Voclosporin Oral Capsules

What is this medication?

VOCLOSPORIN (vok loe SPOR in) is used to treat active lupus nephritis (lupus-related kidney inflammation). This drug is used with standard therapy for this condition. It is not a cure.

This medicine may be used for other purposes; ask your health care provider or pharmacist if you have questions.

COMMON BRAND NAME(S): LUPKYNIS

What should I tell my care team before I take this medication?

They need to know if you have any of these conditions:

• heart disease
• high blood pressure
• immune system problems
• infection
• irregular heartbeat or rhythm
• kidney disease
• liver disease
• recent or upcoming vaccination
• an unusual or allergic reaction to voclosporin, other medicines, foods, dyes, or preservatives
• pregnant or trying to get pregnant
• breast-feeding

How should I use this medication?

Take this medicine by mouth with water. Take it as directed on the prescription label at the same time every day. Do not cut, crush or chew this medicine. Swallow the capsules whole. Take it on an empty stomach, at least 1 hour before and 2 hours after food. Take it as close as possible to 12 hours between doses. Do not take your doses less than 8 hours apart. Keep taking it unless your health care provider tells you to stop. Do not take this medicine with grapefruit juice.

A special MedGuide will be given to you by the pharmacist with each prescription and refill. Be sure to read this information carefully each time. The sheet may change often.

Talk to your health care provider about the use of this medicine in children. Special care may be needed.

Overdosage: If you think you have taken too much of this medicine contact a poison control center or emergency room at once.

NOTE: This medicine is only for you. Do not share this medicine with others.

What if I miss a dose?

If you miss a dose, take it as soon as you can within 4 hours after missing the dose. If more than 4 hours has passed, skip the missed dose and take only the next dose at the regular time. Do not take extra or 2 doses at the same time to make up for the missed dose.

What may interact with this medication?

Do not take this medicine with any of the following medicines:

• ceritinib
• certain antivirals for HIV or hepatitis like atazanavir, cobicistat, darunavir, delavirdine, fosamprenavir, grazoprevir, indinavir, nelfinavir, ritonavir, saquinavir, tipranavir
• certain medicines for fungal infections like fluconazole, ketoconazole, itraconazole, posaconazole, or voriconazole
• chloramphenicol
• cidofovir
• cisapride
• clarithromycin
• cyclophosphamide
• dronedarone
• grapefruit juice
• idelalisib
• lefamulin
• lonafarnib
• mifepristone
• nefazodone
• other medicines that prolong the QT interval (an abnormal heart rhythm)
• pimozide
• ribociclib
• telithromycin
• thioridazine
• tucatinib

This medicine may also interact with the following medicines:

• bosentan
• carbamazepine
• certain medicines for cholesterol like atorvastatin, lovastatin, simvastatin, rosuvastatin
• cimetidine
• diltiazem
• efavirenz
• erythromycin
• fluvoxamine
• live virus vaccines
• phenobarbital
• phenytoin
• rifampin
• St. John's wort
• verapamil

This list may not describe all possible interactions. Give your health care provider a list of all the medicines, herbs, non-prescription drugs, or dietary supplements you use. Also tell them if you smoke, drink alcohol, or use illegal drugs. Some items may interact with your medicine.

What should I watch for while using this medication?

Visit your health care provider for regular checks on your progress. Tell your health care provider if your symptoms do not start to get better or if they get worse.

This medicine may increase your risk of getting an infection. Call your health care provider for advice if you get a fever, chills, sore throat, or other symptoms of a cold or flu. Do not treat yourself. Try to avoid being around people who are sick.

This medicine can make you more sensitive to the sun. Keep out of the sun. If you cannot avoid being in the sun, wear protective clothing and use sunscreen. Do not use sun lamps or tanning beds/booths.

Avoid taking medicines that contain aspirin, acetaminophen, ibuprofen, naproxen, or ketoprofen unless instructed by your health care provider. These medicines may hide a fever.

Do not become pregnant while taking this medicine. Women should inform their health care provider if they wish to become pregnant or think they might be pregnant. There is potential for serious harm to an unborn child. Talk to your health care provider for more information. Do not breast-feed an infant while taking this medicine.

Talk to your health care provider about your risk of cancer. You may be more at risk for certain types of cancers if you take this medicine.

What side effects may I notice from receiving this medication?

Side effects that you should report to your doctor or health care professional as soon as possible:

• allergic reactions (skin rash, itching or hives; swelling of the face, lips, or tongue)
• changes in vision
• confusion
• fast, irregular heartbeat
• high potassium levels (chest pain; fast, irregular heartbeat; muscle weakness)
• increase in blood pressure
• infection (fever, chills, cough, sore throat, pain or trouble passing urine)
• low red blood cell counts (trouble breathing; feeling faint; lightheaded, falls; unusually weak or tired)
• kidney injury (trouble passing urine or change in the amount of urine)
• mouth sores
• pain, tingling, numbness in the hands or feet
• seizures
• tremors

Side effects that usually do not require medical attention (report these to your doctor or health care professional if they continue or are bothersome):

• diarrhea
• hair loss
• headache
• stomach pain
• tiredness
• upset stomach

This list may not describe all possible side effects. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Where should I keep my medication?

Keep out of the reach of children and pets.

Store at room temperature between 20 and 25 degrees C (68 and 77 degrees F). Keep this medicine in the original packaging until you are ready to take it. Throw away any unused medicine after the expiration date.

NOTE: This sheet is a summary. It may not cover all possible information. If you have questions about this medicine, talk to your doctor, pharmacist, or health care provider.