Avsola is a prescription medication used to treat conditions in which the immune system attacks the body causing inflammation. This includes rheumatoid arthritis, psoriatic arthritis, Crohn's disease, ankylosing spondylitis, plaque psoriasis, and ulcerative colitis.

Avsola is a biosimilar to Remicade.  

Avsola belongs to a group of drugs called tumor necrosis factor-alpha (TNF-alpha) inhibitors which block natural substances that cause inflammation.

This medication comes in an injectable form that is given directly into a vein (IV) by a healthcare provider. 

Common side effects include sinus infection, headaches, and cough.

Avsola is a prescription medication used for patients with:

• Crohn’s Disease - children 6 years and older and adults with Crohn's disease who have not responded well to other medicines
• Ulcerative Colitis - children 6 years and older and adults with moderately to severely active ulcerative colitis who have not responded well to other medicines
• Rheumatoid Arthritis - adults with moderately to severely active rheumatoid arthritis, along with the medicine methotrexate
• Ankylosing Spondylitis
• Psoriatic Arthritis
• Plaque Psoriasis - adult patients with plaque psoriasis that is chronic (doesn't go away) severe, extensive, and/or disabling.

This medication may be prescribed for other uses. Ask your doctor or pharmacist for more information.

Avsola can cause serious side effects. See "Avsola Precautions" section.

The most common side effects of infliximab products such as Avsola include:

• respiratory infections, such as sinus 
• infections and sore throat
• coughing  
• stomach pain 
• headache

Infusion reactions can happen up to 2 hours after your infusion of Avsola. Symptoms of infusion reactions may include:

• fever
• chills
• chestpain
• low blood pressure or high blood pressure
• shortness of breath 
• rash
• itching

Children with Crohn’s disease showed some differences in side effects compared with adults with Crohn’s disease. The side effects that happened more in children were: anemia (low red blood cells), leukopenia (low white blood cells), flushing (redness or blushing), viral infections, neutropenia (low neutrophils, the white blood cells that fight infection), bone fracture, bacterial infection and allergic reactions of the breathing tract. Among patients who received infliximab for ulcerative colitis in clinical studies, more children had infections as compared with adults.

Tell your doctor about any side effect that bothers you or does not go away. 

These are not all of the side effects with Avsola. Ask your doctor or pharmacist for more information. 

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

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.

Especially tell your doctor if you take:

• Kineret (anakinra)
• Orencia (abatacept)
• Actemra (tocilizumab)
• other medicines called biologics that are used to treat the same conditions as Avsola.

This is not a complete list of Avsola drug interactions. Ask your doctor or pharmacist for more information.

Risk of infection. Avsola is a medicine that affects your immune system. Avsola can lower the ability of your immune system to fight infections. Serious infections have happened in patients receiving Avsola. These infections include tuberculosis (TB) and infections caused by viruses, fungi or bacteria that have spread throughout the body. Some patients have died from these infections. 

After starting Avsola, if you have an infection, any sign of an infection including a fever, cough, flu-like symptoms, or have open cuts or sores on your body, call your doctor right away. Avsola can make you more likely to get infections or make any infection that you have worse.

• Your doctor should test you for TB before starting Avsola.
• Your doctor should monitor you closely for signs and symptoms of TB during treatment with Avsola.

Risk of Cancer. There have been cases of unusual cancers in children and teenage patients using tumor necrosis factor (TNF)-blocker medicines, such as Avsola.

• For children and adults receiving TNF-blocker medicines, including Avsola, the chances of getting lymphoma or other cancers may increase.
• Some people receiving TNF-blockers, including Avsola, developed a rare type of cancer called hepatosplenic T-cell lymphoma. This type of cancer often results in death. Most of these people were male teenagers or young men. Also, most people were being treated for Crohn’s disease or ulcerative colitis with a TNF-blocker and another medicine called azathioprine or 6-mercaptopurine.
• People who have been treated for rheumatoid arthritis, Crohn’s disease, ulcerative colitis, ankylosing spondylitis, psoriatic arthritis and plaque psoriasis for a long time may be more likely to develop lymphoma. This is especially true for people with very active disease.
• Some people treated with infliximab products such as Avsola have developed certain kinds of skin cancer. If any changes in the appearance of your skin or growths on your skin occur during or after your treatment with Avsola, tell your doctor.
• Patients with Chronic Obstructive Pulmonary Disease (COPD), a specific type of lung disease, may have an increased risk for getting cancer while being treated with Avsola.
• Some women being treated for rheumatoid arthritis with infliximab products have developed cervical cancer. For women receiving Avsola, including those over 60 years of age, your doctor may recommend that you continue to be regularly screened for cervical cancer.
• Tell your doctor if you have ever had any type of cancer. Discuss with your doctor any need to adjust medicines you may be taking.

Heart Failure. 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. Treatment with Avsola may need to be stopped if you get new or worse congestive heart failure. Be sure to tell your doctor of any new or worse symptoms including:

• shortness of breath
• sudden weight gain 
• swelling of ankles or feet

Other possible side effects include:

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 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)
• difficulty breathing 
• chest pain
• high or low blood pressure 
• fever
• 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 delayed allergic reaction to Avsola:

• fever
• rash
• headache
• sore throat
• muscle or joint pain
• swelling of the face and hands
• difficulty swallowing

Lupus-like Syndrome. Some patients have developed symptoms that are like the symptoms of Lupus. If you develop any of the following symptoms, your doctor may decide to stop your treatment with Avsola.

• chest discomfort or pain that does not go away 
• joint pain
• shortness of breath 
• rash on the cheeks or arms that gets worse in the sun

Psoriasis. Some people receiving infliximab products had new psoriasis or worsening of psoriasis they already had. Tell your doctor if you develop red scaly patches or raised bumps on the skin that are filled with pus. Your doctor may decide to stop your treatment with Avsola.

You should not receive Avsola if you have:

• heart failure, unless your doctor has examined you and decided that you are able to receive Avsola. Talk to your doctor about your heart failure.
• had an allergic reaction to infliximab products, or any of the other ingredients in Avsola.

Medicines can interact with certain foods. In some cases, this may be harmful and your doctor may advise you to avoid certain foods. In the case of Avsola there are no specific foods that you must exclude from your diet when receiving this medication.

Your doctor will assess your health before each treatment.
Tell your doctor about all of your medical conditions, including if you:

• have an infection.
• 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.

Tell your doctor about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

Tell your doctor if you are pregnant or planning 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 planning to become pregnant.

If you have a baby and you were receiving Avsola during your pregnancy, it is important to tell your baby’s doctor and other health care professionals about your Avsola use so they can decide when your baby should receive any vaccine. Certain vaccinations can cause infections.

If you received Avsola while you were pregnant, your baby may be at higher risk for getting an infection. 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. This includes live vaccines such as the BCG, rotavirus, or any other live vaccines. For other types of vaccines, talk with your doctor.

Tell your doctor if you are breastfeeding or planning 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 taking Avsola. You should not breastfeed while taking 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.

Crohn's Disease

The recommended dose of Avsola is 5 mg/kg given as an intravenous induction regimen at 0, 2 and 6 weeks followed by a maintenance regimen of 5 mg/kg every 8 weeks thereafter for the treatment of adults with moderately to severely active Crohn's disease or fistulizing Crohn's disease. For adult patients who respond and then lose their response, consideration may be given to treatment with 10 mg/kg. Patients who do not respond by Week 14 are unlikely to respond with continued dosing and consideration should be given to discontinue Avsola in these patients.

Pediatric Crohn's Disease

The recommended dose of Avsola for pediatric patients 6 years and older with moderately to severely active Crohn's disease is 5 mg/kg given as an intravenous induction regimen at 0, 2 and 6 weeks followed by a maintenance regimen of 5 mg/kg every 8 weeks.

Ulcerative Colitis

The recommended dose of Avsola is 5 mg/kg given as an intravenous induction regimen at 0, 2 and 6 weeks followed by a maintenance regimen of 5 mg/kg every 8 weeks thereafter for the treatment of adult patients with moderately to severely active ulcerative colitis.

Pediatric Ulcerative Colitis

The recommended dose of Avsola for pediatric patients 6 years and older with moderately to severely active ulcerative colitis is 5 mg/kg given as an intravenous induction regimen at 0, 2 and 6 weeks followed by a maintenance regimen of 5 mg/kg every 8 weeks.

Rheumatoid Arthritis

The recommended dose of Avsola is 3 mg/kg given as an intravenous induction regimen at 0, 2 and 6 weeks followed by a maintenance regimen of 3 mg/kg every 8 weeks thereafter for the treatment of moderately to severely active rheumatoid arthritis. Avsola should be given in combination with methotrexate. For patients who have an incomplete response, consideration may be given to adjusting the dose up to 10 mg/kg or treating as often as every 4 weeks bearing in mind that risk of serious infections is increased at higher doses.

Ankylosing Spondylitis

The recommended dose of Avsola is 5 mg/kg given as an intravenous induction regimen at 0, 2 and 6 weeks followed by a maintenance regimen of 5 mg/kg every 6 weeks thereafter for the treatment of active ankylosing spondylitis..

Psoriatic Arthritis

The recommended dose of Avsola is 5 mg/kg given as an intravenous induction regimen at 0, 2 and 6 weeks followed by a maintenance regimen of 5 mg/kg every 8 weeks thereafter for the treatment of psoriatic arthritis. Avsola can be used with or without methotrexate.

Plaque Psoriasis

The recommended dose of Avsola is 5 mg/kg given as an intravenous induction regimen at 0, 2 and 6 weeks followed by a maintenance regimen of 5 mg/kg every 8 weeks thereafter for the treatment of chronic severe (i.e., extensive and/or disabling) plaque psoriasis.

Avsola is usually administered by a healthcare provider in a medical setting making it unlikely for an overdose to occur. However, if overdose is suspected, seek emergency medical attention.

Keep all medical and laboratory appointments. For the best possible benefit, it is important to receive each scheduled dose of Avsola as directed. If you miss a dose, contact your doctor right away.

WARNING: SERIOUS INFECTIONS AND MALIGNANCY

SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING.

• Increased risk of serious infections leading to hospitalization or death, including tuberculosis (TB), bacterial sepsis, invasive fungal infections (such as histoplasmosis) and infections due to other opportunistic pathogens. 
• Discontinue AVSOLA if a patient develops a serious infection. 
• Perform test for latent TB; if positive, start treatment for TB prior to starting AVSOLA. Monitor all patients for active TB during treatment, even if initial latent TB test is negative. 
• Lymphoma and other malignancies, some fatal, have been reported in children and adolescent patients treated with tumor necrosis factor (TNF) blockers, including infliximab products. 
• Postmarketing cases of fatal hepatosplenic T-cell lymphoma (HSTCL) have been reported in patients treated with TNF-blockers including infliximab products. Almost all had received azathioprine or 6-mercaptopurine concomitantly with a TNF-blocker at or prior to diagnosis. The majority of cases were reported in patients with Crohn’s disease or ulcerative colitis, most of whom were adolescent or young adult males.