CUVITRU is indicated as replacement therapy for primary humoral immunodeficiency (PI) in adult and pediatric patients ≥2 years. CUVITRU is for subcutaneous use only.
When you start a patient on CUVITRU their dose is determined by whether they are switching from an IVIG treatment, HYQVIA [Immune Globulin Infusion 10% (Human) with Recombinant Human Hyaluronidase] Solution, or other SCIG treatments.
Patients who are:
Treatment with CUVITRU should begin 1 week after the patient’s last IVIG or HYQVIA infusion.
Establish the initial weekly dose by converting the monthly IVIG or HYQVIA dose into an equivalent weekly dose and increasing it using a dose adjustment factor (1.30).
Initial weekly dose = Previous IVIG or HYQVIA dose (in grams) / Number of weeks between IVIG or HYQVIA doses * 1.30
The initial weekly dose is recommended to be the same as the weekly dose of the prior SCIG treatment.
Regardless of prior IG treatment history, if the desire is to dose CUVITRU more frequently than once weekly, divide the calculated weekly dose by the desired frequency per week1
If the desired frequency is biweekly, multiply the weekly dose1 by 2
Multiply the calculated dose by 5 to convert from grams to milliliters1
Initial and subsequent infusion rate parameters
The rate of infusion and volume per site should be adjusted based on each individual
patient's needs, preferences, and ability to tolerate treatment.
|First Two Infusions||Subsequent Infusions|
|Patients <40kg||Patients ≥40kg||Patients <40kg||Patients ≥40kg|
*If the initial infusions are well tolerated, then subsequent infusions can be administered at the maximum tolerated rate.
Personalizing dose adjustments
Individualize each patient's dose by monitory pharmacokinetic and clinical response, as well as IgG trough levels, making dose adjustments as needed.1
Change in Volume to Be Administered Weekly/Biweekly for Intended IgG Trough Level Changea1
|30 kg||50 kg||70kg||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|
aDerived using a linear approximation of trough levels and weekly dose per kg body mass with a slope of 52.1 kg/dL.
If the difference between measured and target trough levels is <100 mg/dL, then no adjustment is necessary.1
Explore administration parameter combinations based on needlesticks and infusion frequency, and check out the proper ancillary supplies.Infusion Calculator & Ancillary Supplies