Dosing & Uses
Dosage Forms & Strengths
injectable solution
- 312 Units/mL
- 220 Units/mL
Post Exposure Prophylaxis
Include uninfected sexual partners
0.06 mL/kg IM once AND HepB vaccine (subsequently complete full course of vaccination, 28-30 days post initial)
Post-Exposure timeline for vaccination
- < 24 hr post needle stick, ocular, or mucosal exposure
- <14 days post sexual exposure
Prophylaxis for Known Nonresponders to Vaccine or Vaccine Refusal
0.06 mL/kg IM immediately AND a second dose 1 month later
Liver Transplant (HepaGam only)
Designed to attain serum levels of HBsAb >500 IU/L
- 20,000 IU IV per dose
First dose admin concurrently w/grafting of transplanted liver, THEN
- qDay x7 days, THEN q2wk 2-12 wk post-op, THEREAFTER qMonth starting on month 4
Hepatitis B Virus Reinfection (Orphan)
Prophylaxis against hepatitis B virus reinfection in liver transplant patients
Orphan indication sponsor
- Biotest Pharmaceuticals Corporation; 5800 Park of Commerce Blvd., NW; Boca Raton, FL 33487
Administration
Anterolateral thigh or deltoid region
Other Indications & Uses
Acute exposure to HBsAg+ blood
- Needle stick, bite
Infants born to HBsAg+ mothers
Sexual contact with HBsAg+ individuals
Infants <12 mo whose family members are HBsAg+
Prophylaxis against hepatitis B reinfection in HBsAg+ liver transplantees (HepaGam)
Newborns Born to HBs Ag-positive Mothers
0.5 mL IM <12 hr after birth
If vaccination delayed by 3 months, repeat HBIG at 3 months
If not vaccinated at all, repeat HBIG at 3 & 6 months
Postexposure Prophylaxis
<12 months: 0.05 mL/kg IM; initiate HepB vaccine
>12 months: 0.06 mL/kg IM once AND HepB vaccine (subsequently complete full course of vaccination, 28-30 days post initial)
Post-Exposure timeline for vaccination
- < 24 hr post needle stick, ocular, or mucosal exposure
- <14 days post sexual exposure
Administration
Anterolateral thigh or deltoid region
Interactions
Interaction Checker
No Results
Contraindicated
Serious - Use Alternative
Significant - Monitor Closely
Minor
Contraindicated (0)
Serious - Use Alternative (6)
- axicabtagene ciloleucel
hepatitis B immune globulin (HBIG), axicabtagene ciloleucel. Either increases effects of the other by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.
- brexucabtagene autoleucel
hepatitis B immune globulin (HBIG), brexucabtagene autoleucel. Either increases effects of the other by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.
- ciltacabtagene autoleucel
hepatitis B immune globulin (HBIG), ciltacabtagene autoleucel. Either increases effects of the other by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.
- idecabtagene vicleucel
hepatitis B immune globulin (HBIG), idecabtagene vicleucel. Either increases effects of the other by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.
- lisocabtagene maraleucel
hepatitis B immune globulin (HBIG), lisocabtagene maraleucel. Either increases effects of the other by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.
- tisagenlecleucel
hepatitis B immune globulin (HBIG), tisagenlecleucel. Either increases effects of the other by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.
Monitor Closely (10)
- BCG vaccine live
hepatitis B immune globulin (HBIG) decreases effects of BCG vaccine live by pharmacodynamic antagonism. Use Caution/Monitor. Separate by 3 months.
- efgartigimod alfa
efgartigimod alfa will decrease the level or effect of hepatitis B immune globulin (HBIG) by receptor binding competition. Use Caution/Monitor. Coadministration of efgartigimod with medications that bind to the human neonatal Fc receptor may lower systemic exposures and effectiveness of such medications. Closely monitor for reduced effectiveness of medications that bind to the human neonatal Fc receptor. If long-term use of such medications is essential, consider discontinuing efgartigimod and using alternative therapies.
- efgartigimod/hyaluronidase SC
efgartigimod/hyaluronidase SC will decrease the level or effect of hepatitis B immune globulin (HBIG) by receptor binding competition. Use Caution/Monitor. Coadministration of efgartigimod with medications that bind to the human neonatal Fc receptor may lower systemic exposures and effectiveness of such medications. Closely monitor for reduced effectiveness of medications that bind to the human neonatal Fc receptor. If long-term use of such medications is essential, consider discontinuing efgartigimod and using alternative therapies.
- measles (rubeola) vaccine
hepatitis B immune globulin (HBIG) decreases effects of measles (rubeola) vaccine by pharmacodynamic antagonism. Use Caution/Monitor. Separate by 3 months.
- measles mumps and rubella vaccine, live
hepatitis B immune globulin (HBIG) decreases effects of measles mumps and rubella vaccine, live by pharmacodynamic antagonism. Use Caution/Monitor. Separate by 3 months.
- measles, mumps, rubella and varicella vaccine, live
hepatitis B immune globulin (HBIG) decreases effects of measles, mumps, rubella and varicella vaccine, live by pharmacodynamic antagonism. Use Caution/Monitor. Separate by 3 months.
- rozanolixizumab
rozanolixizumab will decrease the level or effect of hepatitis B immune globulin (HBIG) by receptor binding competition. Use Caution/Monitor. Coadministration of rozanolixizumab with medications that bind to the human neonatal Fc receptor may lower systemic exposures and effectiveness of such medications. Closely monitor for reduced effectiveness of medications that bind to the human neonatal Fc receptor. If long-term use of such medications is essential, consider discontinuing rozanolixizumab and using alternative therapies.
- rubella vaccine
hepatitis B immune globulin (HBIG) decreases effects of rubella vaccine by pharmacodynamic antagonism. Use Caution/Monitor. Separate by 3 months.
- smallpox (vaccinia) vaccine, live
hepatitis B immune globulin (HBIG) decreases effects of smallpox (vaccinia) vaccine, live by pharmacodynamic antagonism. Use Caution/Monitor. Separate by 3 months.
- varicella virus vaccine live
hepatitis B immune globulin (HBIG) decreases effects of varicella virus vaccine live by pharmacodynamic antagonism. Use Caution/Monitor. Separate by 3 months.
Minor (1)
- protein a column
protein a column decreases levels of hepatitis B immune globulin (HBIG) by Other (see comment). Minor/Significance Unknown. Comment: Since Prosorba binds IgG, it could theoretically interfere with the levels and/or effects of pharmacologic immune globulins.
Adverse Effects
>10%
Headache (14%)
Erythema (12%)
1-10%
Myalgia (10%)
Malaise (6%)
Nausea (4%)
Generalized pain, injection site pain (4%)
Vomiting (2%)
Ecchymosis (2%)
<1%
Fever
Lethargy
Chest tightness
Anaphylaxis
Angioneurotic edema
Nephrotic syndrome (rare)
Warnings
Contraindications
Hypersensitivity to human globulin
IGA deficiency
History of severe thrombocytopenia or any coagulation disorder that would contraindicate intramuscular injections unless expected benefits outweigh potential risks
Cautions
Do NOT give IV
Separate live vaccines by 3 months
Liver transplant patients should be monitored regularly for serum anti-HBs antibody levels using a quantitative assay to ensure that adequate protective levels are maintained
Certain adverse drug reactions may be related to rate of infusion; the recommended infusion rate given under dosage and administration must be closely followed; patients must be closely monitored and carefully observed for any symptoms throughout infusion period and immediately following an infusion
Because this product is made from human plasma, it may carry a risk of transmitting infectious agents, eg, viruses, and, theoretically, theCreutzfeldt-Jakob disease (CJD) agent; no cases of transmission of viral diseases or CJD have been associated with use of this product; if infections suspected by a physician possibly to have been transmitted by this product should be reported by the physician or other healthcare provider to Cangene Corporation at 1-800-768-2304
For postexposure prophylaxis indications, this product must be administered intramuscularly only; in patients who have severe thrombocytopenia or any coagulation disorder that would contraindicate intramuscular injections, administer only if expectedbenefits outweigh potential risks
Hypersensitivity
- Severe hypersensitivity reactions may occur; drug should be administered in a setting with appropriate equipment, medication and personnel trained in the management of hypersensitivity, anaphylaxis and shock
- In case of hypersensitivity, discontinue therapy immediately and begin appropriate emergency treatment; medications such as epinephrine and antihistamines should be available for immediate treatment of acute hypersensitivity reactions
- This product contains trace amounts of IgA (<40 micrograms per milliliter); patients with known antibodies to IgA may have a greater risk of severe hypersensitivity and anaphylactic reactions
- HepaGam B is contraindicated in IgA deficient patients with antibodies against IgA and history of hypersensitivity reaction
Glucose testing
- The maltose contained in this product can interfere with some types of blood glucose monitoring systems, eg, those based on glucose dehydrogenase pyrroloquinequinone(GDH-PQQ) method
- This can result in falsely elevated glucose readings and, consequently, in the inappropriate administration of insulin, resulting in life-threatening hypoglycemia
- Cases of true hypoglycemia may go untreated if hypoglycemic state is masked by falsely elevated results
Thrombotic events
- Thrombotic events may occur during or following treatment with IGIV products; patients at risk include those with history of atherosclerosis, multiple cardiovascular risk factors, advanced age, impaired cardiac output, coagulation disorders, prolonged periods of immobilization, and/or known/suspected hyperviscosity
- Consider baseline assessment of blood viscosity in patients at risk for hyperviscosity including those with cryoglobulins, fasting chylomicronemia/markedly high triacylglycerols (triglycerides), or monoclonal gammopathies; for patients who are at risk of developing thrombotic events, administer product at minimum rate of infusion practicable
Pregnancy & Lactation
Pregnancy
Not known whether this product can cause fetal harm when administered to pregnant woman or can affect reproductive capacity; this product should be given to a pregnant woman only if clearly indicated
Animal data
- Animal reproduction studies have not been conducted with this product
Lactation
Not known whether this product is excreted in human milk; because many drugs are excreted in human milk, exercise caution when therapy administered to a nursing mother
Pregnancy Categories
A: Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.
B: May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk. C: Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done. D: Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk. X: Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist. NA: Information not available.Pharmacology
Mechanism of Action
Pooled human immune globulins from donors; nonpyrogenic solution that contains immunoglobulin G specific to hepatitis B surface antigen.
Pharmacokinetics
Half-Life: 17-25 days
Peak Plasma Time: 2-10 days (IM)
Duration: 3-6 months (postexposure prophylaxis)
Vd: 7-15 L
Clearance: 0.35 L/day
Images
| BRAND | FORM. | UNIT PRICE | PILL IMAGE |
|---|---|---|---|
| HyperHEP B intramuscular - | 220 unit/mL (5 mL) vial |  | |
| HyperHEP B intramuscular - | 220 unit/mL solution |  | |
| HyperHEP B Neonatal intramuscular - | 110 unit/0.5 mL solution |  |
Copyright © 2010 First DataBank, Inc.
Patient Handout
hepatitis B immune globulin intramuscular
HEPATITIS B IMMUNE GLOBULIN - INJECTION
(hep-a-TYE-tis bee i-MYUN-GLOB-yoo-lin)
COMMON BRAND NAME(S): Hepagam B, Hyperhep B, Nabi-HB
WARNING: This medication may rarely cause serious blood clots (such as pulmonary embolism, stroke, heart attack, deep vein thrombosis). 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 arm/leg, sudden/severe headache, trouble speaking, weakness on one side of the body, sudden vision changes, or confusion.
USES: This medication is used to prevent a certain serious virus infection (hepatitis B) in people who have been exposed to this virus under certain conditions (such as direct contact with blood or body fluids containing this virus). Certain brands of this medication may also be given after a liver transplant to prevent return of hepatitis B infection in people with previous infection. Ask your doctor or pharmacist if you have questions about your particular brand. This medication is made from healthy human blood that has high levels of certain defensive substances (antibodies) that help fight hepatitis B.
HOW TO USE: If this medication is given for prevention of hepatitis B after direct exposure to the virus, it is given by injection into a muscle by a healthcare professional. It is best to receive this medication as soon as possible after exposure. If you wait too long after being exposed, the medication may not be effective. Your doctor may also recommend vaccination after receiving this medication. Talk with your doctor about the best treatment for you.If this medication is given after a liver transplant to prevent return of hepatitis B infection, it is given by injection into a vein by a healthcare professional. For this use, it should be given on a regular schedule. To help you remember, mark your calendar with an appointment reminder.The dosage and schedule of injections is based on your medical condition, weight, and response to treatment.
SIDE EFFECTS: See also Warning section.Redness, pain, or tenderness at the injection site may occur. Nausea, vomiting, fever, chills, dizziness, headache, or back/joint pain may also occur. If any of these effects last or get worse, tell your doctor or pharmacist promptly.Remember that this medication has been prescribed because your doctor has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist promptly.In the US -Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch.In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.
PRECAUTIONS: See also Warning section.Before receiving hepatitis B immune globulin, tell your doctor or pharmacist if you are allergic to it; or to other immune globulin products; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.Before using this medication, tell your doctor or pharmacist your medical history, especially of: bleeding/blood clotting problems, a certain immune system problem (immunoglobulin A deficiency).This drug may make you dizzy. Alcohol or marijuana (cannabis) can make you more dizzy. Do not drive, use machinery, or do anything that needs alertness until you can do it safely. Limit alcoholic beverages. Talk to your doctor if you are using marijuana (cannabis).This medication is made from human blood. Even though the blood is carefully tested, and this medication goes through a special manufacturing process, there is an extremely small chance that you may get infections (such as hepatitis A) from the medication. Consult your doctor or pharmacist for more information.Some immune globulin products are made with maltose. This substance can cause false high blood sugar levels when your blood sugar is normal or even low. If you have diabetes, check with your doctor or pharmacist whether the product you are using contains maltose and whether your blood sugar testing supplies will work with this product. Rarely, serious problems have occurred when too much insulin was given because of false high sugar readings or when low blood sugar went untreated.Tell your doctor of any recent or planned immunizations/vaccinations. This medication may prevent a good response to certain live viral vaccines (such as measles, mumps, rubella, varicella). If you have recently received any of these vaccines, your doctor may have you tested for a response or have you vaccinated again later. If you plan on getting any of these vaccines, your doctor will instruct you about the best time to receive them so you get a good response.Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor.It is unknown if this drug passes into breast milk. Consult your doctor before breast-feeding.
DRUG INTERACTIONS: See also Warning section.Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval.This medication may interfere with certain lab tests (including certain blood sugar tests, Coomb's test), possibly causing false test results. The blood sugar interference can lead to serious (possibly fatal) consequences. Make sure lab personnel and all your doctors and pharmacists know you use this drug, and which type of blood sugar testing strips you use.
OVERDOSE: If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center.
NOTES: If you are receiving this medication on a regular schedule, lab and/or medical tests (such as levels of antibody in the blood) may be done while you are using this medication. Keep all medical and lab appointments. Consult your doctor for more details.
MISSED DOSE: It is important to get each dose of this medication as scheduled. If you miss a dose, ask your doctor or pharmacist right away for a new dosing schedule.
STORAGE: Not applicable. This medication is given in a hospital or doctor's office and will not be stored at home.
Information last revised July 2023. Copyright(c) 2023 First Databank, Inc.
IMPORTANT: HOW TO USE THIS INFORMATION: This is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate for you. This information is not individual medical advice and does not substitute for the advice of your health care professional. Always ask your health care professional for complete information about this product and your specific health needs.
Formulary
Adding plans allows you to compare formulary status to other drugs in the same class.
To view formulary information first create a list of plans. Your list will be saved and can be edited at any time.
Adding plans allows you to:
- View the formulary and any restrictions for each plan.
- Manage and view all your plans together – even plans in different states.
- Compare formulary status to other drugs in the same class.
- Access your plan list on any device – mobile or desktop.
