AVSOLA's active ingredient is infliximab, a tumor necrosis factor (TNF) blocker. It is supplied as a sterile, white lyophilized powder for intravenous infusion after reconstitution with Sterile Water for Injection. Each vial contains a 100 mg dose of infliximab, along with key inactive ingredients such as dibasic sodium phosphate dihydrate, monobasic sodium phosphate monohydrate, polysorbate 80, and sucrose. The drug is intended for intravenous administration.

How should I use this medication?

This medication is injected into a vein. It is given by your care team in a hospital or clinic setting.

A special MedGuide will be given to you before each treatment. Be sure to read this information carefully each time.

Talk to your care team about the use of this medication in children. While it may be prescribed for children as young as 6 years for selected conditions, precautions do apply.

Overdosage: If you think you have taken too much of this medicine contact a poison control center or emergency room at once.

NOTE: This medicine is only for you. Do not share this medicine with others.

What if I miss a dose?

Keep appointments for follow-up doses. It is important not to miss your dose. Call your care team if you are not able to keep your appointment.

Where should I keep my medication?

This medication is given in a hospital or clinic. It will not be stored at home.

NOTE: This sheet is a summary. It may not cover all possible information. If you have questions about this medicine, talk to your doctor, pharmacist, or health care provider.

What side effects may I notice from receiving this medication?

Side effects that you should report to your care team as soon as possible:

• Allergic reactions—skin rash, itching, hives, swelling of the face, lips, tongue, or throat
• Heart attack—pain or tightness in the chest, shoulders, arms, or jaw, nausea, shortness of breath, cold or clammy skin, feeling faint or lightheaded
• Heart failure—shortness of breath, swelling of the ankles, feet, or hands, sudden weight gain, unusual weakness or fatigue
• Heart rhythm changes—fast or irregular heartbeat, dizziness, feeling faint or lightheaded, chest pain, trouble breathing
• Increase in blood pressure
• Infection—fever, chills, cough, sore throat, wounds that don't heal, pain or trouble when passing urine, general feeling of discomfort or being unwell
• Infusion reactions—chest pain, shortness of breath or trouble breathing, feeling faint or lightheaded
• Liver injury—right upper belly pain, loss of appetite, nausea, light-colored stool, dark yellow or brown urine, yellowing skin or eyes, unusual weakness or fatigue
• Low blood pressure—dizziness, feeling faint or lightheaded, blurry vision
• Low red blood cell level—unusual weakness or fatigue, dizziness, headache, trouble breathing
• Lupus-like syndrome—joint pain, swelling, or stiffness, butterfly-shaped rash on the face, rashes that get worse in the sun, fever, unusual weakness or fatigue
• New or worsening psoriasis—rash with itchy, scaly patches
• Pain, tingling, or numbness in the hands or feet, muscle weakness, change in vision, confusion or trouble speaking, loss of balance or coordination, trouble walking, seizures
• Stroke—sudden numbness or weakness of the face, arm, or leg, trouble speaking, confusion, trouble walking, loss of balance or coordination, dizziness, severe headache, change in vision
• Unusual bruising or bleeding

Side effects that usually do not require medical attention (report these to your care team if they continue or are bothersome):

• Cough
• Diarrhea
• Headache
• Nausea
• Runny or stuffy nose
• Sore throat
• Stomach pain

This list may not describe all possible side effects. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What should I tell my care team before I take this medication?

They need to know if you have any of these conditions:

• Cancer
• COPD, including chronic bronchitis and emphysema
• Cut or sore on your skin that has not healed
• Diabetes
• Have had hepatitis
• Have had light therapy
• Have tuberculosis (TB) or have been in close contact with someone who does
• Heart disease
• Infection
• Infection that does not go away or keeps coming back
• Live or have lived in the Ohio or Mississippi River valleys
• Liver disease
• Nervous system conditions, such as Guillain-Barre syndrome, multiple sclerosis, seizures
• Recent or upcoming vaccine
• Weakened immune system
• An unusual or allergic reaction to infliximab, mouse proteins, other medications, foods, dyes, or preservatives
• Pregnant or trying to get pregnant
• Breastfeeding

What may interact with this medication?

Do not take this medication with any of the following:

• Live virus vaccines
• Other TNF blockers

This medication may also interact with the following:

• Abatacept
• Anakinra
• Cyclosporine
• Methotrexate
• Theophylline
• Tocilizumab
• Warfarin

This list may not describe all possible interactions. Give your health care provider a list of all the medicines, herbs, non-prescription drugs, or dietary supplements you use. Also tell them if you smoke, drink alcohol, or use illegal drugs. Some items may interact with your medicine.

What should I watch for while using this medication?

Visit your care team for regular checks on your progress. Tell your care team if your symptoms do not start to get better or if they get worse.

You may need blood work done while you are taking this medication.

This medication can cause serious infusion reactions. To reduce the risk, your care team may give you other medications to take before receiving this one. Follow the directions from your care team.

This medication may increase your risk of getting an infection. Call your care team for advice if you get a fever, chills, sore throat, or other symptoms of a cold or flu. Do not treat yourself. Try to avoid being around people who are sick.

Your care team will screen you for tuberculosis (TB) before you start this medication. If they think you are at risk, you may be treated with medication for TB. You should start taking the medication for TB before you start this medication. Make sure to finish the full course of TB medication.

Talk to your care team about your vaccination history. You should not receive live vaccines while you're being treated with this medication and until your care team tells you that your immune system is no longer weakened. You may need to get some vaccines before you start treatment. If you need a non-live vaccine while you are being treated, talk to your care team.

Talk to your care team about your risk of cancer. You may be more at risk for certain types of cancer if you take this medication. People with active disease who take this medication for a long time may be at risk of lymphoma. Other people have developed skin, lung, or cervical cancer. The risk of lung cancer is increased in people with chronic obstructive pulmonary disease (COPD). Some people have developed a rare type of lymphoma that affects the liver and spleen. Most of these people were male teens or young adults. Also, they were taking certain other medications for Crohn disease or ulcerative colitis.To lower your risk of skin cancer, keep out of the sun. If you cannot avoid being in the sun, wear protective clothing and sunscreen. Do not use sun lamps, tanning beds, or tanning booths.

Before having surgery or dental work, talk to your care team to make sure it is ok. This medication can increase the risk of poor healing of your surgical site or wound.

What are the most serious risks of this medication?

This medication affects your immune system. It can reduce your body's ability to fight off infections. This increases your risk of infection. It also increases your risk of serious infection. Tell your care team about any infections you have now or have had in the past that keep coming back. Also tell them about all the medications you take. Talk to your care team right away if you have fever, cough, sore throat, wounds that don't heal, or feeling of being unwell while you are taking this medication.