Voclosporin (voe-kloe-SPOR-in)

Treats active lupus nephritis.

Brand Name(s):

When This Medicine Should Not Be Used:

How to Use This Medicine:

Capsule

• Take your medicine as directed. Your dose may need to be changed several times to find what works best for you.
• Swallow the capsule whole. Do not crush, break, chew, or dissolve it.
• It is best to take this medicine on an empty stomach, either 1 hour before or 2 hours after a meal.
• Take this medicine 2 times a day at least 12 hours apart. Do not take it less than 8 hours apart.
• This medicine should come with a Medication Guide. Ask your pharmacist for a copy if you do not have one.
• Missed dose: If you miss a dose and it is less than 4 hours, take it as soon as possible. If you miss a dose and it is more than 4 hours, skip the missed dose and take your next dose at the regular time. Do not use extra medicine to make up for a missed dose.
• Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep this medicine in its original container.

Drugs and Foods to Avoid:

Ask your doctor or pharmacist before using any other medicine, including over-the-counter medicines, vitamins, and herbal products.

• Do not use this medicine if you are also using cyclophosphamide or medicine to treat infections (including clarithromycin, itraconazole, ketoconazole).
• Some medicines can affect how voclosporin works. Tell your doctor if you are using diltiazem, efavirenz, fluconazole, verapamil, or medicine that may cause heart rhythm problems.
• This medicine may interfere with vaccines. Ask your doctor before you get a flu shot or any other vaccines. You should not receive live vaccines during treatment with this medicine.
• Do not eat grapefruit or drink grapefruit juice while you are using this medicine.

Warnings While Using This Medicine:

• It is not safe to take this medicine during pregnancy. It could harm an unborn baby. Tell your doctor right away if you become pregnant.
• Tell your doctor if you are breastfeeding, or if you have kidney disease, liver disease, heart rhythm problems, or high blood pressure.
• This medicine may cause the following problems:
  • Increased risk for cancer, including skin cancer, lymphoma
  • Increased risk for infection
  • Kidney problems
  • High blood pressure
  • Brain or nerve problems (including posterior reversible encephalopathy syndrome)
  • Heart rhythm problems (including QT prolongation)
  • Blood disorder (including pure red cell aplasia)
• Avoid people who are sick or have infections.
• This medicine may make your skin more sensitive to sunlight. Wear sunscreen. Do not use sunlamps or tanning beds.
• Your doctor will do lab tests at regular visits to check on the effects of this medicine. Keep all appointments.
• Keep all medicine out of the reach of children. Never share your medicine with anyone.

Possible Side Effects While Using This Medicine:

Call your doctor right away if you notice any of these side effects:

• Allergic reaction: Itching or hives, swelling in your face or hands, swelling or tingling in your mouth or throat, chest tightness, trouble breathing
• Blurred vision, confusion, headache, seizures
• Change in how much or how often you urinate, bloody or cloudy urine, difficult or painful urination, lower back or side pain
• Confusion, weakness, trouble breathing, numbness or tingling in your hands, feet, or lips
• Fast, pounding, or uneven heartbeat
• Fainting, dizziness, lightheadedness
• Fever, chills, cough, sore throat, body aches
• Sores, reddish patch or irritated area, shiny bump, pink growth, or white, yellow or waxy scar-like area on the skin
• Unusual bleeding, bruising, or weakness

If you notice these less serious side effects, talk with your doctor:

• Diarrhea, stomach pain or upset
• Hair loss

If you notice other side effects that you think are caused by this medicine, tell your doctor

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088