Uses of Avsola
AVSOLA is a prescription medicine that is approved for patients with:
- Rheumatoid Arthritis – adults with moderately to severely active rheumatoid arthritis, along with the medicine methotrexate.
- Crohn’s Disease – children 6 years and older and adults with Crohn’s disease who have not responded well to other medicines.
- Ankylosing Spondylitis.
- Psoriatic Arthritis.
- Plaque Psoriasis – adult patients with plaque psoriasis that is chronic (does not go away), severe, extensive, and/or disabling.
- Ulcerative Colitis – children 6 years and older and adults with moderately to severely active ulcerative colitis who have not responded well to other medicines.
AVSOLA blocks the action of a protein in your body called tumor necrosis factor-alpha (TNF-alpha). TNF-alpha is made by your body’s immune system. People with certain diseases have too much TNF-alpha that can cause the immune system to attack normal healthy parts of the body. AVSOLA can block the damage caused by too much TNF-alpha.
Side Effects of Avsola
Serious Infections
Some patients, especially those 65 years and older have had serious infections while receiving infliximab products, such as AVSOLA. These serious infections include TB and infections caused by viruses, fungi, or bacteria that have spread throughout the body. Some patients die from these infections. If you get an infection while receiving treatment with AVSOLA your doctor will treat your infection and may need to stop your AVSOLA
treatment.
Tell your doctor right away if you have any of the following signs of an infection while receiving or after receiving AVSOLA:
- a fever o have flu-like symptoms
- feel very tired o warm, red, or painful skin
- have a cough
Your doctor will examine you for TB and perform a test to see if you have TB. If your doctor feels that you are at risk for TB, you may be treated with medicine for TB before you begin treatment with AVSOLA and during treatment with AVSOLA. Even if your TB test is negative, your doctor should carefully monitor you for TB infections while you are
receiving AVSOLA. Patients who had a negative TB skin test before receiving infliximab products have developed active TB.
If you are a chronic carrier of the hepatitis B virus, the virus can become active while you are being treated with AVSOLA. In some cases, patients have died as a result of the hepatitis B virus being reactivated. Your doctor should do a blood test for the hepatitis B virus before you start treatment with AVSOLA and occasionally while you are being treated.
Tell your doctor if you have any of the following symptoms:
If you have a heart problem called congestive heart failure, your doctor should check you closely while you are receiving AVSOLA. Your congestive heart failure may get worse while you are receiving AVSOLA.
Be sure to tell your doctor of any new or worse symptoms including
- shortness of breath
- sudden weight gain
- swelling of ankles or feet
Treatment with AVSOLA may need to be stopped if you get new or worsening congestive heart failure.
Other Heart Problems
Some patients have experienced a heart attack (some of which led to death), low blood flow to the heart, or abnormal heart rhythm within 24 hours of beginning their infusion of infliximab products.
Symptoms may include 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.
Tell your doctor right away if you have any of these symptoms.
Liver Injury
Some patients receiving infliximab products have developed serious liver problems. Tell your doctor if you have:
- jaundice (skin and eyes turning yellow)
- dark brown-colored urine
- pain on the right side of your stomach area (right-sided abdominal pain)
- fever
- extreme tiredness (severe fatigue)
Blood Problems
In some patients receiving infliximab products, the body may not make enough of the blood cells that help fight infections or help stop bleeding.
Tell your doctor if you:
- have a fever that does not go away
- look very pale
- bruise or bleed very easily
Nervous System Disorders
Some patients receiving infliximab products have developed problems with their nervous system.
Tell your doctor if you have:
- changes in your vision
- numbness or tingling in any part of your body
- weakness in your arms or legs
- seizures
Some patients have experienced a stroke within approximately 24 hours of their infusion with infliximab products.
Tell your doctor right away if you have symptoms of a stroke which may include: 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
Some patients have had allergic reactions to infliximab products. Some of these reactions were severe. These reactions can happen while you are getting your AVSOLA treatment or shortly afterward. Your doctor may need to stop or pause your treatment with AVSOLA and may give you medicines to treat the allergic reaction.
Signs of an allergic reaction can include:
- hives (red, raised, itchy patches of skin)
- high or low blood pressure
- difficulty breathing
- fever
- chest pain
- chills
Some patients treated with infliximab products have had delayed allergic reactions. The delayed reactions occurred 3 to 12 days after receiving treatment with infliximab products. Tell your doctor right away if you have any of these signs of a delayed allergic reaction to AVSOLA:
- fever
- muscle or joint pain
- rash
- swelling of the face and hands
- headache
- difficulty swallowing
Warnings & Precautions
Your doctor will assess your health before each treatment.
Tell your doctor about all of your medical conditions, including if you:
- have an infection (see “What is the most important information I should know about AVSOLA?”).
- have other liver problems including liver failure.
- have heart failure or other heart conditions. If you have heart failure, it may get worse while you receive AVSOLA.
- have or have had any type of cancer.
- have had phototherapy (treatment with ultraviolet light or sunlight along with a medicine to make your skin sensitive to light) for psoriasis. You may have a higher chance of getting skin cancer while receiving AVSOLA.
- have COPD, a specific type of lung disease. Patients with COPD may have an increased risk of getting cancer while receiving AVSOLA.
- have or have had a condition that affects your nervous system such as:
- multiple sclerosis, or Guillain-Barré syndrome, or
- if you experience any numbness or tingling, or
- if you have had a seizure.
- have recently received or are scheduled to receive a vaccine. Adults and children receiving AVSOLA should not receive live vaccines (for example, the Bacille Calmette-Guérin [BCG] vaccine) or treatment with a weakened bacteria (such as BCG for bladder cancer). Children should have all of their vaccines brought up to date before starting treatment with AVSOLA.
- are pregnant or plan to become pregnant. It is not known if AVSOLA harms your unborn baby. AVSOLA should be given to a pregnant woman only if clearly needed. Talk to your doctor about stopping AVSOLA if you are pregnant or plan to become pregnant.
- are breastfeeding or plan to breastfeed. It is not known whether AVSOLA passes into your breast milk. Talk to your doctor about the best way to feed your baby while receiving AVSOLA. You should not breastfeed while receiving AVSOLA.
- Do not take AVSOLA together with medications such as KINERET (anakinra), ORENCIA (abatacept), ACTEMRA(tocilizumab), or other medicines called biologics that are used to treat the same conditions as AVSOLA.Tell your doctor about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. These include any other medicines to treat Crohn’s disease, ulcerative colitis,rheumatoid arthritis, ankylosing spondylitis, psoriatic arthritis or psoriasis.Know the medicines you take. Keep a list of your medicines and show them to your doctor and pharmacist when youget a new medicine
Dosage Of Avsola
You will be given AVSOLA through a needle placed in a vein (IV or intravenous infusion) in your arm.
- Your doctor may decide to give you medicine before starting the AVSOLA infusion to prevent or lessen side effects.
- Only a healthcare professional should prepare the medicine and administer it to you.
- AVSOLA will be given to you over a period of about 2 hours.
- If you have side effects from AVSOLA, the infusion may need to be adjusted or stopped. In addition, your healthcare professional may decide to treat your symptoms.
- A healthcare professional will monitor you during the AVSOLA infusion and for a period of time afterward for side effects. Your doctor may do certain tests while you are receiving AVSOLA to monitor you for side effects and to see how well you respond to the treatment.
- Your doctor will determine the right dose of AVSOLA for you and how often you should receive it. Make sure to discuss with your doctor when you will receive infusions and to come in for all your infusions and follow-up appointments.
Other
Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use AVSOLA for a condition for which it was not prescribed. Do not give AVSOLA to other people, even if they have the same symptoms that you have. It may harm them. You can ask your doctor or pharmacist for information about AVSOLA that is written for health professionals.
Source
All information has been provided courtesy of MedLinePlus from the National Library of Medicine and from the FDA.
