Safety and tolerability of XEMBIFY were established in an open-label phase 3 study1

Table that visualizes the open-label phase three study, including

An additional open-label, phase 4 study evaluated every-2-week dosing of XEMBIFY and use in treatment-naive patients2

Every-2-week dosing of XEMBIFY was noninferior to weekly dosing3

Maximum potency and proven tolerability with XEMBIFY1,2

Observed in the phase 3 study:

Number zero representing drug-related serious adverse events

0 drug-related SAEs

Number zero representing serious or severe injection site reactions

0 serious or severe infusion-site reactions

Number 0.001 representing headaches per infusion

< 0.001 headaches per infusion

Number zero representing reports of nausea or fatigue

0 reports of nausea or fatigue

No noticeable tolerability differences were observed between age groups1

  • All but one adverse event were mild or moderate*
  • Results per subject: overall rate of headaches (1/49); overall rate of systemic adverse reactions (7/49)

*One subject, who experienced a severe potentially related AE during the SC phase (on day 20), had polymyalgia rheumatica, 
  which was considered unlikely related to study drug and resolved by day 75.1

> 50% fewer infusion-site reactions by week 241

Table visualizing percentage of subjects reporting local site reactions were 50% fewer by week 24

Adverse reactions in ≥ 5% of subjects1,2

Local adverse reactions

Adverse Reactions*

Infusion-site erythema
By Subject
n (%)
(N=49 subjects)

19 (39%)

By Infusion
n (rate)†
(N=1053 infusions)

123 (0.117)

Infusion-site pain
By Subject
n (%)
(N=49 subjects)

9 (18%)

By Infusion
n (rate)†
(N=1053 infusions)

32 (0.030)

Infusion-site swelling
By Subject
n (%)
(N=49 subjects)

8 (16%)

By Infusion
n (rate)†
(N=1053 infusions)

124 (0.118)

Infusion-site bruising
By Subject
n (%)
(N=49 subjects)

8 (16%)

By Infusion
n (rate)†
(N=1053 infusions)

26 (0.025)

Infusion-site nodule
By Subject
n (%)
(N=49 subjects)

8 (16%)

By Infusion
n (rate)†
(N=1053 infusions)

13 (0.012)

Infusion-site pruritus
By Subject
n (%)
(N=49 subjects)

5 (10%)

By Infusion
n (rate)†
(N=1053 infusions)

28 (0.027)

Infusion-site induration
By Subject
n (%)
(N=49 subjects)

4 (8%)

By Infusion
n (rate)†
(N=1053 infusions)

6 (0.006)

Infusion-site scab
By Subject
n (%)
(N=49 subjects)

3 (6%)

By Infusion
n (rate)†
(N=1053 infusions)

6 (0.006)

Infusion-site edema
By Subject
n (%)
(N=49 subjects)

3 (6%)

By Infusion
n (rate)†
(N=1053 infusions)

5 (0.005)

Adverse Reactions* By Subject
n (%)
(N=49 subjects)		 By Infusion
n (rate)†
(N=1053 infusions)

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

Adverse Reactions*

Cough
By Subject
n (%)
(N=49 subjects)

3 (6%)

By Infusion
n (rate)†
(N=1053 infusions)

4 (0.004)

Diarrhea
By Subject
n (%)
(N=49 subjects)

3 (6%)

By Infusion
n (rate)†
(N=1053 infusions)

3 (0.003)

*Including all adverse reactions that occurred after the first dose of XEMBIFY regardless of causality, excluding infections.2
†Rate per infusion is calculated as the total number of adverse reactions divided by the total number of infusions.2

*Including all adverse reactions that occurred after the first dose of XEMBIFY regardless of causality, excluding infections.2
†Rate per infusion is calculated as the total number of adverse reactions divided by the total number of infusions.2
Adverse Reactions* By Subject
n (%)
(N=49 subjects)		 By Infusion
n (rate)†
(N=1053 infusions)

Cough

3 (6%)

4 (0.004)

Diarrhea

3 (6%)

3 (0.003)
Table that visualizes the phase three study, including

View the complete data from the phase 3 study

View phase 3 study

Proven tolerability with the first and only FDA-approved 20% SCIG for treatment-naive patients with PIDD1,2

0 drug-related serious adverse events

< 0.001 headaches per infusion

0 reports of nausea or fatigue

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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, 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.

Terms to know

AE, adverse event; IG, immune globulin; IGIV-C 10%, immune globulin injection (human) 10% caprylate/chromatography purified; IV, intravenous; PIDD, primary humoral immunodeficiency disease; SAE, serious adverse event; SC, subcutaneous; SCIG, subcutaneous immunoglobulin.

 

References

  1. 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.
  2. XEMBIFY Prescribing Information, Grifols. July 2024.
  3. Lumry W, Palumbo M, Hsu C, et al. Pharmacokinetics, efficiency, and safety of weekly/biweekly dosing using Xembify® in treatment-experienced patients, and loading/maintaining dosing in treatment-naive patients with primary humoral immunodeficiency. Poster presented at: CIS 2024 Annual Meeting; May 1-4 2024; Minneapolis, MN.