Details

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.

Lupkynis (voclosporin) should not be taken with a medicine called cyclophosphamide.

It is available in capsule form, each containing 7.9 mg voclosporin.

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.

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.

Where has Lupkynis (voclosporin) been approved?

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

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

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:

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

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).

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.

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.

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

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:

Serious adverse reactions

The serious adverse reactions listed in the prescribing information include:

Use in a specific population

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

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

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

References

Clinical trials

The Food and Drug Administration (FDA) approval of Lupkynis (voclosporin) for treatment of adults with active lupus nephritis (LN) was based on the data of the AURA-LV study and the AURORA study (NCT03021499 and NCT02141672).

AURA–LV was a phase 2, multicenter, randomized, double-blind, placebo-controlled trial that compared the efficacy of two doses of Lupkynis in combination with standard of care versus standard of care with placebo. The study involved 265 patients with active LN who received either voclosporin 23.7 mg twice a day, voclosporin 39.5 mg twice a day, or placebo for 48 weeks.

AURORA was a phase III global, double-blind, placebo-controlled study to evaluate whether voclosporin in combination with standard of care is able to reduce disease activity. The study involved 357 patients with active LN who received either 23.7 mg voclosporin or placebo twice daily for 52 weeks.

Results

The main efficacy outcome of AURA-LV was the number of patients achieving improved kidney function (complete renal remission: CRR) after 24 weeks and at the end of the treatment period. A secondary endpoint was the renal response (RR) ability of the treatment to reduce the level of proteinuria (as measured by urine protein/creatinine ratio (UPCR)).

After half a year, a higher proportion of patients receiving voclosporin achieved CRR compared to those receiving placebo. These effects were still seen after a year of treatment. Voclosporin treatment showed to improve disease, as compared to standard of care.

At 24 weeks, the proportion of patients that achieved CRR was:

At the end of the treatment period:

Patients treated with voclosporin achieved statistically better and a more rapid RR compared to patients treated placebo.

A 50% reduction in UPCR from baseline was achieved by 93.7% of patients in the voclosporin group, compared with 75.2% of patients in the placebo group.

Please refer to the summary of product characteristics below and in the resource section for comprehensive information about the safety and effectiveness of Lupkynis (voclosporin) for the approved indication.

References

Price & Costs

Lupkynis (voclosporin) price in other currencies*

Package	Euro	Australian dollars	Canadian dollar	New Zealand dollar	Nigerian naira	Singapore dollar	Pound sterling	United States dollar
60 capsules of 7.9 mg	19683 EUR	32495 AUD	29370 CAD	35751 NZD	32698776 NGN	27804 SGD	16227 GBP	20730 USD
3 wallets with 60 capsules of 7.9 mg	19683 EUR	32495 AUD	29370 CAD	35751 NZD	32698776 NGN	27804 SGD	16227 GBP	20730 USD

*The prices listed above are based on the cheapest package size and strength everyone.org has access to. Please make an enquiry for more specific pricing. The prices listed above are a guide only, we operate in Euros.

Lupkynis (voclosporin) treatment costs

The cost for a monthly or yearly treatment of Lupkynis (voclosporin) depends on your prescription requirements which includes the dosage in mg and medicine type (Capsules).

The price of the medicines you see on sale is the cost set by the manufacturer. In addition, shipping costs and a Named Patient support fee will apply.

Make an enquiry and we will help you calculate the total price to buy Lupkynis (voclosporin) online and have it delivered where you live. From your side, we’ll simply need a prescription from your treating doctor. In some countries we might also need an import license. Our Patient Support team will guide you throughout the process.

Lupkynis (voclosporin) price and additional costs

Lupkynis (voclosporin) reimbursement

It might be possible for you to claim the cost of Lupkynis (voclosporin) via your country's healthcare system. Some countries have a government fund providing financial assistance for citizens to access lifesaving medical treatment abroad. The best thing would be to check with your country's own health ministry. We also highly recommend checking out local patient blogs, communities and patient organisations to find out more about your options.

Medical insurance

Generally, we do not support medical insurance, but we do provide you with an invoice after you make the payment that you may send to your medical insurance company so they can reimburse you. In some limited circumstances, we do accept insurance. Contact us for more details. You can pay by bank transfer or credit card.

Crowdfunding

Crowdfunding might also be an option for you. It is a means of raising funds by using an online platform to group together many small donations from friends, family and others, in order to help you afford medical treatment. Here are some crowdfunding platforms where you can seek support: GoFundMe, GiveForward, FundRazr and Watsi.

Shipping

Room temperature shipping

For this medication, standard shipping applies. This means that a consistent room temperature of 15 to 25°C is maintained during transit.

Your order will be shipped to you by our partner couriers, such as DHL, UPS and specialised cold chain couriers. If you would like your order to be shipped by a specific courier, please inform us when you place the order.

Our standard delivery time varies from 5 to 10 working days.

The shipping cost depends on the medicine and the destination country. After making an enquiry, you will receive a detailed quote that includes the shipping costs.

You can also pick up your medicine from our partner pharmacy in Amsterdam or our partner pharmacy in Luxembourg after the order has been paid for.

Our Process

Four steps to access the medicines you need

How and where to access and buy Lupkynis: You can access Lupkynis from everyone.org if the drug has not been approved or is not available in your country.