Tofidence (tocilizumab-bavi) is an interleukin-6 (IL-6) receptor blocker that is administered as an intravenous infusion by a healthcare provider and may be used to treat patients who meet certain criteria with rheumatoid arthritis, or polyarticular or systemic juvenile idiopathic arthritis. Tofidence is a biosimilar to Actemra (tocilizumab).

A biosimilar is a biological product that is like a reference biologic (in this case Actemra) and for which there are no clinically meaningful differences in terms of safety, purity, and potency. A biosimilar is not considered a “generic” because they are made from living cells rather than chemicals, making them naturally variable, and they are expensive to make. Generic drugs contain identical medicinal ingredients to their reference products and are not expensive to make.

Tofidence is not approved to treat as many conditions as the reference product, Actrema. Tofidence may be used to treat:

• Adults with moderately to severely active rheumatoid arthritis (RA) who have had an inadequate response to one or more Disease-Modifying Anti-Rheumatic Drugs (DMARDs)
• Children aged 2 years of age and older with active polyarticular or systemic juvenile idiopathic arthritis.

Tofidence works by binding to interleukin-6 (IL-6) receptors. Interleukin 6 is considered one of the most important cytokines – these are signaling molecules that aid cell-to-cell communication during an immune response and stimulate the movement of cells toward sites of inflammation, infection, or trauma. IL-6 is also produced by synovial and endothelial cells within a joint. By binding to IL-6 receptors, Tofidence decreases inflammation in conditions such as rheumatoid arthritis and polyarticular or systemic juvenile arthritis.

Tofidence was FDA-approved on 29 September 2023. It belongs to the class of medicines called interleukin inhibitors. It may also be called a monoclonal antibody.

Should not be given to people with a known hypersensitivity to Tofidence or tocilizumab or any of the inactive ingredients in the infusion.

Tofidence affects your immune system. Life-threatening infections, including tuberculosis, bacterial, invasive fungal, viral, or other opportunistic infections have occurred in people receiving tocilizumab. Before you start treatment, your doctor may perform tests to make sure you do not have tuberculosis or other infections. Tofidence should not be administered during an active infection, even small infections. While using Tofidence, you may need frequent medical tests and you should avoid being administered live vaccines.

Use with caution in patients at increased risk of gastrointestinal perforation (a hole or tear in your stomach or intestines), such as those with diverticulitis. Tell your doctor if you have a fever and stomach pain with a change in your bowel habits.

May cause liver problems. Tell your doctor right away if you develop right-sided stomach pain, vomiting, loss of appetite, tiredness, dark urine, clay-colored stools, or yellowing of your skin or eyes.

Your doctor will conduct regular blood tests to check your liver function, and cholesterol, and monitor you for blood cell abnormalities.

Tofidence is given by a healthcare provider as an intravenous infusion into a vein in your arm every 2 to 4 weeks depending on the condition being treated. The infusion usually takes 1 hour.

• The dose may need to be modified for dose-related laboratory changes.
• Keep all of your follow-up appointments and get your blood tests as ordered by your healthcare provider.

Rheumatoid arthritis

• Used in combination with DMARDS or as monotherapy.
• Initially: 4mg/kg every 4 weeks. May be increased to 8 mg/kg every 4 weeks based on clinical response.

Polyarticular Juvenile Idiopathic Arthritis

The dosage depends on the weight.

• Less than 30kg: 10mg/kg
• 30kg or more: 8mg/kg

Administered every 4 weeks

Systemic Juvenile Idiopathic Arthritis

The dosage depends on the weight.

• Less than 30kg: 12mg/kg
• 30kg or more: 8mg/kg

Administered every 2 weeks

You should not be given Tofidence if you are allergic to tocilizumab or any of the inactive ingredients in the infusion.

Tell your doctor if you have any signs of infection such as fever, chills, cough, body aches, tiredness, open sores or skin wounds, diarrhea, stomach pain, weight loss, painful urination, or coughing up blood.

Tell your doctor if you've had or been exposed to tuberculosis, or if you recently traveled. Some infections are more common in certain parts of the world, and you may have been exposed during travel.

To make sure Tofidence is safe for you, tell your doctor if you:

• are being treated for an infection
• get a lot of infections or have infections that keep coming back
• have TB, or have been in close contact with someone with TB
• have cancer
• have diabetes, HIV, or a weak immune system
• have diverticulitis, ulcers in your stomach or intestines, or stomach pain
• have liver disease
• live or have lived, or have traveled to certain parts of the country (such as the Ohio and Mississippi River valleys and the Southwest) where there is an increased chance for certain kinds of fungal infections
• have or have had hepatitis B (or if you are a carrier of the virus)
• have received or are scheduled to receive any vaccines. All vaccines should be brought up-to-date before starting Tofidence unless urgent treatment initiation is required.  You should not receive live vaccines while you are being administered Tofidence, but you can receive non-live vaccines
• plan to have surgery or a medical procedure.

Pregnancy and Breastfeeding

Tell your doctor if you are pregnant or breastfeeding.

Based on animal data Tofidence may cause harm to an unborn baby. Monoclonal antibodies, such as Tofidence are actively transported across the placenta during the third trimester and may affect the unborn baby’s immune response. Use effective contraception during treatment with Tofidence if you are a woman of childbearing age. Tell your doctor right away if you inadvertently become pregnant.

Breastfeeding is not recommended while taking Tofidence. No data is available on the presence of tocilizumab in human milk, the effects of the drug on the breastfed infant, or the effects on milk production.

The safety and effectiveness of Tofidence in children with conditions other than active systemic or polyarticular juvenile idiopathic arthritis is not known.

Call your doctor for instructions if you miss an appointment for your Tofidence injection.

Since this medicine is given by a healthcare professional in a medical setting, an overdose is unlikely to occur.

Tofidence can cause serious side effects, including:

• Serious allergic reactions. Tell your healthcare provider before your next dose if you had hives, rash, or flushing after previous injections. Seek medical attention right away if you have any of the following signs of a serious allergic reaction: shortness of breath or trouble breathing, swelling of the lips, tongue, or face chest pain, feeling dizzy or faint, moderate or severe abdominal pain or vomiting
• Hepatitis B infection in those who are carriers of the virus. Tell your healthcare provider if you have any signs of a possible hepatitis B infection such as feeling very tired, yellow skin or eyes,  little or no appetite, vomiting, clay-colored bowel movements, fevers, chills, stomach discomfort, muscle aches, a rash, or dark urine.

Multiple Sclerosis has been diagnosed rarely in people who take Tofidence.

The most common side effects of Tofidence  occurring in at least 5% of people include:

• Upper respiratory tract infections (common cold, sinus infections)
• Headache
• Increased blood pressure (hypertension)
• Injection site reactions
• Increased liver function tests.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088. You may also report side effects to Biogen MA Inc. at 1-866-633-4636.

What other drugs will affect Tofidence?

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

Tell your healthcare provider if you take:

• any other medicines to treat your RA. You should not take etanercept (Enbrel), adalimumab (Humira), infliximab (Remicade), rituximab (Rituxan), abatacept (Orencia), anakinra (Kineret), certolizumab (Cimzia), or golimumab (Simponi), while you are taking Tofidence because it may increase your risk of infection.
• medicines that affect the way certain liver enzymes work. Ask your healthcare provider if you are not sure if your medicine is one of these.

Know the medicines you take. Keep a list of them to show to your healthcare provider and pharmacist when you get a new medicine.

This list is not complete and many other drugs may interact with tocilizumab. This includes prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible drug interactions are listed here.

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

Tell your healthcare provider if you take:

• any other medicines to treat your RA. You should not take etanercept (Enbrel), adalimumab (Humira), infliximab (Remicade), rituximab (Rituxan), abatacept (Orencia), anakinra (Kineret), certolizumab (Cimzia), or golimumab (Simponi), while you are taking Tofidence because it may increase your risk of infection.
• medicines that affect the way certain liver enzymes work. Ask your healthcare provider if you are not sure if your medicine is one of these.

Know the medicines you take. Keep a list of them to show to your healthcare provider and pharmacist when you get a new medicine.

This list is not complete and many other drugs may interact with tocilizumab. This includes prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible drug interactions are listed here.