Is Voclosporin approved by the FDA?

Voclosporin, marketed under the brand name Lupkynis, is an oral medication that belongs to the drug class of calcineurin inhibitors. Voclosporin was approved by the U.S. Food and Drug Administration (FDA) on January 22, 2021. This approval marked a significant advancement in the treatment of lupus nephritis, offering a new therapeutic option for patients suffering from this severe condition.

Uses and Administration

Uses:

Voclosporin is prescribed to treat adults with active lupus nephritis in combination with background immunosuppressive therapy such as mycophenolate mofetil (MMF) and corticosteroids.
The primary goal is to reduce kidney inflammation and prevent further kidney damage.

Administration:

The usual adult dose is 23.7 mg taken orally twice a day.
The medication should be taken on an empty stomach, at least one hour before or two hours after a meal.
Doses should be taken at regular intervals 12 hours apart, and missed doses should be skipped if more than four hours late.
Patients should swallow the capsule whole without crushing, chewing, breaking, or opening it.

Precautions and Considerations

Before Taking Voclosporin:

Inform your doctor of any allergies or adverse reactions to medications.
Discuss all other medications, including over-the-counter drugs, vitamins, and herbal supplements, with your healthcare provider to avoid potential interactions.
Do not use voclosporin if you are pregnant or planning to become pregnant, as it contains alcohol and can harm the unborn baby. Use effective birth control during treatment and for at least seven days after the last dose.
Breastfeeding is not recommended during treatment with voclosporin.

Potential Interactions:

Voclosporin should not be used in combination with cyclophosphamide, nefazodone, certain antibiotics (e.g., clarithromycin, telithromycin), antifungal medicines (e.g., itraconazole, ketoconazole), or certain antiviral medications used to treat HIV or hepatitis C (e.g., boceprevir, cobicistat).
Avoid grapefruit products as they may lead to unwanted side effects.

Side Effects

Common Side Effects:

Kidney problems
Anemia
High blood pressure
Stomach pain, heartburn, loss of appetite, diarrhea
Tremors
Mouth sores
Headache, tiredness
Painful urination
Cough
Hair loss

Serious Side Effects:

Signs of an allergic reaction: hives, difficult breathing, swelling of the face, lips, tongue, or throat
Pain or burning during urination
Kidney problems: little or no urination, swelling in the feet or ankles, feeling tired or short of breath
High blood pressure: severe headache, blurred vision, pounding in the neck or ears
Nervous system problems: confusion, vision changes, headache, feeling less alert, tremors, numbness, tingling, seizure
High potassium level: nausea, weakness, chest pain, irregular heartbeats
Low red blood cells (anemia): pale skin, unusual tiredness, light-headedness, shortness of breath, cold hands and feet

Patients experiencing serious side effects should seek immediate medical attention. For any concerns about side effects, contacting a healthcare provider is recommended, and adverse effects can be reported to the FDA at 1-800-FDA-1088.

Conclusion

It offers an important treatment option to help manage this serious kidney condition in patients with systemic lupus erythematosus. As with any medication, patients should follow their healthcare provider's instructions and be aware of potential side effects and interactions with other medications.

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