XEMBIFY is supplied in 1, 2, 4, and 10 gram single use vials.
Package NDC Number Container NDC Number Size Gram Protein
13533-810-05 13533-810-06 5 ml 1
13533-810-10 13533-810-11 10 ml 2
13533-810-20 13533-810-21 20 ml 4
13533-810-50 13533-810-51 50 ml 10
Components used in the packaging are not made with natural rubber latex and contains no preservative.
Store XEMBIFY at 2�8�C (36�46�F).
Note: XEMBIFY may be stored at temperatures not to exceed 25�C (77�F) for up to 6
months any time prior to the expiration date. Following 25�C (77�F) storage, use the
product immediately or discard.
Do not freeze.
Do not use solutions that have been frozen.
Do not use after expiration date.
Discard unused portion. These highlights do not include all the information needed to use XEMBIFY safely and effectively. See full prescribing information for XEMBIFY.
XEMBIFY (immune globulin subcutaneous, human � klhw)
20% solution
Initial U.S. Approval: 2019
WARNING: THROMBOSIS
See full prescribing information for complete boxed warning.
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 for hyperviscosity.
INDICATIONS AND USAGE
XEMBIFY� (immune globulin subcutaneous, human- klhw) is a 20% immune globulin solution for subcutaneous injection indicated for treatment of Primary Humoral Immunodeficiency (PI) in patients 2 years of age and older. (1)
DOSAGE AND ADMINISTRATION
For subcutaneous infusion only.
Before switching to XEMBIFY, obtain the patient�s serum IgG trough level to guide subsequent dose adjustments.
Dose (2.1)
Switching from immune globulin intravenous (human), 10% (IVIG) to XEMBIFY: calculate the dose by using a dose adjustment factor (1.37)
Weekly: Begin XEMBIFY one week after last IVIG infusion.
Establish initial weekly dose by converting the monthly (or every 3 weeks) IVIG dose into an equivalent weekly dose and increasing it using a dose adjustment factor (1.37).
Initial weekly = Prior IVIG dose (in grams) � 1.37
dose (grams) Number of weeks between IVIG doses
Frequent dosing (2-7 times per week): Divide the calculated weekly dose by the desired number of times per week.
Switching from immune globulin subcutaneous (human) treatment (IGSC): Weekly dose (grams) should be the same as the weekly dose of prior IGSC treatment (grams).
Administration (2.3)
Infusion sites: up to 6 infusion sites simultaneously, with at least 2 inches (5 cm) between sites avoiding bony prominences. Rotate sites for each administration
DOSAGE FORMS AND STRENGTHS
XEMBIFY is a solution containing 0.2 g/mL (200 mg/mL; 20%) protein solution for subcutaneous infusion. (3)
CONTRAINDICATIONS
Anaphylactic or severe systemic reactions to human immunoglobulin or inactive ingredients of XEMBIFY such as polysorbate 80. (4)
IgA deficient patients with antibodies against IgA and a history of hypersensitivity (4)
WARNINGS AND PRECAUTIONS
Hypersensitivity and anaphylactic reactions may occur. IgA deficient patients with antibodies against IgA are at greater risk of developing severe hypersensitivity or anaphylactic reactions. (5.1)
Aseptic Meningitis Syndrome (AMS) may occur within two days of treatment. (5.3)
Monitor for renal function in patients at risk for renal failure. (5.4)
Hemolysis can develop. Risk factors include high doses and non-O blood group. Closely monitor for hemolysis and hemolytic anemia. (5.5)
Monitor patients for pulmonary adverse reactions (transfusion-related acute lung injury [TRALI]). (5.6)
XEMBIFY is made from human plasma and may carry a risk of transmitting infectious agents, e.g., viruses, the variant Creutzfeldt-Jakob disease (vCJD) agent and, theoretically, the Creutzfeldt-Jakob disease (CJD) agent. (5.7)
Passive transfer of antibodies may confound serologic testing. (5.8)
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. (6.1)
To report SUSPECTED ADVERSE REACTIONS, contact Grifols Therapeutics LLC at 1-800-520-2807 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
(6)
DRUG INTERACTIONS
The passive transfer of antibodies may transiently interfere with the response to live virus vaccines, such as measles, mumps, rubella, and varicella. (7.2)
USE IN SPECIFIC POPULATIONS
Geriatric: In patients over 65 years, do not exceed the recommended dose and infuse XEMBIFY at the minimum rate practicable. (8.5)
See 17 for PATIENT COUNSELING INFORMATION and FDA-approved patient labeling.
Revised: 7/2019
