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Infliximab - Subcutaneous Injection

Pronunciation: in-FLIX-i-mab

Common Brand Name(s): Remsima SC

Important: How To Use This Information

This is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate for you. This information is not individual medical advice and does not substitute for the advice of your health care professional. Always ask your health care professional for complete information about this product and your specific health needs.

Warning

This medication can decrease your body's ability to fight an infection. This effect can lead to very serious (possibly fatal) infections (such as fungal infections, bacterial infections including tuberculosis). You should have tuberculosis (TB) skin tests before and during treatment with this medication. Also tell your doctor your medical history, especially of past/recent/current infections. You should also tell your doctor if you have lived or traveled in areas where certain fungal infections (such as coccidioidomycosis, histoplasmosis) are common or if you have been near someone with tuberculosis. Areas where these types of fungal infections are commonly found include the Ohio and Mississippi River valleys and the southwestern United States. See Side Effects section for infection symptoms to watch out for, and get medical help right away if you have any of these symptoms.

The immune system also helps prevent and control cancer. There is a very small risk (especially in children/teens/young adults) of developing cancer (such as lymphoma, skin cancer) due to this medication or due to your medical condition. A rare, mostly fatal cancer (hepatosplenic T-cell lymphoma) has occurred in people receiving this medication along with certain other drugs (azathioprine or 6-mercaptopurine) to treat Crohn's disease or ulcerative colitis. Talk to your doctor about the risks and benefits of treatment. Tell your doctor right away if you have symptoms such as unusual lumps/growths, swollen glands, swollen or painful abdomen, unexplained weight loss, unusual tiredness, loss of appetite, fever that doesn't go away, or night sweats.

Uses

This medication is used to treat a certain type of arthritis (rheumatoid arthritis) after you have finished treatment with the form injected into a vein. This form of infliximab is used for injection under the skin as directed by your doctor, usually once every 2 weeks. It is usually used in combination with a medication taken by mouth (methotrexate) for maintenance treatment of rheumatoid arthritis. In rheumatoid arthritis, the body's defense system (immune system) attacks healthy tissues. Infliximab belongs to a class of medications known as monoclonal antibodies. It works by blocking the actions of a certain natural substance (tumor necrosis factor alpha) in the body. This helps to decrease swelling (inflammation) and weaken your immune system, which slows or stops the damage from the disease.

How To Use

Read the Medication Guide and Instructions for Use provided by your pharmacist before you start using infliximab and each time you get a refill. If you have any questions, ask your doctor or pharmacist.

This medication is given by injection under the skin of the abdomen, thigh, or upper arm as directed by your doctor, usually once every 2 weeks. The dosage is based on your medical condition and response to treatment.

If you are using this medication at home, learn all preparation and usage instructions from your health care professional and the manufacturer. Do not shake this medication. Remove this medication from the refrigerator and leave it at room temperature for at least 30 minutes before use. Do not warm up this medication any other way such as by heating in the microwave or placing in hot water. Before using, check this product visually for particles or discoloration. If either is present, do not use the liquid.

Before injecting each dose, clean the injection site with rubbing alcohol. Change the injection site each time to lessen injury under the skin. Do not inject into skin that is tender, damaged, bruised, or scarred. Learn how to store and discard medical supplies safely.

Use this medication regularly to get the most benefit from it. To help you remember, mark the days on the calendar when you need to use the medication.

Tell your doctor if your condition does not get better or if it gets worse.

Side Effects

See also Warning section.

Injection site redness, pain, itching, or swelling may occur. Headache, upset stomach, back pain, diarrhea, tiredness, or dizziness may also occur. If any of these effects last or get worse, tell your doctor or pharmacist promptly.

Remember that this medication has been prescribed because your doctor has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell your doctor right away if you have any serious side effects, including:

  • joint/muscle pain
  • easy bruising/bleeding
  • seizures
  • confusion
  • muscle weakness
  • numbness/tingling of arms/legs
  • butterfly-shaped facial rash
  • pain/redness/swelling of arms or legs
  • new or worsening symptoms of heart failure (such as shortness of breath, swelling ankles/feet, unusual tiredness, unusual/sudden weight gain)

Tell your doctor right away if you develop signs of infection while using this drug, such as:

  • cough/sore throat that doesn't go away
  • fever
  • chills
  • night sweats
  • trouble breathing
  • painful/frequent urination
  • unusual vaginal discharge
  • white patches in the mouth (oral thrush)

This drug may rarely cause serious (possibly fatal) liver disease. Get medical help right away if you have any symptoms of liver damage, such as:

  • extreme tiredness
  • nausea/vomiting that doesn't stop
  • loss of appetite
  • stomach/abdominal pain
  • yellowing eyes/skin
  • dark urine

A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including:

  • rash
  • itching/swelling (especially of the face/tongue/throat)
  • severe dizziness
  • trouble breathing

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

Precautions

Before using infliximab, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of:

  • tuberculosis (previous infection or positive skin test)
  • past/recent/current infections (such as cold sores, valley fever)
  • heart disease (such as heart failure)
  • blood/bone marrow disorder (such as leukopenia, thrombocytopenia)
  • nervous system disorder (such as numbness/tingling, seizures, multiple sclerosis)
  • cancer (such as breast cancer, skin cancer, lymphoma)
  • a certain lung disorder (chronic obstructive pulmonary disease-COPD)
  • liver problems (such as hepatitis B)
  • light treatment for psoriasis (phototherapy)

This drug may make you dizzy. Alcohol or marijuana (cannabis) can make you more dizzy. Do not drive, use machinery, or do anything that needs alertness until you can do it safely. Limit alcoholic beverages. Talk to your doctor if you are using marijuana (cannabis).

Infliximab can make you more likely to get infections or may make current infections worse. Stay away from anyone who has an infection that may easily spread (such as chickenpox, COVID-19, measles, flu). Talk to your doctor if you have been exposed to an infection or for more details.

Tell your doctor your vaccine history and ask if you need to get any vaccines before starting treatment with this medication. Tell your health care professional that you are using infliximab before having any immunizations/vaccinations. Avoid contact with people who have recently received live vaccines (such as flu vaccine inhaled through the nose).

Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).

Older adults may be more sensitive to the side effects of this drug, especially risk for infections.

Tell your doctor if you are pregnant or plan to become pregnant. You should not become pregnant while using infliximab. Infliximab may harm an unborn baby. Ask about reliable forms of birth control while using this medication and for 6 months after the last dose. If you become pregnant, talk to your doctor right away about the risks and benefits of this medication. If this medication is used during pregnancy, be sure to tell your baby's doctors about its use. The doctor may change the baby's vaccination schedule to decrease the risk of infection.

This drug may pass into breast milk, but it is unlikely to harm a nursing infant. Consult your doctor before breast-feeding.

Drug Interactions

Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval.

Some products that may interact with this drug are:

  • other drugs that weaken the immune system/increase the risk of infection (such as abatacept, anakinra)
  • treatment with weakened bacteria/viruses (such as live vaccines, BCG for bladder cancer)

Overdose

If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call their local poison control center at 1-800-222-1222. Alberta residents can call PADIS (Poison and Drug Information Service) 24 hours a day at 1-800-332-1414. Canada residents can call a provincial poison control center.

Notes

Do not share this medication with others.

Lab and/or medical tests (such as complete blood count, liver function test, skin exams, Pap smear) should be done while you are using this medication. Keep all medical and lab appointments. Consult your doctor for more details.

Missed Dose

If you miss a dose up to 7 days after the regularly scheduled dose, use it as soon as you remember. If it is 8 days or more after the regularly scheduled dose, skip the missed dose. Use your next dose on the regularly scheduled day. Do not double the dose to catch up.

If you have questions about missing a dose or you don't have more medication, contact your healthcare provider or pharmacist.

Storage

Store in the original package in the refrigerator away from light and moisture. Do not freeze. This medication can also be stored in the original package at room temperature for up to 28 days. If stored at room temperature, do not put it back in the refrigerator. Throw away this product if it has been stored at room temperature for longer than 28 days. Keep all medications away from children and pets.

Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company.

Medical Alert

Your condition can cause complications in a medical emergency. For information about enrolling in MedicAlert, call 1-888-633-4298 (US) or 1-800-668-1507 (Canada).

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