FDA = Food and Drug Administration.
Important Safety Information
Only your doctor can recommend a course of treatment after checking your health condition. AVSOLA™ (infliximab-axxq) can cause serious side effects such as lowering your ability to fight infections. Some patients, especially those 65 years and older, have had serious infections caused by viruses, fungi or bacteria that have spread throughout the body, including tuberculosis (TB) and histoplasmosis. Some of these infections have been fatal. Your doctor should monitor you closely for signs and symptoms of TB during treatment with AVSOLA™.
Unusual cancers have been reported in children and teenage patients taking TNF-blocker medicines. Hepatosplenic T-cell lymphoma, a rare form of fatal lymphoma, has occurred mostly in teenage or young adult males with Crohn’s disease or ulcerative colitis who were taking infliximab products and azathioprine or 6-mercaptopurine. For children and adults taking TNF-blockers, including AVSOLA™, the chances of getting lymphoma or other cancers may increase.
You should discuss any concerns about your health and medical care with your doctor.
What should I tell my doctor before I take AVSOLA™?
You should let your doctor know if you have or ever had any of the following:
- Tuberculosis (TB) or have been near someone who has TB. Your doctor will check you for TB with a skin test. If you have latent (inactive) TB, you will begin TB treatment before you start AVSOLA™.
- Lived in a region where certain fungal infections like histoplasmosis, coccidioidomycosis or blastomycosis are common.
- Infections that keep coming back, have diabetes or an immune system problem.
- Any type of cancer or a risk factor for developing cancer, for example, chronic obstructive pulmonary disease (COPD) or had phototherapy for psoriasis.
- Heart failure or any heart condition. Many people with heart failure should not take AVSOLA™.
- Hepatitis B virus (HBV) infection or think you may be a carrier of HBV. Your doctor will test you for HBV. Nervous system disorders (like multiple sclerosis or Guillain-Barré syndrome).
Also tell your doctor if you:
- Use the medicines Kineret (anakinra), Orencia (abatacept) or Actemra (tocilizumab) or other medicines called biologics used to treat the same problems as AVSOLA™.
- Are pregnant, plan to become pregnant, are breast-feeding, or have a baby and were using AVSOLA™ during your pregnancy. Tell your baby’s doctor about your AVSOLA™ use. If your baby receives a live vaccine within 6 months after birth, your baby may develop infections with serious complications that can lead to death.
- Recently received or are scheduled to receive a vaccine. Adults and children taking AVSOLA™ should not receive live vaccines or treatment with a weakened bacteria (such as BCG for bladder cancer) while taking AVSOLA™.
What should I watch for and talk to my doctor about before or while taking AVSOLA™?
The following serious (sometimes fatal) side effects have been reported in people taking AVSOLA™.
You should tell your doctor right away if you have any of the signs listed below:
- Infections (like TB, blood infections, pneumonia)—fever, tiredness, cough, flu, or warm, red or painful skin or any open sores. AVSOLA™ can make you more likely to get an infection or make any infection that you have worse.
- Reactivation of HBV—feeling unwell, poor appetite, tiredness, fever, skin rash and/or joint pain.
- Lymphoma, or any other cancers in adults and children.
- Skin cancer—any changes in or growths on your skin.
- Cervical cancer—your doctor may recommend that you be regularly screened. Some women with rheumatoid arthritis, particularly those over 60, have developed cervical cancer.
- Heart failure—new or worsening symptoms, such as shortness of breath, swelling of your ankles or feet, or sudden weight gain.
- Other heart problems within 24 hours of infusion, including heart attack, low blood flow to the heart, or abnormal heart rhythm—chest discomfort or pain, arm pain, stomach pain, shortness of breath, anxiety, lightheadedness, dizziness, fainting, sweating, nausea, vomiting, fluttering or pounding in your chest, and/or a fast or a slow heartbeat.
- Liver injury—jaundice (yellow skin and eyes), dark brown urine, right-sided abdominal pain, fever, or severe tiredness.
- Blood disorders—fever that doesn’t go away, bruising, bleeding or severe paleness.
- Nervous system disorders—numbness, weakness, tingling, changes in your vision or seizures.
- Stroke within 24 hours of infusion—numbness or weakness of the face, arm or leg, especially on one side of the body; sudden confusion, trouble speaking or understanding; sudden trouble seeing in one or both eyes; sudden trouble walking; dizziness; loss of balance or coordination; or a sudden, severe headache.
- Allergic reactions during or after the infusion—hives, difficulty breathing, chest pain, high or low blood pressure, and fever or chills.
- Delayed allergic reactions (3 to 12 days after infusion)—fever, rash, headache, sore throat, muscle or joint pain, swelling of the face and hands, or difficulty swallowing.
- Lupus-like syndrome—chest discomfort or pain that does not go away, shortness of breath, joint pain, rash on the cheeks or arms that gets worse in the sun.
- Psoriasis—new or worsening psoriasis such as red scaly patches or raised bumps on the skin that are filled with pus.
The most common side effects of infliximab products include respiratory infections (that may include sinus infections and sore throat), headache, rash, coughing and stomach pain.
Please read the full Prescribing Information and Medication Guide for AVSOLA™ and discuss any questions you have with your doctor.
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088.
AVSOLA™ is indicated for:
Moderate to Severe Crohn’s Disease: Can reduce signs and symptoms and induce and maintain remission in adult patients with moderately to severely active Crohn’s disease who haven’t responded well to other therapies
Moderate to Severe Pediatric Crohn’s Disease: Can reduce signs and symptoms and induce and maintain remission in children (ages 6-17) with moderately to severely active Crohn’s disease who haven’t responded well to other therapies
Moderate to Severe Ulcerative Colitis (UC): Can reduce signs and symptoms, induce and maintain remission, promote intestinal healing, and reduce or stop the need for steroids in adult patients with moderately to severely active UC who haven’t responded well to other therapies
Moderate to Severe Pediatric Ulcerative Colitis: Can reduce signs and symptoms and induce and maintain remission in children (ages 6-17) with moderately to severely active ulcerative colitis who haven’t responded well to other therapies
Moderate to Severe Rheumatoid Arthritis (RA): Can reduce signs and symptoms, help stop further joint damage, and improve physical function in patients with moderately to severely active RA, in combination with methotrexate
Psoriatic Arthritis (PsA): Can reduce signs and symptoms of active arthritis, help stop further joint damage, and improve physical function in patients with PsA
Ankylosing Spondylitis (AS): Can reduce signs and symptoms in patients with active AS
Chronic Severe Plaque Psoriasis: Approved for the treatment of adult patients with severe (extensive and/or disabling) plaque psoriasis under the care of a physician who will determine if AVSOLA™ is appropriate considering other available therapies
Please see full Prescribing Information.
AVSOLA™ is a trademark of Amgen, Inc.