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What is Lupkynis (voclosporin) for?

Lupkynis (voclosporin) is a calcineurin-inhibitor immunosuppressant indicated to treat adults with active lupus nephritis (LN). It is taken in combination with standard of care therapies and works by suppressing the immune system.^[1]

Lupkynis (voclosporin) should not be taken with a medicine called cyclophosphamide.^[1]

It is available in capsule form, each containing 7.9 mg voclosporin.^[1]

How does Lupkynis (voclosporin) work?

Approximately 50% of people with the autoimmune disease systemic lupus erythematosus (SLE) will develop lupus nephritis (LN). LN is an inflammation of the kidneys, which causes irreversible kidney damage and significantly increases the risk of kidney failure, cardiac events, and death.^[2]

Voclosporin can inhibit a protein in the body called calcineurin. Calcineurin is a protein that can activate T cells of the body’s immune system. By binding and blocking calcineurin, voclosporin can stop T cells from initiating an autoimmune response, and thereby reduce inflammation and damage to the kidneys.^[2,3]

Where has Lupkynis (voclosporin) been approved?

Lupkynis (voclosporin) was approved for the treatment of people with active LN by:

• The Food and Drug Administration (FDA), USA on January 22, 2021.^[4]

Lupkynis (voclosporin) was approved under Priority Review and was previously granted Fast Track designation by the FDA in 2016.^[4]

Please note that this medicine may have also been approved in other regions than the ones we’ve listed. If you have a question about its approval in a specific country feel free to contact our support team.

How is Lupkynis (voclosporin) taken?

The standard dosage is:^[1]

• 23.7 mg (3 capsules) as a starting dose, taken orally twice a day

It it used in combination with current standard of care of mycophenolate mofetil (MMF).^[1]

The tablets must be swallowed whole on an empty stomach, either 1 hour before or 2 hours after a meal and as close to a 12-hour schedule as possible (with at least 8 hours between doses).^[1]

Before starting with Lupkynis (voclosporin) treatment, an accurate baseline estimated glomerular filtration rate (eGFR) should be established. Dosage of this medicine is based on the patient’s eGFR. Your treating doctor may change your dose, if needed. During the course of treatment, eGFR and blood pressure should be monitored regularly.^[1]

Lupkynis (voclosporin) may affect the way other medicines work, and other medicines may affect how this medicine works, so it is important that you inform your doctor about all medicines you take.^[1]

Complete information about Lupkynis (voclosporin) dosage (modifications) and administration can be found in the official prescribing information listed in our references section.^[1]

Note: Please consult with your treating doctor for personalised dosing.

Are there any known adverse reactions or side effects of Lupkynis (voclosporin)?

Common adverse reactions

The most common side effects ( ≥3% of patients) listed in the prescribing information include:^[1]

• Diarrhea
• Headache
• Cough
• Urinary tract infection
• Stomach pain
• Heartburn
• Loss of hair (alopecia)
• High blood pressure (hypertension)
• Low red blood cell count (anemia)
• Mouth ulcers
• Tiredness (fatigue)

Serious adverse reactions

The serious adverse reactions listed in the prescribing information include:^[1]

• Increased risk of cancer
• Increased risk of infection
• Kidney problems
• Nervous system problems

Use in a specific population

Lupkynis (voclosporin) can be fatal for a fetus, it is advised to avoid pregnancies and breastfeeding.^[1]

Before starting with treatment, tell your doctor about all of your medical conditions, including if you:

• Plan to receive any vaccines. You should not receive live vaccines while on Lupkynis (voclosporin) treatment.
• Have or have had liver, kidney, or heart problems.
• Have high blood pressure (hypertension)

For a comprehensive list of side effects and adverse reactions please refer to the official prescribing information.^[1]

References

1. Full prescribing information [FDA]: Lupkynis (voclosporin) [PDF] Aurinia Pharmaceuticals, Jan 2021

2. Lupkynis Information
Lupkynis.com, cited Feb 2021

3. Lupkynis (voclosporin)
Lupus.org, cited Feb 2021

4. FDA Approves Aurinia Pharmaceuticals’ LUPKYNIS™ (voclosporin) for Adult Patients with Active Lupus Nephritis
Press release, Jan 2021