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
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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)

No Results

     activity indicator 
    No Interactions Found
    Interactions Found

    Contraindicated

      Serious - Use Alternative

        Significant - Monitor Closely

          Minor

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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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            Formulary

            FormularyPatient Discounts

            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.

            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.
            OR Other Restrictions
            Drugs that have restrictions other than prior authorization, quantity limits, and step therapy associated with each prescription.
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