Actemra ACTPen tocilizumab 162 mg/.9mL Injection, Solution, 1 syringe — NDC 50242-143-01 (Billing 50242-0143-01)

1 INDICATIONS AND USAGE ACTEMRA ® (tocilizumab) is an interleukin-6 (IL-6) receptor antagonist indicated for treatment of: Rheumatoid Arthritis (RA) ( 1.1 ) Adult patients with moderately to severely active rheumatoid arthritis who have had an inadequate response to one or more Disease-Modifying Anti-Rheumatic Drugs (DMARDs). Giant Cell Arteritis (GCA) ( 1.2 ) Adult patients with giant cell arteritis. Systemic Sclerosis-Associated Interstitial Lung Disease (SSc-ILD) ( 1.3 ) Slowing the rate of decline in pulmonary function in adult patients with systemic sclerosis-associated interstitial lung disease (SSc-ILD) Polyarticular Juvenile Idiopathic Arthritis (PJIA) ( 1.4 ) Patients 2 years of age and older with active polyarticular juvenile idiopathic arthritis.

Systemic Juvenile Idiopathic Arthritis (SJIA) ( 1.5 ) Patients 2 years of age and older with active systemic juvenile idiopathic arthritis. Cytokine Release Syndrome (CRS) ( 1.6 ) Adults and pediatric patients 2 years of age and older with chimeric antigen receptor (CAR) T cell-induced severe or life-threatening cytokine release syndrome. Coronavirus Disease 2019 (COVID-19) ( 1.7 ) Hospitalized adult and pediatric patients aged 2 years and older with coronavirus disease 2019 (COVID-19) who are receiving systemic corticosteroids and require supplemental oxygen, non-invasive or invasive mechanical ventilation, or extracorporeal membrane oxygenation (ECMO).

1.1Rheumatoid Arthritis (RA) ACTEMRA ® (tocilizumab) is indicated for the treatment of adult patients with moderately to severely active rheumatoid arthritis who have had an inadequate response to one or more Disease-Modifying Anti-Rheumatic Drugs (DMARDs).

1.2Giant Cell Arteritis (GCA) ACTEMRA ® (tocilizumab) is indicated for the treatment of giant cell arteritis (GCA) in adult patients.

1.3Systemic Sclerosis-Associated Interstitial Lung Disease (SSc-ILD) ACTEMRA ® (tocilizumab) is indicated for slowing the rate of decline in pulmonary function in adult patients with systemic sclerosis-associated interstitial lung disease.

1.4Polyarticular Juvenile Idiopathic Arthritis (PJIA) ACTEMRA ® (tocilizumab) is indicated for the treatment of active polyarticular juvenile idiopathic arthritis in patients 2 years of age and older.

1.5Systemic Juvenile Idiopathic Arthritis (SJIA) ACTEMRA ® (tocilizumab) is indicated for the treatment of active systemic juvenile idiopathic arthritis in patients 2 years of age and older.

1.6Cytokine Release Syndrome (CRS) ACTEMRA ® (tocilizumab) is indicated for the treatment of chimeric antigen receptor (CAR) T cell-induced severe or life-threatening cytokine release syndrome in adults and pediatric patients 2 years of age and older.

1.7Coronavirus Disease 2019 (COVID-19) ACTEMRA® (tocilizumab) is indicated for the treatment of coronavirus disease 2019 (COVID-19) in hospitalized adult and pediatric patients aged 2 years and older who are receiving systemic corticosteroids and require supplemental oxygen, non-invasive or invasive mechanical ventilation, or extracorporeal membrane oxygenation (ECMO).

2 DOSAGE AND ADMINISTRATION For RA, pJIA and sJIA, ACTEMRA may be used alone or in combination with methotrexate: and in RA, other non-biologic DMARDs may be used. ( 2 ) General Administration and Dosing Information ( 2.1 ) RA, GCA, SSc-ILD, PJIA and SJIA – It is recommended that ACTEMRA not be initiated in patients with an absolute neutrophil count (ANC) below 2000 per mm 3 , platelet count below 100,000 per mm 3 , or ALT or AST above 1.5 times the upper limit of normal (ULN) ( 5.3 , 5.4 ) . COVID-19 – It is recommended that ACTEMRA not be initiated in patients with an absolute neutrophil count (ANC) below 1000 per mm 3 , platelet count below 50,000 mm 3 , or ALT or AST above 10 times ULN ( 5.3 , 5.4 ) .

In RA, CRS or COVID-19 patients, ACTEMRA doses exceeding 800 mg per infusion are not recommended. ( 2.2 , 2.7 , 12.3 ) In GCA patients, ACTEMRA doses exceeding 600 mg per infusion are not recommended. ( 2.3 , 12.3 ) Rheumatoid Arthritis ( 2.2 ) Recommended Adult Intravenous Dosage: When used in combination with non-biologic DMARDs or as monotherapy the recommended starting dose is 4 mg per kg every 4 weeks followed by an increase to 8 mg per kg every 4 weeks based on clinical response.

Recommended Adult Subcutaneous Dosage: 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 Giant Cell Arteritis ( 2.3 ) Recommended Adult Intravenous Dosage: The recommended dose is 6 mg per kg every 4 weeks in combination with a tapering course of glucocorticoids. ACTEMRA can be used alone following discontinuation of glucocorticoids. Recommended Adult Subcutaneous Dosage: The recommended dose 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. Systemic Sclerosis-Associated Interstitial Lung Disease (SSc-ILD) ( 2.4 ) Recommended Adult Subcutaneous Dosage: The recommended dose of ACTEMRA for adult patients with SSc-ILD is 162 mg given once every week as a subcutaneous injection.

Polyarticular Juvenile Idiopathic Arthritis ( 2.5 ) 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 Recommended Subcutaneous PJIA Dosage Patients less than 30 kg weight 162 mg once every three weeks Patients at or above 30 kg weight 162 mg once every two weeks Systemic Juvenile Idiopathic Arthritis ( 2.6 ) 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 Recommended Subcutaneous SJIA Dosage Patients less than 30 kg weight 162 mg every two weeks Patients at or above 30 kg weight 162 mg every week Cytokine Release Syndrome ( 2.7 ) 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.

Coronavirus Disease 2019 ( 2.8 ) Recommended Intravenous COVID-19 Dosage Patients less than 30 kg weight 12 mg per kg Patients at or above 30 kg weight 8 mg per kg Administered by a 60-minute intravenous infusion Administration of Intravenous formulation ( 2.9 ) For patients with RA, GCA, COVID-19, CRS, PJIA, and SJIA patients at or above 30 kg, dilute to 100 mL in 0.9% or 0.45% Sodium Chloride Injection, USP for intravenous infusion using aseptic technique. For PJIA, SJIA, CRS and COVID-19 patients less than 30 kg, dilute to 50 mL in 0.9% or 0.45% Sodium Chloride Injection, USP for intravenous infusion using aseptic technique.

Administer as a single intravenous drip infusion over 1 hour; do not admini… [Excerpted — this section continues on DailyMed.]

3 DOSAGE FORMS AND STRENGTHS Intravenous Infusion Injection: 80 mg/4 mL (20 mg/mL), 200 mg/10 mL (20 mg/mL), 400 mg/20 mL (20 mg/mL) in single-dose vials for further dilution prior to intravenous infusion ( 3 ) Subcutaneous Injection Injection: 162 mg/0.9 mL in a single-dose prefilled syringe or single-dose prefilled ACTPen ® autoinjector ( 3 ) 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 or single-dose prefilled ACTPen ® autoinjector.

17 PATIENT COUNSELING INFORMATION Advise the patient to read the FDA-approved patient labeling ( Medication Guide and Instructions for Use ). Serious Infections Inform patients that ACTEMRA may lower their resistance to infections [see Warnings and Precautions (5.1) ] . Instruct the patient of the importance of contacting their doctor immediately when symptoms suggesting infection appear in order to assure rapid evaluation and appropriate treatment.

Gastrointestinal Perforation Inform patients that some patients who have been treated with ACTEMRA have had serious side effects in the stomach and intestines [see Warnings and Precautions (5.2) ] . Instruct the patient of the importance of contacting their doctor immediately when symptoms of fever, severe, persistent abdominal pain, and change in bowel habits appear to assure rapid evaluation and appropriate treatment. Hypersensitivity and Serious Allergic Reactions Inform patients that some patients who have been treated with ACTEMRA have developed serious allergic reactions, including anaphylaxis, as well as serious skin reactions [see Warnings and Precautions (5.6) ] .

Advise patients to stop taking ACTEMRA and seek immediate medical attention if they experience any symptom of serious allergic reactions (including rash, hives, and swelling of the face, lips, tongue, and throat that may cause difficulty in breathing or swallowing). Instruction on Injection Technique Assess patient suitability for home use for subcutaneous injection. Perform the first injection under the supervision of a qualified healthcare professional.

If a patient or caregiver is to administer subcutaneous ACTEMRA, instruct him/her in injection techniques and assess his/her ability to inject subcutaneously to ensure proper administration of subcutaneous ACTEMRA and the suitability for home use [see Instructions for Use ]. Prior to use, remove the prefilled syringe (PFS) or autoinjector from the refrigerator and allow to sit at room temperature outside of the carton for 30 minutes (PFS) or 45 minutes (autoinjector), out of the reach of children. Do not warm ACTEMRA in any other way.

Advise patients to consult their healthcare provider if the full dose is not received. A puncture-resistant container for disposal of needles, syringes and autoinjectors should be used and should be kept out of the reach of children. Instruct patients or caregivers in the technique as well as proper needle, syringe and autoinjector disposal, and caution against reuse of these items.

Pregnancy Inform female patients of reproductive potential that ACTEMRA may cause fetal harm and to inform their prescriber of a known or suspected pregnancy [see Use in Specific Populations (8.1) ].

Medication Guide has been approved by the U.S. Food and Drug Administration Revised: 08/2025 Medication Guide ACTEMRA ® (AC-TEM-RA) (tocilizumab) injection for intravenous use ACTEMRA ® (AC-TEM-RA) (tocilizumab) injection for subcutaneous use What is the most important information I should know about ACTEMRA? ACTEMRA can cause serious side effects including : 1.

Serious Infections . ACTEMRA is a medicine that affects your immune system. ACTEMRA can lower the ability of your immune system to fight infections.

Some people have serious infections while taking ACTEMRA, including tuberculosis (TB), and infections caused by bacteria, fungi, or viruses that can spread throughout the body. Some people have died from these infections. Your healthcare provider should assess you for TB before starting ACTEMRA (except if you have COVID-19).

If you have COVID-19, your healthcare provider should monitor you for signs and symptoms of new infections during and after treatment with ACTEMRA. Your healthcare provider should monitor you closely for signs and symptoms of TB during and after treatment with ACTEMRA. You should not start taking ACTEMRA if you have any kind of infection unless your healthcare provider says it is okay.

Before starting ACTEMRA, tell your healthcare provider if you: think you have an infection or have symptoms of an infection, with or without a fever, such as: sweating or chills shortness of breath warm, red, or painful skin or sores on your body feel very tired muscle aches blood in phlegm diarrhea or stomach pain cough weight loss burning when you urinate or urinating more often than normal 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 for 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 for getting certain kinds of fungal infections (histoplasmosis, coccidiomycosis, or blastomycosis). These infections may happen or become more severe if you use ACTEMRA. Ask your healthcare provider, 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 healthcare provider 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. 2.

Tears (perforation) of the stomach or intestines. Tell your healthcare provider 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 healthcare provider right away if you have fever and new onset stomach-area pain that does not go away, and a change in your bowel habits. 3.

Liver problems (Hepatotoxicity): Some people have experienced serious life-threatening liver problems, which required a liver transplant or led to death. Your healthcare provider may tell you to stop taking ACTEMRA if you develop new or worse liver problems during treatment with ACTEMRA. Tell your healthcare provider right away if you have any of the following symptoms: feeling tired (fatigue) lack of appetite for several days or longer (anorexia) yellowing of your skin or the whites of your eyes (jaundice) abdominal swelling and pain on the right side of your stomach-area light colored stools weakness nausea and vomiting confusion dark "tea-colored" urine 4.

Changes in certain laboratory test results . Your healthcare provider should do blood tests before you start receiving ACTEMRA. If you have rheumatoid arthritis (RA), giant cell arteritis (GCA), o… [Excerpted — this section continues on DailyMed.]

Instructions for Use ACTEMRA ® (AC-TEM-RA) (tocilizumab) Injection, For Subcutaneous Use Single-dose Prefilled Syringe Read and follow the Instructions for Use that come with your ACTEMRA prefilled syringe before you start using it and each time you get a prescription refill. Before you use ACTEMRA prefilled syringe for the first time, make sure your healthcare provider shows you the right way to use it. Do not remove the needle cap until you are ready to inject ACTEMRA.

Do not try to take apart the syringe at any time. Do not reuse the same syringe. Parts of your ACTEMRA Prefilled Syringe (See Figure A ).

Figure A Supplies needed for your ACTEMRA Prefilled Syringe Injection (See Figure B ): ACTEMRA prefilled syringe alcohol pad sterile cotton ball or gauze puncture-resistant container or sharps container for safe disposal of needle cap and used syringe (See Step 4 "Dispose of the syringe" ) Figure B Step 1. Preparing for an ACTEMRA Injection Find a comfortable space with a clean, flat, working surface. Take the box containing the syringe out of the refrigerator and open the box.

Do not touch the trigger fingers on the syringe as this may damage the syringe. Remove 1 single-use ACTEMRA prefilled syringe from the box and let it warm up for 30 minutes to allow it to reach room temperature. If the syringe does not reach room temperature, this could cause your injection to feel uncomfortable and make it difficult to push the plunger in.

Do not speed up the warming process in any way, such as using the microwave or placing the syringe in warm water. Check the expiration date on the ACTEMRA prefilled syringe (See Figure A ). Do not use it if the expiration date has passed because it may not be safe to use.

If the expiration date has passed safely dispose of the syringe in a sharps container and get a new one. Do not remove the needle cap while allowing your ACTEMRA prefilled syringe to reach room temperature. Keep your unused syringes in the original carton and keep in the refrigerator at 36°F to 46°F (2°C to 8°C).

Do not freeze. Once removed from the refrigerator, your prefilled syringe can be stored up to 2 weeks at or below 86°F (30°C). Your prefilled syringe must always be kept in the original carton in order to protect from light and moisture.

Hold your ACTEMRA prefilled syringe with the covered needle pointing down (See Figure C ). Figure C Check the liquid in the ACTEMRA prefilled syringe. It should be clear and colorless to pale yellow.

Do not inject ACTEMRA if the liquid is cloudy, discolored, or has lumps or particles in it because it may not be safe to use. Safely dispose of the syringe in a sharps container and get a new one. Wash your hands well with soap and water.

Step 2. Choose and Prepare an Injection Site Choose an Injection Site The front of your thigh and your abdomen except for the 2-inch area around your navel are the recommended injection sites (See Figure D ). The outer area of the upper arms may also be used only if the injection is being given by a caregiver.

Do not attempt to use the upper arm area by yourself (See Figure D ). Rotate Injection Site Choose a different injection site for each new injection at least 1-inch from the last area you injected. Do not inject into moles, scars, bruises, or areas where the skin is tender, red, hard or not intact.

Figure D Prepare the Injection Site Wipe the injection site with an alcohol pad in a circular motion and let it air dry to reduce the chance of getting an infection. Do not touch the injection site again before giving the injection. Do not fan or blow on the clean area.

Step 3. Inject ACTEMRA Hold the ACTEMRA prefilled syringe with 1 hand and pull the needle cap straight off with your other hand (See Figure E ). Do not hold the plunger while you remove the needle cap.

If you cannot remove the needle cap you should ask a caregiver for help or contact your healthcare provider. Figure E Throw away the needle cap in a sharps container. There may be a small air b… [Excerpted — this section continues on DailyMed.]