Soleo Health Selected by Grifols as Limited Drug Distribution Partner for XEMBIFY®

Company Continues to Leverage its Real-World Evidence Data Capabilities and Strengthens Position as Limited Distribution Specialty Pharmacy Provider

Soleo Health, an innovative national provider of complex specialty pharmacy and infusion services, announced today it has been selected by Grifols, a global healthcare company dedicated to enhancing the health and well-being of people around the world, as one of their specialty pharmacy limited drug distribution providers of XEMBIFY® (immune globulin subcutaneous human-klhw). This is Grifols’ first 20% immune globulin and is indicated for the treatment of primary immunodeficiencies in patients 2 years of age and older. XEMBIFY is for subcutaneous injection only and was approved by the U.S. Food & Drug Administration (FDA) in July 2019.

Soleo Health was chosen as a limited distributor of XEMBIFY, based on the company’s dedicated immunology disorders program, deep clinical knowledge and experience in the provision of subcutaneous immunoglobulin (IG) services, and its ability to collect real-world evidence clinical outcomes through its exclusive and proprietary clinical outcomes program, SoleMetrics®.

Soleo Health is recognized nationally for its ability to gather disease-specific, drug-specific and patient-specific data for patients under its clinical care through SoleMetrics. SoleMetrics has the distinct and unparalleled ability to collect data specific to XEMBIFY, including details on side effects, adverse events, site of administration challenges, therapy response and the patient experience.

"Soleo Health’s distinctive model allows us to provide subcutaneous IG delivery across a variety of settings, including the home, ambulatory infusion sites and physicians’ offices. The extensive immunoglobulin experience of our dedicated clinical team and the ability for us to treat patients wherever they need, along with our real-world evidence data capabilities through SoleMetrics, is precisely why Soleo Health was selected to distribute XEMBIFY. We work closely with pharmaceutical manufacturers to offer flexibility of services and data they need to help improve patient care and experiences. Our current portfolio of many limited drug distribution relationships speaks directly to this," said Craig Vollmer, chief commercial officer at Soleo Health.

Barbara Prosser, Soleo Health’s vice president, health outcomes and research, said, "The real-world data Soleo Health collects and delivers offers drug manufacturers a keen understanding and in-depth details of patients under our care. SoleMetrics distinguishes Soleo Health within the specialty pharmaceutical landscape marketplace by providing a vital service that assists in enhancing the levels of quality clinical care we provide each and every day through the application and sharing of clinical and economic data."

About Soleo Health

Frisco, Texas-based Soleo Health is an innovative national provider of complex specialty pharmacy and infusion services, administered in the home or at alternate sites of care. Soleo Health’s interdisciplinary team, comprised of experienced clinical pharmacists and registered nurses, utilizes a consistent patient management process, which leads to quantifiable clinical and economic value while improving patients’ experience.

Soleo Health operates 20 locations throughout the U.S. with national nursing coverage and pharmacy licensure in 50 states, and is accredited by The Joint Commission. For more information, visit www.soleohealth.com or connect with Soleo Health on Facebook, Twitter and LinkedIn.

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.

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Contacts

Susan Turkell, 303-766-4343, sturkell@pairelations.com