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Asceniv is given by a health care provider into one of your veins to give you antibodies when your body has a problem making its own. Common side effects can include headache, tiredness, and nausea. 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 Asceniv. 

Uses

What is Asceniv used for?

Asceniv (immune globulin intravenous, human-slra) is commonly used for primary humoral immunodeficiency, which is a type of primary immunodeficiency.

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

How does Asceniv work (mechanism of action)?

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

How is Asceniv supplied (dosage forms)?

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

How should I store Asceniv?

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

Side Effects

What are the most common side effects of Asceniv?

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

  • Headache
  • Sinus infections
  • Infection in the nose or throat, sore throat, or common cold symptoms
  • Lung infection, such as bronchitis
  • Diarrhea, nausea, or stomach flu

There may be other side effects of Asceniv 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 Asceniv?

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

Severe Allergic Reactions. Asceniv 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, which 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. Asceniv 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 more than 65 years old, have certain health conditions, or take certain medicines. Drink plenty of fluids while you are using Asceniv. Your health care provider may need to check lab results to see if you are at higher risk for a blood clot. Keep all of your appointments, including those for lab tests, while using Asceniv. 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 Asceniv. This damage can be severe, possibly leading to kidney failure or even 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 Asceniv. Your health care provider may need to check lab results to monitor your kidneys while you are using Asceniv. Keep all of your appointments, including those for lab tests, while using Asceniv. 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. Asceniv may cause your red blood cells to be destroyed, which is called hemolytic anemia. Your health care provider may run tests and stop Asceniv 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 Asceniv, 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 Asceniv. 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 Asceniv 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 so your health care provider can monitor your health. Talk with your health care provider about any concerns you may have.

Central Nervous System Swelling. Asceniv 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 Asceniv?

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

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

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

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 Asceniv. Asceniv has some IgA in it. These things put you at a higher risk of having a severe allergic reaction to Asceniv.

What should I know about Asceniv before using it?

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

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

Tell all of your health care providers that you are using Asceniv, especially if they are ordering lab tests for you. Using Asceniv 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 Asceniv. 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 Asceniv?

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

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

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

How can I get more information about Asceniv?

For more information about Asceniv, you can visit the drugmaker’s website at www.asceniv.com/patient-discover-asceniv or call them at 800-458-4244.

Interactions

Does Asceniv interact with foods or drinks?

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

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

Does Asceniv interact with other medicines (drug interactions)?

Asceniv 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 Asceniv?

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

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

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

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