Voclosporin Capsules

What is this medication?

VOCLOSPORIN (vok loe SPOR in) treats certain types of lupus. It works by slowing down an overactive immune system, which reduces inflammation and other symptoms of lupus.

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 medications, foods, dyes, or preservatives
• Pregnant or trying to get pregnant
• Breast-feeding

How should I use this medication?

Take this medication by mouth with water. Do not take this medication with grapefruit juice. Take it as directed on the prescription label at the same time every day. Do not cut, crush, or chew this medication. Swallow the capsules whole. Take it on an empty stomach, at least 1 hour before or 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 care team tells you to stop.

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.

Talk to your care team about the use of this medication 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 medication with any of the following:

• Adagrasib
• Ceritinib
• Certain antibiotics, such as clarithromycin or telithromycin
• Certain antivirals for HIV or hepatitis, such as atazanavir, cobicistat, darunavir, delavirdine, fosamprenavir, grazoprevir, indinavir, nelfinavir, ritonavir, saquinavir, tipranavir
• Certain medications for fungal infections, such as fluconazole, ketoconazole, itraconazole, posaconazole, or voriconazole
• Chloramphenicol
• Cidofovir
• Cisapride
• Cyclophosphamide
• Dronedarone
• Grapefruit juice
• Idelalisib
• Lefamulin
• Lonafarnib
• Mifepristone
• Nefazodone
• Other medications that cause heart rhythm changes
• Pimozide
• Ribociclib
• Thioridazine
• Tucatinib

This medication may also interact with the following:

• Bosentan
• Certain medications for cholesterol, such as atorvastatin, lovastatin, simvastatin, rosuvastatin
• Certain medications for seizures, such as carbamazepine, phenobarbital, phenytoin
• Cimetidine
• Diltiazem
• Efavirenz
• Erythromycin
• Fluvoxamine
• Live virus vaccines
• 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 care team for regular checks on your progress. Tell your care team if your symptoms do not start to get better or if they get worse.

This medication may increase your risk of getting an infection. Call your care team 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 medication 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 medications that contain aspirin, acetaminophen, ibuprofen, naproxen, or ketoprofen unless instructed by your care team. These medications may hide a fever.

Talk to your care team if you wish to become pregnant or think you might be pregnant. This medication can cause serious birth defects.

Do not breast-feed while taking this medication and for 7 days after stopping therapy.

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

What side effects may I notice from receiving this medication?

Side effects that you should report to your care team as soon as possible:

• Allergic reactions—skin rash, itching, hives, swelling of the face, lips, tongue, or throat
• Burning or tingling sensation in hands or feet
• Heart rhythm changes—fast or irregular heartbeat, dizziness, feeling faint or lightheaded, chest pain, trouble breathing
• High potassium level—muscle weakness, fast or irregular heartbeat
• Increase in blood pressure
• Infection—fever, chills, cough, sore throat, wounds that don't heal, pain or trouble when passing urine, general feeling of discomfort or being unwell
• Kidney injury—decrease in the amount of urine, swelling of the ankles, hands, or feet
• Low red blood cell level—unusual weakness or fatigue, dizziness, headache, trouble breathing
• Sudden and severe headache, confusion, change in vision, seizures, which may be signs of posterior reversible encephalopathy syndrome (PRES)
• Tremors or shaking

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

• Diarrhea
• Fatigue
• Hair loss
• Headache
• Pain, redness, or swelling with sores inside the mouth or throat
• Stomach pain
• 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 it in the original packaging until you are ready to take it. Get rid of any unused medication after the expiration date.

To get rid of medications that are no longer needed or have expired:

• Take the medication to a medication take-back program. Check with your pharmacy or law enforcement to find a location.
• If you cannot return the medication, check the label or package insert to see if the medication should be thrown out in the garbage or flushed down the toilet. If you are not sure, ask your care team. If it is safe to put it in the trash, take the medication out of the container. Mix the medication with cat litter, dirt, coffee grounds, or other unwanted substance. Seal the mixture in a bag or container. Put it in the trash.

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.