Pronunciation:

voe-kloe-SPOR-in

Brand Names:

• Lupkynis

Dosage Forms:

• Capsule, Liquid Filled

Warnings:

Warning: Malignancies and Serious InfectionsIncreased risk for developing malignancies and serious infections with voclosporin or other immunosuppressants that may lead to hospitalization or death .

Classifications:

Therapeutic—

Immune Suppressant

Pharmacologic—

Calcineurin Inhibitor

Uses of This Medicine:

Voclosporin is used to treat active lupus nephritis. It is a calcineurin inhibitor that changes the immune system to help control lupus symptoms.

This medicine is available only with your doctor's prescription.

Before Using This Medicine:

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies—

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Children—

Appropriate studies have not been performed on the relationship of age to the effects of voclosporin in the pediatric population. Safety and efficacy have not been established.

Older adults—

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of voclosporin in the elderly. However, elderly patients are more likely to have age-related liver, kidney, or heart problems, which may require caution and an adjustment in the dose for patients receiving voclosporin.

Breast-feeding—

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Other medicines—

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.

• Bepridil
• Boceprevir
• Cisapride
• Clarithromycin
• Cobicistat
• Conivaptan
• Dronedarone
• Fluconazole
• Idelalisib
• Indinavir
• Itraconazole
• Ketoconazole
• Levoketoconazole
• Lopinavir
• Mesoridazine
• Nefazodone
• Nelfinavir
• Pimozide
• Piperaquine
• Posaconazole
• Ritonavir
• Saquinavir
• Sparfloxacin
• Telaprevir
• Telithromycin
• Terfenadine
• Thioridazine
• Voriconazole
• Ziprasidone

Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Adagrasib
• Adenovirus Vaccine, Live
• Alfuzosin
• Amiodarone
• Amisulpride
• Amitriptyline
• Anagrelide
• Apalutamide
• Apomorphine
• Aprepitant
• Aripiprazole
• Aripiprazole Lauroxil
• Arsenic Trioxide
• Asenapine
• Astemizole
• Atazanavir
• Azithromycin
• Bacillus of Calmette and Guerin Vaccine, Live
• Bedaquiline
• Belzutifan
• Bosentan
• Buprenorphine
• Buserelin
• Carbamazepine
• Cenobamate
• Ceritinib
• Chloroquine
• Chlorpromazine
• Cholera Vaccine, Live
• Ciprofloxacin
• Citalopram
• Clofazimine
• Clomipramine
• Clothiapine
• Clozapine
• Crizotinib
• Cyclobenzaprine
• Cyclosporine
• Dabrafenib
• Dasatinib
• Degarelix
• Delamanid
• Dengue Tetravalent Vaccine, Live
• Desipramine
• Deslorelin
• Deutetrabenazine
• Dexmedetomidine
• Digoxin
• Diltiazem
• Disopyramide
• Dofetilide
• Dolasetron
• Domperidone
• Donepezil
• Doxepin
• Droperidol
• Duvelisib
• Ebastine
• Ebola Zaire Vaccine, Live
• Efavirenz
• Encorafenib
• Entrectinib
• Enzalutamide
• Eribulin
• Erythromycin
• Escitalopram
• Etravirine
• Famotidine
• Fedratinib
• Felbamate
• Fexinidazole
• Fingolimod
• Flecainide
• Fluoxetine
• Fluvoxamine
• Formoterol
• Foscarnet
• Fosnetupitant
• Fosphenytoin
• Galantamine
• Gatifloxacin
• Gemifloxacin
• Gepirone
• Glasdegib
• Gonadorelin
• Goserelin
• Granisetron
• Halofantrine
• Haloperidol
• Histrelin
• Hydroquinidine
• Hydroxychloroquine
• Hydroxyzine
• Ibutilide
• Iloperidone
• Imatinib
• Imipramine
• Influenza Virus Vaccine, Live
• Inotuzumab Ozogamicin
• Ivabradine
• Ivosidenib
• Lapatinib
• Larotrectinib
• Lenacapavir
• Lenvatinib
• Letermovir
• Leuprolide
• Levofloxacin
• Lofexidine
• Lorlatinib
• Lumacaftor
• Lumefantrine
• Macimorelin
• Mavacamten
• Measles Virus Vaccine, Live
• Mefloquine
• Methadone
• Methotrimeprazine
• Metronidazole
• Mifepristone
• Mitotane
• Mizolastine
• Mobocertinib
• Modafinil
• Moricizine
• Moxifloxacin
• Mumps Virus Vaccine, Live
• Nafarelin
• Nafcillin
• Netupitant
• Nilotinib
• Norfloxacin
• Octreotide
• Ofloxacin
• Olanzapine
• Olutasidenib
• Omaveloxolone
• Ondansetron
• Osilodrostat
• Osimertinib
• Oxaliplatin
• Pacritinib
• Paliperidone
• Panobinostat
• Papaverine
• Paroxetine
• Pasireotide
• Pazopanib
• Pentamidine
• Perphenazine
• Phenobarbital
• Phenytoin
• Pimavanserin
• Pipamperone
• Pirtobrutinib
• Pitolisant
• Poliovirus Vaccine, Live
• Ponesimod
• Primidone
• Probucol
• Procainamide
• Prochlorperazine
• Promethazine
• Propafenone
• Protriptyline
• Quetiapine
• Quinidine
• Quinine
• Quizartinib
• Ranolazine
• Relugolix
• Ribociclib
• Rifabutin
• Rifampin
• Risperidone
• Ritlecitinib
• Rotavirus Vaccine, Live
• Rubella Virus Vaccine, Live
• Selpercatinib
• Sertindole
• Sertraline
• Sevoflurane
• Siponimod
• Smallpox Monkeypox Vaccine, Live Non-Replicating
• Smallpox Vaccine
• Sodium Phosphate
• Sodium Phosphate, Dibasic
• Sodium Phosphate, Monobasic
• Solifenacin
• Sorafenib
• Sotalol
• St John's Wort
• Sulpiride
• Sultopride
• Sunitinib
• Tacrolimus
• Tamoxifen
• Telavancin
• Tetrabenazine
• Tizanidine
• Tocilizumab
• Tolterodine
• Toremifene
• Trazodone
• Triclabendazole
• Trimipramine
• Triptorelin
• Trofinetide
• Typhoid Vaccine, Live
• Vandetanib
• Vardenafil
• Varicella Virus Vaccine, Live
• Vemurafenib
• Venlafaxine
• Verapamil
• Vilanterol
• Vinflunine
• Vorinostat
• Yellow Fever Vaccine
• Zoster Vaccine, Live
• Zotepine
• Zuclopenthixol

Other interactions—

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following is usually not recommended, but may be unavoidable in some cases. If used together, your doctor may change the dose or how often you use this medicine, or give you special instructions about the use of food, alcohol, or tobacco.

• Grapefruit Juice

Other medical problems—

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

• Heart rhythm problems or
• Hyperkalemia (high levels of potassium in the blood) or
• Hypertension (high blood pressure)—Use with caution. May make these conditions worse.

• Kidney disease, severe or
• Liver disease, mild or moderate—Use with caution. The effects may be increased because of slower removal of the medicine from the body.

• Liver disease, severe—Avoid use in patients with this condition.

Proper Use of This Medicine:

Take this medicine only as directed by your doctor. Do not take more of it, do not take it more often, and do not take it for a longer time than your doctor ordered. Do not stop taking or change your dose without checking first with your doctor.

This medicine comes with a Medication Guide. Read and follow these instructions carefully. Ask your doctor if you have any questions.

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.

Do not eat grapefruit or drink grapefruit juice while you are using this medicine.

Dosing—

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

• For oral dosage form (capsules):
  • For active lupus nephritis:
    • Adults—23.7 milligrams (mg) 2 times a day at least 12 hours apart. Do not take it less than 8 hours apart. Your doctor may adjust your dose as needed and tolerated.
    • Children—Use and dose must be determined by your doctor.

Missed dose—

If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

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.

Storage—

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep this medicine in its original container.

Precautions While Using This Medicine:

It is very important that your doctor check your progress at regular visits to make sure that this medicine is working properly. Blood and urine tests may be needed to check for unwanted effects.

Do not use this medicine if you are also using cyclophosphamide or medicine to treat infections (eg, clarithromycin, itraconazole, ketoconazole).

Using this medicine while you are pregnant can harm your unborn baby. Use an effective form of birth control to keep from getting pregnant during treatment. If you think you have become pregnant while using the medicine, tell your doctor right away.

This medicine may increase your risk for certain cancers, including lymphoma or skin cancer. Avoid sun exposure. Use a sunscreen when you are outdoors. Avoid sunlamps and tanning beds. Talk to your doctor if you have concerns about this risk.

Your body's ability to fight infection may be reduced while you are being treated with voclosporin. It is very important that you call your doctor at the first signs of any infection. Check with your doctor right away if you or your child have fever, chills, cough or hoarseness, flu-like symptoms, lower back or side pain, painful or difficult urination, or unusual tiredness or weakness.

This medicine may cause serious kidney problems. Check with your doctor right away if you have blood in your urine, change in frequency of urination or amount of urine, difficulty in breathing, drowsiness, increased thirst, loss of appetite, nausea or vomiting, swelling of the feet or lower legs, or weakness.

This medicine may cause high blood pressure. Check with your doctor right away if you have blurred vision, dizziness, headache, nervousness, pounding in the ears, or slow or fast heartbeat.

This medicine may cause serious nervous system problems (eg, posterior reversible encephalopathy syndrome). Check with your doctor right away if you have blurred or double vision, difficulty in walking, headache, jaw pain, numbness or tingling in the fingers and toes, pain in the fingers and toes, pain the testicles, or weakness.

Tell your doctor right away if you have confusion, difficult breathing, irregular heartbeat, nausea or vomiting, nervousness, numbness or tingling in the hands, feet, or lips, stomach pain, or weakness or heaviness of the legs. These may be symptoms of hyperkalemia.

This medicine may cause heart rhythm problems (eg, QT prolongation). Check with your doctor right away if you have chest pain or discomfort, fainting, irregular or slow heart rate, or trouble breathing.

While you are being treated with voclosporin, and after you stop treatment with it, do not have any immunizations (vaccinations) without your doctor's approval. Voclosporin may lower your body's resistance and there is a chance you might get the infection the immunization is meant to prevent. In addition, other persons living in your household should not take or should not have taken oral polio vaccine within the last several months since there is a chance they could pass the polio virus on to you. Also, avoid other persons who have taken oral polio vaccine. Do not get close to them and do not stay in the same room with them for very long. If you cannot take these precautions, you should consider wearing a protective face mask that covers the nose and mouth.

This medicine may cause a blood disorder called pure red cell aplasia. Check with your doctor right away if you have fever, sore throat, pale skin, unusual bleeding or bruising, or unusual tiredness or weakness.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.

Side Effects of This Medicine:

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

More common

Agitation

anxiety

back pain

black, tarry stools

bloody or cloudy urine

blurred vision

body aches or pain

burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings

change in frequency of urination or amount of urine

chest pain or discomfort

chills

coma

confusion

cough

decreased urine output

diarrhea

difficult, burning, or painful urination

dizziness

drowsiness

dry mouth

ear congestion

fainting

fever

frequent urge to urinate

general feeling of illness

hallucinations

headache

hostility

increased thirst

irregular or slow heart rate

irritability

loss of appetite

loss of voice

lower back or side pain

mood or mental changes

muscle twitching

nausea or vomiting

nervousness

numbness or tingling in the hands, feet, or lips

painful blisters on trunk of body

pale skin

pounding in the ears

rapid weight gain

restlessness

seizures

slow or fast heartbeat

sneezing

sore throat

stiff neck

stomach pain

stuffy or runny nose

swelling of the face, feet, lower legs, ankles, or hands

swollen glands

trouble breathing

unusual bleeding or bruising

unusual tiredness or weakness

weakness or heaviness of the legs

weight loss

yellow skin and eyes

Less common

Persistent non-healing sore

pink growth

reddish patch or irritated area

shakiness in the legs, arms, hands, feet

shiny bump

trembling or shaking of the hands or feet

white, yellow or waxy scar-like area

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common

Acid or sour stomach

belching

hair loss, thinning of hair

heartburn

indigestion

stomach discomfort or upset

Less common

Decreased appetite

irritation or soreness of the mouth

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

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