Primary immune deficiency:

Indications for: CUTAQUIG

Primary humoral immunodeficiency (eg, common variable immunodeficiency, X-linked agammaglobulinemia, congenital agammaglobulinemia, Wiskott-Aldrich syndrome, severe combined immunodeficiencies).

Adults and Children:

<2yrs: not established. See full labeling. Individualize. Give by SC infusion using an infusion pump into abdomen, thigh, upper arm, and/or upper leg/hip areas. May use up to 6 infusion sites (at least 2 inches apart) simultaneously. Rotate infusion sites. Prior to initiation: obtain serum IgG trough level to guide subsequent dose adjustments. Start 1 week after last IGIV or IGSC infusion (for weekly or frequent dosing), or 1–2 weeks after last IGIV infusion or 1 week after last IGSC infusion (for biweekly dosing). ≥2yrs: Switching from IGIV: Initial weekly dose = (previous IGIV dose [in grams] x 1.30)/number of weeks between IGIV doses. Biweekly dose: multiply the calculated weekly dose by 2. Frequent dosing (2–7 times/week): divide calculated weekly dose by the desired number of infusions per week. Switching from other IGSC: maintain previous IGSC weekly dose. Dose adjustments: based on serum IgG trough levels after 2–3 months of initiation and desired clinical response (see full labeling). Risk of measles exposure and receives <245mg/kg weekly, may increase to 245mg/kg; if exposed, give as soon as possible and within 6 days of exposure.

CUTAQUIG Contraindications:

IgA deficiency with antibodies against IgA. Previous severe reaction to human immune globulin.

Boxed Warning:


CUTAQUIG Warnings/Precautions:

Advanced age, prolonged immobilization, hypercoagulable conditions, history of venous or arterial thrombosis, use of estrogens, indwelling central vascular catheters, hyperviscosity, cardiovascular risk factors: increased risk of thrombosis. Monitor for signs/symptoms of thrombosis; assess blood viscosity in those at risk for hyperviscosity. Ensure adequate hydration. Pre-existing renal insufficiency, diabetes, >65yrs, hypovolemia, sepsis, paraproteinemia: increased risk of renal dysfunction or acute renal failure. Correct volume depletion; assess renal function, BUN, serum creatinine, urine output before and during therapy; discontinue if renal function deteriorates. Discontinue if hypersensitivity reactions occur; have epinephrine available. Monitor for aseptic meningitis, hemolysis, and delayed hemolytic anemia. Monitor for pulmonary dysfunction; perform test for anti-neutrophil antibodies if transfusion-related acute lung injury (TRALI) suspected. Risk of transmission of viral diseases. Elderly. Pregnancy. Nursing mothers.

CUTAQUIG Classification:

Immune globulin.

CUTAQUIG Interactions:

Concomitant nephrotoxic drugs: increased risk of acute renal failure. Falsely elevated results with some blood glucose tests (eg, GDH-PQQ based or glucose-dye-oxidoreductase methods); use glucose-specific method only. May affect response to live virus vaccines (eg, measles, mumps, rubella, varicella). May lead to misinterpretation of serological test results.

Adverse Reactions:

Local infusion site reactions (eg, redness, swelling, itching), headache, fever, dermatitis, asthma, diarrhea, cough; aseptic meningitis syndrome, hemolytic anemia, TRALI, thrombosis.

Generic Drug Availability:


How Supplied:

Single-use vial (6mL, 10mL, 12mL, 20mL, 24mL, 48mL)—1