Tocilizumab-aazg (toe-si-LIZ-oo-mab - aazg)

Treats rheumatoid arthritis, giant cell arthritis, polyarticular juvenile idiopathic arthritis, and systemic juvenile idiopathic arthritis.

Brand Name(s):

Tyenne, Tyenne Autoinjector, Tyenne PFS

When This Medicine Should Not Be Used:

How to Use This Medicine:

Injectable

• Your doctor will prescribe your dose and schedule. This medicine is given through an IV catheter placed into a vein or as a shot under your skin.
• If tocilizumab-aazg is injected into a vein, it must be given slowly, so the IV will have to stay in place for at least 1 hour.
• A nurse or other health provider will give you this medicine.
• You may be taught how to give your medicine at home. Make sure you understand all instructions before giving yourself an injection. Do not use more medicine or use it more often than your doctor tells you to.
• Allow the prefilled syringe to warm to room temperature for 30 minutes or the autoinjector for 45 minutes before using it. Do not warm the medicine in any other way (including microwave, hot water, or direct sunlight).
• Check the liquid in the prefilled syringe or autoinjector. It should be clear and colorless to pale yellow. Do not use if it is cloudy, discolored, or has lumps or particles in it. Do not use if it is damaged or has been dropped.
• 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. Do not inject into skin areas that are red, bruised, tender, hard, scaly, or skin that has lesions, moles, scars, stretch marks, or tattoos.
• 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.
• Use a new needle and syringe each time you inject your medicine.
• Never share your prefilled syringe or autoinjector with others. Sharing needles can result in transmission of infection.
• This medicine should come with a Medication Guide. Ask your pharmacist for a copy if you do not have one.
• Missed dose: Take a dose as soon as you remember. If it is almost time for your next dose, wait until then and take a regular dose. Do not take extra medicine to make up for a missed dose.
• If you store this medicine at home, keep it in the refrigerator. Do not freeze. Protect the medicine from direct light. Keep it in its original package until you are ready to use it.
• You may store the autoinjector at room temperature for up to 14 days. Do not put it back in the refrigerator. Throw it away if it has been out of the refrigerator for more than 14 days
• If needed, when traveling, you may store the prefilled syringeat room temperature for up to 14 days. Do not put it back in the refrigerator. Throw it away if it has been out of the refrigerator for more than 14 days.
• Throw away used needles in a hard, closed container that the needles cannot poke through. Keep this container away from children and pets.

Drugs and Foods to Avoid:

Ask your doctor or pharmacist before using any other medicine, including over-the-counter medicines, vitamins, and herbal products.

• Some medicines can affect how tocilizumab-aazg works. Tell your doctor if you are using any of the following:
  • Abatacept, adalimumab, anakinra, certolizumab, cyclosporine, dextromethorphan, etanercept, golimumab, infliximab, methotrexate, omeprazole, rituximab, theophylline
  • Birth control pills
  • Blood thinner (including warfarin)
  • Medicine that weakens the immune system (including a cancer or steroid medicine)
  • Medicine to lower cholesterol (including atorvastatin, lovastatin, simvastatin)
  • NSAIDs or arthritis medicine
• This medicine may interfere with vaccines. Ask your doctor before you get a flu shot or any other vaccines.

Warnings While Using This Medicine:

• Tell your doctor if you are pregnant or breastfeeding, or if you have kidney disease, liver disease, diabetes, high cholesterol, multiple sclerosis, stomach or bowel disease (including diverticulitis, ulcers), or a weak immune system (including HIV, cancer). Tell your doctor if you have any type of infection (including hepatitis B or tuberculosis) or an infection that keeps coming back.
• This medicine may cause the following problems:
  • Increased risk for serious infections
  • Stomach or bowel problems
  • Liver problems
  • High cholesterol in the blood
  • Increased risk of cancer
  • Serious skin reactions
• You will need to have a skin test for tuberculosis (TB) before you start using this medicine. Tell your doctor if you or anyone in your home has ever had a positive TB skin test or has been exposed to TB.
• This medicine may make you bleed, bruise, or get infections more easily. Take precautions to prevent illness and injury. Wash your hands often.
• Your doctor will do lab tests at regular visits to check on the effects of this medicine. Keep all appointments.
• Keep all medicine out of the reach of children. Never share your medicine with anyone.

Possible Side Effects While Using This Medicine:

Call your doctor right away if you notice any of these side effects:

• Allergic reaction: Itching or hives, swelling in your face or hands, swelling or tingling in your mouth or throat, chest tightness, trouble breathing
• Blistering, peeling, red skin rash
• Bloody, black, or tarry stools, severe stomach pain, diarrhea
• Change in how much or how often you urinate
• Chest pain, trouble breathing
• Dark urine or pale stools, nausea, vomiting, loss of appetite, stomach pain, yellow skin or eyes
• Fast, slow, or pounding heartbeat
• Fever, chills, cough, stuffy or runny nose, sore throat, body aches
• Unusual bleeding, bruising, weakness
• Vomiting of material that looks like coffee grounds

If you notice these less serious side effects, talk with your doctor:

• Headache
• Pain, itching, burning, swelling, bleeding, or a lump under your skin where the needle was placed

If you notice other side effects that you think are caused by this medicine, tell your doctor

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