PROVEN TOLERABILITY
Maximum purity and proven tolerability
Demonstrated tolerability with mild to moderate local and systemic reactions†
Results from an open-label, multicenter, phase 3 clinical study of patients with primary immunodeficiency (n=49).
No noticeable tolerability differences were observed between age groups1
- All but one adverse event were mild or moderate1†
- Results per subject: overall rate of headaches (1/49); overall rate of systemic adverse reactions (7/49)1
Local site reactions decreased by >50% over time
Percent subjects reporting local site reactions
Results from an open-label, multicenter, phase 3 clinical study of patients with primary immunodeficiency (n=49).
- Local infusion-site reactions decreased from ~34% to ~14%, from the start to the end of the 24-week SC phase, reflecting a >50% reduction1
Adverse reactions in ≥5% of subjects
| Adverse Reactions* | By Subject N (%)† (N=49 subjects) |
By Infusion N (rate)‡ (N=1053 infusions) |
|---|---|---|
| Local adverse reactions | ||
| Infusion-site erythema | 19 (39%) | 123 (0.117) |
| Infusion-site pain | 9 (18%) | 32 (0.030) |
| Infusion-site swelling | 8 (16%) | 124 (0.118) |
| Infusion-site bruising | 8 (16%) | 26 (0.025) |
| Infusion-site nodule | 8 (16%) | 13 (0.012) |
| Infusion-site pruritus | 5 (10%) | 28 (0.027) |
| Infusion-site induration | 4 (8%) | 6 (0.006) |
| Infusion-site scab | 3 (6%) | 6 (0.006) |
| Infusion-site edema | 3 (6%) | 5 (0.005) |
| Systemic adverse reactions | ||
| Cough | 3 (6%) | 4 (0.004) |
| Diarrhea | 3 (6%) | 3 (0.003) |
| Adverse Reactions* | Local adverse reactions |
| By Subject N (%)† (N=49 subjects) |
|
| By Infusion N (rate)‡ (N=1053 infusions) |
| Adverse Reactions* | Infusion-site erythema |
| By Subject N (%)† (N=49 subjects) |
19 (39%) |
| By Infusion N (rate)‡ (N=1053 infusions) |
123 (0.117) |
| Adverse Reactions* | Infusion-site pain |
| By Subject N (%)† (N=49 subjects) |
9 (18%) |
| By Infusion N (rate)‡ (N=1053 infusions) |
32 (0.030) |
| Adverse Reactions* | Infusion-site swelling |
| By Subject N (%)† (N=49 subjects) |
8 (16%) |
| By Infusion N (rate)‡ (N=1053 infusions) |
124 (0.118) |
| Adverse Reactions* | Infusion-site bruising |
| By Subject N (%)† (N=49 subjects) |
8 (16%) |
| By Infusion N (rate)‡ (N=1053 infusions) |
26 (0.025) |
| Adverse Reactions* | Infusion-site nodule |
| By Subject N (%)† (N=49 subjects) |
8 (16%) |
| By Infusion N (rate)‡ (N=1053 infusions) |
13 (0.012) |
| Adverse Reactions* | Infusion-site pruritus |
| By Subject N (%)† (N=49 subjects) |
5 (10%) |
| By Infusion N (rate)‡ (N=1053 infusions) |
28 (0.027) |
| Adverse Reactions* | Infusion-site induration |
| By Subject N (%)† (N=49 subjects) |
4 (8%) |
| By Infusion N (rate)‡ (N=1053 infusions) |
6 (0.006) |
| Adverse Reactions* | Infusion-site scab |
| By Subject N (%)† (N=49 subjects) |
3 (6%) |
| By Infusion N (rate)‡ (N=1053 infusions) |
6 (0.006) |
| Adverse Reactions* | Infusion-site edema |
| By Subject N (%)† (N=49 subjects) |
3 (6%) |
| By Infusion N (rate)‡ (N=1053 infusions) |
5 (0.005) |
| Adverse Reactions* | Systemic adverse reactions |
| By Subject N (%)† (N=49 subjects) |
|
| By Infusion N (rate)‡ (N=1053 infusions) |
| Adverse Reactions* | Cough |
| By Subject N (%)† (N=49 subjects) |
3 (6%) |
| By Infusion N (rate)‡ (N=1053 infusions) |
4 (0.004) |
| Adverse Reactions* | Diarrhea |
| By Subject N (%)† (N=49 subjects) |
3 (6%) |
| By Infusion N (rate)‡ (N=1053 infusions) |
3 (0.003) |
Unique formulation
Manufactured to help protect a wide range of PIDD patients2,3*
Dosing
Customizable dosing to fit the needs of patients.
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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
- Sleasman JW, Lumry WR, Hussain I, et al. Immune globulin subcutaneous, human - klhw 20% for primary humoral immunodeficiency: an open-label, Phase III study. Immunotherapy. 2019;11(16):1371-1386.
- Data on file, Grifols.
- Alonso W, Vandeberg P, Lang J, et al. Immune globulin subcutaneous, human 20% solution (Xembify®), a new high concentration immunoglobulin product for subcutaneous administration. Biologicals. 2020;64:34-40.
TERMS TO KNOW
SCIG, subcutaneous immune globulin.