Hepagam B Inj, 5ml
It is used to prevent hepatitis B infection.
Drug Class
Immunizing agent (passive)
Pharmacologic Class
Immune globulin; Hepatitis B immune globulin (Human)
Pregnancy Category
Category C
FDA Approved
Jul 1999
DEA Schedule
Not Controlled
Overview
What is this medicine?
HepaGam B is a medicine made from human blood that contains antibodies to fight the Hepatitis B virus. It provides immediate, temporary protection against Hepatitis B infection, especially after exposure to the virus or to prevent it from coming back after a liver transplant.
How to Use This Medicine
Taking Your Medication
To use this medication correctly, follow your doctor's instructions and read all the information provided. It is essential to follow the instructions carefully. This medication is administered either as an injection into a muscle or as an infusion into a vein over a specified period.
Storing and Disposing of Your Medication
If you need to store this medication at home, consult with your doctor, nurse, or pharmacist to determine the proper storage method.
Missing a Dose
If you miss a dose, contact your doctor to receive guidance on the next steps to take.
To use this medication correctly, follow your doctor's instructions and read all the information provided. It is essential to follow the instructions carefully. This medication is administered either as an injection into a muscle or as an infusion into a vein over a specified period.
Storing and Disposing of Your Medication
If you need to store this medication at home, consult with your doctor, nurse, or pharmacist to determine the proper storage method.
Missing a Dose
If you miss a dose, contact your doctor to receive guidance on the next steps to take.
Lifestyle & Tips
- Continue to follow all recommended precautions to prevent Hepatitis B transmission (e.g., safe sex practices, avoiding sharing needles).
- Ensure completion of the Hepatitis B vaccine series if indicated, as HepaGam B provides only temporary protection.
Available Forms & Alternatives
Available Strengths:
Dosing & Administration
Adult Dosing
Standard Dose:
For post-exposure prophylaxis: 0.06 mL/kg (IM). For prevention of HBV recurrence post-liver transplant: Initial dose 20,000 IU (IV) within 24 hours of transplant, then 10,000 IU (IV) daily for 7 days, then 10,000 IU (IV) weekly or monthly based on anti-HBs levels.
Condition-Specific Dosing:
postExposureProphylaxis:
0.06 mL/kg IM, ideally within 24 hours of exposure, but may be effective up to 7 days.
liverTransplantProphylaxis:
Initial: 20,000 IU IV within 24 hours of transplant. Maintenance: 10,000 IU IV daily for 7 days, then 10,000 IU IV weekly or monthly to maintain anti-HBs levels >500 IU/L.
Pediatric Dosing
Neonatal:
For perinatal exposure: 0.5 mL IM within 12 hours of birth (along with Hepatitis B vaccine).
Infant:
For post-exposure prophylaxis: 0.06 mL/kg IM.
Child:
For post-exposure prophylaxis: 0.06 mL/kg IM.
Adolescent:
For post-exposure prophylaxis: 0.06 mL/kg IM.
Dose Adjustments
Renal Impairment:
Mild:
No specific adjustment needed.
Moderate:
No specific adjustment needed.
Severe:
No specific adjustment needed.
Dialysis:
No specific adjustment needed; immunoglobulins are catabolized like endogenous proteins.
Hepatic Impairment:
Mild:
No specific adjustment needed.
Moderate:
No specific adjustment needed.
Severe:
No specific adjustment needed.
Pharmacology
Mechanism of Action
Hepatitis B Immune Globulin (Human) provides passive immunity to Hepatitis B virus (HBV) by supplying high titers of antibodies to the Hepatitis B surface antigen (anti-HBs). These antibodies neutralize circulating HBV, preventing infection or recurrence in susceptible individuals.
Pharmacokinetics
Absorption:
Bioavailability:
Not applicable (administered directly as antibodies)
Tmax:
IM: 1-6 days; IV: Immediate
FoodEffect:
Not applicable
Distribution:
Vd:
Approximately plasma volume and extracellular fluid
ProteinBinding:
Not applicable (is a protein)
CnssPenetration:
Limited
Elimination:
HalfLife:
Approximately 17-25 days (variable depending on individual and route of administration)
Clearance:
Not precisely quantified, but involves catabolism.
ExcretionRoute:
Not applicable (catabolized)
Unchanged:
Not applicable
Pharmacodynamics
OnsetOfAction:
Immediate (upon administration)
PeakEffect:
IM: 1-6 days; IV: Within minutes
DurationOfAction:
Approximately 3-6 weeks (related to half-life)
Safety & Warnings
Side Effects
Important Side Effects to Report to Your Doctor 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 signs or symptoms, seek medical attention immediately:
Signs of an allergic reaction, such as:
+ 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
+ Swelling of the mouth, face, lips, tongue, or throat
Blood Clots (If Given Intravenously)
There is a risk of blood clots associated with this medication, which may be higher in older adults, people with thick blood, heart problems, or a history of blood clots. Additionally, the risk may increase if you are bedridden or chair-bound for an extended period, taking estrogen, or using certain catheters. However, blood clots can occur even without these underlying health issues. Seek medical attention immediately if you experience:
Numbness or weakness on one side of your body
Pain, redness, tenderness, warmth, or swelling in the arms or legs
Change in color of an arm or leg
Chest pain or pressure
Shortness of breath
Fast heartbeat
Coughing up blood
Other Possible Side Effects
Like all medications, this drug can cause side effects, although many people may not experience any or may only have mild side effects. If you are concerned about any of the following side effects or if they persist, consult your doctor:
* Intramuscular Injection:
+ Headache
+ Muscle pain
+ Feeling tired or weak
+ Pain or redness at the injection site
Reporting Side Effects
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 signs or symptoms, seek medical attention immediately:
Signs of an allergic reaction, such as:
+ 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
+ Swelling of the mouth, face, lips, tongue, or throat
Blood Clots (If Given Intravenously)
There is a risk of blood clots associated with this medication, which may be higher in older adults, people with thick blood, heart problems, or a history of blood clots. Additionally, the risk may increase if you are bedridden or chair-bound for an extended period, taking estrogen, or using certain catheters. However, blood clots can occur even without these underlying health issues. Seek medical attention immediately if you experience:
Numbness or weakness on one side of your body
Pain, redness, tenderness, warmth, or swelling in the arms or legs
Change in color of an arm or leg
Chest pain or pressure
Shortness of breath
Fast heartbeat
Coughing up blood
Other Possible Side Effects
Like all medications, this drug can cause side effects, although many people may not experience any or may only have mild side effects. If you are concerned about any of the following side effects or if they persist, consult your doctor:
* Intramuscular Injection:
+ Headache
+ Muscle pain
+ Feeling tired or weak
+ Pain or redness at the injection site
Reporting Side Effects
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:
- Signs of an allergic reaction: difficulty breathing, wheezing, hives, rash, swelling of the face or throat, dizziness, rapid heartbeat.
- Fever, chills, headache, nausea, vomiting, or general discomfort after injection/infusion.
Before Using This Medicine
Before Taking This Medication: Important Information to Share with Your Doctor
To ensure safe treatment, inform your doctor of 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.
If you have IgA deficiency, a condition where you lack a specific antibody.
Additional Considerations for Injection Administration (Intramuscular):
* If you have bleeding problems or a low platelet count, inform your doctor, as these conditions may affect the safety of the injection.
This list is not exhaustive, and it is crucial to discuss all your medications (prescription, over-the-counter, natural products, and vitamins) and health issues with your doctor and pharmacist. They will help determine if it is safe to take this medication with your other treatments and health conditions. Never start, stop, or adjust the dose of any medication without first consulting your doctor.
To ensure safe treatment, inform your doctor of 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.
If you have IgA deficiency, a condition where you lack a specific antibody.
Additional Considerations for Injection Administration (Intramuscular):
* If you have bleeding problems or a low platelet count, inform your doctor, as these conditions may affect the safety of the injection.
This list is not exhaustive, and it is crucial to discuss all your medications (prescription, over-the-counter, natural products, and vitamins) and health issues with your doctor and pharmacist. They will help determine if it is safe to take this medication with your other treatments and health conditions. Never start, stop, or adjust the dose of any medication without first consulting your doctor.
Precautions & Cautions
It is essential to inform all your healthcare providers, including doctors, nurses, pharmacists, and dentists, that you are taking this medication. Before receiving any vaccines while taking this drug or after stopping treatment, consult with your doctor to discuss the potential risks and benefits. The use of vaccines with this medication may increase the risk of infection or reduce the vaccine's effectiveness.
Regular blood tests will be necessary, as directed by your doctor, to monitor your condition. Discuss any concerns or questions you have with your doctor.
As this medication is derived from human plasma, there is a small risk of transmitting viruses that can cause disease. However, the medication is thoroughly screened, tested, and treated to minimize this risk. Your doctor can provide more information on this topic.
This medication may interfere with certain laboratory tests, so it is crucial to inform all your healthcare providers and lab personnel that you are taking this drug. Additionally, it may affect the accuracy of certain glucose tests, which can lead to incorrect diagnoses or treatments for low blood sugar or insulin management. This can have serious, long-lasting, or even life-threatening consequences.
If you have diabetes, consult with your doctor to determine the most suitable glucose tests for your condition. It is also essential to 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 of this medication for both you and your baby.
Regular blood tests will be necessary, as directed by your doctor, to monitor your condition. Discuss any concerns or questions you have with your doctor.
As this medication is derived from human plasma, there is a small risk of transmitting viruses that can cause disease. However, the medication is thoroughly screened, tested, and treated to minimize this risk. Your doctor can provide more information on this topic.
This medication may interfere with certain laboratory tests, so it is crucial to inform all your healthcare providers and lab personnel that you are taking this drug. Additionally, it may affect the accuracy of certain glucose tests, which can lead to incorrect diagnoses or treatments for low blood sugar or insulin management. This can have serious, long-lasting, or even life-threatening consequences.
If you have diabetes, consult with your doctor to determine the most suitable glucose tests for your condition. It is also essential to 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 of this medication for both you and your baby.
Overdose Information
Overdose Symptoms:
- Overdose is unlikely to cause severe symptoms beyond those seen with normal administration (e.g., local pain, mild systemic reactions).
- High doses may increase the risk of fluid overload, especially in patients with cardiac or renal impairment (if IV administered).
What to Do:
Discontinue administration. Symptomatic and supportive care. Monitor vital signs. Call 1-800-222-1222 (Poison Control) for advice if severe symptoms occur.
Drug Interactions
Major Interactions
- Live virus vaccines (e.g., Measles, Mumps, Rubella, Varicella): May interfere with the immune response to live attenuated virus vaccines. Administration of such vaccines should be deferred for at least 3 months after HBIG administration.
Monitoring
Baseline Monitoring
HBsAg and anti-HBs status (for recipient and source if applicable)
Rationale: To confirm susceptibility or infection status and guide treatment decisions.
Timing: Prior to administration, especially for post-exposure prophylaxis.
Allergy history
Rationale: To identify potential risk of hypersensitivity reactions, especially to human immunoglobulins.
Timing: Prior to administration.
Routine Monitoring
Signs of allergic reaction (e.g., rash, urticaria, dyspnea, hypotension)
Frequency: During and for at least 20 minutes after administration (especially IV infusion).
Target: Absence of symptoms
Action Threshold: Any signs of allergic reaction require immediate cessation of infusion and appropriate medical intervention.
Vital signs (if IV administration)
Frequency: Periodically during infusion.
Target: Stable
Action Threshold: Significant changes may indicate adverse reaction.
Anti-HBs levels (for liver transplant patients)
Frequency: Weekly or monthly, as per protocol, to guide dosing.
Target: >500 IU/L (post-liver transplant)
Action Threshold: Levels below target may require dose adjustment or increased frequency.
Symptom Monitoring
- Fever
- Chills
- Headache
- Nausea
- Vomiting
- Malaise
- Rash
- Urticaria
- Dyspnea
- Hypotension
- Anaphylaxis
Special Patient Groups
Pregnancy
Category C. HepaGam B is generally considered safe and is often used in pregnant women for post-exposure prophylaxis (e.g., perinatal exposure) when the benefits outweigh the potential risks. Human immunoglobulins are not known to cause fetal harm.
Trimester-Specific Risks:
First Trimester:
No specific risks identified.
Second Trimester:
No specific risks identified.
Third Trimester:
No specific risks identified.
Lactation
L3 (Moderately safe). Immunoglobulins are naturally present in breast milk. While the amount of exogenous HBIG transferred into breast milk is likely minimal due to its large molecular size, and oral absorption by the infant is unlikely, caution is advised. However, the benefits of preventing HBV infection in the mother often outweigh theoretical risks to the infant.
Infant Risk:
Low risk. Immunoglobulins are large proteins and are poorly absorbed orally by the infant. No adverse effects on breastfed infants have been reported.
Pediatric Use
Dosing is established for neonates, infants, and children based on weight or specific indications (e.g., perinatal exposure). Generally well-tolerated.
Geriatric Use
No specific dose adjustments are typically required for elderly patients. Use with caution in patients with pre-existing cardiovascular or renal conditions, especially with IV administration, due to potential for fluid overload.
Clinical Information
Clinical Pearls
- HepaGam B provides immediate, but temporary, passive immunity. It is crucial for post-exposure prophylaxis, especially in conjunction with active Hepatitis B vaccination for long-term protection.
- For perinatal exposure, HBIG and the first dose of Hepatitis B vaccine should be given within 12 hours of birth.
- For post-liver transplant prophylaxis, maintaining adequate anti-HBs levels is critical to prevent HBV recurrence.
- Always check the specific product's package insert for administration route (IM vs. IV) and detailed dosing instructions, as different HBIG products may have different approved routes and concentrations.
Alternative Therapies
- Other Hepatitis B Immune Globulin (Human) products (e.g., HyperRAB, Nabi-HB)
- Hepatitis B vaccine (for active immunization and long-term protection)
Cost & Coverage
Average Cost:
Highly variable, typically several hundred to thousands of dollars per dose depending on strength and volume. per vial
Insurance Coverage:
Specialty Tier / Tier 4 (often requires prior authorization due to high cost and specific indications)
General Drug Facts
If your symptoms or health problems do not improve or worsen over time, it is essential to contact your doctor for further evaluation and guidance.
To ensure safe use, do not share your medication with others, and never take someone else's medication. Store all medications in a secure location, out of reach of children and pets, to prevent accidental ingestion.
Proper disposal of unused or expired medications is crucial. Do not flush medications down the toilet or pour them down the drain unless specifically instructed to do so. If you are unsure about the best disposal method, consult your pharmacist for guidance. Many communities have drug take-back programs, which your pharmacist can help you locate.
Some medications may come with an additional patient information leaflet. Check with your pharmacist to see if this applies to your prescription. If you have any questions or concerns about your 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. Be prepared to provide critical information, including the name of the medication, the amount taken, and the time it was taken, to ensure prompt and effective treatment.
To ensure safe use, do not share your medication with others, and never take someone else's medication. Store all medications in a secure location, out of reach of children and pets, to prevent accidental ingestion.
Proper disposal of unused or expired medications is crucial. Do not flush medications down the toilet or pour them down the drain unless specifically instructed to do so. If you are unsure about the best disposal method, consult your pharmacist for guidance. Many communities have drug take-back programs, which your pharmacist can help you locate.
Some medications may come with an additional patient information leaflet. Check with your pharmacist to see if this applies to your prescription. If you have any questions or concerns about your 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. Be prepared to provide critical information, including the name of the medication, the amount taken, and the time it was taken, to ensure prompt and effective treatment.