Prescribing Info, Safety Info, and complete BOXED WARNING and Patient Information and Instructions for Use: https://labeling.pfizer.com/ShowLabeling.aspx?id=12505
Important Safety Information
https://www.cutaquiginfo.com/
Full Prescribing Information, including complete BOXED WARNING and Patient Information and Instructions for Use
https://labeling.pfizer.com/ShowLabeling.aspx?id=12505
IN
DICATIONS AND USAGE
CUTAQUIG (Immune Globulin Subcutaneous [Human] - hipp) is a 16.5% immune globulin solution for subcutaneous infusion indicated for treatment of primary humoral immunodeficiency (PI) in adults and pediatric patients 2 years of age and older. CUTAQUIG is a liquid medicine for infusion that contains immunoglobulin G (IgG), which are proteins that help fight infection. It is made from human plasma that is donated by healthy people and contains antibodies that replace the missing antibodies in patients with PI. CUTAQUIG is given under the skin (subcutaneous). Most of the time, infusions under the skin are given at home by self-infusion or by a caregiver. Only use CUTAQUIG by yourself after you have been instructed on use by a healthcare provider (HCP). IMPORTANT SAFETY INFORMATION
WARNING: THROMBOSIS
See full Prescribing Information for complete BOXED WARNING
Thrombosis may occur with immune globulin products, including CUTAQUIG. 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 CUTAQUIG 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. What is the most important information I need to know about CUTAQUIG? CUTAQUIG can cause the following serious reactions:
• Severe allergic reactions causing difficulty in breathing or skin rashes
• Blood clots in the heart, brain, lungs, or elsewhere in the body
• Severe headache, drowsiness, fever, painful eye movements, or nausea and vomiting
• Decreased kidney function or kidney failure
• Dark colored urine, swelling, fatigue, or difficulty breathing
CUTAQUIG is made from human blood. The risk of transmission of infectious agents, including viruses, the variant Creutzfeldt-Jakob disease (vCJD) agent, and, theoretically, the Creutzfeldt-Jakob disease (CJD) agent cannot be completely eliminated. What should I know while taking CUTAQUIG?
• CUTAQUIG can make vaccines (like measles/mumps/rubella or chickenpox vaccines) not work as well for you. Before you get any vaccines, tell your HCP that you take CUTAQUIG
• Tell your HCP if you are pregnant, or plan to become pregnant, or if you are nursing
CUTAQUIG can cause serious side effects. If any of the following problems occur after starting
CUTAQUIG, contact your HCP or call emergency services. If any of the following problems occur during
CUTAQUIG infusion, stop the infusion immediately and contact your HCP or call emergency services:
• Hives, swelling in the mouth or throat, itching, trouble breathing, wheezing, fainting, or dizziness. These could be signs of a serious allergic reaction
• Bad headache with nausea, vomiting, stiff neck, fever, and sensitivity to light. These could be signs of irritation and swelling of the lining around your brain
• Reduced urination, sudden weight gain, or swelling in your legs. These could be signs of a kidney problem
• Pain, swelling, warmth, redness, or a lump in your legs or arms. These could be signs of a blood clot
• Brown or red urine, fast heart rate, yellow skin or eyes. These could be signs of a liver or blood problem
• Chest pain or trouble breathing, or blue lips or extremities. These could be signs of a serious heart or lung problem
• Fever over 100°F. This could be a sign of an infection
Ask your HCP whether you should have rescue medications available, such as antihistamines or epinephrine. What are the possible or reasonably likely side effects of CUTAQUIG? The most common side effects of CUTAQUIG are:
• Infusion site reactions (including but not limited to redness, swelling, itching, fluid in tissue, pain, mass, bruising)
• Headache
• Elevated body temperature
One or more of the following possible side effects may occur at the site of infusion; these may go away within a few hours and are less likely after the first few infusions:
• Mild or moderate pain
• Redness
• Itching
These are not all the possible side effects. Talk to your HCP about any side effect that bothers you or that does not go away. Patients should always ask their doctors for medical advice about adverse events. You may report any issues related to Pfizer products by calling Pfizer at 1-800-438-1985 (US only). Or if you prefer, you may contact the US Food and Drug Administration (FDA) directly. The FDA has established a reporting service known as MedWatch where healthcare professionals and consumers can report problems they suspect may be associated with the drugs and medical devices they prescribe, dispense, or use. Visit www.fda.gov/MedWatch or call 1-800-FDA-1088. This site is intended only for US residents. The products discussed in this site may have different product labeling in different countries. The information provided is for educational purposes only and is not intended to replace discussions with a healthcare provider. CUTAQUIG® is a registered trademark of Octapharma AG. Manufactured by Octapharma Pharmazeutika Produktionsges m.b.H. Distributed by Pfizer Labs, Division of Pfizer Inc.
