Immune globulin (IG) replacement therapy for patients with PIDD can improve antibody levels and reduce disease impact¹

IG: the standard for PIDD therapy²

IG is a purified plasma product with antibodies made by the body’s immune system.

Plasma is the liquid part of blood that remains after blood cells are removed, and it contains many proteins, including antibodies¹

The immune globulin G (IgG) antibody is a Y-shaped molecule with antigen-binding sites at the tip of each arm of the Y^3,4

Although there are 5 types of antibodies (IgG, IgM, IgD, IgA, and IgE), IG products predominantly contain IgG²

Antibodies protect against infection by coating the microbes and signaling the body to destroy them²

What is IG used for?

IG is used to treat a spectrum of immune disorders.⁵*

Immunodeficiency disorders
Primary immunodeficiency disease (PIDD)

Autoimmune disorders
Chronic inflammatory demyelinating polyneuropathy (CIDP)^†
Immune thrombocytopenia (ITP)^†

The patented Grifols process protects the integrity of the IgG protein⁷

Grifols manufactures IG utilizing a proprietary caprylate/chromatography process that can take up to 12 months from donation to finished product.

This unique caprylate/chromatography process yields maximum percentage of IgG protein^{6-8 ‡}

Maintains IgG in liquid phase⁷
Minimizes the risk of denaturing the IgG protein⁷

^‡The average IgA content is ≤0.07 mg/mL and the average IgM content is <0.004 mg/mL.⁷

In PIDD, IG provides the body with antibodies⁶

IG therapy delivers antibodies which the body needs to fight off infections

XEMBIFY and GAMUNEX-C: an IG therapy portfolio for your patients with PIDD

Proven SCIG and IVIG treatments to meet the needs of your patients with PIDD^{6, 7, 9, 10}

Product characteristics

Concentrations

XEMBIFY (immune globulin subcutaneous human–klhw) 20%: 20%

GAMUNEX-C (immune globulin injection [human], 10% caprylate/chromatography purified): 10%

Routes of Administration and Indications

XEMBIFY (immune globulin subcutaneous human–klhw) 20%: Subcutaneous PIDD in patients 2 years of age and older

GAMUNEX-C (immune globulin injection [human], 10% caprylate/chromatography purified)

Intravenous
PIDD in patients 2 years of age and older, idiopathic thrombocytopenic purpura (ITP) in adults and children, and chronic inflammatory demyelinating polyneuropathy (CIDP) in adults

Subcutaneous
PIDD in patients 2 years of age and older

Gamma Globulin Content (%)

XEMBIFY (immune globulin subcutaneous human–klhw) 20%: 100

GAMUNEX-C (immune globulin injection [human], 10% caprylate/chromatography purified): 100

Monomers (%)

XEMBIFY (immune globulin subcutaneous human–klhw) 20%: 99±1 monomers + dimers

GAMUNEX-C (immune globulin injection [human], 10% caprylate/chromatography purified): 100 monomers + dimers

IgG Content (%)

XEMBIFY (immune globulin subcutaneous human–klhw) 20%: ≥98

GAMUNEX-C (immune globulin injection [human], 10% caprylate/chromatography purified): ≥98

IgA Content

XEMBIFY (immune globulin subcutaneous human–klhw) 20%: ≤0.07 mg/mL

GAMUNEX-C (immune globulin injection [human], 10% caprylate/chromatography purified): 0.046 mg/mL

IgM Content

XEMBIFY (immune globulin subcutaneous human–klhw) 20%: <0.004 mg/mL

GAMUNEX-C (immune globulin injection [human], 10% caprylate/chromatography purified): <0.005 mg/mL

pH

XEMBIFY (immune globulin subcutaneous human–klhw) 20%: 4.1-4.8

GAMUNEX-C (immune globulin injection [human], 10% caprylate/chromatography purified): 4.0-4.5

Sodium Content

XEMBIFY (immune globulin subcutaneous human–klhw) 20%: Trace

GAMUNEX-C (immune globulin injection [human], 10% caprylate/chromatography purified): Trace (<7 mEq/L)

Stabilizer and Tonicity Modifier

XEMBIFY (immune globulin subcutaneous human–klhw) 20%: Glycine

GAMUNEX-C (immune globulin injection [human], 10% caprylate/chromatography purified): Glycine

Product characteristics	XEMBIFY (immune globulin subcutaneous human–klhw) 20%	GAMUNEX-C (immune globulin injection [human], 10% caprylate/chromatography purified)
Concentrations	20%	10%
Routes of Administration and Indications	Subcutaneous PIDD in patients 2 years of age and older	Intravenous PIDD in patients 2 years of age and older, idiopathic thrombocytopenic purpura (ITP) in adults and children, and chronic inflammatory demyelinating polyneuropathy (CIDP) in adults Subcutaneous PIDD in patients 2 years of age and older
Gamma Globulin Content (%)	100	100
Monomers (%)	99±1 monomers + dimers	100 monomers + dimers
IgG Content (%)	≥98	≥98
IgA Content	≤0.07 mg/mL	0.046 mg/mL
IgM Content	<0.004 mg/mL	<0.005 mg/mL
pH	4.1-4.8	4.0-4.5
Sodium Content	Trace	Trace (<7 mEq/L)
Stabilizer and Tonicity Modifier	Glycine	Glycine

Grifols’ consistent purification process allows a seamless
transition from IVIG to SCIG

Factors to consider when choosing between IVIG and SCIG¹¹

Factors

Patient dexterity

Intravenous IG: Not important

Subcutaneous IG: Important

Compliance

Intravenous IG: Healthcare professional dependent

Subcutaneous IG: Patient dependent

Independence

Intravenous IG: Rely on nurse or center

Subcutaneous IG: Rely on self

Portability

Intravenous IG: Limited

Subcutaneous IG: Yes

School/work absence

Intravenous IG: Likely, if at infusion suite

Subcutaneous IG: Less likely, if at home

Length of infusion

Intravenous IG: 1-4 hours

Subcutaneous IG: ~1 hour

Frequency

Intravenous IG: Every 3-4 weeks

Subcutaneous IG: Flexible: daily, up to weekly

Location

Intravenous IG: Home or infusion suite

Subcutaneous IG: Home usually

Home nurse (for initial treatment)

Intravenous IG: Yes

Subcutaneous IG: Yes

Ongoing nurse support

Intravenous IG: Yes

Subcutaneous IG: Partial support

Number of needle sticks per infusion

Intravenous IG: 1

Subcutaneous IG: 1 or more

Pharmacokinetics

Intravenous IG: Peaks/troughs

Subcutaneous IG: Steady state

Factors	Intravenous IG	Subcutaneous IG
Patient dexterity	Not important	Important
Compliance	Healthcare professional dependent	Patient dependent
Independence	Rely on nurse or center	Rely on self
Portability	Limited	Yes
School/work absence	Likely, if at infusion suite	Less likely, if at home
Length of infusion	1-4 hours	~1 hour
Frequency	Every 3-4 weeks	Flexible: daily, up to weekly
Location	Home or infusion suite	Home usually
Home nurse (for initial treatment)	Yes	Yes
Ongoing nurse support	Yes	Partial support
Number of needle sticks per infusion	1	1 or more
Pharmacokinetics	Peaks/troughs	Steady state

Contraindications

GAMUNEX-C and XEMBIFY are contraindicated in patients who have had an anaphylactic or severe systemic reaction to the administration of human immune globulin and in IgA-deficient patients with antibodies against IgA and a history of hypersensitivity.

You and your patient with PIDD can decide together whether XEMBIFY or GAMUNEX-C is right for them

*The disorders shown above do not include all indications for IG therapy.⁵
^†XEMBIFY is not indicated for CIDP or ITP.⁶

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XEMBIFY® (immune globulin subcutaneous, human–klhw), 20% and GAMUNEX®-C (immune globulin injection [human], 10% caprylate/chromatography purified) are immune globulins indicated for treatment of primary humoral immunodeficiency disease (PIDD) in patients 2 years of age and older.

XEMBIFY is a 20% solution for subcutaneous administration only. GAMUNEX-C is a 10% solution for intravenous and subcutaneous administration in PIDD.

Important Safety Information

WARNING: THROMBOSIS
Thrombosis may occur with immune globulin products, including XEMBIFY and GAMUNEX-C. Risk factors may include: advanced age, prolonged immobilization, hypercoagulable conditions, history of venous or arterial thrombosis, estrogens, indwelling vascular catheters, hyperviscosity, and cardiovascular risk factors. Thrombosis may occur in the absence of known risk factors.

For patients at risk of thrombosis, administer XEMBIFY and GAMUNEX-C at the minimum dose and infusion rate practicable. Ensure adequate hydration in patients before administration. Monitor for signs and symptoms of thrombosis and assess blood viscosity in patients at risk of hyperviscosity.

WARNING: RENAL DYSFUNCTION and ACUTE RENAL FAILURE
Renal dysfunction, acute renal failure, osmotic nephrosis, and death may occur with GAMUNEX-C in predisposed patients. Patients predisposed to renal dysfunction include those with any degree of preexisting renal insufficiency, diabetes mellitus, age greater than 65, volume depletion, sepsis, paraproteinemia, or patients receiving known nephrotoxic drugs.

Renal dysfunction and acute renal failure occur more commonly in patients receiving IVIG products containing sucrose. GAMUNEX-C does not contain sucrose.

For patients at risk of renal dysfunction or failure, administer GAMUNEX-C at the minimum concentration available and the minimum infusion rate practicable.

Contraindications
XEMBIFY and GAMUNEX-C are contraindicated in:
Patients who have had an anaphylactic or severe systemic reaction to the administration of human immune globulin.
IgA-deficient patients with antibodies against IgA and a history of hypersensitivity.

Warnings and Precautions
Hypersensitivity. Severe hypersensitivity reactions may occur with immune globulin products, including XEMBIFY and GAMUNEX-C. In case of hypersensitivity, discontinue infusion immediately and institute appropriate treatment. XEMBIFY and GAMUNEX-C contain IgA. Patients with known antibodies to IgA may have a greater risk of developing potentially severe hypersensitivity and anaphylactic reactions.

Thrombosis. Thrombosis may occur following treatment with immune globulin products, including XEMBIFY and GAMUNEX-C, even in the absence of known risk factors. In patients at risk, administer at the minimum dose and infusion rate practicable. Ensure adequate hydration before administration. Monitor for signs and symptoms of thrombosis and assess blood viscosity in patients at risk of hyperviscosity.

Hyperproteinemia, Increased Serum Viscosity, and Hyponatremia. Hyperproteinemia, increased serum viscosity, and hyponatremia may occur in patients receiving IVIG treatment, including GAMUNEX-C.

Aseptic meningitis syndrome (AMS). AMS may occur with human immune globulin treatment, including XEMBIFY and GAMUNEX-C. Conduct a thorough neurological exam on patients exhibiting signs and symptoms of AMS to rule out other causes of meningitis. Discontinuation of treatment has resulted in remission within several days without sequelae.

Renal dysfunction/failure. Acute renal dysfunction/failure, acute tubular necrosis, proximal tubular nephropathy, osmotic nephrosis, and death may occur with use of human immune globulin products, especially those containing sucrose. XEMBIFY and GAMUNEX-C do not contain sucrose. Ensure patients are not volume-depleted prior to starting infusion. In patients at risk due to preexisting renal insufficiency or predisposition to acute renal failure, assess renal function (including blood urea nitrogen (BUN), serum creatinine, and urine output) prior to the initial infusion and again at appropriate intervals thereafter. If renal function deteriorates, consider discontinuation.

Hemolysis. XEMBIFY and GAMUNEX-C may contain blood group antibodies that may cause a positive direct antiglobulin reaction and hemolysis. Monitor patients for clinical signs and symptoms of hemolysis. If signs and symptoms are present after infusion, perform confirmatory lab testing.

Transfusion-related acute lung injury (TRALI). Noncardiogenic pulmonary edema may occur in patients following treatment with immune globulin products, including XEMBIFY and GAMUNEX-C. Monitor patients for pulmonary adverse reactions. If TRALI is suspected, perform appropriate tests for the presence of antineutrophil and anti-HLA antibodies in both the product and patient serum. TRALI may be managed using oxygen therapy with adequate ventilatory support.

Transmissible infectious agents. Because XEMBIFY and GAMUNEX-C are made from human blood, they 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.

Interference with lab tests. Passively transferred antibodies in the patient’s blood may yield positive serological testing results, with the potential for misleading interpretation.

Adverse Reactions
The most common adverse reactions in ≥ 5% of subjects in clinical trials were:

XEMBIFY
PIDD, subcutaneous: local adverse reactions, including infusion-site erythema (redness), infusion-site pain, infusion-site swelling (puffiness), infusion-site bruising, infusion-site nodule, infusion-site pruritus (itching), infusion-site induration (firmness), infusion-site scab, infusion-site edema, and systemic reactions including cough and diarrhea.

GAMUNEX-C
PIDD, subcutaneous: local infusion-site reactions, fatigue, headache, upper respiratory tract infection, arthralgia, diarrhea, nausea, sinusitis, bronchitis, depression, allergic dermatitis, migraine, myalgia, viral infection, and pyrexia.
PIDD, intravenous: cough, rhinitis, pharyngitis, headache, asthma, nausea, fever, diarrhea, and sinusitis.
The most serious adverse reaction in clinical studies with GAMUNEX-C in PIDD was an exacerbation of autoimmune pure red cell aplasia in 1 subject.

Drug Interactions
Passive transfer of antibodies may transiently interfere with the immune responses to live attenuated virus vaccines (eg, measles, mumps, rubella, and varicella).

Please see accompanying full Prescribing Information for XEMBIFY.
Please see accompanying full Prescribing Information for GAMUNEX-C.

Terms to know

IG, immune globulin; IgA, immunoglobulin A; IgD, immunoglobulin D; IgE, immunoglobulin E; IgG, immunoglobulin G; IgM, immunoglobulin M; IVIG, intravenous immunoglobulin; PIDD, primary immunodeficiency disease; SCIG, subcutaneous immunoglobulin.

References

Mathew J, Sankar P, Varacallo M. Physiology, Blood Plasma. In: StatPearls. Treasure Island (FL): StatPearls Publishing; April 24, 2023.
Justiz Vaillant AA, Jamal Z, Patel P, Ramphul K. Immunoglobulin. In: StatPearls. Treasure Island (FL): StatPearls Publishing; August 28, 2023.
Alberts B, Johnson A, Lewis J, et al. Molecular Biology of the Cell. 4th edition. B Cells and Antibodies. New York: Garland Science; 2002.
Godwin L, Sinawe H, Crane JS. Biochemistry, Immunoglobulin E. In: StatPearls. Treasure Island (FL): StatPearls Publishing; September 24, 2022.
Orange JS, Hossny EM, Weiler CR, et al. Use of intravenous immunoglobulin in human disease: a review of evidence by members of the Primary Immunodeficiency Committee of the American Academy of Allergy, Asthma and Immunology [published correction appears in J Allergy Clin Immunol. 2006 Jun;117(6):1483. Dosage error in article text]. J Allergy Clin Immunol. 2006;117(4 Suppl):S525-S553.
XEMBIFY® (immune globulin subcutaneous human-klhw) 20% Prescribing Information. Grifols.
Alonso W, Vandeberg P, Lang J, et al. Immune globulin subcutaneous, human 20% solution (Xembify®), a new high concentration immunoglobulin product for subcutaneous administration. Biologicals. 2020;64:34-40.
Lebing W, Remington KM, Schreiner C, Paul HI. Properties of a new intravenous immunoglobulin (IGIV-C, 10%) produced by virus inactivation with caprylate and column chromatography. Vox Sang. 2003;84(3):193-201.
GAMUNEX®-C (immune globulin injection [human], 10% caprylate/chromatography purified) Prescribing Information. Grifols.
Siegel J. Immune globulins: therapeutic, pharmaceutical, cost, and administration considerations. Pharm Pract News. 2023.
Jolles S, Orange JS, Gardulf A, et al. Current treatment options with immunoglobulin G for the individualization of care in patients with primary immunodeficiency disease. Clin Exp Immunol. 2015;179(2):146-160.

Immune globulin (IG) replacement therapy for patients with PIDD can improve antibody levels and reduce disease impact1

IG: the standard for PIDD therapy2