Xembify Connexions provides comprehensive services to support you and your patients with PIDD

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Financial support to help PIDD patients start and stay on their treatment

Copay assistance program

Eligible patients may save up to $5000 over 12 months, with no monthly cap, on their prescription for XEMBIFY*

  • Copay assistance program covers deductibles, copayment, and coinsurance medication costs
  • Eligibility - patients must be enrolled in Xembify Connexions and have commercial insurance that:
    • Covers medication costs for XEMBIFY
    • Allows for copay or coupon assistance

Patient assistance program

  • Provides uninsured PIDD patients access to the therapy they need
 

For all your questions regarding copay assistance, coverage authorization, or to access XEMBIFY through our distribution partners, call Xembify Connexions at 1-844-MYXEMBIFY (1-844-699-3624).

TERMS AND CONDITIONS FOR COPAY ASSISTANCE PROGRAM

*This manufacturer coupon program is not valid for prescriptions reimbursed, in whole or in part, by Medicaid, Medicare, Medigap, VA, DoD, TRICARE, or any other federal or state healthcare programs, including state pharmaceutical assistance programs, and where prohibited by the health insurance provider or by law. This coupon program provides a maximum benefit of $5000 for eligible out-of-pocket costs and expires 12 months from the date of first assisted fill. Eligible costs include deductible, copayment, and coinsurance costs for XEMBIFY medication. Nonmedication expenses, such as ancillary supplies or administration-related costs, are not eligible. To be eligible, patients must 1) be starting or receiving treatment with (and have a current prescription for) XEMBIFY with an ICD9 or ICD10, as applicable of primary immunodeficiency disease (PIDD); and 2) have commercial insurance that covers medication costs for XEMBIFY treatment and allows for copay/coupon assistance. Acceptance of this offer must be consistent with the terms of benefits provided by patient's health insurance provider. Offer limited to outpatient IG treatment and may not be combined with any other coupon, discount, prescription savings card, rebate, free trial, or other offer. This program is only valid for residents of the United States, excluding Puerto Rico and other US territories. Grifols reserves the right to change or discontinue this program at any time without notice. This is not health insurance.

Characteristics

Formulated to meet the needs of a wide range of PIDD patients1-3

Efficacy

Proven efficacy to reduce the impact of PIDD on patients' lives

Tolerability

Proven safety and tolerability profile

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.


REFERENCES
  1. Vandeberg P, Lang J, Alonso W. A new 20% concentration immunoglobulin for subcutaneous administration (IGSC 20%). Poster presented at: American Academy of Allergy, Asthma & Immunology; February 23, 2019; San Francisco, CA.
  2. Data on file, Grifols.
  3. Gelfand EW. Differences between IGIV products: impact on clinical outcome. Int Immunopharmacol. 2006;6(4):592-599.

TERMS TO KNOW

SCIG, subcutaneous immune globulin.