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 {{{adverseReactions}}}.
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
|
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
There is limited information regarding Voclosporin Clinical Trials Experience in the drug label.
Postmarketing Experience
There is limited information regarding Voclosporin Postmarketing Experience in the drug label.
Drug Interactions
There is limited information regarding Voclosporin Drug Interactions in the drug label.
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.