Avsola

Common name: infliximab (in FLIX ih mab)
Product Name: Avsola, Inflectra, Remicade, Renflexis
Drug class: TNF alpha inhibitors

What is Avsola?

Avsola is used to treat rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, and plaque psoriasis severe or deformed in adults.

Avsola is also used to treat ulcerative colitis or Crohn’s disease in adults and children at least 6 years of age.

Avsola is often used when other drugs do not work.

Avsola may be used for purposes not listed in this medication guide.¶

Warnings

Using Avsola may increase the risk of certain types of cancer, including a rare and rapidly growing form of lymphoma that can be fatal. Ask your doctor about your specific risk.

Avsola affects your immune system. You can easily get sick, even the worst or most deadly diseases. Before you start using this medication, your doctor may perform tests to make sure that you do not have certain infections.

Call your doctor if you have a fever, fatigue, flu-like symptoms, cough, or skin lesions.

Before taking this medicine

You should not be treated with Avsola if you are sick with it.

Tell your doctor if you have ever had TB or if anyone in your family has TB. Also tell your doctor if you have recently visited. Tuberculosis and other fungal infections are very common in some parts of the world, and they may have been exposed during travel.

Tell your doctor if you have:

• active infections (fever, cough, flu symptoms, open sores or skin sores);
• heart failure or other heart problems;
• diabetes;
• weakened immune system;
• liver failure, hepatitis B, or other liver problems;
• chronic obstructive pulmonary disease (COPD);
• heart problems;
• cancer;
• fainting;
• numbness or biting anywhere in your body;
• nerve-muscle disorders, such as multiple sclerosis or Guillain-Barré syndrome;
• phototherapy for psoriasis;
• BCG vaccination (Bacille Calmette-Guérin); or
• if you are scheduled to receive any vaccinations.

Make sure your child is on all immunizations before starting Avsola treatment.

Avsola may cause a rare form of lymphoma (cancer) of the liver, spleen, and bone marrow, which can be fatal. This is especially true for young people and young men with Crohn’s disease or ulcerative colitis. However, anyone with autoimmune inflammation may have a higher risk of lymphoma. Talk to your doctor about your risks.

Avsola may cause other types of cancer, such as skin cancer or cervical cancer. Ask your doctor about this risk.

If you are using Avsola during pregnancy, make sure that any doctor who cares for your new baby knows that you have used the medication during pregnancy. Exposure to this drug in the womb may affect your baby’s immunization schedule during the first 6 months of life.

You should not breastfeed while receiving Avsola.

Avsola is not used for children under 6 years of age.

How is Avsola given?

Before starting treatment with this medication, your doctor may perform tests to make sure that you do not have TB or other infections.

Avsola is given as an intravenous infusion. Your healthcare provider will give you this injection.

Avsola should be given lightly, and giving it may take at least 2 hours to complete.

You may be closely monitored after receiving Avsola, to ensure that the drug did not cause serious side effects.

Avsola affects your immune system. You can easily get sick, even the worst or most deadly diseases. Your doctor will need to get tested regularly, and you may need regular TB tests.

Serious infections are most likely in adults.

If you need surgery, tell your surgeon early that you are using this medication.

If you have ever had hepatitis B, using this medication, may cause the virus to become active or worse. You may need to check your liver function normally while using this medication and for a few months after quitting.

What happens if I miss a dose?

Call your doctor for instructions if you are miss the medication.

What happens if I overdose?

Get emergency medical help or call the Poison Help line at 1-800-222-1222.

What should I avoid while getting Avsola?

Avoid activities that may increase the risk of bleeding.

Do not get a “live” vaccine while using Avsola, or you may get a serious illness. Live vaccines include measles, mumps, rubella (MMR), polio, rotavirus, typhoid, yellow fever, varicella (chickenpox), and zoster (shingles).

Side effects of Avsola

Get emergency medical help if you have symptoms of allergies: hives; chest pain, shortness of breath; fever, chills, dizziness; swelling of your face, lips, tongue, or throat.

Other side effects may occur during the injection. Tell your caregiver if you feel dizzy, nauseous, lightheaded, itchy or itchy, short of breath, or have a headache, fever, chills, muscle or joint pain, sore or stiff throat, chest pain, or swallowing problems during an injection. The reaction may occur within 1 or 2 hours after the injection.

Severe and sometimes fatal infections may occur during Avsola treatment. Call your doctor right away if you have symptoms of infection such as fever, extreme tiredness, flu symptoms, cough, or skin symptoms (pain, fever, or redness).

Also call your doctor if you have:

• skin changes, new growths on the skin;
• pale skin, easy scratches or bleeding;
• delayed allergy (up to 12 days after receiving Avsola) – fever, sore throat, swallowing problem, headache, joint or muscle pain, skin rash, or swelling of your face or hands;
• liver problems – upper abdominal pain on the right side, loss of appetite, yellow skin or eyes, and discomfort;
• lupus-like syndrome – joint pain or swelling, chest tightness, shortness of breath, skin rash on your cheeks or arms (worse in sunlight);
• emotional problems – numbness or tingling, vision problems, weakness in the arms or legs, fainting;
• new or degenerative psoriasis – redness of the skin or scaly patches, raised pores full of redness;
• symptoms of heart failure – shortness of breath and swelling of the ankles or feet, rapid weight gain;
• symptoms of stroke – sudden numbness or weakness, slurred speech or comprehension, loss of vision or balance, headache;
• symptoms of lymphoma – fever, night sweats, weight loss, abdominal pain or swelling, chest pain, cough, shortness of breath, swollen glands (neck, armpits, or uterus); or
• symptoms of tuberculosis — fever, cough, night sweats, loss of appetite, weight loss, constant tiredness.

Serious infections are most likely to occur in adults 65 years of age or older.

• Common side effects may include:
• empty nose, sinus pain;
• fever, chills, sore throat;
• cough, chest pain, shortness of breath;
• high or low blood pressure;
• headache, headache;
• rash, itching; or
• abdominal pain.

This is not a complete list of side effects and some may occur. Call your doctor for medical advice about side effects. You can report side effects to the FDA at 1-800-FDA-1088.

What other drugs will affect Avsola?

Tell your doctor about all your other medications, especially:

• abatacept;
• anakinra;
• tocilizumab;
• any “biologic” medicines to treat your condition – adalimumab, certolizumab, etanercept, golimumab, natalizumab, rituximab, and others; or
• any other treatment for Crohn’s disease, ulcerative colitis, rheumatoid arthritis, ankylosing spondylitis, psoriatic arthritis, or psoriasis.

This list is not exhaustive. Other medications may affect Avsola, including prescription and over-the-counter medications, vitamins, and herbal products.

Further detail

Please contact your provider for any further information regarding this medication