Actemra (Tocilizumab (Intravenous))

Name: Actemra (Tocilizumab (Intravenous))

Uses of Actemra

  • 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.

What do I need to tell my doctor BEFORE I take Actemra?

  • If you have an allergy to tocilizumab or any other part of this medicine.
  • If you are allergic to any drugs like this one, any other drugs, foods, or other substances. Tell your doctor about the allergy and what signs you had, like rash; hives; itching; shortness of breath; wheezing; cough; swelling of face, lips, tongue, or throat; or any other signs.
  • If you have liver disease or raised liver enzymes.
  • If you have an infection.
  • If you are taking any of these drugs: Abatacept, adalimumab, anakinra, certolizumab, etanercept, golimumab, infliximab, or rituximab.

This is not a list of all drugs or health problems that interact with Actemra.

Tell your doctor and pharmacist about all of your drugs (prescription or OTC, natural products, vitamins) and health problems. You must check to make sure that it is safe for you to take this medicine with all of your drugs and health problems. Do not start, stop, or change the dose of any drug without checking with your doctor.

What are some side effects that I need to call my doctor about right away?

WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:

  • Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
  • Signs of infection like fever, chills, very bad sore throat, ear or sinus pain, cough, more sputum or change in color of sputum, pain with passing urine, mouth sores, or wound that will not heal.
  • Signs of bleeding like throwing up blood or throw up that looks like coffee grounds; coughing up blood; blood in the urine; black, red, or tarry stools; bleeding from the gums; vaginal bleeding that is not normal; bruises without a reason or that get bigger; or any bleeding that is very bad or that you cannot stop.
  • Signs of liver problems like dark urine, feeling tired, not hungry, upset stomach or stomach pain, light-colored stools, throwing up, or yellow skin or eyes.
  • Signs of high blood pressure like very bad headache or dizziness, passing out, or change in eyesight.
  • Signs of nervous system problems like change in mood or actions, feeling confused, fever, numbness or tingling in the hands or feet, stiff neck, bright lights bother your eyes, or very bad muscle weakness.
  • A skin lump or growth.
  • Change in color or size of a mole.
  • Shortness of breath.
  • Chest pain or pressure.
  • Very upset stomach or throwing up.
  • Change in bowel habits.
  • Tears in the stomach or bowel wall have happened in certain people taking Actemra. Call your doctor right away if you have swelling or pain in your stomach that is very bad, gets worse, or does not go away. Call your doctor right away if you throw up blood or have throw up that looks like coffee grounds; upset stomach or throwing up that does not go away; or black, tarry, or bloody stools.

Liver Dose Adjustments

The safety and efficacy of this drug has not been studied in patients with hepatic impairment, including patients with positive HBV and HCV serology.

LIVER ENZYME ABNORMALITIES:
-Liver enzyme elevations greater than 1 to 3 x ULN, modify the dose of concomitant DMARDs if appropriate. For persistent increases in this range, reduce the IV dose to 4 mg/kg or interrupt therapy until the ALT/AST levels have normalized. For subcutaneous administration, reduce the injection frequency to every other week or interrupt therapy until ALT or AST have normalized. Resume at every other week and increase to every week as clinically appropriate.
-For liver enzyme elevations greater than 3 to 5 x ULN (confirmed by repeat testing), interrupt therapy until less than 3 x ULN and follow the recommendations for lab values greater than 1 to 3 x ULN. For persistent increases greater than 3 x ULN discontinue therapy.
-Discontinue therapy for liver enzyme elevations greater than 5 x ULN.

Dose Adjustments

Hold therapy if a patient develops a serious infection until the infection is controlled.

LOW ABSOLUTE NEUTROPHIL COUNT (ANC):
-ANC greater than 1000 cells/mm3: Maintain current dose
-ANC from 500 cells/mm3 to 1000 cells/mm3: Interrupt therapy; when the ANC is greater than 1000 cells/mm3, resume IV therapy at 4 mg/kg and increase to 8 mg/kg as clinically appropriate. For subcutaneous therapy, resume at every other week and increase frequency to every week as clinically appropriate.
-ANC less than 500 cells/mm3: Discontinue therapy

LOW PLATELET COUNT:
-Platelet count 50,000 to 100,000 cells/mm3: Interrupt therapy; when the platelet count is greater than 100,000 cells/mm3, resume IV therapy at 4 mg/kg and increase to 8 mg/kg as clinically appropriate. For subcutaneous therapy, reduce the injection frequency to every other week and increase to every week as clinically appropriate.
-Platelet count less than 50,000 cells/mm3: Discontinue therapy

Polyarticular and Systemic Juvenile Idiopathic Arthritis:
-Dose reduction has not been studied in the PJIA and SJIA populations.
-Dose interruptions are recommended for liver enzyme abnormalities, low neutrophil counts, and low platelet counts in patients with PJIA and SJIA at levels like what is outlined for adult patients with RA.
-If appropriate, dose modify or stop concomitant methotrexate and/or other medications and hold therapy until the clinical situation has been evaluated.
-In PJIA and SJIA the decision to discontinue therapy for a laboratory abnormality should be based on the individual patient.

Precautions

US BOXED WARNINGS:
WARNING: RISK OF SERIOUS INFECTIONS:
-Patients treated with this drug are at increased risk for developing serious infections that may lead to hospitalization or death. Most patients who developed these infections were taking concomitant immunosuppressants such as methotrexate or corticosteroids.
-If a serious infection develops, interrupt therapy until the infection is controlled.
REPORTED INFECTIONS INCLUDE:
1) Active tuberculosis, which may present with pulmonary or extrapulmonary disease. Patients should be tested for latent tuberculosis before beginning and during therapy. Treatment for latent infection should be initiated prior to therapy.
2) Invasive fungal infections, including candidiasis, aspergillosis, and pneumocystis. Patients with invasive fungal infections may present with disseminated, rather than localized, disease.
3) Bacterial, viral and other infections due to opportunistic pathogens.
-The risks and benefits of this drug should be carefully considered prior to initiating therapy in patients with chronic or recurrent infection.
-Patients should be closely monitored for the development of signs and symptoms of infection during and after treatment with this drug, including the possible development of tuberculosis in patients who tested negative for latent tuberculosis infection prior to initiating therapy.

Safety and efficacy of the IV formulation of this drug have not been established in patients younger than 2 years.

Safety and efficacy of the subcutaneous formulation of this drug have not been established in patients younger than 18 years.

Consult WARNINGS section for additional precautions.

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