Lupkynis Side Effects

Generic name: voclosporin

Medically reviewed by Philip Thornton, DipPharm. Last updated on Jan 13, 2024.

Note: This document provides detailed information about Lupkynis Side Effects associated with voclosporin. Some dosage forms listed on this page may not apply specifically to the brand name Lupkynis.

Applies to voclosporin: oral capsule liquid filled.

Precautions

It is very important that your doctor check your progress at regular visits to make sure that this medicine is working properly. Blood and urine tests may be needed to check for unwanted effects.

Do not use this medicine if you are also using cyclophosphamide or medicine to treat infections (eg, clarithromycin, itraconazole, ketoconazole).

Using this medicine while you are pregnant can harm your unborn baby. Use an effective form of birth control to keep from getting pregnant during treatment. If you think you have become pregnant while using the medicine, tell your doctor right away.

This medicine may increase your risk for certain cancers, including lymphoma or skin cancer. Avoid sun exposure. Use a sunscreen when you are outdoors. Avoid sunlamps and tanning beds. Talk to your doctor if you have concerns about this risk.

Your body's ability to fight infection may be reduced while you are being treated with voclosporin (the active ingredient contained in Lupkynis) It is very important that you call your doctor at the first signs of any infection. Check with your doctor right away if you or your child have fever, chills, cough or hoarseness, flu-like symptoms, lower back or side pain, painful or difficult urination, or unusual tiredness or weakness.

This medicine may cause serious kidney problems. Check with your doctor right away if you have blood in your urine, change in frequency of urination or amount of urine, difficulty in breathing, drowsiness, increased thirst, loss of appetite, nausea or vomiting, swelling of the feet or lower legs, or weakness.

This medicine may cause high blood pressure. Check with your doctor right away if you have blurred vision, dizziness, headache, nervousness, pounding in the ears, or slow or fast heartbeat.

This medicine may cause serious nervous system problems (eg, posterior reversible encephalopathy syndrome). Check with your doctor right away if you have blurred or double vision, difficulty in walking, headache, jaw pain, numbness or tingling in the fingers and toes, pain in the fingers and toes, pain the testicles, or weakness.

Tell your doctor right away if you have confusion, difficult breathing, irregular heartbeat, nausea or vomiting, nervousness, numbness or tingling in the hands, feet, or lips, stomach pain, or weakness or heaviness of the legs. These may be symptoms of hyperkalemia.

This medicine may cause heart rhythm problems (eg, QT prolongation). Check with your doctor right away if you have chest pain or discomfort, fainting, irregular or slow heart rate, or trouble breathing.

While you are being treated with voclosporin, and after you stop treatment with it, do not have any immunizations (vaccinations) without your doctor's approval. Voclosporin may lower your body's resistance and there is a chance you might get the infection the immunization is meant to prevent. In addition, other persons living in your household should not take or should not have taken oral polio vaccine within the last several months since there is a chance they could pass the polio virus on to you. Also, avoid other persons who have taken oral polio vaccine. Do not get close to them and do not stay in the same room with them for very long. If you cannot take these precautions, you should consider wearing a protective face mask that covers the nose and mouth.

This medicine may cause a blood disorder called pure red cell aplasia. Check with your doctor right away if you have fever, sore throat, pale skin, unusual bleeding or bruising, or unusual tiredness or weakness.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.

Serious side effects of Lupkynis

Along with its needed effects, voclosporin may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur while taking voclosporin:

Other side effects of Lupkynis

Some side effects of voclosporin may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects.

Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

For healthcare professionals

Applies to voclosporin: oral capsule.

General adverse events

The most frequently reported side effect was decreased in glomerular filtration rate.^[Ref]

Ocular

• Frequency not reported: Cytomegalovirus chorioretinitis^[Ref]

Metabolic

• Frequency not reported: Hyperkalemia^[Ref]

Genitourinary

• Very common (10% or more): Urinary tract infection (10%)
• Frequency not reported: Azotemia, oliguria, proteinuria^[Ref]

Oncologic

• Frequency not reported: Cervical carcinoma, breast tumor excision, malignant lymphoma, malignant neoplasm, skin neoplasm^[Ref]

Respiratory

• Very common (10% or more): Cough (11%)
• Frequency not reported: Pneumonia, bacterial and viral upper respiratory tract infection^[Ref]

Nervous system

• Very common (10% or more): Headache (15%)
• Common (1% to 10%): Fatigue, tremor
• Frequency not reported: Nervous system disorders, headache, tremor, dizziness, post herpetic neuralgia, migraine, paresthesia, hypoesthesia, seizure, tension headache, and disturbance in attention, migraine, seizure, and posterior reversible encephalopathy syndrome^[Ref]

Renal

• Very common (10% or more): Decrease in glomerular filtration rate (26%)
• Common (1% to 10%): Acute kidney injury, renal dysfunction
• Frequency not reported: Renal impairment, acute kidney injury, increased blood creatinine, renal failure

Cardiovascular

• Very common (10% or more): Hypertension (19%)
• Frequency not reported: QT prolongation^[Ref]

Dermatologic

• Common (1% to 10%): Alopecia, hypertrichosis
• Frequency not reported: Pyoderma gangrenosum^[Ref]

Gastrointestinal

• Very common (10% or more): Diarrhea (19%)
• Common (1% to 10%): Abdominal pain, decreased appetite, dyspepsia, gingivitis, mouth ulceration, upper abdominal pain
• Frequency not reported: Gastroenteritis^[Ref]

Other

• Frequency not reported: Herpes zoster infection, serious infections, opportunistic infection (including cytomegalovirus infection, and herpes zoster cutaneous disseminated)

Hematologic

• Very common (10% or more): Anemia (12%)^[Ref]

See also:

Frequently asked questions

• What's the difference between Lupkynis and Benlysta?
• Is Lupkynis a limited distribution drug?

Further information

Lupkynis side effects can vary depending on the individual. Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Note: Medication side effects may be underreported. If you are experiencing side effects that are not listed, submit a report to the FDA by following this guide.

Medical Disclaimer