Source: FDA, National Drug Code (US) Revision Year: 2021
CUVITRU is an Immune Globulin Subcutaneous (Human) (IGSC), 20% Solution indicated as replacement therapy for primary humoral immunodeficiency (PI) in adult and pediatric patients two years of age and older. This includes, but is not limited to, common variable immunodeficiency (CVID), X-linked agammaglobulinemia, congenital agammaglobulinemia, Wiskott-Aldrich syndrome, and severe combined immunodeficiencies1,2.
For subcutaneous administration only. Do not administer intravenously or intramuscularly.
For patients switching from Immune Globulin Intravenous (Human) treatment (IGIV) or adult patients switching from HYQVIA [Immune Globulin Infusion 10% (Human) with Recombinant Human Hyaluronidase]:
Initial Weekly dose = Previous IGIV or HYQVIA dose (in grams) / Number of weeks between IGIV or HYQVIA doses X 1.30
To guide dose adjustments, see section Dose Adjustments (Table 1).
For patients switching from Immune Globulin Subcutaneous (Human) treatment (IGSC):
To guide dose adjustments, see section Dose Adjustments (Table 1).
For patients at risk for measles exposure:
To guide dose adjustment, calculate the difference between the patient’s target serum IgG trough level and the IgG trough level during subcutaneous treatment. Find this difference in Table 1 and the corresponding amount (in mL) by which to increase (or decrease) the weekly/biweekly dose based on the patient’s body weight. If the difference between measured and target trough levels is less than 100 milligram/dL, then no adjustment is necessary. However, the patient’s clinical response should be the primary consideration in dose adjustment.
Table 1. Change in Volume to Be Administered Weekly/Biweekly for Intended IgG Trough Level Change*:
| Body Weight | ||||||
|---|---|---|---|---|---|---|
| Difference from Target Serum IgG Trough Levels | Dosing Frequency | 30 kg | 50 kg | 70 kg | 90 kg | 110 kg |
| 100 mg/dL | Weekly | 3 mL | 5 mL | 7 mL | 9 mL | 11 mL |
| Biweekly | 6 mL | 10 mL | 13 mL | 17 mL | 21 mL | |
| 200 mg/dL | Weekly | 6 mL | 10 mL | 13 mL | 17 mL | 21 mL |
| Biweekly | 12 mL | 19 mL | 27 mL | 35 mL | 42 mL | |
| 300 mg/dL | Weekly | 9 mL | 14 mL | 20 mL | 26 mL | 32 mL |
| Biweekly | 17 mL | 29 mL | 40 mL | 52 mL | 63 mL | |
* Derived using a linear approximation of trough levels and weekly dose per kg body mass with a slope of 52.1 kg/dL.
Example 1: A patient with a body weight of 70 kg who is on a weekly treatment has a measured IgG trough level of 600 milligrams/dL, and the target trough level is 800 milligrams/dL. The desired target trough level difference is 200 milligrams/dL (800 milligrams/dL minus 600 milligrams/dL). The weekly dose of CUVITRU should be increased by 13 mL.
Example 2: A patient with a body weight of 50 kg who is on a biweekly treatment has a measured IgG trough of 900 milligrams/dL, and the target trough level is 700 milligrams/dL. The desired target trough level difference is 200 milligrams/dL (900 milligrams/dL minus 700 milligrams/dL). The biweekly dose of CUVITRU should be decreased by 19 mL.
Table 2. Infusion Volume and Rate*:
| Infusion Parameters | First 2 Infusions | Subsequent Infusions | ||
|---|---|---|---|---|
| Patients <40 kg | Patients ≥40 kg | Patients <40 kg | Patients ≥40 kg | |
| Volume (mL/site) | ≤20 | ≤60 | ≤60 | |
| Rate (mL/hr/site) | 10-20 | ≤60 | ||
* If the initial infusions are well tolerated then subsequent infusions can begin at the maximum tolerated rate
Selection of Infusion Site: Suggested areas for subcutaneous infusion of CUVITRU are abdomen, thighs, upper arms, or lateral hip. CUVITRU may be infused into multiple infusion sites. Use up to 4 sites simultaneously. Infusion sites should be at least four inches apart, avoiding bony prominences. Rotate sites with each administration.
Volume per Site: To calculate the number of sites to be used, divide the total volume to be infused by the maximum volume/site (up to 60 mL/site) to be infused. Simultaneous subcutaneous infusion at multiple sites can be facilitated by use of a multi-needle administration set.
Infusion rate: For the first two infusions of CUVITRU, the recommended infusion rate is 10-20 mL/hr/site. For subsequent infusions, the infusion rate may be increased to 60 mL/hr/site as tolerated (e.g., 60 mL/hr/site × 2 sites = 120 mL/hr). For patients utilizing 4 infusion sites, the maximum infusion rate for all sites combined is 240 mL/hr.
Use aseptic technique when preparing and administering CUVITRU for infusion.
1. Inspect the vials: Inspect for clarity, color, and expiration date(s). [See Dosage and Administration (2.1)]
2. Prepare for infusion:
3. Prepare the CUVITRU:
4. Prepare the infusion pump and tubing:
5. Prepare the infusion site(s):
6. Insert and secure the subcutaneous needle set:
7 Start the infusion of CUVITRU based on prescriber’s order:
Follow the manufacturer’s instructions to turn on the infusion pump.
8. Remove subcutaneous needle(s) from the infusion site(s):
After the infusion is complete, remove the needle set and cover with a protective dressing. Discard any partially used vial(s) and disposable supplies in accordance with local requirements.
9. Document the infusion:
Remove the peel-off label from each vial of CUVITRU used and affix to the patient’s treatment record or infusion log. In addition, record the time, date, dose, infusion site location and any reactions after each infusion.
For self-administration, provide the patient with instructions and training for infusion in the home or other appropriate setting.
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