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Lupkynis

  • Generic Name: voclosporin capsules
  • Brand Name: Lupkynis

Lupkynis (Voclosporin Capsules) side effects drug center

 

PROFESSIONAL

CONSUMER

SIDE EFFECTS

 

Lupkynis Side Effects Center

What Is Lupkynis?

Lupkynis (voclosporin) is a calcineurin-inhibitor immunosuppressant indicated in combination with a background immunosuppressive therapy regimen for the treatment of adult patients with active lupus nephritis (LN).

What Are Side Effects of Lupkynis?

Side effects of Lupkynis include:

Dosage for Lupkynis

The recommended starting dose of Lupkynis is 23.7 mg orally, twice a day.

Lupkynis In Children

The safety and efficacy of Lupkynis in pediatric patients has not been established.

What Drugs, Substances, or Supplements Interact with Lupkynis?

Lupkynis may interact with other medicines such as:

  • strong CYP3A4 inhibitors (e.g., ketoconazole, itraconazole, clarithromycin),
  • moderate CYP3A4 inhibitors (e.g., verapamil, fluconazole, diltiazem),
  • strong and moderate CYP3A4 inducers,
  • certain P-gp substrates, and
  • possibly, statins

Tell your doctor all medications and supplements you use.

Lupkynis During Pregnancy and Breastfeeding

Lupkynis is not recommended for use during pregnancy; it may harm a fetus.

It is unknown if Lupkynis passes into breast milk. Given the serious adverse reactions seen in adult patients treated with Lupkynis such as increased risk of serious infections, advise patients that breastfeeding is not recommended during treatment and for at least 7 days after the last dose of Lupkynis (approximately 6 elimination half-lives).

Additional Information

Our Lupkynis (voclosporin) Capsules, for Oral Use Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

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.

 

Lupkynis Consumer Information

Get emergency medical help if you have signs of an allergic reaction: 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 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.

Read the entire detailed patient monograph for Lupkynis (Voclosporin Capsules)

 

Lupkynis Professional Information

SIDE EFFECTS

The following clinically significant adverse reactions are described elsewhere in the labeling:

  • Lymphoma and Other Malignancies [see WARNINGS AND PRECAUTIONS]
  • Serious Infections [see WARNINGS AND PRECAUTIONS]
  • Nephrotoxicity due to LUPKYNIS and Drug Interactions [see WARNINGS AND PRECAUTIONS]
  • Hypertension [see WARNINGS AND PRECAUTIONS]
  • Neurotoxicity [see WARNINGS AND PRECAUTIONS]
  • Hyperkalemia [see WARNINGS AND PRECAUTIONS]
  • QTc Prolongation [see WARNINGS AND PRECAUTIONS]
  • Pure Red Cell Aplasia [see WARNINGS AND PRECAUTIONS]

Clinical Trials Experience

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.

A total of 355 patients with LN were treated with voclosporin in the Phase 2 and 3 clinical studies with 224 exposed for at least 48 weeks.

Patients in Study 1 were randomized to LUPKYNIS 23.7 mg twice a day or placebo [see Clinical Studies]. Patients in Study 2 were randomized to LUPKYNIS 23.7 mg twice a day, voclosporin 39.5 mg twice a day, or placebo.

Patients received background treatment with MMF 2 g daily and an IV bolus of corticosteroids followed by a pre-specified oral corticosteroid taper dosing schedule; LUPKYNIS dosing was adjusted based on eGFR and BP.

A total of 267 patients received at least 1 dose of LUPKYNIS 23.7 mg twice a day with 184 exposed for at least 48 weeks. A total of 88 patients received at least 1 dose of voclosporin 39.5 mg twice a day with 40 exposed for 48 weeks.

Table 1 lists common adverse reactions occurring in at least 3% of patients receiving LUPKYNIS and at an incidence at least 2% greater than placebo in Studies 1 and 2.

Table 1: Adverse Reactions in ≥3% of Patients Treated with LUPKYNIS 23.7 mg Twice a Day and ≥2% Higher than Placebo in Studies 1 and 2

Adverse ReactionLUPKYNIS 23.7 mg twice a day
(n=267)		Placebo
(n=266)
Glomerular filtration rate decreased*26%9%
Hypertension19%9%
Diarrhea19%13%
Headache15%8%
Anemia12%6%
Cough11%2%
Urinary tract infection10%6%
Abdominal pain upper7%2%
Dyspepsia6%3%
Alopecia6%3%
Renal Impairment*6%3%
Abdominal pain5%2%
Mouth ulceration4%1%
Fatigue4%1%
Tremor3%1%
Acute kidney injury*3%1%
Decreased appetite3%1%
*See Specific Adverse Reactions below (Nephrotoxicity)

Other adverse reactions reported in less than 3% of patients in the LUPKYNIS 23.7 mg group and at a 2% higher rate than in the placebo group through 48/52 weeks included gingivitis and hypertrichosis.

The integrated LN dataset is presented in the Specific Adverse Reactions section:

Placebo-controlled Studies: Studies 1 and 2 were integrated to represent safety through 48/52 weeks for placebo (n=266), LUPKYNIS 23.7 mg twice a day (n=267), and voclosporin 39.5 mg twice a day (n=88).

Exposure adjusted incidence rates were adjusted by study for all the adverse events reported in this section.

Specific Adverse Reactions

Infections

Infections were reported in 146 patients (107.4 per 100 patient-years) treated with placebo, 166 patients (135.2 per 100 patient-years) treated with LUPKYNIS 23.7 mg, and 58 patients (167.5 per 100 patient-years) treated with voclosporin 39.5 mg twice a day. The most frequent infections were upper respiratory tract infections, urinary tract infections, viral upper respiratory tract infections, and herpes zoster.

Serious infections were reported in 27 patients (12.0 per 100 patient-years) treated with placebo, 27 patients (11.9 per 100 patient-years) treated with LUPKYNIS 23.7 mg, and 10 patients (14.4 per 100 patient-years) treated with voclosporin 39.5 mg twice a day. The most frequent serious infections were pneumonia, gastroenteritis, and urinary tract infections.

Opportunistic infections were reported in 2 patients (0.9 per 100 patient-years) treated with placebo, 3 patients (1.3 per 100 patient-years) treated with LUPKYNIS 23.7 mg, and 1 patient (1.4 per 100 patient-years) treated with voclosporin 39.5 mg twice a day. The most frequent opportunistic infections were cytomegalovirus chorioretinitis, cytomegalovirus infection, and herpes zoster cutaneous disseminated.

Nephrotoxicity

Glomerular filtration rate decreased was the most frequently reported adverse reaction, reported in 25 patients (11.3 per 100 patient-years) treated with placebo, 70 patients (37.1 per 100 patient-years) treated with LUPKYNIS 23.7 mg, and 27 patients (48.7 per 100 patient-years) treated with voclosporin 39.5 mg twice a day. In patients treated with LUPKYNIS 23.7 mg twice a day, decreases in glomerular filtration rate occurred within the first 3 months of LUPKYNIS treatment in 50/70 (71%), with 39/50 (78%) resolved or improved following dose modification, and of those 25/39 (64%) resolved or improved within 1 month [see DOSAGE AND ADMINISTRATION]. Decreases in glomerular filtration rate resulted in permanent discontinuation of LUPKYNIS in 10/70 (14%), and resolved in 4/10 (40%) 3 months after treatment discontinuation.

Renal adverse reactions (defined as renal impairment, acute kidney injury, blood creatinine increased, azotemia, renal failure, oliguria, and proteinuria) were reported in 22 patients (9.5 per 100 patient-years) treated with placebo, 26 patients (11.3 per 100 patient-years) treated with LUPKYNIS 23.7 mg, and 11 patients (16.5 per 100 patient-years) treated with voclosporin 39.5 mg twice a day.

Serious renal adverse reactions were reported in 9 patients (3.7 per 100 patient-years) treated with placebo, 13 patients (5.6 per 100 patient-years) treated with LUPKYNIS 23.7 mg, and 0 patients (0 per 100 patient-years) treated with voclosporin 39.5 mg twice a day. The most frequent serious renal adverse reactions were acute kidney injury and renal impairment.

Hypertension

Hypertension was reported in 23 patients (10.3 per 100 patient-years) treated with placebo, 51 patients (25.2 per 100 patient-years) treated with LUPKYNIS 23.7 mg, and 16 patients (26.0 per 100 patient-years) treated with voclosporin 39.5 mg twice a day.

Serious hypertension was reported in 1 patient (0.4 per 100 patient-years) treated with placebo, 5 patients (2.1 per 100 patient-years) treated with LUPKYNIS 23.7 mg, and 2 patients (2.8 per 100 patient-years) treated with voclosporin 39.5 mg twice a day.

Neurotoxicity

Nervous system disorders were reported in 44 patients (21.6 per 100 patient-years) treated with placebo, 74 patients (38.9 per 100 patient-years) treated with LUPKYNIS 23.7 mg, and 24 patients (42.5 per 100 patient-years) treated with voclosporin 39.5 mg twice a day. The most frequent neurological adverse reactions were headache, tremor, dizziness, post herpetic neuralgia, migraine, paresthesia, hypoaesthesia, seizure, tension headache, and disturbance in attention.

Serious nervous system disorders were reported in 2 patients (0.9 per 100 patient-years) treated with placebo, 9 patients (3.9 per 100 patient-years) treated with LUPKYNIS 23.7 mg, and 3 patients (4.3 per 100 patient-years) treated with voclosporin 39.5 mg twice a day. The most frequent serious neurological adverse reactions were headache, migraine, seizure, and posterior reversible encephalopathy syndrome.

Malignancy

Malignancies were reported in 0 patients (0 per 100 patient-years) treated with placebo, 4 patients (1.7 per 100 patient-years) treated with LUPKYNIS 23.7 mg, and 0 patients (0 per 100 patient-years) treated with voclosporin 39.5 mg twice a day. These consisted of single occurrences of stage 0 cervical carcinoma, skin neoplasm, pyoderma gangrenosum, and breast tumor excision.

Hyperkalemia

Hyperkalemia was reported in 2 patients (0.8 per 100 patient-years) treated with placebo, 5 patients (2.1 per 100 patient-years) treated with LUPKYNIS 23.7 mg, and 1 patient (1.4 per 100 patient-years) treated with voclosporin 39.5 mg twice a day.

QT Prolongation

QT prolongation was reported in 0 patients (0 per 100 patient-years) treated with placebo, 2 patients (0.9 per 100 patient-years) treated with LUPKYNIS 23.7 mg, and 1 patient (1.4 per 100 patient-years) treated with voclosporin 39.5 mg twice a day.

Read the entire FDA prescribing information for Lupkynis (Voclosporin Capsules)

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&Copy; Lupkynis Patient Information is supplied by Cerner Multum, Inc. and Lupkynis Consumer information is supplied by First Databank, Inc., used under license and subject to their respective copyrights.