Dosage & Administration Administration :
* LUPKYNIS must be swallowed whole on an empty stomach. ( 2.1) * Administer consistently as close to a 12-hour schedule as possible, and with at least 8 hours between doses. ( 2.1) * 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. ( 2.1) * Instruct patients to avoid eating grapefruit or drinking grapefruit juice while taking LUPKYNIS. ( 2.1, 7.1) 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 m2 unless the benefit exceeds the risk; these patients may be at increased risk for acute and/or chronic nephrotoxicity. ( 2.2, 5.3) * Do not initiate LUPKYNIS in patients with baseline BP >165/105 mmHg or with hypertensive emergency. ( 2.2, 5.4) * Recommended starting dose: 23.7 mg orally, twice a day. ( 2.3) * Use LUPKYNIS in combination with mycophenolate mofetil (MMF) and corticosteroids. ( 2.3) * Modify the LUPKYNIS dose based on eGFR ( 2.3, 5.3):* 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 m2 and 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 m2 and 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. ( 2.3, 5.4) * If the patient has not experienced therapeutic benefit by 24 weeks, consider discontinuation of LUPKYNIS. ( 2.3) Dosage Adjustments :
* Patients with severe renal impairment: the recommended dose is 15.8 mg twice daily. ( 2.4, 8.6) * Patients with mild and moderate hepatic impairment: the recommended dose is 15.8 mg twice daily. ( 2.4, 8.7)
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Lupkynis Prescribing Information
Lupkynis Prior Authorization Resources
Lupkynis Financial Assistance Options
Learn More Reduce patient OOP costs for drug (and occasionally for drug administration/infusion costs or drug-related test costs) A portion (or all) of patient OOP (deductible, copay), typically up to monthly and/or annual max Patient must enroll or activate (may permit HCPs to enroll on patient’s behalf for HCP-administered drugs) Generally, must have commercial insurance (rarely, may permit uninsured patients to use) May never be used with government insurance Cards may be downloadable digital cards or hard copies Some pharmacos offer debit cards with pre-loaded copay benefit Typically, available through multiple channels (e.g., rep to HCP to patient; pharmacy to patient; patient via website, Hub live agent, or copay vendor (live agent or IVR); patient and HCP via Hub enrollment form) Some HCP-administered product programs permit HCPs to enroll on a patient’s behalf through via Hub form
Learn More Provide patient immediate access to therapy during an insurance delay (typically new starts; some may cover change in insurance) Limited time/ fill (typically 7-30 days; some may offer additional fill for continued delay up to certain limit) 100% free (outside of insurance) HCP must enroll patient May be limited to commercially insured patients (i.e., no government beneficiaries); some programs may allow government beneficiaries Typically HCP assisted enrollment (via form)
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Lupkynis FAQs How is the dosage of Lupkynis?
Lupkynis is available in 1 dosages, including 7.9 mg Cap
What does Lupkynis treat?
Lupkynis treats Lupus Nephritis
What is Lupkynis made of?
Lupkynis contains voclosporin which is a Calcineurin Inhibitor Immunosuppressant
How Is Lupkynis Administered?
Lupkynis is administered as a Oral Pill
What Are The Lupkynis Mechanism Of Action?
Lupkynis mechanism of action is Calcineurin Inhibitors, P-Glycoprotein Inhibitors, Organic Anion Transporting Polypeptide 1B1 Inhibitors or Organic Anion Transporting Polypeptide 1B3 Inhibitors
We receive information directly from the FDA and PrescriberPoint is updated as frequently as change are made available
