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CUVITRU (immune globulin subcutaneous- human injection, solution


  1. Patient Information
  2. Cuvitru Can Cause The Following Serious Reactions:
  3. What Is Cuvitru?
  4. Who Should Not Use Cuvitru?
  5. How Should I Use Cuvitru?
  6. What Should I Avoid While Taking Cuvitru?
  7. What Are The Possible Or Reasonably Likely Side Effects Of Cuvitru?
  8. The Most Common Side Effects With Cuvitru Are:
  9. How Do I Store Cuvitru?
  10. Resources At Baxalta Available To The Patients:

Patient 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. [SeeWarnings 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. [SeeWarnings 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. [SeeWarnings and Precautions (5.3)]
    • Severe headache, neck stiffness, drowsiness, fever, sensitivity to light, painful eye movements, nausea, and vomiting. [SeeWarnings and Precautions (5.4)]
    • Increased heart rate, fatigue, yellowing of the skin or eyes, and dark-colored urine. [SeeWarnings 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. [SeeWarnings 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. [SeeWarnings 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. [SeeDrug Interactions (7)]

Self-administrationIf 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.

Baxaltaand Cuvitruare trademarks of Baxalta Incorporated, a wholly-owned, indirect subsidiary of Shire plc.

SHIRE and the Shire Logo are trademarks or registered trademarks of Shire Pharmaceutical Holdings Ireland Limited or its affiliates.

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

17H012-CUV-US

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.

Resources At Baxalta Available To The Patients: 

For more information on patient resources, education, or insurance assistance please visit www.immunedisease.com.

Issue Date: MAY2019

17H012-CUV-US



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