Actemra

Name: Actemra

How should this medicine be used?

Tocilizumab injection comes as a solution (liquid) to be injected intravenously (into a vein) in your arm by a doctor or nurse in a medical office or hospital outpatient clinic or as a prefilled syringe to inject subcutaneously (under the skin) by yourself at home. When tocilizumab is given intravenously to treat rheumatoid arthritis or polyarticular juvenile idiopathic arthritis, it is usually given once every 4 weeks. When tocilizumab is given intravenously to treat systemic juvenile idiopathic arthritis, it is usually given once every 2 weeks. It will take about 1 hour for you to receive your dose of tocilizumab injection intravenously. When tocilizumab is given subcutaneously to treat rheumatoid arthritis, it is usually given once weekly or once every other week.

You will receive your first subcutaneous dose of tocilizumab injection in your doctor's office. If you will be injecting tocilizumab injection subcutaneously by yourself at home or having a friend or relative inject the medication for you, your doctor will show you or the person who will be injecting the medication how to inject it. You and the person who will be injecting the medication should also read the written instructions for use that come with the medication.

Thirty minutes before you are ready to inject tocilizumab injection, you will need to remove the medication from the refrigerator, take it out of its carton, and allow it to reach room temperature. When removing a prefilled syringe from the box, be careful not to touch the trigger fingers on the syringe. Do not try to warm the medication by heating it in a microwave, placing it in warm water, or through any other method.

Do not remove the cap from the prefilled syringe while the medication is warming. You should remove the cap no more than 5 minutes before you inject the medication. Do not replace the cap after you remove it. Do not use the syringe if you drop it on the floor.

Check the prefilled syringe to be sure that the expiration date printed on the package has not passed, Holding the syringe with the covered needle pointing down, look closely at the liquid in the syringe. The liquid should be clear or pale yellow and should not be cloudy or discolored or contain lumps or particles. Call your pharmacist if there are any problems with the package or the syringe and do not inject the medication.

You may inject tocilizumab injection on the front of the thighs or anywhere on your stomach except your navel (belly button) and the area 2 inches around it. If another person is injecting your medication, the outer area of the upper arms also may be used. Do not inject the medication into skin that is tender, bruised, red, hard, or not intact, or that has scars, moles, or bruises. Choose a different spot each time you inject the medication, at least 1 inch away from a spot that you have used before. If the full dose is not injected, call your doctor or pharmacist.

Do not reuse tocilizumab prefilled syringes and do not recap the syringes after use. Throw away used syringes in a puncture-resistant container and ask your pharmacist how to throw away the container.

Tocilizumab injection may help control your symptoms, but it will not cure your condition. Your doctor will watch you carefully to see how well tocilizumab injection works for you. Your doctor may adjust your dose or delay your treatment if you have certain changes in your laboratory results. It is important to tell your doctor how you are feeling during your treatment.

What should I avoid while receiving tocilizumab?

Avoid being near people who are sick or have infections. Tell your doctor at once if you develop signs of infection.

Do not receive a "live" vaccine while using tocilizumab. The vaccine may not work as well during this time, and may not fully protect you from disease. Live vaccines include measles, mumps, rubella (MMR), polio, rotavirus, typhoid, yellow fever, varicella (chickenpox), zoster (shingles), and nasal flu (influenza) vaccine.

Interactions for Actemra

May alter expression of CYP isoenzymes including 1A2, 2B6, 2C9, 2C19, 2D6, and 3A4; effects on CYP2C8 or transporters (e.g., P-glycoprotein) not elucidated.1

Drugs Metabolized by Hepatic Microsomal Enzymes

Possible increased metabolism of drugs metabolized by CYP isoenzymes.1 Because IL-6 may down-regulate CYP isoenzymes, inhibition of IL-6 by tocilizumab in rheumatoid arthritis patients may restore CYP enzyme activity to higher levels.1 Effects on CYP enzyme activity may persist for several weeks after drug discontinuance.1

Drugs metabolized by CYP isoenzymes that have a low therapeutic index and require individualized dosing: Carefully monitor therapeutic effect and serum concentrations following initiation or discontinuance of tocilizumab; adjust dosage as needed.1

Other CYP3A4 substrates: Caution advised when a reduction in efficacy would be undesirable.1

Vaccines

Avoid live vaccines.1

Information not available regarding immune response to vaccines in patients receiving tocilizumab or regarding secondary transmission of infection from individuals receiving live vaccines to patients receiving tocilizumab.1

Inhibition of IL-6 may interfere with normal immune response to new antigens; all patients (particularly those with polyarticular or systemic JIA) should receive all appropriate vaccines recommended by current immunization guidelines prior to initiation of tocilizumab therapy.1 Consult current vaccination guidelines regarding interval between administration of live vaccines and initiation of immunosuppressive (e.g., tocilizumab) therapy.1

Specific Drugs

Drug

Interaction

Comments

Contraceptives, oral

Possible increased metabolism of oral contraceptive1

Caution advised1

Corticosteroids

Concomitant use does not appear to affect clearance of tocilizumab1

Cyclosporine

Possible increased metabolism of cyclosporine1

Carefully monitor therapeutic effect and serum concentrations of cyclosporine following initiation or discontinuance of tocilizumab; adjust dosage as needed1

Dextromethorphan

Reduction in exposure to dextromethorphan and dextrorphan following initiation of IV tocilizumab reported in rheumatoid arthritis patients receiving dextromethorphan1

(In rheumatoid arthritis patients not receiving tocilizumab, systemic exposure to dextromethorphan is similar to, but exposure to dextrorphan is decreased, compared with values in healthy individuals1 )

DMARDs, biologic (e.g., TNF blocking agents)

Possible increased immunosuppression and increased risk of infection; concomitant use not studied1

Concomitant use not recommended1

HMG CoA reductase inhibitors (statins)

Statins metabolized by CYP isoenzymes (e.g., atorvastatin, lovastatin): Possible increased metabolism of the statin1

Simvastatin: Reduction in exposure to simvastatin and simvastatin acid following initiation of tocilizumab reported in rheumatoid arthritis patients receiving simvastatin (values were similar to or slightly higher than values observed after simvastatin administration in healthy individuals); exposure to simvastatin and simvastatin acid increased following discontinuance of tocilizumab1

(Systemic exposure to simvastatin and simvastatin acid is increased in rheumatoid arthritis patients not receiving tocilizumab compared with healthy individuals)1

Caution advised1

When selecting simvastatin dosages for patients with rheumatoid arthritis, consider the potential for altered systemic exposure to the drug following initiation or discontinuance of tocilizumab1

Methotrexate

Concomitant use does not appear to affect clearance of tocilizumab or exposure to methotrexate1

NSAIAs

Concomitant use does not appear to affect clearance of tocilizumab1

Omeprazole

Reduction in exposure to omeprazole following initiation of IV tocilizumab reported in rheumatoid arthritis patients receiving omeprazole (values were slightly higher than values observed after omeprazole administration in healthy individuals)1

(Systemic exposure to omeprazole is increased in rheumatoid arthritis patients not receiving tocilizumab compared with healthy individuals1 )

Theophylline

Possible increased metabolism of theophylline1

Carefully monitor therapeutic effect and serum concentrations of theophylline following initiation or discontinuance of tocilizumab; adjust dosage as needed1

Warfarin

Possible increased metabolism of warfarin1

Carefully monitor therapeutic effect of warfarin following initiation or discontinuance of tocilizumab; adjust dosage as needed1

Preparations

Excipients in commercially available drug preparations may have clinically important effects in some individuals; consult specific product labeling for details.

Please refer to the ASHP Drug Shortages Resource Center for information on shortages of one or more of these preparations.

Tocilizumab (recombinant)

Routes

Dosage Forms

Strengths

Brand Names

Manufacturer

Parenteral

Injection, for subcutaneous use

162 mg/0.9 mL

Actemra (available as single-use prefilled syringe)

Genentech

Injection concentrate, for IV infusion

20 mg/mL

Actemra

Genentech

Actemra Dosage and Administration

Rheumatoid Arthritis

Actemra may be used as monotherapy or concomitantly with methotrexate or other non-biologic DMARDs as an intravenous infusion or as a subcutaneous injection.

Recommended Intravenous (IV) Dosage Regimen:

The recommended dosage of Actemra for adult patients given as a 60-minute single intravenous drip infusion is 4 mg per kg every 4 weeks followed by an increase to 8 mg per kg every 4 weeks based on clinical response.

  • Reduction of dose from 8 mg per kg to 4 mg per kg is recommended for management of certain dose-related laboratory changes including elevated liver enzymes, neutropenia, and thrombocytopenia [see Dosage and Administration (2.9), Warnings and Precautions (5.3), and Adverse Reactions (6.1)].
  • Doses exceeding 800 mg per infusion are not recommended in RA patients [see Clinical Pharmacology (12.3)].

Recommended Subcutaneous (SC) Dosage Regimen:

Patients less than 100 kg weight 162 mg administered subcutaneously every other week, followed by an increase to every week based on clinical response
Patients at or above 100 kg weight 162 mg administered subcutaneously every week

When transitioning from Actemra intravenous therapy to subcutaneous administration administer the first subcutaneous dose instead of the next scheduled intravenous dose.

Interruption of dose or reduction in frequency of administration of subcutaneous dose from every week to every other week dosing is recommended for management of certain dose-related laboratory changes including elevated liver enzymes, neutropenia, and thrombocytopenia [see Dosage and Administration (2.9), Warnings and Precautions (5.3), and Adverse Reactions (6.2)].

Giant Cell Arteritis

The recommended dose of Actemra for adult patients with GCA is 162 mg given once every week as a subcutaneous injection in combination with a tapering course of glucocorticoids.

A dose of 162 mg given once every other week as a subcutaneous injection in combination with a tapering course of glucocorticoids may be prescribed based on clinical considerations.

Actemra can be used alone following discontinuation of glucocorticoids.

  • Interruption of dosing may be needed for management of dose-related laboratory abnormalities including elevated liver enzymes, neutropenia, and thrombocytopenia [see Dosage and Administration (2.9)].
  • Intravenous administration is not approved for GCA.

Polyarticular Juvenile Idiopathic Arthritis

Actemra may be used alone or in combination with methotrexate. The recommended dosage of Actemra for PJIA patients given once every 4 weeks as a 60-minute single intravenous drip infusion is:

Recommended Intravenous PJIA Dosage Every 4 Weeks
Patients less than 30 kg weight 10 mg per kg
Patients at or above 30 kg weight 8 mg per kg
  • Do not change dose based solely on a single visit body weight measurement, as weight may fluctuate.
  • Interruption of dosing may be needed for management of dose-related laboratory abnormalities including elevated liver enzymes, neutropenia, and thrombocytopenia [see Dosage and Administration (2.9)].
  • Subcutaneous administration is not approved for PJIA.

Systemic Juvenile Idiopathic Arthritis

Actemra may be used alone or in combination with methotrexate. The recommended dose of Actemra for SJIA patients given once every 2 weeks as a 60-minute single intravenous drip infusion is:

Recommended Intravenous SJIA Dosage Every 2 Weeks
Patients less than 30 kg weight 12 mg per kg
Patients at or above 30 kg weight 8 mg per kg
  • Do not change a dose based solely on a single visit body weight measurement, as weight may fluctuate.
  • Interruption of dosing may be needed for management of dose-related laboratory abnormalities including elevated liver enzymes, neutropenia, and thrombocytopenia [see Dosage and Administration (2.9)].
  • Subcutaneous administration is not approved for SJIA.

Cytokine Release Syndrome (CRS)

Use only the intravenous route for treatment of CRS. The recommended dose of Actemra for treatment of CRS given as a 60-minute intravenous infusion is:

Recommended Intravenous CRS Dosage
Patients less than 30 kg weight 12 mg per kg
Patients at or above 30 kg weight 8 mg per kg
Alone or in combination with corticosteroids
  • If no clinical improvement in the signs and symptoms of CRS occurs after the first dose, up to 3 additional doses of Actemra may be administered. The interval between consecutive doses should be at least 8 hours.
  • Doses exceeding 800 mg per infusion are not recommended in CRS patients.
  • Subcutaneous administration is not approved for CRS.

General Considerations for Administration

  • Actemra has not been studied in combination with biological DMARDs such as TNF antagonists, IL-1R antagonists, anti-CD20 monoclonal antibodies and selective co-stimulation modulators because of the possibility of increased immunosuppression and increased risk of infection. Avoid using Actemra with biological DMARDs.
  • It is recommended that Actemra 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). –

    Patients with severe or life-threatening CRS frequently have cytopenias or elevated ALT or AST due to the lymphodepleting chemotherapy or the CRS. The decision to administer Actemra should take into account the potential benefit of treating the CRS versus the risks of short-term treatment with Actemra.

Preparation and Administration Instructions for Intravenous Infusion

Actemra for intravenous infusion should be diluted by a healthcare professional using aseptic technique as follows:

  • Patients less than 30 kg: use a 50 mL infusion bag or bottle of 0.9% or 0.45% Sodium Chloride Injection, USP, and then follow steps 1 and 2 below.
  • Patients at or above 30 kg weight: use a 100 mL infusion bag or bottle, and then follow steps 1 and 2 below.

Step 1. Withdraw a volume of 0.9% or 0.45% Sodium Chloride Injection, USP, equal to the volume of the Actemra injection required for the patient's dose from the infusion bag or bottle [see Dosage and Administration (2.1, 2.3, 2.4, 2.5)].

For Intravenous Use: Volume of Actemra Injection per kg of Body Weight
Dosage Indication Volume of Actemra injection per kg of body weight
4 mg/kg Adult RA 0.2mL/kg
8 mg/kg Adult RA
SJIA, PJIA and CRS (≥30 kg of body weight)
0.4mL/kg
10 mg/kg PJIA (< 30 kg of body weight) 0.5 mL/kg
12 mg/kg SJIA and CRS (< 30 kg of body weight) 0.6mL/kg

Step 2. Withdraw the amount of Actemra for intravenous infusion from the vial(s) and add slowly into the 0.9% or 0.45% Sodium Chloride Injection, USP infusion bag or bottle. To mix the solution, gently invert the bag to avoid foaming.

  • The fully diluted Actemra solutions for infusion using 0.9% Sodium Chloride Injection, USP may be stored at 2° to 8°C (36° to 46°F) or room temperature for up to 24 hours and should be protected from light.
  • The fully diluted Actemra solutions for infusion using 0.45% Sodium Chloride Injection, USP may be stored at 2° to 8°C (36° to 46°F) for up to 24 hours or room temperature for up to 4 hours and should be protected from light.
  • Actemra solutions do not contain preservatives; therefore, unused product remaining in the vials should not be used.
  • Allow the fully diluted Actemra solution to reach room temperature prior to infusion.
  • The infusion should be administered over 60 minutes, and must be administered with an infusion set. Do not administer as an intravenous push or bolus.
  • Actemra should not be infused concomitantly in the same intravenous line with other drugs. No physical or biochemical compatibility studies have been conducted to evaluate the co-administration of Actemra with other drugs.
  • Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. If particulates and discolorations are noted, the product should not be used.
  • Fully diluted Actemra solutions are compatible with polypropylene, polyethylene and polyvinyl chloride infusion bags and polypropylene, polyethylene and glass infusion bottles.

Preparation and Administration Instructions for Subcutaneous Injection

Actemra for subcutaneous injection is only approved for adult indications and is not indicated for the treatment of pediatric patients with PJIA or SJIA. Actemra for subcutaneous injection is not intended for intravenous drip infusion.

  • Assess suitability of patient for SC home use and instruct patients to inform a healthcare professional before administering the next dose if they experience any symptoms of allergic reaction. Patients should seek immediate medical attention if they develop symptoms of serious allergic reactions. Actemra subcutaneous injection is intended for use under the guidance of a healthcare practitioner. After proper training in subcutaneous injection technique, a patient may self-inject Actemra or the patient's caregiver may administer Actemra if a healthcare practitioner determines that it is appropriate. Patients, or patient caregivers, should be instructed to follow the directions provided in the Instructions for Use (IFU) for additional details on medication administration.
  • Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration. Do not use Actemra prefilled syringes (PFS) exhibiting particulate matter, cloudiness, or discoloration. Actemra for subcutaneous administration should be clear and colorless to pale yellow. Do not use if any part of the PFS appears to be damaged.
  • Patients using Actemra for subcutaneous administration should be instructed to inject the full amount in the syringe (0.9 mL), which provides 162 mg of Actemra, according to the directions provided in the IFU.
  • Injection sites should be rotated with each injection and should never be given into moles, scars, or areas where the skin is tender, bruised, red, hard, or not intact.

Dosage Modifications due to Serious Infections or Laboratory Abnormalities

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

Rheumatoid Arthritis and Giant Cell Arteritis

Liver Enzyme Abnormalities [see Warnings and Precautions (5.3)]:
Lab Value Recommendation
Greater than 1 to 3× ULN Dose modify concomitant DMARDs (RA) or immunomodulatory agents (GCA) if appropriate
For persistent increases in this range:
  • For patients receiving intravenous Actemra, reduce dose to 4 mg per kg or hold Actemra until ALT or AST have normalized
  • For patients receiving subcutaneous Actemra, reduce injection frequency to every other week or hold dosing until ALT or AST have normalized. Resume Actemra at every other week and increase frequency to every week as clinically appropriate.
Greater than 3 to 5× ULN Hold Actemra dosing until less than 3× ULN and follow recommendations above for greater than 1 to 3× ULN
(confirmed by repeat testing) For persistent increases greater than 3× ULN, discontinue Actemra
Greater than 5× ULN Discontinue Actemra
Low Absolute Neutrophil Count (ANC) [see Warnings and Precautions (5.3)]:
Lab Value
(cells per mm3)
Recommendation
ANC greater than 1000 Maintain dose
ANC 500 to 1000 Hold Actemra dosing
When ANC greater than 1000 cells per mm3:
  • For patients receiving intravenous Actemra, resume Actemra at 4 mg per kg and increase to 8 mg per kg as clinically appropriate
  • For patients receiving subcutaneous Actemra, resume Actemra at every other week and increase frequency to every week as clinically appropriate
ANC less than 500 Discontinue Actemra
Low Platelet Count [see Warnings and Precautions (5.3)]:
Lab Value
(cells per mm3)
Recommendation
50,000 to 100,000 Hold Actemra dosing
When platelet count is greater than 100,000 cells per mm3:
  • For patients receiving intravenous Actemra, resume Actemra at 4 mg per kg and increase to 8 mg per kg as clinically appropriate
  • For patients receiving subcutaneous Actemra, resume Actemra at every other week and increase frequency to every week as clinically appropriate
Less than 50,000 Discontinue Actemra

Polyarticular and Systemic Juvenile Idiopathic Arthritis:

Dose reduction of Actemra has not been studied in the PJIA and SJIA populations. Dose interruptions of Actemra are recommended for liver enzyme abnormalities, low neutrophil counts, and low platelet counts in patients with PJIA and SJIA at levels similar to what is outlined above for patients with RA. If appropriate, dose modify or stop concomitant methotrexate and/or other medications and hold Actemra dosing until the clinical situation has been evaluated. In PJIA and SJIA the decision to discontinue Actemra for a laboratory abnormality should be based upon the medical assessment of the individual patient.

Dosage Forms and Strengths

Intravenous Infusion

Injection: 80 mg/4 mL, 200 mg/10 mL, 400 mg/20 mL as a clear, colorless to pale yellow solution in 20 mg/mL single-dose vials for further dilution prior to intravenous infusion.

Subcutaneous Injection

Injection: 162 mg/0.9 mL clear, colorless to slightly yellowish solution in a single-dose prefilled syringe

How Supplied/Storage and Handling

For Intravenous Infusion

Actemra (tocilizumab) injection is a preservative-free, sterile clear, colorless to pale yellow solution. Actemra is supplied as 80 mg/4 mL (NDC 50242-135-01), 200 mg/10 mL (NDC 50242-136-01), and 400 mg/20 mL (NDC 50242-137-01) individually packaged 20 mg/mL single-dose vials for further dilution prior to intravenous infusion.

For Subcutaneous Injection

Actemra (tocilizumab) injection is supplied as a preservative-free, sterile, clear, colorless to slightly yellowish solution for subcutaneous administration. Each single-dose prefilled syringe delivers 162 mg/0.9 mL (NDC 50242-138-01).

Storage and Stability: Do not use beyond expiration date on the container, package or prefilled syringe. Actemra must be refrigerated at 2ºC to 8ºC (36°F to 46°F). Do not freeze. Protect the vials and syringes from light by storage in the original package until time of use, and keep syringes dry. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. If visibly opaque particles, discoloration or other foreign particles are observed, the solution should not be used.

PRINCIPAL DISPLAY PANEL - 10 mL Vial Box

NDC 50242-136-01

Actemra®
(tocilizumab)
Injection

200 mg/10 mL

(20 mg/mL)

For Intravenous Infusion only after
dilution.
Single-Use Vial; Discard unused portion

ATTENTION PROVIDER: Each patient is
required to receive the enclosed
Medication Guide

No Preservative

Rx only

Genentech

10175059

Manufacturer

  • Genentech, Inc.

Side Effects of Actemra

Actemra can cause serious side effects. See "Drug Precautions" for some serious side effects of Actemra.

Actemra may cause Hepatitis B infection in people who carry the virus in their blood. Your doctor may do blood tests before you start, and during treatment with Actemra. Tell your doctor if you have any of the following symptoms of a possible hepatitis B infection:
  • feel very tired
  • chills
  • skin or eyes look yellow
  • stomach discomfort
  • little or no appetite
  • muscle aches
  • vomiting
  • dark urine
  • clay-colored bowel movements
  • skin rash 
  • fevers
Serious allergic reactions, including death, can happen with Actemra. Tell your doctor right away if you have any of the following signs of a serious allergic reaction: 
  • shortness of breath or trouble breathing 
  • skin rash
  • swelling of the lips, tongue, or face 
  • chest pain
  • feeling dizzy or faint

Multiple Sclerosis (an autoimmune disease that affects the brain and spinal chord) has been diagnosed rarely in people who take Actemra. It is not known what effect Actemra may have some nervous system disorders. Common side effects of Actemra include:

  • upper respiratory tract infections (common cold, sinus infections)
  • increased blood pressure (hypertension)
  • headache 
Tell your doctor if you have any side effect that bothers you or that does not go away. These are not all of the possible side effects of Actemra. For more information, ask your doctor or pharmacist.

Actemra Precautions

Actemra can cause serious infections by lowering the ability of your immune system to fight infections including tuberculosis (TB), as well as others. These are serious infections that may cause death. 

  • Your doctor should test you for TB before starting Actemra as well as monitor you closely for signs and symptoms of TB during treatment with Actemra.
You should not start taking Actemra if you have any kind of infection unless your doctor says it is okay. Before starting Actemra, tell your doctor if you think you have an infection or have symptoms of an infection such as:
  • fever, sweating, or chills
  • warm, red, or painful skin or sores
  • muscle aches on your body
  • cough
  • diarrhea or stomach pain
  • shortness of  breath
  • burning when you urinate or urinating more often than normal
  • blood in phlegm
  • weight loss
  • feel very tired

Before starting Actemra, tell your doctor if you:

  • are being treated for an infection
  • get a lot of infections or have infections that keep coming back
  • have diabetes, HIV, or a weak immune system. People with these conditions have a higher chance of infections.
  • have TB, or have been in close contact with someone with TB
  • live or have lived, or have traveled to certain parts of the country (such as the Ohio and Mississippi River valleys and the Southwest) where there is an increased chance of getting certain kinds of fungal infections (histoplasmosis, coccidiomycosis, or blastomycosis). These infections may happen or become more severe if you use Actemra. Ask your doctor, if you do not know if you have lived in an area where these infections are common.
  • have or have had hepatitis B.
  After starting Actemra, call your doctor right away if you have any symptoms of an infection. Actemra can make you more likely to get infections or make worse any infection that you have.    Actemra can cause tears (perforation) of the stomach or intestines.
  • Before taking Actemra, tell your doctor if you have had diverticulitis (inflammation in parts of the large intestine) or ulcers in your stomach or intestines. Some people taking Actemra get tears in their stomach or intestine. This happens most often in people who also take nonsteroidal anti-inflammatory drugs (NSAIDs), corticosteroids, or methotrexate.
  • Tell your doctor right away if you have a fever and stomach-area pain that does not go away, and a change in your bowel habits. 
  Actemra can cause changes in certain laboratory test results. Your doctor should do blood tests before you start receiving Actemra and every 4 to 8 weeks for rheumatoid arthritis and every 2 to 4 weeks for SJIA during treatment to check for the following side effects of Actemra
  • low neutrophil count. Neutrophils are white blood cells that help the body fight off bacterial infections.
  • low platelet count. Platelets are blood cells that help with blood clotting and stop bleeding.
  • increase in certain liver function tests.

You should not receive Actemra if your neutrophil or platelet counts are too low or your liver function tests are too high. Your doctor may stop your Actemra treatment for a period of time or change your dose of medicine if needed because of changes in these blood test results. 

You may also have changes in other laboratory tests, such as your blood cholesterol levels. Your doctor should do blood tests to check your cholesterol levels 4 to 8 weeks after you start receiving Actemra, and then every 6 months after that.    Actemra may increase the risk of developing certain cancers. Tell your doctor if you have any type of cancer.   Do not take Actemra if you are allergic to Actemra, or any of the ingredients in Actemra. Actemra has caused serious allergic reactions and anaphylaxis, which is a type of allergic reaction that occurs suddenly and may cause death. Symptoms include itchy rash, throat swelling and low blood pressure.

Actemra Overdose

Actemra is usually administered by a healthcare provider in a medical setting making it unlikely for an overdose to occur. However, if an overdose is suspected, seek emergency medical attention.

Where can i get more information?

Your doctor or pharmacist can provide more information about tocilizumab.

Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.

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Actemra dosing information

Usual Adult Dose for Rheumatoid Arthritis:

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.

RECOMMENDED IV DOSAGE REGIMEN: 4 mg/kg IV given once every 4 weeks as a 60 minute single drip infusion, 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
Maximum dose: 800 mg per infusion in RA patients

RECOMMENDED SUBCUTANEOUS DOSAGE REGIMEN:
-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

Comments:
-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:

This drug may be used as monotherapy or concomitantly with methotrexate:
POLYARTICULAR JUVENILE IDIOPATHIC ARTHRITIS:
2 years or older:
-Weight less than 30 kg: 10 mg/kg IV given once every 4 weeks as a 60 minute single drip infusion
-Weight 30 kg or more: 8 mg/kg given once every 4 weeks as a 60 minute single drip infusion

This drug may be used as monotherapy or concomitantly with methotrexate:
SYSTEMIC JUVENILE IDIOPATHIC ARTHRITIS:
2 years or older:
-Weight less than 30 kg: 12 mg/kg IV given once every 2 weeks as a 60 minute single drip infusion
-Weight 30 kg or more: 8 mg/kg IV given once every 2 weeks as a 60 minute single drip infusion

Comments:
-The weight of the patient may fluctuate; therefore, a dose adjustment should not be based on a single visit body weight measurement.
-This drug may be used as monotherapy or in combination with methotrexate.
-Not recommended for use in children less than 2 years of age.
-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)

What other drugs will affect Actemra?

Tell your doctor about all your current medicines and any you start or stop using, especially:

  • any other medicines to treat rheumatoid arthritis, such as abatacept, adalimumab, anakinra, certolizumab, etanercept, golimumab, infliximab, or rituximab.

This list is not complete and many other drugs can interact with tocilizumab. This includes prescription and over-the-counter medicines, vitamins, and herbal products. Give a list of all your medicines to any healthcare provider who treats you. Not all possible interactions are listed in this medication guide.

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