Norditropin Flexpro 15mg/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 1985
DEA Schedule
Not Controlled
Overview
What is this medicine?
Somatropin is a man-made version of human growth hormone. It's used to help children grow taller if they have certain medical conditions that cause short stature, and to treat growth hormone deficiency in adults. It works by stimulating growth and metabolism in the body.
How to Use This Medicine
Proper Use of This Medication
To ensure safe and effective use, follow your doctor's instructions and read all accompanying information carefully.
Administration
This medication is administered via injection into the fatty tissue under the skin. If you are self-administering, your doctor or nurse will provide guidance on the proper technique.
Before use, if the medication has been stored in the refrigerator, allow it to reach room temperature. However, be aware of the specific time frame for leaving it at room temperature before administration. Do not heat the medication.
To minimize the risk of complications, rotate the injection site with each use. Avoid injecting into skin that is irritated, bruised, red, infected, hard, or scarred. Additionally, do not administer the injection near the belly button or waistline.
Preparation and Inspection
Do not shake the solution before use. Inspect the solution for any signs of cloudiness, leakage, or particles, and do not use if any of these conditions are present. Also, check the solution for any changes in color, and do not use if a change is observed.
Hygiene and Disposal
Wash your hands thoroughly before and after handling the medication. Dispose of used needles and other sharp objects in a designated disposal box. Do not reuse needles or any other components. Once the disposal box is full, follow local regulations for its proper disposal. If you have any questions or concerns, consult your doctor or pharmacist.
Specific Instructions for Prefilled Syringes or Pens
When preparing a dose, you may hear a clicking sound. However, do not rely on the number of clicks to determine the dose, as this could lead to an incorrect dose. Remove all pen needle covers before injecting (note that there may be two covers). If you are unsure about the type of pen needle or how to use it, consult your doctor.
It is crucial not to share pen or cartridge devices with others, even if the needle has been changed, as this can spread infections, including those that may not be apparent.
Cartridge Injection Devices (Pens)
Ensure that you are using the correct pen for your specific cartridge and dose strength, as using the wrong pen can result in an incorrect dose.
Storage and Disposal
For Saizen, store the medication at room temperature. After mixing, refrigerate the medication. If you have questions about the shelf life of the mixed medication, consult your doctor or pharmacist.
Missed Dose
If you miss a dose, take it as soon as you remember. However, if it is close to the time for your next scheduled dose, skip the missed dose and continue with your regular dosing schedule. Do not take two doses at the same time or take extra doses.
To ensure safe and effective use, follow your doctor's instructions and read all accompanying information carefully.
Administration
This medication is administered via injection into the fatty tissue under the skin. If you are self-administering, your doctor or nurse will provide guidance on the proper technique.
Before use, if the medication has been stored in the refrigerator, allow it to reach room temperature. However, be aware of the specific time frame for leaving it at room temperature before administration. Do not heat the medication.
To minimize the risk of complications, rotate the injection site with each use. Avoid injecting into skin that is irritated, bruised, red, infected, hard, or scarred. Additionally, do not administer the injection near the belly button or waistline.
Preparation and Inspection
Do not shake the solution before use. Inspect the solution for any signs of cloudiness, leakage, or particles, and do not use if any of these conditions are present. Also, check the solution for any changes in color, and do not use if a change is observed.
Hygiene and Disposal
Wash your hands thoroughly before and after handling the medication. Dispose of used needles and other sharp objects in a designated disposal box. Do not reuse needles or any other components. Once the disposal box is full, follow local regulations for its proper disposal. If you have any questions or concerns, consult your doctor or pharmacist.
Specific Instructions for Prefilled Syringes or Pens
When preparing a dose, you may hear a clicking sound. However, do not rely on the number of clicks to determine the dose, as this could lead to an incorrect dose. Remove all pen needle covers before injecting (note that there may be two covers). If you are unsure about the type of pen needle or how to use it, consult your doctor.
It is crucial not to share pen or cartridge devices with others, even if the needle has been changed, as this can spread infections, including those that may not be apparent.
Cartridge Injection Devices (Pens)
Ensure that you are using the correct pen for your specific cartridge and dose strength, as using the wrong pen can result in an incorrect dose.
Storage and Disposal
For Saizen, store the medication at room temperature. After mixing, refrigerate the medication. If you have questions about the shelf life of the mixed medication, consult your doctor or pharmacist.
Missed Dose
If you miss a dose, take it as soon as you remember. However, if it is close to the time for your next scheduled dose, skip the missed dose and continue with your regular dosing schedule. Do not take two doses at the same time or take extra doses.
Lifestyle & Tips
- Administer injection subcutaneously as directed by your healthcare provider, usually once daily in the evening.
- Rotate injection sites to prevent skin problems (e.g., lipoatrophy). Common sites include thigh, abdomen, buttocks, and upper arm.
- Store medication as directed (refrigerated, protect from light). Do not freeze.
- Do not shake the pen/vial.
- Follow up with your doctor regularly for blood tests (e.g., IGF-1, thyroid, glucose) and monitoring of growth/symptoms.
- Maintain a healthy diet and regular exercise as advised by your doctor.
- Report any new or worsening symptoms immediately, especially severe headache, vision changes, joint pain, or swelling.
Available Forms & Alternatives
Dosing & Administration
Adult Dosing
Standard Dose:
Highly individualized based on indication and IGF-1 levels. For adult GHD, initial dose typically 0.2 mg/day (0.6 IU/day) subcutaneously, titrated up to a maximum of 0.8 mg/day (2.4 IU/day). Lower initial doses (e.g., 0.15-0.3 mg/day) for older or obese patients.
Dose Range:
0.15 - 0.8 mg
Condition-Specific Dosing:
Adult Growth Hormone Deficiency (GHD):
Initial: 0.2 mg/day (0.6 IU/day) SC. Titrate every 1-2 months by 0.1-0.2 mg/day based on clinical response and IGF-1 levels. Max: 0.8 mg/day (2.4 IU/day). Older or obese patients may start lower (0.15-0.3 mg/day).
Prevention of Catabolism in Critical Illness:
Contraindicated.
Pediatric Dosing
Neonatal:
Not established for routine use in neonates. Used off-label in specific conditions like short bowel syndrome, but not for GHD.
Infant:
Dosing for GHD, Turner Syndrome, Prader-Willi, SGA, CKD, ISS, Noonan Syndrome is weight-based or BSA-based and highly individualized. E.g., for GHD: 0.024-0.034 mg/kg/day (0.07-0.1 IU/kg/day) SC.
Child:
Dosing varies by indication. For GHD: 0.024-0.034 mg/kg/day (0.07-0.1 IU/kg/day) SC. For Turner Syndrome: 0.05 mg/kg/day (0.15 IU/kg/day) SC. For Prader-Willi: 0.034 mg/kg/day (0.1 IU/kg/day) SC. For Idiopathic Short Stature: 0.04-0.05 mg/kg/day (0.12-0.15 IU/kg/day) SC.
Adolescent:
Dosing continues as per pediatric guidelines until epiphyseal closure or achievement of desired height. Transition to adult GHD dosing if GHD persists after epiphyseal closure.
Dose Adjustments
Renal Impairment:
Mild:
No specific dose adjustment recommended.
Moderate:
No specific dose adjustment recommended.
Severe:
No specific dose adjustment recommended, but caution advised. Patients with chronic kidney disease (CKD) are an approved indication for somatropin; dosing is typically 0.05 mg/kg/day (0.15 IU/kg/day) SC.
Dialysis:
No specific dose adjustment recommended. Somatropin is not significantly removed by dialysis. Monitor IGF-1 levels and clinical response.
Hepatic Impairment:
Mild:
No specific dose adjustment recommended.
Moderate:
No specific dose adjustment recommended, but caution advised due to hepatic metabolism.
Severe:
No specific dose adjustment recommended, but caution advised due to hepatic metabolism. Monitor IGF-1 levels and clinical response closely.
Pharmacology
Mechanism of Action
Somatropin is a recombinant human growth hormone (rhGH) that stimulates somatic growth and metabolism. It binds to specific growth hormone receptors on target cells, leading to signal transduction and activation of various intracellular pathways. Its primary effects are mediated indirectly through insulin-like growth factor-1 (IGF-1), which is produced primarily in the liver in response to GH stimulation. IGF-1 promotes protein synthesis, cell proliferation, and skeletal growth.
Pharmacokinetics
Absorption:
Bioavailability:
Approximately 80% (subcutaneous)
Tmax:
3-6 hours (subcutaneous)
FoodEffect:
Not applicable for subcutaneous injection.
Distribution:
Vd:
Approximately 0.07-0.1 L/kg
ProteinBinding:
Low (binds to GH binding protein, but not extensively to plasma proteins)
CnssPenetration:
Limited
Elimination:
HalfLife:
Approximately 2-3 hours (intravenous); 3-5 hours (subcutaneous)
Clearance:
Approximately 0.14 L/kg/hr
ExcretionRoute:
Renal (metabolites)
Unchanged:
<0.1%
Pharmacodynamics
OnsetOfAction:
Metabolic effects (e.g., lipolysis, protein synthesis) within hours; growth effects over weeks to months.
PeakEffect:
IGF-1 levels peak within 12-24 hours after a dose; growth effects are cumulative.
DurationOfAction:
Effects on IGF-1 levels can last up to 24 hours; growth effects are sustained with daily dosing.
Confidence:
High
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 immediately or seek emergency 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 abdominal 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. While many people may not experience any side effects or only mild 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
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, 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 immediately or seek emergency 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 abdominal 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. While many people may not experience any side effects or only mild 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
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, 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
- Changes in vision (blurred vision, double vision)
- Nausea or vomiting
- Limping or hip/knee pain (in children)
- Increased thirst or urination (signs of high blood sugar)
- Numbness, tingling, or pain in hands (carpal tunnel syndrome)
- Significant swelling in hands or feet
- New or worsening skin lesions (especially moles)
- Difficulty breathing or snoring (especially in Prader-Willi patients)
- Signs of allergic reaction (rash, hives, itching, swelling of face/lips/tongue, difficulty 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 you experienced, such as symptoms and signs.
Certain health conditions, including:
+ Breathing problems, like sleep apnea
+ Cancer or other tumors, such as a brain tumor
+ Diabetic eye disease
+ Illness 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 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, such as symptoms and signs.
Certain health conditions, including:
+ Breathing problems, like sleep apnea
+ Cancer or other tumors, such as a brain tumor
+ Diabetic eye disease
+ Illness 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 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.
High Blood Sugar Risk
You may be at risk of developing high blood sugar, including new or worsening diabetes, while taking this medication. Monitor your blood sugar levels as directed by your doctor and undergo regular blood tests and eye exams as recommended.
Lab Test Interference
This medication may affect certain laboratory tests. 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, the risk of new tumors may be higher in some patients.
Special Considerations
If you have Turner syndrome, talk to your doctor about the potential increased risk of ear infections, high blood pressure, and severe blood vessel problems, such as stroke and bleeding in the brain.
Raised Pressure in the Head
Rarely, this medication can cause raised pressure in the head, which may be more likely in patients 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 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, planning to become pregnant, or breastfeeding, as you will need to 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 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 curve in the spine), discuss the potential risks of this medication with your doctor, as it may worsen the condition in growing children.
Additionally, children using this medication can rarely 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 have benzyl alcohol, which can cause serious side effects in newborns or infants. If possible, avoid products with benzyl alcohol in these age groups, and 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.
High Blood Sugar Risk
You may be at risk of developing high blood sugar, including new or worsening diabetes, while taking this medication. Monitor your blood sugar levels as directed by your doctor and undergo regular blood tests and eye exams as recommended.
Lab Test Interference
This medication may affect certain laboratory tests. 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, the risk of new tumors may be higher in some patients.
Special Considerations
If you have Turner syndrome, talk to your doctor about the potential increased risk of ear infections, high blood pressure, and severe blood vessel problems, such as stroke and bleeding in the brain.
Raised Pressure in the Head
Rarely, this medication can cause raised pressure in the head, which may be more likely in patients 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 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, planning to become pregnant, or breastfeeding, as you will need to 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 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 curve in the spine), discuss the potential risks of this medication with your doctor, as it may worsen the condition in growing children.
Additionally, children using this medication can rarely 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 have benzyl alcohol, which can cause serious side effects in newborns or infants. If possible, avoid products with benzyl alcohol in these age groups, and 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, facial changes, insulin resistance).
What to Do:
Seek immediate medical attention. Call 911 or your local emergency number. For advice, call a poison control center at 1-800-222-1222. Management is supportive, addressing hypoglycemia if present, and discontinuing somatropin in chronic overdose.
Drug Interactions
Major Interactions
- Glucocorticoids (may inhibit growth-promoting effects of somatropin)
- Oral Estrogens (may require higher somatropin doses in adult GHD patients)
Moderate Interactions
- Insulin (somatropin may decrease insulin sensitivity, requiring insulin dose adjustment)
- Thyroid hormones (somatropin may unmask central hypothyroidism or affect thyroid hormone metabolism)
- CYP450 metabolized drugs (somatropin may increase clearance of drugs metabolized by CYP3A4, e.g., corticosteroids, sex steroids, cyclosporine, anticonvulsants)
Confidence Interactions
Monitoring
Baseline Monitoring
IGF-1 and IGFBP-3 levels
Rationale: To confirm GHD diagnosis (in adults) and establish baseline for monitoring treatment efficacy and safety.
Timing: Prior to initiation of therapy.
Thyroid function tests (TSH, free T4)
Rationale: To rule out hypothyroidism, which can mimic GHD symptoms or be unmasked by somatropin therapy.
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.
Bone age (pediatric patients)
Rationale: To assess skeletal maturity and predict adult height potential.
Timing: Prior to initiation of therapy.
Funduscopic examination
Rationale: To rule out pre-existing papilledema, especially in patients with risk factors for intracranial hypertension.
Timing: Prior to initiation of therapy.
Scoliosis screening (pediatric patients)
Rationale: To assess for pre-existing scoliosis, which can progress during rapid growth.
Timing: Prior to initiation of therapy.
Routine Monitoring
IGF-1 levels
Frequency: Every 4-8 weeks initially, then every 3-6 months once stable (adults); every 3-6 months (pediatrics)
Target: Adults: Age- and gender-adjusted normal range; Pediatrics: Upper half of age- and gender-adjusted normal range.
Action Threshold: Levels significantly above normal range may indicate overdose and require dose reduction.
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 require thyroid hormone replacement.
Fasting glucose and HbA1c
Frequency: Every 6-12 months, or if clinical signs of glucose intolerance develop.
Target: Normal range.
Action Threshold: Elevated levels may require 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: Poor growth response may indicate inadequate dosing or other underlying issues.
Funduscopic examination
Frequency: Periodically, or if symptoms of intracranial hypertension (e.g., headache, visual changes) occur.
Target: No papilledema.
Action Threshold: Presence of papilledema requires immediate evaluation and potential somatropin discontinuation.
Scoliosis progression (pediatric patients)
Frequency: Periodically during rapid growth.
Target: No significant progression.
Action Threshold: Significant progression may require orthopedic consultation.
Symptom Monitoring
- Headache (especially severe or persistent)
- Visual changes (blurred vision, double vision)
- Nausea/vomiting
- Joint pain
- Muscle pain
- Peripheral edema
- Carpal tunnel syndrome symptoms (numbness, tingling in hands)
- Fatigue
- Weight gain
- Changes in skin texture or hair growth
- 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 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 (Moderate risk). It is unknown if somatropin is excreted in human milk. Endogenous growth hormone is present in human milk. Caution should be exercised when somatropin is administered to a nursing mother. Consider the benefits of breastfeeding and the potential risks.
Infant Risk:
Potential for adverse effects on the infant is unknown. Monitor for any unusual symptoms.
Pediatric Use
Approved for various pediatric indications including GHD, Turner syndrome, Prader-Willi syndrome, Noonan syndrome, Idiopathic Short Stature (ISS), Small for Gestational Age (SGA) without catch-up growth, and short stature associated with chronic kidney disease. Dosing is highly individualized based on weight, BSA, and specific indication. Close monitoring of growth, IGF-1, thyroid function, glucose, and potential adverse effects (e.g., scoliosis, intracranial hypertension) is crucial.
Geriatric Use
Adult GHD patients over 65 years of age may be more sensitive to the effects of somatropin and may require lower initial doses and slower titration to avoid adverse effects. Increased risk of fluid retention and arthralgia. Monitor closely for adverse reactions.
Clinical Information
Clinical Pearls
- Somatropin dosing is highly individualized and requires careful titration based on clinical response, IGF-1 levels, and patient tolerance.
- 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 unmask central hypothyroidism; thyroid function should be monitored regularly.
- Monitor for signs of intracranial hypertension (e.g., severe headache, visual changes, nausea/vomiting) and perform funduscopic examination if suspected.
- Diabetic patients may require adjustments to their insulin or antidiabetic medication due to somatropin's effect on insulin sensitivity.
- Rotate injection sites to prevent lipoatrophy or lipohypertrophy.
- Norditropin Flexpro pens are pre-filled and designed for ease of use, but proper injection technique must be taught and reinforced.
Alternative Therapies
- Mecasermin (recombinant IGF-1) for severe primary IGF-1 deficiency.
- For short stature not due to GHD, other treatments may include specific therapies for underlying conditions (e.g., thyroid hormone for hypothyroidism, nutritional support for malnutrition).
- No direct pharmacological alternatives for true growth hormone deficiency.
Cost & Coverage
Average Cost:
Highly variable, typically several thousand dollars per month per 15mg/1.5ml pen
Insurance Coverage:
Specialty Tier (requires prior authorization, often subject to step therapy and high co-pays/coinsurance)
General Drug Facts
If your symptoms or health issues persist or worsen, it is essential to contact your doctor promptly. To ensure safe and effective treatment, 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 for more information. If you have any questions or concerns about your 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 details about the medication taken, the amount, and the time it happened.