Description and Brand Names

Drug information provided by: Micromedex

US Brand Name

  1. Actemra

Descriptions


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

Tocilizumab injection is also used to treat polyarticular juvenile idiopathic arthritis (PJIA) and systemic juvenile idiopathic arthritis (SJIA) in children 2 years of age and older.

This medicine is to be given only by or under the direct supervision of a doctor.

This product is available in the following dosage forms:

  • Solution

Before Using

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:

Allergies

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.

Pediatric

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

Geriatric

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.

Pregnancy

Information about this tocilizumab-intravenous-route
Pregnancy Category Explanation
All Trimesters C Animal studies have shown an adverse effect and there are no adequate studies in pregnant women OR no animal studies have been conducted and there are no adequate studies in pregnant women.

Breastfeeding

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.

Drug Interactions

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 receiving 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.

  • Infliximab

Other Interactions

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.

Other Medical Problems

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 (including hepatitis B), history of or
  • Multiple sclerosis or
  • Neutropenia (low level of white blood cells) or
  • Stomach or bowel problems (eg, diverticulosis, perforations, ulcers) or
  • Thrombocytopenia (low number of platelets) or
  • Weak immune system (eg, cancer history or steroid use)—Use with caution. May make these conditions worse.
  • Infection, active or recurring or
  • Liver disease, active—Should not be used in patients with this condition.
  • Tuberculosis, history of—Use with caution. May cause infection to come back (reactivate).

Proper Use

A nurse or other trained health professional will give you this medicine. This medicine is given through a needle placed in one of your veins. This medicine must be given slowly, so the needle will remain in place for at least 1 hour.

This medicine should come with a Medication Guide. It is very important that you read and understand this information. Be sure to ask your doctor about anything you do not understand.

Precautions

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 tests may be needed to check for unwanted effects.

You will need to have a skin test for tuberculosis before you or your child 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 may increase your risk of developing infections. Avoid being near people who are sick or have infections while you or your child are using this medicine. Wash your hands often. 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 kept coming back.

Using this medicine may increase your risk of having certain cancers. Talk to your doctor if you or your child have concerns about this risk.

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 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. Anaphylaxis can be life-threatening and requires immediate medical attention. Tell your doctor right away if you or your child have a rash, hives, itching, swelling of the face, tongue, and throat, trouble breathing, or chest pain after you receive the medicine.

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.

While you or your child are being treated with tocilizumab, and after you stop treatment, do not have 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 immunization is meant to prevent. In addition, other persons living in your household should not get live vaccines (eg, nasal flu virus vaccine). Try to avoid being around persons who have received live vaccines. Do not get close to them and do not stay in the same room with them for very long. If you or your child cannot take these precautions, you should wear a protective face mask that covers the nose and mouth. Talk to your doctor if you have questions about this.

Your child's vaccines need to be current before he or she begins using tocilizumab injection. Be sure to ask your child's doctor if you have any questions about this.

This medicine may increase the level of cholesterol and fats in your blood. If this condition occurs, your doctor may give you a medicine to lower the cholesterol and fats. 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.

Side Effects

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:

More common

  1. Abdominal or stomach pain
  2. black, tarry stools
  3. bloody or cloudy urine
  4. blurred vision
  5. body aches or pain
  6. chest pain
  7. cough
  8. cough producing mucus
  9. diarrhea
  10. difficult, burning, or painful urination
  11. difficulty breathing
  12. difficulty swallowing
  13. dizziness
  14. ear congestion
  15. fast heartbeat
  16. feeling of warmth
  17. fever or chills
  18. frequent urge to urinate
  19. headache
  20. hives
  21. itching
  22. loss of appetite
  23. loss of consciousness
  24. loss of voice
  25. lower back or side pain
  26. nasal congestion
  27. nausea
  28. nervousness
  29. pain or tenderness around the eyes and cheekbones
  30. painful blisters on the trunk of the body
  31. pale skin
  32. pounding in the ears
  33. puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
  34. redness of the face, neck, arms, and occasionally, upper chest
  35. shortness of breath or troubled breathing
  36. skin rash
  37. slow or fast heartbeat
  38. sneezing
  39. sore throat
  40. stuffy or runny nose
  41. sudden sweating
  42. tightness of the chest or wheezing
  43. ulcers, sores, or white spots in the mouth
  44. unusual bleeding or bruising
  45. unusual tiredness or weakness
  46. weakness

Less common

  1. Bladder pain
  2. blurred vision
  3. burning feeling in the chest or stomach
  4. confusion
  5. dark urine
  6. decrease in height
  7. difficulty moving
  8. dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position
  9. fast, irregular, pounding, or racing heartbeat or pulse
  10. feeling hot
  11. frequent urge to urinate
  12. general feeling of discomfort or illness
  13. heartburn
  14. indigestion
  15. itching, pain, redness, swelling, tenderness, or warmth on the skin at the injection site
  16. joint pain
  17. light-colored stools
  18. muscle aches and pains
  19. muscle cramps or stiffness
  20. pain in the back, ribs, arms, or legs
  21. pain in the groin or genitals
  22. pale skin
  23. severe stomach pain
  24. sharp back pain just below the ribs
  25. shivering
  26. stomach upset
  27. sweating
  28. swelling
  29. swollen joints
  30. swollen, painful, or tender lymph glands in the face, neck, armpit, or groin
  31. tenderness in the stomach area
  32. trouble with sleeping
  33. troubled breathing with exertion
  34. unexplained runny nose or sneezing
  35. upper right abdominal or stomach pain
  36. vomiting
  37. yellow eyes and skin

Rare

  1. Acid or sour stomach
  2. belching
  3. changes in skin color
  4. confusion
  5. coughing or spitting up blood
  6. fainting
  7. gaseous abdominal or stomach pain
  8. lightheadedness
  9. neck pain
  10. night sweats
  11. noisy breathing
  12. pain
  13. pain, swelling, or redness in the joints
  14. rapid, shallow breathing
  15. recurrent fever
  16. red, tender, or oozing skin at incision
  17. stomach bloating, burning, cramping, or pain
  18. sudden high fever or low-grade fever for months
  19. swelling of the foot or leg
  20. swollen lymph nodes
  21. weight loss

Incidence not known

  1. Dilated neck veins
  2. extreme fatigue
  3. severe abdominal or stomach pain, cramping, or burning
  4. swelling of the face, fingers, feet, or lower legs
  5. vomiting of material that looks like coffee grounds, severe and continuing
  6. 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:

More common

  1. Burning, dry, or itching eyes
  2. constipation
  3. discharge, excessive tearing
  4. redness, pain, or swelling of the eye, eyelid, or inner lining of the eyelid
  5. skin rash, encrusted, scaly and oozing
  6. swelling or inflammation of the mouth
  7. warmth on the skin

Less common

  1. Abnormal or decreased touch sensation
  2. accumulation of pus
  3. back pain
  4. bleeding gums
  5. blemishes on the skin
  6. bloody eye
  7. chapped, red, or swollen lips
  8. earache
  9. feeling of constant movement of self or surroundings
  10. hives or welts
  11. irritation in the mouth
  12. loose teeth
  13. persistent breath odor or bad taste in your mouth
  14. pimples
  15. redness and swelling of the gums
  16. redness of the eye
  17. redness of the skin
  18. redness or swelling in the ear
  19. scaling, redness, burning, pain, or other signs of inflammation of the lips
  20. sensation of spinning
  21. sleeplessness
  22. sore mouth or tongue
  23. sores on the skin
  24. stomach soreness or discomfort
  25. swollen, red, or tender area of infection
  26. unable to sleep
  27. white patches in the mouth or on the tongue

Rare

  1. Bleeding after defecation
  2. blindness
  3. bloody nose
  4. burning, numbness, tingling, or painful sensations
  5. change in hearing
  6. continuing ringing or buzzing or other unexplained noise in the ears
  7. coughing or spitting up blood
  8. decreased vision or other changes in vision
  9. dry mouth
  10. ear drainage
  11. earache
  12. flushed, dry skin
  13. fruit-like breath odor
  14. hearing loss
  15. increased hunger
  16. increased thirst
  17. increased urination
  18. itching ears
  19. loss of consciousness
  20. redness, swelling, or soreness of the tongue
  21. thirst
  22. uncomfortable swelling around the anus
  23. unexplained weight loss
  24. unsteadiness or awkwardness
  25. 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.