Dosage & Administration
For subcutaneous infusion only.
Administer at regular intervals from daily up to every two weeks (biweekly).
Individualize dose based on the patient's pharmacokinetic and clinical response.
Monitor serum IgG trough levels regularly to guide subsequent dose adjustments and dosing intervals as needed.
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 IGIVor HYQVIA dose (in grams) × 1.30 |
| No. of weeks between IGIV or HYQVIA doses |
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Cuvitru Prescribing Information
- Thrombosis may occur with immune globulin products, including CUVITRU. 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.
- For patients at risk of thrombosis, administer CUVITRU 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.
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.
Preparation and Handling
- Inspect the drug product visually for particulate matter and discoloration prior to administration. CUVITRU is a clear and colorless or pale yellow or light brown solution and clear of particulate matter. Do not use if the solution is cloudy, turbid, or if it contains particulates.
- Do not mix CUVITRU with other products.
- Do not shake.
- Do not dilute.
- CUVITRU comes in a single-dose vial. Any vial that has been entered should be used promptly. Partially used vials should be discarded. CUVITRU contains no preservative.
- Record the name and lot number of the product in the recipient's records.
Dose
- CUVITRU can be administered at regular intervals from daily up to every two weeks (biweekly).
- Individualize the dose based on the patient's pharmacokinetic and clinical response.
- Monitor serum IgG trough levels regularly to guide subsequent dose adjustments and dosing intervals as needed (see Dose Adjustment).
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]:
- Begin treatment with CUVITRU one week after the patient's last IGIV or HYQVIA infusion.
- Establish the initial weekly dose by converting the monthly IGIV or HYQVIA dose into an equivalent weekly dose and increasing it using a dose adjustment factor.
- To calculate the initial weekly dose, divide the previous IGIV or HYQVIA dose in grams by the number of weeks between intravenous doses; then multiply this dose by the dose adjustment factor of 1.30.
Initial Weekly dose = Previous IGIV or HYQVIA dose (in grams) × 1.30 Number of weeks between IGIV or HYQVIA doses - To convert the dose (in grams) to milliliters (mL), multiply the calculated dose (in grams) by 5.
- Doses divided over the course of a week, or once weekly, or biweekly, achieve similar exposure when administered regularly at steady-state.
- To determine the dose for alternative regular dosing intervals:
- ‒
- Frequent dosing (2-7 times per week): Divide the calculated weekly dose by the desired number of times per week.
- ‒
- Biweekly dosing: Multiply the calculated weekly dose by 2.
To guide dose adjustments, see section Dose Adjustments (Table 1).
For patients switching from Immune Globulin Subcutaneous (Human) treatment (IGSC):
- The weekly dose of CUVITRU (in grams) is recommended to be the same as the weekly dose of prior IGSC treatment (in grams).
- Doses divided over the course of a week, once weekly, or biweekly, achieve similar exposure when administered regularly at steady-state.
- To determine the dose for alternative regular dosing intervals:
- ‒
- Frequent dosing (2-7 times per week): Divide the calculated weekly dose by the desired number of times per week.
- ‒
- Biweekly dosing: Multiply the calculated weekly dose by 2.
- To convert the dose (in grams) to milliliters (mL), multiply the calculated dose (in grams) by 5.
To guide dose adjustments, see section Dose Adjustments (Table 1).
For patients at risk for measles exposure:
- If a patient has been exposed to measles, it may be prudent to administer a dose of Immune Globulin Intravenous as soon as possible and within 6 days of exposure. A dose of 400 mg/kg should provide a serum level >240 mIU/mL of measles antibodies for at least two weeks.
- If a patient is at risk of future measles exposure and receives a dose of CUVITRU of less than 230 mg/kg subcutaneously per week, the dose should be increased to at least 230 mg/kg per week, or the weekly equivalent of 230 mg/kg for dosing intervals other than weekly.
Dose Adjustment:
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.
| 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 | |
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.
Administration
| 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 | ||
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.
Instructions for Administration:
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:
- Gather supplies: CUVITRU vial(s), ancillary supplies, sharps container and infusion pump.
- Prepare a clean work area.
- Wash hands.
- 3.
- Prepare the CUVITRU:
- Wipe each stopper with a sterile alcohol wipe and allow to dry.
- Transfer into syringe(s), preferably using a vented spike.
- Start the infusion promptly after drawing CUVITRU into the syringe. It is suggested to complete the administration within 2 hours due to the potential formation of particles caused by siliconized syringes.
- 4.
- Prepare the infusion pump and tubing:
- Follow manufacturer directions for priming the tubing and pump usage.
- Attach the syringe filled with CUVITRU to the needle set.
- Prime the needle set up to the needle hub.
- 5.
- Prepare the infusion site(s):
- Potential sites for infusion include the abdomen, thighs, upper arms, or lateral hip.
- Avoid: bony areas, visible blood vessels, scars and any areas of inflammation (irritation) or infection.
- The number and location of infusion sites depends on the volume of the total dose.
- Infusion sites should be at least 4 inches apart.
- Rotate sites of the body between successive infusions.
- Cleanse the infusion site(s) with a sterile alcohol wipe beginning at the center of each infusion site and moving outward in a circular motion. Allow the infusion site(s) to dry.
- 6.
- Insert and secure the subcutaneous needle set:
- Pinch at least one inch of skin between two fingers. Insert the needle at a 90-degree angle into the subcutaneous tissue and secure the needle with sterile tape.
- If more than one site is used, repeat steps.
- Secure the needle in place with a sterile protective dressing.
- 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.
CUVITRU is a 200 mg/mL (20%) protein solution for subcutaneous infusion.
Pregnancy
Risk Summary
No human data are available to indicate the presence or absence of drug-associated risk. Animal reproduction studies have not been conducted with CUVITRU. It is also not known whether CUVITRU can cause fetal harm when administered to a pregnant woman or can affect reproductive capacity. Immune globulins cross the placenta from maternal circulation increasingly after 30 weeks of gestation. CUVITRU should be given to a pregnant woman only if clearly indicated. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2-4% and 15-20%, respectively.
Lactation
Risk Summary
No human data are available to indicate the presence or absence of drug-associated risk. The developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for CUVITRU and any potential adverse effects on the breastfed infant from CUVITRU or from the underlying maternal condition.
Pediatric Use
CUVITRU was evaluated in 21 pediatric subjects with PI (2 to 16 years of age) in a multicenter clinical study. The safety and efficacy profiles were similar to adult subjects. No pediatric-specific dose requirements were necessary to achieve the desired serum IgG levels.
Safety and effectiveness of CUVITRU has not been evaluated in neonates or infants <2 years old.
Geriatric Use
CUVITRU was evaluated in 9 subjects over the age of 65 years in a multicenter clinical study. No differences in safety or efficacy were observed for this group when compared to the rest of the study population.
Monitor patients who are at an increased risk for developing renal failure or thrombotic events. Do not exceed the recommended dose, and infuse at the minimum infusion rate practicable [see Boxed Warning, Warnings and Precautions (5.2, 5.4), Dosage and Administration (2.3)].
- CUVITRU is contraindicated in patients who have had an anaphylactic or severe systemic hypersensitivity reaction to the subcutaneous administration of human immune globulin.
- CUVITRU is contraindicated in IgA-deficient patients with antibodies against IgA and a history of hypersensitivity to human immune globulin treatment.