Frequently asked questions
The questions and responses below may provide more information about treatment with XEMBIFY. If you have any further questions, contact a member of our team.
Is XEMBIFY the same as GAMUNEX-C?
Grifols manufactures both plasma-derived medicines. XEMBIFY® (immune globulin subcutaneous human–klhw) 20% is indicated for the treatment of PIDD in patients 2 years of age and older. GAMUNEX®-C (immune globulin injection [human], 10% caprylate/chromatography purified) is indicated for treatment of PIDD in patients 2 years of age and older, ITP in adults and children, and CIDP in adults.
The manufacturing process for XEMBIFY retains the caprylate/chromatography fractionation and purification process and stabilizer (glycine) used to produce GAMUNEX-C 10%, with an additional ultrafiltration step to increase the concentration of the product to 20%.
How is XEMBIFY stored?
XEMBIFY comes in single-use vials.
- Keep XEMBIFY refrigerated. Do not freeze
- If needed, you can store XEMBIFY at room temperature for up to 6 months (should not exceed 77 °F), but you must use it within that time or you must throw it away
- Do not return XEMBIFY to the refrigerator if it was warmed to room temperature
- Check the expiration date on the carton and vial label
- Do not use XEMBIFY after the expiration date
Please see full Prescribing Information for XEMBIFY.
Do you offer nurse support for our office and patients?
Yes, you and your patients have access to nurse support. Our Nurse Educators are responsible for providing your office with education on IG therapy for PIDD and training on how to administer SCIG for positive patient experiences. In-home nurse visits for patients may be provided directly through the patient’s selected specialty pharmacy. The nurse will train the patient on how to properly self-infuse XEMBIFY. Each specialty pharmacy will have their own procedures regarding in-home support, so you or your patient should contact the specialty pharmacy directly.
Do you offer a support program?
Our Xembify ConnexionsTM support program is available for you and your patients. Through Xembify Connexions, you and your office have access to a team who can help with benefits investigation, copay reimbursement, prescription triage to an appropriate specialty pharmacy, and more.
Through Xembify Connexions, eligible patients receive up to $10,000 per calendar year in copay assistance. Once enrolled, patients can utilize this to cover deductibles, copayment, and coinsurance medication costs for XEMBIFY.
Additionally, patients who enroll in Xembify Connexions have access to:
- Educational resources about PIDD and XEMBIFY
- Financial support through copay assistance and patient assistance program (PAP)
- The XEMBIFY patient starter kit
What is the coverage like for XEMBIFY?
More than 90% of patients with commercial insurance have coverage for XEMBIFY.* Commercial insurance coverage for XEMBIFY will vary according to each plan's benefit and formulary structure.
XEMBIFY is eligible for appropriate coverage and reimbursement by Medicare Part B/DME.
XEMBIFY is eligible for coverage by all state Medicaid programs. State Medicaid and Medicare managed plans can vary. Please contact your Grifols Sales Representative for more information.
*The information included is based on current publicly available data which is subject to change and may not reflect coverage for all plan types or benefits.
Review how to start your patients on treatment with XEMBIFY
Learn how Xembify ConnexionsTM can support your patients
See what makes the XEMBIFY process different
Find out more about XEMBIFY—speak to a Sales Representative, Nurse Educator, or Medical Science Liaison.
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
CIDP, chronic inflammatory demyelinating polyneuropathy; IG, immune globulin; ITP, idiopathic thrombocytopenic purpura; PIDD, primary immunodeficiency disease; SCIG, subcutaneous immunoglobulin.