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The unique manufacturing process yields a highly purified IG product with a maximum percentage of IgG.
Distinct Process Provides ≥98% IgG Protein
The unique manufacturing process yields a highly purified IG product with a maximum percentage of IgG.
Talking to your patients about starting XEMBIFY.
Talking to your patients about starting XEMBIFY.
Our SCIG quick reference guide can help get your patients started.
Download Quick Reference Guide
Our SCIG quick reference guide can help get your patients started.
No noticeable tolerability differences were observed between age groups.
Know the signs and symptoms
Know the signs and symptoms
Untreated PIDD is associated with increased healthcare costs.
Factors to consider when choosing between IVIG and SCIG.
Tests to Confirm a PIDD Diagnosis
Tests to confirm a PIDD diagnosis include blood tests to identify specific immune system abnormalities.
SCIG therapy with customizable dosing.
Dosing and Administration for XEMBIFY
SCIG therapy with customizable dosing.
Safety and tolerability of XEMBIFY were established in an open-label phase III study.
Safety and tolerability of XEMBIFY were established in an open-label phase III study.
An easy-to-understand guide on coverage, coding, reimbursement, and claims submissions. Download guide.
Coverage and Reimbursement Guide
An easy-to-understand guide on coverage, coding, reimbursement, and claims submissions. Download guide.
Grifols manufactures IG utilizing a proprietary caprylate/chromatography process.
Grifols manufactures IG utilizing a proprietary caprylate/chromatography process.
Please see the FAQ page for answers to most commonly questions about XEMBIFY.
Mild and moderate infusion-site reactions.
What to Look for During and After SCIG Administration
Mild and moderate infusion-site reactions.
Get patient copay form.
Get patient copay form.
Consider a variety of factors when selecting infusion sites for XEMBIFY.
Selecting Infusion Sites for XEMBIFY
Consider a variety of factors when selecting infusion sites for XEMBIFY.
IG is used to treat a spectrum of immune disorders.
IG is used to treat a spectrum of immune disorders.
Convenient handling and storage.
Peak IG levels reached in just 3 days.
Patients with Undiagnosed PIDD
Patients with undiagnosed PIDD may experience increased morbidity and mortality.
Most common symptoms to consider for identifying a patient with PIDD.
Most common symptoms to consider for identifying a patient with PIDD.
The Nurse Educator program provides customized training and education.
The Nurse Educator program provides customized training and education.
Local and systemic adverse reactions by subject and by infusion.
0 serious bacterial infections per subject-year. 2 infections per subject-year.
0 serious bacterial infections per subject-year. 2 infections per subject-year.
Percentage of subjects reporting local site reactions.
50% Fewer Infusion-Site Reactions by Week 24
Percentage of subjects reporting local site reactions.
A free XEMBIFY Patient Starter Kit is available for adult and pediatric patients. Get the details.
A free XEMBIFY Patient Starter Kit is available for adult and pediatric patients. Get the details.
PIDD can affect multiple systems in the body. Download our guide to learn about signs and symptoms that may indicate that testing is needed.
PIDD can affect multiple systems in the body. Download our guide to learn about signs and symptoms that may indicate that testing is needed.
Consider a variety of factors when selecting infusion sites for XEMBIFY.
Selecting Infusion Sites for XEMBIFY
Consider a variety of factors when selecting infusion sites for XEMBIFY.
Please see the FAQ page for answers to most commonly questions about XEMBIFY.
Sugar-free, stabilized with glycine, trace amounts of sodium.
Financial assistance is available for eligible, uninsured patients. Download PAP application.
Patient Assistance Program (PAP)
Financial assistance is available for eligible, uninsured patients. Download PAP application.
$0 copay for eligible patients. Up to $10,000 copay assistance per calendar year.
Xembify Connexions Copay Program
$0 copay for eligible patients. Up to $10,000 copay assistance per calendar year.
Xembify Connexions Support Program
Working with Xembify Connexions
Complete the PDF.
XEMBIFY Prescription Referral Form
Complete the PDF.
To order XEMBIFY 20% Injection Single-Use Vial 1 g/5 mL, 2 g/10 mL, 4 g/20 mL, and 10 g/50 mL, contact a field representative or order through your distributor listed below.
To order XEMBIFY 20% Injection Single-Use Vial 1 g/5 mL, 2 g/10 mL, 4 g/20 mL, and 10 g/50 mL, contact a field representative or order through your distributor listed below.
Get the full details on XEMBIFY dosing and administration.
Get the full details on XEMBIFY dosing and administration.
Proven SCIG and IVIG treatments to meet the needs of your patients with PIDD.
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.