Voclosporin

Voclosporin decreases the activity of your immune system. This may increase the risk that you will get a serious infection. If you experience any of the following symptoms, call your doctor immediately: cough; sore throat; fever; chills; flu-like symptoms; warm, red, or painful skin; pain or burning on urination; frequent urination; lower back pain; or other signs of infection.

Taking voclosporin may increase the risk that you will develop cancer, especially lymphoma (cancer of a part of the immune system) or skin cancer. Tell your doctor if you have or have ever had any type of cancer. To reduce your risk of skin cancer, plan to avoid unnecessary or prolonged exposure to sunlight and to wear protective clothing, sunglasses, and sunscreen during your treatment. If you experience any of the following symptoms, call your doctor immediately: new sores or discoloration on the skin; lumps or masses anywhere in your body; night sweats; swollen glands in the neck, armpits, or groin; trouble breathing; chest pain; weakness or tiredness that does not go away; or pain, swelling, or fullness in the stomach.

Your doctor or pharmacist will give you the manufacturer’s patient information sheet (Medication Guide) when you begin treatment with voclosporin and each time you refill your prescription. Read the information carefully and ask your doctor or pharmacist if you have any questions. You can also visit the Food and Drug Administration (FDA) website (http://www.fda.gov/Drugs/DrugSafety/ucm085729.htm) to obtain the Medication Guide.

Keep all appointments with your doctor and the laboratory. Your doctor will order certain lab tests to check your body’s response to voclosporin.

🔔 Why is this medication prescribed?

Voclosporin is used in combination with other mycophenolate mofetil (Cellcept) and corticosteroids like methylprednisolone or prednisone for treatment of lupus nephritis (an autoimmune disease in which the immune system attacks the kidneys) in adults. Voclosporin is in a class of medications called immunosupressants. It works by decreasing the activity of the immune system to prevent it from attacking the transplanted organ.

🔔 How should this medicine be used?

Voclosporin comes as a capsule to take by mouth. It is usually taken twice a day for up to 1 year. Voclosporin capsules should be taken on an empty stomach 1 hour before or 2 hours after a meal, as close to every 12 hours as possible. There should be at least 8 hours between doses. Take voclosporin at around the same times every day. Follow the directions on your prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand. Take voclosporin exactly as directed. Do not take more or less of it or take it more often than prescribed by your doctor.

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Swallow the capsules whole; do not split, chew, crush, or dissolve them.

Voclosporin controls lupus nephritis but does not cure it. Continue to take voclosporin even if you feel well. Do not stop taking voclosporin without talking to your doctor.

It is not known if taking voclosporin for longer than one year is safe. Talk to your doctor about benefits and risks of continuing to take voclosporin after 1 year.

🔔 Other uses for this medicine

This medication may be prescribed for other uses; ask your doctor or pharmacist for more information.

🔔 What special precautions should I follow?

Before taking voclosporin,

• tell your doctor and pharmacist if you are allergic to voclosporin, any other medications, or any of the ingredients in voclosporin capsules. Ask your pharmacist or check the Medication Guide for a list of the ingredients.
• tell your doctor if you are taking clarithromycin, itraconazole (Sporanox, Tolsura), ketoconazole or ritonavir (Norvir, in Kaletra). Your doctor may tell you not to take voclosporin if you are taking /one or more of these medications.
• tell your doctor and pharmacist what prescription and nonprescription medications, vitamins, and nutritional supplements you are taking or plan to take. Be sure to mention any of the following: amiloride (Midamor); angiotensin-converting enzyme (ACE) inhibitors such as benazepril (Lotensin), captopril, enalapril (Vasotec), fosinopril (Monopril), lisinopril (Prinivil, Zestril, Qbrelis, in Zestoretic), moexipril, perindopril (in Prestalia), quinapril (Accupril, in Accuretic, in Quinaretic), ramipril (Altace), and trandolapril; angiotensin II receptor antagonists such as candesartan (Atacand), irbesartan (Avapro, in Avalide), losartan (Cozaar, in Hyzaar), olmesartan (Benicar, in Azor, in Tribenzor), telmisartan (Micardis), and valsartan (Diovan, in Entresto, in Exforge); carbamazepine (Carbatrol, Epitol, Equetro, Tegretol, Teril); digoxin (Lanoxin); diltiazem (Cardizem, Cartia XT, Taztia XT, Tiazac); efavirenz (Sustiva; in Atripla, in Symfi); erythromycin (E.E.S., ERY-C, Ery-Tab, Erythrocin); fluconazole (Diflucan); nevirapine (Viramune); oxcarbazepine (Oxtellar XR, Trileptal); phenobarbital; phenytoin (Dilantin, Phenytek); rifabutin (Mycobutin, in Talicia); rifampin (Rifadin, Rimactane); spironolactone (Aldactone, Carospir, in Aldactazide); triamterene (Dyrenium, in Maxzide); and verapamil (Calan, Verelan). Your doctor may need to change the doses of your medications or monitor you carefully for side effects. Many other medications may also interact with voclosporin, so be sure to tell your doctor about all the medications you are taking, even those that do not appear on this list.
• tell your doctor what herbal products you are taking, especially St. John’s wort.
• tell your doctor if you have or have ever had any of the conditions mentioned in the IMPORTANT WARNING section or any of the following: long QT syndrome (an inherited condition in which a person is more likely to have QT prolongation); an irregular heartbeat; heart disease; low levels of potassium, calcium, or magnesium in your blood: high blood pressure; or liver or kidney disease.
• tell your doctor if you are pregnant or plan to become pregnant. Voclosporin capsules contain a small amount of alcohol and it is not known what effect it an have on an unborn baby if taken during pregnancy. If you become pregnant while taking voclosporin, call your doctor.
• tell your doctor if you are breastfeeding. Your doctor may tell you not to breastfeed during your treatment and for 7 days after your final dose.
• you should know that voclosporin may cause high blood pressure. Your doctor will monitor your blood pressure carefully, and may prescribe medication to treat high blood pressure if it develops.
• do not have any vaccinations without talking to your doctor.

🔔 What special dietary instructions should I follow?

Do not eat grapefruit or drink grapefruit juice while taking this medication.