Lupkynis is a brand-name prescription medication approved for treating lupus nephritis in adults, when used in combination with other drugs that weaken the immune system* (immunosuppressants).

Lupus is an autoimmune condition, which means your body’s immune system becomes overactive and mistakenly attacks your own cells. Lupus nephritis is a condition where the immune system mistakenly targets and attacks cells in your kidneys.

* Note: Using Lupkynis in combination with the drug cyclophosphamide for treating lupus nephritis is not recommended. To learn more, see the “Lupkynis uses” section below.

Drug details

Lupkynis contains the active ingredient voclosporin, which belongs to a class of drugs called calcineurin inhibitors. It’s considered an immunosuppressant drug.

Lupkynis comes as a capsule that you swallow. It’s available in one strength: 7.9 milligrams (mg).

FDA approval

The Food and Drug Administration (FDA) approved Lupkynis for treating lupus nephritis in adults in 2021.

Effectiveness

For information about the effectiveness of Lupkynis, see the “Lupkynis uses” section below.

Lupkynis is available only as a brand-name medication. It’s not currently available in generic form.

A generic drug is an exact copy of the active drug in a brand-name medication. Generics usually cost less than brand-name drugs.

Lupkynis can cause mild or serious side effects. The following lists contain some of the key side effects that may occur while taking Lupkynis. These lists do not include all possible side effects.

For more information about the possible side effects of Lupkynis, talk with your doctor or pharmacist. They can give you tips on how to manage any side effects that may be concerning or bothersome.

Note: The Food and Drug Administration (FDA) tracks side effects of drugs it has approved. If you would like to notify the FDA about a side effect you’ve had with Lupkynis, you can do so through MedWatch.

Mild side effects

Below is a partial list of mild side effects of Lupkynis. To learn about other mild side effects, talk with your doctor or pharmacist, or view Lupkynis’ prescribing information.

Mild side effects of Lupkynis can include:

Most of these side effects may go away within a few days to a couple of weeks. However, if they become more severe or don’t go away, talk with your doctor or pharmacist.

* For more information about allergic reaction and Lupkynis, see “Allergic reaction” below.

Serious side effects

Serious side effects from Lupkynis aren’t common, but they can occur. Call your doctor right away if you have serious side effects. Call 911 or your local emergency number if your symptoms feel life threatening or if you think you’re having a medical emergency.

Serious side effects and their symptoms can include:

  • Kidney damage. Symptoms can include:
    • appetite loss
    • fatigue
    • urination changes, such as producing less urine than usual
    • swelling in your lower legs, ankles, or feet
    • weakness
  • Nervous system problems, including a condition called posterior reversible encephalopathy syndrome. Symptoms can include:
    • feeling confused or less alert than usual
    • headache
    • muscle tremor
    • numbness and tingling, such as in your arms or legs
    • vision changes, such as blurry vision
  • A severe form of anemia called pure red cell aplasia. Symptoms can include:
    • dizziness
    • fatigue
    • headache
    • skin paleness
  • Hyperkalemia (high blood potassium levels). Symptoms can include:
    • difficulty breathing
    • feeling that your heart is skipping beats (heart palpitations)
    • muscle weakness
    • nausea and vomiting
  • Severe high blood pressure. Immediately seek medical help if you have symptoms such as:
    • blurry vision
    • confusion
    • seizures
    • severe headache
  • Serious infection.*
  • Cancer.*
  • Severe allergic reaction.†

* Lupkynis has a boxed warning for this side effect. This is a serious warning from the FDA. To learn more, see the “Lupkynis precautions” section below.
† For details about allergic reaction and Lupkynis, see “Allergic reaction” below.

ALLERGIC REACTION

As with most drugs, some people can have an allergic reaction after taking Lupkynis. This side effect wasn’t reported in clinical trials of this drug but can still occur.

Symptoms of a mild allergic reaction can include:

A more severe allergic reaction is rare but possible. Symptoms of a severe allergic reaction can include:

  • swelling under your skin, typically in your eyelids, lips, hands, or feet
  • swelling of your tongue, mouth, or throat
  • trouble breathing

Call your doctor right away if you have an allergic reaction to Lupkynis, as the reaction could become severe. Call 911 or your local emergency number if your symptoms feel life threatening or if you think you’re having a medical emergency.

Other drugs are available that can treat lupus nephritis. Some may be a better fit for you than others. If you’re interested in finding an alternative to Lupkynis, talk with your doctor. They can tell you about other medications that may work well for you.

Note: Some of the drugs listed here are used off-label to treat these specific conditions. Off-label drug use is when a drug that’s approved by the Food and Drug Administration (FDA) is prescribed for a purpose other than what it’s approved for.

Alternatives for lupus nephritis

Examples of other drugs that may be used to treat lupus nephritis include:

As with all medications, the cost (including your annual cost) of Lupkynis can vary. The actual price you’ll pay depends on your insurance plan, your location, and the pharmacy you use.

Keep in mind that you may be able to get a 90-day supply of Lupkynis. If approved by your insurance company, getting a 90-day supply of the drug could reduce your number of trips to the pharmacy and help lower the cost. If you’re interested in this option, check with your doctor, pharmacist, or insurance company.

It’s important to note that you’ll have to get Lupkynis from an approved specialty pharmacy. This type of pharmacy is authorized to carry specialty medications. These are drugs that may be expensive or may require help from healthcare professionals to be used safely and effectively.

Before approving coverage for Lupkynis, your insurance company may require you to get prior authorization. This means that your doctor and insurance company will need to communicate about your prescription before the insurance company will cover the drug. The insurance company will review the prior authorization request and decide if the drug will be covered.

If you’re not sure if you’ll need to get prior authorization for Lupkynis, contact your insurance company.

Financial and insurance assistance

If you need financial support to pay for Lupkynis, or if you need help understanding your insurance coverage, help is available.

A program called Aurinia Alliance is available for Lupkynis. For more information and to find out if you’re eligible for support, call 833-AURINIA (833-287-4642) or visit the program website.

To learn more about saving money on prescriptions, check out this article.

Mail-order pharmacies

Lupkynis is only available through select specialty pharmacies, which will typically mail your medication to you.

If recommended by your doctor, you may be able to receive a 90-day supply of Lupkynis, so there’s less concern about running out of the medication. If you’re interested in this option, check with your doctor, pharmacist, or insurance company. Some Medicare plans may help cover the cost of mail-order medications.

If you don’t have insurance, you can ask your doctor or pharmacist about online pharmacy options.

Generic version

Lupkynis is not available in a generic form. A generic drug is an exact copy of the active drug in a brand-name medication. Generics tend to cost less than brand-name drugs.

The Lupkynis dosage your doctor prescribes will depend on several factors. These include:

  • how well your kidney’s function
  • other medical conditions you may have
  • other medications you take

The following information describes dosages that are commonly used or recommended. However, be sure to take the dosage your doctor prescribes for you. Your doctor will determine the best dosage to fit your needs.

Drug forms and strengths

Lupkynis comes as a capsule that you swallow. It’s available in one strength: 7.9 milligrams (mg).

Dosage for lupus nephritis

The recommended Lupkynis dose for treating lupus nephritis is 23.7 mg twice per day.

What if I miss a dose?

If you miss a dose of Lupkynis, try to take it as soon as you remember.

However, if it’s been more than 4 hours since your scheduled dose, skip the missed dose. Take your next dose at the scheduled time as usual. Do not take more than one dose of Lupkynis at a time.

To help make sure that you don’t miss a dose, try using a medication reminder. This can include setting an alarm or using a timer. You could also download a reminder app on your phone.

Will I need to use this drug long term?

Treatment with Lupkynis beyond 1 year hasn’t been studied. It’s not known if it’s safe to take the drug for longer than 1 year, or whether it remains effective for lupus nephritis past this point.

Your doctor can provide more information on how long you may be treated with Lupkynis. Depending on how well the drug works for you and other factors such as your kidney health, they may have you stop or continue taking the drug after 1 year.

The Food and Drug Administration (FDA) approves prescription drugs such as Lupkynis to treat certain conditions.

Lupkynis for lupus nephritis

Lupkynis is approved by the FDA for treating lupus nephritis in adults.

Lupus nephritis explained

Lupus is a condition where your immune system becomes overactive and mistakenly attacks your body’s own cells. (This is known as an autoimmune condition.) With lupus nephritis, your immune system attacks your kidneys. Inflammation caused by your immune system can cause your kidneys to stop working.

Over time, nearly 5 out of 10 adults and 8 out of 10 children with lupus will develop lupus nephritis.

Symptoms of lupus nephritis can include:

  • joint pain or swelling
  • pain in your muscles
  • fever without an apparent cause
  • malar rash, a red or purplish, butterfly shaped rash across the nose and cheeks
  • foamy urine
  • high blood pressure

Effectiveness for lupus nephritis

Lupkynis has been found effective for treating lupus nephritis in adults. To learn more about how the drug performed in clinical studies, refer to the full prescribing information for Lupkynis. You can also talk with your pharmacist or doctor to learn more.

Note: Lupkynis should not be used in combination with the drug cyclophosphamide to treat lupus nephritis. See “Lupkynis use with other drugs” just below to learn more.

Lupkynis and children

Lupkynis is not approved for use in children.

Talk with your child’s doctor if you’d like to learn about treatment options for lupus nephritis in children.

Lupkynis should be used in combination with other drugs for treating lupus nephritis. Specifically, it’s prescribed with at least one other immunosuppressant (drugs that weaken your immune system).

In clinical studies, most people who took Lupkynis with the drug mycophenolate mofetil (CellCept) and with a corticosteroid, such as methylprednisolone (Medrol) or prednisone (Rayos).

It’s important to note that Lupkynis should not be prescribed along with the drug cyclophosphamide. It’s not known if this combination is safe or effective.

Your doctor will provide more information on which other immunosuppressant drugs you’ll take with Lupkynis.

There’s no known interaction between taking Lupkynis and drinking alcohol. In fact, the drug is formulated using a small quantity of alcohol.

However, it’s possible that other drugs you’re prescribed in combination with Lupkynis for treating lupus nephritis could be affected by alcohol. For example, if your doctor prescribes the drug mycophenolate mofetil (CellCept), they may advise you to avoid alcohol completely. This is because both alcohol and mycophenolate mofetil can cause liver scarring and failure (cirrhosis).

Talk with your doctor or pharmacist if you have additional questions about consuming alcohol and taking Lupkynis or other treatments for lupus nephritis.

Lupkynis can interact with several other medications. It can also interact with certain supplements as well as certain foods.

Different interactions can cause different effects. For instance, some interactions can interfere with how well a drug works. Other interactions can increase side effects or make them more severe. Drug-condition interactions can also cause certain effects. For information about these interactions, see the “Lupkynis precautions” section below.

Lupkynis and other medications

Below is a list of medications that can interact with Lupkynis. This list does not contain all drugs that may interact with Lupkynis.

Before taking Lupkynis, talk with your doctor and pharmacist. Tell them about all prescription, over-the-counter, and other drugs you take. Also tell them about any vitamins, herbs, and supplements you use. Sharing this information can help you avoid potential interactions.

If you have questions about drug interactions that may affect you, ask your doctor or pharmacist.

Certain drugs that affect how your body absorbs Lupkynis

Certain drugs can affect how well your body absorbs Lupkynis. This can affect how well the medication works or whether it causes side effects. Because this effect is so strong with certain drugs, doctors typically won’t prescribe them along with Lupkynis.

Examples of these drugs include:

  • certain antifungals, such as ketoconazole or itraconazole (Sporanox)
  • certain antibiotics, such as clarithromycin and rifampin (Rifadin)
  • efavirenz (Sustiva) and drugs that contain it, such as efavirenz/emtricitabine/tenofovir disoproxil fumarate (Atripla)

Some other drugs don’t have as strong of an effect on how your body absorbs Lupkynis. Your doctor may prescribe these drugs with Lupkynis, but they will likely lower your dose of Lupkynis.

Examples of these drugs include:

Lupkynis and herbs and supplements

There aren’t any herbs or supplements that have been specifically reported to interact with Lupkynis. However, you should still check with your doctor or pharmacist before using any of these products while taking Lupkynis.

Lupkynis and foods

It’s recommended that you avoid eating grapefruit or drinking grapefruit juice while taking Lupkynis. This is because grapefruit can affect how your body absorbs Lupkynis, which could raise your risk for side effects from the medication.

It’s important to note that you should avoid eating food at least 1 hour before or 2 hours after taking Lupkynis. This is because taking Lupkynis with food lowers the level of the drug in your body, which may make it less effective.

Lupkynis and vaccines

It’s recommended to avoid receiving live vaccines while taking Lupkynis.

Live vaccines are vaccines made using a live version of the disease they provide protection against. Because Lupkynis weakens your immune system, getting a live vaccine while taking the drug could cause you to contract the disease-causing agent in the live vaccine.

Examples of live vaccines include:

Talk with your doctor or pharmacist if you’d like to learn more about receiving vaccines while taking Lupkynis.

You should take Lupkynis according to the instructions your doctor gives you.

When to take

You’ll likely take Lupkynis twice per day. You should try to take your dose every 12 hours if possible, with at least 8 hours between doses.

Taking the medication around the same time of day helps keep a steady level of the drug in your body. This helps Lupkynis work effectively.

To help make sure that you don’t miss a dose, try using a medication reminder. This can include setting an alarm or using a timer. You could also download a reminder app on your phone.

Accessible labels and containers

If your prescription label is hard to read, talk with your doctor or pharmacist. Some pharmacies offer labels that have large print, braille, or a code you scan with a smartphone to convert text to speech. If your local pharmacy doesn’t have these options, your doctor or pharmacist may be able to direct you to one that does.

Taking Lupkynis with food

Lupkynis should be taken on an empty stomach. You should avoid eating food at least 1 hour before or 2 hours after taking Lupkynis. Do not eat meals or snacks with your Lupkynis dose. Food can affect how well your body absorbs the medication and can cause Lupkynis to not work as well.

Can Lupkynis be crushed, split, or chewed?

No, it’s important that you do not crush, split, or chew Lupkynis capsules. Lupkynis capsules must be swallowed whole. This means the capsules also should not be opened and sprinkled on food or in a drink.

If you’re struggling to swallow capsules, talk with your pharmacist or doctor. They may be able to suggest ways to help swallow pills.

Lupkynis is approved to treat lupus nephritis in adults.

Lupus is a condition where your immune system becomes overactive and mistakenly attacks your body’s own cells. (This is known as an autoimmune condition.) With lupus nephritis, your immune system attacks your kidneys. Inflammation caused by your immune system can cause your kidneys to stop working.

Lupkynis works to treat symptoms of lupus nephritis by weakening your immune system. It’s unknown exactly how this happens. However, we know Lupkynis blocks a protein called calcineurin. Blocking calcineurin decreases activity in your immune system.

How long does it take to work?

Lupkynis can take weeks or months to begin working to treat symptoms of lupus nephritis. If Lupkynis hasn’t begun working to improve your symptoms after 24 weeks of treatment, your doctor will likely have you stop taking the drug.

It’s not recommended to take Lupkynis while pregnant. This is because Lupkynis contains alcohol, and there is no safe amount of alcohol to consume during pregnancy.

If you are pregnant or planning to become pregnant, talk with your doctor about other possible treatments for your condition besides Lupkynis.

It’s not known if Lupkynis is safe to take during pregnancy. If you’re sexually active and you or your partner can become pregnant, talk with your doctor about your birth control needs while you’re using Lupkynis.

For more information about taking Lupkynis during pregnancy, see the “Lupkynis and pregnancy” section above.

Breastfeeding while using Lupkynis is not recommended by the drug’s manufacturer. It’s not known if Lupkynis passes into breast milk, or if it can cause side effects in a breastfed child.

It’s also recommended that you avoid breastfeeding for at least 7 days after your last dose of Lupkynis.

If you’re breastfeeding or plan to breastfeed, talk with your doctor about whether Lupkynis is right for you.

Here are answers to some frequently asked questions about Lupkynis.

Can Lupkynis treatment help lower my steroid dosage?

It’s possible but not guaranteed. If Lupkynis works to treat your lupus nephritis symptoms, it’s possible your doctor may lower your steroid dosage. In clinical trials, people treated with Lupkynis were able to avoid taking higher doses of prednisone compared with people who were treated with a placebo (pill with no active medication).

Do not change the dose of any medication you take without talking with your doctor. They can also tell you more information about how Lupkynis may affect your current treatment regimen.

Is Lupkynis a type of immunosuppressant drug?

Yes, Lupkynis is a type of immunosuppressant drug called a calcineurin inhibitor. (Immunosuppressants are drugs that weaken your immune system.)

Lupkynis works to treat symptoms of lupus nephritis by weakening your immune system. It’s unknown how this happens. However, we know Lupkynis blocks a protein called calcineurin. Blocking calcineurin decreases activity in your immune system.

You can learn more about how Lupkynis works and what happens with lupus nephritis by referring to the “Lupkynis uses” section above.

How will I know that Lupkynis is working for my lupus nephritis?

While you’re taking Lupkynis, your doctor will order certain lab tests that help determine if Lupkynis is working for your lupus nephritis. These tests help your doctor evaluate your kidney health.

If you’d like to learn more about how your doctor will monitor Lupkynis’ effectiveness, including more information about these tests, talk with your doctor.

This drug comes with several precautions. These are considered drug-condition interactions.

FDA warnings

This drug has boxed warnings. A boxed warning is the most serious warning from the Food and Drug Administration (FDA). It alerts doctors and patients about drug effects that may be dangerous.

Serious infection. Treatment with Lupkynis can increase your risk of serious infections, which can be life threatening in rare cases. This side effect occurs because Lupkynis works to treat lupus nephritis by weakening your immune system. Symptoms of an infection can include:

Contact your doctor right away if you develop symptoms of an infection while taking Lupkynis.

Cancer. Rarely, drugs such as Lupkynis can raise your risk of developing cancer, including lymphoma and skin cancers. It’s possible that this risk may increase based on how long you’re treated with the drug and if you take a higher dose of Lupkynis.

To lower your risk of cancer, you should try to avoid artificial UV light, such as that used by tanning beds or sun lamps. You should also limit or avoid sun exposure. Wear long-sleeve clothing when possible and use a sunscreen with an SPF of at least 30.

You should also contact your doctor right away if you notice symptoms of cancer while taking Lupkynis. These symptoms can vary depending on the type of cancer, but some general symptoms for lymphoma and skin cancer may include:

  • fatigue
  • swelling in your lymph nodes
  • unintentional weight loss
  • irregularly shaped or discolored skin lumps or bumps

Your doctor will likely want to see you to examine your symptoms further. They can advise you on if you should continue taking Lupkynis.

Other precautions

Before taking Lupkynis, talk with your doctor about your health history. Lupkynis may not be right for you if you have certain medical conditions or other factors affecting your health. These include:

  • Heart problems, including high blood pressure. Lupkynis can affect your heart rhythm as a side effect. While rare, this may be serious if you have an existing heart problem such as heart failure. Lupkynis can also cause high blood pressure as a side effect. If you have existing high blood pressure, the drug may not be safe for you to take. Your doctor can tell you more about the benefits and risks of taking Lupkynis if you have a heart problem.
  • Kidney problems (besides lupus nephritis). Let your doctor know if you have a kidney problem besides lupus nephritis before you start taking Lupkynis. The drug can cause kidney damage, and you may be at higher risk if you have a kidney condition such as chronic kidney disease. Finally, if you have a severe kidney problem, you may need a lower dose of Lupkynis. This is because your body relies on your kidneys to get rid of the drug after you take a dose. Your doctor can discuss the risks and benefits of Lupkynis with you.
  • Liver problem. It’s usually safe for people with a mild or moderate liver problem to take Lupkynis. However, your doctor will likely prescribe a lower dose for you. Doctors typically won’t prescribe Lupkynis if your liver problem is considered severe such as liver cirrhosis. Talk with your doctor before you start taking Lupkynis if you have a liver problem.
  • Allergic reaction. If you’ve had an allergic reaction to Lupkynis or any of its ingredients, your doctor will likely not prescribe Lupkynis. Ask your doctor what other medications may be better options for you.
  • Pregnancy. Doctors will typically recommend you do not use Lupkynis while pregnant. For more information, see the “Lupkynis and pregnancy” section above.
  • Breastfeeding. Doctors typically recommend that you do not breastfeed while taking Lupkynis. For more information, see the “Lupkynis and breastfeeding” section above.

Note: For more information about the potential negative effects of Lupkynis, see the “Lupkynis side effects” section above.

Using more than the recommended dosage of Lupkynis can lead to serious side effects. Do not use more Lupkynis than your doctor recommends. (For information on the recommended dosages of Lupkynis, see the “Lupkynis dosage” section above.)

Overdose symptoms

Symptoms of an overdose can include:

What to do in case of overdose

If you think you’ve taken too much of this drug, call your doctor. You can also call the American Association of Poison Control Centers at 800-222-1222 or use its online tool. However, if your symptoms are severe, call 911 or your local emergency number, or go to the nearest emergency room right away.

When you get Lupkynis from the pharmacy, the pharmacist will add an expiration date to the label on the packaging. This date is typically 1 year from the date they dispensed the medication.

The expiration date helps guarantee that the medication is effective during this time. The current stance of the Food and Drug Administration (FDA) is to avoid using expired medications. If you have unused medication that has gone past the expiration date, talk with your pharmacist about whether you might still be able to use it.

Storage

How long a medication remains good to use can depend on many factors, including how and where you store the medication.

Lupkynis tablets should be stored at room temperature in the original container. Avoid storing this medication in areas where it could get damp or wet, such as bathrooms.

Disposal

If you no longer need to take Lupkynis and have leftover medication, it’s important to dispose of it safely. This helps prevent others, including children and pets, from taking the drug by accident. It also helps keep the drug from harming the environment.

This article provides several useful tips on medication disposal. You can also ask your pharmacist for information about how to dispose of your medication.

Disclaimer: Medical News Today has made every effort to make certain that all information is factually correct, comprehensive, and up to date. However, this article should not be used as a substitute for the knowledge and expertise of a licensed healthcare professional. You should always consult your doctor or another healthcare professional before taking any medication. The drug information contained herein is subject to change and is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. The absence of warnings or other information for a given drug does not indicate that the drug or drug combination is safe, effective, or appropriate for all patients or all specific uses.