Ruvan-Z, a super combination of super statin i.e. Rosuvastatin & Ezetimibe, a USFDA approved lipid lowering agent which possesses superior efficacy in reducing LDL-C as well as achieving the target LDL-C goal in ASCVD patients with less Drug Discontinuation rates due to adverse effects of high dose statin monotherapy.
Ruvan-Z is a combination of rosuvastatin and ezetimibe, a dietary cholesterol absorption inhibitor which is indicated in adults as an adjunct to diet in patients with primary non-familial hyperlipidemia to reduce LDL-C & in patients with homozygous familial hypercholesterolemia (HoFH) to reduce LDL-C. Rosuvastatin reduces cholesterol synthesis in the liver, while Ezetimibe inhibits intestinal cholesterol absorption, offering a dual mechanism for LDL-C reduction. Ruvan-Z is available in 5/10 mg, 10/10 mg, and 20/10 mg strengths and is designed to support effective lipid management in patients requiring additional LDL-C reduction alongside lifestyle modification.
Ruvan-Z 5/10 mg Tablet: Each film coated tablet contains Rosuvastatin Calcium BP equivalent to Rosuvastatin 5 mg & Ezetimibe USP 10 mg.
Ruvan-Z 10/10 mg Tablet: Each film coated tablet contains Rosuvastatin Calcium BP equivalent to Rosuvastatin 10 mg & Ezetimibe USP 10 mg.
Ruvan-Z 20/10 mg Tablet: Each film coated tablet contains Rosuvastatin Calcium BP equivalent to Rosuvastatin 20 mg & Ezetimibe USP 10 mg.
Ruvan-Z is indicated in adults:
• As an adjunct to diet in patients with primary non-familial hyperlipidemia to reduce low-density lipoprotein cholesterol (LDL-C).
• Alone or as an adjunct to other LDL-C lowering therapies in patients with homozygous familial hypercholesterolemia (HoFH) to reduce LDL-C.
The dosage range is 5 mg/10 mg to 40 mg/10 mg once daily. The recommended dose of Ruvan-Z depends on a patient’s indication for usage, LDL-C, and individual risk for cardiovascular events. The starting dosage for patients switching to Ruvan-Z from co-administration of a statin and ezetimibe is based on an equivalent dose of rosuvastatin and 10 mg of ezetimibe. Dosage in Asian Patients: Initiate Ruvan-Z at 5 mg/10 mg daily due to increased rosuvastatin plasma concentrations. Consider the risk/benefit when treating Asian patients not adequately controlled at doses up to 20 mg/10 mg once daily. Dosage in Patients with Renal Impairment: In patients with severe renal impairment (CLcr less than 30 mL/min/1.73 m2) not on hemodialysis, the recommended starting dosage is 5 mg/10 mg once daily and should not exceed 10 mg/10 mg once daily. There are no dosage adjustment recommendations for patients with mild and moderate renal impairment.
Ruvan-Z is contraindicated in patients with:
• Acute liver failure or decompensated cirrhosis.
• Hypersensitivity to rosuvastatin, ezetimibe, or any excipients in rosuvastatin & ezetimibe.
Hypersensitivity reactions including anaphylaxis, angioedema, and erythema multiforme have been reported.
Myopathy and Rhabdomyolysis: Risk factors include age 65 years or greater, uncontrolled hypothyroidism, renal impairment, concomitant use with certain other drugs, and higher Ruvan-Z dosage. Discontinue Ruvan-Z if markedly elevated CK levels occur or myopathy is diagnosed or suspected. Temporarily discontinue Ruvan-Z in patients experiencing an acute or serious condition at high risk of developing renal failure secondary to rhabdomyolysis. Inform patients about the risk of myopathy and rhabdomyolysis when starting or increasing Ruvan-Z dosage. Instruct patients to promptly report unexplained muscle pain, tenderness, or weakness, particularly if accompanied by malaise or fever. Immune-Mediated Necrotizing Myopathy (IMNM): Rare reports of IMNM, an autoimmune myopathy, have been reported with statin use. Hepatic Dysfunction: Increases in serum transaminases have occurred, some persistent. Rare reports of fatal and non-fatal hepatic failure have occurred. Consider testing liver enzyme tests before initiating therapy and as clinically indicated thereafter. If serious hepatic injury with clinical symptoms and/or hyperbili rubinemia or jaundice occurs, promptly discontinue Ruvan-Z.
Most common adverse reactions for: • Rosuvastatin (incidence >2% and greater than placebo) are headache, nausea, myalgia, arthralgia, dizziness, asthenia, constipation, and abdominal pain. • Ezetimibe (incidence >2% and greater than placebo) are upper respiratory tract infection, diarrhea, arthralgia, sinusitis, pain in extremity, fatigue, and influenza. • Ezetimibe co-administered with a statin (incidence >2% and greater than statin alone) are nasopharyngitis, myalgia, upper respiratory tract infection, arthralgia, diarrhea, back pain, influenza, pain in extremity, and fatigue.
.• Gemfibrozil or Cyclosporin: Avoid concomitant use with Ruvan-Z.
• Antivirals: Avoid concomitant use of Ruvan-Z with certain antivirals and adjust the dose with other antivirals
.• Darolutamide: Do not exceed 5 mg/10 mg once daily.
• Regorafenib: Do not exceed 10 mg/10 mg once daily.
• Fenofibrates, Niacin, Colchine: Consider the risks and benefits of concomitant use with the drug.
Use in Pregnancy: May cause fetal harm. Lactation: Breastfeeding not recommended during treatment with Ruvan-Z. Pediatric Use: The safety and effectiveness of Ruvan-Z have not been established in pediatric patients. Geriatric Use: Dose selection for an elderly patient should be cautious, recognizing the greater frequency of decreased hepatic, renal, or cardiac function, concomitant disease or other drug therapy and the higher risk of myopathy.
Ruvan-Z 5/10 Tablet: Each box contains 30’s tablets in Alu-Alu blister pack.
Ruvan-Z 10/10 Tablet: Each box contains 30’s tablets in Alu-Alu blister pack.
Ruvan-Z 20/10 Tablet: Each box contains 20’s tablets in Alu-Alu blister pack
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