Voclosporin -(LUPKYNIS) - Jan 2021)

 

PATIENT COUNSELING INFORMATION

 

Advise the patient to read the FDA-approved patient labeling (Medication Guide). 

 

Administration Advise patients to: • Swallow LUPKYNIS capsules whole, and not to open, crush, or divide LUPKYNIS capsules.     

 

• Take LUPKYNIS on an empty stomach consistently as close to a 12-hour schedule as possible, and with a minimum of 8 hours between doses.                                                  • If a dose is missed, take it as soon as possible within 4 hours after missing the dose. Beyond the 4-hour time frame, wait until the usual scheduled time to take the next regular dose. Do not double the next dose.                                                                        • Avoid eating grapefruit or drinking grapefruit juice while taking LUPKYNIS. 

 

Development of Lymphoma and Other Malignancies-                                                       Inform patients that they are at an increased risk of developing lymphomas and other malignancies, particularly of the skin, due to immunosuppression. Advise patients to limit exposure to sunlight and ultraviolet (UV) light by wearing protective clothing and use a sunscreen with a high protection factor.

 

Increased Risk of Infection-                                                                                              Inform patients that they are at an increased risk of developing a variety of infections, including opportunistic infections, due to immunosuppression and to contact their physician if they develop any symptoms of infection such as fever, sweats or chills, cough or flu-like symptoms, muscle aches, or warm, red, painful areas on the skin

 

Nephrotoxicity (Acute and/or Chronic) Inform patients that LUPKYNIS can have toxic effects on the kidney that should be monitored. Advise patients to attend all visits and complete all blood tests ordered by their medical team

 

 

Hypertension-                                                                                                                     Inform patients that LUPKYNIS can cause high blood pressure which may require treatment with antihypertensive therapy. Advise patients to monitor their blood pressure.

 

Neurotoxicity-                                                                                                                     Inform patients that they are at risk of developing adverse neurologic effects including seizure, altered mental status, and tremor. Advise patients to contact their physician should they develop vision changes, delirium, or tremors

 

 Hyperkalemia-                                                                                                                   Inform patients that LUPKYNIS can cause hyperkalemia. Monitoring of potassium levels may be necessary, especially with concomitant use of other drugs known to cause hyperkalemia.

 

Drug Interactions -                                                                                                            Advise patients to tell their healthcare provider when they start or stop taking any concomitant medications. Strong CYP3A4 inhibitors (e.g., ketoconazole, itraconazole, clarithromycin) are contraindicated with LUPKYNIS, and other CYP3A4 enzyme modulating drugs can alter LUPKYNIS exposure.

   

Pregnancy-                                                                                                                        Inform female patients of the potential risk to a fetus and to avoid use of LUPKYNIS during pregnancy. When LUPKYNIS is administered in combination with MMF, refer patients to the MMF medication guide.

Advise females to inform their healthcare provider if they are pregnant or become pregnant.

 

Lactation -                                                                                                                       Advise women not to breastfeed during treatment with LUPKYNIS and for 7 days after the last dose of LUPKYNIS 

 

Immunizations-                                                                                                                 Inform patients that LUPKYNIS can interfere with the usual response to immunizations and that they should avoid live vaccines

 

 

 

Manufactured for: Aurinia Pharmaceuticals Inc. #1203-4464 Markham Street Victoria, BC V8Z7X8 Canada 

 

Distributed by: Aurinia Pharma U.S., Inc. 77 Upper Rock Circle  Suite 700 Rockville, MD 20850 USA