Lupkynis
Pronunciation: loop-kye-nis
Generic name: voclosporin
Dosage form: oral capsule (7.9 mg)
Drug class: Calcineurin inhibitors
What is Lupkynis?
Lupkynis is used to treat active lupus nephritis (kidney problems associated with system lupus erythematosus (SLE)) in adults, together with other medicines.
Lupkynis's mechanism of action is not fully understood but involves the inhibition of calcineurin. Calcineurin is an enzyme that activates T-cells of the immune system (these are a type of white blood cell involved in various inflammatory conditions). Lupkynis for lupus belongs to the drug class called calcineurin inhibitors, and these medications are immunosuppressants. Lupkynis is not a steroid.
- Lupkynis should not be taken with a medicine called cyclophosphamide. Talk with your healthcare provider if you are not sure if you take this medicine.
- Lupkynis is an oral treatment for active lupus nephritis that works in a different way to Benlysta, an injectable medication (see What is the difference between Lupkynis and Benlysta?).
Lupkynis gained FDA approval on January 22, 2021. Lupkynis is a limited-distribution drug, which means you will receive it from a specialty pharmacy.
Lupkynis side effects
The most common side effects of Lupkynis are:
- diarrhea
- urinary tract infection
- heartburn
- headache
- stomach pain
- hair loss (alopecia)
- cough.
Serious side effects and warnings
Lupkynis carries a Boxed Warning for an increased risk of developing cancer or infections.
Increased risk of cancer. People who take Lupkynis have an increased risk of getting certain kinds of cancer, including skin cancer and cancer of the lymph glands (lymphoma).
Increased risk of infection. Lupkynis for lupus is a medicine that affects your immune system and can lower the ability of your immune system to fight infections. Serious infections can happen in people receiving Lupkynis which can lead to hospitalizations and can cause death. Call your healthcare provider right away if you have symptoms of an infection such as:
- fever
- cough or flu-like symptoms
- warm, red, or painful areas on your skin
- sweats or chills
- muscle aches.
Kidney problems. Kidney problems are common side effects of Lupkynis and may be serious. Your healthcare provider may do certain tests to check your kidney function while you take Lupkynis.
High blood pressure. High blood pressure is a common side effect of Lupkynis and may be serious. Your
healthcare provider will monitor your blood pressure while you take Lupkynis and may ask you to check your blood pressure at home.
Nervous system problems. Nervous system problems are a common side effect of Lupkynis and may be serious. Call your healthcare provider or go to the nearest hospital emergency room right away if you get any of these symptoms while taking Lupkynis. These could be signs of serious nervous system problems:
- confusion
- numbness and tingling
- seizures
- changes in alertness
- headache
- vision changes
- muscle tremors
- high levels of potassium in your blood. Your healthcare provider may do certain tests to check your potassium
levels while you take Lupkynis. - a serious heart rhythm problem (QT prolongation).
- severe low red blood cell count (anemia).
Get emergency medical help if you have signs of an allergic reaction to Lupkynis such as hives; difficulty breathing; or swelling of your face, lips, tongue, or throat.
Call your doctor at once if you have:
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pain or burning when you urinate;
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kidney problems - little or no urination, swelling in your feet or ankles, feeling tired or short of breath;
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high blood pressure - severe headache, blurred vision, pounding in your neck or ears;
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nervous system problems - confusion, vision changes, headache, feeling less alert, tremors, numbness, tingling, seizure;
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high potassium level - nausea, weakness, tingly feeling, chest pain, irregular heartbeats, loss of movement; or
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low red blood cells (anemia) - pale skin, unusual tiredness, feeling light-headed or short of breath, cold hands and feet.
This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.
Related/similar drugs
Before taking
Do not take Lupkynis with medicines known as strong CYP3A4 inhibitors such as ketoconazole, itraconazole, and clarithromycin.
Do not take this medicine if you are allergic to voclosporin, Lupkynis, or any of the inactive ingredients in the medicine.
Before you take Lupkynis, tell your healthcare provider about all your medical conditions, including if you:
- plan to receive any vaccines. You should not receive any live vaccines during treatment with Lupkynis. Ask your healthcare provider if you are not sure if your vaccine is a live vaccine. Other vaccines may not work as well during treatment with Lupkynis
- have or have had liver, kidney, or heart problems
- have high blood pressure
- are pregnant or plan to become pregnant
- are breastfeeding or plan to breastfeed.
Taking Lupkynis may increase your risk of certain cancers such as skin cancer or lymphoma. Ask your doctor about your specific risk.
Pregnancy
Lupkynis may harm your unborn baby. When taking Lupkynis in combination with mycophenolate mofetil, you should also read the Medication Guide for mycophenolate mofetil for important pregnancy information.
Breastfeeding
Lupkynis can pass into breastmilk. You and your healthcare provider should decide if you will take Lupkynis while you are breastfeeding.
How should I take Lupkynis?
Take Lupkynis exactly as prescribed by your doctor. Follow all directions on your prescription label and read all medication guides or instruction sheets. Your doctor may occasionally change your dose.
Swallow the Lupkynis capsule whole. Do not break, crush, chew, or dissolve the Lupkynis capsules before swallowing. If you cannot swallow Lupkynis capsules whole, tell your healthcare provider.
- Take Lupkynis on an empty stomach, at least 1 hour before or 2 hours after a meal.
- Take your doses at regular intervals 12 hours apart. Do not take your doses less than 8 hours apart.
- If you have not experienced a benefit within 24 weeks from taking Lupkynis, your healthcare provider may decide to stop treatment.
Lupkynis affects your immune system. You may get infections more easily, even serious or fatal infections. You will need frequent medical tests. Your treatment with Lupkynis may be delayed or stopped based on the results.
Lupkynis dosing
Usual Adult Dose of Lupkynis for Lupus Nephritis: Lupkynis 23.7 mg (3 capsules) orally 2 times a day.
- Each capsule of Lupkynis contains 7.9 mg.
Your healthcare provider will check your kidney function before treatment and monitor your blood pressure throughout treatment.
What happens if I miss a dose?
If a dose of Lupkynis is missed, take it as soon as possible within 4 hours after missing the dose. If more than 4 hours have passed, skip the missed dose and take the next dose at the regular time. Do not take 2 doses at the same time.
What happens if I overdose?
If you take too much Lupkynis, call your healthcare provider or go to the nearest hospital emergency room right away. Overdose symptoms may include headache, weakness, tremors, vomiting, infections, rash, or fast heartbeats.
What should I avoid while taking Lupkynis?
Do not receive a "live" vaccine while using Lupkynis. The vaccine may not work as well and may not fully protect you from disease. Live vaccines include measles, mumps, rubella (MMR), rotavirus, typhoid, yellow fever, varicella (chickenpox), zoster (shingles), and nasal flu (influenza) vaccine.
Lupkynis could make you sunburn more easily. Avoid sunlight or tanning beds. Wear protective clothing and use sunscreen (SPF 30 or higher) when you are outdoors.
Grapefruit may interact with voclosporin and lead to unwanted side effects. Avoid the use of grapefruit products.
What other drugs will affect Lupkynis?
Many drugs can interact and cause dangerous effects. Some drugs should not be used together with Lupkynis. Your doctor may change your treatment plan if you also use:
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an antibiotic - clarithromycin, telithromycin;
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antifungal medicine - itraconazole, ketoconazole, posaconazole, voriconazole; or
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antiviral medicine to treat HIV or hepatitis C -boceprevir, cobicistat, dasabuvir, elvitegravir, indinavir, lopinavir/ritonavir, nelfinavir, ombitasvir, paritaprevir saquinavir, telaprevir, tipranavir.
Lupkynis may affect your heart. Your risk may be higher if you also use certain other medicines for infections, asthma, heart problems, high blood pressure, depression, mental illness, cancer, malaria, or HIV.
Lupkynis can interact with medications that are OATP1B1 substrates, such as statins, some heart disease medications, and cancer drugs. Ask your healthcare provider if you take one of these medications.
Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter
medicines, vitamins, and herbal supplements. Lupkynis may affect the way other medicines work, and other
medicines may affect how Lupkynis works.
Lupkynis storage
Store at room temperature between 68⁰F to 77⁰F (20⁰C to 25⁰C). Do not put Lupkynis in another container. Keep capsules in their original package until you are ready to take them.
Keep out of the reach of children.
Lupkynis ingredients
Active ingredient: voclosporin 7.9 mg
Inactive ingredients: alcohol, Vitamin E polyethylene glycol succinate, polysorbate 40, medium-chain triglycerides, gelatin.
Lupkynis is supplied as an oval pink/orange capsule, imprinted on one side with VCS in white ink, packed in aluminum blisters. The Lupkynis capsule strength is 7.9 mg.
Who makes Lupkynis?
Aurinia Pharmaceuticals Inc. manufacture Lupkynis.
Popular FAQ
Does Lupkynis cause hair loss?
Yes, hair loss (also called alopecia) has been reported as a common side effect with Lupkynis. In studies, hair loss was reported in 6% of patients treated with Lupkynis 23.7 mg twice a day compared to 3% of patients receiving a placebo (an inactive agent).
What's the difference between Lupkynis and Benlysta?
Benlysta injection is approved to treat adults and children 5 years of age and older with systemic lupus erythematosus (SLE) and active lupus nephritis (lupus-related kidney inflammation), while oral Lupkynis is only approved to treat lupus nephritis in adults. Lupkynis has not yet been approved for use in children Continue reading
Is Lupkynis a steroid?
No, Lupkynis is not a steroid medicine. It is a calcineurin-inhibitor immunosuppressant that helps to control lupus nephritis and protect the kidneys from inflammation and further permanent damage. It works by calming overactive cells in your immune system that may attack the kidney.
How long do you take Lupkynis for?
Talk with your healthcare provider if you have been taking Lupkynis for close to one year, as it is not known if it’s safe or effective beyond a year. If you have not had any therapeutic benefit by 24 weeks, your doctor may decide to stop treatment. Continue treatment as long as your doctor recommends. Do not change your dose or stop taking your treatment without talking to your doctor first.
Is Lupkynis a limited distribution drug?
Lupkynis (voclosporin) is an expensive drug that has limited distribution, meaning you will receive this medicine from a specialty pharmacy, not your local pharmacy. Specialty drugs may be mailed to your house. A specialty pharmacy can help you access the medicine if prescribed by your doctor, answer insurance questions, and monitor for the drug’s safety and effectiveness. Continue reading
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Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.