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%.
Can XEMBIFY be used in treatment-naive patients?
Yes, XEMBIFY is the first and only 20% SCIG approved for treatment-naive patients with PIDD. This allows the patient to go straight to SCIG without initial IVIG therapy.
How often do patients need to administer XEMBIFY?
XEMBIFY can be administered at regular intervals from daily to up to every 2 weeks. This flexible dosing schedule allows you and your patient to work together and tailor the dosing frequency to their needs.
What is the dosing rate for XEMBIFY?
In 2024, the FDA approved a 40% increase in the dosing rate for XEMBIFY, allowing patients 10 years of age and older to infuse XEMBIFY at 35 mL/hour/site. For children 2 to 9 years of age, the dosing rate is 25 mL/hour/site.
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 (should not exceed 77 °F) for up to 6 months, 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.
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, hypercoagulable conditions, history of venous or arterial thrombosis, use of 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
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.
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.
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.
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 full Prescribing Information for XEMBIFY.
Important Safety Information
GAMUNEX®-C (immune globulin injection [human], 10% caprylate/chromatography purified) is indicated for the treatment of primary humoral immunodeficiency disease (PIDD) in patients 2 years of age and older, idiopathic thrombocytopenic purpura (ITP) in adults and children, and chronic inflammatory demyelinating polyneuropathy (CIDP) in adults.
Thrombosis may occur with immune globulin products, including GAMUNEX-C. Risk factors may include: advanced age, prolonged immobilization, hypercoagulable conditions, history of venous or arterial thrombosis, use of estrogens, indwelling central vascular catheters, hyperviscosity, and cardiovascular risk factors. Thrombosis may occur in the absence of known risk factors. For patients at risk of thrombosis, administer 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 for hyperviscosity.
Renal dysfunction, acute renal failure, osmotic nephrosis, and death may occur with immune globulin intravenous (IVIG) products 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.
GAMUNEX-C 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 history of hypersensitivity.
Severe hypersensitivity reactions may occur with IVIG products, including GAMUNEX-C. In case of hypersensitivity, discontinue GAMUNEX-C infusion immediately and institute appropriate treatment.
Monitor renal function, including blood urea nitrogen (BUN), serum creatinine, and urine output in patients at risk of developing acute renal failure.
Hyperproteinemia, increased serum viscosity, and hyponatremia may occur in patients receiving IVIG treatment, including GAMUNEX-C.
There have been reports of aseptic meningitis, hemolytic anemia, and noncardiogenic pulmonary edema (transfusion-related acute lung injury [TRALI]) in patients administered with IVIG, including GAMUNEX-C.
The high-dose regimen (1g/kg x 1-2 days) is not recommended for individuals with expanded fluid volumes or where fluid volume may be a concern.
Because GAMUNEX-C 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.
Do not administer GAMUNEX-C subcutaneously in patients with ITP because of the risk of hematoma formation.
Periodic monitoring of renal function and urine output is particularly important in patients judged to be at increased risk of developing acute renal failure. Assess renal function, including measurement of BUN and serum creatinine, before the initial infusion of GAMUNEX-C and at appropriate intervals thereafter.
Consider baseline assessment of blood viscosity in patients at risk for hyperviscosity, including those with cryoglobulins, fasting chylomicronemia/markedly high triacylglycerols (triglycerides), or monoclonal gammopathies, because of the potentially increased risk of thrombosis.
If signs and/or symptoms of hemolysis are present after an infusion of GAMUNEX-C, perform appropriate laboratory testing for confirmation.
If TRALI is suspected, perform appropriate tests for the presence of antineutrophil antibodies and anti-HLA antibodies in both the product and patient's serum.
After infusion of IgG, the transitory rise of the various passively transferred antibodies in the patient's blood may yield positive serological testing results, with the potential for misleading interpretation.
In clinical studies, the most common adverse reactions with GAMUNEX-C were headache, pyrexia, hypertension, chills, rash, nausea, arthralgia, and asthenia (in CIDP); cough, rhinitis, pharyngitis, headache, asthma, nausea, fever, diarrhea, and sinusitis with intravenous use (in PIDD) and local infusion-site reactions, fatigue, headache, upper respiratory tract infection, arthralgia, diarrhea, nausea, sinusitis, bronchitis, depression, allergic dermatitis, migraine, myalgia, viral infection, and pyrexia with subcutaneous use (in PIDD); and headache, ecchymosis, vomiting, fever, nausea, rash, abdominal pain, back pain, and dyspepsia (in ITP).
The most serious adverse reactions in clinical studies were pulmonary embolism (PE) in 1 subject with a history of PE (in CIDP), an exacerbation of autoimmune pure red cell aplasia in 1 subject (in PIDD), and myocarditis in 1 subject that occurred 50 days post-study drug infusion and was not considered drug related (in ITP).
Please see full Prescribing Information for GAMUNEX-C.
Terms to know
CIDP, chronic inflammatory demyelinating polyneuropathy; DME, durable medical equipment; IG, immune globulin; ITP, idiopathic thrombocytopenic purpura; IVIG, intravenous immunoglobulin; PIDD, primary humoral immunodeficiency disease; SCIG, subcutaneous immunoglobulin.