Tocilizumab-anoh

WARNING: RISK OF SERIOUS INFECTIONS

BOXED WARNING SECTION

Patients treated with tocilizumab products including Tocilizumab-anoh are at increased risk for developing serious infections that may lead to hospitalization or death [see Warnings and Precautions (5.1) , Adverse Reactions (6.1) ] . Most patients who developed these infections were taking concomitant immunosuppressants such as methotrexate or corticosteroids. If a serious infection develops, interrupt Tocilizumab-anoh until the infection is controlled. Reported infections include: Active tuberculosis, which may present with pulmonary or extrapulmonary disease. Patients, except those with COVID-19, should be tested for latent tuberculosis before Tocilizumab-anoh use and during therapy. Treatment for latent infection should be initiated prior to Tocilizumab-anoh use. Invasive fungal infections, including candidiasis, aspergillosis, and pneumocystis. Patients with invasive fungal infections may present with disseminated, rather than localized, disease. Bacterial, viral and other infections due to opportunistic pathogens. The risks and benefits of treatment with Tocilizumab-anoh 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 Tocilizumab-anoh, including the possible development of tuberculosis in patients who tested negative for latent tuberculosis infection prior to initiating therapy [see Warnings and Precautions (5.1) ] .

RECENT MAJOR CHANGES

RECENT MAJOR CHANGES SECTION

1 INDICATIONS AND USAGE

INDICATIONS & USAGE SECTION

2 DOSAGE AND ADMINISTRATION

DOSAGE & ADMINISTRATION SECTION

3 DOSAGE FORMS AND STRENGTHS

DOSAGE FORMS & STRENGTHS SECTION

4 CONTRAINDICATIONS

CONTRAINDICATIONS SECTION

Tocilizumab-anoh is contraindicated in patients with known hypersensitivity to tocilizumab products [see Warnings and Precautions (5.6) ].

5 WARNINGS AND PRECAUTIONS

WARNINGS AND PRECAUTIONS SECTION

6 ADVERSE REACTIONS

ADVERSE REACTIONS SECTION

The following serious adverse reactions are described elsewhere in labeling: Serious Infections [see Warnings and Precautions (5.1) ] Gastrointestinal Perforations [see Warnings and Precautions (5.2) ] Laboratory Parameters [see Warnings and Precautions (5.4) ] Immunosuppression [see Warnings and Precautions (5.5) ] Hypersensitivity Reactions, Including Anaphylaxis [see Warnings and Precautions (5.6) ] Demyelinating Disorders [see Warnings and Precautions (5.7) ] Active Hepatic Disease and Hepatic Impairment [see Warnings and Precautions (5.8) ] Because clinical studies are conducted under widely varying conditions, adverse reaction rates observed in the clinical studies of a drug cannot be directly compared to rates in the clinical studies of another drug and may not predict the rates observed in a broader patient population in clinical practice.

7 DRUG INTERACTIONS

DRUG INTERACTIONS SECTION

8 USE IN SPECIFIC POPULATIONS

USE IN SPECIFIC POPULATIONS SECTION

9 DRUG ABUSE AND DEPENDENCE

DRUG ABUSE AND DEPENDENCE SECTION

No studies on the potential for tocilizumab products to cause dependence have been performed. However, there is no evidence from the available data that tocilizumab products treatment results in dependence.

10 OVERDOSAGE

OVERDOSAGE SECTION

There are limited data available on overdoses with tocilizumab products. One case of accidental overdose was reported with intravenous tocilizumab in which a patient with multiple myeloma received a dose of 40 mg per kg. No adverse drug reactions were observed. No serious adverse drug reactions were observed in healthy volunteers who received single doses of up to 28 mg per kg, although all 5 patients at the highest dose of 28 mg per kg developed dose-limiting neutropenia. In case of an overdose, it is recommended that the patient be monitored for signs and symptoms of adverse reactions. Patients who develop adverse reactions should receive appropriate symptomatic treatment.

11 DESCRIPTION

DESCRIPTION SECTION

Tocilizumab-anoh is a recombinant humanized anti-human interleukin 6 (IL-6) receptor monoclonal antibody of the immunoglobulin IgG1κ (gamma 1, kappa) subclass with a typical H2L2 polypeptide structure. Each light chain and heavy chain consists of 214 and 448 amino acids, respectively. The four polypeptide chains are linked intra- and inter-molecularly by disulfide bonds. Tocilizumab-anoh has a molecular weight of approximately 148 kDa. The antibody is produced in mammalian (Chinese hamster ovary) cells.

12 CLINICAL PHARMACOLOGY

CLINICAL PHARMACOLOGY SECTION

13 NONCLINICAL TOXICOLOGY

NONCLINICAL TOXICOLOGY SECTION

14 CLINICAL STUDIES

CLINICAL STUDIES SECTION

16 HOW SUPPLIED/STORAGE AND HANDLING

HOW SUPPLIED SECTION

17 PATIENT COUNSELING INFORMATION

INFORMATION FOR PATIENTS SECTION

Advise the patient to read the FDA-approved patient labeling (Medication Guide and Instructions for Use).

SPL UNCLASSIFIED SECTION

SPL UNCLASSIFIED SECTION

Tocilizumab-anoh Manufactured by: CELLTRION, Inc. 23, Academy-ro, Yeonsu-gu, Incheon, 22014, Republic of Korea US License Number 1996 Distributed by: CELLTRION USA, Inc. One Evertrust Plaza Suite 1207 Jersey City, NJ 07302

SPL MEDGUIDE SECTION

SPL MEDGUIDE SECTION

Medication Guide has been approved by the U.S. Food and Drug Administration Issued: 1/2025 Medication Guide Tocilizumab-anoh (toe si liz' ue mab-anoh) injection for intravenous use Tocilizumab-anoh (toe si liz' ue mab-anoh) injection for subcutaneous use What is the most important information I should know about Tocilizumab-anoh? Tocilizumab-anoh can cause serious side effects including : 1. Serious Infections . Tocilizumab-anoh is a medicine that affects your immune system. Tocilizumab-anoh can lower the ability of your immune system to fight infections. Some people have serious infections while taking Tocilizumab-anoh , 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 Tocilizumab-anoh (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 Tocilizumab-anoh. Your healthcare provider should monitor you closely for signs and symptoms of TB during and after treatment with Tocilizumab-anoh . You should not start taking Tocilizumab-anoh if you have any kind of infection unless your healthcare provider says it is okay. Before starting Tocilizumab-anoh , 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 Tocilizumab-anoh . 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 Tocilizumab-anoh, call your healthcare provider right away if you have any symptoms of an infection. Tocilizumab-anoh 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 Tocilizumab-anoh 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 Tocilizumab-anoh if you develop new or worse liver problems during treatment with Tocilizumab-anoh . 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 Tocilizumab-anoh. If you have rheumatoid arthritis (RA) or giant cell arteritis (GCA) your healthcare provider should do blood tests every 4 to 8 weeks after you start receiving Tocilizumab-anoh for the first 6 months and then every 3 months after that. If you have polyarticular juvenile idiopathic arthritis (PJIA) you will have blood tests done every 4 to 8 weeks during treatment. If you have systemic juvenile idiopathic arthritis (SJIA) you will have blood tests done every 2 to 4 weeks during treatment. These blood tests are to check for the following side effects of Tocilizumab-anoh: 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. increase in blood cholesterol levels. You may also have changes in other laboratory tests, such as your blood cholesterol levels. Your healthcare provider should do blood tests to check your cholesterol levels 4 to 8 weeks after you start receiving Tocilizumab-anoh. Your healthcare provider will determine how often you will have follow-up blood tests. Make sure you get all your follow-up blood tests done as ordered by your healthcare provider. You should not receive Tocilizumab-anoh if your neutrophil or platelet counts are too low or your liver function tests are too high. Your healthcare provider may stop your Tocilizumab-anoh treatment for a period of time or change your dose of medicine if needed because of changes in these blood test results. 5. Cancer. Tocilizumab-anoh may increase your risk of certain cancers by changing the way your immune system works. Tell your healthcare provider if you have ever had any type of cancer. See " What are the possible side effects with Tocilizumab-anoh? " for more information about side effects. What is Tocilizumab-anoh? Tocilizumab-anoh is a prescription medicine called an Interleukin-6 (IL-6) receptor antagonist. Tocilizumab-anoh is used: To treat adults with moderately to severely active rheumatoid arthritis (RA), after at least one other medicine called a Disease-Modifying Anti-Rheumatic Drug (DMARD) has been used and did not work well. To treat adults with giant cell arteritis (GCA). To treat people with active PJIA ages 2 and above. To treat people with active SJIA ages 2 and above. To treat hospitalized adults with coronavirus disease 2019 (COVID-19) receiving systemic corticosteroids and requiring supplemental oxygen or mechanical ventilation. Tocilizumab-anoh is not approved for subcutaneous use in people with COVID-19. It is not known if Tocilizumab-anoh is safe and effective in children with PJIA or SJIA under 2 years of age or in children with conditions other than PJIA or SJIA. Do not take Tocilizumab-anoh: if you are allergic to tocilizumab products, or any of the ingredients in Tocilizumab-anoh. See the end of this Medication Guide for a complete list of ingredients in Tocilizumab-anoh. Before you receive Tocilizumab-anoh, tell your healthcare provider about all of your medical conditions, including if you: have an infection. See " What is the most important information I should know about Tocilizumab-anoh? " have liver problems. have any stomach-area (abdominal) pain or been diagnosed with diverticulitis or ulcers in your stomach or intestines. have had a reaction to tocilizumab products or any of the ingredients in Tocilizumab-anoh before. have or had a condition that affects your nervous system, such as multiple sclerosis. have recently received or are scheduled to receive a vaccine: All vaccines should be brought up-to-date before starting Tocilizumab-anoh, unless urgent treatment initiation is required. People who take Tocilizumab-anoh should not receive live vaccines. People taking Tocilizumab-anoh can receive non-live vaccines. plan to have surgery or a medic...

Instructions for Use

INSTRUCTIONS FOR USE SECTION

Tocilizumab-anoh (toe si liz' ue mab-anoh) Injection, For Subcutaneous Use Single-dose Prefilled Syringe Read and follow the Instructions for Use that come with your Tocilizumab-anoh Prefilled Syringe before you start using it and each time you get a refill. There may be new information. Before you use Tocilizumab-anoh, make sure your healthcare provider shows you the right way to use it. Important Information Do not remove the prefilled syringe cap until you are ready to inject Tocilizumab-anoh. Do not try to take apart the prefilled syringe at any time. Do not reuse the same syringe. Do not shake the prefilled syringe. Do not use the prefilled syringe if it has been dropped or damaged. Storing Tocilizumab-anoh Store the unused prefilled syringe in the original carton in a refrigerator between 36°F to 46°F (2°C to 8°C). Do not freeze. When removed from the refrigerator, Tocilizumab-anoh can be stored up to 3 weeks at or below 77°F (25°C). If not used within the 3 weeks, Tocilizumab-anoh should be thrown away (discarded). Keep the prefilled syringe out of direct sunlight. Do not remove the prefilled syringe from its original carton during storage. Do not leave the prefilled syringe unattended. Keep the prefilled syringe out of the reach of children. Parts of your Prefilled Syringe (See Figure A ). Figure A Preparing for the Injection 1. Gather the supplies for the injection. a.Prepare a clean, flat surface, such as a table or countertop, in a well-lit area.b.Take the carton containing the prefilled syringe out of the refrigerator.c.Make sure you have the following supplies (see Figure B ):-Carton containing Tocilizumab-anoh prefilled syringe Not included in the carton: -Cotton ball or gauze-Adhesive bandage-FDA-cleared sharps disposal container-Alcohol swab Figure B 2. Inspect the carton (see Figure C ). a.Look at the carton and make sure you have the correct medicine and dose strength. (Tocilizumab-anoh)b.Check the expiration (EXP) date on the carton to make sure the date has not passed. Do not use the prefilled syringe if the expiration (EXP) date has passed. Do not use the prefilled syringe if the carton looks like it has been opened or damaged if you are opening the carton for the first time and check to make sure that it is properly sealed. Figure C 3. Inspect the Prefilled Syringe. a.Open the carton and remove 1 single-dose prefilled syringe from the carton. Return any remaining Tocilizumab-anoh prefilled syringes in the carton to the refrigerator.b.Check the expiration (EXP) date on the Tocilizumab-anoh prefilled syringe ( see Figure D ). Do not use the prefilled syringe if the expiration (EXP) date has passed. If the expiration (EXP) date has passed, safely throw away (dispose of) the prefilled syringe in your FDA-cleared sharps disposal container and get a new one. c.Check the prefilled syringe to make sure it is not damaged and shows no sign of leakage. Do not use the prefilled syringe if it has been dropped, damaged, or has leaked. Figure D 4. Wait 30 minutes. a.Leave the prefilled syringe outside of the carton at room temperature between 68°F to 77°F (20°C to 25°C) for 30 minutes to allow it to warm up (see Figure E ). Do not warm the prefilled syringe using heat sources such as hot water or a microwave. Do not leave the prefilled syringe in the direct sunlight. Do not remove the cap while allowing your prefilled syringe to reach room temperature. If the prefilled syringe does not reach room temperature, this could cause discomfort and make it hard to push the plunger. Figure E 5. Inspect the medicine. a.Hold your Tocilizumab-anoh with the cap pointing down.b.Look at the medicine and confirm that the liquid is clear, to slightly pearly and colorless to yellow and does not contain any particles or flakes (see Figure F ). Do not use the prefilled syringe if the liquid is discolored, cloudy, or has particles or flakes in it. Safely dispose of the prefilled syringe in a FDA-cleared sharps disposal container and use a new one. Air bubbles are normal. Figure F 6. Wash your hands. a.Wash your hands with soap and water and dry them thoroughly (see Figure G ). Figure G 7. Choose an injection site (see Figure H ). a.You may inject into-The front of the thighs-The stomach (abdomen), except for the 2 inches (5 cm) around the belly button.-The outer area of the upper arm (only if you are a caregiver). Do not inject into the upper arm by yourself. Choose a different injection site for each new injection at least 1 inch (2.5 cm) 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 H 8. Clean the injection site. a.Wipe the injection site with an alcohol swab and let it air dry for about 10 seconds (see Figure I ). This will 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. Figure I Giving the Injection 9. Remove the cap. a.Hold the prefilled syringe by the syringe body using 1 hand. Gently pull the cap straight off with the other hand (see Figure J ). Note: If you cannot remove the cap, you should ask a caregiver for help or contact your healthcare provider. Do not hold the plunger while removing the cap. You may see a drop of liquid at the tip of the needle. This is normal. If the prefilled syringe is not used within 5 minutes of needle cap removal, the prefilled syringe should be thrown away (disposed of) in the puncture resistant container or sharps container and a new prefilled syringe should be used. b.Throw away (dispose of) the cap right away in your FDA-cleared sharps disposal container (see step 14 and Throw away (dispose of) prefilled syringe and Figure N ) Do not re-cap the prefilled syringe. Do not touch the needle shield at the tip of the prefilled syringe to avoid accidental needle stick injury. Figure J 10. Insert the prefilled syringe into the injection site. a.Gently pinch a fold of skin at the injection site with 1 hand. Note: Pinching the skin is important to make sure that you inject under the skin (into fatty tissue) but not any deeper (into muscle).b.With a quick and "dart-like" motion, insert the Needle completely into the fold of skin at a 45 to 90-degree angle (see Figure K ). Note: It is important to use the correct angle to make sure the medicine is delivered under the skin (into fatty tissue), or the injection could be painful, and the medicine may not work. Do not touch the plunger while inserting the needle into the skin. Do not pull back on the plunger rod at any time. Figure K 11. Give the injection. a.After the needle is inserted, release the pinch.b.Slowly push the plunger all the way down until the full dose of medicine gets injected, and the syringe is empty (see Figure L ). Do not change the position of the prefilled syringe after the injection has started. If the plunger is not fully pressed, the needle guard will not extend to cover the needle when it is removed. If the needle is not covered, proceed carefully to dispose of the syringe (see step 14. Throw away (dispose of) prefilled syringe . Figure L 12. Remove the prefilled syringe from the injection site. a.After the prefilled syringe is empty, remove the needle from the injection site and release the plunger until the entire needle is covered by the guard (see Figure M ). Some bleeding may occur (see step 13. Care for the injection site ). In case of skin contact with medicine, wash the area that touched the medicine with water. Do not reuse the prefilled syringe. Figure M After the Injection 13. Care for the injection site. a.If a little bleeding occurs, treat the injection site by gently pressing, not rubbing, a cotton ball or gauze to the site and apply an adhesive bandage if needed. Do not rub the injection site. 14. Throw away (dispose of) the prefilled syringe. a.Put the used prefilled syringe and other supplies in your FDA-cleared sharps disposal container right away after use (see F...

Instructions for Use

INSTRUCTIONS FOR USE SECTION

Tocilizumab-anoh (toe si liz' ue mab-anoh) Injection, For Subcutaneous Use Single-dose Prefilled Autoinjecto Read and follow the Instructions for Use that come with your Tocilizumab-anoh prefilled autoinjector before you start using it and each time you get a refill. There may be new information. Before you use Tocilizumab-anoh, make sure your healthcare provider shows you the right way to use it. Important Information Do not remove the prefilled autoinjector cap until you are ready to inject Tocilizumab-anoh. Do not try to take apart the prefilled autoinjector at any time. Do not reuse the same prefilled autoinjector. Do not inject through clothing. Do not use the prefilled autoinjector if it has been dropped or damaged. Storing Tocilizumab-anoh Store the unused prefilled autoinjector in the original carton in a refrigerator between 36°F to 46ºF (2°C to 8ºC). Do not freeze. When removed from the refrigerator, Tocilizumab-anoh can be stored up to 3 weeks at or below 77°F (25°C). If not used within the 3 weeks, Tocilizumab-anoh should be thrown away (discarded). Keep the prefilled autoinejctor out of direct sunlight. Do not remove the prefilled autoinjector from its original carton during storage. Do not leave the prefilled autoinjector unattended. Keep the prefilled autoinjector out of the reach of children. Parts of your Tocilizumab-anoh prefilled autoinjector (See Figure A ). Figure A Preparing for the Injection 1. Gather the supplies for the injection. a.Prepare a clean, flat surface, such as a table or countertop, in a well-lit area.b.Take the carton containing the prefilled autoinjector out of the refrigerator.c.Make sure you have the following supplies (see Figure B ):-Carton containing Tocilizumab-anoh prefilled autoinjector Not included in the carton: -Cotton ball or gauze-Adhesive bandage-FDA-cleared Sharps disposal container-Alcohol swab Figure B 2. Inspect the carton (see Figure C ). a.Look at the carton and make sure you have the correct medicine and dose strength. (Tocilizumab-anoh)b.Check the expiration (EXP) date on the carton to make sure the date has not passed. Do not use the prefilled autoinjector if the expiration (EXP) date has passed. If you are opening the carton for the first time, check to make sure that it is properly sealed. Do not use the prefilled autoinjector if the carton looks like it has been opened or damaged. Figure C 3. Inspect the Prefilled autoinjector . a.Open the carton and remove one single-dose prefilled autoinjector from the carton. Return any remaining Tocilizumab-anoh prefilled autoinjectors in the box to the refrigerator.b.Check the expiration (EXP) date on the Tocilizumab-anoh prefilled autoinjector ( see Figure D ). Do not use the prefilled autoinjector if the expiration (EXP) date has passed. If the expiration (EXP) date has passed, safely throw away (dispose of) the prefilled autoinjector in your sharps disposal container and get a new one. c.Check the prefilled autoinjector to make sure it is not damaged and shows no sign of leakage. Do not use the prefilled autoinjector if it has been dropped, damaged, or has leaked. Note: A small gap between the orange cap and injector body is normal. Figure D 4. Wait 45 minutes. a.Leave the prefilled autoinjector outside of the carton at room temperature between 68°F to 77°F (20°C to 25°C) for 45 minutes to allow it to warm up (see Figure E ). Do not warm the prefilled autoinjector using heat sources such as hot water or a microwave. Do not leave the prefilled autoinjector in the direct sunlight. Do not remove the cap while allowing your prefilled autoinjector to reach room temperature. If the prefilled autoinjector does not reach room temperature, this could cause discomfort. Figure E 5. Inspect the medicine. a.Hold your Tocilizumab-anoh with the cap pointing down.b.Look at the medicine and confirm that the liquid is clear, to slightly pearly and colorless to yellow and does not contain any particles or flakes (see Figure F ). Do not use the prefilled autoinjector if the liquid is discolored, cloudy, or has particles or flakes in it. Safely dispose of the prefilled autoinjector in a FDA-cleared sharps disposal container and use a new one. Air bubbles are normal. Figure F 6. Wash your hands. a.Wash your hands with soap and water and dry them thoroughly (see Figure G ). Figure G 7. Choose an injection site (see Figure H ). a.You may inject into-The front of the thighs-The stomach (abdomen), except for the 2 inches (5 cm) around the belly button.-The outer area of the upper arm (only if you are a caregiver). Do not inject into the upper arm by yourself. Choose a different injection site for each new injection at least 1 inch (2.5 cm) 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 H 8. Clean the injection site. b.Wipe the injection site with an alcohol swab and let it air dry (see Figure I ). This will 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. Figure I Giving the Injection 9. Remove the cap. a.Hold the prefilled autoinjector by the injector body with the cap on top using 1 hand. Gently pull the cap straight off with the other hand (see Figure J ). Note: If you cannot remove the cap, you should ask a caregiver for help or contact your healthcare provider.b.Throw away (dispose of) the cap right away in your FDA-cleared sharps disposal container (see step 14 and Figure O ) Do not re-cap the prefilled autoinjector. Do not touch the needle shield at the tip of the prefilled autoinjector to avoid accidental needle stick injury. After you remove the cap, the prefilled autoinjector is ready for use. If the prefilled autoinjector is not used within 3 minutes of cap removal, throw away the prefilled autoinjector in a FDA-cleared sharps disposal container and use a new prefilled autoinjector. Figure J 10. Place the prefilled autoinjector on the injection site. a.Hold the prefilled autoinjector comfortably in 1 hand so that you can see the window (see Figure K ).b.Without pinching or stretching the skin, place the prefilled autoinjector against the skin at a 90-degree angle (see Figure L ). Note: It is important to use the correct angle to make sure the medicine is delivered under the skin (into fatty tissue), or the injection could be painful, and the medicine may not work Do not inject into muscle or a blood vessel. Figure K Figure L 11. Give the injection. a.Firmly press the prefilled autoinjector into the skin to begin the injection.b.When the injection starts you will hear the 1st "click" and the orange indicator will begin to fill the window (see Figure M ).c.Keep holding the prefilled autoinjector firmly against the skin and listen for the 2 nd "click".d.After you hear the 2 nd "click", continue to hold the prefilled autoinjector firmly against the skin and count slowly to 5 to make sure you inject the full dose (see Figure M ).e.Watch the orange indicator until it stops moving and has reached the end of the window to be sure the full dose of medicine is injected. Figure M 12. Remove the prefilled autoinjector from the injection site. a.When the orange indicator has stopped moving, lift the prefilled autoinjector straight off of the injection site at a 90-degree angle to remove the needle from the skin. The needle cover will automatically move out and lock into place covering the needle (see Figure N ). Note: If the window has not turned completely orange or if the medicine is still injecting, this means you have not received a full dose. Carefully place the prefilled autoinjector into the FDA-cleared sharps disposal container and call your healthcare provider immediately. Do not touch the needle cover of the prefilled autoinjector. Do not try to re-use the prefilled autoinjector. Do not repeat the injection with another prefilled autoinjector. Figure N After the Injection 13. ...

PRINCIPAL DISPLAY PANEL - 80 mg/4 mL Vial Carton

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 72606-048-01 Rx only Tocilizumab-anoh Injection 80 mg/4 mL (20 mg/mL) For Intravenous Infusion After Dilution. Single-Dose Vial. Discard Unused Portion. 1 vial CELLTRION USA CELLTRION

PRINCIPAL DISPLAY PANEL - 200 mg/10 mL Vial Carton

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 72606-049-01 Rx only Tocilizumab-anoh Injection 200 mg/10 mL (20 mg/mL) For Intravenous Infusion After Dilution. Single-Dose Vial. Discard Unused Portion. 1 vial CELLTRION USA CELLTRION

PRINCIPAL DISPLAY PANEL - 400 mg/20 mL Vial Carton

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 72606-050-01 Rx only Tocilizumab-anoh Injection 400 mg/20 mL (20 mg/mL) For Intravenous Infusion After Dilution. Single-Dose Vial. Discard Unused Portion. 1 vial CELLTRION USA CELLTRION

PRINCIPAL DISPLAY PANEL - 162 mg/0.9 mL Autoinjector Carton

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Tocilizumab-anoh Injection 162 mg/0.9 mL FOR SUBCUTANEOUS USE ONLY ATTENTION: Dispense the enclosed Medication Guide to each patient NDC 72606-051-04 Rx only Each carton contains 1 single-dose Autoinjector, 1 Medication Guide, 1 Prescribing Information and 1 Instructions for Use x 1 1 single-dose Autoinjector CELLTRION USA CELLTRION