GamaSTAN^®

(immune globulin [human])

Treating With GamaSTAN

GamaSTAN is a sterile solution of immune globulin for intramuscular administration indicated for use in the following situations^¹:

GAMASTAN is indicated for prophylaxis following exposure to hepatitis A
- GamaSTAN is not indicated in persons with clinical manifestations of hepatitis A or in those exposed more than 2 weeks previously
Prevention or modification of measles (rubeola) in susceptible persons exposed fewer than 6 days previously; a susceptible person is one who has not been vaccinated and has not had measles previously
Passive immunization in immunocompromised patients may modify varicella if varicella-zoster immune globulin (human) is not available
Modification of rubella in exposed pregnant women who will not consider a therapeutic abortion

Trusted Dependability¹

Established history—more than 75 years of consistent supply and product support
Preservative free and not made with natural rubber latex
FDA labeling for capacity to remove pathogenic prions
Tamper-evident packaging
36-month shelf life

Clinical Efficacy

Peak levels of immunoglobulin G (IgG) are obtained approximately 2 days after intramuscular (IM) injection of GamaSTAN. The half-life of IgG in the circulation of individuals with normal IgG levels is 23 days.¹

Thrombosis may occur with immune globulin products, including GamaSTAN. Risk factors may include: advanced age, prolonged immobilization, hypercoagulable conditions, history of venous or arterial thrombosis, use of estrogens, indwelling central vascular catheters, hyperviscosity, and cardiovascular risk factors. Thrombosis may occur in the absence of known risk factors. For patients at risk of thrombosis, do not exceed the recommended dose of GamaSTAN. Ensure adequate hydration in patients before administration. Monitor for signs and symptoms of thrombosis and assess blood viscosity in patients at risk for hyperviscosity.¹

Safety Is a Priority

Manufacturing Process¹

Pathogen Safety

The following manufacturing steps for GamaSTAN contribute to inactivation and/or removal capacity:

Caprylate precipitation
Depth filtration
Caprylate incubation
Column chromatography
Nanofiltration
Low pH final container incubation

The caprylate/chromatography manufacturing process was also investigated for its capacity to decrease the infectivity of an experimental agent of transmissible spongiform encephalopathy (TSE), considered as a model for the variant Creutzfeldt-Jakob disease (vCJD) and Creutzfeldt-Jakob disease (CJD) agents. These studies provide reasonable assurance that low levels of vCJD/CJD agent infectivity, if present in the starting material, would be removed by the caprylate/chromatography manufacturing process.

GamaSTAN is made from human blood and may carry a risk of transmitting infectious agents, eg, viruses, the vCJD agent, and, theoretically, the CJD agent.

Traceability and Transparency of Information

Grifols' manufacturing process has a comprehensive computer system called PediGri® that ensures full traceability from every donation.

Each plasma unit is coded and computer-traced from the start of the process until the units are transformed into a final product
Users can access the donation number and the viral screening conducted at the origin of the donation with the product lot number
- Specific information is also available, including the total number of plasma units, the total volume of plasma, the certificate of analysis showing the plasma origin viral screening, and biochemical characteristics of the final product

For immediate, easy, and convenient access to all of the information on the origin and quality of Grifols' plasma derivatives, visit www.pedigri.grifols.com

Coding Information

This resource provides coding guidance for GamaSTAN® (immune globulin [human]); however, the treating physician is ultimately responsible for certifying the codes that best describe the patient’s diagnosis and treatment. Government and other third-party payer coding requirements change periodically; therefore, please verify current coding requirements directly with the payer being billed. All codes listed in this guide are for informational purposes, and this guide is not an exhaustive list of possible codes. The CPT®, HCPCS, and ICD-10-CM diagnosis codes provided are based on AMA or CMS guidelines.

Coding System

HCPCS

Coding for GamaSTAN: J1460

Description: Injection, gamma globulin, intramuscular, 1 cc

Coding for GamaSTAN: J1560

Description: Injection, gamma globulin, intramuscular, 10 cc

Administration
Procedures CPT Code*

Coding for GamaSTAN: 96372

Description: Therapeutic, prophylactic, or diagnostic injection (specify substance or drug); intramuscular

ICD-10-CM^†

Coding for GamaSTAN: B01.0

Description: Varicella meningitis

Coding for GamaSTAN: B01.11

Description: Varicella encephalitis and encephalomyelitis

Coding for GamaSTAN: B01.12

Description: Varicella myelitis

Coding for GamaSTAN: B01.2

Description: Varicella pneumonia

Coding for GamaSTAN: B01.81

Description: Varicella keratitis

Coding for GamaSTAN: B01.89

Description: Other varicella complications

Coding for GamaSTAN: B01.9

Description: Varicella without complications

Coding for GamaSTAN: B05.0

Description: Measles complicated by encephalitis

Coding for GamaSTAN: B05.1

Description: Measles complicated by meningitis

Coding for GamaSTAN: B05.2

Description: Measles complicated by pneumonia

Coding for GamaSTAN: B05.3

Description: Measles complicated by otitis media

Coding for GamaSTAN: B05.4

Description: Measles with intestinal complications

Coding for GamaSTAN: O98.511

Description: Other viral diseases complicating pregnancy. first trimester

Coding for GamaSTAN: O98.512

Description: Other viral diseases complicating pregnancy, second trimester

Coding for GamaSTAN: O98.513

Description: Other viral diseases complicating pregnancy, third trimester

Coding for GamaSTAN: O98.519

Description: Other viral diseases complicating pregnancy, unspecified trimester

Coding for GamaSTAN: Z20.4

Description: Contact with and (suspected) exposure to rubella

Coding for GamaSTAN: Z20.5

Description: Contact with and (suspected) exposure to viral hepatitis

Coding for GamaSTAN: Z20.820

Description: Contact with and (suspected) exposure to varicella

Coding for GamaSTAN: Z41.8

Description: Encounter for other procedures for purpose other than remedying health state

Product NDC^‡

Coding for GamaSTAN: 13533-0335-04

Description: 2-mL vial

Coding for GamaSTAN: 13533-0335-12

Description: 10-mL vial

*Centers for Medicare and Medicaid Services (CMS). Healthcare Common Procedure Coding System (HCPCS) file located at: http://www.cms.gov/Medicare/Coding/HCPCSReleaseCodeSets/Alpha-Numeric-HCPCS.html.
†Current Procedural Terminology (CPT) is a registered trademark of the American Medical Association (AMA).
‡Optum, for Hospitals and Payers, Volumes 1, 2, and 3 (with International Classification of Diseases, Tenth Revision, Clinical Modification [ICD-10-CM]), publisher of the official code set issued by the Department of Health and Human Services.

*Centers for Medicare and Medicaid Services (CMS). Healthcare Common Procedure Coding System (HCPCS) file located at: http://www.cms.gov/Medicare/Coding/HCPCSReleaseCodeSets/Alpha-Numeric-HCPCS.html.
†Current Procedural Terminology (CPT) is a registered trademark of the American Medical Association (AMA).
‡Optum, for Hospitals and Payers, Volumes 1, 2, and 3 (with International Classification of Diseases, Tenth Revision, Clinical Modification [ICD-10-CM]), publisher of the official code set issued by the Department of Health and Human Services.
Coding System	Coding for GamaSTAN	Description
HCPCS	J1460	Injection, gamma globulin, intramuscular, 1 cc
HCPCS	J1560	Injection, gamma globulin, intramuscular, 10 cc
Administration Procedures CPT Code*	96372	Therapeutic, prophylactic, or diagnostic injection (specify substance or drug); intramuscular
ICD-10-CM^†	B01.0	Varicella meningitis
	B01.11	Varicella encephalitis and encephalomyelitis
	B01.12	Varicella myelitis
	B01.2	Varicella pneumonia
	B01.81	Varicella keratitis
	B01.89	Other varicella complications
	B01.9	Varicella without complications
	B05.0	Measles complicated by encephalitis
	B05.1	Measles complicated by meningitis
	B05.2	Measles complicated by pneumonia
	B05.3	Measles complicated by otitis media
	B05.4	Measles with intestinal complications
	O98.511	Other viral diseases complicating pregnancy. first trimester
	O98.512	Other viral diseases complicating pregnancy, second trimester
	O98.513	Other viral diseases complicating pregnancy, third trimester
	O98.519	Other viral diseases complicating pregnancy, unspecified trimester
	Z20.4	Contact with and (suspected) exposure to rubella
	Z20.5	Contact with and (suspected) exposure to viral hepatitis
	Z20.820	Contact with and (suspected) exposure to varicella
	Z41.8	Encounter for other procedures for purpose other than remedying health state
Product NDC^‡	13533-0335-04	2-mL vial
Product NDC^‡	13533-0335-12	10-mL vial

The information is provided for informational purposes only and is subject to change. Providers are encouraged to contact their payers for specific information. Coding rules and guidelines are subject to payer discretion and should always be verified by the paying entity. Healthcare providers make the ultimate determination as to when to use a specific product, based on clinical appropriateness for a patient. This guide is not intended to provide specific guidance on how to use, code, bill, or charge for any product or service. Third-party payment for medical products and services is affected by numerous factors, and Grifols cannot make any representation or guarantee concerning reimbursement or coverage for any service or item.

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Important Safety Information for GamaSTAN® (immune globulin [human])

INDICATIONS AND USAGE

GamaSTAN (immune globulin [human]) is indicated for prophylaxis following exposure to hepatitis A infection, prevention or modification of measles in susceptible persons exposed fewer than 6 days previously, modification of varicella, and modification of rubella in exposed women who will not consider a therapeutic abortion.

Limitations of Use

GAMASTAN is not indicated for routine prophylaxis or treatment of viral hepapitis type B, rubella, poliomyelitis, mumps, or varicella.

IMPORTANT SAFETY INFORMATION

For patients at risk of thrombosis, do not exceed the recommended dose of GamaSTAN. Ensure adequate hydration in patients before administration. Monitor for signs and symptoms of thrombosis and assess blood viscosity in patients at risk for hyperviscosity.

GamaSTAN is contraindicated in patients who have had anaphylactic or severe systemic hypersensitivity reactions to immune globulin (human) and in IgA-deficient patients with antibodies against IgA and a history of hypersensitivity.

Administer GamaSTAN cautiously to patients with a history of prior systemic allergic reactions following the administration of human immunoglobulin preparations. Have epinephrine available for treatment of acute allergic symptoms, should they occur.

Inject intramuscularly only. Do not administer GamaSTAN intravenously because of the potential for serious reactions (eg, renal dysfunction/failure/hemolysis, transfusion-related acute lung injury [TRALI]). Do not inject into a blood vessel.

GamaSTAN is made from human blood; it may carry a risk of transmitting infectious agents, eg, viruses, the variant Creutzfeldt-Jakob disease (vCJD) agent, and, theoretically, the Creutzfeldt-Jakob disease (CJD) agent.

The most common adverse reaction reported for GamaSTAN S/D during post-approval use was fatigue.

Antibodies in GamaSTAN may interfere with the response to live virus vaccines such as measles, mumps, polio, rubella, and varicella. Defer live vaccine administration for up to 6 months after GamaSTAN administration.

Please see full Prescribing Information for GamaSTAN.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.

Reference:

GamaSTAN® (immune globulin [human]) Prescribing Information. Grifols.

GamaSTAN®