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Overview: Cuvitru is given as an infusion under your skin to give you antibodies when your body has a problem making its own. Common side effects include pain, itching, swelling, or redness near where you give the medicine, headache, nausea, vomiting, or diarrhea. Serious side effects are less common and include kidney problems, breathing problems, blood disorders, or blood clots. Contact your health care provider right away if you have swelling in your feet, ankles, or legs, trouble breathing, or a fast or abnormal heart beat while using Cuvitru. With proper training, you may be able to use Cuvitru at home.

Uses

What is Cuvitru used for?

Cuvitru (immune globulin subcutaneous, human) is commonly used for primary humoral immunodeficiency, which is a type of primary immunodeficiency. 

Cuvitru may also be used for other conditions as determined by your health care provider.

How does Cuvitru work (mechanism of action)?

Primary immunodeficiency is a condition where your body has trouble making its own antibodies. Cuvitru provides certain human immunoglobulins, called IgG antibodies. Using it provides passive immunity, which helps to prevent or decrease the severity of certain infections in people with primary humoral immunodeficiency.

How is Cuvitru supplied (dosage forms)?

Brands and other names

  • Cuvitru

Dosage forms and strengths

  • 20% solution for injection, single-dose vials

How should I store Cuvitru?

Cuvitru should be stored in the original carton (to protect it from light) in the refrigerator, between 36 F and 46 F (2 C and 8 C). When kept in the refrigerator, it can be used for up to three years after the date the medicine was made (manufacturing date). It can be stored at room temperature, up to 77 F (25 C), for up to two years. Once it has been stored at room temperature, it should not be returned to the refrigerator. If it is not used within two years of being stored at room temperature, it should be thrown away. Do not freeze it or shake it. 

This medicine is a single-use product. Do not save unused medicine for a future dose. You should throw it away.

Side Effects

What are the most common side effects of Cuvitru?

The most common side effects of Cuvitru are listed below. Tell your health care provider if you have any of these side effects that bother you.

  • Pain, itching, swelling, or redness near where the medicine is given
  • Headache
  • Nausea
  • Tiredness
  • Diarrhea
  • Vomiting

There may be other side effects of Cuvitru that are not listed here. Contact your health care provider if you think you are having a side effect of a medicine. In the U.S., you can report side effects to the FDA at www.fda.gov/medwatch or by calling 800-FDA-1088 (800-332-1088). In Canada, you can report side effects to Health Canada at www.health.gc.ca/medeffect or by calling 866-234-2345.

What are the serious side effects of Cuvitru?

While less common, the most serious side effects of Cuvitru are described below, along with what to do if they happen.

Severe Allergic Reactions. Cuvitru may cause allergic reactions, which can be serious. Stop using Cuvitru and get help right away if you have any of the following symptoms of a serious allergic reaction.

  • Breathing problems or wheezing
  • Racing heart
  • Fever or general ill feeling
  • Swollen lymph nodes
  • Swelling of the face, lips, mouth, tongue, or throat
  • Trouble swallowing or throat tightness
  • Itching or skin rash
  • Bumps on the skin called hives that can be red, pink, white, or brown depending on your skin tone
  • Nausea or vomiting
  • Dizziness, feeling lightheaded, or fainting
  • Stomach cramps
  • Joint pain

Blood Clots. Cuvitru may cause a blood clot in your arteries or veins and could cause a stroke, heart attack, or venous thromboembolism, including a blood clot in the lungs (pulmonary embolism) or deep vein thrombosis (DVT). You may be at higher risk for blood clots if you are older than 65, have certain health conditions, or take certain medicines. Drink plenty of fluids while you are using Cuvitru. Your health care provider may need to check labs to see if you are at higher risk for a blood clot. Keep all of your appointments, including those for lab work, while using Cuvitru. Stop using Cuvitru and get emergency help if you have any of the following signs of blood clots. 

  • Chest pain or pressure
  • Fast or abnormal heartbeat
  • Trouble breathing
  • Pain in your back, jaw, throat, or arm
  • Sweating, upset stomach, vomiting, or dizziness
  • Sudden weakness on one side of your body
  • Sudden and severe headache
  • Slurred speech or trouble understanding speech
  • Pain, swelling, or tenderness in your arm or leg
  • Vision loss
  • Bulging eyes 
  • Double vision

Kidney Damage. Kidney damage can happen when using Cuvitru. This damage can be severe, possibly leading to kidney failure or death. You may be at higher risk for kidney damage if you have diabetes, are overweight, or if you are dehydrated. Drink plenty of fluids while you are using Cuvitru. Your health care provider may need to order lab tests to monitor your kidneys while you are using Cuvitru. Keep all of your appointments, including those for lab tests, while using Cuvitru. Tell your health care provider right away if you have any of the following symptoms of kidney damage.

  • Reduced need to pee
  • Swelling in your feet, ankles, or legs
  • Weakness or unusual tiredness
  • A hard time catching your breath or chest pain/pressure
  • Unexplained sudden weight gain
  • Confusion
  • Nausea
  • Seizures

Blood Disorders. Cuvitru may cause your red blood cells to be destroyed, which is called hemolytic anemia. Your health care provider may run tests and stop Cuvitru if you have hemolytic anemia. Tell your health care provider right away if you have any of the following symptoms. 

  • Fatigue
  • Increased heart rate
  • Yellowing of skin or eyes
  • Dark-colored urine

Lung Damage. If your body reacts a certain way to the antibodies in Cuvitru, this can lead to fluid in your lungs (pulmonary edema) and a certain kind of lung damage called transfusion-related acute lung injury (TRALI). This usually happens within six hours of using Cuvitru. Tell your health care provider right away if you have any of the following. 

  • Trouble breathing
  • Chest pain
  • Fever
  • Lips turn blue

Risk of Infection. The process to make Cuvitru involves the use of human substances. These substances may carry germs that can cause infections. Though steps are taken to reduce this risk, there is still a small chance you could get an infection. Some infections may not cause symptoms. Keep all medical appointments so your health care provider can monitor your health. Talk with your health care provider about any concerns you have.

Central Nervous System Swelling. Cuvitru may cause irritation of the tissue that surrounds your brain and spinal cord, leading to aseptic meningitis. Tell your health care provider right away if you have any of the following symptoms of meningitis. 

  • Severe headache
  • Stiff neck
  • Sleepiness
  • Fever
  • Light sensitivity
  • Painful eye movements
  • Nausea or vomiting

Warnings & Precautions

Who should not use Cuvitru?

Allergies to Ingredients. People who are allergic to any of the following should not use Cuvitru.

  • Cuvitru
  • Human immune globulin
  • Any of the ingredients in the specific product dispensed

Your pharmacist can tell you all of the ingredients in Cuvitru.

Immunoglobulin A (IgA) Antibodies. If you do not have enough of your own IgA, have antibodies to IgA, and have a history of an allergic reaction to human immune globulin, you should not use Cuvitru. Cuvitru has some IgA in it. These things put you at a higher risk of having a severe allergic reaction to Cuvitru. 

What should I know about Cuvitru before using it?

Do not use Cuvitru unless it has been prescribed to you by a health care provider. Use it as prescribed.

Do not share Cuvitru with other people, even if they have the same condition as you. It may harm them.

Keep Cuvitru out of the reach of children. Since this medicine may be kept in a refrigerator, take special precautions to keep it away from children who also use the refrigerator.

Cuvitru is injected under the skin. Make sure that you or a caregiver understands how to properly prepare and use Cuvitru. If the liquid is cloudy, has particles in it, or has changed color, you should not use it. You should also rotate where you give it to avoid using the same site over and over. If you have any questions, talk to your health care provider. You should also keep a log of your doses, including the following information.

  • Date and time of dose
  • Infusion site (where you give yourself your medicine)
  • Dose used
  • Lot number from the vial used for the dose
  • Any side effects

It is normal to have mild pain, itching, swelling, or redness near the infusion site where you use Cuvitru. These reactions usually go away on their own. But if the pain, itching, swelling, or redness is not going away or seems to be getting worse, contact your health care provider. 

Keep all of your health care appointments while using Cuvitru, including those for lab work. Your health care provider will likely order lab tests to see how Cuvitru is working for you and to watch for side effects. 

Tell all of your health care providers that you are using Cuvitru, especially if they are ordering lab tests for you. Using Cuvitru may affect certain test results. Knowing that you are using it can help your health care providers understand your lab results.

People who are 65 or older can be at greater risk of some side effects from Cuvitru. Talk to your health care provider about your risks if you are in this age group.

What should I tell my health care provider before using Cuvitru?

Tell your health care provider about all of your health conditions and any prescription or over-the-counter (OTC) medicines, vitamins/minerals, herbal products, and other supplements you are using. This will help them know if Cuvitru is right for you.

In particular, make sure that you discuss any of the following.

Current and Past Health Conditions. Tell your health care provider if you have any of the following.

Vaccines. Talk with your health care provider about any vaccines that you may need. You should not receive certain vaccines right before or while using Cuvitru. Tell your health care provider about any vaccines you have recently received or have scheduled.

Pregnancy. It is not known if or how Cuvitru could affect pregnancy or harm a fetus. Tell your health care provider if you are pregnant or plan to become pregnant. Your health care provider will let you know if you should use Cuvitru while you are pregnant or trying to get pregnant.

Breastfeeding. It is not known if Cuvitru passes into breast milk. Tell your health care provider if you are breastfeeding or plan to breastfeed. Your health care provider will let you know if you should use Cuvitru while breastfeeding.

How can I get more information about Cuvitru?

For more information about Cuvitru, you can visit the drugmaker’s website at www.cuvitru.com or call them at 877-825-3327.

Interactions

Does Cuvitru interact with foods or drinks?

There are no known interactions between Cuvitru and foods or drinks.

It is unknown if drinking alcohol will affect Cuvitru, but heavy drinking can slow your immune response and make it harder for your body to fight infections.

Does Cuvitru interact with other medicines (drug interactions)?

Cuvitru may interact with certain medicines. Always tell your health care provider about any prescription or over-the-counter (OTC) medicines, vitamins/minerals, herbal products, and other supplements you are using.

Does interact with other drugs you are taking?

Enter your medication into the WebMD interaction checker

Overdose/Missed Dose

What should I do if I accidentally use too much Cuvitru?

If you or someone else has used too much Cuvitru, get medical help right away, call 911, or contact a Poison Control center at 800-222-1222.

What should I do if I miss a dose of Cuvitru?

Missing doses of Cuvitru can cause it to not work as well over time. So it is important not to miss or skip doses.

If you get your doses of Cuvitru at a hospital or clinic, your health care provider will make sure you are receiving it as scheduled. If you miss an appointment to get your Cuvitru dose, call to make another appointment as soon as possible. 

If you use Cuvitru at home and you miss a dose, contact your health care provider for advice on what to do.