Professional Information
Hepatitis B Immune Globulin (Human Systemic )
VA CLASSIFICATION
Primary: IM402
Commonly used brand name(s): Nabi-HB.
Note: For a listing of dosage forms and brand names by country availability, see Dosage Forms section(s).
Category:
Immunizing agent (passive) —
Indications
Note: Bracketed information in the Indications section refers to uses that are not included in U.S. product labeling.
Accepted
Hepatitis B, following percutaneous or permucosal exposure (prophylaxis) —Hepatitis B immune globulin (human) is indicated for prophylaxis of hepatitis B infection following acute exposure to hepatitis B surface antigen (HBsAg)-positive blood, plasma, or serum.
{01}
Hepatitis B, following perinatal exposure (prophylaxis)—Hepatitis B immune globulin (human) is indicated for prophylaxis of hepatitis B infection in infants born to mothers positive for HBsAg with or without hepatitis B e antigen (HBeAg).
{01}
Hepatitis B, following sexual exposure (prophylaxis)—Hepatitis B immune globulin (human) is indicated for prophylaxis of hepatitis B infection in sexual partners of HBsAg-positive persons.
{01}
Hepatitis B, following household exposure (prophylaxis)—Hepatitis B immune globulin (human) is indicated for prophylaxis of hepatitis B infection in infants less than 12 months of age whose mother or primary caregiver is positive for HBsAg and in other household contacts with an identifiable blood exposure to the index patient.
{01}
[Hepatitis B virus infection, recurrence of in liver transplant recipients (prophylaxis)]—Long-term administration of hepatitis B immune globulin (human) is indicated to prevent the recurrence of hepatitis B virus infection in liver transplant recipients.{07}{08}{09}{10}{11}{12}{13}{14}{15}{16}{17}{18}{19}
Pharmacology/Pharmacokinetics
Physicochemical characteristics:
Source—
The Nabi-HB manufacturing process includes a solvent/detergent treatment step (using tri-n-butyl phosphate and Triton X-100) that is effective in inactivating known enveloped viruses such as hepatitis B virus (HBV), hepatitis C virus (HCV), and human immunodeficiency virus (HIV). Nabi-HB is filtered using a Planova 35nm Virus Filter designed to increase product safety by reducing some known enveloped and non-enveloped viruses.{01}{05}
pH
6.25.{01}
Protective action
Hepatitis B immune globulin (human) products provide passive immunization for individuals exposed to the hepatitis B virus as evidenced by a reduction in the attack rate of hepatitis B following use.{01}
Protective effect
For an infant with perinatal exposure to a hepatitis B surface antigen (HBsAg)-positive and hepatitis B e antigen (HBeAg)-positive mother, a regimen combining one dose of hepatitis B immune globulin (human) with the hepatitis B vaccine series started soon after birth is 85–98% effective in preventing development of the HBV carrier state{01}. A regimen involving either multiple doses of hepatitis B immune globulin (human) alone or the vaccine series alone has a 70–90% efficacy, while a single dose of hepatitis B immune globulin (human) alone has 50% efficacy{01}.
Sexual partners of HBsAg-positive persons are at increased risk of acquiring HBV infection. A single dose of hepatitis B immune globulin (human) is 75% effective if administered within two weeks of the last sexual exposure to a person with acute hepatitis B{01}.
Distribution:
Volume of distribution (Vol D)— 15.3 ± 6.2L.{01}
Half-life:
24.8 ± 5.6 days.{01}
Time to peak concentration:
Maximum concentrations of hepatitis B immune globulin (human) were reached in 6.6± 3 days{01}.
Precautions to Consider
Pregnancy/Reproduction
Pregnancy—
Studies in humans have not been done.{01}
Studies in animals have not been done.{01}
FDA Pregnancy Category C.{01}
Breast-feeding
It is not known whether hepatitis B immune globulin (human) is distributed in human breast milk.{01}
Pediatrics
Appropriate studies performed to date have not demonstrated pediatrics-specific problems that would limit the usefulness of hepatitis B immune globulin (human) in children.{01}
Geriatrics
No information is available on the relationship of age to the effects of hepatitis B immune globulin in geriatric patients.
Drug interactions and/or related problems
The following drug interactions and/or related problems have been selected on the basis of their potential clinical significance (possible mechanism in parentheses where appropriate)—not necessarily inclusive (» = major clinical significance):
Note: Combinations containing any of the following medications, depending on the amount present, may also interact with this medication.
» Vaccines, live virus ( vaccination with live virus vaccines [with the exception of the oral poliovirus{06} and yellow fever{04}{06} vaccines] should be deferred until approximately three months after administration of hepatitis B immune globulin (human). It may be necessary to revaccinate persons who receive hepatitis immune globulin (human) shortly after live virus vaccination )
{01}
Medical considerations/Contraindications
The medical considerations/contraindications included have been selected on the basis of their potential clinical significance (reasons given in parentheses where appropriate)— not necessarily inclusive (» = major clinical significance).
Except under special circumstances, this medication should not be used when the following medical problem exists:
» Hypersensitivity to any human immune globulin, including hepatitis B immune globulin {01}
Risk-benefit should be considered when the following medical problems exist
» Coagulations disorders{01} or
» Thrombocytopenia, severe{01}{02} (intramuscular injections generally are contraindicated in patients with these conditions;{01} therefore, hepatitis B immune globulin [human] should be used only if the expected benefits outweigh the potential risks{01})
» Immunoglobulin A (IgA) deficiency{01} (individuals who are deficient in IgA may have the potential to develop IgA antibodies and have an anaphylactoid reaction)
{01}
Patient monitoring
The following may be especially important in patient monitoring (other tests may be warranted in some patients, depending on condition; » = major clinical significance):
» Antibodies, hepatitis B surface antigen{07} (monthly monitoring is recommended for the first 3 months of therapy to prevent early reinfection in liver transplant recipients;{07} thereafter, monitoring should continue on a periodic, but less frequent, schedule{07})
Side/Adverse Effects
The following side/adverse effects have been selected on the basis of their potential clinical significance (possible signs and symptoms in parentheses where appropriate)—not necessarily inclusive:
Note: Anaphylactic reactions have occurred rarely following administration of human immune globulins.{01}{05} However, there have been no reports of anaphylactic reactions following administration of hepatitis B immune globulin (human).{01}
Products made from human plasma may carry a risk of transmitting infectious agents, e.g., viruses, and theoretically, the Creutzfeldt-Jakob disease agent.{01}
Those indicating need for medical attention only if they continue or are bothersome
Incidence more frequent
Back pain {20}
headache {01}{20}
malaise (general feeling of discomfort){01}
myalgia (muscle aches or pain){01}
nausea {01}{12}
pain at injection site
{01}
Incidence less frequent or rare
Abdominal cramping {01}
ache at injection site {01}
arthralgia (joint pain){12}{18}
burning at injection site {01}
chills {01}
diarrhea {01}
erythema at injection site ( redness of skin; unusually warm skin){01}
fatigue (unusual tiredness or weakness ){01}
heat at injection site {01}
lightheadedness {01}
retching (feeling as if you are going to vomit){01}
skin rash {12}
Patient Consultation
As an aid to patient consultation, refer to Advice for the Patient, Hepatitis B Immune Globulin (Human) (Systemic) .
In providing consultation, consider emphasizing the following selected information (» = major clinical significance):
Before using this medication
» Conditions affecting use, especially:
Hypersensitivity to any human immune globulin, including hepatitis B immune globulin
Other medications, especially vaccines produced from a live virus (except the oral poliovirus and yellow fever vaccines)
Other medical problems, especially coagulation disorders, immunoglobulin A (IgA) deficiency, or severe thrombocytopenia
Proper use of this medication
Medication preferably injected into a muscle in the upper arm or outer thigh
» Proper dosing
General Dosing Information
Hepatitis B immune globulin is indicated for intramuscular use only.{01} The preferred site of injection in infants and neonates is the anterolateral aspect of the upper thigh.{03}{05} The preferred sites of injection in other patients are the anterolateral aspect of the upper thigh and the deltoid muscle of the upper arm.{01} If the buttock must be used, the injection should be made into the outer or upper quadrant and not into the central region.{01} To minimize the possiblity of involving the sciatic nerve, the needle should be directed anteriorly rather than inferiorly or perpendicular to the skin.{01}
Any infections thought by a physician possibly to have been transmitted by Nabi-HB™ should be reported by the physician or other health care provider to Nabi at 1-800-458-4244.{01}
For prophylaxis following percutaneous or permucosal exposure to hepatitis B
Hepatitis B immune globulin should be administered as soon as possible following exposure.{01} The degree of efficacy is not known if the product is given more than 7 days following exposure.{01}
For prophylaxis following perinatal exposure to hepatitis B
The degree of efficacy is not known if hepatitis B immune globulin is given more than 48 hours following birth.{01}
Parenteral Dosage Forms
Note: Bracketed uses in the Dosage Forms section refer to categories of use and/or indications that are not included in U.S. product labeling.
HEPATITIS B IMMUNE GLOBULIN USP
Note: Each vial of hepatits B immune globulin is labeled with the anti–hepatitis B surface antigen (anti-HBs) activity expressed in International Units (IU) per vial.{01} This potency assignment is referenced to the World Health Organization (WHO) standard and exceeds the potency of anti-HBs activity in a U.S. reference hepatitis B immune globulin.{01} The U.S. reference has been tested against the WHO standard and has been found to be equal to 208 IU per mL.{01}{02}
Usual Adult Dose
Percutaneous or permucosal exposure to hepatitis B {01}
• For unvaccinated patients— Intramuscular, 0.06 mL per kg of body weight followed by initiation of the hepatitis B virus vaccine recombinant vaccination series.{01}
• For vaccinated patients— Intramuscular, if tests reveal < 10 mIU per mL of anti-HBs activity, 0.06 mL per kg of body weight in addition to a hepatitis B virus vaccine recombinant booster dose.{01}
Sexual exposure to hepatitis B{01}
Intramuscular, 0.06 mL per kg of body weight followed by initiation of the hepatitis B virus vaccine recombinant vaccination series within 14 days of the last sexual contact or if sexual contact with the infected person will continue.
{01}
[Prevention of hepatitis B virus infection recurrence in liver transplant recipients]
Because various dosing protocols are used by different liver transplant centers, the medical literature should be consulted for a specific dosage regimen.{07}
Usual Pediatric Dose
Perinatal exposure to hepatitis B{01}
• For infants of HBsAg-positive mothers— Intramuscular, 0.5 mL within the first 12 hours after birth.{01}
• For infants of mothers not screened for HBsAg— Intramuscular, 0.5 mL as soon as possible and within the first 7 days after birth if the mother is found to be HBsAg positive.{01}
Household exposure to hepatitis B{01}
Infants less than 12 months of age: Intramuscular, 0.5 mL.
{01}
Note: Infants should receive standard hepatitis B virus vaccine recombinant vaccinations regardless of their mothers' infection status.{01}
Strength(s) usually available
U.S.—
1 mL single dose vial (greater than 312 IU) (Rx) [Nabi-HB (glycine 0.15 M) ( polysorbate 80 0.01%) (sodium chloride 0.075 M){01}]
5 mL single dose vial (greater than 1560 IU) [Nabi-HB (glycine 0.15 M) (polysorbate 80 0.01% ) (sodium chloride 0.075 M)]{01}
Packaging and storage:
Store between 2 and 8°C (36 and 46°F), in a refrigerator. Do not freeze.{01}
Stability:
Administration of hepatitis B immune globulin should begin within 6 hours after entering the vial.{01} Partially used vials should be discarded.{01}
Incompatibilities:
It is recommended that hepatitis B immune globulin be administered at a separate site and without mixing with intravenous fluids or other medications.{05}
Developed: 09/10/2001
Revised: 06/02/2002
References
- Product Information: Nabi-HB™, hepatitis B immune globulin (human). Nabi, Boca Raton, FL. (PI revised 06/2000) reviewed 08/2001.
- Manufacturer comment, 10/17/2001.
- Expert committee comment, 10/12/2001.
- Expert committee comment, 10/08/2001.
- Expert committee comment, 10/26/2001.
- Expert committee comment, 10/11/2001.
- Consensus on review of evidence table, 04/03/2002.
- Sawyer RG, McGory RW, Gaffey MJ, et al. Improved clinical outcomes with liver transplantation for hepatitis B–induced chronic liver failure using passive immunization. Ann Surg 1998; 227: 841-7.
- Gugenheim J, Ouzan D, Mouiel J. Absence of initial viral replication and long-term high dose immunoglobulin administration improve results of hepatitis B virus recurrence prophylaxis after liver transplantation. Transplant Proc 1997; 29: 517-8.
- Grazi GL, Mazziotti A, Sama C, et al. Liver transplantation in HBsAg-positive HBV-DNA–negative cirrhotics: immunoprophylaxis and long-term outcome. Liver Transpl Surg 1996; 2: 418-25.
- Nymann T, Shokouh-Amiri MH, Vera SR, et al. Prevention of hepatitis B recurrence with indefinite hepatitis B immune globulin (HBIG) prophylaxis after liver transplantation. Clin Transplant 1996; 10: 668-75.
- Terrault NA, Zhou S, Combs C, et al. Prophylaxis in liver transplant recipients using a fixed dosing schedule of hepatitis B immunoglobulin. Hepatology 1996; 24: 1327-33.
- Langrehr JM, Lemmens HP, Keck H, et al. Liver transplantation in hepatitis B surface antigen positive patients with postoperative long-term immunoprophylaxis. Transplant Proc 1995; 27: 1215-6.
- König V, Hopf U, Neuhaus P, et al. Long-term follow-up of hepatitis B virus–infected recipients after orthotopic liver transplantation. Transplantation 1994; 58: 553-9.
- Terrault NA, Hahn J, Ascher N, et al. Prophylactic therapy is the most important factor determining recurrence in hepatitis B surface antigen positive (HBsAg+) patients undergoing liver transplantation (OLT) [abstract]. Hepatology 1994; 20: 138A.
- Samuel D, Muller R, Alexander G, et al. Liver transplantation in European patients with the hepatitis B surface antigen. N Engl J Med 1993; 329: 1842-7.
- Müller R, Gubernatis G, Farle M, et al. Liver transplantation in HBs antigen (HBsAg) carriers: prevention of hepatitis B virus (HBV) recurrence by passive immunization. J Hepatol 1991; 13: 90-6.
- Samuel D, Bismuth A, Mathieu D, et al. Passive immunoprophylaxis after liver transplantation in HBsAg-positive patients. Lancet 1991; 337: 813-5.
- Blumhardt G, Neuhaus P, Bechstein WO, et al. Liver transplantation in HBsAg positive patients. Transplant Proc 1990; 22: 1517-8.
- Al-Hemsi B, McGory RW, Shepard B, et al. Liver transplantation for hepatitis B cirrhosis: clinical sequela of passive immunization. Clin Transplantation 1996; 10: 668-75.
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