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CUTAQUIG- immunoglobulin g solution


  1. Patient Information
  2. Inform Patients To Immediately Report The Following Signs And Symptoms To Their Healthcare Provider:
  3. Manufactured By:
  4. Distributed By:

Patient Information 

Advise the patients to read the FDA-approved patient labeling (Patient Information and Instructions for Use).

Inform Patients To Immediately Report The Following Signs And Symptoms To Their Healthcare Provider: 

  • Hypersensitivity reactions to CUTAQUIG (including hives, generalized hives, tightness of the chest, wheezing, low blood pressure, and anaphylaxis): Advise patients to have epinephrine immediately available to treat any acute severe hypersensitivity reaction and ensure patients and their caregivers are properly trained in its use. [seeWarnings and Precautions(5.1)].
  • Pain and/or swelling of an arm or leg with warmth over the affected area, discoloration of an arm or leg, unexplained shortness of breath, chest pain or discomfort that worsens on deep breathing, unexplained rapid pulse, or numbness or weakness on one side of the body [seeWarnings and Precautions(5.2)].
  • Severe headache, neck stiffness, drowsiness, fever, sensitivity to light, painful eye movements, nausea, and vomiting [seeWarnings and Precautions(5.4)].
  • Decreased urine output, sudden weight gain, fluid retention/edema, and/or shortness of breath [seeWarnings and Precautions(5.5)].
  • Fatigue, increased heart rate, yellowing of the skin or eyes, and dark-colored urine [seeWarnings and Precautions(5.6)].
  • Severe breathing problems, lightheadedness, drops in blood pressure, and fever [seeWarnings and Precautions(5.7)].

Inform patients to be tested periodically to make sure they have the appropriate levels of IgG in their blood. These tests may result in adjustments to the CUTAQUIG dose.

Inform patients/caregivers that because CUTAQUIG is made from human blood, it may carry a risk of transmitting infectious agents, e.g., viruses, the variant Creutzfeldt-Jakob disease (vCJD) agent and, theoretically, the Creutzfeldt-Jakob disease (CJD) agent [seeWarnings and Precautions(5.8),Description(11)].

Inform patients that CUTAQUIG may interfere with the response to live virus vaccines (e.g., measles, mumps, rubella, and varicella) and to notify their immunizing physician of recent therapy with CUTAQUIG [seeDrug Interactions(7.2)].


Home treatment/Self administration

  • If self-administration is deemed appropriate by the physician, it is highly important that the patient/caregiver receives clear instructions and thorough training on subcutaneous administration of CUTAQUIG. The patient/caregiver needs to demonstrate the ability to independently administer subcutaneous infusions and this should be documented.
  • Ensure the patient/caregiver understands the importance of regular subcutaneous infusions to maintain appropriate steady state IgG levels.
  • Instruct the patient/caregiver to keep a treatment diary/log where all information about each infusion should be clearly documented.
  • Inform patients to interrupt or terminate the CUTAQUIG infusion if a hypersensitivity reaction occurs.
  • Inform patients that they should be tested regularly to make sure they have the correct levels of CUTAQUIG (IgG) in their blood. These tests may result in adjustment to the CUTAQUIG dose.
  • Instruct the patient/caregiver that local injection site reactions (such as swelling, redness, itching) are a common side effect of subcutaneous treatment, but also tell them to contact their healthcare provider if local reactions increase in severity or persist for more than a few days.
  • Inform the patient that injection sites should be rotated between infusions and that CUTAQUIG is for subcutaneous infusion only.

Manufactured By: 

Octapharma Pharmazeutika Produktionsges.m.b.H.

Oberlaaer Strasse 235

1100 Vienna, Austria

U.S. License No. 1646

Distributed By: 

Octapharma USA Inc.

121 River Street, Suite 1201

Hoboken, NJ 07030






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