General Information

Cutaquig (Immune Globulin Subcutaneous (Human) - hipp) is a 16.5% immune globulin solution.

Cutaquig is specifically indicated for the treatment of pediatric patients age 2 and older with primary humoral immunodeficiency (PI).

Cutaquig is supplied for subcutaneous infusion. 

• Switching from Immune Globulin Intravenous (IGIV) to Cutaquig: calculate the dosing by using a dose conversion factor
• Switching from other Immune Globulin Subcutaneous (IGSC): dosing should be the same as for previous IGSC.
• Weekly : Start Cutaquig one week after last IGIV infusion Initial weekly dose = Previous IGIV dose (in grams) x 1.30 No. of weeks between IGIV doses
• Every other week : Start Cutaquig 1 or 2 weeks after the last IGIV dosing or 1 week after the last IGSC administration. Infuse twice the calculated weekly dose.
• More frequent than weekly (2-7 times a week): start Cutaquig 1 week after last IGIV or IGSC administration. Divide the calculated weekly dose by the desired number of infusions per week.

Adjust dosing according to patient’s pharmacokinetics and clinical response.

Mechanism of Action

Cutaquig supplies a broad spectrum of opsonizing and neutralizing Immunoglobulin G (IgG) antibodies against a wide variety of bacterial and viral agents. It has a distribution of immune globulin subclasses closely proportional to that in native human plasma. The mechanism of action in primary humoral immunodeficiency (PI) has not been fully elucidated; however adequate doses may restore abnormally low immune globulin G levels to the normal range and thus help in preventing infections.

Side Effects

Adverse effects associated with Cutaquig may include, but are not limited to, the following:

• local infusion site reactions
• headache
• fever
• dermatitis
• asthma
• diarrhea
• cough

Clinical Trial Results

The FDA approval of Cutaquig was based on the results of two clinical trials, which observed 75 PI patients, 37 adults and 38 pediatric patients between ages 2 and 17. The patients received weekly infusions with cutaquig during a 12-week wash-in/wash-out period followed by a 12-month efficacy period. The main objective of the research was to assess the efficacy of cutaquig in preventing serious bacterial infections, defined as bacteremia/sepsis, bacterial meningitis, osteomyelitis/septic arthritis, bacterial pneumonia and visceral abscess. No serious bacterial infections were reported.