Generic Name: tocilizumab (Intravenous route)
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 .
Commonly used brand name(s)
In the U.S.
Available Dosage Forms:
Therapeutic Class: Immunological Agent
Pharmacologic Class: Monoclonal Antibody
Uses For Actemra
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.
Before Using Actemra
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 with PJIA and SJIA. However, safety and efficacy have not been established in children younger than 2 years of age.
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.
|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.|
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.
Interactions with Medicines
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.
Interactions with Food/Tobacco/Alcohol
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 of Actemra
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 While Using Actemra
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.
Actemra 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
- Abdominal or stomach pain
- black, tarry stools
- bloody or cloudy urine
- blurred vision
- body aches or pain
- chest pain
- cough producing mucus
- difficult, burning, or painful urination
- difficulty breathing
- difficulty swallowing
- ear congestion
- fast heartbeat
- feeling of warmth
- fever or chills
- frequent urge to urinate
- loss of appetite
- loss of consciousness
- loss of voice
- lower back or side pain
- nasal congestion
- 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
- shortness of breath or troubled breathing
- skin rash
- slow or fast heartbeat
- sore throat
- stuffy or runny nose
- sudden sweating
- tightness of the chest or wheezing
- ulcers, sores, or white spots in the mouth
- unusual bleeding or bruising
- unusual tiredness or weakness
- Bladder pain
- blurred vision
- burning feeling in the chest or stomach
- 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
- frequent urge to urinate
- general feeling of discomfort or illness
- 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, or legs
- pain in the groin or genitals
- pale skin
- severe stomach pain
- sharp back pain just below the ribs
- stomach upset
- 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
- upper right abdominal or stomach pain
- yellow eyes and skin
- Acid or sour stomach
- changes in skin color
- coughing or spitting up blood
- gaseous abdominal or stomach pain
- neck pain
- night sweats
- noisy breathing
- pain, swelling, or redness in the joints
- rapid, shallow breathing
- recurrent fever
- red, tender, or oozing skin at incision
- stomach bloating, burning, cramping, or pain
- sudden high fever or low-grade fever for months
- swelling of the foot or leg
- swollen lymph nodes
- weight loss
- Dilated neck veins
- extreme fatigue
- severe abdominal or 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:More common
- Burning, dry, or itching eyes
- 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
- back pain
- bleeding gums
- blemishes on the skin
- bloody eye
- chapped, red, or swollen lips
- feeling of constant movement of self or surroundings
- hives or welts
- irritation in the mouth
- loose teeth
- persistent breath odor or bad taste in your mouth
- redness and swelling of the gums
- redness of the eye
- redness of the skin
- redness or swelling in the ear
- scaling, redness, burning, pain, or other signs of inflammation of the lips
- sensation of spinning
- sore mouth or tongue
- sores on the skin
- stomach soreness or discomfort
- swollen, red, or tender area of infection
- unable to sleep
- white patches in the mouth or on the tongue
- Bleeding after defecation
- 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
- increased thirst
- increased urination
- itching ears
- loss of consciousness
- redness, swelling, or soreness of the tongue
- 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.
See also: Side effects (in more detail)
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