FDA Label for Adalimumab-ryvk

View Indications, Usage & Precautions

    1. WARNING: SERIOUS INFECTIONS AND MALIGNANCY
    2. 1.1 RHEUMATOID ARTHRITIS
    3. 1.2 JUVENILE IDIOPATHIC ARTHRITIS
    4. 1.3 PSORIATIC ARTHRITIS
    5. 1.4 ANKYLOSING SPONDYLITIS
    6. 1.5 CROHN’S DISEASE
    7. 1.6 ULCERATIVE COLITIS
    8. 1.7 PLAQUE PSORIASIS
    9. 1.8 HIDRADENITIS SUPPURATIVA
    10. 1.9 UVEITIS
    11. 2.1 RHEUMATOID ARTHRITIS, PSORIATIC ARTHRITIS, AND ANKYLOSING SPONDYLITIS
    12. 2.2 JUVENILE IDIOPATHIC ARTHRITIS
    13. 2.3 CROHN’S DISEASE
    14. 2.4 ULCERATIVE COLITIS
    15. 2.5 PLAQUE PSORIASIS OR ADULT UVEITIS
    16. 2.6 HIDRADENITIS SUPPURATIVA
    17. 2.7 MONITORING TO ASSESS SAFETY
    18. 2.8 GENERAL CONSIDERATIONS FOR ADMINISTRATION
    19. 3 DOSAGE FORMS AND STRENGTHS
    20. 4 CONTRAINDICATIONS
    21. 5.1 SERIOUS INFECTIONS
    22. 5.2 MALIGNANCIES
    23. 5.3 HYPERSENSITIVITY REACTIONS
    24. 5.4 HEPATITIS B VIRUS REACTIVATION
    25. 5.5 NEUROLOGIC REACTIONS
    26. 5.6 HEMATOLOGICAL REACTIONS
    27. 5.7 INCREASED RISK OF INFECTION WHEN USED WITH ANAKINRA
    28. 5.8 HEART FAILURE
    29. 5.9 AUTOIMMUNITY
    30. 5.10 IMMUNIZATIONS
    31. 5.11 INCREASED RISK OF INFECTION WHEN USED WITH ABATACEPT
    32. 6 ADVERSE REACTIONS
    33. 6.1 CLINICAL TRIALS EXPERIENCE
    34. 6.2 IMMUNOGENICITY
    35. 6.3 POSTMARKETING EXPERIENCE
    36. 7.1 METHOTREXATE
    37. 7.2 BIOLOGICAL PRODUCTS
    38. 7.3 LIVE VACCINES
    39. 7.4 CYTOCHROME P450 SUBSTRATES
    40. 8.1 PREGNANCY
    41. 8.2 LACTATION
    42. 8.4 PEDIATRIC USE
    43. 8.5 GERIATRIC USE
    44. 10 OVERDOSAGE
    45. 11 DESCRIPTION
    46. 12.1 MECHANISM OF ACTION
    47. 12.2 PHARMACODYNAMICS
    48. 12.3 PHARMACOKINETICS
    49. 13.1 CARCINOGENESIS, MUTAGENESIS, IMPAIRMENT OF FERTILITY
    50. 14.1 RHEUMATOID ARTHRITIS
    51. 14.2 JUVENILE IDIOPATHIC ARTHRITIS
    52. 14.3 PSORIATIC ARTHRITIS
    53. 14.4 ANKYLOSING SPONDYLITIS
    54. 14.5 ADULT CROHN’S DISEASE
    55. 14.6 PEDIATRIC CROHN’S DISEASE
    56. 14.7 ADULT ULCERATIVE COLITIS
    57. 14.8 PLAQUE PSORIASIS
    58. 14.9 HIDRADENITIS SUPPURATIVA
    59. 14.10 ADULT UVEITIS
    60. 15 REFERENCES
    61. 16 HOW SUPPLIED/STORAGE AND HANDLING
    62. 17 PATIENT COUNSELING INFORMATION
    63. PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Adalimumab-ryvk Product Label

The following document was submitted to the FDA by the labeler of this product Quallent Pharmaceuticals Health Llc. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.

* Please review the disclaimer below.