Lupkynis

Voclosporin is used in combination with other medications to treat a certain kidney disorder (lupus nephritis). Lupus nephritis is an immune disorder where certain proteins in your own body attack and cause damage to the kidneys. Symptoms may include blood/protein in the urine, high blood pressure, and poor kidney function. Voclosporin belongs to a class of drugs known as immunosuppressants. It works by weakening the immune system to help decrease damage to your kidneys.

Read the Medication Guide provided by your pharmacist before you start taking voclosporin and each time you get a refill. If you have any questions, ask your doctor or pharmacist.

Take this medication by mouth on an empty stomach (1 hour before or 2 hours after a meal) as directed by your doctor, usually twice daily. Take your doses of this medication as close to 12 hours apart as you can. Do not take your doses less than 8 hours apart. Swallow this medication whole. Do not open, crush, chew, or dissolve the capsules. Doing so may increase the risk of side effects.

The dosage is based on your medical condition and response to treatment.

Avoid eating grapefruit or drinking grapefruit juice while using this medication unless your doctor or pharmacist says you may do so safely. Grapefruit can increase the chance of side effects with this medicine. Ask your doctor or pharmacist for more details.

Use this medication regularly to get the most benefit from it. To help you remember, take it at the same times each day.

See also Warning section.

Headache, tiredness, dizziness, diarrhea, shaking, upset stomach, or abdominal pain may occur. If any of these effects last or get worse, tell your doctor or pharmacist promptly.

Temporary hair loss may occur. Normal hair growth should return after treatment has ended.

People using this medication may have serious side effects. However, your doctor has prescribed this drug because he or she has judged that the benefit to you is greater than the risk of side effects. Careful monitoring by your doctor may decrease your risk.

This medication may raise your blood pressure. Check your blood pressure regularly and tell your doctor if the results are high. Your doctor may control your blood pressure with medication.

Tell your doctor right away if you have any serious side effects, including: signs of kidney problems (such as a change in the amount of urine), mental/mood changes (such as confusion, changes in alertness), easy bruising/bleeding, numbness/tingling, vision changes.

Get medical help right away if you have any very serious side effects, including: fast/irregular heartbeat, severe dizziness, fainting, seizures.

A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US - Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

Before taking voclosporin, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: kidney problems, liver problems, high blood pressure, recent/current infections.

This drug may make you dizzy. Alcohol or marijuana (cannabis) can make you more dizzy. Do not drive, use machinery, or do anything that needs alertness until you can do it safely. Limit alcoholic beverages. Talk to your doctor if you are using marijuana (cannabis).

Voclosporin may cause a condition that affects the heart rhythm (QT prolongation). QT prolongation can rarely cause serious (rarely fatal) fast/irregular heartbeat and other symptoms (such as severe dizziness, fainting) that need medical attention right away.

The risk of QT prolongation may be increased if you have certain medical conditions or are taking other drugs that may cause QT prolongation. Before using voclosporin, tell your doctor or pharmacist of all the drugs you take and if you have any of the following conditions: certain heart problems (heart failure, slow heartbeat, QT prolongation in the EKG), family history of certain heart problems (QT prolongation in the EKG, sudden cardiac death).

Low levels of potassium or magnesium in the blood may also increase your risk of QT prolongation. This risk may increase if you use certain drugs (such as diuretics/"water pills") or if you have conditions such as severe sweating, diarrhea, or vomiting.

Voclosporin can make you more likely to get infections or may worsen any current infections. Avoid contact with people who have infections that may spread to others (such as chickenpox, measles, flu). Consult your doctor if you have been exposed to an infection or for more details.

Do not have immunizations/vaccinations without the consent of your doctor. Avoid contact with people who have recently received live vaccines (such as flu vaccine inhaled through the nose).

This medication may increase your risk of developing skin cancer. Limit your time in the sun. Avoid tanning booths and sunlamps. Use sunscreen and wear protective clothing when outdoors. Tell your doctor right away if you get sunburned, have skin blisters/redness, or notice new or changed moles/skin lesions.

Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).

Older adults may be more sensitive to the side effects of this drug, especially QT prolongation (see above).

Tell your doctor if you are pregnant or plan to become pregnant. You should not become pregnant while using voclosporin. Voclosporin contains alcohol and may harm an unborn baby. If you become pregnant, talk to your doctor right away about the risks and benefits of this medication.

This medication passes into breast milk. Because of the possible risk to the infant, breast-feeding while using this drug and for at least 7 days after the last dose is not recommended. Consult your doctor before breast-feeding.

Store in the original package at room temperature away from heat and moisture. Do not store in the bathroom. Keep all medications away from children and pets.

Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company.

See also How to Use section.

Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval.

Some products that may interact with this drug are: cyclophosphamide, drugs that may increase potassium levels (such as potassium supplements, certain diuretics/"water pills" including amiloride, spironolactone).

Other medications can affect the removal of voclosporin from your body, which may affect how voclosporin works. Examples include azole antifungals (such as itraconazole, ketoconazole), boceprevir, HIV protease inhibitors (such as lopinavir, saquinavir), macrolide antibiotics (such as clarithromycin, erythromycin), rifamycins (such as rifabutin, rifampin), St. John's wort, telaprevir, drugs used to treat seizures (such as carbamazepine, phenytoin), among others.

If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center.

If you miss a dose, take it as soon as you remember if it is within 4 hours after the missed dose. If it is more than 4 hours after the missed dose, skip the missed dose. Take your next dose at the regular time. Do not double the dose to catch up.

Do not share this medication with others.

Lab and/or medical tests (such as kidney function, blood pressure, blood mineral levels, complete blood count, skin exam) should be done while you are taking this medication. Keep all medical and lab appointments. Consult your doctor for more details.