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Generic Name

Adalimumab-AATY

Brand Names
Adalimumab, Yuflyma
FDA approval date: May 23, 2023
Form: Kit

What is Adalimumab (Adalimumab-AATY)?

Adalimumab-aaty is a tumor necrosis factor blocker indicated for: Reducing signs and symptoms, inducing major clinical response, inhibiting the progression of structural damage, and improving physical function in adult patients with moderately to severely active r heumatoid arthritis.

Approved To Treat

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Brand Information

    Adalimumab (adalimumab-aaty)
    1DOSAGE FORMS AND STRENGTHS
    Adalimumab-aaty is a clear to opalescent, and colorless to pale brown solution available as:
    • Auto-injector (Adalimumab-aaty AI)
      Injection: 80 mg/0.8 mL in a single-dose auto-injector.
      Injection: 40 mg/0.4 mL in a single-dose auto-injector.
    • Prefilled Syringe with Safety Guard
      Injection: 80 mg/0.8 mL in a single-dose prefilled syringe with safety guard.
      Injection: 40 mg/0.4 mL in a single-dose prefilled syringe with safety guard.
    • Prefilled Syringe
      Injection: 80 mg/0.8 mL in a single-dose prefilled syringe.
      Injection: 40 mg/0.4 mL in a single-dose prefilled syringe.
      Injection: 20 mg/0.2 mL in a single-dose prefilled syringe.
    2CONTRAINDICATIONS
    None.
    3ADVERSE REACTIONS
    The following clinically significant adverse reactions are described elsewhere in the labeling:
    • Serious Infections
    • Malignancies
    • Hypersensitivity Reactions
    • Hepatitis B Virus Reactivation
    • Neurologic Reactions
    • Hematological Reactions
    • Heart Failure
    • Autoimmunity
    3.1Clinical Trials Experience
    Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.
    The most common adverse reaction with adalimumab was injection site reactions. In placebo-controlled trials, 20% of subjects treated with adalimumab developed injection site reactions (erythema and/or itching, hemorrhage, pain or swelling), compared to 14% of subjects receiving placebo. Most injection site reactions were described as mild and generally did not necessitate drug discontinuation.
    The proportion of subjects who discontinued treatment due to adverse reactions during the double-blind, placebo-controlled portion of studies in subjects with RA (i.e., Studies RA-I, RA-II, RA-III and RA-IV) was 7% for subjects taking adalimumab and 4% for placebo-treated subjects. The most common adverse reactions leading to discontinuation of adalimumab in these RA studies were clinical flare reaction (0.7%), rash (0.3%) and pneumonia (0.3%).
    3.2Immunogenicity
    The observed incidence of anti-drug antibodies is highly dependent on the sensitivity and specificity of the assay. Differences in assay methods preclude meaningful comparisons of the incidence of anti-drug antibodies in the studies described below with the incidence of anti-drug antibodies in other studies, including those of adalimumab or of other adalimumab products.
    There are two assays that have been used to measure anti-adalimumab antibodies. With the ELISA, antibodies to adalimumab could be detected only when serum adalimumab concentrations were < 2 mcg/mL. The ECL assay can detect anti-adalimumab antibody titers independent of adalimumab concentrations in the serum samples. The incidence of anti­-adalimumab antibody (AAA) development in patients treated with adalimumab are presented in Table 2.
    3.3Postmarketing Experience
    The following adverse reactions have been identified during post-approval use of adalimumab products. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to adalimumab products exposure.
    Gastrointestinal disorders: Diverticulitis, large bowel perforations including perforations associated with diverticulitis and appendiceal perforations associated with appendicitis, pancreatitis
    General disorders and administration site conditions: Pyrexia
    Hepato-biliary disorders: Liver failure, hepatitis, autoimmune hepatitis
    Immune system disorders: Sarcoidosis
    Neoplasms benign, malignant and unspecified (including cysts and polyps): Merkel Cell Carcinoma (neuroendocrine carcinoma of the skin)
    Nervous system disorders: Demyelinating disorders (e.g., optic neuritis, Guillain-Barré syndrome), cerebrovascular accident
    Respiratory disorders: Interstitial lung disease, including pulmonary fibrosis, pulmonary embolism
    Skin reactions: Stevens Johnson Syndrome, cutaneous vasculitis, erythema multiforme, new or worsening psoriasis (all sub-types including pustular and palmoplantar), alopecia, lichenoid skin reaction
    Vascular disorders: Systemic vasculitis, deep vein thrombosis
    4OVERDOSAGE
    Doses up to 10 mg/kg have been administered to patients in clinical trials without evidence of dose-limiting toxicities. In case of overdosage, it is recommended that the patient be monitored for any signs or symptoms of adverse reactions or effects and appropriate symptomatic treatment instituted immediately.
    Consider contacting the Poison Help line (1-800-222-1222) or medical toxicologist for additional overdose management recommendations.
    5DESCRIPTION
    Adalimumab-aaty is a tumor necrosis factor blocker. Adalimumab-aaty is a recombinant human IgG1 monoclonal antibody created using phage display technology resulting in an antibody with human derived heavy and light chain variable regions and human IgG1:k constant regions. Adalimumab-aaty is produced by recombinant DNA technology in a mammalian cell (Chinese Hamster Ovary (CHO)) expression system and is purified by a process that includes specific viral inactivation and removal steps. It consists of 1330 amino acids and has a molecular weight of approximately 148 kilodaltons.
    Adalimumab-aaty injection is supplied as a sterile, preservative-free solution for subcutaneous administration. The drug product is supplied as either a single-dose, auto-injector (Adalimumab-aaty AI), as a single-dose, 1 mL prefilled syringe with safety guard, or a single-dose, 1 mL prefilled syringe. Enclosed within the auto-injector is a single-dose, 1 mL prefilled syringe. The solution of Adalimumab-aaty is clear to opalescent, and colorless to pale brown, with a pH of about 5.2.
    Each 80 mg/0.8 mL prefilled syringe or prefilled syringe with safety guard or auto-injector delivers 0.8 mL (80 mg) of drug product. Each 0.8 mL of Adalimumab-aaty contains adalimumab-aaty (80 mg), acetic acid (0.13 mg), glycine (15.02 mg), polysorbate 80 (0.8 mg), sodium acetate (0.48 mg) and Water for Injection, USP.
    Each 40 mg/0.4 mL prefilled syringe or prefilled syringe with safety guard or auto-injector delivers 0.4 mL (40 mg) of drug product. Each 0.4 mL of Adalimumab-aaty contains adalimumab-aaty (40 mg), acetic acid (0.06 mg), glycine (7.51 mg), polysorbate 80 (0.4 mg), sodium acetate (0.24 mg) and Water for Injection, USP.
    Each 20 mg/0.2 mL prefilled syringe delivers 0.2 mL (20 mg) of drug product. Each 0.2 mL of Adalimumab-aaty contains adalimumab-aaty (20 mg), acetic acid (0.03 mg), glycine (3.75 mg), polysorbate 80 (0.2 mg), sodium acetate (0.12 mg) and Water for Injection, USP.
    6REFERENCES
    1. National Cancer Institute. Surveillance, Epidemiology, and End Results Database (SEER) Program. SEER Incidence Crude Rates, 17 Registries, 2000-2007.
    7HOW SUPPLIED/STORAGE AND HANDLING
    Adalimumab-aaty is supplied as a preservative-free, sterile, clear to opalescent, and colorless to pale brown solution for subcutaneous administration. The following packaging configurations are available.
    • Adalimumab-aaty AI Carton - 40 mg/0.4 mL (1 Count)
      Adalimumab-aaty is supplied in a carton containing two alcohol preps and one dose tray. The dose tray consists of a single-dose prefilled auto-injector, containing a 1 mL prefilled syringe with a fixed thin wall, ½ inch needle, providing 40 mg/0.4 mL of Adalimumab-aaty. The NDC number is 72606-022-09.
    • Adalimumab-aaty AI Carton - 40 mg/0.4 mL (2 Count)
      Adalimumab-aaty is supplied in a carton containing two alcohol preps and two dose trays. Each dose tray consists of a single-dose prefilled auto-injector, containing a 1 mL prefilled syringe with a fixed thin wall, ½ inch needle, providing 40 mg/0.4 mL of Adalimumab-aaty. The NDC number is 72606-022-10.
    • Adalimumab-aaty AI Carton - 40 mg/0.4 mL (4 Count)
      Adalimumab-aaty is supplied in a carton containing four alcohol preps and four dose trays. Each dose tray consists of a single-dose prefilled auto-injector, containing a 1 mL prefilled syringe with a fixed thin wall, ½ inch needle, providing 40 mg/0.4 mL of Adalimumab-aaty. The NDC number is 72606-022-11.
    • Adalimumab-aaty AI Carton - 40 mg/0.4 mL (6 Count)
      Adalimumab-aaty is supplied in a carton containing six alcohol preps and six dose trays. Each dose tray consists of a single-dose prefilled auto-injector, containing a 1 mL prefilled syringe with a fixed thin wall, ½ inch needle, providing 40 mg/0.4 mL of Adalimumab-aaty. The NDC number is 72606-022-12.
    • Prefilled Syringe with Safety Guard Carton - 40 mg/0.4 mL (1 Count)
      Adalimumab-aaty is supplied in a carton containing two alcohol preps and one dose tray. The dose tray consists of a single-dose prefilled syringe with safety guard, containing a 1 mL prefilled syringe with a fixed thin wall, ½ inch needle, providing 40 mg/0.4 mL of Adalimumab-aaty. The NDC number is 72606-022-05.
    • Prefilled Syringe with Safety Guard Carton - 40 mg/0.4 mL (2 Count)
      Adalimumab-aaty is supplied in a carton containing two alcohol preps and two dose trays. Each dose tray consists of a single-dose prefilled syringe with safety guard, containing a 1 mL prefilled syringe with a fixed thin wall, ½ inch needle, providing 40 mg/0.4 mL of Adalimumab-aaty. The NDC number is 72606-022-06.
    • Prefilled Syringe with Safety Guard Carton - 40 mg/0.4 mL (4 Count)
      Adalimumab-aaty is supplied in a carton containing four alcohol preps and four dose trays. Each dose tray consists of a single-dose prefilled syringe with safety guard, containing a 1 mL prefilled syringe with a fixed thin wall, ½ inch needle, providing 40 mg/0.4 mL of Adalimumab-aaty. The NDC number is 72606-022-07.
    • Prefilled Syringe with Safety Guard Carton - 40 mg/0.4 mL (6 Count)
      Adalimumab-aaty is supplied in a carton containing six alcohol preps and six dose trays. Each dose tray consists of a single-dose prefilled syringe with safety guard, containing a 1 mL prefilled syringe with a fixed thin wall, ½ inch needle, providing 40 mg/0.4 mL of Adalimumab-aaty. The NDC number is 72606-022-08.
    • Prefilled Syringe Carton - 40 mg/0.4 mL (1 Count)
      Adalimumab-aaty is supplied in a carton containing two alcohol preps and one dose tray. The dose tray consists of a single-dose prefilled syringe, containing a 1 mL prefilled syringe with a fixed thin wall, ½ inch needle, providing 40 mg/0.4 mL of Adalimumab-aaty. The NDC number is 72606-022-01.
    • Prefilled Syringe Carton - 40 mg/0.4 mL (2 Count)
      Adalimumab-aaty is supplied in a carton containing two alcohol preps and two dose trays. Each dose tray consists of a single-dose prefilled syringe, containing a 1 mL prefilled syringe with a fixed thin wall, ½ inch needle, providing 40 mg/0.4 mL of Adalimumab-aaty. The NDC number is 72606-022-02.
    • Prefilled Syringe Carton - 40 mg/0.4 mL (4 Count)
      Adalimumab-aaty is supplied in a carton containing four alcohol preps and four dose trays. Each dose tray consists of a single-dose prefilled syringe, containing a 1 mL prefilled syringe with a fixed thin wall, ½ inch needle, providing 40 mg/0.4 mL of Adalimumab-aaty. The NDC number is 72606-022-03.
    • Prefilled Syringe Carton - 40 mg/0.4 mL (6 Count)
      Adalimumab-aaty is supplied in a carton containing six alcohol preps and six dose trays. Each dose tray consists of a single-dose prefilled syringe, containing a 1 mL prefilled syringe with a fixed thin wall, ½ inch needle, providing 40 mg/0.4 mL of Adalimumab-aaty. The NDC number is 72606-022-04.
    • Adalimumab-aaty AI Carton - 80 mg/0.8 mL (1 Count)
      Adalimumab-aaty is supplied in a carton containing two alcohol preps and one dose tray. The dose tray consists of a single-dose prefilled auto-injector, containing a 1 mL prefilled syringe with a fixed thin wall, ½ inch needle, providing 80 mg/0.8 mL of Adalimumab-aaty. The NDC number is 72606-040-04.
    • Adalimumab-aaty AI Carton - 80 mg/0.8 mL (2 Count)
      Adalimumab-aaty is supplied in a carton containing two alcohol preps and two dose trays. Each dose tray consists of a single-dose prefilled auto-injector, containing a 1 mL prefilled syringe with a fixed thin wall, ½ inch needle, providing 80 mg/0.8 mL of Adalimumab-aaty. The NDC number is 72606-040-05.
    • Prefilled Syringe with Safety Guard Carton - 80 mg/0.8 mL (1 Count)
      Adalimumab-aaty is supplied in a carton containing two alcohol preps and one dose tray. The dose tray consists of a single-dose prefilled syringe with safety guard, containing a 1 mL prefilled syringe with a fixed thin wall, ½ inch needle, providing 80 mg/0.8 mL of Adalimumab-aaty. The NDC number is 72606-040-02.
    • Prefilled Syringe with Safety Guard Carton - 80 mg/0.8 mL (2 Count)
      Adalimumab-aaty is supplied in a carton containing two alcohol preps and two dose trays. Each dose tray consists of a single-dose prefilled syringe with safety guard, containing a 1 mL prefilled syringe with a fixed thin wall, ½ inch needle, providing 80 mg/0.8 mL of Adalimumab-aaty. The NDC number is 72606-040-03.
    • Prefilled Syringe Carton - 80 mg/0.8 mL (1 Count)
      Adalimumab-aaty is supplied in a carton containing two alcohol preps and one dose tray. The dose tray consists of a single-dose prefilled syringe, containing a 1 mL prefilled syringe with a fixed thin wall, ½ inch needle, providing 80 mg/0.8 mL of Adalimumab-aaty. The NDC number is 72606-040-01.
    • Prefilled Syringe Carton - 20 mg/0.2 mL (2 Count)
      Adalimumab-aaty is supplied in a carton containing two alcohol preps and two dose trays. Each dose tray consists of a single-dose prefilled syringe, containing a 1 mL prefilled syringe with a fixed thin wall, ½ inch needle, providing 20 mg/0.2 mL of Adalimumab-aaty. The NDC number is 72606-041-01.
    • Adalimumab-aaty AI 80 mg/0.8 mL - Crohn's Disease, Ulcerative Colitis or HIdradenitis Suppurativa Starter Package (3 Count)
      Adalimumab-aaty is supplied in a carton containing four alcohol preps and three dose trays (Crohn’s Disease Starter Package). Each dose tray consists of a single-dose prefilled auto-injector, containing a 1 mL prefilled syringe with a fixed thin wall, ½ inch needle, providing 80 mg/0.8 mL of Adalimumab aaty. The NDC number is 72606-040-06.
    8PATIENT COUNSELING INFORMATION
    Advise the patient or caregiver to read the FDA-approved patient labeling (Medication Guide and Instructions for Use).
    9INSTRUCTIONS FOR USE Adalimumab-aaty (ada-LIM-u-mab aaty) injection, for subcutaneous use mg/0.8 mL, 40 mg/0.4 mL Single-Dose Auto-injector This product is YUFLYMA (adalimumab-aaty).
    For subcutaneous use only
    Read and follow the Instructions for Use that come with your Adalimumab-aaty Auto-injector before you start using it and each time you get a refill. There may be new information. This information does not take the place of talking to your doctor about your medical condition or treatment.
    Important Information
    • Use the Auto-injector
    • Ask your doctor how often you will need to give an injection.
    • Do not shake the Auto-injector at any time.
    • Do not remove the Cap until you are ready to inject.
    • Do not share the Auto-injector with anyone.
    How to store the Auto-injector
    • Store the Auto-injector in a refrigerator between 36°F to 46°F (2°C to 8°C).
    • Keep the Auto-injector in the original carton until use to protect it from light.
    • Do not use an Auto-injector that has been left in direct sunlight.
    • Do not freeze the Auto-injector. If the Auto-injector has been frozen, do not use the Auto-injector even if it is thawed.
    • If needed, you may store the Auto-injector at room temperature up to 77°F (25°C) for up to 31 days.
    • After the Auto-injector has reached room temperature,
    • Keep the Auto-injector and all medicines out of the reach of children.
    Read Instructions on All Pages Before Using the Adalimumab-aaty Auto-injector
    Prepare for Injection
    10INSTRUCTIONS FOR USE Adalimumab-aaty (ada-LIM-u-mab aaty) injection for subcutaneous use mg/0.8 mL, 40 mg/0.4 mL Single-Dose Prefilled Syringe with Safety Guard This product is YUFLYMA (adalimumab-aaty).
    For subcutaneous use only
    Read and follow the Instructions for Use that come with your Adalimumab-aaty Prefilled Syringe before you start using it and each time you get a refill. There may be new information. This information does not take the place of talking to your doctor about your medical condition or treatment.
    Important Information
    • Use the Prefilled Syringe with Needle Guard
    • Ask your doctor how often you will need to give an injection.
    • Do not shake the Prefilled Syringe at any time.
    • Do not remove the Cap until you are ready to inject.
    • Do not share the Prefilled Syringe with anyone.
    • Only use each Prefilled Syringe for one injection.
    • Do not pull back on the plunger rod at any time.
    How to store the Prefilled Syringe
    • Store the Prefilled Syringe in a refrigerator between 36°F to 46°F (2°C to 8°C).
    • Keep the Prefilled Syringe in the original carton to protect it from light.
    • Do not use a Prefilled Syringe that has been left in direct sunlight.
    • Do not freeze the Prefilled Syringe. If the Prefilled Syringe has been frozen, do not use the Prefilled Syringe even if it is thawed.
    • If needed, you may store the Prefilled Syringe at room temperature up to 77°F (25°C) for up to 31 days.
    • After the Prefilled Syringe has reached room temperature,
    • Keep the Prefilled Syringe and all medicines out of the reach of children.
    Read Instructions on All Pages Before Using the Adalimumab-aaty Prefilled Syringe
    Prepare for Injection
    11INSTRUCTIONS FOR USE Adalimumab-aaty (ada-LIM-u-mab aaty) injection, for subcutaneous use mg/0.8 mL, 40 mg/0.4 mL, 20 mg/0.2 mL Single-Dose Prefilled Syringe This product is YUFLYMA (adalimumab-aaty).
    For subcutaneous use only
    Read and follow the Instructions for Use that come with your Adalimumab-aaty Prefilled Syringe before you start using it and each time you get a refill. There may be new information. This information does not take the place of talking to your doctor about your medical condition or treatment.
    Important Information
    • Use the Prefilled Syringe
    • Ask your doctor how often you will need to give an injection.
    • Do not shake the Prefilled Syringe at any time.
    • Do not remove the Cap until you are ready to inject.
    • Do not share the Prefilled Syringe with anyone.
    • Do not pull back on the plunger rod at any time.
    How to store the Prefilled Syringe
    • Store the Prefilled Syringe in a refrigerator between 36°F to 46°F (2°C to 8°C).
    • Keep the Prefilled Syringe in the original carton to protect it from light.
    • Do not use a Prefilled Syringe that has been left in direct sunlight.
    • Do not freeze the Prefilled Syringe. If the Prefilled Syringe has been frozen,
    • If needed, you may store the Prefilled Syringe at room temperature up to 77°F (25°C) for up to 31 days.
    • After the Prefilled Syringe has reached room temperature,
    • Keep the Prefilled Syringe and all medicines out of the reach of children.
    Read Instructions on All Pages Before Using the Adalimumab-aaty Prefilled Syringe
    Prepare for Injection
    12PRINCIPAL DISPLAY PANEL - 40 mg/0.4 mL Auto-injector Label
    NDC 72606-022-09
    Adalimumab-aaty 40 mg/0.4 mL
    Subcutaneous use 
    CELLTRION Inc.
    LM-0000-00
    Lot: Exp:
    PRINCIPAL DISPLAY PANEL - 40 mg/0.4 mL Auto-injector Label
    13PRINCIPAL DISPLAY PANEL - 40 mg/0.4 mL Auto-injector Carton
    • PRINCIPAL DISPLAY PANEL - 40 mg/0.4 mL Auto-injector Carton 1PK
    40 mg/0.4 mL Auto-injector Carton 1PK
    1 Single-dose Auto-injector
    Rx only
    Adalimumab-aaty 40 mg/0.4 mL
    FOR SUBCUTANEOUS USE ONLY
    1 auto-injector + 2 alcohol preps
    NDC 72606-022-09 
    CELLTRION Inc.
    • PRINCIPAL DISPLAY PANEL - 40 mg/0.4 mL Auto-injector Carton 2PK 
    40 mg/0.4 mL Auto-injector Carton 2PK

    2 Single-dose Auto-injector
    Rx only
    Adalimumab-aaty 40 mg/0.4 mL
    FOR SUBCUTANEOUS USE ONLY
    2 auto-injector + 2 alcohol preps
    NDC 72606-022-10 
    CELLTRION Inc.
    • PRINCIPAL DISPLAY PANEL - 40 mg/0.4 mL Auto-injector Carton 4PK 
    40 mg/0.4 mL Auto-injector Carton 4PK
     4 Single-dose Auto-injector
    Rx only
    Adalimumab-aaty 40 mg/0.4 mL
    FOR SUBCUTANEOUS USE ONLY
    4 auto-injector + 4 alcohol preps
    NDC 72606-022-11
    CELLTRION Inc.
    • PRINCIPAL DISPLAY PANEL - 40 mg/0.4 mL Auto-injector Carton 6PK 
    40 mg/0.4 mL Auto-injector Carton 6PK
    6 Single-dose Auto-injector
    Rx only
    Adalimumab-aaty 40 mg/0.4 mL
    FOR SUBCUTANEOUS USE ONLY
    6 auto-injector + 6 alcohol preps
    NDC 72606-022-12 
    CELLTRION Inc.
    14PRINCIPAL DISPLAY PANEL - 40 mg/0.4 mL Syringe Label- with Guard
    Lot:
    NDC 72606-022-05
    Adalimumab-aaty 40 mg/0.4 mL
    Subcutaneous use
    CELLTRION Inc.
    LM000000-00000
    PRINCIPAL DISPLAY PANEL - 40 mg/0.4 mL Syringe with safety guard Label
    15PRINCIPAL DISPLAY PANEL - 40 mg/0.4 mL Syringe Carton - with Guard
    • 40 mg/0.4 mL Syringe Carton - with Guard 1PK 
    40 mg/0.4 mL Syringe Carton - with Guard 1PK
    1 Single-dose Prefilled Syringe with Safety Guard
    Rx only
    Adalimumab-aaty 40 mg/0.4 mL
    FOR SUBCUTANEOUS USE ONLY
    1 prefilled syringe with safety guard + 2 alcohol preps
    NDC 72606-022-05
    CELLTRION Inc.
    • 40 mg/0.4 mL Syringe Carton - with Guard 2PK 
    40 mg/0.4 mL Syringe Carton - with Guard 2PK
    2 Single-dose Prefilled Syringe with Safety Guard
    Rx only
    Adalimumab-aaty 40 mg/0.4 mL
    FOR SUBCUTANEOUS USE ONLY
    2 prefilled syringe with safety guard + 2 alcohol preps
    NDC 72606-022-06
    CELLTRION Inc.
    • 40 mg/0.4 mL Syringe Carton - with Guard 4PK 
    40 mg/0.4 mL Syringe Carton - with Guard 4PK
    4 Single-dose Prefilled Syringe with Safety Guard
    Rx only
    Adalimumab-aaty 40 mg/0.4 mL
    FOR SUBCUTANEOUS USE ONLY
    4 prefilled syringe with safety guard + 4 alcohol preps
    NDC 72606-022-07
    CELLTRION Inc.
    • 40 mg/0.4 mL Syringe Carton - with Guard 6PK  
    40 mg/0.4 mL Syringe Carton - with Guard 6PK
    6 Single-dose Prefilled Syringe with Safety Guard
    Rx only
    Adalimumab-aaty 40 mg/0.4 mL
    FOR SUBCUTANEOUS USE ONLY
    6 prefilled syringe with safety guard + 6 alcohol preps
    NDC 72606-022-08
    CELLTRION Inc.
    16PRINCIPAL DISPLAY PANEL - 40 mg/0.4 mL Syringe Label
    Lot:
    NDC 72606-022-01
    Adalimumab-aaty 40 mg/0.4 mL
    Subcutaneous use
    CELLTRION Inc.
    LM000000-00000
    PRINCIPAL DISPLAY PANEL - 40 mg/0.4 mL Syringe Label
    17PRINCIPAL DISPLAY PANEL - 40 mg/0.4 mL Syringe Carton
    • 40 mg/0.4 mL Syringe Carton 1PK
    40 mg/0.4 mL Syringe Carton 1PK
    1 Single-dose Prefilled Syringe
    FOR SUBCUTANEOUS USE ONLY
    1 prefilled syringe + 2 alcohol preps
    NDC 72606-022-01
    CELLTRION Inc.
    • 40 mg/0.4 mL Syringe Carton 2PK
    40 mg/0.4 mL Syringe Carton 2PK
    2 Single-dose Prefilled Syringe
    FOR SUBCUTANEOUS USE ONLY
    2 prefilled syringe + 2 alcohol preps
    NDC 72606-022-02
    CELLTRION Inc.
    • 40 mg/0.4 mL Syringe Carton 4PK
    40 mg/0.4 mL Syringe Carton 4PK
    4 Single-dose Prefilled Syringe
    FOR SUBCUTANEOUS USE ONLY
    4 prefilled syringe + 4 alcohol preps
    NDC 72606-022-03
    CELLTRION Inc.
    • 40 mg/0.4 mL Syringe Carton 6PK
    i40 mg/0.4 mL Syringe Carton 6PK
    6 Single-dose Prefilled Syringe
    FOR SUBCUTANEOUS USE ONLY
    6 prefilled syringe + 6 alcohol preps
    NDC 72606-022-04
    CELLTRION Inc.
    18PRINCIPAL DISPLAY PANEL - 80 mg/0.8 mL Auto-injector Label
    NDC 72606-040-04
    Adalimumab-aaty 80 mg/0.8 mL
    Subcutaneous use
    CELLTRION Inc.
    LM-0000-00
    Lot: Exp:
    PRINCIPAL DISPLAY PANEL - 80 mg/0.8 mL Auto-injector Label
    19PRINCIPAL DISPLAY PANEL - 80 mg/0.8 mL Auto-injector Carton
    • PRINCIPAL DISPLAY PANEL - 80 mg/0.8 mL Auto-injector Carton 1PK
    80 mg/0.8 mL Auto-injector Carton 1PK
    1 Single-dose Auto-injector
    Rx only
    Adalimumab-aaty 80 mg/0.8 mL
    FOR SUBCUTANEOUS USE ONLY
    1 auto-injector + 2 alcohol preps
    NDC 72606-040-04
    CELLTRION Inc.
    • PRINCIPAL DISPLAY PANEL - 80 mg/0.8 mL Auto-injector Carton 2PK
    80 mg/0.8 mL Auto-injector Carton 2PK
    2 Single-dose Auto-injector
    Rx only
    Adalimumab-aaty 80 mg/0.8 mL
    FOR SUBCUTANEOUS USE ONLY
    2 auto-injector + 2 alcohol preps
    NDC 72606-040-05
    CELLTRION Inc.
    20PRINCIPAL DISPLAY PANEL - 80 mg/0.8 mL Syringe Label- with Guard
    Lot:
    NDC 72606-040-02
    Adalimumab-aaty 80 mg/0.8 mL
    Subcutaneous use
    CELLTRION Inc.
    LM000000-00000
    PRINCIPAL DISPLAY PANEL - 80 mg/0.8 mL Syringe with safety guard Label
    21PRINCIPAL DISPLAY PANEL - 80 mg/0.8 mL Syringe Carton - with Guard
    • 80 mg/0.8 mL Syringe Carton - with Guard 1PK
    80 mg/0.8 mL Syringe Carton - with Guard 1PK
    1 Single-dose Prefilled Syringe with Safety Guard
    Rx only
    Adalimumab-aaty 80 mg/0.8 mL
    FOR SUBCUTANEOUS USE ONLY
    1 prefilled syringe with safety guard + 2 alcohol preps
    NDC 72606-040-02
    CELLTRION Inc.
    • 80 mg/0.8 mL Syringe Carton - with Guard 2PK
    80 mg/0.8 mL Syringe Carton - with Guard 1PK
    2 Single-dose Prefilled Syringe with Safety Guard
    Rx only
    Adalimumab-aaty 80 mg/0.8 mL
    FOR SUBCUTANEOUS USE ONLY
    2 prefilled syringe with safety guard + 2 alcohol preps
    NDC 72606-040-03
    CELLTRION Inc.
    22PRINCIPAL DISPLAY PANEL - 80 mg/0.8 mL Syringe Label
    Lot:
    NDC 72606-040-01
    Adalimumab-aaty 80 mg/0.8 mL
    Subcutaneous use
    CELLTRION Inc.
    LM000000-00000
    PRINCIPAL DISPLAY PANEL - 80 mg/0.8 mL Syringe Label
    23PRINCIPAL DISPLAY PANEL - 80 mg/0.8 mL Syringe Carton
    • 80 mg/0.8 mL Syringe Carton 1PK
    80 mg/0.8 mL Syringe Carton 1PK
    1 Single-dose Prefilled Syringe
    FOR SUBCUTANEOUS USE ONLY
    1 prefilled syringe + 2 alcohol preps
    NDC 72606-040-01
    CELLTRION Inc.
    24PRINCIPAL DISPLAY PANEL - 20 mg/0.2 mL Syringe Label
    Lot:
    NDC 72606-041-01
    Adalimumab-aaty 20 mg/0.2 mL
    Subcutaneous use
    CELLTRION Inc.
    LM000000-00000
    PRINCIPAL DISPLAY PANEL - 20 mg/0.2 mL Syringe Label
    25PRINCIPAL DISPLAY PANEL - 20 mg/0.2 mL Syringe Carton
    • 20 mg/0.2 mL Syringe Carton 2PK
    20 mg/0.2 mL Syringe Carton 2PK
    2 Single-dose Prefilled Syringes
    Rx only Adalimumab-aaty 20 mg/0.2 mL
    FOR SUBCUTANEOUS USE ONLY
    2 prefilled syringes + 2 alcohol preps
    NDC 72606-041-01
    CELLTRION Inc.
    26PRINCIPAL DISPLAY PANEL - Kit Carton (STARTER PACKAGE - 80 mg/0.8 mL Auto-injector)
    STARTER PACKAGE 80 mg/0.8 mL Auto-injector Carton
    NDC 72606-040-06
    Rx only
    Adalimumab-aaty
    injection
    80 mg/0.8 mL
    FOR SUBCUTANEOUS USE ONLY
    ATTENTION: Dispense the enclosed
    Medication Guide to each patient
    STARTER PACKAGE
    CROHN'S DISEASE
    STARTER PACKAGE 80 mg/0.8 mL Auto-injector Carton
    STARTER PACKAGE 80 mg/0.8 mL Auto-injector Carton
    STARTER PACKAGE 80 mg/0.8 mL Auto-injector Carton

    Each carton contains 3 single-dose Auto-injector.
    4 alohol preps, 1 Medication Guide.
    1 Prescribing Information, and 1 Instriction for Use
    3 Single-dose
    Auto-Injector
    CELLTRION
    Adalimumab has been selected.