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.
Indication
LUPKYNIS is indicated in combination with a background immunosuppressive therapy
regimen for the treatment of adult patients with active lupus nephritis (LN).
Limitations of Use: Safety and efficacy of LUPKYNIS have not been established in
combination with cyclophosphamide. Use of LUPKYNIS is not recommended in this situation.
Please see full Prescribing Information, including BOXED WARNING, and Medication Guide for additional Important Safety Information about LUPKYNIS.
