Lupkynis is a calcineurin-inhibitor immunosuppressant medicine.

Lupkynis is a prescription medicine used together with other medicines to treat kidney problems (active lupus nephritis) in adults with system lupus erythematous (SLE).

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 supplied as an oval pink/orange capsule, imprinted on one side with VCS in white ink, packed in aluminum blisters.

Taking Lupkynis may increase your risk of certain cancers such as skin cancer or lymphoma.

Voclosporin affects your immune system. You may get infections more easily, even serious or fatal infections. Call your doctor if you have a fever, chills, sweating, cough, skin sores, muscle aches, or other flu-like symptoms.

Do not take Lupkynis with medicines known as strong CYP3A4 inhibitors such as ketoconazole, itraconazole, and clarithromycin.

Tell your doctor about all your current medicines and any you start or stop using. Many drugs can interact, and some drugs should not be used together.

Before taking this medicine

You should not use Lupkynis if you are allergic to voclosporin.

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:

• cyclophosphamide;

• nefazodone;

• an antibiotic - clarithromycin, telithromycin;

• antifungal medicine - itraconazole, ketoconazole, posaconazole, voriconazole; or

• antiviral medicine to treat HIV or hepatitis C -boceprevir, cobicistat, dasabuvir, elvitegravir, indinavir, lopinavir/ritonavir, nelfinavir, ombitasvir, paritaprevir saquinavir, telaprevir, tipranavir.

When taking Lupkynis with other medicine: To make sure all medicines are safe for you, tell your doctor about all your medical conditions, and if you are pregnant or breastfeeding.

:

• heart rhythm problems;

• long QT syndrome (in you or a family member);

• an electrolyte imbalance (such as low levels of potassium or magnesium in your blood);

• high blood pressure; or

• liver or kidney disease.

Taking Lupkynis may increase your risk of certain cancers such as skin cancer or lymphoma. Ask your doctor about your specific risk.

Tell your doctor if you are pregnant or plan to become pregnant. Voclosporin contains alcohol and should not be used during pregnancy. However, having untreated active lupus nephritis during pregnancy may cause complications such eclampsia (dangerously high blood pressure that can lead to medical problems in both mother and baby). The benefit of treating your kidney problems may outweigh any risks to the baby.

Lupkynis is sometimes used in combination with another medicine called mycophenolate mofetil. Using mycophenolate mofetil during pregnancy can cause a miscarriage or birth defects. Both men and women should use effective birth control to prevent pregnancy during and shortly after treatment with mycophenolate mofetil (women for 6 weeks after and men for 90 days after).

Do not breastfeed while using Lupkynis, and for at least 7 days after your last dose.

Use 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 capsule whole and do not crush, chew, break, or open it. Tell your doctor if you have trouble swallowing a Lupkynis capsule whole.

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.

Voclosporin 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.

Your blood pressure will also need to be checked often.

Store Lupkynis in the original container at room temperature, away from moisture and heat.

It is not known if taking Lupkynis is safe or effective for longer than 1 year.

Usual Adult Dose for Lupus Nephritis:

23.7 mg orally twice a day

Comments:
-The use of this drug in combination with cyclophosphamide is not recommended as safety and efficacy have not been established.
-Use this drug in combination with mycophenolate mofetil (MMF) and corticosteroids.
-Determine an actual baseline estimated glomerular filtration rate (eGFR) prior to initiating treatment.
-Dosage of this drug is based on the patient's eGFR and should be modified accordingly.
-Check blood pressure (BP) at baseline and do not initiate treatment in patients with BP greater than 165/105 mmHg or with hypertensive emergency.
-Treatment discontinuation should be considered if the patient does not experience therapeutic benefit by 24 weeks.
-Safety and efficacy have not been established beyond one year.

Use: In combination with a background immunosuppressive therapy regimen for the treatment of adult patients with active lupus nephritis

You should not use Lupkynis if you are allergic to voclosporin.

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:

• cyclophosphamide;

• nefazodone;

• an antibiotic - clarithromycin, telithromycin;

• antifungal medicine - itraconazole, ketoconazole, posaconazole, voriconazole; or

• antiviral medicine to treat HIV or hepatitis C -boceprevir, cobicistat, dasabuvir, elvitegravir, indinavir, lopinavir/ritonavir, nelfinavir, ombitasvir, paritaprevir saquinavir, telaprevir, tipranavir.

When taking Lupkynis with other medicine: To make sure all medicines are safe for you, tell your doctor about all your medical conditions, and if you are pregnant or breastfeeding.

:

• heart rhythm problems;

• long QT syndrome (in you or a family member);

• an electrolyte imbalance (such as low levels of potassium or magnesium in your blood);

• high blood pressure; or

• liver or kidney disease.

Taking Lupkynis may increase your risk of certain cancers such as skin cancer or lymphoma. Ask your doctor about your specific risk.

Tell your doctor if you are pregnant or plan to become pregnant. Voclosporin contains alcohol and should not be used during pregnancy. However, having untreated active lupus nephritis during pregnancy may cause complications such eclampsia (dangerously high blood pressure that can lead to medical problems in both mother and baby). The benefit of treating your kidney problems may outweigh any risks to the baby.

Lupkynis is sometimes used in combination with another medicine called mycophenolate mofetil. Using mycophenolate mofetil during pregnancy can cause a miscarriage or birth defects. Both men and women should use effective birth control to prevent pregnancy during and shortly after treatment with mycophenolate mofetil (women for 6 weeks after and men for 90 days after).

Do not breastfeed while using Lupkynis, and for at least 7 days after your last dose.

Take the medicine as soon as you can, but skip the missed dose if you are more than 4 hours late for the dose. Do not take two doses at one time.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

Overdose symptoms may include headache, weakness, tremors, vomiting, infections, rash, or fast heartbeats.

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.

Voclosporin 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.

Get emergency medical help if you have signs of an allergic reaction to Lupkynis: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have:

• pain or burning when you urinate;

• kidney problems - little or no urination, swelling in your feet or ankles, feeling tired or short of breath;

• high blood pressure - severe headache, blurred vision, pounding in your neck or ears;

• nervous system problems - confusion, vision changes, headache, feeling less alert, tremors, numbness, tingling, seizure;

• high potassium level - nausea, weakness, tingly feeling, chest pain, irregular heartbeats, loss of movement; or

• low red blood cells (anemia) - pale skin, unusual tiredness, feeling light-headed or short of breath, cold hands and feet.

Common Lupkynis side effects may include:

• kidney problems;

• anemia;

• high blood pressure;

• stomach pain, heartburn, loss of appetite, diarrhea;

• tremors;

• mouth sores;

• headache, tiredness;

• painful urination;

• cough; or

• hair loss.

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 FDA at 1-800-FDA-1088.

Voclosporin can cause a serious heart problem. 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.

Many drugs can interact with voclosporin, and some drugs should not be used at the same time. Tell your doctor about all your current medicines and any medicine you start or stop using. This includes prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible interactions are listed here.