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IMPORTANT SAFETY INFORMATION

BOXED WARNING: MALIGNANCIES AND SERIOUS INFECTIONS

LUPKYNIS increases the risk of serious infections and malignancies that may result in hospitalization or death. See full Prescribing Information for complete BOXED WARNING.

CONTRAINDICATIONS

  • DO NOT use with strong CYP3A4 inhibitors (e.g., ketoconazole, itraconazole, clarithromycin).
  • DO NOT use LUPKYNIS if a patient has a history of serious hypersensitivity reactions, including anaphylaxis, to LUPKYNIS or any of its components.

WARNINGS AND PRECAUTIONS

  • Nephrotoxicity may occur. Monitor eGFR and adjust dose as needed.
  • Hypertension is common. Monitor blood pressure. May require antihypertensive therapy; watch for possibility of drug interactions with some antihypertensives.
  • Neurotoxicity: Monitor for neurologic symptoms including risk of posterior reversible encephalopathy syndrome (PRES).
  • Hyperkalemia: Monitor potassium, especially with concomitant agents associated with hyperkalemia.
  • QT Prolongation: Monitor ECG and electrolytes in high-risk patients.
  • Hypersensitivity Reactions (Including Anaphylaxis and Angioedema): Monitor and discontinue if reaction occurs.
  • Pure Red Cell Aplasia: Monitor and consider discontinuation if diagnosed.
  • Immunizations: Avoid live vaccines.
  • Lymphomas and Other Cancers: Immunosuppressants increase the risk of lymphomas and other cancers, especially of the skin. Monitor for skin changes and advise sun protection and avoidance of artificial UV light.

ADVERSE REACTIONS

The most common adverse reactions (≥3% and ≥2% against placebo) include decreased GFR, hypertension, diarrhea, headache, anemia, cough, urinary tract infection, abdominal pain upper, dyspepsia, alopecia, renal impairment, abdominal pain, mouth ulceration, fatigue, tremor, acute kidney injury, and decreased appetite. Nausea and vomiting have been reported during post-approval use.

SPECIFIC POPULATIONS

Pregnancy: Inform female patients of the potential risk to a fetus and to avoid use of LUPKYNIS during pregnancy.

These are not all the possible side effects of LUPKYNIS. For more information, ask your healthcare provider. You may report side effects to FDA at 1-800-FDA-1088. You may also report side effects to www.fda.gov/medwatch.

WHAT IS LUPKYNIS?

LUPKYNIS is a prescription medicine used with other medicines to treat adults with active lupus nephritis. LUPKYNIS should not be taken with a medicine called cyclophosphamide. Talk with your healthcare provider if you are not sure if you take this medicine.

Please see full Prescribing Information, including BOXED WARNING, and Medication Guide for additional Important Safety Information about LUPKYNIS.