature, if stored in the fridge. Be aware of the recommended time frame for leaving it at room temperature before use.
Not heat the medication in any way.
Rotate the injection site with each dose to avoid irritation.
Avoid injecting into skin that is irritated, bruised, red, infected, hard, or scarred.
Not inject near the belly button or waistline.
Important Handling Instructions
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.
Be aware of any changes in the solution's color, and do not use it if you notice any discrepancies.
Wash your hands thoroughly before and after handling the medication.
Dispose of needles and other sharp objects in a designated container. Do not reuse needles or other items, and follow local regulations for disposing of the container when it's full.
Using Prefilled Syringes or Pens
You may hear a clicking sound when preparing the dose. However, do not rely on the clicks to determine the correct dose, as this could lead to an incorrect dose.
Remove all pen needle covers before injecting a dose (you may have two covers).
If you're unsure about the type of pen needle you have or how to use it, consult your doctor.
Do not share pen or cartridge devices with others, even if you've changed the needle. Sharing these devices can spread infections, including those you may not be aware of.
Cartridge Injection Devices (Pens)
Not all injection devices are compatible with all strengths of this medication. Ensure you have the correct pen for your specific 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. If you have questions about the storage duration after mixing, consult your doctor or pharmacist.
Missing a Dose
If you miss a dose, take it as soon as you remember.
If it's 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 make up for a missed dose.
To ensure you get the most out of your treatment, it's essential to use this medication exactly as directed by your doctor. Carefully read all the information provided to you and follow the instructions closely.
Administration
This medication is administered via injection into the fatty tissue under the skin. If you'll be self-administering the injection, your doctor or nurse will provide guidance on the proper technique.
Before using the medication, make sure to:
Remove it from the refrigerator and let it come to room temperature, if stored in the fridge. Be aware of the recommended time frame for leaving it at room temperature before use.
Not heat the medication in any way.
Rotate the injection site with each dose to avoid irritation.
Avoid injecting into skin that is irritated, bruised, red, infected, hard, or scarred.
Not inject near the belly button or waistline.
Important Handling Instructions
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.
Be aware of any changes in the solution's color, and do not use it if you notice any discrepancies.
Wash your hands thoroughly before and after handling the medication.
Dispose of needles and other sharp objects in a designated container. Do not reuse needles or other items, and follow local regulations for disposing of the container when it's full.
Using Prefilled Syringes or Pens
You may hear a clicking sound when preparing the dose. However, do not rely on the clicks to determine the correct dose, as this could lead to an incorrect dose.
Remove all pen needle covers before injecting a dose (you may have two covers).
If you're unsure about the type of pen needle you have or how to use it, consult your doctor.
Do not share pen or cartridge devices with others, even if you've changed the needle. Sharing these devices can spread infections, including those you may not be aware of.
Cartridge Injection Devices (Pens)
Not all injection devices are compatible with all strengths of this medication. Ensure you have the correct pen for your specific 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. If you have questions about the storage duration after mixing, consult your doctor or pharmacist.
Missing a Dose
If you miss a dose, take it as soon as you remember.
If it's 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 make up for a missed dose.
Lifestyle & Tips
- Store the pen in the refrigerator (2°C to 8°C or 36°F to 46°F). Do not freeze. Once in use, the pen can be stored at room temperature (up to 25°C or 77°F) for up to 3 weeks or in the refrigerator for up to 4 weeks.
- Always use a new needle for each injection and dispose of it properly in a sharps container.
- Rotate injection sites (e.g., abdomen, thigh, buttocks, upper arm) to prevent skin problems.
- Follow your doctor's instructions carefully regarding dose and injection technique.
- Do not share your pen with anyone else, even if the needle is changed.
- Maintain a healthy diet and exercise routine 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, adjusted based on IGF-1 levels and clinical response. Typical maintenance range 0.2-0.6 mg/day (0.6-1.8 IU/day).
Dose Range:
0.2 - 0.6 mg
Condition-Specific Dosing:
Adult Growth Hormone Deficiency (GHD):
Initial dose 0.2 mg/day (0.6 IU/day) subcutaneously, increased gradually every 1-2 months by 0.1-0.2 mg/day (0.3-0.6 IU/day) based on IGF-1 levels, clinical response, and adverse effects. Max dose typically 1.0 mg/day (3.0 IU/day). Lower initial doses for older or obese patients.
Short Bowel Syndrome (SBS):
Not an approved indication for Norditropin.
Pediatric Dosing
Neonatal:
Not typically used in neonates unless for specific, rare conditions (e.g., severe GHD) under specialist guidance. Dosing would be highly individualized and off-label for most indications.
Infant:
For 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). For Prader-Willi Syndrome: 0.034 mg/kg/day (0.1 IU/kg/day).
Child:
For 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). For Prader-Willi Syndrome: 0.034 mg/kg/day (0.1 IU/kg/day). For Small for Gestational Age (SGA) without catch-up growth: 0.033-0.067 mg/kg/day (0.1-0.2 IU/kg/day). For Noonan Syndrome: 0.066 mg/kg/day (0.2 IU/kg/day). For Idiopathic Short Stature (ISS): 0.034 mg/kg/day (0.1 IU/kg/day).
Adolescent:
Dosing continues as per child guidelines until epiphyseal fusion. For GHD, once epiphyseal fusion occurs, transition to adult GHD dosing may be considered.
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. Patients with chronic kidney disease (CKD) may have altered growth hormone sensitivity; dose adjustments may be needed based on clinical response and IGF-1 levels.
Dialysis:
Somatropin is used in children with CKD. Dosing is typically 0.05 mg/kg/day (0.15 IU/kg/day) for children with CKD. No specific adjustments for dialysis patients beyond general CKD dosing, but close monitoring is essential.
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. Somatropin is metabolized in the liver; caution and close monitoring for adverse effects are advised.
Pharmacology
Mechanism of Action
Somatropin is a recombinant human growth hormone (rhGH) that is identical to naturally occurring pituitary-derived human growth hormone. It binds to specific growth hormone receptors on target cells, stimulating linear growth in children and adolescents, and maintaining body composition in adults. Its primary effects are mediated through insulin-like growth factor-1 (IGF-1), which is produced predominantly in the liver and also locally in other tissues. IGF-1 stimulates chondrogenesis and skeletal growth, as well as protein synthesis, cell proliferation, and organ growth.
Pharmacokinetics
Absorption:
Bioavailability:
Approximately 80% (subcutaneous)
Tmax:
Approximately 4-6 hours (subcutaneous)
FoodEffect:
Not applicable for subcutaneous administration.
Distribution:
Vd:
Approximately 0.07-0.1 L/kg
ProteinBinding:
Limited binding to plasma proteins; binds to growth hormone binding protein (GHBP).
CnssPenetration:
Limited
Elimination:
HalfLife:
Approximately 2-3 hours (intravenous); 3-5 hours (subcutaneous)
Clearance:
Approximately 0.13-0.21 L/kg/hr
ExcretionRoute:
Renal (metabolites)
Unchanged:
<0.1%
Pharmacodynamics
OnsetOfAction:
Growth effects are gradual, typically observed over weeks to months. Metabolic effects (e.g., glucose, lipid changes) can be seen within hours to days.
PeakEffect:
Peak IGF-1 levels typically occur within 12-24 hours post-dose. Clinical growth effects are cumulative.
DurationOfAction:
IGF-1 levels remain elevated for approximately 24 hours after a single daily dose.
Confidence:
Medium
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 immediate medical attention:
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, excessive 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 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, 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. Many people experience no side effects or only 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 persist:
Headache
Fatigue or weakness
Back, muscle, or joint pain
Muscle stiffness
Difficulty sleeping
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, 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 immediate medical attention:
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, excessive 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 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, 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. Many people experience no side effects or only 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 persist:
Headache
Fatigue or weakness
Back, muscle, or joint pain
Muscle stiffness
Difficulty sleeping
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, 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 vision changes (blurred vision, double vision)
- Numbness, tingling, or pain in hands/wrists (carpal tunnel syndrome)
- Severe joint or muscle pain
- Swelling in hands or feet (edema)
- Increased thirst or frequent urination (signs of high blood sugar)
- Changes in existing moles or new skin growths
- Limping or new hip/knee pain in children
- Signs of an allergic reaction: rash, itching, hives, swelling of face/lips/tongue, difficulty breathing or swallowing.
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 you experienced, including the symptoms that occurred.
Certain health conditions, such as:
+ Breathing problems, including sleep apnea
+ Cancer or other tumors, including brain tumors
+ Diabetic eye disease
+ Illnesses that have developed shortly 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 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 first.
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 you experienced, including the symptoms that occurred.
Certain health conditions, such as:
+ Breathing problems, including sleep apnea
+ Cancer or other tumors, including brain tumors
+ Diabetic eye disease
+ Illnesses that have developed shortly 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 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 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. Regularly check your blood sugar levels as directed by your doctor.
Follow your doctor's instructions for regular blood tests and eye exams to monitor your condition.
Interference with Lab Tests
This medication may affect certain laboratory test results. Inform all your healthcare providers and laboratory 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, some patients may be at a higher risk of developing new tumors.
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 been reported rarely 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 headache, 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.
Pregnant or breastfeeding women should discuss the benefits and risks of this medication with their doctor.
Pediatric Considerations
Children with Prader-Willi syndrome are at risk of severe and potentially life-threatening lung or breathing problems. Monitor your child's condition closely, and seek medical attention immediately if they experience fever (100.4°F or 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 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 tests and eye exams to monitor your condition.
Interference with Lab Tests
This medication may affect certain laboratory test results. Inform all your healthcare providers and laboratory 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, some patients may be at a higher risk of developing new tumors.
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 been reported rarely 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 headache, 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.
Pregnant or breastfeeding women should discuss the benefits and risks of this medication with their doctor.
Pediatric Considerations
Children with Prader-Willi syndrome are at risk of severe and potentially life-threatening lung or breathing problems. Monitor your child's condition closely, and seek medical attention immediately if they experience fever (100.4°F or 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 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, excessive sweating, facial changes).
What to Do:
Seek immediate medical attention or call a poison control center (1-800-222-1222). Acute overdose may require glucose administration for hypoglycemia. Chronic overdose requires discontinuation of the drug and symptomatic management.
Drug Interactions
Major Interactions
- Glucocorticoids (e.g., Prednisone, Dexamethasone): May inhibit the growth-promoting effects of somatropin. Patients requiring glucocorticoid treatment should have their somatropin dose adjusted or consider alternative therapies.
- Non-glucocorticoid corticosteroids (e.g., Fludrocortisone): May also reduce somatropin efficacy.
Moderate Interactions
- Thyroid hormones (e.g., Levothyroxine): 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 or requiring increased thyroid hormone dose.
- Insulin and other antidiabetic agents: Somatropin may decrease insulin sensitivity, leading to hyperglycemia. Dose adjustments of antidiabetic agents may be required.
- Oral Estrogens: May decrease IGF-1 response to somatropin. Higher somatropin doses may be required in women taking oral estrogens.
- Cytochrome P450-metabolized drugs (e.g., Corticosteroids, Sex Steroids, Cyclosporine, Phenytoin, Carbamazepine): Somatropin may increase the clearance of drugs metabolized by CYP3A4. Monitor drug levels and adjust doses as needed.
Monitoring
Baseline Monitoring
IGF-1 and IGFBP-3 levels
Rationale: To confirm GHD diagnosis (in adults) and establish baseline for monitoring treatment response and safety.
Timing: Prior to initiation of therapy.
Thyroid function tests (TSH, free T4)
Rationale: To rule out hypothyroidism, which can mimic GHD or impair response to somatropin. Somatropin can also unmask central hypothyroidism.
Timing: Prior to initiation of therapy.
Fasting glucose and HbA1c
Rationale: To assess baseline glucose metabolism, as somatropin can induce insulin resistance.
Timing: Prior to initiation of therapy.
Lipid profile
Rationale: To assess baseline cardiovascular risk factors.
Timing: Prior to initiation of therapy.
Height and Weight (pediatric)
Rationale: To establish baseline growth parameters and calculate initial dose.
Timing: Prior to initiation of therapy.
Bone age (pediatric)
Rationale: To assess skeletal maturity and predict remaining growth potential.
Timing: Prior to initiation of therapy.
Fundoscopic examination (pediatric, especially with headache/visual changes)
Rationale: To screen for papilledema, a sign of benign intracranial hypertension.
Timing: Prior to initiation of therapy, or if symptoms arise.
Routine Monitoring
IGF-1 levels
Frequency: Every 4-8 weeks during dose titration, then every 3-6 months once stable.
Target: Age- and sex-adjusted normal range (0 to +2 SD score).
Action Threshold: If consistently above +2 SD, consider dose reduction. If consistently below -2 SD, consider dose increase (after ruling out non-compliance or other issues).
Growth velocity (pediatric)
Frequency: Every 3-6 months.
Target: Increased growth velocity 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 symptoms of hypothyroidism develop.
Target: Normal range.
Action Threshold: If abnormal, adjust thyroid hormone replacement if applicable, or investigate for central hypothyroidism.
Fasting glucose and HbA1c
Frequency: Every 6-12 months, or if symptoms of hyperglycemia develop.
Target: Normal range.
Action Threshold: If elevated, consider dose reduction of somatropin or initiation/adjustment of antidiabetic therapy.
Lipid profile
Frequency: Annually.
Target: Normal range.
Action Threshold: If abnormal, consider lifestyle modifications or lipid-lowering therapy.
Scoliosis screening (pediatric, especially Turner/Prader-Willi)
Frequency: Annually.
Target: Not applicable.
Action Threshold: If scoliosis develops or worsens, refer to orthopedics.
Fundoscopic examination (if headache/visual changes)
Frequency: As needed.
Target: No papilledema.
Action Threshold: If papilledema present, discontinue somatropin and investigate for benign intracranial hypertension.
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)
- Changes in skin lesions (size, color, new moles)
- Limping or hip/knee pain (pediatric, Slipped Capital Femoral Epiphysis)
- Increased thirst or urination (signs of hyperglycemia)
- Signs of allergic reaction (rash, itching, swelling, difficulty breathing)
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. Growth hormone levels naturally increase during pregnancy.
Trimester-Specific Risks:
First Trimester:
Limited data, theoretical risk of fetal harm.
Second Trimester:
Limited data, theoretical risk of fetal harm.
Third Trimester:
Limited data, theoretical risk of fetal harm.
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, but monitor for any adverse effects.
Pediatric Use
Somatropin is primarily used in pediatric patients for various growth disorders (e.g., GHD, Turner Syndrome, Prader-Willi Syndrome, SGA, Noonan Syndrome, ISS). Dosing is weight-based and adjusted based on IGF-1 levels and growth response. Close monitoring for scoliosis, slipped capital femoral epiphysis, and benign intracranial hypertension is crucial.
Geriatric Use
Older adults (over 65 years) with GHD may be more sensitive to the effects of somatropin and may require lower initial doses and slower dose titration to minimize adverse effects. They may also be at increased risk for adverse events such as edema, arthralgia, and carpal tunnel syndrome. Close monitoring is recommended.
Clinical Information
Clinical Pearls
- Norditropin Flexpro pens are pre-filled and designed for ease of use, but proper injection technique and site rotation are crucial for efficacy and to prevent lipoatrophy.
- IGF-1 levels are the primary biochemical marker for monitoring somatropin therapy, but clinical response (e.g., growth velocity in children, body composition in adults) is equally important.
- Patients with Prader-Willi Syndrome should be carefully screened for upper airway obstruction, sleep apnea, and respiratory infections prior to initiation of somatropin and monitored closely during therapy due to increased risk of sudden death.
- Somatropin can cause insulin resistance; monitor glucose levels, especially in patients with diabetes or risk factors for diabetes.
- Hypothyroidism can reduce the response to somatropin; ensure patients are euthyroid before and during therapy.
- Benign intracranial hypertension (BIH) is a rare but serious side effect; educate patients/parents on symptoms (headache, visual changes) and advise immediate medical attention if they occur.
- Slipped Capital Femoral Epiphysis (SCFE) and scoliosis progression can occur in rapidly growing children; monitor for limping or back pain.
Alternative Therapies
- Other recombinant human growth hormone products (e.g., Genotropin, Humatrope, Omnitrope, Saizen, Nutropin AQ, Skytrofa, Opko Somatrogon).
- For specific conditions, other treatments may exist (e.g., GnRH analogs for central precocious puberty, aromatase inhibitors for short stature in boys, specific therapies for underlying conditions causing short stature).
Cost & Coverage
Average Cost:
Varies significantly, typically several thousand USD per 30mg/3ml pen
Generic Available:
Yes
Insurance Coverage:
Specialty Tier (Tier 4 or higher), often requires prior authorization and 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 details. If you have any questions or concerns about your 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 medical attention. When seeking help, be prepared to provide information about the medication taken, the amount, and the time it happened.