Voclosporin

Pronunciation: VOE-kloe-SPOR-in
Generic name: voclosporin
Brand name: Lupkynis
Dosage form: oral capsule (7.9 mg)
Drug class: Calcineurin inhibitors

Medically reviewed by Carmen Pope, BPharm. Last updated on Nov 11, 2024.

What is voclosporin?

Voclosporin (brand name Lupkynis) is used to treat active lupus nephritis (kidney problems associated with system lupus erythematosus (SLE)) in adults, together with other medicines.

Voclosporin's mechanism of action is not fully understood but involves the inhibition of calcineurin. Calcineurin is an enzyme that activates T-cells of the immune system (these are a type of white blood cell involved in various inflammatory conditions). Voclosporin belongs to the drug class called calcineurin inhibitors, and these medications are immunosuppressants. Voclosporin is not a steroid.

• Voclosporin should not be taken with a medicine called cyclophosphamide. Talk with your healthcare provider if you are not sure if you take this medicine.
• Voclosporin is an oral treatment for active lupus nephritis that works in a different way to Benlysta, an injectable medication (see What is the difference between Lupkynis and Benlysta?).

Voclosporin gained FDA approval on January 22, 2021 under the brand name Lupkynis. Voclosporin is a limited-distribution drug, which means you will receive it from a specialty pharmacy. There is no voclosporin generic.

Voclosporin side effects

The most common side effects of voclosporin are:

• diarrhea
• urinary tract infection
• heartburn
• headache
• stomach pain
• hair loss (alopecia)
• cough.

Serious side effects and warnings

Voclosporin for lupus nephritis carries a Boxed Warning for an increased risk of developing cancer or infections.

Increased risk of cancer. People who take voclosporin have an increased risk of getting certain kinds of cancer, including skin cancer and cancer of the lymph glands (lymphoma).

Increased risk of infection. Voclosporin is a medicine that affects your immune system and can lower the ability of your immune system to fight infections. Serious infections can happen in people receiving voclosporin which can lead to hospitalizations and can cause death. Call your healthcare provider right away if you have symptoms of an infection such as:

• fever
• cough or flu-like symptoms
• warm, red, or painful areas on your skin
• sweats or chills
• muscle aches.

Kidney problems. Kidney problems are common side effects of voclosporin and may be serious. Your healthcare provider may do certain tests to check your kidney function while you take voclosporin.

High blood pressure. High blood pressure is a common side effect of voclosporin and may be serious. Your healthcare provider will monitor your blood pressure while you take voclosporin and may ask you to check your blood pressure at home.

Nervous system problems. Nervous system problems are a common side effect of voclosporin and may be serious. Call your healthcare provider or go to the nearest hospital emergency room right away if you get any of these symptoms while taking voclosporin. These could be signs of serious nervous system problems:

• confusion
• numbness and tingling
• seizures
• changes in alertness
• headache
• vision changes
• muscle tremors
• high levels of potassium in your blood. Your healthcare provider may do certain tests to check your potassium levels while you take voclosporin.
• a serious heart rhythm problem (QT prolongation).
• severe low red blood cell count (anemia).

Get emergency medical help if you have signs of an allergic reaction to voclosporin such as hives; difficulty breathing; or swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have:

• pain or burning when you urinate;

• kidney problems - little or no urination, swelling in your feet or ankles, feeling tired or short of breath;

• high blood pressure - severe headache, blurred vision, pounding in your neck or ears;

• nervous system problems - confusion, vision changes, headache, feeling less alert, tremors, numbness, tingling, seizure;

• high potassium level - nausea, weakness, tingly feeling, chest pain, irregular heartbeats, loss of movement; or

• low red blood cells (anemia) - pale skin, unusual tiredness, feeling light-headed or short of breath, cold hands and feet.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

Related/similar drugs

Before taking

Do not take voclosporin with medicines known as strong CYP3A4 inhibitors such as ketoconazole, itraconazole, and clarithromycin.

Do not take this medicine if you are allergic to voclosporin, Lupkynis, or any of the inactive ingredients in the medicine.

Before you take voclosporin, tell your healthcare provider about all your medical conditions, including if you:

• plan to receive any vaccines. You should not receive any live vaccines during treatment with voclosporin. Ask your healthcare provider if you are not sure if your vaccine is a live vaccine. Other vaccines may not work as well during treatment with voclosporin
• have or have had liver, kidney, or heart problems
• have high blood pressure
• are pregnant or plan to become pregnant
• are breastfeeding or plan to breastfeed.

Taking voclosporin may increase your risk of certain cancers such as skin cancer or lymphoma. Ask your doctor about your specific risk.

Pregnancy

Voclosporin may harm your unborn baby. When taking voclosporin in combination with mycophenolate mofetil, you should also read the Medication Guide for mycophenolate mofetil for important pregnancy information.

Breastfeeding

Voclosporin can pass into breastmilk. You and your healthcare provider should decide if you will take voclosporin while you are breastfeeding.

How should I take voclosporin?

Take voclosporin exactly as prescribed by your doctor. Follow all directions on your prescription label and read all medication guides or instruction sheets. Your doctor may occasionally change your dose.

Swallow the voclosporin capsule whole. Do not break, crush, chew, or dissolve the voclosporin capsules before swallowing. If you cannot swallow voclosporin capsules whole, tell your healthcare provider.

• Take voclosporin on an empty stomach, at least 1 hour before or 2 hours after a meal.
• Take your doses at regular intervals 12 hours apart. Do not take your doses less than 8 hours apart.
• If you have not experienced a benefit within 24 weeks from taking voclosporin, your healthcare provider may decide to stop treatment.

Voclosporin affects your immune system. You may get infections more easily, even serious or fatal infections. You will need frequent medical tests. Your treatment with voclosporin may be delayed or stopped based on the results.

Voclosporin dosing

Usual Adult Dose of Voclosporin for Lupus Nephritis: voclosporin 23.7 mg (3 capsules) orally 2 times a day.

• Each capsule of voclosporin contains 7.9 mg.

Your healthcare provider will check your kidney function before treatment and monitor your blood pressure throughout treatment.

What happens if I miss a dose?

If a dose of voclosporin is missed, take it as soon as possible within 4 hours after missing the dose. If more than 4 hours have passed, skip the missed dose and take the next dose at the regular time. Do not take 2 doses at the same time.

What happens if I overdose?

If you take too much voclosporin, call your healthcare provider or go to the nearest hospital emergency room right away. Overdose symptoms may include headache, weakness, tremors, vomiting, infections, rash, or fast heartbeats.

What should I avoid while taking voclosporin?

Do not receive a "live" vaccine while using voclosporin. The vaccine may not work as well and may not fully protect you from disease. Live vaccines include measles, mumps, rubella (MMR), rotavirus, typhoid, yellow fever, varicella (chickenpox), zoster (shingles), and nasal flu (influenza) vaccine.

Voclosporin could make you sunburn more easily. Avoid sunlight or tanning beds. Wear protective clothing and use sunscreen (SPF 30 or higher) when you are outdoors.

Grapefruit may interact with voclosporin and lead to unwanted side effects. Avoid the use of grapefruit products.

What other drugs will affect voclosporin?

Many drugs can interact and cause dangerous effects. Some drugs should not be used together with voclosporin. Your doctor may change your treatment plan if you also use:

• cyclophosphamide;

• nefazodone;

• an antibiotic - clarithromycin, telithromycin;

• antifungal medicine - itraconazole, ketoconazole, posaconazole, voriconazole; or

• antiviral medicine to treat HIV or hepatitis C -boceprevir, cobicistat, dasabuvir, elvitegravir, indinavir, lopinavir/ritonavir, nelfinavir, ombitasvir, paritaprevir saquinavir, telaprevir, tipranavir.

Voclosporin may affect your heart. Your risk may be higher if you also use certain other medicines for infections, asthma, heart problems, high blood pressure, depression, mental illness, cancer, malaria, or HIV.

Voclosporin can interact with medications that are OATP1B1 substrates, such as statins, some heart disease medications, and cancer drugs. Ask your healthcare provider if you take one of these medications.

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter
medicines, vitamins, and herbal supplements. Voclosporin may affect the way other medicines work, and other
medicines may affect how voclosporin works.

Voclosporin storage

Store at room temperature between 68⁰F to 77⁰F (20⁰C to 25⁰C). Do not put voclosporin in another container. Keep capsules in their original package until you are ready to take them.

Keep out of the reach of children.

Voclosporin ingredients

Voclosporin is only available under the brand name Lupkynis.

Active ingredient: voclosporin 7.9 mg
Lupkynis inactive ingredients: alcohol, Vitamin E polyethylene glycol succinate, polysorbate 40, medium-chain triglycerides, gelatin.

Lupkynis is supplied as an oval pink/orange capsule, imprinted on one side with VCS in white ink, packed in aluminum blisters. The Lupkynis capsule strength is 7.9 mg.

Who makes voclosporin?

Aurinia Pharmaceuticals Inc. manufactures voclosporin under the brand name Lupkynis.

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Medical Disclaimer