Tocilizumab Intravenous

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

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

tocilizumab 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 tocilizumab. Also tell your doctor if you have ever had an infection that would not go away or an infection that kept coming back.

Call your doctor right away if you or your child start to have a cough that won't 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.

tocilizumab 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 tocilizumab.

Using tocilizumab 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.

tocilizumab may cause serious types of allergic reactions, including anaphylaxis. This can be life-threatening and requires 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 tocilizumab.

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 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.

tocilizumab 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.

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor or nurse immediately if any of the following side effects occur:

• Black, tarry stools
• bloody or cloudy urine
• blurred vision
• body aches or pain
• chest pain
• cough with or without mucus
• diarrhea
• difficult, burning, or painful urination
• difficulty breathing
• difficulty swallowing
• dizziness
• ear congestion
• fast heartbeat
• feeling of warmth
• fever or chills
• frequent urge to urinate
• headache
• hives, itching, skin rash
• loss of appetite
• loss of consciousness
• loss of voice
• lower back or side pain
• nasal congestion
• nausea
• nervousness
• pain or tenderness around the eyes and cheekbones
• painful blisters on the trunk of the body
• pale skin
• pounding in the ears
• puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
• redness of the face, neck, arms, and occasionally, upper chest
• slow or fast heartbeat
• sneezing
• sore throat
• stomach pain
• stuffy or runny nose
• sudden sweating
• tightness of the chest
• ulcers, sores, or white spots in the mouth
• unusual bleeding or bruising
• unusual tiredness or weakness

• Bladder pain
• burning feeling in the chest or stomach
• confusion
• dark urine
• decrease in height
• difficulty moving
• dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position
• fast, irregular, pounding, or racing heartbeat or pulse
• feeling hot
• general feeling of discomfort or illness
• heartburn
• indigestion
• itching, pain, redness, swelling, tenderness, or warmth on the skin at the injection site
• joint pain
• light-colored stools
• muscle aches and pains
• muscle cramps or stiffness
• pain in the back, ribs, arms, legs, or groin or genitals
• pale skin
• severe stomach pain
• sharp back pain just below the ribs
• shivering
• stomach upset
• sweating
• swollen joints
• swollen, painful, or tender lymph glands in the face, neck, armpit, or groin
• tenderness in the stomach area
• trouble with sleeping
• troubled breathing with exertion
• unexplained runny nose or sneezing
• vomiting
• yellow eyes and skin

• Belching
• changes in skin color
• coughing or spitting up blood
• fainting
• gaseous stomach pain
• lightheadedness
• neck pain
• night sweats
• noisy breathing
• rapid, shallow breathing
• recurrent fever
• red, tender, or oozing skin at the wounded area
• sudden high fever or low-grade fever for months
• swelling of the foot or leg
• weight loss

• Dilated neck veins
• extreme fatigue
• severe stomach pain, cramping, or burning
• swelling of the face, fingers, feet, or lower legs
• vomiting of material that looks like coffee grounds, severe and continuing
• weight gain

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

• Burning, dry, or itching eyes
• constipation
• discharge, excessive tearing
• redness, pain, or swelling of the eye, eyelid, or inner lining of the eyelid
• skin rash, encrusted, scaly and oozing
• swelling or inflammation of the mouth
• warmth on the skin

• Abnormal or decreased touch sensation
• accumulation of pus
• bleeding or redness and swelling of the gums
• blemishes on the skin
• bloody eye
• chapped, red, or swollen lips
• earache
• feeling of constant movement of self or surroundings
• irritation in the mouth
• loose teeth
• persistent breath odor or bad taste in your mouth
• pimples
• redness of the eye or skin
• redness or swelling in the ear
• scaling, redness, burning, pain, or other signs of inflammation on the lips
• sensation of spinning
• sore mouth or tongue
• swollen, red, or tender area of infection
• white patches in the mouth or on the tongue

• Bleeding after passing stool
• blindness
• bloody nose
• burning, numbness, tingling, or painful sensations
• change in hearing
• continuing ringing or buzzing or other unexplained noise in the ears
• coughing or spitting up blood
• decreased vision or other changes in vision
• dry mouth
• ear drainage
• flushed, dry skin
• fruit-like breath odor
• hearing loss
• increased hunger, thirst, urination
• itching ears
• loss of consciousness
• uncomfortable swelling around the anus
• unexplained weight loss
• unsteadiness or awkwardness
• weakness in the arms, hands, legs, or feet

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

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

• It is used to treat rheumatoid arthritis.
• It is used to treat juvenile arthritis.
• It may be given to you for other reasons. Talk with the doctor.

Use this medicine as ordered by your doctor. Read all information given to you. Follow all instructions closely.

• It is given as an infusion into a vein over a period of time.

What do I do if I miss a dose?

• Call your doctor to find out what to do.

• If you need to store this medicine at home, talk with your doctor, nurse, or pharmacist about how to store it.

See also Warning section.

Headache or pain/redness/swelling at the injection site may occur. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.

Remember that your doctor has prescribed this medication because he or she 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: severe stomach/abdominal pain.

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.