Norditropin Flexpro 5mg/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; Pituitary hormone
Pregnancy Category
C
FDA Approved
Mar 1995
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 when their bodies don't make enough natural growth hormone, or for other specific growth problems. In adults, it's used when their bodies don't make enough growth hormone, which can cause problems with energy, body fat, and bone strength. It's given as an injection under the skin.
How to Use This Medicine
Proper Use of This Medication
To use this medication correctly, follow your doctor's instructions and read all the information provided. Your doctor or nurse will teach you how to administer the injection if you will be giving it to yourself.
Administration Instructions
This medication is given as a subcutaneous injection, which means it is injected into the fatty part of the skin.
If the medication has been stored in the refrigerator, allow it to come to room temperature before using it. Be sure to follow the recommended time for letting it sit at room temperature.
Do not heat the medication.
Rotate the injection site with each dose to avoid irritation.
Avoid injecting into skin that is irritated, bruised, red, infected, hard, or scarred.
Do not inject near the belly button or waistline.
Do not shake the solution.
Check the solution for cloudiness, leaks, 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.
Handling and Disposal
Wash your hands before and after using the medication.
Dispose of needles and other sharp objects in a designated disposal box. Do not reuse needles or other items.
When the disposal box is full, follow local regulations for proper disposal.
If you have any questions, consult your doctor or pharmacist.
Using Prefilled Syringes or Pens
This product may make 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. 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 spread infections.
Cartridge Injection Devices (Pens)
Not all injection devices are compatible with all strengths of this medication. Ensure you have the correct pen for your dose, as using the wrong pen may result in an incorrect dose.
Storage and Disposal
Store Saizen at room temperature.
After mixing, store the medication in the refrigerator. Consult your doctor or pharmacist if you have questions about the storage duration after mixing.
Missed Dose
If you miss a dose, take it as soon as you remember.
If it is close to the time for your next dose, skip the missed dose and resume your regular schedule.
Do not take two doses at the same time or extra doses.
To use this medication correctly, follow your doctor's instructions and read all the information provided. Your doctor or nurse will teach you how to administer the injection if you will be giving it to yourself.
Administration Instructions
This medication is given as a subcutaneous injection, which means it is injected into the fatty part of the skin.
If the medication has been stored in the refrigerator, allow it to come to room temperature before using it. Be sure to follow the recommended time for letting it sit at room temperature.
Do not heat the medication.
Rotate the injection site with each dose to avoid irritation.
Avoid injecting into skin that is irritated, bruised, red, infected, hard, or scarred.
Do not inject near the belly button or waistline.
Do not shake the solution.
Check the solution for cloudiness, leaks, 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.
Handling and Disposal
Wash your hands before and after using the medication.
Dispose of needles and other sharp objects in a designated disposal box. Do not reuse needles or other items.
When the disposal box is full, follow local regulations for proper disposal.
If you have any questions, consult your doctor or pharmacist.
Using Prefilled Syringes or Pens
This product may make 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. 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 spread infections.
Cartridge Injection Devices (Pens)
Not all injection devices are compatible with all strengths of this medication. Ensure you have the correct pen for your dose, as using the wrong pen may result in an incorrect dose.
Storage and Disposal
Store Saizen at room temperature.
After mixing, store the medication in the refrigerator. Consult your doctor or pharmacist if you have questions about the storage duration after mixing.
Missed Dose
If you miss a dose, take it as soon as you remember.
If it is close to the time for your next dose, skip the missed dose and resume your regular schedule.
Do not take two doses at the same time or extra doses.
Lifestyle & Tips
- Maintain a healthy diet and regular exercise as advised by your doctor.
- Follow up with your doctor regularly for blood tests and check-ups.
- Learn proper injection technique from your healthcare provider.
- Rotate injection sites to prevent skin problems.
- Store the medication as directed (usually refrigerated).
Available Forms & Alternatives
Dosing & Administration
Adult Dosing
Standard Dose:
Highly individualized based on patient's weight, age, and clinical response (IGF-1 levels). Typically initiated at a low dose and titrated.
Dose Range:
0.15 - 0.3 mg
Condition-Specific Dosing:
Adult Growth Hormone Deficiency (GHD):
Initial dose: 0.2 mg/day (0.006 mg/kg/day) subcutaneously. May be increased gradually every 1-2 months based on clinical response and IGF-1 levels. Max dose: 0.8 mg/day (0.024 mg/kg/day). For patients >60 years, initial dose 0.1 mg/day.
Pediatric Dosing
Neonatal:
Not established for routine use in neonates. Use in very young infants is rare and highly specialized.
Infant:
Not established for routine use in infants. Use in very young infants is rare and highly specialized.
Child:
Growth Hormone Deficiency (GHD): 0.024-0.034 mg/kg/day subcutaneously. Noonan Syndrome: 0.066 mg/kg/day. Turner Syndrome: 0.05 mg/kg/day. Small for Gestational Age (SGA): 0.033-0.067 mg/kg/day. Idiopathic Short Stature (ISS): 0.034 mg/kg/day. Chronic Kidney Disease (CKD): 0.05 mg/kg/day.
Adolescent:
Dosing continues as per child guidelines until epiphyseal fusion. For GHD, may transition to adult dosing after epiphyseal closure.
Dose Adjustments
Renal Impairment:
Mild:
No specific dose adjustment recommended, but monitor IGF-1 levels and clinical response.
Moderate:
No specific dose adjustment recommended, but monitor IGF-1 levels and clinical response.
Severe:
No specific dose adjustment recommended, but monitor IGF-1 levels and clinical response. Somatropin is extensively metabolized in the kidneys, but renal impairment does not significantly alter its pharmacokinetics.
Dialysis:
Not available. Use with caution and close monitoring.
Hepatic Impairment:
Mild:
No specific dose adjustment recommended, but monitor IGF-1 levels and clinical response.
Moderate:
No specific dose adjustment recommended, but monitor IGF-1 levels and clinical response.
Severe:
No specific dose adjustment recommended, but monitor IGF-1 levels and clinical response. Somatropin is extensively metabolized in the liver, but hepatic impairment does not significantly alter its pharmacokinetics.
Pharmacology
Mechanism of Action
Somatropin is a recombinant human growth hormone (rhGH) that binds to specific growth hormone receptors on target cells, including hepatocytes, adipocytes, and muscle cells. This binding initiates intracellular signal transduction pathways, primarily the JAK-STAT pathway, leading to the production of insulin-like growth factor-1 (IGF-1) and IGF-binding proteins. IGF-1 mediates most of the growth-promoting effects of growth hormone, including linear growth (epiphyseal plate stimulation), protein synthesis, and effects on carbohydrate and lipid metabolism.
Pharmacokinetics
Absorption:
Bioavailability:
Approximately 70-80% (subcutaneous)
Tmax:
3-6 hours (subcutaneous)
FoodEffect:
Not applicable (parenteral administration)
Distribution:
Vd:
Approximately 0.07-0.1 L/kg (similar to plasma volume)
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 0.15-0.27 L/hr/kg
ExcretionRoute:
Renal (as metabolites)
Unchanged:
<0.1%
Pharmacodynamics
OnsetOfAction:
Biochemical effects (e.g., IGF-1 increase) within hours; clinical growth effects over weeks to months.
PeakEffect:
Peak IGF-1 levels typically observed within 24 hours of administration; clinical growth effects are cumulative.
DurationOfAction:
Effects on IGF-1 levels persist for approximately 24 hours; clinical effects are sustained with daily administration.
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 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 stomach pain, severe back pain, or severe nausea and vomiting.
Signs of adrenal gland problems: severe nausea and vomiting, severe dizziness or fainting, muscle weakness, extreme fatigue, mood changes, decreased appetite, or weight loss.
Signs of low thyroid levels: constipation, sensitivity to cold, memory problems, mood changes, or abnormal burning, numbness, or tingling sensations.
Signs of a urinary tract infection (UTI): blood in the urine, painful or burning urination, frequent or urgent need to urinate, fever, lower abdominal pain, or pelvic pain.
Signs of high blood pressure: severe headache or dizziness, fainting, or changes in vision.
Weakness on one side of the body, 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. 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 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
Enlarged breasts
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 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 stomach pain, severe back pain, or severe nausea and vomiting.
Signs of adrenal gland problems: severe nausea and vomiting, severe dizziness or fainting, muscle weakness, extreme fatigue, mood changes, decreased appetite, or weight loss.
Signs of low thyroid levels: constipation, sensitivity to cold, memory problems, mood changes, or abnormal burning, numbness, or tingling sensations.
Signs of a urinary tract infection (UTI): blood in the urine, painful or burning urination, frequent or urgent need to urinate, fever, lower abdominal pain, or pelvic pain.
Signs of high blood pressure: severe headache or dizziness, fainting, or changes in vision.
Weakness on one side of the body, 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. 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 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
Enlarged breasts
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 nausea/vomiting or vision changes (could be signs of increased pressure in the brain)
- New or worsening limping, hip or knee pain (in children, could be a slipped growth plate)
- Sudden or severe swelling in hands, feet, or ankles
- Numbness or tingling in the hands (carpal tunnel syndrome)
- Changes in moles or skin lesions (report to doctor)
- Symptoms of high blood sugar (increased thirst, frequent urination, fatigue)
- Symptoms of low thyroid function (fatigue, weight gain, feeling cold)
Before Using This Medicine
Before Taking This Medication: Important Information to Share with Your Doctor
It is essential to inform your doctor about the following conditions to ensure safe treatment:
Any allergies you have 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, 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 treatments. Never start, stop, or adjust the dose of any medication without consulting your doctor first.
It is essential to inform your doctor about the following conditions to ensure safe treatment:
Any allergies you have 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, 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 treatments. Never start, stop, or adjust the dose of any medication without consulting your doctor first.
Precautions & Cautions
Important Warnings and Cautions for Patients Taking This Medication
If you are taking this medication, it is essential to inform all your healthcare providers, including doctors, nurses, pharmacists, and dentists, about your treatment.
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 laboratory tests. Inform all your healthcare providers and laboratory personnel that you are taking this medication.
Cancer and Tumor Risk
If you have a history of cancer or tumors, discuss the potential risks 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.
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
Although rare, this medication can cause increased pressure in the head, particularly in patients with Turner syndrome or Prader-Willi syndrome. Signs of this condition often occur within the first 8 weeks of treatment and may include changes in vision, severe headaches, nausea, or vomiting. Seek medical attention immediately if you experience any of these symptoms.
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 medical attention immediately 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 curve in the spine), discuss the potential risks 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 using products with benzyl alcohol in newborns or infants, as serious side effects can occur with certain doses of benzyl alcohol, especially when combined with other medications containing benzyl alcohol. Consult your doctor to determine if this product contains benzyl alcohol.
If you are taking this medication, it is essential to inform all your healthcare providers, including doctors, nurses, pharmacists, and dentists, about your treatment.
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 laboratory tests. Inform all your healthcare providers and laboratory personnel that you are taking this medication.
Cancer and Tumor Risk
If you have a history of cancer or tumors, discuss the potential risks 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.
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
Although rare, this medication can cause increased pressure in the head, particularly in patients with Turner syndrome or Prader-Willi syndrome. Signs of this condition often occur within the first 8 weeks of treatment and may include changes in vision, severe headaches, nausea, or vomiting. Seek medical attention immediately if you experience any of these symptoms.
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 medical attention immediately 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 curve in the spine), discuss the potential risks 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 using products with benzyl alcohol in newborns or infants, as serious side effects can occur with certain doses of benzyl alcohol, especially when combined with other medications containing benzyl alcohol. Consult your doctor to determine if this product contains benzyl alcohol.
Overdose Information
Overdose Symptoms:
- Acute overdose: Hypoglycemia (low blood sugar) initially, followed by hyperglycemia (high blood sugar).
- Chronic overdose: Signs and symptoms of acromegaly (e.g., enlarged hands/feet, joint pain, carpal tunnel syndrome, diabetes, hypertension).
What to Do:
Seek immediate medical attention. For acute overdose, manage hypoglycemia if present. For chronic overdose, discontinue somatropin and manage symptoms. Call 1-800-222-1222 (Poison Control) for advice.
Drug Interactions
Major Interactions
- Glucocorticoids (may inhibit growth-promoting effects of somatropin)
- Insulin (somatropin may decrease insulin sensitivity, requiring insulin dose adjustment)
- Oral Estrogens (may increase somatropin dose requirement in women)
Moderate Interactions
- Thyroid hormones (may need dose adjustment of thyroid hormone replacement)
- Cytochrome P450-metabolized drugs (somatropin may increase clearance of drugs metabolized by CYP3A4, e.g., corticosteroids, sex steroids, cyclosporine, anticonvulsants)
Monitoring
Baseline Monitoring
Growth Hormone Deficiency (GHD) diagnosis
Rationale: Confirm diagnosis before initiating therapy.
Timing: Prior to initiation
IGF-1 and IGFBP-3 levels
Rationale: Confirm GHD and establish baseline for monitoring treatment response.
Timing: Prior to initiation
Thyroid function tests (TSH, Free T4)
Rationale: Rule out hypothyroidism, which can mimic GHD symptoms and affect response to somatropin.
Timing: Prior to initiation
Fasting glucose and HbA1c
Rationale: Assess baseline glucose metabolism, as somatropin can affect insulin sensitivity.
Timing: Prior to initiation
Bone age (pediatric patients)
Rationale: Assess skeletal maturity and potential for further growth.
Timing: Prior to initiation
Funduscopic examination
Rationale: Rule out pre-existing papilledema, a potential adverse effect.
Timing: Prior to initiation
Scoliosis screening (pediatric patients)
Rationale: Assess for pre-existing scoliosis, which may progress with rapid growth.
Timing: Prior to initiation
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 consistently above +2 SD, consider dose reduction; if consistently below -2 SD, consider dose increase.
Thyroid function tests (TSH, Free T4)
Frequency: Every 6-12 months, or if symptoms of hypothyroidism develop
Target: Normal range
Action Threshold: Treat hypothyroidism if detected, as it can impair response to somatropin.
Fasting glucose and HbA1c
Frequency: Annually, or more frequently if risk factors for diabetes are present
Target: Normal range
Action Threshold: If elevated, consider dose adjustment or initiation of antidiabetic therapy.
Growth velocity (pediatric patients)
Frequency: Every 3-6 months
Target: Increased growth velocity appropriate for age and condition
Action Threshold: Lack of adequate growth may indicate need for dose adjustment or re-evaluation of diagnosis.
Bone age (pediatric patients)
Frequency: Annually
Target: Not applicable (monitor progression)
Action Threshold: Rapid advancement of bone age may indicate need for dose adjustment.
Funduscopic examination
Frequency: Annually, or if symptoms of pseudotumor cerebri (e.g., severe headache, visual changes) develop
Target: No papilledema
Action Threshold: If papilledema is present, discontinue somatropin and refer to neurology/ophthalmology.
Scoliosis screening (pediatric patients)
Frequency: Annually
Target: Not applicable (monitor progression)
Action Threshold: If scoliosis progresses, refer to orthopedics.
Symptom Monitoring
- Headache (especially severe or persistent)
- Visual changes (blurred vision, double vision)
- Nausea/vomiting
- Joint pain
- Muscle pain
- Peripheral edema (swelling of hands/feet)
- Carpal tunnel syndrome symptoms (numbness, tingling in hands)
- Changes in skin lesions (e.g., moles)
- Limping or hip/knee pain (in children, suggestive of slipped capital femoral epiphysis)
- Injection site reactions (pain, redness, swelling)
- Symptoms of hypothyroidism (fatigue, weight gain, cold intolerance)
- Symptoms of hyperglycemia (increased thirst, urination, fatigue)
Special Patient Groups
Pregnancy
Category C. Use only if the potential benefit justifies the potential risk to the fetus. Human data are limited.
Trimester-Specific Risks:
First Trimester:
Limited data; animal studies show no direct evidence of teratogenicity but some effects on fetal growth at high doses.
Second Trimester:
Limited data.
Third Trimester:
Limited data.
Lactation
L3 (Moderate risk). It is unknown whether somatropin is excreted in human milk. Caution should be exercised when somatropin is administered to a nursing mother.
Infant Risk:
Potential for adverse effects on the breastfed infant is unknown. Consider the developmental and health benefits of breastfeeding along with the mother’s clinical need for somatropin and any potential adverse effects on the breastfed infant from somatropin or from the underlying maternal condition.
Pediatric Use
Primary indication for various growth disorders. Dosing is weight-based and adjusted according to IGF-1 levels and growth response. Close monitoring for adverse effects like pseudotumor cerebri, slipped capital femoral epiphysis, and scoliosis progression is crucial.
Geriatric Use
Adults >60 years may be more sensitive to the effects of somatropin and may experience more adverse events. Lower initial doses and slower titration are recommended. Monitor for fluid retention, arthralgia, and glucose intolerance.
Clinical Information
Clinical Pearls
- Dosing is highly individualized; titration based on IGF-1 levels and clinical response is critical.
- Patients should be educated on proper subcutaneous injection technique and rotation of injection sites.
- Monitor for signs of pseudotumor cerebri (severe headache, visual changes) and discontinue therapy if suspected.
- In children, monitor for slipped capital femoral epiphysis (new limping, hip/knee pain) and progression of scoliosis.
- Thyroid function should be monitored, as somatropin can unmask central hypothyroidism.
- Somatropin can decrease insulin sensitivity; monitor glucose levels, especially in patients with diabetes or risk factors.
- Contraindicated in patients with active malignancy; careful screening for malignancy is required before initiation and during therapy.
Alternative Therapies
- Other brands of Somatropin (e.g., Genotropin, Humatrope, Saizen, Omnitrope, Zomacton, Skytrofa, Sogroya)
- Mecasermin (recombinant human IGF-1) for severe primary IGF-1 deficiency (not GHD)
Cost & Coverage
Average Cost:
Highly variable, typically several thousand USD per month supply
Generic Available:
Yes
Insurance Coverage:
Tier 4 (Specialty Drug) or higher, often requiring 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 information. If you have any questions or concerns about this medication, don't hesitate to reach out to your doctor, nurse, pharmacist, or other healthcare provider. In the event of a suspected overdose, immediately call your local poison control center or seek emergency medical attention. When seeking help, be prepared to provide details about the overdose, including the medication taken, the amount, and the time it occurred.