Hepagam B Inj, 1ml
It is used to prevent hepatitis B infection.
Drug Class
Immunizing Agent, Passive
Pharmacologic Class
Immune Globulin; Hepatitis B Immune Globulin (Human)
Pregnancy Category
Not available
FDA Approved
Jul 2006
DEA Schedule
Not Controlled
Overview
What is this medicine?
HepaGam B is a shot that contains antibodies (protective proteins) against the Hepatitis B virus. It's given to people who have been exposed to Hepatitis B or to prevent the virus from coming back in liver transplant patients. It provides immediate, temporary protection.
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's essential to follow the dosage instructions carefully. This medication is administered either as an injection into a muscle or as an infusion into a vein, which is given over a period of time.
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 best way to store it.
Missing a Dose
If you miss a dose, contact your doctor to find out what steps to take next. They will provide guidance on how to get back on schedule with your medication.
To use this medication correctly, follow your doctor's instructions and read all the information provided. It's essential to follow the dosage instructions carefully. This medication is administered either as an injection into a muscle or as an infusion into a vein, which is given over a period of time.
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 best way to store it.
Missing a Dose
If you miss a dose, contact your doctor to find out what steps to take next. They will provide guidance on how to get back on schedule with your medication.
Lifestyle & Tips
- Follow all instructions from your healthcare provider regarding follow-up vaccinations (e.g., Hepatitis B vaccine series).
- Report any unusual or severe side effects immediately.
Available Forms & Alternatives
Available Strengths:
Dosing & Administration
Adult Dosing
Standard Dose:
Post-exposure prophylaxis: 0.06 mL/kg (IM) as a single dose. Liver transplant: 20,000 IU (IV) daily for 7 days post-transplant, then weekly/monthly based on anti-HBs levels.
Condition-Specific Dosing:
Post-exposure prophylaxis:
Administer as soon as possible after exposure (within 24 hours for percutaneous, within 14 days for sexual).
Prevention of HBV recurrence post-liver transplant:
Initial dose of 20,000 IU IV within 24 hours pre-transplant or intraoperatively, then 20,000 IU IV daily for 7 days post-transplant. Maintenance dosing is individualized to maintain anti-HBs levels >500 IU/L.
Pediatric Dosing
Neonatal:
0.5 mL (IM) within 12 hours of birth for infants born to HBsAg-positive mothers, along with Hepatitis B vaccine.
Infant:
Post-exposure prophylaxis: 0.06 mL/kg (IM) as a single dose.
Child:
Post-exposure prophylaxis: 0.06 mL/kg (IM) as a single dose.
Adolescent:
Post-exposure prophylaxis: 0.06 mL/kg (IM) as a single dose.
Dose Adjustments
Renal Impairment:
Mild:
No specific adjustment needed.
Moderate:
No specific adjustment needed.
Severe:
No specific adjustment needed.
Dialysis:
No specific adjustment needed; not significantly cleared by dialysis.
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 by supplying antibodies (anti-HBs) against the Hepatitis B surface antigen (HBsAg). These antibodies neutralize circulating Hepatitis B virus (HBV), preventing infection or recurrence.
Pharmacokinetics
Absorption:
Bioavailability:
Not available (IM administration leads to systemic absorption; IV is 100%)
Tmax:
IM: 1-6 days
FoodEffect:
Not applicable
Distribution:
Vd:
Distributed throughout the extracellular fluid.
ProteinBinding:
Not applicable (it is a protein)
CnssPenetration:
Limited
Elimination:
HalfLife:
Approximately 17-25 days
Clearance:
Not available (catabolic clearance)
ExcretionRoute:
Catabolism
Unchanged:
Not applicable (catabolized)
Pharmacodynamics
OnsetOfAction:
Immediate (IV); within hours to days (IM)
PeakEffect:
Within 1-6 days (IM)
DurationOfAction:
Approximately 3-6 weeks (based on half-life)
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 signs or symptoms, contact your doctor or seek immediate medical attention:
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, particularly in older adults and individuals with thick blood, heart problems, or a history of blood clots. The risk may also be higher if you are bedridden or use certain catheters, including estrogen therapy. However, blood clots can occur even without these underlying health issues. Seek immediate medical attention if you experience:
Numbness or weakness on one side of your body
Pain, redness, tenderness, warmth, or swelling in your arms or legs
Changes in skin color on an arm or leg
Chest pain or pressure
Shortness of breath
Rapid heartbeat
Coughing up blood
Discuss Your Concerns with Your Doctor
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 symptoms. If you are concerned about any of the following side effects or if they persist, contact your doctor:
* Intramuscular Injection:
+ Headache
+ Muscle pain
+ Feeling tired or weak
+ Pain or redness at the injection site
Not All Side Effects Are Listed
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, contact your doctor or seek immediate medical attention:
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, particularly in older adults and individuals with thick blood, heart problems, or a history of blood clots. The risk may also be higher if you are bedridden or use certain catheters, including estrogen therapy. However, blood clots can occur even without these underlying health issues. Seek immediate medical attention if you experience:
Numbness or weakness on one side of your body
Pain, redness, tenderness, warmth, or swelling in your arms or legs
Changes in skin color on an arm or leg
Chest pain or pressure
Shortness of breath
Rapid heartbeat
Coughing up blood
Discuss Your Concerns with Your Doctor
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 symptoms. If you are concerned about any of the following side effects or if they persist, contact your doctor:
* Intramuscular Injection:
+ Headache
+ Muscle pain
+ Feeling tired or weak
+ Pain or redness at the injection site
Not All Side Effects Are Listed
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 a severe allergic reaction: difficulty breathing, wheezing, hives, rash, swelling of the face or throat, dizziness, feeling faint.
- Severe pain or swelling at the injection site.
- Unusual bleeding or bruising (rare).
- Signs of kidney problems (rare with IM use): decreased urination, swelling in legs/feet.
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 your body doesn't produce enough immunoglobulin A, an important antibody.
Additional Considerations for Injection (Intramuscular Administration):
* If you have bleeding problems or a low platelet count, inform your doctor, as these conditions may affect the administration of this medication.
It's crucial to disclose all your medications, including prescription and over-the-counter (OTC) drugs, natural products, and vitamins, to your doctor and pharmacist. This includes any health problems you have, as they may interact with this medication. Always check with your doctor before starting, stopping, or changing the dose of any medication to ensure your safety.
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 your body doesn't produce enough immunoglobulin A, an important antibody.
Additional Considerations for Injection (Intramuscular Administration):
* If you have bleeding problems or a low platelet count, inform your doctor, as these conditions may affect the administration of this medication.
It's crucial to disclose all your medications, including prescription and over-the-counter (OTC) drugs, natural products, and vitamins, to your doctor and pharmacist. This includes any health problems you have, as they may interact with this medication. Always check with your doctor before starting, stopping, or changing the dose of any medication to ensure your safety.
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 potential risks. 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 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. If you have concerns, consult with your doctor.
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 treatment of low blood sugar or excessive insulin use, resulting in severe or 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, planning to become pregnant, or breastfeeding, as you will need to discuss the potential benefits and risks of this medication to 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 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. If you have concerns, consult with your doctor.
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 treatment of low blood sugar or excessive insulin use, resulting in severe or 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, planning to become pregnant, or breastfeeding, as you will need to discuss the potential benefits and risks of this medication to both you and your baby.
Overdose Information
Overdose Symptoms:
- Overdose is unlikely to cause severe toxicity due to the nature of the product. High doses may increase the risk of mild adverse reactions.
What to Do:
Management is supportive. Contact a poison control center or seek immediate medical attention if overdose is suspected. Call 1-800-222-1222 (Poison Control).
Drug Interactions
Major Interactions
- Live virus vaccines (e.g., Measles, Mumps, Rubella, Varicella): HBIG can interfere with the immune response to live virus vaccines. Administration of live virus vaccines should be delayed for 3-6 months after HBIG administration.
Monitoring
Baseline Monitoring
History of allergies (especially to human immunoglobulins or IgA deficiency)
Rationale: To assess risk of hypersensitivity reactions.
Timing: Prior to administration
Baseline liver function tests (for transplant patients)
Rationale: To establish baseline and monitor liver health.
Timing: Prior to transplant and HBIG initiation
Routine Monitoring
Anti-HBs levels (for liver transplant patients)
Frequency: Weekly initially, then monthly or as clinically indicated
Target: >500 IU/L (post-transplant)
Action Threshold: Adjust HBIG dose if levels fall below target
Signs and symptoms of adverse reactions (e.g., allergic reactions, injection site reactions)
Frequency: During and after administration
Target: Absence of symptoms
Action Threshold: Manage symptoms, consider stopping infusion/injection if severe
Symptom Monitoring
- Signs of allergic reaction (rash, hives, itching, swelling of face/throat, difficulty breathing, wheezing, dizziness, faintness)
- Injection site reactions (pain, tenderness, swelling, redness)
- Fever, chills, headache, malaise
- Signs of hemolysis (rare, e.g., dark urine, jaundice, fatigue)
- Signs of renal dysfunction (rare, e.g., decreased urine output, swelling)
Special Patient Groups
Pregnancy
Pregnancy Category C (older classification). The FDA label states: 'Risk Summary: There are no adequate and well-controlled studies of HepaGam B in pregnant women. HepaGam B should be given to a pregnant woman only if clearly needed.' Immunoglobulins are known to cross the placenta, particularly in the third trimester. However, no adverse fetal effects have been reported.
Trimester-Specific Risks:
First Trimester:
Limited data, but generally considered low risk as immunoglobulins are naturally occurring.
Second Trimester:
Limited data, but generally considered low risk.
Third Trimester:
Immunoglobulins are actively transported across the placenta, but no known adverse effects on the fetus.
Lactation
Compatible with breastfeeding. Immunoglobulins are naturally present in human milk and are not expected to cause adverse effects in a breastfed infant. The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for HepaGam B and any potential adverse effects on the breastfed infant from HepaGam B or from the underlying maternal condition.
Infant Risk:
L2 (Safer) - Minimal to no risk to the infant.
Pediatric Use
Safe and effective for post-exposure prophylaxis in children and for infants born to HBsAg-positive mothers. Dosing is weight-based for prophylaxis.
Geriatric Use
No specific dose adjustments are typically required. Use with caution in patients with pre-existing cardiovascular or renal conditions, particularly with IV administration, due to potential for volume overload or increased viscosity, though less relevant for IM administration.
Clinical Information
Clinical Pearls
- Administer HepaGam B as soon as possible after exposure to Hepatitis B virus for optimal efficacy.
- For IM administration, do not inject intravenously due to risk of severe reactions.
- Do not mix HepaGam B with other medicinal products.
- HepaGam B can interfere with the immune response to live virus vaccines (e.g., MMR, varicella). Delay administration of these vaccines for at least 3 months (and up to 6 months) after HBIG.
- Ensure the patient has received or will receive the Hepatitis B vaccine series for long-term active immunity, as HBIG provides only temporary passive immunity.
Alternative Therapies
- Hepatitis B vaccine (for active immunization and long-term protection).
- Antiviral agents (e.g., entecavir, tenofovir) for treatment of chronic Hepatitis B infection (not for prophylaxis).
Cost & Coverage
Average Cost:
Varies significantly (specialty biologic) per vial
Insurance Coverage:
Specialty tier; often covered under medical benefit for specific indications.
General Drug Facts
If your symptoms or health problems persist or worsen, it is essential to contact your doctor for further guidance. To ensure safe use, never share your medication with others, and do not take medication prescribed for someone else. Store all medications in a secure location, out of reach of children and pets, to prevent accidental ingestion. Dispose of unused or expired medications properly. Unless instructed otherwise, avoid flushing medications down the toilet or pouring them down the drain. If you are unsure about the correct disposal method, consult your pharmacist for advice. Many communities offer drug take-back programs, which your pharmacist can help you locate. Some medications may come with an additional patient information leaflet, so be sure to check with your pharmacist. If you have any questions or concerns about your medication, discuss them with your doctor, nurse, pharmacist, or other healthcare provider. In the event of a suspected overdose, immediately contact your local poison control center or seek emergency medical attention. Be prepared to provide information about the medication taken, the amount, and the time it occurred.