NABI-HB- hepatitis b immune globulin (human) liquid

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Active ingredient:
HUMAN HEPATITIS B VIRUS IMMUNE GLOBULIN (UNII: XII270YC6M) (HUMAN HEPATITIS B VIRUS IMMUNE GLOBULIN - UNII:XII270YC6M)
Available from:
ADMA Biologics, Inc.
Administration route:
INTRAMUSCULAR
Prescription type:
PRESCRIPTION DRUG
Therapeutic indications:
Nabi-HB, Hepatitis B Immune Globulin (Human), is indicated for treatment of acute exposure to blood containing HBsAg, perinatal exposure of infants born to HBsAg-positive mothers, sexual exposure to HBsAg-positive persons and household exposure to persons with acute HBV infec- tion in the following settings: - Acute Exposure to Blood Containing HBsAg: Following either parenteral exposure (needlestick, bite, sharps), direct mucous membrane contact (accidental splash), or oral ingestion (pipetting accident), involving HBsAg-positive materials such as blood, plasma, or serum. - Perinatal Exposure of Infants Born to HBsAg-positive Mothers: Infants born to mothers positive for HBsAg with or without HBeAg12 . - Sexual Exposure to HBsAg-positive Persons: Sexual partners of HBsAg-positive persons. - Household Exposure to Persons with Acute HBV Infection: Household Exposure to Persons with Acute HBV Infection: Infants less than 12 months old whose mother or primary caregiver is positive for HBsAg. Other househol
Product summary:
Nabi-HB, Hepatitis B Immune Globulin (Human), is supplied as:
Authorization status:
Biologic Licensing Application
Authorization number:
69800-4202-1, 69800-4203-1

NABI-HB- hepatitis b immune globulin (human) liquid

ADMA Biologics, Inc.

----------

Hepatitis B Immune Globulin (Human)

Nabi-HB

Solvent/Detergent Treated and Filtered

DESCRIPTION

Hepatitis B Immune Globulin (Human), Nabi-HB, is a sterile solution of immunoglobulin (5 ± 1%

protein) containing antibodies to hepatitis B surface antigen (anti-HBs). It is prepared from plasma

donated by individuals with high titers of anti-HBs. The plasma is processed using a modified Cohn 6 /

Oncley 9 cold-alcohol fractionation process

with two added viral reduction steps described below.

Nabi-HB is formulated in 0.042-0.108 M sodium chloride, 0.10-0.20 M glycine, and 0.005-0.050%

polysorbate 80, at pH 5.8-6.5. The product is supplied as a nonturbid sterile liquid in single dose vials

and appears as clear to opalescent. It contains no preservative and is intended for single use by the

intramuscular route only.

Each plasma donation used for the manufacture of Nabi-HB is tested for the presence of hepatitis B

virus (HBV) surface antigen (HBsAg), human immunodeficiency viruses (HIV) 1/2, and hepatitis C virus

(HCV) antibodies. In addition, pooled samples of Source Plasma used in the manufacture of this product

are tested by FDA licensed Nucleic Acid Testing (NAT) for HIV and HCV and found to be negative.

Investigational NAT for hepatitis A virus (HAV) and HBV is also performed on pooled samples of all

Source Plasma used, and found to be negative; however, the significance of a negative result has not

been established. Investigational NAT for parvovirus B19 (B19) is also performed on pooled samples

of all Source Plasma and the limit for B19 DNA in a manufacturing pool is set not to exceed 10 IU/mL.

The manufacturing steps for Nabi-HB are designed to reduce the risk of transmission of viral disease.

The solvent/detergent treatment step, using tri-n-butyl phosphate and Triton X-100, is effective in

inactivating known enveloped viruses such as hepatitis B virus (HBV), hepatitis C virus (HCV), and

human immunodeficiency virus (HIV) . Virus filtration, using a Planova

35 nm Virus Filter, is

effective in reducing some known enveloped and non-enveloped viruses . The inactivation and

reduction of known enveloped and non-enveloped model viruses were validated in laboratory studies as

summarized in the following table:

Table 1 Log Reduction of Test Viruses

BVD = Bovine Viral Diarrhea Virus

EMC = Encephalomyocarditis Virus

HIV = Human Immunodeficiency Virus

PVB19 = Parvovirus B19

PPV = Porcine Parvovirus

PRV = Pseudorabies Virus

NT = not tested

* Value not included in

cumulative clearance

Test Virus

HIV

BVD

PRV

EMC

PPV

Model Virus:

Hepatitis A

PVB19

Envelope/Genome:

yes/RNA

yes/RNA

yes/DNA

no/RNA

no/DNA

Manufacturing Step

Precipitation of Cohn

Fraction III

>5.9

Cuno Filtration

>6.6

Solvent/Detergent

>4.2

>6.9

>6.4

Nanofiltration

>7.4

>6.9

>5.7

Cumulative

>17.5

>17.4

>15.8

>14.0

9.3

®

5

Product potency is expressed in international units (IU) by comparison to the World Health Organization

(WHO) standard. Each milliliter (mL) of product contains greater than 312 IU anti-HBs. The potency of

each milliliter of Nabi-HB exceeds the potency of anti-HBs in a U.S. reference hepatitis B immune

globulin (FDA). The U.S. reference has been tested by Biotest Pharmaceuticals against the WHO

standard and found to be equal to 208 IU/mL.

CLINICAL PHARMACOLOGY

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

Clinical studies

conducted prior to 1983 with hepatitis B immune globulins similar to Nabi-HB

indicate the advantage of simultaneous administration of hepatitis B vaccine and Hepatitis B Immune

Globulin (Human). The Centers for Disease Control and Prevention Advisory Committee on

Immunization Practices (ACIP) advises that the combination prophylaxis be provided in certain instances

of exposure based upon the increased efficacy found with that regimen in neonates

. Cases of

hepatitis B are rarely seen following exposure to HBV in persons with preexisting anti-HBs. However,

no prospective studies have been performed on the efficacy of concurrent hepatitis B vaccine and

Hepatitis B Immune Globulin (Human) administration following parenteral exposure, mucous membrane

contact, or oral ingestion in adults.

Infants born to HBsAg-positive mothers are at risk of being infected with HBV and becoming chronic

carriers

. The risk is especially great if the mother is also HBeAg-positive

. Studies conducted with

hepatitis B immune globulins similar to Nabi-HB indicated that for an infant with perinatal exposure to

an HBsAg-positive and HBeAg-positive mother, a regimen combining one dose of Hepatitis B Immune

Globulin (Human) at birth with the hepatitis B vaccine series started soon after birth is 85-98%

effective in preventing development of the HBV carrier state

. Regimens involving either multiple

doses of Hepatitis B Immune Globulin (Human) alone or the vaccine series alone have a 70-90%

efficacy, while a single dose of Hepatitis B Immune Globulin (Human) alone has 50% efficacy

Since infants have close contact with primary caregivers and they have a higher risk of becoming HBV

carriers after acute HBV infection, prophylaxis of an infant less than 12 months of age with Hepatitis B

Immune Globulin (Human) and hepatitis B vaccine is indicated if the mother or primary caregiver has

acute HBV infection

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

Pharmacokinetics

Pharmacokinetics trials

of Nabi-HB, Hepatitis B Immune Globulin (Human), given intramuscularly to

50 healthy volunteers demonstrated pharmacokinetic parameters similar to those reported by

Scheiermann and Kuwert

. The half-life for Nabi-HB was 23.1 ± 5.5 days. The clearance rate was

0.35 ± 0.12 L/day and the volume of distribution was 11.2 ± 3.4 L.

Maximum concentration of Nabi-HB was reached in 6.5 ± 4.3 days. The maximum concentration of anti-

HBs and the area under the time-concentration curve achieved by Nabi-HB were bioequivalent to that of

another licensed Hepatitis B Immune Globulin (Human) when compared in the same pharmacokinetics

trial. Comparability of pharmacokinetics between Nabi-HB and a commercially available hepatitis B

immunoglobulin indicate that similar efficacy of Nabi-HB should be inferred.

INDICATIONS AND USAGE

10,11

15-17

Nabi-HB, Hepatitis B Immune Globulin (Human), is indicated for treatment of acute exposure to blood

containing HBsAg, perinatal exposure of infants born to HBsAg-positive mothers, sexual exposure to

HBsAg-positive persons and household exposure to persons with acute HBV infec- tion in the

following settings:

Acute Exposure to Blood Containing HBsAg:

Following either parenteral exposure (needlestick, bite, sharps), direct mucous membrane contact

(accidental splash), or oral ingestion (pipetting accident), involving HBsAg-positive materials such as

blood, plasma, or serum.

Perinatal Exposure of Infants Born to HBsAg-positive Mothers:

Infants born to mothers positive for HBsAg with or without HBeAg

Sexual Exposure to HBsAg-positive Persons:

Sexual partners of HBsAg-positive persons.

Household Exposure to Persons with Acute HBV Infection:

Infants less than 12 months old whose mother or primary caregiver is positive for HBsAg. Other

household contacts with an identifiable blood exposure to the index patient.

Nabi-HB is indicated for intramuscular use only.

CONTRAINDICATIONS

Individuals known to have had an anaphylactic or severe systemic reaction to human globulin should not

receive Nabi-HB, Hepatitis B Immune Globulin (Human), or any other human immune globulin. Nabi-HB

contains not more than 40 micrograms per mL IgA. Individuals who are deficient in IgA have the

potential to develop antibodies against IgA and anaphylactic reactions. The physician must weigh the

potential benefit of treatment with Nabi-HB against the potential for hypersensitivity reactions.

WARNINGS

In patients who have severe thrombocytopenia or any coagulation disorder that would contraindicate

intramuscular injections, Nabi-HB, Hepatitis B Immune Globulin (Human), should be given only if the

expected benefits outweigh the potential risks.

Nabi-HB is made from human plasma. Products made from human plasma may contain

infectious agents, e.g., viruses, and theoretically, the Creutzfeldt-Jakob disease (CJD) agent. The

risk that such products can transmit an infectious agent has been reduced by screening plasma

donors for prior exposure to certain viruses, by testing for the presence of certain current viral

infections, and by inactivating and/or reducing certain viruses. 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 HBV, HCV, and HIV. Nabi-

HB is filtered using a Planova

35 nm Virus Filter that is effective in reducing the levels of some

enveloped and non-enveloped viruses. These two processes are designed to increase product

safety. Despite these measures, such products can still potentially transmit disease. There is also

the possibility that unknown infectious agents may be present in such products. ALL infections

thought by a physician possibly to have been transmitted by this product should be reported by

the physician or other health care provider to ADMA Biologics at 1-800-458-4244. The physician

should discuss the risks and benefits of this product with the patient.

®

®

PRECAUTIONS

General

Nabi-HB, Hepatitis B Immune Globulin (Human), must be administered only intramuscularly for post-

exposure prophylaxis. The preferred sites for intramuscular injections are the anterolateral aspect of

the upper thigh and the deltoid muscle. If the buttock is used due to the volume to be injected, the central

region should be avoided; only the upper, outer quadrant should be used, and the needle should be

directed anterior (i.e., not inferior or perpendicular to the skin) to minimize the possibility of

involvement with the sciatic nerve

The 50 healthy volunteers who received Nabi-HB in pharmacokinetic studies were followed for 84

days for possible development of anti-HCV antibodies. No subject seroconverted.

Drug Interactions

Vaccination with live virus vaccines should be deferred until approximately three months after

administration of Nabi-HB, Hepatitis B Immune Globulin (Human). It may be necessary to revaccinate

persons who received Nabi-HB shortly after live virus vaccination.

There are no available data on concomitant use of Nabi-HB and other drugs; therefore, Nabi-HB should

not be mixed with other drugs.

Pregnancy Category C

Animal reproduction studies have not been conducted with Nabi-HB. It is also not known whether Nabi-

HB can cause fetal harm when administered to a pregnant woman or can affect a woman’s ability to

conceive. Nabi-HB should be given to a pregnant woman only if clearly indicated.

Nursing Mothers

It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human

milk, caution should be exercised when Nabi-HB is administered to a nursing mother.

Pediatric Use

Safety and effectiveness in the pediatric population have not been established for Nabi-HB. However,

the safety and effectiveness of similar hepatitis B immune globulins have been demonstrated in infants

and children

Geriatric Use

Clinical studies of Nabi-HB did not include sufficient numbers of subjects aged 65 and over to

determine whether they respond differently than younger subjects. Other reported clinical experience

has not identified differences in responses between the elderly and younger patients.

ADVERSE REACTIONS SECTION

Fifty male and female volunteers received Nabi-HB, Hepatitis B Immune Globulin (Human),

intramuscularly in pharmacokinetics trials

. The number of patients with reactions related to the

administration of Nabi-HB included local reactions such as erythema 6 (12%) and ache 2 (4%) at the

injection site, as well as systemic reactions such as headache 7 (14%), myalgia 5 (10%), malaise 3 (6%),

nausea 2 (4%), and vomiting 1 (2%). The majority (92%) of reactions were reported as mild. The

following adverse events were reported in the pharmacokinetics trials and were considered probably

related to Nabi-HB: elevated alkaline phosphatase 2 (4%), ecchymosis 1 (2%), joint stiffness 1 (2%),

elevated AST 1 (2%), decreased WBC 1 (2%), and elevated creatinine 1 (2%). All adverse events were

mild in intensity. There were no serious adverse events.

No anaphylactic reactions with Nabi-HB have been reported. However, these reactions, although rare,

have been reported following the injection of human immune globulins

OVERDOSAGE

Although no data are available, clinical experience reported with other human immune globulins

suggests that the only manifestations of overdose with Nabi-HB, Hepatitis B Immune Globulin (Human),

would be pain and tenderness at the injection site.

DOSAGE AND ADMINISTRATION

This product is for intramuscular use only. The use of this product by the intravenous route is not

indicated. Parenteral drug products should be inspected visually for particulate matter and discoloration

prior to administration.

It is important to use a separate vial, sterile syringe, and needle for each individual patient, in order to

prevent transmission of infectious agents from one person to another. Any vial of Nabi-HB, Hepatitis

B Immune Globulin (Human) that has been entered should be used promptly. Do not reuse or

save for future use. This product contains no preservative; therefore, partially used vials should

be discarded immediately.

Hepatitis B Immune Globulin (Human) may be administered at the same time (but at a different site), or up

to one month preceding hepatitis B vaccination without impairing the active immune response to

hepatitis B vaccine

Acute Exposure to Blood Containing HBsAg

Table 2 summarizes prophylaxis for percutaneous (needlestick, bite, sharps), ocular, or mucous

membrane exposure to blood according to the source of exposure and vaccination status of the exposed

person. For greatest effectiveness, passive prophylaxis with Hepatitis B Immune Globulin (Human)

should be given as soon as possible after exposure, as its value after seven days following exposure is

unclear

. An injection of 0.06 mL/kg of body weight should be administered intramuscularly as soon

as possible after exposure and within 24 hours, if possible. Consult the hepatitis B vaccine package

insert for dosage information regarding the vaccine.

For persons who refuse hepatitis B vaccine or are known non-responders to vaccine, a second dose of

Hepatitis B Immune Globulin (Human) should be given one month after the first dose

Table 2 Recommendations for Hepatitis B Prophylaxis Following Percutaneous or Permucosal

Expos ure

Exposed Person

Source

Unvaccinated

Vaccinated

HBsAg-positive

1. Hepatitis B Immune Globulin

(Human) X1 immediately*

2. Initiate HB vaccine series†

1. Test exposed person for anti-

2. If inadequate antibody ,

Hepatitis B Immune Globulin

(Human) X 1 immediately plus

either HB vaccine booster

dose or second dose of

Hepatitis B Immune Globulin

(Human) one month later

12

Hepatitis B Immune Globulin (Human) dose of 0.06 mL/kg IM.

See manufacturers’ recommendation for appropriate dose.

Less than 10 mIU/mL anti-HBs by radioimmunoassay, negative by enzyme immunoassay.

Two doses of Hepatitis B Immune Globulin (Human) is preferred if no response after at least four

doses of vaccine.

Known Source - High Risk for

HBsAg-positive

1. Initiate HB vaccine series

2. Test source for HBsAg. If

positive, Hepatitis B Immune

Globulin (Human) X 1

1. Test source for HBsAg only

if exposed is vaccine

nonresponder; if source is

HBsAg-positive, give

Hepatitis B Immune Globulin

(Human) X 1 immediately plus

either HB vaccine booster

dose or second dose of

Hepatitis B Immune Globulin

(Human) one month later

Known Source - Low Risk for

HBsAg-positive

Initiate HB vaccine series

Nothing required

Unknown Source

Initiate HB vaccine series

Nothing required

Prophylaxis of Infants Born to Mothers who are Positive for HBsAg with or without HBeAg

Table 3 contains the recommended schedule of hepatitis B prophylaxis for infants born to mothers that

are either known to be positive for HBsAg or have not been screened. Infants born to mothers known to

be HBsAg-positive should receive 0.5 mL Hepatitis B Immune Globulin (Human) after physiologic

stabilization of the infant and preferably within 12 hours of birth. The hepatitis B vaccine series should

be initiated simultaneously, if not contraindicated, with the first dose of the vaccine given concurrently

with the Hepatitis B Immune Globulin (Human), but at a different site. Subsequent doses of the vaccine

should be administered in accordance with the recommendations of the manufacturer.

Women admitted for delivery, who were not screened for HBsAg during the prenatal period, should be

tested. While test results are pending, the newborn infant should receive hepatitis B vaccine within 12

hours of birth (see manufacturers’ recommendations for dose). If the mother is later found to be

HBsAg-positive, the infant should receive 0.5 mL Hepatitis B Immune Globulin (Human) as soon as

possible and within seven days of birth; however, the efficacy of Hepatitis B Immune Globulin (Human)

administered after 48 hours of age is not known

. Testing for HBsAg and anti-HBs is recommended

at 12-15 months of age. If HBsAg is not detectable and anti-HBs is present, the child has been

protected

Table 3 Recommended Schedule of Hepatitis B Immunoprophylaxis to Prevent Perinatal

Transmission of Hepatitis B Virus Infection

Age of Infant

Administer

Infant Born to mother known to be

HBsAg-positive

Infant born to mother not

screened for HBsAg

First Vaccination

Birth (within 12 hours)

Birth (within 12 hours)

Hepatitis B Immune Globulin

(Human)

Birth (within 12 hours)

If mother is found to be HBsAg-

positive, administer dose to infant

as soon as possible, not later than

1 week after birth

Second Vaccination

1 month

1-2 months

Third Vaccination

6 months

6 months

10,19

19

See manufacturers’ recommendations for appropriate dose.

0.5 mL administered IM at a site different from that used for the vaccine.

See ACIP recommendation.

Sexual Exposure to HBsAg-positive Persons

All susceptible persons whose sexual partners have acute hepatitis B infection should receive a single

dose of Hepatitis B Immune Globulin (Human) (0.06 mL/kg) and should begin the hepatitis B vaccine

series, if not contraindicated, within 14 days of the last sexual contact or if sexual contact with the

infected person will continue. Administering the vaccine with Hepatitis B Immune Globulin (Human)

may improve the efficacy of post exposure treatment. The vaccine has the added advantage of

conferring long-lasting protection

Household Exposure to Persons with Acute HBV Infection

Prophylaxis of an infant less than 12 months of age with 0.5 mL Hepatitis B Immune Globulin (Human)

and hepatitis B vaccine is indicated if the mother or primary caregiver has acute HBV infection.

Prophylaxis of other household contacts of persons with acute HBV infection is not indicated unless

they had an identifiable blood exposure to the index patient, such as by sharing toothbrushes or razors.

Such exposures should be treated

like sexual exposures. If the index patient becomes an HBV carrier, all household contacts should

receive hepatitis B vaccine

HOW SUPPLIED

Nabi-HB, Hepatitis B Immune Globulin (Human), is supplied as:

NDC Number

Contents

69800-4202-1 a carton containing a 1 mL dose in a single-use vial (>312 IU) and package insert

69800-4203-1 a carton containing a 5 mL dose in a single-use vial (>1560 IU) and package insert

STORAGE

Refrigerate between 2 to 8 °C (36 to 46 °F). Do not freeze. Do not use after expiration date. Use within

6 hours after the vial has been entered.

REFERENCES

1. Cohn E.J., Strong W.L., Mulford D.J., Ashworth J.N., Melin M., Taylor H.L. Preparation and

Properties of Serum and Plasma Proteins IV. A system for the separation into fractions of the protein

and lipoprotein components of biological tissues and fluids. J Am Chem Soc 1946, 68: 459-475.

2. Oncley J.L, Melin M, Richert D.A, Cameron J. W, Gross P.M. The separation of antibodies,

isoagglutinins, prothrombin, plasminogen and b1-lipoproteins into sub-fractions of human plasma. J

Am Chem Soc 1949, 71:541-550.

3. Horowitz B: Investigations into the application of tri(n-butyl)phosphate/detergent mixtures to blood

derivatives. Morgenthaler J (ed): Virus Inactivation in Plasma Products, Curr Stud Hematol Blood

Transfus 1989; 56:83-96.

4. Burnouf T: Value of virus filtration as method for improving the safety of plasma products. Vox

Sang 1996; 70:235-236.

5. Unpublished data on file, Viral Validation Study Reports, Biotest Pharmaceuticals.

6. Grady GF, and Lee VA: Hepatitis B immune globulin - prevention of hepatitis from accidental

exposure among medical personnel. N Engl J Med 1975; 293:1067-1070.

7. Seeff LB, et al.: Type B hepatitis after needle-stick exposure: Prevention with hepatitis B immune

globulin. Ann Int Med 1978; 88:285-293.

8. Krugman S, and Giles JP: Viral hepatitis, type B (MS-2-strain). Further observations on natural

history and prevention. N Engl J Med 1973; 288:755-760.

9. Hoofnagle JH, et al.: Passive - active immunity from hepatitis B immune globulin. Ann Int Med 1979;

91:813-818.

10. Beasley RP, et al.: Efficacy of hepatitis B immune globulin for prevention of perinatal transmission

of the hepatitis B virus carrier state: Final report of a randomized double-blind, placebo - controlled

trial. Hepatology 1983; 3:135-141.

11. Szmuness W, et al.: Passive active immunisation against hepatitis B: Immunogenicity studies in adult

Americans. Lancet 1981; 1:575-577.

12. Centers for Disease Control: Recommendations for protection against viral hepatitis.

Recommendations of the Immunization Practices Advisory Committee (ACIP). MMWR 1985;

34(22):313-335.

13. Shiraki Y, et al.: Hepatitis B surface antigen and chronic hepatitis in infants born to asymptomatic

carrier mothers. Am J Dis Child 1977; 131:644-647.

14. Beasley RP, et al.: The e antigen and vertical transmission of hepatitis B surface antigen. Am J

Epidemiol 1977; 105:94-98.

15. Wong VCW, et al.: Prevention of the HBsAg carrier state in newborn infants of mothers who are

chronic carriers of HBsAg and HBeAg by administration of hepatitis B vaccine and hepatitis B

immunoglobulin: Double-blind randomized placebo-controlled study. Lancet 1984; 1:921-926.

16. Poovorawan Y, et al.: Long term hepatitis B vaccine in infants born to hepatitis B e antigen positive

mothers. Archives of Diseases in Childhood 1997; 77:F47-F51.

17. Stevens CE, et al.: Perinatal Hepatitis B virus transmission in the United States: Prevention by

passive-active immunization. JAMA 1985; 253:1740-1745.

18. Jhaveri R, et al.: High titer multiple dose therapy with HBIG in newborn infants of HBsAg positive

mothers. J Pediatr 1980; 97:305-308.

19. Centers for Disease Control: Hepatitis B virus: A comprehensive strategy for eliminating

transmission in the United States through universal childhood vaccination. Recommendations of the

Immunization Practices Advisory Committee (ACIP). MMWR 1991; 40(13):1-25.

20. Data on file, Biotest Pharmaceuticals.

21. Scheiermann N, Kuwert EK: Uptake and elimination of hepatitis B immunoglobulins after

intramuscular application in man. Develop Biol Standard 1983; 54:347.

22. Centers for Disease Control: General recommendations on immunization. Recommendations of the

Advisory Committee on Immunization Practices (ACIP). MMWR 1994; 43:1-38.

23. Ellis EF, Henney CS: Adverse reactions following administration of human gamma globulin. J

Allerg 1969; 43:45-54.

Manufactured by: ADMA Biologics, Inc. Boca Raton, FL 33487

U.S. License No. 2019

July 2019

PRINCIPAL DISPLAY PANEL - NDC: 69800-4202-2 - Vial Label

PRINCIPAL DISPLAY PANEL - NDC: 69800-4202-1 - Carton

Nabi-HB Carton (1 mL)

PRINCIPAL DISPLAY PANEL - NDC: 69800-4203-2 - Vial Label

PRINCIPAL DISPLAY PANEL - NDC: 69800-4202-1 - Carton

Nabi-HB Carton (5 mL)

NABI-HB

hepatitis b immune globulin (human) liquid

Product Information

Product T ype

HUMAN PRESCRIPTION DRUG

Ite m Code (Source )

NDC:6 9 8 0 0 -420 2

Route of Administration

INTRAMUSCULAR

Active Ingredient/Active Moiety

Ingredient Name

Basis of Strength

Stre ng th

HUMAN HEPATITIS B VIRUS IMMUNE GLO BULIN (UNII: XII270 YC6 M) (HUMAN

HUMAN HEPATITIS B VIRUS

312 [iU]

HEPATITIS B VIRUS IMMUNE GLOBULIN - UNII:XII270 YC6 M)

IMMUNE GLOBULIN

in 1 mL

Packag ing

#

Item Code

Package Description

Marketing Start

Date

Marketing End

Date

1

NDC:6 9 8 0 0 -420 2-

1 in 1 CARTON

10 /23/20 0 1

1

1 mL in 1 VIAL, SINGLE-USE; Type 0 : No t a Co mbinatio n

Pro duc t

Marketing Information

Marke ting Cate gory

Application Numbe r or Monograph Citation

Marke ting Start Date

Marke ting End Date

BLA10 39 45

10 /23/20 0 1

NABI-HB

hepatitis b immune globulin (human) liquid

Product Information

Product T ype

HUMAN PRESCRIPTION DRUG

Ite m Code (Source )

NDC:6 9 8 0 0 -420 3

Route of Administration

INTRAMUSCULAR

Active Ingredient/Active Moiety

Ingredient Name

Basis of Strength

Stre ng th

HUMAN HEPATITIS B VIRUS IMMUNE GLO BULIN (UNII: XII270 YC6 M) (HUMAN

HEPATITIS B VIRUS IMMUNE GLOBULIN - UNII:XII270 YC6 M)

HUMAN HEPATITIS B VIRUS

IMMUNE GLOBULIN

156 0 [iU]

in 5 mL

Inactive Ingredients

Ingredient Name

Stre ng th

GLYCINE (UNII: TE76 6 0 XO1C)

SO DIUM CHLO RIDE (UNII: 451W47IQ8 X)

PO LYSO RBATE 8 0 (UNII: 6 OZP39 ZG8 H)

Packag ing

#

Item Code

Package Description

Marketing Start

Date

Marketing End

Date

1

NDC:6 9 8 0 0 -420 3-

1 in 1 CARTON

10 /23/20 0 1

1

5 mL in 1 VIAL, SINGLE-USE; Type 0 : No t a Co mbinatio n

Pro duc t

ADMA Biologics, Inc.

Marketing Information

Marke ting Cate gory

Application Numbe r or Monograph Citation

Marke ting Start Date

Marke ting End Date

BLA10 39 45

10 /23/20 0 1

Labeler -

ADMA Biologics, Inc. (969455026)

Registrant -

ADMA Biologics, Inc. (969455026)

Establishment

Name

Ad d re s s

ID/FEI

Busine ss Ope rations

ADMA Bio lo gics, Inc.

9 6 9 4550 26

api manufacture(6 9 8 0 0 -420 2, 6 9 8 0 0 -420 3)

Establishment

Name

Ad d re s s

ID/FEI

Busine ss Ope rations

Ajino mo to Althea,

Inc .

0 230 50 730

manufacture(6 9 8 0 0 -420 2, 6 9 8 0 0 -420 3) , pack(6 9 8 0 0 -420 2, 6 9 8 0 0 -420 3) , label(6 9 8 0 0 -

420 2, 6 9 8 0 0 -420 3)

Revised: 7/2019

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