Serostim 4mg 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
C
FDA Approved
May 1996
DEA Schedule
Not Controlled
Overview
What is this medicine?
Serostim is a man-made version of human growth hormone. It is used to help people with HIV who are losing weight and muscle (HIV-associated wasting) to gain back lean body mass and strength. It works by helping your body build protein and muscle.
How to Use This Medicine
Proper Administration of This Medication
To ensure safe and effective use, follow your doctor's instructions and read all accompanying information carefully. This medication is administered via subcutaneous injection, which involves injecting the drug into the fatty tissue beneath the skin. If you are self-administering the medication, your doctor or nurse will provide guidance on the proper injection technique.
Before administering the injection, allow the medication to reach room temperature if it has been stored in the refrigerator. Be aware of the recommended time frame for leaving the medication at room temperature before use. Do not attempt to heat the medication.
To minimize the risk of adverse reactions, rotate the injection site with each dose. Avoid injecting into skin that is irritated, bruised, red, infected, hard, or scarred. Additionally, do not administer the injection near the belly button or waistline.
Important Handling and Preparation Instructions
Do not shake the solution before administration.
Inspect the solution for cloudiness, leakage, or particles before use. If any of these conditions are present, do not use the medication.
Check the solution for any changes in color. If a change is observed, do not use the medication.
Wash your hands thoroughly before and after handling the medication.
* Dispose of used needles and syringes in a designated sharps disposal container. Do not reuse needles or other equipment. When the container is full, follow local regulations for proper disposal.
Storage and Disposal
Store this medication at room temperature, away from direct sunlight and moisture. Keep all medications in a secure location, out of reach of children and pets.
Missed Dose Instructions
If you miss a dose, take it as soon as you remember. However, if the missed dose is near the time of your next scheduled dose, skip the missed dose and resume your regular dosing schedule. Do not take two doses at the same time or attempt to catch up by taking extra doses. If you have any questions or concerns, consult your doctor or pharmacist for guidance.
To ensure safe and effective use, follow your doctor's instructions and read all accompanying information carefully. This medication is administered via subcutaneous injection, which involves injecting the drug into the fatty tissue beneath the skin. If you are self-administering the medication, your doctor or nurse will provide guidance on the proper injection technique.
Before administering the injection, allow the medication to reach room temperature if it has been stored in the refrigerator. Be aware of the recommended time frame for leaving the medication at room temperature before use. Do not attempt to heat the medication.
To minimize the risk of adverse reactions, rotate the injection site with each dose. Avoid injecting into skin that is irritated, bruised, red, infected, hard, or scarred. Additionally, do not administer the injection near the belly button or waistline.
Important Handling and Preparation Instructions
Do not shake the solution before administration.
Inspect the solution for cloudiness, leakage, or particles before use. If any of these conditions are present, do not use the medication.
Check the solution for any changes in color. If a change is observed, do not use the medication.
Wash your hands thoroughly before and after handling the medication.
* Dispose of used needles and syringes in a designated sharps disposal container. Do not reuse needles or other equipment. When the container is full, follow local regulations for proper disposal.
Storage and Disposal
Store this medication at room temperature, away from direct sunlight and moisture. Keep all medications in a secure location, out of reach of children and pets.
Missed Dose Instructions
If you miss a dose, take it as soon as you remember. However, if the missed dose is near the time of your next scheduled dose, skip the missed dose and resume your regular dosing schedule. Do not take two doses at the same time or attempt to catch up by taking extra doses. If you have any questions or concerns, consult your doctor or pharmacist for guidance.
Lifestyle & Tips
- Maintain a balanced, high-protein diet as recommended by your healthcare provider or dietitian.
- Engage in regular, appropriate exercise as tolerated and advised by your doctor.
- Follow proper injection technique and rotate injection sites to prevent skin problems.
- Store the medication as directed (refrigerated, protected from light).
Available Forms & Alternatives
Available Strengths:
Dosing & Administration
Adult Dosing
Standard Dose:
0.1 mg/kg/day subcutaneously, up to a maximum of 6 mg/day, for HIV-associated wasting. Administer daily for 12 weeks, then consider alternate day dosing for maintenance.
Dose Range:
0.1 - 6 mg
Condition-Specific Dosing:
HIV-associated wasting:
0.1 mg/kg/day subcutaneously, up to a maximum of 6 mg/day. Initial treatment for 12 weeks, followed by alternate day dosing for maintenance if clinically appropriate.
Pediatric Dosing
Neonatal:
Not established
Infant:
Not established
Child:
Not established
Adolescent:
Not established
Dose Adjustments
Renal Impairment:
Mild:
No specific dose adjustment recommended, but monitor for fluid retention.
Moderate:
No specific dose adjustment recommended, but monitor for fluid retention.
Severe:
No specific dose adjustment recommended, but monitor for fluid retention.
Dialysis:
Use with caution; monitor for fluid retention and IGF-1 levels. Somatropin is not significantly removed by dialysis.
Hepatic Impairment:
Mild:
No specific dose adjustment recommended.
Moderate:
No specific dose adjustment recommended.
Severe:
No specific dose adjustment recommended.
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 synthesis, and cellular proliferation. 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 by increasing protein anabolism and reducing protein catabolism.
Pharmacokinetics
Absorption:
Bioavailability:
Approximately 70-80% (subcutaneous)
Tmax:
Approximately 3-6 hours (subcutaneous)
FoodEffect:
Not applicable for subcutaneous administration.
Distribution:
Vd:
Approximately 0.07-0.1 L/kg
ProteinBinding:
Low (binds to growth hormone binding protein, but not extensively to plasma proteins)
CnssPenetration:
Limited
Elimination:
HalfLife:
Approximately 2-3 hours (intravenous); 3-6 hours (subcutaneous)
Clearance:
Approximately 15 L/hour (adults)
ExcretionRoute:
Renal (metabolites)
Unchanged:
<0.1%
Pharmacodynamics
OnsetOfAction:
Weeks to months for significant clinical effect (e.g., lean body mass gain)
PeakEffect:
Peak IGF-1 levels typically occur within 1-2 weeks of initiating therapy.
DurationOfAction:
Effects on body composition are sustained with continued therapy.
Confidence:
High
Safety & Warnings
Side Effects
Urgent Side Effects: Seek Medical Help Right Away
Although rare, some people may experience severe and potentially life-threatening side effects while taking this medication. If you notice any of the following symptoms, contact your doctor or seek immediate 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, 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, 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 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 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
Difficulty sleeping
Diarrhea, stomach pain, nausea, or vomiting
Gas
Irritation at the injection site
Common cold symptoms
Flu-like symptoms
Hair loss
Breast enlargement
This is not an exhaustive list of possible side effects. If you have questions or concerns, consult your doctor. You can also report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch.
Although rare, some people may experience severe and potentially life-threatening side effects while taking this medication. If you notice any of the following symptoms, contact your doctor or seek immediate 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, 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, 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 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 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
Difficulty sleeping
Diarrhea, stomach pain, nausea, or vomiting
Gas
Irritation at the injection site
Common cold symptoms
Flu-like symptoms
Hair loss
Breast enlargement
This is not an exhaustive list of possible side effects. If you have questions or concerns, consult your doctor. You can also report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch.
Seek Immediate Medical Attention If You Experience:
- Severe or persistent swelling in hands, feet, or ankles
- New or worsening joint pain or stiffness
- Numbness or tingling in fingers or hands (carpal tunnel syndrome)
- Persistent headache
- Vision changes
- Symptoms of high blood sugar (increased thirst, increased urination, unusual fatigue)
- Symptoms of low thyroid (fatigue, weight gain, feeling cold, dry skin)
- Any signs of an allergic reaction (rash, itching, swelling, severe dizziness, trouble 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 you experienced, including any symptoms that occurred.
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 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 you experienced, including any symptoms that occurred.
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 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.
This medication may affect 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
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.
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. 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.
This medication may affect 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
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.
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. Consult with your doctor if you have any questions or concerns.
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, fluid retention, diabetes).
What to Do:
Seek immediate medical attention. Call 911 or your local emergency number. For advice, call a poison control center at 1-800-222-1222. Management involves supportive care, monitoring blood glucose levels, and addressing specific symptoms.
Drug Interactions
Major Interactions
- Glucocorticoids (may inhibit growth-promoting effects of somatropin)
- Insulin and/or other antidiabetic agents (somatropin may decrease insulin sensitivity, requiring dose adjustments of antidiabetic agents)
Moderate Interactions
- Thyroid hormones (may alter somatropin metabolism; monitor thyroid function)
- CYP450 metabolized drugs (somatropin may increase the clearance of compounds metabolized by CYP3A4, e.g., corticosteroids, sex steroids, cyclosporine)
Monitoring
Baseline Monitoring
IGF-1 (Insulin-like Growth Factor-1)
Rationale: To establish baseline and guide dosing, ensuring levels are within age- and sex-appropriate ranges.
Timing: Prior to initiation of therapy.
Glucose (Fasting Plasma Glucose or 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 assess baseline thyroid status, as somatropin can unmask central hypothyroidism.
Timing: Prior to initiation of therapy.
Lipid Profile
Rationale: To assess baseline cardiovascular risk factors.
Timing: Prior to initiation of therapy.
Body Composition (e.g., DEXA scan)
Rationale: To quantify baseline lean body mass and fat mass for tracking treatment efficacy.
Timing: Prior to initiation of therapy.
Routine Monitoring
IGF-1
Frequency: Every 2-4 weeks initially, then every 3-6 months once stable.
Target: Within age- and sex-appropriate normal range, or upper half of normal range.
Action Threshold: If consistently above upper normal limit, consider dose reduction or temporary discontinuation to avoid adverse effects.
Glucose (Fasting Plasma Glucose or HbA1c)
Frequency: Every 3-6 months, or more frequently if patient has diabetes or develops symptoms of hyperglycemia.
Target: FPG <100 mg/dL, HbA1c <6.5%
Action Threshold: If FPG >126 mg/dL or HbA1c >6.5%, evaluate for new-onset diabetes or worsening glycemic control; adjust antidiabetic medications as needed.
Thyroid Function Tests (TSH, Free T4)
Frequency: Every 6-12 months, or if symptoms of hypothyroidism develop.
Target: Within normal limits.
Action Threshold: If TSH is elevated and Free T4 is low, consider thyroid hormone replacement.
Clinical Assessment for Adverse Effects (e.g., fluid retention, arthralgia, carpal tunnel syndrome)
Frequency: At each clinical visit.
Target: Absence of significant symptoms.
Action Threshold: If significant symptoms occur, consider dose reduction or temporary discontinuation.
Symptom Monitoring
- Peripheral edema
- Arthralgia (joint pain)
- Myalgia (muscle pain)
- Carpal tunnel syndrome (numbness/tingling in hands)
- Headache
- Hyperglycemia symptoms (increased thirst, urination, fatigue)
- Hypothyroidism symptoms (fatigue, weight gain, cold intolerance)
- Injection site reactions (pain, redness, swelling)
Special Patient Groups
Pregnancy
Category C. Use only if the potential benefit justifies the potential risk to the fetus. There are no adequate and well-controlled studies in pregnant women.
Trimester-Specific Risks:
First Trimester:
Potential for adverse effects on fetal development, though human data are limited.
Second Trimester:
Potential for adverse effects on fetal development, though human data are limited.
Third Trimester:
Potential for adverse effects on fetal development, though human data are limited.
Lactation
It is unknown whether somatropin is excreted in human milk. Caution should be exercised when Serostim is administered to a nursing mother. The decision to discontinue nursing or discontinue the drug should take into account the importance of the drug to the mother.
Infant Risk:
Low potential for systemic absorption by the infant due to large protein molecule, but theoretical risk of altered infant growth or metabolism. Monitor infant for adverse effects.
Pediatric Use
Serostim is specifically indicated for HIV-associated wasting in adults. Its safety and efficacy have not been established in pediatric patients for this indication. Other somatropin products are approved 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. No specific dose adjustment is recommended based on age, but elderly patients may be more sensitive to the effects of somatropin and may be at increased risk for adverse events such as fluid retention and glucose intolerance. Monitor closely.
Clinical Information
Clinical Pearls
- Serostim is specifically for HIV-associated wasting, not general weight gain or growth hormone deficiency in children.
- Patients should be well-nourished and receiving optimal antiretroviral therapy before initiating Serostim.
- Monitor IGF-1 levels closely to ensure they remain within the age- and sex-appropriate normal range, as excessively high levels can increase the risk of adverse effects.
- Patients with diabetes or glucose intolerance require careful monitoring of blood glucose and potential adjustment of antidiabetic medications.
- Fluid retention (edema, arthralgia, carpal tunnel syndrome) is a common side effect, especially early in therapy. Dose reduction or temporary discontinuation may be necessary.
- Injection sites should be rotated to prevent lipoatrophy or lipohypertrophy.
Alternative Therapies
- Megestrol acetate (appetite stimulant)
- Dronabinol (appetite stimulant)
- Anabolic steroids (e.g., oxandrolone, nandrolone decanoate - for lean body mass gain, but different mechanism and side effect profile)
- Nutritional counseling and support
Cost & Coverage
Average Cost:
Highly variable, typically several thousand USD per month per month
Generic Available:
Yes
Insurance Coverage:
Specialty Tier (requires prior authorization and often specific criteria for coverage)
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 occurred.