What is Tofidence?

Patients treated with tocilizumab are at increased risk for infections, some progressing to serious infections leading to hospitalization or death. These infections have included bacterial infection, tuberculosis, invasive fungal, or other opportunistic infections. Evaluate for latent tuberculosis and treat if necessary prior to initiation of therapy. Monitor patients receiving tocilizumab for signs and symptoms of infection, including tuberculosis, even if initial latent tuberculosis test is negative .

Patients treated with tocilizumab are at increased risk for infections, some progressing to serious infections leading to hospitalization or death. These infections have included bacterial infection, tuberculosis, invasive fungal, or other opportunistic infections. Evaluate for latent tuberculosis and treat if necessary prior to initiation of therapy. Monitor patients receiving tocilizumab for signs and symptoms of infection, including tuberculosis, even if initial latent tuberculosis test is negative .

Tocilizumab injection is used alone or together with other medicines to reduce the signs and symptoms of moderate to severe active rheumatoid arthritis. This medicine helps keep joint damage from getting worse after other medicines (eg, adalimumab, etanercept, infliximab) have been used and did not work well. It is a monoclonal antibody.

Tocilizumab injection is also used alone or together with glucocorticoids (steroid medicine) to treat giant cell arteritis (inflammation of the arteries). It can be used alone after stopping treatment with glucocorticoids.

Tocilizumab injection is also used to slow the rate of decline in lung function in patients with systemic sclerosis-associated interstitial lung disease (SSc-ILD).

Tocilizumab injection is also used alone or together with methotrexate to treat polyarticular juvenile idiopathic arthritis (PJIA) and systemic juvenile idiopathic arthritis (SJIA) in children 2 years of age and older. It is also used to treat severe or life-threatening cytokine release syndrome (CRS) in adults and children 2 years of age and older.

This medicine is available only with your doctor's prescription.

A nurse or other trained health professional will give you this medicine in a medical facility. It is given through a needle placed into one of your veins to treat rheumatoid arthritis, PJIA, SJIA, or CRS. It must be given slowly, so the needle will have to remain in place for at least 1 hour.

Tocilizumab injection may also be given as a shot under your skin to treat rheumatoid arthritis, SSc-ILD, PJIA, SJIA, or giant cell arteritis. It may sometimes be given at home to patients who do not need to be in the hospital or clinic. If you are using this medicine at home, your doctor or nurse will teach you how to inject the medicine. Be sure that you understand exactly how to use this.

This medicine comes with a Medication Guide and patient instructions. Read and follow these instructions carefully. Ask your doctor or pharmacist if you have any questions.

This medicine is available in 2 forms. You may use a prefilled syringe or an autoinjector.

If you use this medicine at home, you will be shown the body areas where this shot can be given. Use a different body area each time you give yourself a shot. Keep track of where you give each shot to make sure you rotate body areas. This will help prevent skin problems. Do not inject into scars, moles, or skin areas that are red, bruised, tender, hard, or not intact.

Allow the prefilled syringe to warm to room temperature 30 minutes or the autoinjector for 45 minutes before using it. Do not warm it in any other way.

Check the liquid in the prefilled syringe or autoinjector. It should be clear and colorless or slightly yellow. Do not use it if it is cloudy, discolored, or has particles in it.

Use all of the medicine in each prefilled syringe or autoinjector. Use each prefilled syringe and autoinjector only one time. Do not save an open syringe or autoinjector.

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

• For injection dosage form (prefilled syringe):
  • For giant cell arteritis:
    • Adults—162 milligrams (mg) injected under the skin once a week or once every other week. Your doctor may adjust your dose as needed and tolerated.
    • Children—Use and dose must be determined by your doctor.
  • For moderate to severe rheumatoid arthritis:
    • Adults weighing 100 kilograms (kg) or more—162 milligrams (mg) injected under the skin once a week. Your doctor may adjust your dose as needed and tolerated.
    • Adults weighing less than 100 kg—At first, 162 mg injected under the skin once every other week. Your doctor may increase the dose to 162 mg once a week as needed and tolerated.
    • Children—Use and dose must be determined by your doctor.
  • For systemic sclerosis-associated interstitial lung disease:
    • Adults—162 milligrams (mg) injected under the skin once a week. Your doctor may adjust your dose as needed and tolerated.
    • Children—Use and dose must be determined by your doctor.
  • For polyarticular juvenile idiopathic arthritis:
    • Adults and children 2 years of age and older weighing 30 kilograms (kg) or more—162 milligrams (mg) injected under the skin once every 2 weeks.
    • Children 2 years of age and older weighing less than 30 kg—162 milligrams (mg) injected under the skin once every 3 weeks.
    • Children younger than 2 years of age—Use and dose must be determined by your doctor.
  • For systemic juvenile idiopathic arthritis:
    • Adults and children 2 years of age and older weighing 30 kilograms (kg) or more—162 milligrams (mg) injected under the skin once a week.
    • Children 2 years of age and older weighing less than 30 kg—162 milligrams (mg) injected under the skin once every 2 weeks.
    • Children younger than 2 years of age—Use and dose must be determined by your doctor.

If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

Store in the refrigerator. Do not freeze.

Protect this medicine from direct light. Keep it in its original package until you are ready to use it.

Throw away used syringes in a hard, closed container where the needles cannot poke through. Keep this container away from children and pets.

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Appropriate studies performed to date have not demonstrated pediatric-specific problems that would limit the usefulness of tocilizumab injection in children 2 years of age and older with PJIA, SJIA, and CRS. However, safety and efficacy have not been established for other conditions and in children younger than 2 years of age with PJIA, SJIA, and CRS.

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of tocilizumab injection in the elderly. However, elderly patients are more likely to have serious infections, which may require caution in patients receiving tocilizumab injection.

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Abatacept
• Adenovirus Vaccine
• Bacillus of Calmette and Guerin Vaccine, Live
• Cholera Vaccine, Live
• Dengue Tetravalent Vaccine, Live
• Infliximab
• Influenza Virus Vaccine, Live
• Measles Virus Vaccine, Live
• Mumps Virus Vaccine, Live
• Poliovirus Vaccine, Live
• Rotavirus Vaccine, Live
• Rubella Virus Vaccine, Live
• Smallpox Vaccine
• Tofacitinib
• Typhoid Vaccine, Live
• Varicella Virus Vaccine, Live
• Yellow Fever Vaccine
• Zoster Vaccine, Live

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

• Chronic inflammatory demyelinating polyneuropathy (nerve problem) or
• Hyperlipidemia (high fats in the blood) or
• Liver disease, history of or
• Multiple sclerosis or
• Neutropenia (low level of white blood cells) or
• Stomach or bowel problems (eg, diverticulitis, perforations, ulcers) or
• Thrombocytopenia (low number of platelets) or
• Weak immune system (eg, HIV, cancer, or steroid use)—Use with caution. May make these conditions worse.

• Herpes zoster, history of or
• Tuberculosis, history of—Use with caution. May cause infections to come back (reactivate).

• Infections (eg, hepatitis B, bacteria, virus, fungus), active or recurring or
• Liver disease, active—Should not be used in patients with these conditions.

It is very important that your doctor check your or your child's progress at regular visits to make sure that this medicine is working properly. Blood and urine tests may be needed to check for unwanted effects.

You or your child will need to have a skin test for tuberculosis before you start using this medicine. Tell your doctor if you or anyone in your home has ever had a positive reaction to a tuberculosis skin test.

This medicine will lower the number of some types of blood cells in your body. Because of this, you may bleed or get infections more easily. To help with these problems, avoid being near people who are sick or have infections. Wash your hands often. Stay away from rough sports or other situations where you could be bruised, cut, or injured. Brush and floss your teeth gently. Be careful when using sharp objects, including razors and fingernail clippers. Tell your doctor if you have any kind of infection before you start using this medicine. Also tell your doctor if you have ever had an infection that would not go away or an infection that keeps coming back.

Call your doctor right away if you or your child start to have a cough that would not go away, weight loss, night sweats, fever, chills, or flu-like symptoms, such as a runny or stuffy nose, headache, blurred vision, or feeling generally ill. These may be signs that you have an infection.

This medicine may cause serious stomach and bowel problems, especially if you have a history of ulcers or diverticulosis. Check with your doctor right away if you or your child start having severe stomach cramps or pain, black, tarry stools, diarrhea, fever, or vomiting that is severe and sometimes bloody while being treated with this medicine.

Check with your doctor right away if you have pain or tenderness in the upper stomach, pale stools, dark urine, loss of appetite, nausea, vomiting, or yellow eyes or skin. These could be symptoms of a serious liver problem.

Using this medicine may increase your risk of having certain cancers. Talk to your doctor if you have unusual bleeding, bruising, or weakness, swollen lymph nodes in the neck, underarms, or groin, or unexplained weight loss. Also, check with your doctor right away if your skin has red, scaly patches, or raised bumps that are filled with pus.

Tocilizumab may cause headaches and skin reactions, such as a rash or itching, while you are receiving the injection or within 24 hours after you receive it. Check with your doctor or nurse right away if you or your child have any of these symptoms.

This medicine may cause serious types of allergic reactions, including anaphylaxis, which can be life-threatening and require immediate medical attention. Tell your doctor right away if you or your child have a rash, itching, hoarseness, trouble breathing, trouble swallowing, or any swelling of your hands, face, or mouth after using this medicine.

While you or your child are being treated with tocilizumab, and after you stop treatment with it, it is important to see your doctor about the immunizations (vaccinations) you should receive. Do not get any immunizations (vaccines) without your doctor's approval. Tocilizumab may lower your body's resistance, and there is a chance you might get the infection the vaccine is meant to prevent. In addition, you should not be around other persons living in your household who receive live virus vaccines because there is a chance that they could pass the virus on to you. Some examples of live vaccines include measles, mumps, influenza (nasal flu vaccine), poliovirus (oral form), rotavirus, and rubella. Do not get close to them and do not stay in the same room with them for very long. If you have questions about this, talk to your doctor.

This medicine may increase the amounts of cholesterol and fats in your blood. If this condition occurs, your doctor may give you some medicines that can lower their amounts. Talk to your doctor if you or your child have concerns.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.