Serostim 6mg 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 (rhGH)
Pregnancy Category
Category C
FDA Approved
May 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 is used in adults with HIV who are losing weight and muscle (wasting or cachexia) to help them gain back lean body mass and strength.
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, remove it from the refrigerator and allow it to reach room temperature. 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 dose. 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.
If the solution changes color, do not use it.
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, keeping it 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, 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, remove it from the refrigerator and allow it to reach room temperature. 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 dose. 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.
If the solution changes color, do not use it.
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, keeping it 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, consult your doctor or pharmacist.
Lifestyle & Tips
- Administer Serostim subcutaneously (under the skin) as directed by your healthcare provider.
- Rotate injection sites daily to prevent skin irritation.
- Follow a healthy, balanced diet as recommended by your doctor or dietitian.
- Engage in regular physical activity or exercise as advised by your healthcare team.
- Store the medication properly as instructed (refrigerate after reconstitution).
- Do not shake the vial vigorously, as this can damage the protein.
Available Forms & Alternatives
Available Strengths:
Dosing & Administration
Adult Dosing
Standard Dose:
0.1 mg/kg/day subcutaneously, up to 6 mg/day
Dose Range:
0.05 - 0.1 mg
Condition-Specific Dosing:
HIV-associated wasting or cachexia:
Initial: 0.1 mg/kg/day subcutaneously (maximum 6 mg/day) for 12 weeks. Maintenance: 0.05 mg/kg/day subcutaneously for patients who have completed 12 weeks of therapy and continue to experience benefits. Dosing should be individualized based on patient weight and response.
Pediatric Dosing
Neonatal:
Not established
Infant:
Not established
Child:
Not established (Serostim is not indicated for pediatric use in HIV-associated wasting)
Adolescent:
Not established (Serostim is not indicated for pediatric use in 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. Use with caution.
Dialysis:
Not available. Use with caution and 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. Use with caution.
Confidence:
Medium
Pharmacology
Mechanism of Action
Somatropin is a recombinant human growth hormone that binds to specific growth hormone receptors on target cells, stimulating linear growth, protein anabolism, and lipid and carbohydrate metabolism. In HIV-associated wasting, it increases lean body mass and body weight, and improves physical performance.
Pharmacokinetics
Absorption:
Bioavailability:
Approximately 80% (subcutaneous)
Tmax:
3-6 hours (subcutaneous)
FoodEffect:
Not applicable (parenteral administration)
Distribution:
Vd:
Approximately 50 L
ProteinBinding:
Low
CnssPenetration:
Limited
Elimination:
HalfLife:
Approximately 2-3 hours (subcutaneous)
Clearance:
Approximately 15 L/hour
ExcretionRoute:
Renal (metabolites)
Unchanged:
Less than 0.1%
Pharmacodynamics
OnsetOfAction:
Weeks to months for clinical effect (e.g., lean body mass increase)
PeakEffect:
Not acutely defined for therapeutic effect; IGF-1 levels peak within hours of administration.
DurationOfAction:
Effects on body composition persist as long as therapy is continued.
Confidence:
Medium
Safety & Warnings
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 notice any of the following symptoms, contact your doctor immediately or seek 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, 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 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, cold intolerance, 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 may not experience any side effects or only minor 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 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, 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 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, 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 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, cold intolerance, 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 may not experience any side effects or only minor 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 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, 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 indicate increased pressure in the brain)
- New or worsening swelling (edema) in your hands, feet, or ankles
- Numbness, tingling, or pain in your hands or wrists (carpal tunnel syndrome)
- Significant joint or muscle pain that interferes with daily activities
- Signs of high blood sugar, such as increased thirst, increased urination, or unusual fatigue
- Any new skin growths or changes in existing moles
- Signs of an allergic reaction (e.g., rash, itching, hives, swelling of the face/lips/tongue/throat, 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, 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 directed by your doctor.
Follow your doctor's instructions for regular blood work and eye exams to monitor your condition.
Interference with Lab Tests
This medication may affect the results of 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, as this medication may increase the chance of cancer or tumor growth. Additionally, the risk of new tumors may be higher in some patients.
If you have Turner syndrome, consult with your doctor, as this medication may increase the risk of ear infections, high blood pressure, and severe blood vessel problems, such as stroke and bleeding in the brain.
Rare but Serious Side Effects
Raised pressure in the head (intracranial hypertension) has been reported rarely with this medication, particularly in patients with Turner syndrome or Prader-Willi syndrome. Symptoms often occur within the first 8 weeks of treatment and may include changes in vision, severe headache, nausea, or vomiting. Seek medical attention immediately 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
Inform your doctor if you are pregnant, plan to become pregnant, or are breastfeeding, as you will need 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, particularly when combined with other medications containing benzyl alcohol. If possible, avoid using products with benzyl alcohol in this population. Consult with your doctor if you have any questions or concerns.
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 directed by your doctor.
Follow your doctor's instructions for regular blood work and eye exams to monitor your condition.
Interference with Lab Tests
This medication may affect the results of 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, as this medication may increase the chance of cancer or tumor growth. Additionally, the risk of new tumors may be higher in some patients.
If you have Turner syndrome, consult with your doctor, as this medication may increase the risk of ear infections, high blood pressure, and severe blood vessel problems, such as stroke and bleeding in the brain.
Rare but Serious Side Effects
Raised pressure in the head (intracranial hypertension) has been reported rarely with this medication, particularly in patients with Turner syndrome or Prader-Willi syndrome. Symptoms often occur within the first 8 weeks of treatment and may include changes in vision, severe headache, nausea, or vomiting. Seek medical attention immediately 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
Inform your doctor if you are pregnant, plan to become pregnant, or are breastfeeding, as you will need 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, particularly when combined with other medications containing benzyl alcohol. If possible, avoid using products with benzyl alcohol in this population. Consult with your doctor if you have any questions or concerns.
Overdose Information
Overdose Symptoms:
- Acute overdose may lead to initial hypoglycemia (low blood sugar) followed by hyperglycemia (high blood sugar).
- Long-term overdose may lead to signs and symptoms of gigantism/acromegaly (e.g., excessive growth, enlarged hands/feet, joint pain).
What to Do:
Seek immediate medical attention. Call 911 or your local emergency number. For poison control, call 1-800-222-1222.
Drug Interactions
Major Interactions
- Glucocorticoids (may inhibit growth-promoting effects of somatropin)
- Insulin and/or other antidiabetic agents (somatropin may induce insulin resistance and hyperglycemia, requiring dose adjustments of antidiabetic agents)
Moderate Interactions
- Thyroid hormones (may affect thyroid function and require dose adjustment of thyroid replacement therapy)
- Oral estrogens (may decrease IGF-1 response to somatropin, potentially requiring higher somatropin doses)
- CYP450 metabolized drugs (somatropin may induce CYP3A4, potentially altering metabolism of drugs like corticosteroids, sex steroids, cyclosporine, carbamazepine, phenytoin, and others)
Monitoring
Baseline Monitoring
Glucose (fasting)
Rationale: To assess baseline glucose metabolism, as somatropin can induce insulin resistance.
Timing: Prior to initiation of therapy
IGF-1 (Insulin-like Growth Factor-1)
Rationale: To assess baseline growth hormone axis activity and guide dosing.
Timing: Prior to initiation of therapy
Thyroid function tests (TSH, Free T4)
Rationale: To assess baseline thyroid status, as somatropin can unmask central hypothyroidism.
Timing: Prior to initiation of therapy
Body weight and lean body mass
Rationale: To establish baseline for assessing treatment efficacy.
Timing: Prior to initiation of therapy
Fluid status (for edema)
Rationale: To assess baseline fluid retention risk.
Timing: Prior to initiation of therapy
Routine Monitoring
Glucose (fasting)
Frequency: Periodically (e.g., every 3-6 months or as clinically indicated)
Target: Normal range (e.g., <100 mg/dL)
Action Threshold: Persistent elevation above normal range or development of diabetes mellitus; consider dose adjustment or discontinuation.
IGF-1
Frequency: Periodically (e.g., every 3-6 months or as clinically indicated)
Target: Within age- and sex-adjusted normal range
Action Threshold: Persistently elevated IGF-1 levels above the normal range; consider dose reduction or interruption.
Thyroid function tests (TSH, Free T4)
Frequency: Periodically (e.g., annually or as clinically indicated)
Target: Normal range
Action Threshold: Development of hypothyroidism; consider thyroid hormone replacement.
Body weight and lean body mass
Frequency: Monthly or every 3 months
Target: Increase in lean body mass and/or body weight
Action Threshold: Lack of response after adequate trial; consider re-evaluation of therapy.
Signs and symptoms of fluid retention (e.g., edema, arthralgia, carpal tunnel syndrome)
Frequency: Regularly during clinical visits
Target: Absence or mildness of symptoms
Action Threshold: Significant or persistent symptoms; consider dose reduction or temporary interruption.
Symptom Monitoring
- Persistent or severe headache
- Vision changes (e.g., blurred vision, double vision)
- Nausea and vomiting (signs of intracranial hypertension)
- Significant swelling (edema) in hands, feet, or face
- Joint pain (arthralgia)
- Muscle pain (myalgia)
- Numbness, tingling, or pain in hands/wrists (carpal tunnel syndrome)
- Signs of allergic reaction (rash, itching, swelling, severe dizziness, trouble breathing)
- Changes in existing moles or new skin lesions (potential malignancy)
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.
Trimester-Specific Risks:
First Trimester:
Potential for adverse effects on fetal development, but human data are limited.
Second Trimester:
Potential for adverse effects on fetal development, but human data are limited.
Third Trimester:
Potential for adverse effects on fetal development, but human data are limited.
Lactation
L3 (Moderately safe, but data limited). It is unknown whether somatropin is excreted in human milk. Caution should be exercised when somatropin is administered to a nursing mother.
Infant Risk:
Unknown. Potential for adverse effects on the breastfed infant is theoretical due to the protein nature of the drug, but absorption by the infant is unlikely.
Pediatric Use
Serostim is not indicated for pediatric patients with HIV-associated wasting or cachexia. Somatropin is used in pediatric patients for growth hormone deficiency and other growth disorders, but under different brand names and dosing regimens.
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. No specific dose adjustment is generally recommended, but elderly patients may be more sensitive to the effects of somatropin and should be monitored closely for adverse reactions, particularly fluid retention and glucose intolerance.
Clinical Information
Clinical Pearls
- Serostim is specifically indicated for HIV-associated wasting or cachexia, not for other growth hormone deficiencies.
- Patients should be carefully screened for active malignancy before initiating therapy, as somatropin may accelerate tumor growth.
- Contraindicated in patients with acute critical illness due to complications following open heart surgery, abdominal surgery, or multiple accidental trauma, or those with acute respiratory failure.
- Monitor for fluid retention (edema, arthralgia, carpal tunnel syndrome) and glucose intolerance, especially at higher doses.
- Rotate injection sites to prevent lipoatrophy or lipohypertrophy.
- Patients should be educated on proper reconstitution and administration techniques.
Alternative Therapies
- Megestrol acetate (for appetite stimulation and weight gain)
- Dronabinol (for appetite stimulation)
- Testosterone replacement therapy (for hypogonadal men with HIV-wasting)
- Nutritional support and counseling
- Resistance exercise training
Cost & Coverage
Average Cost:
Highly variable, typically several thousand dollars per month (e.g., for 30 vials of 6mg)
Generic Available:
Yes
Insurance Coverage:
Specialty Tier (requires prior authorization, often subject to high co-pays or co-insurance)
General Drug Facts
If your symptoms or health issues persist or worsen, it is 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 it's a good idea to check with your pharmacist. If you have any questions or concerns about this 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 information about the medication taken, the amount, and the time it happened.