Lupkynis is a medicine that is used for a specific kidney disease called lupus nephritis. Lupus nephritis is a kidney condition that affects people with systemic lupus erythematosus (SLE). SLE is an autoimmune disease, which means the body’s own immune system is attacking itself. In lupus nephritis, the body’s immune system attacks the kidneys, which can lead to kidney disease or, in severe cases, kidney failure. Lupkynis is used along with other medicines to weaken the immune system so it stops attacking the kidneys.
How Does Lupkynis Work for Lupus Nephritis?
The active ingredient in Lupkynis is voclosporin. It belongs to a class of medicines called calcineurin inhibitors. It works to weaken or calm the immune system down, to keep it from attacking the kidneys.
How Do I Take Lupkynis?
Lupkynis comes as 7.9-milligram capsules. Keep Lupkynis in the original packaging until it is time for your dose. When you take your medication, you will swallow it whole. Do not crush, break, chew, or dissolve the capsules before swallowing them. Lupkynis should be taken on an empty stomach either 1 hour before or 2 hours after a meal.
For lupus nephritis, you will likely start at a dose of 23.7 milligrams (3 tablets) twice a day with a minimum of 8 hours between each of your doses. Ideally, your doses should be taken 12 hours apart. Your health care provider may start you at a lower dose, based on how well your kidneys are working or other medicines you are taking. While you are taking Lupkynis, your health care provider will order blood tests to find out how your kidneys are working. Based on these blood tests, your health care provider may adjust your dose of Lupkynis.
How Was It Studied for Lupus Nephritis?
One early study of Lupkynis lasted for 52 weeks (1 year). It was done in 142 hospitals and clinics across 27 countries in North America, Latin America, Europe, South Africa, and Asia.
The study compared Lupkynis to a placebo containing no medicine. To be in the study, people needed to have a diagnosis of systemic lupus erythematosus (SLE) and lupus nephritis. They also needed to have a kidney biopsy, an elevated urine protein creatinine ratio, and an estimated glomerular filtration rate (eGFR) greater than 45 milliliters per minute (mL/min). Urine protein creatinine ratio and eGFR are used together to find out how well the kidneys are functioning.
The average age of people in the study was 31 years old. Most of the people were female (85%-90%). The ethnic breakdown of people in the study was diverse to include about 36% White, 13% Black, 30% Asian, and 22% of people from other races including American Indian, Alaska Native, Native Hawaiian, Pacific Islander, and other or mixed races, except mixed Black race.
During the study, people needed to take a medicine called mycophenolate mofetil and specific doses of steroids along with either Lupkynis or a placebo containing no medicine. The people in the study did not know if they were getting Lupkynis or a placebo.
The goal of the study was to see if Lupkynis would provide complete kidney response when compared to a placebo. Complete kidney response is determined based on a combination of improved urine protein creatinine ratio results, an eGFR of greater than or equal to 60 mL/min or an eGFR that did not decrease by more than 20%, no use of rescue medicines, and limited use of steroids. At the end of the 1-year study, 41% of people taking Lupkynis reached a completed kidney response, compared to 23% of people taking the placebo. This study demonstrates that Lupkynis taken with mycophenolate mofetil and specific doses of steroids can help kidney function in people with lupus nephritis.
Your results may differ from what was seen in clinical studies.
How Long Does It Take for It to Work?
Lupkynis begins working right away, but it might take a few weeks to see the full benefit. Your health care provider will monitor your progress with laboratory tests. Therefore, it is important to keep all your appointments for laboratory tests or reschedule them in a timely manner. If your health care provider does not see progress at 24 weeks (about 6 months), Lupkynis may be stopped.
How Can I Prevent and Manage Side Effects?
A few common side effects include infections, increased blood pressure, and stomach issues.
Infections of the kidney or bladder known as urinary tract infections were reported with use of Lupkynis. Signs of a urinary tract infection include fever, burning or stinging when you pee, pain in the lower belly, and an urge to pee more often. To lower your chances of getting a urinary tract infection, ensure proper bathroom hygiene, avoid holding your urine, and drink plenty of fluids.
Overall, Lupkynis weakens your immune system, which can increase your chances of getting any type of infection. To lower your chances of an infection, make sure you are up to date with all of your vaccines. You should use good hygiene practices, such as disinfecting surfaces, washing your hands, and avoiding touching your face. You should also avoid being in close contact with someone you know is sick and avoid large crowds. Call your health care provider right away if you think you might have any type of infection. Eating a healthy diet, exercising, and getting plenty of rest can also help keep your body strong.
High blood pressure is a side effect of Lupkynis. Managing blood pressure is important with lupus nephritis, because high blood pressure can impact the kidneys. High blood pressure also can lead to heart attacks and strokes. You can’t always feel your blood pressure increasing, so it is important to monitor your blood pressure routinely. You should also keep a record of the readings to bring with you to your health care appointments. If you measure your blood pressure and the top number (systolic) is 165 mm Hg or higher, or the bottom number (diastolic) is 105 mm Hg or higher, you should contact your medical provider. To help control your blood pressure, you should continue to take any blood pressure medicines prescribed to you, eat a diet that is low in sodium, and exercise.
Lupkynis can cause gut issues including diarrhea, stomach pain, and heartburn. To help manage these issues, you should watch what foods you are eating. Spicy, fried, or fatty foods may worsen stomach issues. You should also watch the portion size of your food. Eating large meals may worsen heartburn or stomach pain. Consider smaller meals more frequently to help with heartburn if it occurs. If you get diarrhea, you may want to avoid foods such as coffee or artificial sweeteners, which can worsen diarrhea. If you have stomach issues that are severe, you should contact your health care provider.
What Kinds of Drug Interactions May Happen?
Several medicines can interact with Lupkynis. This may increase the risk of side effects from it or another medicine or can cause Lupkynis to not work as well.
Medications known as cytochrome P450 3A4 (CYP3A4) inhibitors or inducers can interact with Lupkynis. CYP3A4 is an enzyme that processes and removes some medicines from the body.
Taking CYP3A4 inhibitors (medicines that block the activity of CYP3A4) could increase the amount of Lupkynis in your body, which may lead to excessive or dangerous side effects. Some examples of major CYP3A4 inhibitors are clarithromycin, itraconazole, and ketoconazole. These medications are not recommended to take with Lupkynis. Other CYP3A4 inhibitors are diltiazem, fluconazole, and verapamil. These medications can be used with Lupkynis, but the dose of Lupkynis may need to be adjusted to account for the interaction.
CYP3A4 inducers (medicines that enhance the activity of CYP3A4) can decrease the amount of Lupkynis in your body, causing it to not work as well or not work at all. An example of an interacting medicine in this way is rifampin.
Ask your pharmacist or other health care provider if any of your medicines are CYP3A4 inhibitors or inducers.
Statins are medicines that are typically used for lowering cholesterol. Some examples are atorvastatin, rosuvastatin, and simvastatin. When these medicines are taken with Lupkynis, there is a risk of increased side effects from the statin such as muscle pain. Health care providers may choose to use a lower dose of the statin medicine while you are taking Lupkynis to help avoid this risk.
Food and drink: Lupkynis is known to interact with grapefruit and grapefruit juice because it can increase the amount of the drug in your body, which may cause excessive or dangerous side effects. It is therefore recommended to avoid eating grapefruit or drinking grapefruit juice while you are taking Lupkynis.
Vaccinations: Lupkynis interacts with certain vaccines called live vaccines. Examples of live vaccines include chickenpox, MMR (measles, mumps, rubella), and rotavirus. Lupkynis may keep your body from having a good response to the live vaccine, and because it's a live vaccine, you may get an infection from it. Therefore, you should review your vaccination record with your health care provider before you start taking Lupkynis and get any live vaccines before you start the medicine. It is important to remember that not all vaccines are live vaccines and you should remain up to date with your vaccines to help you avoid infection while taking Lupkynis.
What Do I Need to Do to Get It, and What Kind of Health Care Provider Prescribes It?
Lupkynis will likely be prescribed by the health care provider treating your lupus or a kidney specialist (nephrologist). Lupkynis is a “specialty” medicine. This means that your regular community pharmacy may not be able to fill the prescription for you. If that is the case, you can use a specialty pharmacy, which may ship the medicine to you. The medicine may require prior authorization from your insurance company.
Is There Any Cost Assistance Available?
There is a savings coupon available from the drugmaker that may allow you to pay $0 for your prescription. Whether you are eligible depends on whether you have prescription insurance, and what type of insurance you have. You can find out more at https://www.lupkynis.com/resources.
