immunoglobulin G

What it is used for

CUTAQUIG is a ready-to-use liquid solution of Immunoglobulin G (IgG), also called antibodies, which protect the body against infection. CUTAQUIG is used to treat patients with primary humoral immunodeficiency (PI).

There are many forms of PI. The most common types of PI result in an inability to make a very important type of protein called antibodies, which help the body fight off infections from bacteria or viruses. Regular administration of CUTAQUIG will help your body to fight bacteria and viruses that cause infections. CUTAQUIG is made from human plasma that is donated by healthy people. CUTAQUIG contains antibodies collected from these healthy people; these antibodies replace the missing antibodies in PI patients.

How to take it

CUTAQUIG is given under the skin (subcutaneously). This type of infusion can be given at home by yourself or by your caretaker after appropriate training. Administration of CUTAQUIG should be done at regular intervals. Only use CUTAQUIG by yourself after you have been instructed by your healthcare provider.

Side effects, and when to stop

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

Call your healthcare provider or emergency department immediately if you have any of the following symptoms: difficulty breathing, chest tightness, itching, swelling of the face, rash, hives or dizziness. These could be signs of a serious allergic reaction.

Tell your healthcare provider immediately if you have any of the following symptoms. They could be signs of a serious drug reaction:

• Decreased urination, sudden weight gain, or swelling in the legs. These could be signs of a kidney problem.
• Bad headache with nausea, vomiting, stiff neck, fever, and sensitivity to light. These could be signs of meningitis, which is irritation of the lining around your brain.
• Pain, swelling, warmth, discoloration of an arm or leg, unexplained shortness of breath, chest pain, discomfort that worsens on deep breathing, unexplained rapid pulse, a lump in your legs or arms, or numbness or weakness on one side of the body. These could be signs of a blood clot.
• Chest pain or trouble breathing, or blue lips or extremities. These could be signs of a serious heart or blood problem.
• Brown or red urine, fast heart rate, yellow skin or eyes. These could be signs of a liver or heart problem.
• Fever over 100°F (38°C). This could be sign of an infection.

These are not all of the possible side effects from CUTAQUIG. Ask your healthcare provider for more information. You are encouraged to report side effects to Pfizer Inc. at 1-800-438-1985 or FDA at 1-800-FDA-1088.

Talk to your healthcare provider about any side effect that bothers you or that does not go away. You can ask your healthcare provider for more information on possible side effects.

Whenever giving yourself treatments at home, make sure another responsible person is present to help treat side effects or help if a serious adverse reaction occurs. Ask your healthcare provider whether you should have rescue medications, such as antihistamines or epinephrine. If prescribed epinephrine for severe allergic reactions, make sure you receive adequate training from a healthcare provider for its proper use.

Who should not take it

Do not use CUTAQUIG if you have ever had a severe allergic reaction to immune globulin or other blood products.

Tell your healthcare provider if you:

• ever had any severe reaction to other immune globulin medicines.
• were told that you have a condition called IgA deficiency.
• have a history of heart or blood vessel disease.
• have had blood clots or “thick blood”.
• have been immobile for some time.

What to say before you start

Talk to your healthcare provider about any medical conditions that you have or have had.

Tell your healthcare provider that you are taking CUTAQUIG before you get vaccination as vaccines may not work while you are taking CUTAQUIG.

Tell your healthcare provider about all of the prescription and non-prescription medicines you take, including over-the-counter medicines, dietary supplements, or herbal medicines.

Tell your healthcare provider if you are pregnant or plan to get pregnant, or if you are nursing because CUTAQUIG might not be right for you.

Tell your healthcare provider if you have diabetes. If you need to do glucose testing, your healthcare provider may tell you to use a different way to monitor your blood sugar levels on the day that you receive a CUTAQUIG infusion. Some types of blood glucose testing systems (so called glucometers) falsely interpret the maltose contained in CUTAQUIG as glucose. If you are uncertain ask your healthcare provider which glucose testing system you can use while using CUTAQUIG.

Storing it

Keep CUTAQUIG in the outer carton to protect it from exposure to light.

Do not freeze CUTAQUIG.

Store CUTAQUIG at 36°F- 46°F (+2°C to +8°C) for up to 36 months from the date of manufacture. Within its shelf-life, the product can be stored at room temperature up to 77°F (up to +25°C) for up to 9 months without being refrigerated again during this period, and must be discarded if not used after this.

Do not use CUTAQUIG after the expiration date printed on the vial.

Dispose all materials, including any unused CUTAQUIG, in an appropriate container.

What else should I know about CUTAQUIG?

Do not use CUTAQUIG for a medical condition for which it was not prescribed. Do not share CUTAQUIG with other people, even if they have the same diagnosis and symptoms that you have.

Manufactured by

Octapharma Pharmazeutika Produktionsges.m.b.H.

Oberlaaer Strasse 235

1100 Vienna, Austria

U.S. License No. 1646

Distributed by

Pfizer Labs

Division of Pfizer Inc.

New York, NY 10001

CUTAQUIG ® is a registered trademark of Octapharma.

Patient Instructions for Use

CUTAQUIG

Immune Globulin Subcutaneous (Human) - hipp, 16.5% solution

Detailed patient handling instructions for administration of CUTAQUIG

CUTAQUIG is for subcutaneous use only.

CUTAQUIG only after you have been properly instructed and trained by your healthcare provider.

Follow the administration guidance below step by step and use aseptic/sterile technique when administrating CUTAQUIG. Use gloves if you have been told to do so when preparing the infusion.

8. Starting the infusion

Start the infusion. Follow infusion pump manufacturer’s instructions.

9. Recording the infusion

On each vial of CUTAQUIG, you will find a peel-off portion of the label with the batch number details. Stick this label in your patient’s treatment diary or infusion log book. Record details of the dose, date, time, infusion site location and any infections, side effects or other comments in connection with this infusion.

10. After infusion is complete

Gently remove the dressing and the needle(s) and immediately place into the sharps bin.

Press a small piece of gauze on the needle site and apply a dressing.

Discard all used disposable supplies as well as any unused product and the empty vial(s) as recommended by your healthcare provider and according to local requirements.

Tidy up and securely store all the reusable equipment (e.g., pump) until the next infusion.

If you encounter any problems or experience side effects during or after the infusion, contact your healthcare provider. When doing so, keep your treatment diary or log book with you to be able to give all necessary information.

You can also report side effects to the FDA at 1-800-FDA-1088 or online under www.fda.gov/medwatch.

Manufactured by

Octapharma Pharmazeutika Produktionsges.m.b.H.

Oberlaaer Strasse 235

1100 Vienna, Austria

U.S. License No. 1646

Distributed by

Pfizer Labs

Division of Pfizer Inc.

New York, NY 10001

CUTAQUIG ® is a registered trademark of Octapharma.

Issued 03 2025.