Drug presentation on VOCLOSPORIN
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Voclosporin (Lupkynis) is a calcineurin inhibitor approved in 2021 to treat adult patients with active lupus nephritis in combination with mycophenolate mofetil and corticosteroids. It is formulated as oval, pink/orange capsules containing 23.7 mg of voclosporin, a calcineurin inhibitor. The drug works by inhibiting T-cell activation through calcineurin inhibition. Dosage adjustments are required for patients with renal or hepatic impairment. Common side effects include decreased glomerular filtration rate, hypertension, diarrhea and headache.
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Rifampicin is an antibiotic used to treat tuberculosis and other bacterial infections. It works by inhibiting bacterial RNA polymerase. Common forms include capsules, syrup, ointment, and intravenous powder. Rifampicin must be taken regularly as part of a combination drug regimen to prevent drug resistance and is commonly used with isoniazid, ethambutol, pyrazinamide, and streptomycin to treat tuberculosis. Common side effects include nausea, vomiting, headache, and liver dysfunction. Due to interactions with many other drugs, patients should notify their provider of all medications.
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This document discusses the management of pulmonary artery hypertension. The goals of therapy are to prevent disease progression in stable patients through lifestyle changes and education, and to stabilize right-sided heart function, provide symptomatic relief, and improve hemodynamics in unstable patients. Treatment includes pharmacological therapies like prostanoids, endothelin receptor antagonists, phosphodiesterase type-5 inhibitors, and soluble guanylate cyclase stimulators. Non-pharmacological options include oxygen supplementation and surgical interventions like balloon atrial septostomy and lung transplantation. Combination therapy with multiple drug classes may provide added benefits over monotherapy.
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Topics covered:
-> Definition
->Classification
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->etiology and risk factors
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Drug presentation on VOCLOSPORIN
- 1. PRESENTED BY: CH.BINDU MADHAVI V/VI PHARM D Y17PHD0805 NIRMALA COLLEGE OF PHARMACY
- 2. DRUG DETAILS: DRUG NAME LUPKYNIS ACTIVE INGREDIENT Voclosporin COMPANY Aurinia Pharmaceuticals APPROVED DATE January 22, 2021 CATEGORY Calcineurin Inhibitor LUPKYNIS is a drug used to treat patients with active lupus nephritis. Lupus nephritis (LN) is an inflammation of the kidneys that is caused by systemic lupus erythematous (SLE) - a chronic, autoimmune disease. LUPKYNIS is a calcineurin-inhibitor immunosuppressant indicated in combination with a immunosuppressive therapy regimen ( MMF and Corticosteroids) for the treatment of adult patients with active lupus nephritis (LN).
- 3. • MOL FORMULA: C63H111N11O12 • MOL WEIGHT : 1214.6 g/mole • APPEARANCE: appears as oval, pink/orange capsules, imprinted on one side with VCS in white. • PROPERTIES: voclosporin is freely soluble in acetone, acetonitrile, ethanol, and methanol and is insoluble in water STRUCTURE OF VOCLOSPORIN
- 5. DOSAGE FORMS AND STRENGTHS: Usual Adult dose: 23.7mg P/O BD • Dosage Modifications in Renal impairment- • Modify dose based on GFR • If used in patients with severe renal impairment at baseline, the recommended starting dose is 15.8 mg twice a day • Dosage modifications in Hepatic impairment- • Mild or moderate : Reduce to 15.8 mg BID • Severe : Not recommended GFR REDUCED FROM BASELINE DOSE ADJUSTMENT GFR <60 mL/min/1.73 m2 >20 to <30% Reduce by 7.9 mg BID GFR <60 mL/min/1.73 m2 GFR is still reduced from baseline by >20% reduce dose again by 7.9 mg BID GFR <60 mL/min/1.73 m2 ≥30% Discontinue GFR ≥80% of baseline Consider increasing dose by 7.9 mg BID
- 6. ADVERSE EFFECTS • Glomerular filtration rate decreased • Hypertension • Diarrhoea • Headache • Anaemia • Cough • Urinary tract infection • Upper abdominal pain • Dyspepsia • Renal Impairment • Abdominal pain
- 7. INTERACTIONS: • Voclosporin is a sensitive CYP3A4 substrate. Co-administration with strong or moderate CYP3A4 inhibitors increases voclosporin exposure and leads to increase adrs (e.g., ketoconazole, itraconazole, clarithromycin) • Voclosporin is a P-gp inhibitor. Co-administration of voclosporin increases exposure of P-gp substrates. (e.g., amiodarone, erythromycin, omeprazole) • Some products that may interact with this drug are: cyclophosphamide and drugs that may increase potassium levels (such as potassium supplements, certain diuretics/"water pills" including amiloride, spironolactone). • CONTRAINDICATIONS: • Pregnancy ( causes foetal death) • Hypersensitivity Reactions • Contraindicated in patients with BP greater than 165/105mm Hg or with hypertensive emergency.
- 8. • MONITORING PARAMETERS: • Monitor electrolytes (specially K levels) periodically • Monitor BP • Monitor QT prolongation • GENERAL CONSIDERATIONS: • Take on an empty stomach. Take on an empty stomach, either 1 hour before or 2 hours after a meal and as close to 12 hours between doses as possible.