Label: ADALIMUMAB- adalimumab-adaz injection, solution

  • NDC Code(s): 61314-325-20, 61314-327-20, 61314-327-64, 61314-332-64
  • Packager: Sandoz Inc
  • Category: HUMAN PRESCRIPTION DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Biologic Licensing Application

Drug Label Information

Updated June 1, 2024

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  • HIGHLIGHTS OF PRESCRIBING INFORMATION
    These highlights do not include all the information needed to use ADALIMUMAB-ADAZ safely and effectively. See full prescribing information for ADALIMUMAB-ADAZ. ADALIMUMAB-ADAZ injection, for ...
  • Table of Contents
    Table of Contents
  • BOXED WARNING (What is this?)

    WARNING: SERIOUS INFECTIONS and MALIGNANCY

    SERIOUS INFECTIONS

     
    Patients treated with adalimumab products including Adalimumab-adaz, are at increased risk for developing serious infections that may lead to hospitalization or death [see Warnings and Precautions (5.1)]. Most patients who developed these infections were taking concomitant immunosuppressants such as methotrexate or corticosteroids.

    Discontinue Adalimumab-adaz if a patient develops a serious infection or sepsis.

    Reported infections include:

    Active tuberculosis (TB), including reactivation of latent TB. Patients with TB have frequently presented with disseminated or extrapulmonary disease. Test patients for latent TB before Adalimumab-adaz use and during therapy. Initiate treatment for latent TB prior to Adalimumab-adaz use.
    Invasive fungal infections, including histoplasmosis, coccidioidomycosis, candidiasis, aspergillosis, blastomycosis, and pneumocystosis. Patients with histoplasmosis or other invasive fungal infections may present with disseminated, rather than localized, disease. Antigen and antibody testing for histoplasmosis may be negative in some patients with active infection. Consider empiric anti-fungal therapy in patients at risk for invasive fungal infections who develop severe systemic illness.
    Bacterial, viral and other infections due to opportunistic pathogens, including Legionella and Listeria.

    Carefully consider the risks and benefits of treatment with Adalimumab-adaz prior to initiating therapy in patients with chronic or recurrent infection.

    Monitor patients closely for the development of signs and symptoms of infection during and after treatment with Adalimumab-adaz, including the possible development of TB in patients who tested negative for latent TB infection prior to initiating therapy [see Warnings and Precautions (5.1) and Adverse Reactions (6.1)].

    MALIGNANCY

    Lymphoma and other malignancies, some fatal, have been reported in children and adolescent patients treated with TNF blockers including adalimumab products [see Warnings and Precautions (5.2)]. Post-marketing cases of hepatosplenic T-cell lymphoma (HSTCL), a rare type of T-cell lymphoma, have been reported in patients treated with TNF blockers including adalimumab products. These cases have had a very aggressive disease course and have been fatal. The majority of reported TNF blocker cases have occurred in patients with Crohn's disease or ulcerative colitis and the majority were in adolescent and young adult males. Almost all these patients had received treatment with azathioprine or 6-mercaptopurine (6–MP) concomitantly with a TNF blocker at or prior to diagnosis. It is uncertain whether the occurrence of HSTCL is related to use of a TNF blocker or a TNF blocker in combination with these other immunosuppressants [see Warnings and Precautions (5.2)].

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  • 1 INDICATIONS AND USAGE
    1.1 Rheumatoid Arthritis - Adalimumab-adaz is indicated for reducing signs and symptoms, inducing major clinical response, inhibiting the progression of structural damage, and improving physical ...
  • 2 DOSAGE AND ADMINISTRATION
    2.1 Rheumatoid Arthritis, Psoriatic Arthritis, and Ankylosing Spondylitis - The recommended subcutaneous dosage of Adalimumab-adaz for adult patients with rheumatoid arthritis (RA), psoriatic ...
  • 3 DOSAGE FORMS AND STRENGTHS
    Adalimumab-adaz is a clear, colorless or slightly yellowish solution available as: • Pen (Sensoready Pen)   Injection: 80 mg/0.8 mL in a single-dose pen.   Injection: 40 mg/0.4 mL in a ...
  • 4 CONTRAINDICATIONS
    None.
  • 5 WARNINGS AND PRECAUTIONS
    5.1 Serious Infections - Patients treated with adalimumab products, including Adalimumab-adaz, are at increased risk for developing serious infections involving various organ systems and sites ...
  • 6 ADVERSE REACTIONS
    The following clinically significant adverse reactions are described elsewhere in the labeling: • Serious Infections [see Warnings and Precautions (5.1)] • Malignancies [see Warnings and ...
  • 7 DRUG INTERACTIONS
    7.1 Methotrexate - Adalimumab has been studied in rheumatoid arthritis (RA) patients taking concomitant methotrexate (MTX). Although MTX reduced the apparent adalimumab clearance, the data do not ...
  • 8 USE IN SPECIFIC POPULATIONS
    8.1 Pregnancy - Risk Summary - Available studies with use of adalimumab during pregnancy do not reliably establish an association between adalimumab and major birth defects. Clinical data are ...
  • 10 OVERDOSAGE
    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 ...
  • 11 DESCRIPTION
    Adalimumab-adaz is a tumor necrosis factor blocker. Adalimumab-adaz is a recombinant human IgG1 monoclonal antibody with human derived heavy and light chain variable regions and human IgG1:k ...
  • 12 CLINICAL PHARMACOLOGY
    12.1 Mechanism of Action - Adalimumab products bind specifically to TNF-alpha and block its interaction with the p55 and p75 cell surface TNF receptors. Adalimumab products also lyse surface TNF ...
  • 13 NONCLINICAL TOXICOLOGY
    13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility - Long-term animal studies of adalimumab products have not been conducted to evaluate the carcinogenic potential or its effect on ...
  • 14 CLINICAL STUDIES
    14.1 Rheumatoid Arthritis - The efficacy and safety of adalimumab were assessed in 5 randomized, double-blind studies in patients ≥18 years of age with active rheumatoid arthritis (RA) diagnosed ...
  • 15 REFERENCES
    1. National Cancer Institute. Surveillance, Epidemiology, and End Results Database (SEER) Program. SEER Incidence Crude Rates, 17 Registries, 2000-2007.
  • 16 HOW SUPPLIED/STORAGE AND HANDLING
    Adalimumab-adaz single-dose prefilled Sensoready Pen, Adalimumab-adaz single-dose prefilled syringe with BD UltraSafe Passive™ Needle Guard and add-on finger flange and Adalimumab-adaz ...
  • 17 PATIENT COUNSELING INFORMATION
    Advise the patient or caregiver to read the FDA-approved patient labeling (Medication Guide and Instructions for Use). Infections - Inform patients that Adalimumab-adaz may lower the ability of ...
  • MEDICATION GUIDE
    ADALIMUMAB-ADAZ (ada-LIM-u-mab adaz) injection, for subcutaneous use - This product is HYRIMOZ® (adalimumab-adaz). Read the Medication Guide that comes with Adalimumab-adaz before ...
  • INSTRUCTIONS FOR USE
    Adalimumab-adaz (ada-LIM-u-mab adaz) 80 mg/0.8 mL, 40 mg/0.4 mL - Single-dose prefilled Syringe with BD UltraSafe Passive™ Needle Guard and finger flange - injection, for subcutaneous ...
  • Principal Display Panel
    NDC 61314-327-20 - Rx only - Adalimumab-adaz Injection - 40 mg/0.4 mL - For Subcutaneous Use Only - 2 Single-Dose Prefilled Sensoready® Pens - This product is Hyrimoz® SANDOZ
  • Principal Display Panel
    NDC 61314-327-64 - Rx only - Adalimumab-adaz Injection - 40 mg/0.4 mL - For Subcutaneous Use Only - 2 Single-Dose Prefilled Syringes with needle guard - This product is Hyrimoz® SANDOZ
  • Principal Display Panel
    NDC 61314-332-64 - Rx only - Adalimumab-adaz Injection - 20 mg/0.2 mL - For Subcutaneous Use Only - 2 Single-Dose Prefilled Syringes - This product is Hyrimoz® SANDOZ - Package/Label Display ...
  • INGREDIENTS AND APPEARANCE
    Product Information