Generic Name: infliximab (in FLIX ih mab)
Brand Name: Avsola, Inflectra, Remicade, Renflexis
What is Avsola?
Avsola is often used when other medicines have not been effective.
Avsola may also be used for purposes not listed in this medication guide.
Using Avsola may increase your risk of developing certain types of cancer, including a rare fast-growing type of lymphoma that can be fatal. Ask your doctor about your specific risk.
Avsola affects your immune system. You may get infections more easily, even serious or fatal infections. Before you start using this medicine, your doctor may perform tests to make sure you do not have certain infections.
Call your doctor if you have a fever, tiredness, flu symptoms, cough, or skin sores.
Before taking this medicine
You should not be treated with Avsola if you are allergic to it.
Tell your doctor if you have ever had tuberculosis (TB) or if anyone in your household has tuberculosis. Also tell your doctor if you have recently traveled. Tuberculosis and some fungal infections are more common in certain parts of the world, and you may have been exposed during travel.
Tell your doctor if you have ever had:
an active infection (fever, cough, flu symptoms, open sores or skin wounds);
heart failure or other heart problems;
a weak immune system;
liver failure, hepatitis B, or other liver problems;
numbness or tingling anywhere in your body;
a nerve-muscle disorder, such as multiple sclerosis or Guillain-Barré syndrome;
phototherapy for psoriasis;
vaccination with BCG (Bacille Calmette-Guérin); or
if you are scheduled to receive any vaccines.
Make sure your child is current on all vaccines before he or she starts treatment with Avsola.
Avsola may cause a rare type of lymphoma (cancer) of the liver, spleen, and bone marrow that can be fatal. This has occurred mainly in teenagers and young men with Crohn's disease or ulcerative colitis. However, anyone with an inflammatory autoimmune disorder may have a higher risk of lymphoma. Talk with your doctor about your own risk.
Avsola may cause other types of cancer, such as skin cancer or cancer of the cervix. Ask your doctor about this risk.
If you use Avsola while you are pregnant, make sure any doctor caring for your new baby knows that you used the medicine during pregnancy. Being exposed to this medicine in the womb could affect your baby's vaccination schedule during the first 6 months of life.
You should not breastfeed while you are receiving Avsola.
Avsola is not for use in children younger than 6 years old.
How is Avsola given?
Before you start treatment with Avsola, your doctor may perform tests to make sure you do not have tuberculosis or other infections.
Avsola is given as an infusion into a vein. A healthcare provider will give you this injection.
Avsola must be given slowly, and the infusion can take at least 2 hours to complete.
You may be watched closely after receiving Avsola, to make sure the medicine has not caused any serious side effects.
Avsola affects your immune system. You may get infections more easily, even serious or fatal infections. Your doctor will need to examine you on a regular basis, and you may need frequent TB tests.
Serious infections may be more likely in older adults.
If you need surgery, tell the surgeon ahead of time that you are using Avsola.
If you've ever had hepatitis B, using Avsola can cause this virus to become active or get worse. You may need frequent liver function tests while using this medicine and for several months after you stop.
What happens if I miss a dose?
Call your doctor for instructions if you miss an appointment for your Avsola.
What happens if I overdose?
Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.
What should I avoid while receiving Avsola?
Avoid activities that may increase your risk of bleeding injury.
Do not receive a "live" vaccine while using Avsola, or you could develop a serious infection. Live vaccines include measles, mumps, rubella (MMR), polio, rotavirus, typhoid, yellow fever, varicella (chickenpox), and zoster (shingles).
Avsola side effects
Some side effects may occur during the injection. Tell your caregiver if you feel dizzy, nauseated, light-headed, itchy or tingly, short of breath, or have a headache, fever, chills, muscle or joint pain, pain or tightness in your throat, chest pain, or trouble swallowing during the injection. Infusion reactions may also occur within 1 or 2 hours after injection.
Serious and sometimes fatal infections may occur during treatment with Avsola. Call your doctor right away if you have signs of infection such as: fever, extreme tiredness, flu symptoms, cough, or skin symptoms (pain, warmth, or redness).
Also call your doctor if you have:
skin changes, new growths on the skin;
pale skin, easy bruising or bleeding;
liver problems--right-sided upper stomach pain, loss of appetite, yellowing of your skin or eyes, and not feeling well;
lupus-like syndrome--joint pain or swelling, chest discomfort, feeling short of breath, skin rash on your cheeks or arms (worsens in sunlight);
nerve problems--numbness or tingling, problems with vision, weakness in your arms or legs, seizure;
new or worsening psoriasis--skin redness or scaly patches, raised bumps filled with pus;
signs of heart failure--shortness of breath with swelling of your ankles or feet, rapid weight gain;
signs of a stroke--sudden numbness or weakness, trouble speaking or understanding what is said to you, problems with vision or balance, severe headache;
signs of tuberculosis--fever, cough, night sweats, loss of appetite, weight loss, feeling constantly tired.
Serious infections may be more likely in adults who are 65 years or older.
Common side effects may include:
stuffy nose, sinus pain;
fever, chills, sore throat;
cough, chest pain, shortness of breath;
high or low blood pressure;
headache, feeling light-headed;
rash, itching; or
This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
What other drugs will affect Avsola?
Tell your doctor about all your other medicines, especially:
any other medicines to treat Crohn's disease, ulcerative colitis, rheumatoid arthritis, ankylosing spondylitis, psoriatic arthritis, or psoriasis.
Frequently asked questions
- What are the new drugs for the treatment of rheumatoid arthritis (RA)?
- What are the new drugs for the treatment of plaque psoriasis?
- How many biosimilars have been approved in the United States?
- What is the difference between Inflectra and Remicade?
- What is the difference between Renflexis and Remicade?
- What is the difference between Ixifi and Remicade?
More about Avsola (infliximab)
- Side Effects
- During Pregnancy or Breastfeeding
- Dosage Information
- Drug Interactions
- Pricing & Coupons
- En Español
- Drug class: TNF alfa inhibitors
- FDA Alerts (4)
- FDA Approval History
Related treatment guides
Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.
Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.
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