Actemra (Tocilizumab (Intravenous))

Name: Actemra (Tocilizumab (Intravenous))

What are some things I need to know or do while I take Actemra?

  • Tell all of your health care providers that you take Actemra. This includes your doctors, nurses, pharmacists, and dentists.
  • Very bad and sometimes deadly allergic side effects have rarely happened. Talk with your doctor.
  • You may have more chance of getting an infection. Wash hands often. Stay away from people with infections, colds, or flu.
  • Hepatitis B testing may be done. A hepatitis B infection may get worse during care.
  • This medicine may add to the chance of getting some types of cancer. Talk with the doctor.
  • Have blood work checked as you have been told by the doctor. Talk with the doctor.
  • Make sure you are up to date with all your vaccines before treatment with this medicine.
  • Talk with your doctor before getting any vaccines. Use with Actemra may either raise the chance of an infection or make the vaccine not work as well.
  • If you have high blood sugar (diabetes), talk with your doctor. You may be more likely to get infections.
  • You may bleed more easily. Be careful and avoid injury. Use a soft toothbrush and an electric razor.
  • Treatment with this medicine may lead to higher cholesterol and triglycerides. The effect of these changes on heart health is not known. Talk with the doctor.
  • This medicine may affect how much of some other drugs are in your body. If you are taking other drugs, talk with your doctor. You may need to have your blood work checked more closely while taking Actemra with your other drugs.
  • If you are 65 or older, use this medicine with care. You could have more side effects.
  • Birth control pills and other hormone-based birth control may not work as well to prevent pregnancy. Use some other kind of birth control also like a condom when taking Actemra.
  • Tell your doctor if you are pregnant or plan on getting pregnant. You will need to talk about the benefits and risks of using this medicine while you are pregnant.
  • If you used Actemra (tocilizumab (intravenous)) when you were pregnant, tell your baby's doctor.
  • Tell your doctor if you are breast-feeding. You will need to talk about any risks to your baby.

How is this medicine (Actemra) best taken?

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.

What are some other side effects of Actemra?

All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:

  • Headache.
  • Signs of a common cold.
  • Nose and throat irritation.
  • Irritation where the shot is given.

These are not all of the side effects that may occur. If you have questions about side effects, call your doctor. Call your doctor for medical advice about side effects.

You may report side effects to the FDA at 1-800-FDA-1088. You may also report side effects at http://www.fda.gov/medwatch.

For the Consumer

Applies to tocilizumab: intravenous solution

Along with its needed effects, tocilizumab 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 while taking tocilizumab:

More common
  • 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
Less common
  • 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
Rare
  • 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
Incidence not known
  • 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 of tocilizumab 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
  • 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
Less common
  • 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
Rare
  • 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

Usual Adult Dose for Rheumatoid Arthritis

IV:
4 mg/kg IV as a 60-minute single drip infusion once every 4 weeks, followed by an increase to 8 mg/kg IV given once every 4 weeks as a 60-minute single drip infusion based on clinical response
Dose adjustment: Reduction from 8 mg/kg to 4 mg/kg is recommended for management of certain dose-related laboratory changes including elevated liver enzymes, neutropenia, and thrombocytopenia.
Maximum dose: 800 mg per infusion

Subcutaneous:
-Patients less than 100 kg: 162 mg subcutaneously every other week, followed by an increase to every week based on clinical response
-Patients 100 kg or greater: 162 mg subcutaneously every week
-Dose adjustment: Interruption of dose or reduction in frequency of administration from every week to every other week is recommended for management of certain dose-related laboratory changes including elevated liver enzymes, neutropenia, and thrombocytopenia.

Comments:
-This drug may be used as monotherapy or concomitantly with methotrexate or other non-biologic DMARDs as an IV infusion or as a subcutaneous injection.
-This drug should not be administered as an IV push or bolus.
-When transitioning from IV to subcutaneous therapy, give the first subcutaneous dose instead of the next scheduled IV dose.
-This drug should not be initiated in patients with an absolute neutrophil count (ANC) below 2000 per mm3, platelet count below 100,000 per mm3, or who have ALT or AST above 1.5 times the upper limit of normal (ULN).

Use: For adult patients with moderately to severely active rheumatoid arthritis (RA) who have had an inadequate response to one or more Disease-Modifying Anti-Rheumatic Drugs (DMARDs)

Usual Pediatric Dose for Juvenile Idiopathic Arthritis

Polyarticular Juvenile Idiopathic Arthritis (PJIA):
2 years or older:
-Weight less than 30 kg: 10 mg/kg IV as a 60-minute single drip infusion
once every 4 weeks
-Weight 30 kg or more: 8 mg/kg as a 60-minute single drip infusion
once every 4 weeks

Systemic Juvenile Idiopathic Arthritis (SJIA):
2 years or older:
-Weight less than 30 kg: 12 mg/kg IV as a 60-minute single drip infusion
once every 2 weeks
-Weight 30 kg or more: 8 mg/kg IV as a 60-minute single drip infusion
once every 2 weeks

Comments:
-This drug may be used as monotherapy or concomitantly with methotrexate.
-The weight of the patient may fluctuate; therefore, a dose adjustment should not be based on a single visit body weight measurement.
-Interruption of dosing may be needed for management of dose-related laboratory abnormalities including elevated liver enzymes, neutropenia, and thrombocytopenia.
-Subcutaneous administration is not approved for PJIA or SJIA.
-This drug should not be initiated in patients with an absolute neutrophil count (ANC) below 2000 per mm3, platelet count below 100,000 per mm3, or who have ALT or AST above 1.5 times the upper limit of normal (ULN).

Uses:
-Patients 2 years of age and older with active polyarticular juvenile idiopathic arthritis (PJIA)
-Patients 2 years of age and older with active systemic juvenile idiopathic arthritis (SJIA)

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