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Overview: Qivigy is injected into one of your veins by a health care professional for certain immune system problems. Common side effects can include headache, nausea, diarrhea, or feeling very tired. Serious side effects are less common but may 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 Qivigy.

Uses

What is Qivigy used for?

Qivigy (immune globulin intravenous, human-kthm) is commonly used for certain people to treat primary humoral immunodeficiency, which is a type of primary immunodeficiency.

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

How does Qivigy work (mechanism of action)?

Primary immunodeficiency is a condition where your body has trouble making its own antibodies and fighting infections. Qivigy 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 immunodeficiency.

How is Qivigy supplied (dosage forms)?

Qivigy is available in an injectable form that is given by a health care provider.

How should I store Qivigy?

Qivigy is usually given by a health care provider in a hospital or clinic. If you will store Qivigy at home, follow the instructions given by your health care provider.

Side Effects

What are the most common side effects of Qivigy?

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

  • Headache
  • Tiredness
  • Nausea
  • Infusion reactions (may include fever, chills, flushing, burning where infused) 
  • Sinus infection
  • Dizziness
  • Diarrhea

There may be other side effects of Qivigy 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 Qivigy?

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

Severe Allergic Reactions. Qivigy may cause allergic reactions, which can be serious. 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. Qivigy 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 Qivigy. 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 Qivigy. 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 Qivigy. 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 Qivigy. Your health care provider may need to order lab tests to monitor your kidneys. Keep all of your appointments, including those for lab tests, while using Qivigy. Call 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
  • Confusion
  • Nausea
  • Seizures

Central Nervous System Swelling. Qivigy 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

Blood Disorders. Qivigy may cause your red blood cells to be destroyed, which is called hemolytic anemia. Your health care provider may run tests and stop Qivigy 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 pee (urine)

Lung Damage. If your body reacts a certain way to the antibodies in Qivigy, 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 Qivigy. Tell your health care provider right away if you have any of the following. 

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

Risk of Infection. The process to make Qivigy involves the use of human substances. It is possible that these substances may carry germs that can cause infections. While 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 after using Qivigy, so your health care provider can monitor your health. Talk with your health care provider about any concerns you may have.

Warnings & Precautions

Who should not use Qivigy?

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

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

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

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

What should I know about Qivigy before using it?

Qivigy is usually given by a health care provider in your home, a hospital, or a clinic. 

Tell your health care provider if you may have been exposed to measles or are traveling to an area where there is a measles outbreak. They may recommend a change to your treatment schedule to help protect you from getting the measles. 

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

Tell all of your health care providers that you are using Qivigy, especially if they are ordering lab tests for you. Using Qivigy 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 and older can be at greater risk of some side effects from Qivigy. 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 Qivigy?

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 Qivigy 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 Qivigy. Tell your health care provider about any vaccines you have recently received or have scheduled.

Other Medicines and Supplements. Qivigy may interact with other medicines and supplements. Before using Qivigy, tell your health care provider about any prescription or over-the-counter (OTC) medicines, vitamins/minerals, herbal products, and other supplements you are using. See the Interactions section for more details.

Pregnancy. It is not known if or how Qivigy 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 Qivigy while you are pregnant or trying to get pregnant.

Breastfeeding. It is not known if Qivigy 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 Qivigy while breastfeeding.

How can I get more information about Qivigy?

For more information about Qivigy, you can visit the drugmaker’s website at www.kedrion.us or call them at 855-353-7466.

Interactions

Does Qivigy interact with foods or drinks?

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

It is unknown if drinking alcohol will affect Qivigy, but heavy drinking can slow your immune response and make it harder for your body to fight infections if you have primary immunodeficiency. The risk of dizziness may be increased if you drink alcohol while using Qivigy.

Does Qivigy interact with other medicines (drug interactions)?

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.

In particular, make sure that you discuss if you are using a diuretic, also called a water pill, which is a medicine used to reduce edema (fluid retention) and blood pressure before using Qivigy.

This may not be a complete list of medicines that can interact with Qivigy. Always check with your health care provider.

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 Qivigy?

If you or someone else has used too much Qivigy, 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 Qivigy?

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

Qivigy is usually given by a health care provider. Your health care provider will make sure you are receiving Qivigy as scheduled.

If you miss an appointment to get your Qivigy dose, call to make another appointment as soon as possible.