hepatitis B immune globulin (HBIG) (Rx)

Brand and Other Names:h big, Hep B Gammagee, more...HepaGam B, HyperHep, HyperHEP B S/D
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Dosing & Uses

AdultPediatric

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

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Interactions

Interaction Checker

and hepatitis B immune globulin (HBIG)

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    Contraindicated

      Serious - Use Alternative

        Significant - Monitor Closely

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            Contraindicated (0)

              Serious - Use Alternative (0)

                Monitor Closely (7)

                • BCG vaccine live

                  hepatitis B immune globulin (HBIG) decreases effects of BCG vaccine live by pharmacodynamic antagonism. Use Caution/Monitor. Separate by 3 months.

                • 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.

                • 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.

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                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)

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                Warnings

                Contraindications

                Hypersensitivity to human globulin

                Severe thrombocytopenia or coagulation disorders

                Cautions

                IgA deficiency, thrombocytopenia, coagulopathies

                May elevate alkaline phosphatase, AST, creatinine

                May decrease WBC

                Use caution in patients with bleeding disorders

                Thrombotic events reported

                Do NOT give IV

                Separate live vaccines by 3 months

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                Pregnancy & Lactation

                Pregnancy Category: C

                Lactation: Not known if excreted in breast milk

                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.

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                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

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                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
                Nabi-HB intramuscular
                -
                greatr than 312 unit/mL vial
                Nabi-HB intramuscular
                -
                greater than 1,560 unit/5 mL vial

                Copyright © 2010 First DataBank, Inc.

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                Patient Handout

                Patient Education
                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 persist or worsen, 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, seek immediate medical attention 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 not known whether 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 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. Tell all laboratory personnel and all your doctors and pharmacists that you use this medication, 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, laboratory and/or medical tests (such as levels of antibody in the blood) may be performed periodically to monitor your progress or check for side effects. 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 August 2021. Copyright(c) 2021 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.

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                Formulary

                FormularyPatient Discounts

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                The above information is provided for general informational and educational purposes only. Individual plans may vary and formulary information changes. Contact the applicable plan provider for the most current information.

                Tier Description
                1 This drug is available at the lowest co-pay. Most commonly, these are generic drugs.
                2 This drug is available at a middle level co-pay. Most commonly, these are "preferred" (on formulary) brand drugs.
                3 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs.
                4 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
                5 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
                6 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
                NC NOT COVERED – Drugs that are not covered by the plan.
                Code Definition
                PA Prior Authorization
                Drugs that require prior authorization. This restriction requires that specific clinical criteria be met prior to the approval of the prescription.
                QL Quantity Limits
                Drugs that have quantity limits associated with each prescription. This restriction typically limits the quantity of the drug that will be covered.
                ST Step Therapy
                Drugs that have step therapy associated with each prescription. This restriction typically requires that certain criteria be met prior to approval for the prescription.
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                Medscape prescription drug monographs are based on FDA-approved labeling information, unless otherwise noted, combined with additional data derived from primary medical literature.