Actemra Vial

GENERIC NAME(S): Tocilizumab

OTHER NAME(S): Actemra Solution

WARNINGS:

This medication may lower your ability to fight an infection. This may make you more likely to get a serious (rarely fatal) infection or make any infection you have worse. Your risk may be increased if you are also taking other drugs that can lower your ability to fight an infection (such as methotrexate or corticosteroids). Before using tocilizumab, tell your doctor your medical history, especially of any kind of infection. During treatment, tell your doctor right away if you develop any signs of infection (such as cough, sore throat, fever, chills, pain when urinating).

Before starting this medication, your doctor should test you for tuberculosis (TB). Your doctor should monitor you for symptoms of TB during treatment with this drug. If needed, treatment for tuberculosis or other infections should be given before receiving this medication.

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Uses

Uses

This medication is used alone or with other medications to treat moderate to severe rheumatoid arthritis in adults. It is also used to treat rheumatoid arthritis in children (such as systemic juvenile idiopathic arthritis-SJIA, polyarticular juvenile idiopathic arthritis-PJIA). It helps to reduce pain and swelling due to rheumatoid arthritis. Tocilizumab may also be used to treat a reaction (Cytokine Release Syndrome-CRS) caused by certain cancer treatments. Tocilizumab belongs to a class of drugs known as Interleukin-6 (IL-6) blockers. It works by blocking IL-6, a substance made by the body that causes swelling (inflammation).

How to use Actemra Vial

Read the Medication Guide provided by your pharmacist before you start using tocilizumab and each time you get a refill. If you have any questions, ask your doctor or pharmacist.

This medication is given by a health care professional as directed by your doctor. It is given by slow injection into a vein for 60 minutes. For the treatment of rheumatoid arthritis in adults or PJIA, this medication is usually given every 4 weeks. For the treatment of SJIA, this medication is usually given every 2 weeks. For the treatment of CRS, this medication is given once and then as directed by your doctor if more doses are needed.

The dosage is based on your medical condition, age, weight, laboratory tests, and response to treatment.

Use this medication regularly to get the most benefit from it. To help you remember, mark the days on a calendar when you need to receive the medication.

Tell your doctor if your condition does not improve or if it worsens.

Side Effects

Side Effects

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: stomach/abdominal pain.

Tocilizumab has rarely caused very serious (possibly fatal) liver disease. This effect may occur months to years after starting this medication. Tell your doctor right away if you develop symptoms of liver disease, such as nausea/vomiting that doesn't stop, loss of appetite, yellowing eyes/skin, dark urine.

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.

Precautions

Precautions

Before receiving tocilizumab, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: diabetes, immune system problems, infections (including past/current/returning), liver problems, low blood cell count, nervous system problems (such as multiple sclerosis), stomach/abdominal problems (such as ulcers, diverticulitis).

Tocilizumab can make you more likely to get infections or may worsen any current infections. Therefore, wash your hands well to prevent the spread of infection. Avoid contact with people who have infections that may spread to others (such as chickenpox, measles, tuberculosis, flu). Tell your doctor if you live in, have lived in, or have traveled to certain areas where there is an increased chance of getting certain kinds of fungal infections (blastomycosis, coccidioidomycosis, histoplasmosis). Consult your doctor if you have been exposed to an infection or for more details.

Do not have immunizations/vaccinations without the consent of your doctor. Avoid contact with people who have recently received live vaccines (such as flu vaccine inhaled through the nose).

Drugs that affect the immune system (such as tocilizumab) may increase your risk of certain cancers. Tell your doctor if you have ever had any type of cancer.

Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).

During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor.

It is unknown if this drug passes into breast milk and the effect on a nursing infant is unknown. Consult your doctor before breast-feeding.

Interactions

Interactions

Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval.

Some products that may interact with this drug include: other drugs that can affect the immune system (such as certolizumab).

This medication can speed up the removal of other medications from your body, which may affect how they work. Examples of affected drugs include some cholesterol drugs such as atorvastatin/lovastatin/simvastatin, omeprazole, warfarin, among others.

This medication may decrease the effectiveness of hormonal birth control such as pills, patch, or ring. This could cause pregnancy. Discuss with your doctor or pharmacist if you should use additional reliable birth control methods while using this medication. Also tell your doctor if you have any new spotting or breakthrough bleeding, because these may be signs that your birth control is not working well.

Overdose

Overdose

If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center.

Notes

Laboratory and/or medical tests (such as complete blood counts, liver function, cholesterol tests) should be performed before starting treatment and periodically during treatment to monitor your progress or check for side effects. Consult your doctor for more details.

Missed Dose

For the best possible benefit, it is important to receive each scheduled dose of this medication as directed. If you miss a dose, contact your doctor or pharmacist right away to establish a new dosing schedule.

Storage

Not applicable. This medication is given in a clinic and will not be stored at home.Information last revised June 2019. Copyright(c) 2019 First Databank, Inc.

Images
Actemra 80 mg/4 mL (20 mg/mL) intravenous solution
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Actemra 80 mg/4 mL (20 mg/mL) intravenous solution

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Actemra 200 mg/10 mL (20 mg/mL) intravenous solution
Actemra 200 mg/10 mL (20 mg/mL) intravenous solutioniconicon
Actemra 200 mg/10 mL (20 mg/mL) intravenous solution

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Actemra 400 mg/20 mL (20 mg/mL) intravenous solution
Actemra 400 mg/20 mL (20 mg/mL) intravenous solutioniconicon
Actemra 400 mg/20 mL (20 mg/mL) intravenous solution

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Actemra 80 mg/4 mL (20 mg/mL) intravenous solution
Actemra 80 mg/4 mL (20 mg/mL) intravenous solution

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colorless
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No data.
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No data.
This medicine is a colorless, vial
Actemra 200 mg/10 mL (20 mg/mL) intravenous solution
Actemra 200 mg/10 mL (20 mg/mL) intravenous solution

color
colorless
shape
No data.
imprint
No data.
This medicine is a colorless, clear, vial
Actemra 400 mg/20 mL (20 mg/mL) intravenous solution
Actemra 400 mg/20 mL (20 mg/mL) intravenous solution

color
colorless
shape
No data.
imprint
No data.
This medicine is a colorless, clear, vial

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Selected from data included with permission and copyrighted by First Databank, Inc. This copyrighted material has been downloaded from a licensed data provider and is not for distribution, except as may be authorized by the applicable terms of use.

CONDITIONS OF USE: The information in this database is intended to supplement, not substitute for, the expertise and judgment of healthcare professionals. The information is not intended to cover all possible uses, directions, precautions, drug interactions or adverse effects, nor should it be construed to indicate that use of a particular drug is safe, appropriate or effective for you or anyone else. A healthcare professional should be consulted before taking any drug, changing any diet or commencing or discontinuing any course of treatment.