Lupkynis (Voclosporin) for Lupus

Lupkynis (voclosporin) is a prescription medication approved by the U.S. Food and Drug Administration (FDA) for treating adults with active lupus nephritis (LN).

How Lupkynis Works and How It’s Taken

Lupkynis is a calcineurin-inhibitor immunosuppressant. It blocks calcineurin, which helps activate certain immune cells. The exact way Lupkynis works is not fully known. In LN, this helps reduce immune activity and inflammation that can damage the kidneys.

Doctors prescribe Lupkynis with other immune-suppressing medicines to treat adults with active lupus nephritis.

Lupkynis comes as a capsule taken by mouth. It is usually taken twice a day on an empty stomach. Take each dose as close to 12 hours apart as possible, with at least eight hours between doses.

Swallow the capsules whole. Do not open, crush, or divide them.

Typical Dosing for LN

The recommended starting dose is 23.7 milligrams twice a day. Lupkynis is used with mycophenolate mofetil and corticosteroids.

Doctors check kidney function during treatment. They may lower or stop the dose if estimated glomerular filtration rate (eGFR), a measure of kidney function, falls by certain amounts. If there is no clear benefit by 24 weeks, the doctor may consider stopping treatment.

This information is based on the prescribing information, but your healthcare provider may tailor your treatment plan. Always follow their guidance.

Lupkynis Side Effects

In clinical studies of adults with active LN, the most common side effects reported with Lupkynis occurred in about 3 percent to 26 percent of people. These include:

Diarrhea
Headache
Cough
Urinary tract infection
Abdominal (stomach) pain
Dyspepsia (heartburn or indigestion)
Alopecia (hair loss)
Tiredness (fatigue)
Mouth sores (ulcers)
Anemia (low red blood cell count)
Hypertension (high blood pressure)
Kidney problems
Low appetite

Serious Side Effects and Warnings

Lupkynis can cause serious side effects that may require immediate medical attention. These include:

Serious infections — The immune system may not fight infections as well, and infections can be severe.
Malignancies — There is an increased risk of certain cancers, including lymphoma and skin cancer.
Nephrotoxicity — These kidney problems include kidney injury and sudden worsening of kidney function.
Hypertension — Blood pressure may rise during treatment.
Neurotoxicity — These nervous system problems include seizures and posterior reversible encephalopathy syndrome (PRES), a serious brain condition that can cause headache, confusion, vision changes, or seizures.
Hyperkalemia — High potassium levels can be serious and may affect the heart.
QTc prolongation — This heart rhythm problem can be dangerous.
Hypersensitivity reactions — These allergic reactions include anaphylaxis and angioedema, which involves swelling of the face, lips, tongue, or throat, and trouble breathing or swallowing.

Get medical help right away if you think you are having a serious reaction.

How To Save on Lupkynis

Aurinia Pharmaceuticals, the manufacturer of Lupkynis, offers the Aurinia Alliance program. Eligible people with commercial insurance may pay as little as $0 for their Lupkynis prescription.

The Aurinia Alliance also provides educational resources, insurance and financial support, access to a specialty pharmacy that delivers Lupkynis directly to your home, and one-on-one support from a dedicated nurse case manager.

To learn more, visit the Aurinia Alliance page or call 833-287-4642.

What To Know Before Taking Lupkynis

Before starting Lupkynis, your doctor will check your kidney function and your blood pressure.

Tell your doctor if you:

Plan to get any vaccines
Have or have had liver, kidney, or heart problems
Have high blood pressure
Are allergic to voclosporin or any ingredient in Lupkynis
Are pregnant, plan to become pregnant, are breastfeeding, or plan to breastfeed

Do not receive live vaccines while taking Lupkynis. Other vaccines may not work as well during treatment.

Tell your doctor about all medicines you take, including prescription drugs, over-the-counter medicines, vitamins, and herbal supplements.

Do not take Lupkynis if you use a strong CYP3A4 inhibitor, such as ketoconazole, itraconazole, or clarithromycin. Do not take it if you have had a serious allergic reaction, including anaphylaxis, to Lupkynis or any of its ingredients.

Do not eat grapefruit or drink grapefruit juice while taking Lupkynis.

If you miss a dose, take it as soon as possible within four hours. If more than four hours have passed, skip the missed dose and take your next dose at the regular time. Do not take two doses at the same time.

Avoid using Lupkynis during pregnancy. Lupkynis can pass into breast milk. Talk with your doctor if you are breastfeeding or plan to breastfeed.

Community FAQs

These answers are fact-checked by our editorial staff.

How effective is Lupkynis for LN?

In a 52-week study of adults with active lupus nephritis, 40.8 percent of people taking Lupkynis with mycophenolate mofetil and corticosteroids had a complete renal response. This compared with 22.5 percent of people taking placebo with the same background treatment.

At 24 weeks, 32.4 percent of people taking Lupkynis had a complete renal response, compared with 19.7 percent taking placebo.

People taking Lupkynis reached a urine protein-to-creatinine ratio of 0.5 milligrams per milligram or less sooner. The median time was 169 days with Lupkynis and 372 days with placebo.

How long does Lupkynis take to work for LN?

In the main study, some people had a complete renal response by 24 weeks. The median time to reach a urine protein-to-creatinine ratio of 0.5 milligrams per milligram or less was 169 days with Lupkynis. Individual results may vary.

What tests or monitoring are needed with Lupkynis for LN?

Before starting Lupkynis, your doctor will check your kidney function with an eGFR test and measure your blood pressure.

During treatment, eGFR should be checked every two weeks for the first month, every four weeks through the first year, and every three months after that. Blood pressure should also be checked regularly. Your doctor may also check your potassium level during treatment.