CUVITRU: Package Insert and Label Information (Page 5 of 6)

17 PATIENT COUNSELING INFORMATION

  • Advise patients to read the FDA-approved patient labeling (Information for Patients and Instructions for Use).
  • Prior to starting CUVITRU ask about a history of IgA deficiency, allergic reactions to immune globulin or other blood products. Patients with a history of allergic reactions should not be treated subcutaneously at home until several treatments have been administered and tolerated under medical supervision [see Warnings and Precautions (5.1)].
  • Inform patients to immediately report the following signs and symptoms to their healthcare provider:
    • Decreased urine output, sudden weight gain, fluid retention/edema, and/or shortness of breath [see Warnings and Precautions (5.2)].
    • Instruct patients to immediately report symptoms of thrombosis. These symptoms may include 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, numbness or weakness on one side of the body [see Warnings and Precautions (5.3)].
    • Severe headache, neck stiffness, drowsiness, fever, sensitivity to light, painful eye movements, nausea, and vomiting [see Warnings and Precautions (5.4)].
    • Increased heart rate, fatigue, yellowing of the skin or eyes, and dark-colored urine [see Warnings and Precautions (5.5)].
    • Trouble breathing, chest pain, blue lips or extremities, or fever that can occur 1 to 6 hours after an infusion of CUVITRU [see Warnings and Precautions (5.6)].
  • Inform patients that CUVITRU is made from human plasma and may contain infectious agents that can cause disease (e.g., viruses and, theoretically, the vCJD agent). The risk of CUVITRU transmitting an infectious agent has been reduced by screening plasma donors for prior exposure, testing donated plasma, and inactivating or removing certain viruses during manufacturing. Patients should report any symptoms that concern them which might be caused by virus infections [see Warnings and Precautions (5.7)]
  • Inform patients that CUVITRU can interfere with their immune response to live viral vaccines such as measles, mumps, rubella and varicella, and instruct patients to notify their healthcare professional of this potential interaction when they are receiving vaccinations [see Drug Interactions (7)].

Self-administration – If self-administration is deemed to be appropriate by the physician, clear instructions and training on subcutaneous infusion should be given to the patient/caregiver, and the demonstration of their ability to independently administer subcutaneous infusions should be documented.

  • Ensure the patient understands the importance of consistent subcutaneous infusions to maintain appropriate steady IgG levels.
  • Inform the patient to start the infusion promptly after drawing CUVITRU into the syringe. Ensure the patient understands that it is suggested to complete the administration within 2 hours due to the potential formation of particles caused by siliconized syringes.
  • Instruct the patient to keep a treatment diary/log book. This diary/log book should include information about each infusion such as, the time, date, dose, lot number(s), infusion sites, and any reactions.
  • Inform the patient that mild to moderate local infusion-site reactions (e.g., pain, redness and itching) are a common side effect of subcutaneous treatment, but to contact their healthcare professional if a local reaction increases in severity or persists for more than a few days.

CUVITRU® is a registered trademark of Baxalta Incorporated, a Takeda company.

TAKEDA® and the TAKEDA Logo® are registered trademarks of Takeda Pharmaceutical Company Limited.

Manufactured by:
Baxalta US Inc.
Lexington, MA 02421 USA
U.S. License No. 2020

Issue Date: SEP 2021
CUV350

Information For Patients

CUVITRU ( CUE-vih-troo)
Immune Globulin Subcutaneous (Human), 20% Solution

Subcutaneous Administration

Information for Patients

The following summarizes important information about CUVITRU. Please read it carefully before using this medicine. This information does not take the place of talking with your healthcare provider, and it does not include all of the important information about CUVITRU. If you have any questions after reading this, ask your healthcare provider.

What is the most important information I need to know about CUVITRU?

CUVITRU can cause the following serious reactions:

  • Severe allergic reactions causing difficulty in breathing or skin rashes
  • Decreased kidney function or kidney failure
  • Blood clots in the heart, brain, lungs, or elsewhere in the body
  • Severe headache, drowsiness, fever, painful eye movements, or nausea and vomiting
  • Dark colored urine, swelling, fatigue, or difficulty breathing

What is CUVITRU?

CUVITRU is a ready-to-use, liquid medicine that contains immunoglobulin G (IgG) antibodies, which protect the body against infection. CUVITRU is used to treat patients with primary immunodeficiency diseases (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. CUVITRU is made from human plasma that is donated by healthy people. CUVITRU contains antibodies collected from these healthy people that replace the missing antibodies in PI patients.

Who should not use CUVITRU?

Do not use CUVITRU if you have a known history of a severe allergic reaction to immune globulin or other blood products. If you have such a history, discuss this with your healthcare provider to determine if CUVITRU can be given to you. Tell your healthcare provider if you have a condition called selective (or severe) immunoglobulin A (IgA) deficiency.

How should I use CUVITRU?

CUVITRU is given under the skin (subcutaneously). Most of the time infusions under the skin are given at home by self infusion or by caregivers. Instructions for giving CUVITRU under the skin (subcutaneously) are provided in the Instructions for Use brochure. Only use CUVITRU by yourself after you have been instructed by your healthcare provider.

What should I avoid while taking CUVITRU?

CUVITRU can make vaccines (like measles/mumps/rubella or chickenpox vaccines) not work as well for you. Before you get any vaccines, tell your healthcare provider that you take CUVITRU.

Tell your healthcare provider if you are pregnant, or plan to become pregnant, or if you are nursing.

What are the possible or reasonably likely side effects of CUVITRU?

The following one or more possible reactions may occur at the site of infusion. These generally go away within a few hours, and are less likely after the first few infusions.

  • Mild or moderate pain
  • Redness
  • Itching

The most common side effects with CUVITRU are:

  • Headache
  • Nausea
  • Fatigue
  • Diarrhea
  • Vomiting

If any of the following problems occur after starting treatment with CUVITRU, stop the infusion immediately and contact your healthcare provider or call emergency services. These could be signs of a serious problem.

  • 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 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 problem or a 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.

These are not all of the possible side effects with CUVITRU. You can ask your healthcare provider for physician’s information leaflet. Tell your healthcare provider about any side effect that bothers you or that does not go away.

Whenever giving yourself treatments at home, you should have another responsible person present to help treat side effects or get help if you have a serious adverse reaction occur. Ask your healthcare provider whether you should have rescue medications, such as antihistamines or epinephrine.

How do I store CUVITRU?

Store CUVITRU refrigerated or at room temperature.

  • You can store CUVITRU in the refrigerator (36°F to 46°F [2°C to 8°C]) for up to 36 months or
  • You can store CUVITRU at room temperature (up to 77°F [25°C]) for up to 24 months.
  • Do not return CUVITRU to the refrigerator if you take it out to room temperature.
  • Do not freeze.
  • Do not shake.
  • Check the expiration date on the carton and vial label. Do not use CUVITRU after the expiration date.
  • Protect from light. You can use the original CUVITRU containers to protect it from light.

CUVITRU® is a registered trademark of Baxalta Incorporated, a Takeda company.

TAKEDA® and the TAKEDA Logo® are registered trademarks of Takeda Pharmaceutical Company Limited.

Manufactured by:
Baxalta US Inc.
Lexington, MA 02421 USA
U.S. License No. 2020
Issue Date: SEP 2021 CUV350

Detailed Instructions for Administration for Patients

Do not use CUVITRU at home until you get instructions and training from your healthcare professional.

Prepare CUVITRU vial(s):

  • Remove CUVITRU from the box. Allow vials to reach room temperature. This may take up to 90 minutes.
  • Do not apply heat or place in microwave.
  • Do not shake the vial(s).
1.
Check the vial(s):
  • Do not use beyond expiration date.
  • Do not use if the protective cap is missing or broken.
  • Look at the color: it should be clear and colorless to pale yellow or light brown.
  • Do not use if the solution is cloudy or has particles.
2.
Gather all supplies
  • Gather all supplies:Items include: vial(s) of CUVITRU, infusion supplies: subcutaneous needle set, transfer device(s), syringe(s), sterile tip caps, sterile clear bandage, tape, gauze, sharps container, infusion pump, infusion log.
  • Clean work area.
  • Program the infusion pump according to prescribed infusion rates and manufacturer’s instructions.
  • Wash hands thoroughly and allow to dry.
  • Open supplies as shown by your healthcare professional.

Figure

3.
Prepare the syringe(s):
  • Remove the cap from the vial.
  • Wipe each stopper with a sterile alcohol wipe and allow to dry.
  • Attach a sterile syringe to a vented spike.
  • Insert the vented spike into the center of the IG vial.
  • Turn the vial upside down and pull back on the plunger to pull the IG into the syringe(s).
  • Repeat these steps, if using multiple vials to achieve the desired dose.
  • Start the infusion promptly after drawing CUVITRU into the syringe(s). It is suggested to complete the administration within 2 hours.

Figure
(click image for full-size original)

4.
Prepare the infusion pump and tubing:
  • Use manufacturer directions for filling the tubing and using the pump.
  • Attach the syringe filled with CUVITRU to the needle set.
  • Point the syringe tip up and gently push the plunger of the syringe to remove the air and fill the needle set up to the needle hub.

Figure

5.
Prepare the infusion site(s):
  • Select the number of infusion sites based on the volume of the total dose.
  • Choose infusion site(s): upper arms, abdomen, thighs, or lower back.
  • Avoid: bony areas, visible blood vessels, scars and any areas of inflammation (irritation) or infection.
  • Infuse CUVITRU from 1 to 4 infusion sites at the same time.
  • Select sites at least 4 inches apart.
  • Rotate sites between future infusions.
  • Wipe the infusion site(s) with a sterile alcohol wipe beginning at the center of each infusion site and moving outward in circular motion. Allow the infusion site(s) to dry (at least 30 seconds).

Figure

6.
Insert and secure the subcutaneous needle set:
  • Remove the needle cover. Firmly grasp and pinch at least 1 inch of skin between two fingers.
  • Insert needle with a rapid motion straight into the skin at a 90 degree angle. Tape needle in place with sterile tape (included on transparent dressing).
  • If more than one site is used, repeat the steps.
  • Secure the needle set in place by applying a sterile protective dressing over the site(s).

Figure

7.
Start the infusion:
  • Follow the manufacturer’s instructions to turn pump on and start the infusion.
  • Check infusion site(s) occasionally throughout the infusion.
8.
Remove subcutaneous needle(s) from the infusion site(s):
  • Remove the needle set by loosening the tape on all edges.
  • Pull the needle wings straight up and out.
  • Gently press a small piece of gauze over the needle site and cover with a dressing.
  • Throw away the needle(s) into the sharps container.

Figure

9.
Record the infusion:
  • Remove the peel-off label from the vial(s), which has the product lot number and expiration date, and place the label in your treatment record/infusion log.
  • Write down the date, time, dose, site(s) of infusion (to assist in rotating sites) and any reactions after each infusion.
  • Throw away the disposable supplies, vials, and unused product as recommended by your healthcare professional.

CUVITRU® is a registered trademark of Baxalta Incorporated, a Takeda company.

TAKEDA® and the TAKEDA Logo® are registered trademarks of Takeda Pharmaceutical Company Limited.

Manufactured by:
Baxalta US Inc.
Lexington, MA 02421 USA
U.S. License No. 2020
Issue Date: SEP 2021
CUV350

PRINCIPAL DISPLAY PANEL — 5 mL Vial Label

NDC: 0944-2850-02

Immune Globulin Subcutaneous (Human) 20%
CUVITRU
Rx Only
Single-Dose Vial

1g
5 mL

Solution for Subcutaneous Administration
The vial stopper is not made with natural rubber latex.
Refrigeration: 2°C to 8°C (36°F to 46°F) for up to 36 months.
Do not freeze. Room temperature: not to exceed 25°C (77°F)
for up to 24 months.
Discard unused portion.

LE-07-54772Shire

PRINCIPAL DISPLAY PANEL -- 5 mL Vial Label
(click image for full-size original)

PRINCIPAL DISPLAY PANEL — 5 mL Vial Carton

NDC: 0944-2850-01

1g
5 mL

Immune Globulin Subcutaneous
(Human) 20%CUVITRU

Solution for Subcutaneous Administration

Single-Dose Vial

Rx Only

Shire

PRINCIPAL DISPLAY PANEL -- 5 mL Vial Carton
(click image for full-size original)

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