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Important Safety Information

Important Safety Information

Indications and clinical use:

SAPHNELO (anifrolumab for injection) is indicated in addition to standard therapy for the treatment of adult patients with active, autoantibody positive, systemic lupus erythematosus (SLE).

The safety and efficacy of SAPHNELO have not been evaluated in patients with severe active lupus nephritis or severe active central nervous system lupus. Use of SAPHNELO is not recommended in these situations.

SAPHNELO is not indicated for use in pediatric patients <18 years.

Differences in safety or effectiveness of SAPHNELO between patients ≥65 years and younger have not been determined due to limited clinical trial experience in geriatric patients.

Relevant warnings and precautions:

  • Concomitant use with other biologic therapies
  • Risk for the development of malignancies
  • Risk of fatal respiratory infections and herpes zoster
  • Caution in patients with a chronic infection, a history of recurrent infections, or known risk factors for infection
  • Initiation of treatment in patients with any clinically significant active infection
  • Instruction to patients to seek medical advice if signs or symptoms of a clinically significant infection occur
  • If a patient develops an infection, or is not responding to standard therapy, monitor the patient closely and consider interrupting SAPHNELO therapy until the infection resolves
  • Concurrent use of live or attenuated vaccines in patients treated with SAPHNELO
  • Immunization prior to initiating therapy with SAPHNELO
  • Fertility
  • Pregnancy and in women of childbearing potential not using contraception
  • Nursing women; risk to the breast-fed child
  • Serious hypersensitivity reactions (including anaphylaxis) and angioedema

For more information:

Please consult the Product Monograph at https://www.content.astrazeneca.com/ca/en/00620641016149/ePI.html for important information relating to adverse reactions, drug interactions and dosing information which have not been discussed in this piece. The Product Monograph is also available by calling us at 1-800-668-6000.

References:

  1. SAPHNELO Product Monograph. AstraZeneca Canada Inc. June 13, 2024.
  2. Data on file. AstraZeneca Canada Inc. April 2025.

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