XEMBIFY: Package Insert and Label Information

XEMBIFY- human immunoglobulin g solution
GRIFOLS USA, LLC

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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 central vascular catheters, hyperviscosity, and cardiovascular risk factors. Thrombosis may occur in the absence of known risk factors. [see Warnings and Precautions (5.2), Patient Counseling Information (17)]
  • 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. [see Warnings and Precautions (5.2)]

1 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. This includes, but is not limited to, congenital agammaglobulinemia, common variable immunodeficiency, X-linked agammaglobulinemia, Wiskott-Aldrich syndrome, and severe combined immunodeficiencies.[1-4]

2 DOSAGE AND ADMINISTRATION

For subcutaneous infusion only.

Before switching to XEMBIFY, obtain the patient’s serum IgG trough level to guide subsequent dose adjustments.

2.1 Dose

Individualize the dose based on the patient’s pharmacokinetic and clinical response.

Measure the patient’s serum IgG trough level as early as 5 weeks after initiating XEMBIFY treatment to determine if a dose adjustment is needed.

Monitor the patient’s IgG trough level every 2 to 3 months to determine subsequent dose adjustments and dosing intervals as needed (Table 1).

Doses divided over the course of a week or once weekly achieve similar exposure when administered regularly at steady-state.

For frequent dosing (2-7 times per week), divide the calculated weekly dose by the desired number of times per week.

For dose adjustments, calculate the difference (in mg/dL) of the patient’s serum IgG trough level from the target IgG trough level, then find this difference in Table 1 (below). Locate the corresponding amount (in mL) by which to increase or decrease the weekly dose based on the patient’s body weight. For example, if a patient with a body weight of 70 kg has an actual IgG trough level of 900 mg/dL and the target level is 1,000 mg/dL, this results in a difference of 100 mg/dL. Therefore, increase the weekly dose of subcutaneous dose by 5 mL.

The patient’s clinical response should be the primary consideration in dose adjustment. If a patient on XEMBIFY does not maintain an adequate clinical response or a serum IgG trough level equivalent to that of a previous treatment, adjust the dose accordingly.

Table 1: Adjustment (±mL) of the Weekly Subcutaneous Dose Based on the Difference (±mg/dL) From the Target Serum IgG Trough Level
*
Dose adjustment in mL is based on the slope of the serum IgG trough level response to subcutaneous administration of XEMBIFY dose increments (about 6.6 mg/dL per increment of 1 mg/kg per week).
Difference From Target IgG Trough Level (mg/dL) Body Weight (kg)
10 15 20 30 40 50 60 70 80 90 100 110 120
Dose Adjustment (mL per Week)*
50 0 1 1 1 2 2 2 3 3 3 4 4 5
100 1 1 2 2 3 4 5 5 6 7 8 8 9
150 1 2 2 3 5 6 7 8 9 10 11 13 14
200 2 2 3 5 6 8 9 11 12 14 15 17 18
250 2 3 4 6 8 9 11 13 15 17 19 21 23
300 2 3 5 7 9 11 14 16 18 20 23 25 27
350 3 4 5 8 11 13 16 19 21 24 27 29 32
400 3 5 6 9 12 15 18 21 24 27 30 33 36
450 3 5 7 10 14 17 20 24 27 31 34 38 41
500 4 6 8 11 15 19 23 27 30 34 38 42 45

Switching to XEMBIFY from IVIG

Begin treatment with XEMBIFY one week after the patient’s last IVIG infusion. Calculate the initial weekly dose of XEMBIFY. Divide the previous monthly (or every 3 weeks) IVIG dose in grams by the number of weeks between IVIG infusions, then multiply this dose by the dose adjustment factor of 1.37.

Dosage
(click image for full-size original)

To convert the XEMBIFY dose (in grams) to milliliters (mL), multiply the calculated Initial SC dose (in grams) by 5.

Provided the total weekly dose is maintained, any dosing interval from daily up to weekly will achieve similar systemic IgG exposure when administered regularly at steady-state.

Switching to XEMBIFY from subcutaneous immune globulin (IGSC)

Administer the same weekly dose of XEMBIFY (in grams) as the weekly dose of prior IGSC treatment (in grams).

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