The distinct process provides ≥ 98% IgG protein2

Caprylate precipitation and incubation step of the manufacturing process

Caprylate precipitation and incubation2

  • Caprylate is added to a fractionated plasma solution
  • Viruses and impurities are removed while protecting the structure and function of IgG
  • IgG is maintained in liquid phase to minimize denaturing of the protein
Anion-exchange chromatography step of the manufacturing process

Anion-exchange chromatography2

  • Removes non-IgG proteins
  • Removes caprylate
  • Yields a maximum percentage (≥98%) of IgG and maximum monomeric levels

Maximum purity2

The unique caprylate chromatography process yields a highly potent IgG with ≥98% purity* and proven infection protection

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

Quick and sustained steady state3

  • Peak IG levels reached in just 3 days
    • Reliable IgG level with a low of 1263 mg/dL and a high of 1358 mg/dL achieved at ~3 days with a mean IgG trough level that was 33% higher than IVIG
  • IgG concentrations consistently maintained above the commonly accepted therapeutic threshold
  • No difference in pharmacokinetic (PK) profile among all age groups

Product characteristics to meet a wide range of patient needs2-4

Sugar-free

Stabilized with glycine

Trace amounts of sodium

Formulated for patients with PIDD ≥2 years of age, including those with risk factors

Prediabetes/diabetes

Renal dysfunction

Cardiac impairment

See the demonstrated safety and tolerability for XEMBIFY

See the safety
See the safety

Review the efficacy data from a phase 3 trial

See the efficacy
See the efficacy

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Indication 

XEMBIFY® (immune globulin subcutaneous human–klhw) is a 20% immune globulin indicated for treatment of primary humoral immunodeficiency disease (PIDD) in patients 2 years of age and older. XEMBIFY is for subcutaneous administration only.

Important Safety Information

WARNING: THROMBOSIS 

  • Thrombosis may occur with immune globulin products, including XEMBIFY. Risk factors may include: advanced age, prolonged immobilization, 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 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

Contraindications

XEMBIFY is contraindicated in patients who have had an anaphylactic or severe systemic reaction to the administration of human immune globulin. It is contraindicated in 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. In case of hypersensitivity, discontinue infusion immediately and institute appropriate treatment. XEMBIFY contains 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. Thrombosis may occur 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.

Aseptic meningitis syndrome (AMS). AMS may occur with human immune globulin treatment, including XEMBIFY. Conduct a thorough neurological exam on patients exhibiting signs and symptoms 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 does 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 prior to the initial infusion of XEMBIFY and again at appropriate intervals thereafter. If renal function deteriorates, consider discontinuation.

Hemolysis. XEMBIFY 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. 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 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. No cases of transmission of viral diseases, vCJD, or CJD have ever been associated with the use of XEMBIFY.

Interference with lab tests. After infusion of XEMBIFY, 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 the clinical trial were 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.

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.

Terms to know

IG, immune globulin; IgA, immunoglobulin A; IgG, immunoglobulin G; IgM, immunoglobulin M; IVIG, intravenous immunoglobulin; PIDD, primary immunodeficiency disease.

 

References

  1. 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.
  2. XEMBIFY® (immune globulin subcutaneous human-klhw) 20% Prescribing Information. Grifols.
  3. Sleasman JW, Lumry WR, Hussain I, et al. Immune globulin subcutaneous, human - klhw 20% for primary humoral immunodeficiency: an open-label, phase III study. Immunotherapy. 2019;11(16):1371-1386.
  4. Siegel J. Immune globulins: therapeutic, pharmaceutical, cost, and administration considerations. Pharm Pract News. 2023.