Cuvitru

Name: Cuvitru

Indications

CUVITRU is an Immune Globulin Subcutaneous (Human) (IGSC), 20% Solution indicated as replacement therapy for primary humoral immunodeficiency (PI) in adult and pediatric patients two years of age and older. This includes, but is not limited to, common variable immunodeficiency (CVID), X-linked agammaglobulinemia, congenital agammaglobulinemia, Wiskott-Aldrich syndrome, and severe combined immunodeficiencies1,2.

Warnings

Included as part of the "PRECAUTIONS" Section

Overdose

No Information Provided

Patient information

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 12 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 CUVITRUcontainers 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.

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.
    • S
  • Wash hands thoroughly and allow to dry.
  • Open supplies as shown by your healthcare professional.
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.

If using a sterile needle: Attach a sterile syringe to the sterile needle and pull back the plunger of syringe to fill with air which should equal the amount of the solution you will be taking from the vial. Insert the needle into the center of the stopper, and inject air in. Pull back on the plunger to withdraw the desired volume.
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.
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).
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.
  • Check for proper needle placement by pulling back on the syringe plunger to check for blood return in the tubing of the needle set.
  • If blood is seen in the tubing, remove and discard the subcutaneous needle and repeat steps 4, 5 and 6 with a new subcutaneous needle and infusion site.
  • Secure the needle set in place by applying a sterile protective dressing over the site(s).
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.
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.
  

  • Combivir
  • Epivir
  • Epivir-HBV
  • Hivid
  • Isentress
  • Nebupent
  • Videx
  • Videx EC
  • Zerit

© Cuvitru Patient Information is supplied by Cerner Multum, Inc. and Cuvitru Consumer information is supplied by First Databank, Inc., used under license and subject to their respective copyrights.

Commonly used brand name(s)

In the U.S.

  • Baygam
  • Bivigam
  • Carimune
  • Cuvitru
  • Flebogamma 10% DIF
  • Flebogamma 5%
  • Flebogamma 5% DIF
  • Gamastan S/D
  • Gamimune N
  • Gammagard
  • Gammagard S/D
  • Gammaplex
  • Gammaplex 10%
  • Gammar-P
  • Gamunex
  • Hizentra
  • Iveegam EN
  • Octagam
  • Octagam 10%
  • Panglobulin NF
  • Polygam S/D
  • Privigen
  • Sandoglobulin
  • Venoglobulin-S
  • Vivaglobin

Available Dosage Forms:

  • Solution
  • Powder for Solution

Therapeutic Class: Immune Serum

Uses of Cuvitru

  • It is used to stop or lower the harshness of other infections in people with a weak immune system.
  • It may be given to you for other reasons. Talk with the doctor.

How do I store and/or throw out Cuvitru?

  • Most of the time, this medicine will be given in a hospital or doctor's office. If stored at home, follow how to store as you were told by the doctor.
  • Do not freeze.
  • Keep all drugs in a safe place. Keep all drugs out of the reach of children and pets.
  • Check with your pharmacist about how to throw out unused drugs.

Usual Pediatric Dose for Primary Immunodeficiency Syndrome

Begin treatment one week after receiving a regularly scheduled IGIV infusion.
>=2 years:
Initial dose: calculated by multiplying the previous IGIV dose by 1.37, then dividing this dose into weekly doses based on the patient's previous IGIV treatment, administered subcutaneously; for example, if IGIV was administered every three weeks, divide by 3.

Recommended weekly doses: 100 to 200 mg/kg body weight subcutaneously.

Liver Dose Adjustments

Data not available

Share
(web3)