Voclosporin
Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]; Associate Editor(s)-in-Chief: Parth Vikram Singh, MBBS[2]
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Black Box Warning
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MALIGNANCIES AND SERIOUS INFECTIONS
See full prescribing information for complete Boxed Warning.
Condition Name: (Increased risk for developing serious infections and malignancies with LUPKYNIS or other immunosuppressants that may lead to hospitalization or death.)
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Overview
Voclosporin is a calcineurin-inhibitor immunosuppressant. that is FDA approved for the treatment of adult patients with active lupus nephritis (LN).. There is a Black Box Warning for this drug as shown here. Common adverse reactions include glomerular filtration rate decreased, hypertension, diarrhea, headache, anemia, cough, urinary tract infection, abdominal pain upper, dyspepsia, alopecia, renal impairment, abdominal pain,mouth ulceration, fatigue, tremor, acute kidney injury, and decreased appetite..
Adult Indications and Dosage
FDA-Labeled Indications and Dosage (Adult)
LUPKYNIS 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). Limitations of Use:Safety and efficacy of LUPKYNIS have not been established in combination with cyclophosphamide. Use of LUPKYNIS is not recommended in this situation.
Administration:
- LUPKYNIS must be swallowed whole on an empty stomach.
- Administer consistently as close to a 12-hour schedule as possible, and with at least 8 hours between doses.
- If a dose is missed, instruct the patient to take it as soon as possible within 4 hours after missing the dose. Beyond the 4-hour time frame, instruct the patient to wait until the usual scheduled time to take the next regular dose. Instruct the patient not to double the next dose.
- Instruct patients to avoid eating grapefruit or drinking grapefruit juice while taking LUPKYNIS.
Dosage Recommendations:
- Before initiating LUPKYNIS, establish an accurate baseline estimated glomerular filtration rate (eGFR) and check blood pressure (BP).
- Use of LUPKYNIS is not recommended in patients with a baseline eGFR ≤45 mL/min/1.73 m 2unless the benefit exceeds the risk; these patients may be at increased risk for acute and/or chronic nephrotoxicity.
- Do not initiate LUPKYNIS in patients with baseline BP >165/105 mmHg or with hypertensive emergency.
- Recommended starting dose: 23.7 mg orally, twice a day.
- Use LUPKYNIS in combination with mycophenolate mofetil (MMF) and corticosteroids.
- Modify the LUPKYNIS dose based on eGFR .
- Assess eGFR every two weeks for the first month, every four weeks through the first year, and quarterly thereafter.
- If eGFR <60 mL/min/1.73 m 2and reduced from baseline by >20% and <30%, reduce the dose by 7.9 mg twice a day. Re-assess eGFR within two weeks; if eGFR is still reduced from baseline by >20%, reduce the dose again by 7.9 mg twice a day.
- If eGFR <60 mL/min/1.73 m 2and reduced from baseline by ≥30%, discontinue LUPKYNIS. Re-assess eGFR within two weeks; consider re-initiating LUPKYNIS at a lower dose (7.9 mg twice a day) only if eGFR has returned to ≥80% of baseline.
- For patients that had a decrease in dose due to eGFR, consider increasing the dose by 7.9 mg twice a day for each eGFR measurement that is ≥80% of baseline; do not exceed the starting dose.
- Monitor blood pressure every two weeks for the first month after initiating LUPKYNIS, and as clinically indicated thereafter. For patients with BP >165/105 mmHg or with hypertensive emergency, discontinue LUPKYNIS and initiate antihypertensive therapy.
- If the patient has not experienced therapeutic benefit by 24 weeks, consider discontinuation of LUPKYNIS.
Dosage Adjustments:
- Patients with severe renal impairment: the recommended dose is 15.8 mg twice daily.
- Patients with mild and moderate hepatic impairment: the recommended dose is 15.8 mg twice daily.
DOSAGE FORMS AND STRENGTHS
- Capsules: 7.9 mg.
Off-Label Use and Dosage (Adult)
Guideline-Supported Use
There is limited information regarding Off-Label Guideline-Supported Use of Voclosporin in adult patients.
Non–Guideline-Supported Use
There is limited information regarding Off-Label Non–Guideline-Supported Use of Voclosporin in adult patients.
Pediatric Indications and Dosage
FDA-Labeled Indications and Dosage (Pediatric)
There is limited information regarding Voclosporin FDA-Labeled Indications and Dosage (Pediatric) in the drug label.
Off-Label Use and Dosage (Pediatric)
Guideline-Supported Use
There is limited information regarding Off-Label Guideline-Supported Use of Voclosporin in pediatric patients.
Non–Guideline-Supported Use
There is limited information regarding Off-Label Non–Guideline-Supported Use of Voclosporin in pediatric patients.
Contraindications
- Patients concomitantly using strong CYP3A4 inhibitors (e.g., ketoconazole, itraconazole, clarithromycin).
- Known serious or severe hypersensitivity reaction to LUPKYNIS or any of its excipients.
Warnings
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MALIGNANCIES AND SERIOUS INFECTIONS
See full prescribing information for complete Boxed Warning.
Condition Name: (Increased risk for developing serious infections and malignancies with LUPKYNIS or other immunosuppressants that may lead to hospitalization or death.)
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Lymphoma and Other Malignancies
- Immunosuppressants, including LUPKYNIS, increase the risk of developing lymphomas and other malignancies, particularly of the skin.
- The risk appears to be related to the intensity and duration of immunosuppression rather than to the use of any specific agent. Examine patients for skin changes and advise to avoid or limit sun exposure and to avoid artificial UV light (tanning beds, sun lamps) by wearing protective clothing and using a broad spectrum sunscreen with a high protection factor (SPF 30 or higher).
Serious Infections
- Immunosuppressants, including LUPKYNIS, increase the risk of developing bacterial, viral, fungal, and protozoal infections, including opportunistic infections. These infections may lead to serious, including fatal, outcomes. Viral infections reported include cytomegalovirus and herpes zoster infections.
- Monitor for the development of infection. Consider the benefits and risks for the individual patient; use the lowest effective dose needed to maintain response.
Nephrotoxicity
- LUPKYNIS, like other calcineurin-inhibitors, can cause acute and/or chronic nephrotoxicity. Nephrotoxicity was reported in clinical trials.
- Monitor eGFR regularly during treatment, and consider dose reduction or discontinuation in patients with decreases in eGFR from baseline ; persistent decrease of eGFR should be evaluated for chronic calcineurin-inhibitor nephrotoxicity.
- Consider the risks and benefits of LUPKYNIS treatment in light of the patient’s treatment response and risk of worsening nephrotoxicity, including co-administration with drugs associated with nephrotoxicity. The risk for acute and/or chronic nephrotoxicity is increased when LUPKYNIS is concomitantly administered with drugs associated with nephrotoxicity.
Hypertension
- Hypertension is a common adverse reaction of LUPKYNIS therapy and may require antihypertensive therapy .
- Some antihypertensive drugs can increase the risk for hyperkalemia.
- Certain calcium-channel blocking agents (verapamil and diltiazem) may increase voclosporin blood concentrations and require dosage reduction of *LUPKYNIS.
- Monitor blood pressure regularly during treatment and treat new-onset hypertension and exacerbations of pre-existing hypertension.
- If a patient experiences increases in blood pressure that cannot be managed with dose reduction of LUPKYNIS or other appropriate medical intervention, consider discontinuation of LUPKYNIS.
Neurotoxicity
- LUPKYNIS, like other calcineurin-inhibitors, may cause a spectrum of neurotoxicities.
- The most severe neurotoxicities include posterior reversible encephalopathy syndrome (PRES), delirium, seizure, and coma; others include tremors, paresthesias, headache, mental status changes, and changes in motor and sensory functions.
- Monitor for neurologic symptoms and consider dosage reduction or discontinuation of LUPKYNIS if neurotoxicity occurs.
Hyperkalemia
- Hyperkalemia, which may be serious and require treatment, has been reported with calcineurin-inhibitors including LUPKYNIS.
- Concomitant use of agents associated with hyperkalemia (e.g., potassium-sparing diuretics, ACE inhibitors, angiotensin receptor blockers) may increase the risk for hyperkalemia. Monitor serum potassium levels periodically during treatment.
QTc Prolongation
- LUPKYNIS prolongs the QTc interval in a dose-dependent manner after single dose administration at a dose higher than the recommended lupus nephritis therapeutic dose.
- The use of LUPKYNIS in combination with other drugs that are known to prolong QTc may result in clinically significant QT prolongation.
- Certain circumstances may increase the risk of the occurrence of torsade de pointes and/or sudden death in association with the use of drugs that prolong the QTc interval, including (1) bradycardia; (2) hypokalemia or hypomagnesemia; (3) concomitant use of other drugs that prolong the QTc interval; and (4) presence of congenital prolongation of the QT interval.
Immunizations
- Avoid the use of live attenuated vaccines during treatment with LUPKYNIS (e.g., intranasal influenza, measles, mumps, rubella, oral polio, BCG, yellow fever, varicella, and TY21a typhoid vaccines).
- Inactivated vaccines noted to be safe for administration may not be sufficiently immunogenic during treatment with LUPKYNIS.
Pure Red Cell Aplasia
- Cases of pure red cell aplasia (PRCA) have been reported in patients treated with another calcineurin-inhibitor immunosuppressant. All of these patients reported risk factors for PRCA such as parvovirus B19 infection, underlying disease, or concomitant medications associated with PRCA. A mechanism for calcineurin-inhibitor-induced PRCA has not been elucidated. If PRCA is diagnosed, consider discontinuation of LUPKYNIS.
Adverse Reactions
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, and 92 exposed for 3 years.
- Patients in Study 1 were randomized to LUPKYNIS 23.7 mg twice a day or placebo. A proportion of patients (n=216, 60%) in Study 1 continued in Study 1 extension, double-blinded continuation study, and these patients were observed for up to 2 additional years.
- 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.
- 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 overall profile of adverse events seen in Study 1 extension (representing 203 patient-years of additional exposure) were similar in both nature and severity to those seen in the first year of treatment (Study 1). The annual incidence of adverse reactions reduced each successive year in both treatment groups.
- 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). Among patients from Study 1, 100 patients (56.2%) on placebo twice a day and 116 patients (64.8%) on LUPKYNIS 23.7 mg twice a day continued in a follow-on study period for up to 2 additional years (Study 1 extension), with safety assessments through a total of up to 3 years.
- Exposure adjusted incidence rates were adjusted by study for all the adverse events reported in this section.
Specific Adverse Reactions
Infections
- In the integrated Study 1 and Study 2 data sets, 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.
- In Study 1 extension, infections and infestations were reported in 43 patients (32.3 per 100 patient-years) treated with placebo and 57 patients (41.4 per 100 patient-years) treated with LUPKYNIS 23.7 mg. There were 8 serious infections reported in both placebo treated patients (4.5 per 100 patient-years) and LUPKYNIS treated patients (3.9 per 100 patient-years).
Nephrotoxicity
I*n the integrated Study 1 and Study 2 data sets, 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.
- 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.
- In Study 1 extension, eGFR decreased was reported in 5 patients (2.8 per 100 patient-years) treated with placebo and 12 patients (6.1 per 100 patient-years) treated with LUPKYNIS 23.7 mg. Renal and urinary adverse events were reported in 10 patients (5.7 per 100 patient-years) treated with placebo and 21 patients (10.7 per 100 patient-years) treated with LUPKYNIS. Serious renal and urinary adverse events were reported in 5 patients (2.8 per 100 patient-years) treated with placebo and 2 patients (0.9 per 100 patient-years) treated with LUPKYNIS, and included lupus nephritis in both treatment groups.
Hypertension
- In the integrated Study 1 and Study 2 data sets, 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.
I*n Study 1 extension, hypertension was reported in 7 patients (4.0 per 100 patient-years) treated with placebo and 10 patients (4.9 per 100 patient-years) treated with LUPKYNIS 23.7 mg.
Neurotoxicity
- In the integrated Study 1 and Study 2 data sets, 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.
- In Study 1 extension, nervous system disorders (including headache) were reported in 8 patients (4.7 per 100 patient-years) treated with placebo and 14 patients (7.3 per 100 patient-years) treated with LUPKYNIS 23.7 mg.
Malignancy
- In the integrated Study 1 and Study 2 data sets, 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.
- n Study 1 extension, there were no reports of malignancies in either treatment arm.
Hyperkalemia
- In the integrated Study 1 and Study 2 data sets, 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.
- In Study 1 extension, hyperkalemia was reported in 0 patients treated with placebo and 1 patient (0.5 per 100 patient-years) treated with LUPKYNIS 23.7 mg.
QT Prolongation
- In the integrated Study 1 and Study 2 data sets, 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.
- In Study 1 extension, no patient treated with LUPKYNIS 23.7 mg reported QT prolongation.
Postmarketing Experience
There is limited information regarding Voclosporin Postmarketing Experience in the drug label.
Drug Interactions
Effect of Other Drugs on LUPKYNIS
Strong and Moderate CYP3A4 Inhibitors
- Voclosporin is a sensitive CYP3A4 substrate. Co-administration with strong or moderate CYP3A4 inhibitors increases voclosporin exposure , which may increase the risk of LUPKYNIS adverse reactions. Co-administration of LUPKYNIS with strong CYP3A4 inhibitors (e.g., ketoconazole, itraconazole, clarithromycin) is contraindicated .
- Reduce LUPKYNIS dosage when co-administered with moderate CYP3A4 inhibitors (e.g., verapamil, fluconazole, diltiazem).
- Avoid food or drink containing grapefruit when taking LUPKYNIS.
Strong and Moderate CYP3A4 Inducers
- Voclosporin is a sensitive CYP3A4 substrate. Co-administration with strong or moderate CYP3A4 inducers decreases voclosporin exposure , which may decrease the efficacy of LUPKYNIS. Avoid co-administration of LUPKYNIS with strong or moderate CYP3A4 inducers.
Effect of LUPKYNIS on Other Drugs
Certain P-gp Substrates
- Voclosporin is a P-gp inhibitor. Co-administration of voclosporin increases exposure of P-gp substrates , which may increase the risk of adverse reactions of these substrates. For certain P-gp substrates with a narrow therapeutic window, reduce the dosage of the substrate as recommended in its prescribing information, if needed.
OATP1B1 Substrates
- Voclosporin is an inhibitor of OATP1B1 and OATP1B3 transporters. In one clinical study the concomitant administration of a single 40 mg dose of simvastatin with 23.7 mg BID voclosporin increased C max and AUC of the active metabolite simvastatin acid (an OATP1B1 substrate) by 3.1-fold and 1.8-fold, respectively .
- Monitor for adverse reactions such as myopathy and rhabdomyolysis when OATP1B1/OATP1B3 substrates (e.g., simvastatin, atorvastatin, pravastatin, rosuvastatin, pitavastatin, fluvastatin) are used concomitantly with LUPKYNIS and reduce the dosage of these substrates as recommended in their prescribing information. For example, when taking LUPKYNIS with simvastatin, limit the simvastatin dosage to 20 mg daily, or 40 mg daily for patients who have previously tolerated simvastatin 80 mg daily for at least one year without evidence of muscle toxicity.
Use in Specific Populations
Pregnancy
Pregnancy Category (FDA):
There is no FDA guidance on usage of Voclosporin in women who are pregnant.
Pregnancy Category (AUS):
There is no Australian Drug Evaluation Committee (ADEC) guidance on usage of Voclosporin in women who are pregnant.
Labor and Delivery
There is no FDA guidance on use of Voclosporin during labor and delivery.
Nursing Mothers
There is no FDA guidance on the use of Voclosporin in women who are nursing.
Pediatric Use
There is no FDA guidance on the use of Voclosporin in pediatric settings.
Geriatic Use
There is no FDA guidance on the use of Voclosporin in geriatric settings.
Gender
There is no FDA guidance on the use of Voclosporin with respect to specific gender populations.
Race
There is no FDA guidance on the use of Voclosporin with respect to specific racial populations.
Renal Impairment
There is no FDA guidance on the use of Voclosporin in patients with renal impairment.
Hepatic Impairment
There is no FDA guidance on the use of Voclosporin in patients with hepatic impairment.
Females of Reproductive Potential and Males
There is no FDA guidance on the use of Voclosporin in women of reproductive potentials and males.
Immunocompromised Patients
There is no FDA guidance one the use of Voclosporin in patients who are immunocompromised.
Administration and Monitoring
Administration
There is limited information regarding Voclosporin Administration in the drug label.
Monitoring
There is limited information regarding Voclosporin Monitoring in the drug label.
IV Compatibility
There is limited information regarding the compatibility of Voclosporin and IV administrations.
Overdosage
There is limited information regarding Voclosporin overdosage. If you suspect drug poisoning or overdose, please contact the National Poison Help hotline (1-800-222-1222) immediately.
Pharmacology
There is limited information regarding Voclosporin Pharmacology in the drug label.
Mechanism of Action
There is limited information regarding Voclosporin Mechanism of Action in the drug label.
Structure
There is limited information regarding Voclosporin Structure in the drug label.
Pharmacodynamics
There is limited information regarding Voclosporin Pharmacodynamics in the drug label.
Pharmacokinetics
There is limited information regarding Voclosporin Pharmacokinetics in the drug label.
Nonclinical Toxicology
There is limited information regarding Voclosporin Nonclinical Toxicology in the drug label.
Clinical Studies
There is limited information regarding Voclosporin Clinical Studies in the drug label.
How Supplied
There is limited information regarding Voclosporin How Supplied in the drug label.
Storage
There is limited information regarding Voclosporin Storage in the drug label.
Images
Drug Images
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Package and Label Display Panel
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Patient Counseling Information
There is limited information regarding Voclosporin Patient Counseling Information in the drug label.
Precautions with Alcohol
Alcohol-Voclosporin interaction has not been established. Talk to your doctor about the effects of taking alcohol with this medication.
Brand Names
There is limited information regarding Voclosporin Brand Names in the drug label.
Look-Alike Drug Names
There is limited information regarding Voclosporin Look-Alike Drug Names in the drug label.
Drug Shortage Status
Price
References
The contents of this FDA label are provided by the National Library of Medicine.