Serostim 5mg For Injection
It is used to help patients with HIV gain weight.It may be given to you for other reasons. Talk with the doctor.
Drug Class
Growth hormone
Pharmacologic Class
Recombinant human growth hormone; Somatropin
Pregnancy Category
Category C
FDA Approved
Apr 1996
DEA Schedule
Not Controlled
Overview
What is this medicine?
Serostim is a man-made version of a natural hormone in your body called growth hormone. It helps your body build muscle and gain weight, which can be helpful for people with HIV who are losing weight or muscle. It is given as an injection under the skin.
How to Use This Medicine
Proper Use of This Medication
To use this medication correctly, follow your doctor's instructions and read all the information provided. This medication is administered via injection into the fatty tissue under the skin. If you will be self-administering the injection, your doctor or nurse will instruct you on the proper technique.
Before using the medication, allow it to come to room temperature if it has been stored in the refrigerator. Be aware of the recommended time frame for leaving it at room temperature before use. Do not heat the medication.
To minimize the risk of injection site reactions, rotate the injection site with each use. Avoid injecting into skin that is irritated, bruised, red, infected, hard, or scarred. Do 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 any of these conditions are present, do not use the medication.
Also, check the solution for any changes in color. If a change is observed, do not use the medication.
Wash your hands before and after handling the medication.
* Dispose of used needles in a designated needle/sharp disposal box. Do not reuse needles or other items. When the box is full, follow local regulations for disposal.
Storage and Disposal
Store this medication at room temperature. Keep all medications in a safe location, out of the reach of children and pets.
Missed Dose Instructions
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 resume your regular dosing schedule. Do not take two doses at the same time or take extra doses.
If you have any questions or concerns about using this medication, consult your doctor or pharmacist.
To use this medication correctly, follow your doctor's instructions and read all the information provided. This medication is administered via injection into the fatty tissue under the skin. If you will be self-administering the injection, your doctor or nurse will instruct you on the proper technique.
Before using the medication, allow it to come to room temperature if it has been stored in the refrigerator. Be aware of the recommended time frame for leaving it at room temperature before use. Do not heat the medication.
To minimize the risk of injection site reactions, rotate the injection site with each use. Avoid injecting into skin that is irritated, bruised, red, infected, hard, or scarred. Do 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 any of these conditions are present, do not use the medication.
Also, check the solution for any changes in color. If a change is observed, do not use the medication.
Wash your hands before and after handling the medication.
* Dispose of used needles in a designated needle/sharp disposal box. Do not reuse needles or other items. When the box is full, follow local regulations for disposal.
Storage and Disposal
Store this medication at room temperature. Keep all medications in a safe location, out of the reach of children and pets.
Missed Dose Instructions
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 resume your regular dosing schedule. Do not take two doses at the same time or take extra doses.
If you have any questions or concerns about using this medication, consult your doctor or pharmacist.
Lifestyle & Tips
- Maintain a balanced diet rich in protein and calories as recommended by your healthcare provider or dietitian.
- Engage in regular, moderate exercise as tolerated and advised by your doctor to maximize lean body mass gain.
- Follow all instructions for preparing and injecting the medication carefully.
- Store the medication as directed (refrigerated after reconstitution).
Available Forms & Alternatives
Available Strengths:
Dosing & Administration
Adult Dosing
Standard Dose:
0.1 mg/kg daily subcutaneously, up to a maximum of 6 mg daily
Dose Range:
0.1 - 6 mg
Condition-Specific Dosing:
HIV-associated wasting or cachexia:
0.1 mg/kg daily subcutaneously, up to a maximum of 6 mg daily. Treatment should be discontinued if no response is seen after 12 weeks.
Pediatric Dosing
Neonatal:
Not established (Serostim is indicated for adults with HIV-associated wasting)
Infant:
Not established (Serostim is indicated for adults with HIV-associated wasting)
Child:
Not established (Serostim is indicated for adults with HIV-associated wasting)
Adolescent:
Not established (Serostim is indicated for adults with HIV-associated wasting)
Dose Adjustments
Renal Impairment:
Mild:
No specific dose adjustment recommended, but monitor for adverse effects.
Moderate:
No specific dose adjustment recommended, but monitor for adverse effects.
Severe:
No specific dose adjustment recommended, but monitor for adverse effects.
Dialysis:
No specific dose adjustment recommended; somatropin is not significantly cleared by dialysis. Monitor for adverse effects.
Hepatic Impairment:
Mild:
No specific dose adjustment recommended, but monitor for adverse effects.
Moderate:
No specific dose adjustment recommended, but monitor for adverse effects.
Severe:
No specific dose adjustment recommended, but monitor for adverse effects.
Pharmacology
Mechanism of Action
Somatropin is a recombinant human growth hormone (rhGH) that binds to specific growth hormone receptors on target cells, stimulating linear growth, protein, carbohydrate, and lipid metabolism. It exerts its anabolic effects primarily through insulin-like growth factor-1 (IGF-1), which is produced in the liver and other tissues. In HIV-associated wasting, it promotes lean body mass gain and weight gain.
Pharmacokinetics
Absorption:
Bioavailability:
Approximately 80% (subcutaneous)
Tmax:
3-6 hours (subcutaneous)
FoodEffect:
Not applicable (parenteral administration)
Distribution:
Vd:
Approximately 50 mL/kg
ProteinBinding:
Low (primarily to growth hormone binding protein)
CnssPenetration:
Limited
Elimination:
HalfLife:
Approximately 2-3 hours (subcutaneous)
Clearance:
Approximately 15 L/hour (adults)
ExcretionRoute:
Renal (small amount of intact hormone), primarily degraded and excreted as metabolites.
Unchanged:
<0.1% (renal)
Pharmacodynamics
OnsetOfAction:
Effects on body composition (e.g., lean body mass) are typically observed within weeks.
PeakEffect:
Peak IGF-1 levels occur within 12-24 hours after administration. Clinical effects on body composition are gradual.
DurationOfAction:
Pharmacodynamic effects (e.g., elevated IGF-1) can persist for 24-48 hours after a single dose, despite short half-life.
Confidence:
Medium
Safety & Warnings
BLACK BOX WARNING
Increased mortality in patients with acute critical illness due to complications following open heart surgery, accidental trauma, or acute respiratory failure. The safety of continuing Serostim treatment in patients with these conditions has not been established. Serostim is contraindicated in patients with acute critical illness.
Side Effects
Urgent Side Effects: Seek Medical Help Right Away
Although rare, some people may experience severe and potentially life-threatening side effects while taking this medication. If you notice any of the following symptoms, contact your doctor or seek medical attention immediately:
Signs of an allergic reaction: rash, hives, itching, red, swollen, blistered, or peeling skin (with or without fever), wheezing, tightness in the chest or throat, trouble breathing, swallowing, or talking, unusual hoarseness, or swelling of the mouth, face, lips, tongue, or throat
Signs of high blood sugar: confusion, drowsiness, unusual thirst or hunger, frequent urination, flushing, rapid breathing, or fruity-smelling breath
Signs of pancreatitis (pancreas problem): severe stomach pain, severe back pain, or severe nausea and vomiting
Signs of adrenal 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 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, trouble 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 minor ones, it's essential to discuss any concerns with your doctor. If you experience any of the following side effects or any other unusual symptoms, contact your doctor for advice:
Headache
Fatigue or weakness
Back, muscle, or joint pain
Muscle stiffness
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 list is not exhaustive. If you have questions or concerns about side effects, consult your doctor. You can also report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch.
Although rare, some people may experience severe and potentially life-threatening side effects while taking this medication. If you notice any of the following symptoms, contact your doctor or seek medical attention immediately:
Signs of an allergic reaction: rash, hives, itching, red, swollen, blistered, or peeling skin (with or without fever), wheezing, tightness in the chest or throat, trouble breathing, swallowing, or talking, unusual hoarseness, or swelling of the mouth, face, lips, tongue, or throat
Signs of high blood sugar: confusion, drowsiness, unusual thirst or hunger, frequent urination, flushing, rapid breathing, or fruity-smelling breath
Signs of pancreatitis (pancreas problem): severe stomach pain, severe back pain, or severe nausea and vomiting
Signs of adrenal 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 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, trouble 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 minor ones, it's essential to discuss any concerns with your doctor. If you experience any of the following side effects or any other unusual symptoms, contact your doctor for advice:
Headache
Fatigue or weakness
Back, muscle, or joint pain
Muscle stiffness
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 list is not exhaustive. 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:
- New or worsening swelling in hands or feet (edema)
- Joint pain or stiffness (arthralgia)
- Muscle pain (myalgia)
- Numbness, tingling, or pain in the hands (carpal tunnel syndrome)
- Increased thirst or urination, unusual fatigue (signs of high blood sugar)
- Severe or persistent headache, vision changes, nausea, or vomiting (signs of increased pressure in the brain)
- Any signs of an allergic reaction (rash, itching, swelling, severe dizziness, trouble breathing)
- Unexplained weight loss or fever (could indicate underlying malignancy)
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, including allergies to this medication, its components, or other substances, such as foods or drugs. Be sure to describe the allergic reaction and its symptoms.
Certain health conditions, including:
+ Breathing problems, such as sleep apnea
+ Cancer or other tumors, including brain tumors
+ Diabetic eye disease
+ Recent illness after open heart surgery, stomach surgery, or accidental injury
This list is not exhaustive, and it is crucial to discuss all your health problems and medications with your doctor.
To ensure safe treatment, tell your doctor and pharmacist about:
All prescription and over-the-counter (OTC) medications you are taking
Any natural products or vitamins you are using
* All your health problems
Before starting, stopping, or changing the dose of any medication, including this one, consult with your doctor to confirm it is safe for you to do so.
It is essential to inform your doctor about the following:
Any allergies you have, including allergies to this medication, its components, or other substances, such as foods or drugs. Be sure to describe the allergic reaction and its symptoms.
Certain health conditions, including:
+ Breathing problems, such as sleep apnea
+ Cancer or other tumors, including brain tumors
+ Diabetic eye disease
+ Recent illness after open heart surgery, stomach surgery, or accidental injury
This list is not exhaustive, and it is crucial to discuss all your health problems and medications with your doctor.
To ensure safe treatment, tell your doctor and pharmacist about:
All prescription and over-the-counter (OTC) medications you are taking
Any natural products or vitamins you are using
* All your health problems
Before starting, stopping, or changing the dose of any medication, including this one, consult with your doctor to confirm it is safe for you to do so.
Precautions & Cautions
Important Warnings and Cautions for Patients Taking This Medication
It is essential to inform all your healthcare providers, including doctors, nurses, pharmacists, and dentists, that you are taking this medication.
Monitoring and Testing
High blood sugar, including new or worsening diabetes, has been reported with this medication. Regularly check your blood sugar levels as instructed by your doctor.
Follow your doctor's recommendations for blood work and eye exams to monitor your condition.
This medication may interfere with certain laboratory tests. Be sure to 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 with 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.
Rare but Serious Side Effects
Raised pressure in the head (intracranial hypertension) has rarely occurred with this medication, with a higher risk in patients with Turner syndrome or Prader-Willi syndrome. Symptoms often appear within the first 8 weeks of treatment and may include changes in vision, severe headache, nausea, or vomiting. Seek immediate medical attention if you experience any of these symptoms.
Age-Related Considerations
If you are 65 or older, use this medication with caution, as you may be more susceptible to side effects.
Pregnancy and Breastfeeding
If you are pregnant, plan to become pregnant, or are breastfeeding, consult with your doctor to discuss the potential benefits and risks to you and your baby.
Pediatric Considerations
* This medication contains benzyl alcohol, which can cause serious side effects in newborns and infants, especially when combined with other medications containing benzyl alcohol. If possible, avoid using products with benzyl alcohol in this population. If you have questions or concerns, consult with your doctor.
It is essential to inform all your healthcare providers, including doctors, nurses, pharmacists, and dentists, that you are taking this medication.
Monitoring and Testing
High blood sugar, including new or worsening diabetes, has been reported with this medication. Regularly check your blood sugar levels as instructed by your doctor.
Follow your doctor's recommendations for blood work and eye exams to monitor your condition.
This medication may interfere with certain laboratory tests. Be sure to 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 with 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.
Rare but Serious Side Effects
Raised pressure in the head (intracranial hypertension) has rarely occurred with this medication, with a higher risk in patients with Turner syndrome or Prader-Willi syndrome. Symptoms often appear within the first 8 weeks of treatment and may include changes in vision, severe headache, nausea, or vomiting. Seek immediate medical attention if you experience any of these symptoms.
Age-Related Considerations
If you are 65 or older, use this medication with caution, as you may be more susceptible to side effects.
Pregnancy and Breastfeeding
If you are pregnant, plan to become pregnant, or are breastfeeding, consult with your doctor to discuss the potential benefits and risks to you and your baby.
Pediatric Considerations
* This medication contains benzyl alcohol, which can cause serious side effects in newborns and infants, especially when combined with other medications containing benzyl alcohol. If possible, avoid using products with benzyl alcohol in this population. If you have questions or concerns, consult with your doctor.
Overdose Information
Overdose Symptoms:
- Acute overdose: Hypoglycemia (low blood sugar) initially, followed by hyperglycemia (high blood sugar).
- Chronic overdose: Signs and symptoms of gigantism/acromegaly (e.g., overgrowth of hands/feet, joint pain, carpal tunnel syndrome, glucose intolerance).
What to Do:
Seek immediate medical attention. For acute overdose, manage hypoglycemia if present. For chronic overdose, discontinue Serostim and manage symptoms. Call 1-800-222-1222 (Poison Control).
Drug Interactions
Major Interactions
- Glucocorticoids (e.g., Prednisone, Dexamethasone): May inhibit the growth-promoting effects of somatropin by decreasing IGF-1 production. Avoid concomitant use or adjust somatropin dose.
- Insulin and/or Oral Hypoglycemic Agents: Somatropin can decrease insulin sensitivity, requiring dose adjustments of antidiabetic agents.
Moderate Interactions
- Thyroid Hormones: Hypothyroidism can impair response to somatropin. Thyroid function should be monitored and treated if necessary.
- CYP450 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 (Insulin-like Growth Factor-1) levels
Rationale: To establish baseline and guide dosing, as IGF-1 is the primary mediator of somatropin's effects.
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
Thyroid Function Tests (TSH, Free T4)
Rationale: To rule out hypothyroidism, which can impair response to somatropin and be unmasked by therapy.
Timing: Prior to initiation of therapy
Lipid Profile
Rationale: To assess baseline cardiovascular risk factors.
Timing: Prior to initiation of therapy
Body Weight and Lean Body Mass
Rationale: To establish baseline for monitoring treatment efficacy.
Timing: Prior to initiation of therapy
CD4+ cell count (for HIV patients)
Rationale: To ensure patient is not acutely ill or has uncontrolled HIV, as per contraindications.
Timing: Prior to initiation of therapy
Routine Monitoring
IGF-1 levels
Frequency: Periodically (e.g., every 2-4 weeks initially, then every 3-6 months once stable)
Target: Within age- and sex-adjusted normal range, or slightly above for therapeutic effect.
Action Threshold: If consistently above upper limit of normal, consider dose reduction to minimize adverse effects.
Fasting Glucose and HbA1c
Frequency: Every 3-6 months, or more frequently if symptoms of glucose intolerance develop.
Target: Normal glycemic control.
Action Threshold: If elevated, consider dose reduction of somatropin or initiation/adjustment of antidiabetic therapy.
Thyroid Function Tests
Frequency: Every 6-12 months, or if symptoms of thyroid dysfunction develop.
Target: Euthyroid state.
Action Threshold: If abnormal, initiate or adjust thyroid hormone replacement.
Body Weight and Lean Body Mass
Frequency: Monthly or as clinically indicated.
Target: Increase in lean body mass and overall weight.
Action Threshold: If no significant improvement after 12 weeks, consider discontinuation.
Symptom Monitoring
- Peripheral edema (swelling of hands/feet)
- Arthralgia (joint pain)
- Myalgia (muscle pain)
- Carpal tunnel syndrome (numbness/tingling in hands)
- Headache
- Injection site reactions (pain, redness, swelling)
- Symptoms of glucose intolerance (increased thirst, urination, fatigue)
- Symptoms of intracranial hypertension (severe headache, visual changes, nausea/vomiting)
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. Animal studies have shown adverse effects at high doses.
Trimester-Specific Risks:
First Trimester:
Potential for fetal harm not definitively established, but caution advised.
Second Trimester:
Potential for fetal harm not definitively established, but caution advised.
Third Trimester:
Potential for fetal harm not definitively established, but caution advised.
Lactation
It is unknown whether somatropin is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when Serostim is administered to a nursing mother. Consider the benefits of breastfeeding, the mother's need for the drug, and any potential adverse effects on the breastfed infant.
Infant Risk:
L3 - Moderate risk. Monitor infant for potential adverse effects.
Pediatric Use
Serostim is not indicated for pediatric patients for HIV-associated wasting. Its safety and efficacy in pediatric patients for this indication have not been established. Other somatropin products are indicated for pediatric growth hormone deficiency.
Geriatric Use
Clinical studies of Serostim did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. Elderly patients may be more sensitive to the effects of somatropin and may require lower doses or more careful monitoring for adverse effects (e.g., glucose intolerance, fluid retention).
Clinical Information
Clinical Pearls
- Serostim is specifically indicated for HIV-associated wasting or cachexia, not for general weight gain or other growth hormone deficiencies.
- Patients should be carefully screened for active malignancy and acute critical illness, as these are contraindications.
- Monitor IGF-1 levels to guide dosing and minimize side effects. Dosing should aim to keep IGF-1 levels within the age- and sex-adjusted normal range or slightly above.
- Fluid retention (edema, arthralgia, carpal tunnel syndrome) is a common side effect, often dose-related. Consider dose reduction if severe.
- Somatropin can cause glucose intolerance; monitor blood glucose and HbA1c, especially in patients with pre-existing diabetes or risk factors.
- Hypothyroidism can reduce the response to somatropin; ensure thyroid function is optimized before and during therapy.
- Treatment duration for HIV-wasting is typically 12 weeks; discontinue if no significant response is observed.
Alternative Therapies
- Megestrol acetate (for appetite stimulation and weight gain in AIDS-related cachexia)
- Dronabinol (for appetite stimulation in AIDS-related anorexia)
- Testosterone replacement therapy (for hypogonadism in men with HIV-wasting)
- Anabolic steroids (e.g., Oxandrolone, Nandrolone decanoate - used off-label for muscle wasting)
- Nutritional support and counseling
- Resistance exercise training
Cost & Coverage
Average Cost:
$1,500 - $3,000+ per 5mg vial (highly variable based on quantity and pharmacy)
Generic Available:
Yes
Insurance Coverage:
Specialty Tier (requires prior authorization and often subject to high co-pays or co-insurance)
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 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 emergency medical attention. When seeking help, be prepared to provide details about the medication taken, the amount, and the time it happened.