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Grifols launches XEMBIFY® (immune globulin subcutaneous human-klhw) 20%, a new Primary Immunodeficiency treatment

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BARCELONA, Dec. 12, 2019 /PRNewswire/ -- Grifols ((MCE:GRF, NASDAQ:GRFS), a leading global producer of plasma-derived medicines, today announced the launch of its latest immunoglobulin (IG) innovation, XEMBIFY® (immune globulin subcutaneous human-klhw), the company's first 20% subcutaneous immunoglobulin therapy for the treatment of patients 2 years of age and older with primary immunodeficiency (PI).

With proven safety, efficacy, and tolerability, XEMBIFY® offers subcutaneous administration to patients in the treatment of PI, which are rare and chronic genetic disorders that occur in people born with an impaired or absent immune system. There are roughly 150,0001 patients with PI who may be appropriate for IG therapy.

Strengthening Grifols' growing IG portfolio for PI treatment, XEMBIFY® features a balanced formulation for the treatment of a wide range of PI patients, inclusive of those with risk factors, such as diabetes or cardiac impairment. XEMBIFY® was approved by the U.S. Food and Drug Administration (FDA) in July 2019.

With maximum immunoglobulin G (IgG) potency and purity due to the unique caprylate/chromatography process, XEMBIFY® provides a customizable IG treatment option (from weekly to daily) that offers patients reliable protection from infections.

"Today marks an exciting milestone as we launch XEMBIFY®, an important new medicine for PI patients in the United States," said Joel Abelson, President, Bioscience Commercial Division. "Adding to our existing IG portfolio, XEMBIFY® is another example of Grifols executing on our mission to improve the lives and well-being of people who suffer from serious, rare and chronic diseases."

"People living with PI benefit from having a number of different treatment and dosing options, ultimately giving them an opportunity to tailor treatment to meet their specific needs," said John G. Boyle, President and Chief Executive Officer of the Immune Deficiency Foundation. "Adding XEMBIFY® to the list of available treatments for PI will give members of our community greater flexibility in managing their care and reducing the impact PI has on their lives."

XEMBIFY® will be made available to patients and healthcare professionals through a distribution network that includes the following providers: Advanced InfusionCare, Nufactor a specialty infusion company, CVS/Specialty, Optum Infusion Services, and Accredo.

The launch of XEMBIFY® solidifies Grifols as a frontrunner in disease treatment with immunoglobulins and reflects the company's commitment to R+D+i, which has enabled the company to further expand its industry-leading portfolio of plasma-derived medicines to benefit patients and healthcare professionals. The company is currently working with healthcare authorities to obtain approval for XEMBIFY® in Canada, Europe and other global markets.

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.

Please see Important Safety Information for XEMBIFY on the following pages and refer to the full Prescribing Information or visit xembify.com.

About Grifols

Grifols is a global healthcare company founded in Barcelona in 1909 committed to improving the health and well-being of people around the world. Its four divisions – Bioscience, Diagnostic, Hospital and Bio Supplies – develop, produce and market innovative solutions and services that are sold in more than 100 countries.

Pioneers in the plasma industry, Grifols operates a growing network of donation centers worldwide. It transforms collected plasma into essential medicines to treat rare, chronic and, at times, life-threatening conditions. As a recognized leader in transfusion medicine, Grifols also offers a comprehensive portfolio of solutions designed to enhance safety from donation to transfusion. In addition, the company supplies tools, information and services that enable hospitals, pharmacies and healthcare professionals to efficiently deliver expert medical care.

Grifols, with more than 24,000 employees in 30 countries, is committed to a sustainable business model that sets the standard for continuous innovation, quality, safety and ethical leadership.

The company's class A shares are listed on the Spanish Stock Exchange, where they are part of the Ibex-35 (MCE:GRF). Grifols non-voting class B shares are listed on the Mercado Continuo (MCE:GRF.P) and on the U.S. NASDAQ through ADRs (NASDAQ:GRFS).

For more information, please visit www.grifols.com

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).

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.

Please see full Prescribing Information for XEMBIFY or visit www.xembify.com

1 Kobrynski L, Powell RW, Bowen S. Prevalence and morbidity of primary immunodeficiency diseases, United States 2001-2007. J Clin Immunol. 2014 Nov;34(8):954-61. doi: 10.1007/s10875-014-0102-8. Epub 2014 Sep 26.

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SOURCE Grifols

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