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Drug overview for HYPERHEP B (hepatitis b immune globulin):
Generic name: hepatitis B immune globulin (hep-a-TYE-tis bee i-MYUN-GLOB-yoo-lin)
Drug class: Hepatitis B Immune Globulin
Therapeutic class: Biologicals
Hepatitis B immune globulin (HBIG) is a specific immune globulin (hyperimmune globulin). HBIG contains antibody to hepatitis B surface antigen (anti-HBs) prepared from plasma of donors with high titers of anti-HBs and is used to provide temporary passive immunity to hepatitis B virus (HBV).
Hepatitis B immune globulin (HBIG) is used to provide passive immunity to hepatitis B virus (HBV) infection for prevention of perinatal HBV infection in neonates born to hepatitis B surface antigen-positive (HBsAg-positive) mothers, for postexposure prophylaxis in susceptible individuals exposed to HBV or HBsAg-positive materials (e.g., blood, plasma, serum), and for prevention of HBV recurrence in liver transplant recipients who are HBsAg-positive. A combined regimen that includes passive immunization with HBIG and active immunization with hepatitis B vaccine is used for prevention of perinatal HBV infection. (See Uses: Prevention of Perinatal Hepatitis B Virus (HBV) Infection.)
Depending on the exposure circumstances, a combined regimen of passive immunization with HBIG and active immunization with hepatitis B vaccine also may be indicated for postexposure prophylaxis of HBV infection in individuals exposed to HBV or HBsAg-positive materials (e.g., health-care personnel, sexual or intimate contacts of individuals with acute or chronic HBV infection) since it provides both short- and long-term protection . (See Uses: Postexposure Prophylaxis of Hepatitis B Virus (HBV) Infection.) HBIG is not indicated in the treatment of acute or chronic HBV infection.
Generic name: hepatitis B immune globulin (hep-a-TYE-tis bee i-MYUN-GLOB-yoo-lin)
Drug class: Hepatitis B Immune Globulin
Therapeutic class: Biologicals
Hepatitis B immune globulin (HBIG) is a specific immune globulin (hyperimmune globulin). HBIG contains antibody to hepatitis B surface antigen (anti-HBs) prepared from plasma of donors with high titers of anti-HBs and is used to provide temporary passive immunity to hepatitis B virus (HBV).
Hepatitis B immune globulin (HBIG) is used to provide passive immunity to hepatitis B virus (HBV) infection for prevention of perinatal HBV infection in neonates born to hepatitis B surface antigen-positive (HBsAg-positive) mothers, for postexposure prophylaxis in susceptible individuals exposed to HBV or HBsAg-positive materials (e.g., blood, plasma, serum), and for prevention of HBV recurrence in liver transplant recipients who are HBsAg-positive. A combined regimen that includes passive immunization with HBIG and active immunization with hepatitis B vaccine is used for prevention of perinatal HBV infection. (See Uses: Prevention of Perinatal Hepatitis B Virus (HBV) Infection.)
Depending on the exposure circumstances, a combined regimen of passive immunization with HBIG and active immunization with hepatitis B vaccine also may be indicated for postexposure prophylaxis of HBV infection in individuals exposed to HBV or HBsAg-positive materials (e.g., health-care personnel, sexual or intimate contacts of individuals with acute or chronic HBV infection) since it provides both short- and long-term protection . (See Uses: Postexposure Prophylaxis of Hepatitis B Virus (HBV) Infection.) HBIG is not indicated in the treatment of acute or chronic HBV infection.
DRUG IMAGES
HYPERHEP B VIAL
HYPERHEP B NEONATAL SYRINGE
The following indications for HYPERHEP B (hepatitis b immune globulin) have been approved by the FDA:
Indications:
Hepatitis B prevention
Professional Synonyms:
HBV infection prophylaxis
Hepatitis B prophylaxis
Indications:
Hepatitis B prevention
Professional Synonyms:
HBV infection prophylaxis
Hepatitis B prophylaxis
The following dosing information is available for HYPERHEP B (hepatitis b immune globulin):
No enhanced Dosing information available for this drug.
Hepatitis B immune globulin (HBIG) is administered by IM injection for prevention of perinatal hepatitis B virus (HBV) infection or for postexposure prophylaxis of HBV infection. HBIG is administered by IV infusion for prevention of HBV recurrence in liver transplant recipients Prior to administration, HBIG should be inspected visually for particulate matter and discoloration. HBIG should be administered undiluted and should not be mixed with any other drug or solution.
No dosing information available.
No generic dosing information available.
The following drug interaction information is available for HYPERHEP B (hepatitis b immune globulin):
There are 1 contraindications.
These drug combinations generally should not be dispensed or administered to the same patient. A manufacturer label warning that indicates the contraindication warrants inclusion of a drug combination in this category, regardless of clinical evidence or lack of clinical evidence to support the contraindication.
| Drug Interaction | Drug Names |
|---|---|
| Selected Live Viral Vaccines/Selected Immunoglobulins SEVERITY LEVEL: 1-Contraindicated Drug Combination: This drug combination is contraindicated and generally should not be dispensed or administered to the same patient. MECHANISM OF ACTION: Immune globulin(IG) products may prevent the immune system from properly responding to the vaccine.(1-19) CLINICAL EFFECTS: Administration of selected live viral vaccines after immunoglobulins may impair the efficacy of the vaccine.(1-19) Administration of immunoglobulins within 2-4 weeks after selected live viral vaccines impair the efficacy of the vaccine.(1-4,15) PREDISPOSING FACTORS: The amount of antigen-specific antibody present in the administered immunoglobulin product determines the duration of this interaction.(15) PATIENT MANAGEMENT: The recommendations regarding this interaction are conflicting. The Centers for Disease Control and Prevention(CDC) immunization recommendations for spacing of live vaccines and antibody-containing products include the following(15): - Live attenuated influenza vaccine, rotavirus, zoster and Ty21a typhoid vaccines may be given any time before, concurrent, with, or after administration of any immune globulin. Yellow fever vaccine may also be given in areas where donor blood products are unlikely to contain a substantial quantity of yellow fever antibody. - Administration of measles or varicella containing vaccines should be postponed for the following intervals after immunoglobulin therapy: Hepatitis B IG, Tetanus IG - 3 months Rabies IG - 4 months Varicella IG - 5 months Measles prophylaxis IG - 6 months if nonimmunocompromised Botulinum IG Intravenous, CMV IG Intravenous, Hepatitis A IG - 6 months Intravenous Immune Globulin(IVIG) - 8 to 11 months depending upon the dose Monoclonal antibody to RSV F protein (palivizumab) - none - Administration of antibody-containing products should be delayed 2 weeks after administration of live vaccines, except for influenza, rotavirus, zoster and typhoid vaccines as noted above. CDC guidelines state that in circumstances where there is high-risk of vaccine-preventable disease, it is acceptable to administer a dose of vaccine prior to completion of these intervals.(16) Manufacturer recommendations are as follows: Administration of a live viral vaccine should be postponed for at least three months in patients who have received the following immunoglobulin therapy: anthrax immunoglobulin,(19) cytomegalovirus immunoglobulin,(1) hepatitis B immunoglobulin,(5,6) rabies immunoglobulin,(7) tetanus immunoglobulin,(8-11) vaccinia immunoglobulin,(18) and zoster immunoglobulin.(2) Administration of a live viral vaccine should be postponed for at least six months in patients who have received the following immunoglobulin therapy: botulinum neurotoxin a/b immune globulin.(17) The Australian, Canadian, and US manufacturers of human immunoglobulin state that live viral vaccines should be postponed for three months in patients who have received human immunoglobulin.(6,12,13,18) The UK manufacturer states that vaccines may be compromised for one year and vaccines should be postponed in children for at least seven months.(14) The US manufacturer of immune globulin-hyaluronidase states that immune response to live attenuated vaccines may be impaired for up to 6 months, or for a year or more in the case of measles vaccine.(15) Cytomegalovirus immunoglobulin(1) or human immunoglobulin(3) should not be administered to patients who have received a live vaccine in the previous two weeks. If a live viral vaccine is given within two weeks of zoster immunoglobulin,(1) repetition of the vaccination three months after the completion of immunoglobulin should be considered. DISCUSSION: CDC Immunization Recommendations(15)provide discussion, charts, and further details regarding appropriate use and timing of vaccine therapy.(16) |
ADENOVIRUS TYPE 4, ADENOVIRUS TYPE 4 AND TYPE 7, ADENOVIRUS TYPE 7, DENGVAXIA, M-M-R II VACCINE, PRIORIX, PROQUAD, STAMARIL, VARIVAX VACCINE, YF-VAX |
There are 2 severe interactions.
These drug interactions can produce serious consequences in most patients. Actions required for severe interactions include, but are not limited to, discontinuing one or both agents, adjusting dosage, altering administration scheduling, and providing additional patient monitoring. Review the full interaction monograph for more information.
| Drug Interaction | Drug Names |
|---|---|
| IgG Antibodies and Derivatives/Efgartigimod-alfa SEVERITY LEVEL: 2-Severe Interaction: Action is required to reduce the risk of severe adverse interaction. MECHANISM OF ACTION: The neonatal Fc receptor (FcRn) prevents catabolism and mediates recycling of IgG and albumin, which leads to their long persistence in the body.(1,2) Efgartigimod-alfa binds to FcRn and may decrease systemic exposure of other ligands of FcRn, like immunoglobulins and IgG-based antibodies.(3) CLINICAL EFFECTS: The effectiveness of medicines that bind to FcRn may be decreased.(3) PREDISPOSING FACTORS: None determined. PATIENT MANAGEMENT: The manufacturer of efgartigimod-alfa states that efgartigimod-alfa should not be combined with long-term use of FcRn-binding medications. If the medication is essential for the patient, efgartigimod-alfa should be discontinued.(3) DISCUSSION: Clinical drug interaction studies with efgartigimod-alfa have not been performed. Efgartigimod-alfa may decrease concentrations of compounds that bind to the human FcRn.(3) |
VYVGART, VYVGART HYTRULO |
| IgG Antibodies and Derivatives/Nipocalimab-aahu SEVERITY LEVEL: 2-Severe Interaction: Action is required to reduce the risk of severe adverse interaction. MECHANISM OF ACTION: The neonatal Fc receptor (FcRn) prevents catabolism and mediates recycling of IgG and albumin, which leads to their long persistence in the body.(1,2) Nipocalimab-aahu binds to FcRn and may decrease systemic exposure of other ligands of FcRn, like immunoglobulins and IgG-based antibodies.(3) CLINICAL EFFECTS: The effectiveness of medicines that bind to FcRn may be decreased.(3) PREDISPOSING FACTORS: None determined. PATIENT MANAGEMENT: The manufacturer of nipocalimab-aahu states that nipocalimab-aahu should not be combined with long-term use of FcRn-binding medications. If the medication is essential for the patient, nipocalimab-aahu should be discontinued.(3) DISCUSSION: Clinical drug interaction studies with nipocalimab-aahu have not been performed. Nipocalimab-aahu may decrease concentrations of compounds that bind to the human FcRn.(3) |
IMAAVY |
There are 1 moderate interactions.
The clinician should assess the patient’s characteristics and take action as needed. Actions required for moderate interactions include, but are not limited to, discontinuing one or both agents, adjusting dosage, altering administration.
| Drug Interaction | Drug Names |
|---|---|
| IgG Antibodies and Derivatives/Rozanolixizumab-noli SEVERITY LEVEL: 3-Moderate Interaction: Assess the risk to the patient and take action as needed. MECHANISM OF ACTION: The neonatal Fc receptor (FcRn) prevents catabolism and mediates recycling of IgG and albumin, which leads to their long persistence in the body.(1,2) Rozanolixizumab-noli binds to FcRn and may decrease systemic exposure of other ligands of FcRn, like immunoglobulins and IgG-based antibodies.(3) CLINICAL EFFECTS: The effectiveness of medications that bind to FcRn may be decreased.(3) PREDISPOSING FACTORS: None determined. PATIENT MANAGEMENT: The manufacturer of rozanolixizumab-noli states that concurrent use with medications that bind to the human neonatal Fc receptor (FcRn) should be closely monitored for reduced effectiveness of these medications. If long-term use of such medications is essential for the patient, consider discontinuing rozanolixizumab-noli and use alternative therapies.(3) DISCUSSION: Clinical drug interaction studies with rozanolixizumab-noli have not been performed. Rozanolixizumab-noli may decrease concentrations of compounds that bind to the human FcRn.(3) |
RYSTIGGO |
The following contraindication information is available for HYPERHEP B (hepatitis b immune globulin):
Drug contraindication overview.
No enhanced Contraindications information available for this drug.
No enhanced Contraindications information available for this drug.
There are 0 contraindications.
There are 0 severe contraindications.
There are 1 moderate contraindications.
Clinically significant contraindication, where the condition can be managed or treated before the drug may be given safely.
| Moderate List |
|---|
| No disease contraindications |
The following adverse reaction information is available for HYPERHEP B (hepatitis b immune globulin):
Adverse reaction overview.
No enhanced Common Adverse Effects information available for this drug.
No enhanced Common Adverse Effects information available for this drug.
There are 4 severe adverse reactions.
| More Frequent | Less Frequent |
|---|---|
| None. |
Arthralgia Fever |
| Rare/Very Rare |
|---|
|
Anaphylaxis Thrombotic disorder |
There are 11 less severe adverse reactions.
| More Frequent | Less Frequent |
|---|---|
|
Headache disorder Injection site sequelae Malaise Myalgia Nausea |
Vomiting |
| Rare/Very Rare |
|---|
|
Abdominal pain with cramps Chills Diarrhea Dizziness Fatigue |
The following precautions are available for HYPERHEP B (hepatitis b immune globulin):
No enhanced Pediatric Use information available for this drug.
Contraindicated
Severe Precaution
Management or Monitoring Precaution
Contraindicated
| None |
Severe Precaution
| None |
Management or Monitoring Precaution
| None |
Because of the potential risks to the neonate from exposure to HBV infection, pregnancy and lactation are not considered a contraindications to the use of HBIG when clearly needed. Animal reproduction studies have not been performed with HBIG and it is not known whether HBIG can cause fetal harm when administered to pregnant women. The manufacturers state that HBIG should be given to pregnant women only when clearly needed. The ACIP states there are no known risks associated with use of immune globulins for passive immunization in pregnant women.
Information on the distribution of HBIG into milk is not available; it is not known if transmission of HBIG to a nursing infant presents any unusual risk. HBIG should be administered with caution to nursing women.
No enhanced Geriatric Use information available for this drug.
The following prioritized warning is available for HYPERHEP B (hepatitis b immune globulin):
WARNING: This medication may rarely cause serious problems from blood clots (such as heart attack, stroke, blood clots in the lungs or legs). You may be at increased risk for blood clots if you are an older adult, are severely dehydrated, have a catheter in a vein close to your heart for administering medications, or have a history of blood clots, heart/blood vessel disease, heart failure, stroke, or if you are immobile (such as very long plane flights or bedridden). If you use estrogen-containing products, these may also increase your risk.
Before using this medication, discuss the risks and benefits and if you have any of these conditions, report them to your doctor or pharmacist. Being adequately hydrated before and after receiving this medication may help reduce your risk of blood clots. If you are receiving this medication into a vein, the risk may also be decreased by infusing this medication more slowly or by using a less concentrated form of this medication if available. Get medical help right away if any of these side effects occur: shortness of breath/rapid breathing, chest/jaw/left arm pain, unusual sweating, sudden dizziness/fainting, pain/swelling/warmth in the groin/calf, sudden/severe headaches, trouble speaking, weakness on one side of the body, sudden vision changes, or confusion.
WARNING: This medication may rarely cause serious problems from blood clots (such as heart attack, stroke, blood clots in the lungs or legs). You may be at increased risk for blood clots if you are an older adult, are severely dehydrated, have a catheter in a vein close to your heart for administering medications, or have a history of blood clots, heart/blood vessel disease, heart failure, stroke, or if you are immobile (such as very long plane flights or bedridden). If you use estrogen-containing products, these may also increase your risk.
Before using this medication, discuss the risks and benefits and if you have any of these conditions, report them to your doctor or pharmacist. Being adequately hydrated before and after receiving this medication may help reduce your risk of blood clots. If you are receiving this medication into a vein, the risk may also be decreased by infusing this medication more slowly or by using a less concentrated form of this medication if available. Get medical help right away if any of these side effects occur: shortness of breath/rapid breathing, chest/jaw/left arm pain, unusual sweating, sudden dizziness/fainting, pain/swelling/warmth in the groin/calf, sudden/severe headaches, trouble speaking, weakness on one side of the body, sudden vision changes, or confusion.
The following icd codes are available for HYPERHEP B (hepatitis b immune globulin)'s list of indications:
| Hepatitis B prevention | |
| Z20.5 | Contact with and (suspected) exposure to viral hepatitis |
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