Omnitrope 5.8mg Inj, 1 Vial

Manufacturer SANDOZ Active Ingredient Somatropin (rDNA origin)(soe ma TROE pin) Pronunciation Soe-ma-TROE-pin
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.
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Drug Class
Growth Hormone
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Pharmacologic Class
Recombinant Human Growth Hormone
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Pregnancy Category
C
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FDA Approved
Jun 2006
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DEA Schedule
Not Controlled

Overview

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What is this medicine?

Somatropin is a man-made version of human growth hormone. It helps children grow taller and helps adults and children with certain medical conditions, like growth hormone deficiency, to maintain healthy body composition and metabolism.
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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, leakage, or particles before use. If you notice any of these issues, do not use the medication.
Check the solution for any changes in color before use. If you notice any changes, do not use the medication.
Wash your hands before and after administering the injection.
Dispose of needles and syringes in a sharps disposal container. Do not reuse needles or other items. Follow local regulations for disposing of the container when it is full.
If you have any questions or concerns, consult your doctor or pharmacist.

Special Instructions for Prefilled Syringes or Pens

You may hear a clicking sound when preparing the dose. Do not rely on the clicks to determine the dose, as this could lead to an incorrect dose.
Remove all pen needle covers before injecting a dose. 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. 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 prescribed dose. 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 Instructions

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.
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Lifestyle & Tips

  • Administer injection subcutaneously as directed by your healthcare provider. Rotate injection sites to prevent skin problems.
  • Store medication as directed (refrigerate, protect from light).
  • Do not shake the vial/cartridge vigorously.
  • Follow up with your doctor regularly for blood tests and monitoring of growth/symptoms.
  • Maintain a balanced diet and regular exercise as advised by your doctor.

Dosing & Administration

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Adult Dosing

Standard Dose: Highly individualized based on indication and patient response. For adult GHD, initial dose typically 0.2 mg/day (0.006 mg/kg/day) subcutaneously, adjusted based on IGF-I levels and clinical response, usually up to 0.4-0.8 mg/day.
Dose Range: 0.2 - 0.8 mg

Condition-Specific Dosing:

Adult Growth Hormone Deficiency (GHD): Initial: 0.2 mg/day (0.006 mg/kg/day) SC. May increase every 1-2 months by 0.1-0.2 mg/day. Max: 0.8 mg/day. Lower initial doses for older or estrogen-treated patients.
AIDS Wasting or Cachexia: 6 mg SC once daily.
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Pediatric Dosing

Neonatal: Not established for routine use in neonates, specific indications may vary.
Infant: Dosing for specific conditions (e.g., GHD, Turner Syndrome) is weight-based and highly individualized. Consult specific guidelines.
Child: Growth Hormone Deficiency (GHD): 0.16-0.24 mg/kg/week SC, divided into 6-7 doses. Turner Syndrome: 0.375 mg/kg/week SC, divided into 6-7 doses. Chronic Kidney Disease (CKD): 0.35 mg/kg/week SC, divided into 6-7 doses. Prader-Willi Syndrome (PWS): 0.24 mg/kg/week SC, divided into 6-7 doses. Small for Gestational Age (SGA) without catch-up growth: 0.48 mg/kg/week SC, divided into 6-7 doses. Noonan Syndrome: 0.33 mg/kg/week SC, divided into 6-7 doses. SHOX Deficiency: 0.35 mg/kg/week SC, divided into 6-7 doses.
Adolescent: Dosing continues as per child guidelines until growth cessation or specific adult indications apply.
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Dose Adjustments

Renal Impairment:

Mild: No specific dose adjustment recommended.
Moderate: No specific dose adjustment recommended.
Severe: No specific dose adjustment recommended. Use with caution in patients with severe renal impairment.
Dialysis: Not available. Use with caution. Somatropin is used in CKD, but specific adjustments for dialysis are not well-defined.

Hepatic Impairment:

Mild: No specific dose adjustment recommended.
Moderate: No specific dose adjustment recommended.
Severe: No specific dose adjustment recommended. Use with caution due to potential for altered metabolism.

Pharmacology

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Mechanism of Action

Somatropin is a recombinant human growth hormone (rhGH) that stimulates skeletal and somatic growth in children and adults with growth hormone deficiency. It exerts its anabolic and anti-catabolic effects through specific receptors on target cells, primarily by stimulating the production of insulin-like growth factor-I (IGF-I) in the liver and other tissues. IGF-I mediates many of the growth-promoting effects of growth hormone, including protein synthesis, cell proliferation, and lipolysis.
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Pharmacokinetics

Absorption:

Bioavailability: Approximately 80% (subcutaneous)
Tmax: 3-6 hours (subcutaneous)
FoodEffect: Not applicable (parenteral administration)

Distribution:

Vd: Approximately 50 mL/kg
ProteinBinding: Low (binds to growth hormone binding protein, but not extensively to plasma proteins)
CnssPenetration: Limited

Elimination:

HalfLife: Approximately 2-3 hours (intravenous); 3-5 hours (subcutaneous)
Clearance: Approximately 15 L/hour (adults)
ExcretionRoute: Renal (metabolites)
Unchanged: Less than 0.1%
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Pharmacodynamics

OnsetOfAction: Weeks to months for observable growth effects; metabolic effects (e.g., IGF-I increase) within hours to days.
PeakEffect: Variable, depends on clinical endpoint (e.g., growth velocity, IGF-I levels).
DurationOfAction: Effects persist as long as therapy is continued; metabolic effects are transient after discontinuation.

Safety & Warnings

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Side Effects

Serious Side Effects: Seek Medical Help Right Away

Although rare, some people may experience severe and potentially life-threatening side effects while taking this medication. If you experience any of the following symptoms, contact your doctor or seek medical attention immediately:

Signs of an allergic reaction: rash, hives, itching, red, swollen, blistered, or peeling skin (with or without fever), wheezing, tightness in the chest or throat, trouble breathing, swallowing, or talking, unusual hoarseness, or swelling of the mouth, face, lips, tongue, or throat
Signs of high blood sugar: confusion, 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, intolerance to cold, memory problems, mood changes, or abnormal sensations such as burning, numbness, or tingling
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. Many people experience no side effects or only mild ones. If you experience any of the following side effects, 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 or flu-like symptoms
Hair loss
* Breast enlargement

This is not an exhaustive list of possible side effects. If you have questions or concerns about side effects, contact your doctor. You can also report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch.
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Seek Immediate Medical Attention If You Experience:

  • Severe or persistent headache, especially with nausea/vomiting or vision changes (could be benign intracranial hypertension).
  • Limping or new hip/knee pain (could be slipped capital femoral epiphysis in children).
  • Increased thirst or frequent urination (signs of high blood sugar).
  • Changes in moles or skin lesions (report to doctor immediately).
  • Swelling in hands or feet, joint pain, muscle pain (common side effects, report if bothersome).
  • Signs of an allergic reaction: rash, itching, swelling, severe dizziness, trouble breathing (seek emergency care).
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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, 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. It is crucial to discuss all your medications (prescription, over-the-counter, natural products, and vitamins) and health problems with your doctor and pharmacist to ensure safe use. Do not initiate, discontinue, or modify the dosage of any medication without consulting your doctor.
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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 Precautions

High blood sugar levels, including new or worsening diabetes, have been reported in patients taking this medication. Regularly check your blood sugar levels as advised by your doctor.
Follow your doctor's recommendations for regular blood tests and eye exams.
This medication may interfere with certain laboratory tests. Inform all your healthcare providers and laboratory personnel that you are taking this medication.

Special Considerations

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.
If you have Turner syndrome, consult your doctor about the potential increased risk of ear infections, high blood pressure, and severe blood vessel problems, such as stroke and brain bleeding.
Rarely, this medication has been associated with increased pressure in the head, particularly 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 Considerations

If you are 65 years 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 potential benefits and risks of this medication for you and your baby.

Children

In children with Prader-Willi syndrome, this medication has been associated with severe and potentially life-threatening lung and breathing problems. The risk may be higher in children with sleep apnea, respiratory infections, airway obstruction, or obesity. Seek medical attention immediately if your child develops 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 patterns during sleep.
If your child has scoliosis (an abnormal curvature of the spine), consult your doctor about the potential risk of worsening the condition.
Rarely, children using this medication may experience a bone problem in the hip (slipped growth plate). Seek medical attention immediately if your child complains of hip or knee pain or develops 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, particularly when combined with other medications containing benzyl alcohol. Consult your doctor to determine if this product contains benzyl alcohol.
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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 Center).

Drug Interactions

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Major Interactions

  • Glucocorticoids (may inhibit growth-promoting effects)
  • Oral Estrogen (may decrease IGF-I response, requiring higher somatropin doses)
  • Insulin and/or other antidiabetic agents (somatropin may decrease insulin sensitivity)
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Moderate Interactions

  • Thyroid hormones (monitor thyroid function)
  • Cytochrome P450-metabolized drugs (somatropin may increase clearance of drugs metabolized by CYP3A4, e.g., corticosteroids, sex steroids, cyclosporine)

Monitoring

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Baseline Monitoring

IGF-I and IGFBP-3 levels

Rationale: To establish baseline and guide initial dosing, especially in GHD.

Timing: Prior to initiation of therapy.

Thyroid function tests (TSH, Free T4)

Rationale: To rule out hypothyroidism, which can impair growth response; somatropin can unmask central hypothyroidism.

Timing: Prior to initiation of therapy.

Fasting glucose and HbA1c

Rationale: To assess baseline glucose metabolism, as somatropin can affect insulin sensitivity.

Timing: Prior to initiation of therapy.

Bone age (pediatric)

Rationale: To assess skeletal maturity and growth potential.

Timing: Prior to initiation of therapy and periodically.

Height and weight (pediatric)

Rationale: To establish baseline growth parameters.

Timing: Prior to initiation of therapy.

Fundoscopic exam (pediatric, especially PWS)

Rationale: To screen for papilledema, a sign of benign intracranial hypertension.

Timing: Prior to initiation of therapy.

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Routine Monitoring

IGF-I 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: Levels consistently above +2 SD or below -2 SD may require dose adjustment.

Thyroid function tests (TSH, Free T4)

Frequency: Every 6-12 months, or if clinical signs of thyroid dysfunction.

Target: Normal range.

Action Threshold: Abnormal levels require investigation and potential thyroid hormone replacement.

Fasting glucose and HbA1c

Frequency: Annually, or more frequently if risk factors for diabetes.

Target: Normal range.

Action Threshold: Elevated levels may require dose adjustment or antidiabetic therapy.

Height and weight (pediatric)

Frequency: Every 3-6 months.

Target: Improved growth velocity.

Action Threshold: Poor growth response may indicate need for dose adjustment or re-evaluation of diagnosis.

Scoliosis screening (pediatric, especially Turner, PWS)

Frequency: Annually.

Target: Not applicable.

Action Threshold: Progression of scoliosis may require orthopedic consultation.

Fundoscopic exam (if symptoms of intracranial hypertension)

Frequency: As clinically indicated.

Target: Not applicable.

Action Threshold: Papilledema requires immediate evaluation and potential temporary discontinuation.

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Symptom Monitoring

  • Headache (especially severe or persistent)
  • Visual changes
  • Nausea/vomiting (signs of benign intracranial hypertension)
  • Limping or hip/knee pain (slipped capital femoral epiphysis)
  • Increased thirst or urination (hyperglycemia)
  • Fatigue, cold intolerance, weight gain (hypothyroidism)
  • Joint pain, muscle pain, peripheral edema (common side effects, especially in adults)
  • Changes in skin lesions (monitor for malignancy)

Special Patient Groups

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Pregnancy

Category C. Use only if the potential benefit justifies the potential risk to the fetus. Limited human data; animal studies show adverse effects at high doses. 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.
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Lactation

L3 (Moderately Safe). Unknown if somatropin is excreted in human milk. Endogenous growth hormone is present in breast milk. Caution should be exercised when administering to a nursing mother.

Infant Risk: Potential for altered infant growth or metabolism, though unlikely given large molecular weight and likely poor oral absorption by infant. Monitor infant for adverse effects.
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Pediatric Use

Dosing is weight-based and highly individualized for various growth disorders. Close monitoring of growth velocity, IGF-I, thyroid function, and potential adverse effects (e.g., benign intracranial hypertension, slipped capital femoral epiphysis, scoliosis) is crucial. Contraindicated in children with closed epiphyses.

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Geriatric Use

Lower initial doses and slower titration are recommended for older adults due to increased sensitivity to adverse effects and potential for comorbidities. Monitor for fluid retention, arthralgia, and glucose intolerance.

Clinical Information

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Clinical Pearls

  • Somatropin therapy requires careful patient selection and ongoing monitoring of IGF-I levels to ensure efficacy and minimize adverse effects.
  • Patients with Prader-Willi syndrome should be carefully screened for upper airway obstruction and sleep apnea before and during somatropin therapy due to increased risk of sudden death.
  • Monitor for new onset or worsening of pre-existing scoliosis in pediatric patients, especially those with rapid growth.
  • Patients with diabetes mellitus may require adjustment of their antidiabetic medication due to somatropin's effect on insulin sensitivity.
  • Always rotate injection sites to prevent lipoatrophy or lipohypertrophy.
  • Patients with a history of malignancy should be carefully evaluated before starting somatropin, and monitored for recurrence.
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Alternative Therapies

  • Mecasermin (recombinant human IGF-1) for severe primary IGF-1 deficiency.
  • For short stature not due to GHD, other treatments depend on underlying cause (e.g., specific genetic therapies, nutritional support).
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Cost & Coverage

Average Cost: Varies widely, typically several thousand dollars per vial/cartridge
Generic Available: Yes
Insurance Coverage: Tier 4 (Specialty Drug) - requires prior authorization and often step therapy
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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 is a good idea to consult with your pharmacist. If you have any questions or concerns about this medication, do not 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 reporting the incident, be prepared to provide detailed information, including the name of the medication taken, the amount, and the time it occurred.