Grifols Launches Xembify, A New Primary Immunodeficiency Treatment

Grifols, a global producer of plasma-derived medicines, announced the official launch of their new 20% subcutaneous immunoglobulin therapy, Xembify (immune globulin subcutaneous human-klhw), for the treatment of patients 2 years of age and older suffering from primary humoral immunodeficiency (PI). 

Originally approved in July, Xembify is Grifol’s first 20% subcutaneous immunoglobulin therapy. 

Xembify is contraindicated in patients with known anaphylactic or severe systemic reactions to human immunoglobulin or inactive ingredients of Xembify (ie polysorbate 80). Xembify is also contraindicated in patients deficient in immunoglobulin A (IgA), those with IgA antibodies, and a history or hypersensitivity. 

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A boxed warning issued with Xembify warns of the potential for thrombosis to occur in patients using immunoglobulin products. Risk factors listed in the warning include advanced age, prolonged immobilization, hyper coagulable conditions, history of venous or arterial thrombosis, use of estrogens, indwelling vascular catheters, hyperviscosity, and other cardiovascular risk factors. 

For patients at risk for thrombosis, Xembify should only be administered at the most practicable minimum doses and infusion rates. 

Other warnings and precautions issued with the use of Xembify include aseptic meningitis’s syndrome, which may occur within 2 days of treatment; hemolysis; pulmonary adverse reactions; infectious disease transmission due to human plasma origins; passive transfer of antibodies. 

Adverse reactions reported with the use of Xembify include 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.

References:

• Grifols launches Xembify 20% subcutaneous immunoglobulin, a new Primary Immunodeficiency treatment [news release]. Grifols’ website. https://intranet.grifols.com/documents/38081080/89399853/np-20191212-en.pdf/2a829e8e-9efe-48f8-aa7c-b01956b9520b. Accessed December 16, 2019.

• Xembify Prescribing Information. Xembify’s website. https://www.xembify.com/documents/90180901/0/xembify+prescribing+information+-+2019+-++3054808/9ff0e9a4-1249-4cd7-8b10-3ce50a8fad5d. Accessed December 16 2019.