Note: This document contains side effect information about voclosporin. Some dosage forms listed on this page may not apply to the brand name Lupkynis.
Applies to voclosporin: oral capsule liquid filled.
Warning
Oral route (Capsule)
Warning: Malignancies and Serious InfectionsIncreased risk for developing malignancies and serious infections with voclosporin or other immunosuppressants that may lead to hospitalization or death.
Serious side effects of Lupkynis
Along with its needed effects, voclosporin (the active ingredient contained in Lupkynis) 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:
More common
- Agitation
- anxiety
- back pain
- black, tarry stools
- bloody or cloudy urine
- blurred vision
- body aches or pain
- burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings
- change in frequency of urination or amount of urine
- chest pain or discomfort
- chills
- coma
- confusion
- cough
- decreased urine output
- diarrhea
- difficult, burning, or painful urination
- dizziness
- drowsiness
- dry mouth
- ear congestion
- fainting
- fever
- frequent urge to urinate
- general feeling of illness
- hallucinations
- headache
- hostility
- increased thirst
- irregular or slow heart rate
- irritability
- loss of appetite
- loss of voice
- lower back or side pain
- mood or mental changes
- muscle twitching
- nausea or vomiting
- nervousness
- numbness or tingling in the hands, feet, or lips
- painful blisters on trunk of body
- pale skin
- pounding in the ears
- rapid weight gain
- restlessness
- seizures
- slow or fast heartbeat
- sneezing
- sore throat
- stiff neck
- stomach pain
- stuffy or runny nose
- swelling of the face, feet, lower legs, ankles, or hands
- swollen glands
- trouble breathing
- unusual bleeding or bruising
- unusual tiredness or weakness
- weakness or heaviness of the legs
- weight loss
- yellow skin and eyes
Less common
- Persistent non-healing sore
- pink growth
- reddish patch or irritated area
- shakiness in the legs, arms, hands, feet
- shiny bump
- trembling or shaking of the hands or feet
- white, yellow or waxy scar-like area
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:
More common
- Acid or sour stomach
- belching
- hair loss, thinning of hair
- heartburn
- indigestion
- stomach discomfort or upset
Less common
- Decreased appetite
- irritation or soreness of the mouth
For Healthcare Professionals
Applies to voclosporin: oral capsule.
Hematologic
Very common (10% or more): Anemia (12%)[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)
General
The most frequently reported side effect was decreased in glomerular filtration rate.[Ref]
