This Site Is Intended For US Healthcare Professionals Only

Prescribing Information Important Safety Information

This Site Is Intended For US Healthcare Professionals Only

Prescribing Information Important Safety Information

ezetimibe-rosuvastatin tablets

Available doses: 10mg/5mg, 10mg/10mg, 10mg/20mg, 10mg/40mg

Now Available as a GENERIC
with GENERIC CO-PAY

ezetimibe-rosuvastatin is available at a GENERIC Co-Pay for commercially insured patients

Listed as ezetimibe-rosuvastatin in your EMR

For patients with Commercial Insurance

Patients pay a single generic co-pay for the generic

Co-pay between $5 to $25 p.m. based on patient's insurance

No Prior Auth required (please ignore if PA shows in EMR/EHR)

For patients without Commercial Insurance (e.g., Medicare, Uninsured)

Use GoodRx: Patients typically pay $15 to $30 p.m.

Available in Major Pharmacies except CVS

Help Get Most High-Risk Patients To <70 mg/dL With One Daily Pill

In the EXPLORER Study 2

More patients achieved

LDL-C Goal of < 70 mg/dL

With rosuvastatin-ezetimibe 40-10mg

On rosuvastatin-ezetimibe 40-10 mg, most CHD patients achieved their LDL-C goal† of < 70 mg/dL

vs. with rosuvastatin 40 mg

Only 35% of CHD patients on the highest dose of rosuvastatin achieved LDL-C goal† of < 70 mg/dL

† In the Explorer Study, 469 patients aged ≥ 18 years with hypercholesterolemia and a history of CV risk were randomized on rosuvastatin + ezetimibe 40 mg/10 mg vs. rosuvastatin 40 mg for a total of 6-weeks. Primary endpoint was % of patients at LDL-C goal < 100 mg/dL. Secondary endpoint for CHD patients was % at LDL-C goal < 70 mg/dL.

ezetimibe-rosuvastatin is a generic version of Roszet (rosuvastatin-ezetimibe) tablets

Safety and Tolerability

Roszet adverse experiences1 are expected to be similar to those with co-administered rosuvastatin
and ezetimibe taken separately.

Rosuvastatin (AEs ≥2% of patients)
Adverse Reaction Placebo N=382 Total Rosuvastatin 5 mg-40 mg N=744
Headache 5.0% 5.5%
Nausea 3.1% 3.4%
Myalgia 1.3% 2.8%
Asthenia 2.6% 2.7%
Constipation 2.4% 2.4%
Ezetimibe with S tatins (AEs ≥2% of patients)
Adverse Reaction All Statins (%), n=9361 Ezetimibe + statins (%) N=11,308
Nasopharyngitis 3.3% 3.7%
Myalgia 2.7% 3.2%
Upper respiratory tract infection 2.8% 2.9%
Arthralgia 2.4% 2.6%
Diarrhea 2.2% 2.5%
Back pain 2.3% 2.4%
Influenza 2.1% 2.2%
Pain in extremity 1.9% 2.1%
Fatigue 1.6% 2.0%
  • Roszet (rosvastatin and ezetimibe) Prescribing Information; Morristown, NJ; Althera Pharmaceuticals
  • Ballantyne CM, et al. Efficacy and safety of rosuvastatin 40 mg alone or in combination with ezetimibe in patients at high risk of cardiovascular disease (results from the EXPLORER study). Am J Cardiol 2007; 99: 673-80.

GoodRx is a trademark of GoodRx, Inc.

test

Important Safety Information

Indications and Usage
ROSZET 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.
Important Safety Information
Contraindications: ROSZET is contraindicated in patients with active liver disease or decompensated cirrhosis, and hypersensitivity to any component of this product.
Myopathy and Rhabdomyolysis: ROSZET may cause myopathy (muscle pain, tenderness, or weakness with creatine kinase [CK] above ten times the upper limit of normal) and rhabdomyolysis. Acute kidney injury secondary to myoglobinuria and rare fatalities have occurred as a result of rhabdomyolysis with statins, including rosuvastatin.
Risk factors for myopathy include age 65 years or greater, uncontrolled hypothyroidism, renal impairment, concomitant use with certain other drugs including other lipid-lowering therapies, and higher ROSZET dosage; Asian patients on ROSZET may be at higher risk for myopathy. The myopathy risk is greater in patients taking ROSZET 40 mg/10 mg daily compared with lower ROSZET dosages.
The concomitant use of ROSZET with cyclosporine or gemfibrozil is not recommended. ROSZET dosage modifications are recommended for patients taking certain anti-viral medications, darolutamide, and regorafenib. Niacin, fibrates, and colchicine may also increase the risk of myopathy and rhabdomyolysis.
Discontinue ROSZET if markedly elevated CK levels occur or myopathy is diagnosed or suspected. Muscle symptoms and CK increases may resolve if ROSZET is discontinued. Instruct patients to promptly report any unexplained muscle pain, tenderness or weakness, particularly if accompanied by malaise or fever.
Immune-Mediated Necrotizing Myopathy: There have been rare reports of immune-mediated necrotizing myopathy (IMNM), an autoimmune myopathy, associated with statin use. IMNM is characterized by: proximal muscle weakness and elevated serum creatine kinase, which persist despite discontinuation of statin treatment; positive anti-HMG CoA reductase antibody; muscle biopsy showing necrotizing myopathy; and improvement with immunosuppressive agents. Treatment with immunosuppressive agents may be required. Consider risk of IMNM carefully prior to initiation of a different statin. If therapy is initiated with a different statin, monitor for signs and symptoms of IMNM.
Hepatic Dysfunction: Increases in serum transaminases have occurred with rosuvastatin. Consider liver enzyme testing before ROSZET initiation and thereafter, when clinically indicated. There have been rare post marketing reports of fatal and non-fatal hepatic failure in patients taking statins, including rosuvastatin. Patients who consume substantial quantities of alcohol and/or have a history of liver disease may be at increased risk for hepatic injury. If serious hepatic injury with clinical symptoms and/or hyperbilirubinemia or jaundice occurs, promptly discontinue ROSZET.
Proteinuria and Hematuria: Dipstick-positive proteinuria and microscopic hematuria were observed among rosuvastatin treated patients. These findings were more frequent in patients taking rosuvastatin 40 mg, when compared to lower doses of rosuvastatin or comparator statins, though it was generally transient and was not associated with worsening renal function. Although the clinical significance of this finding is unknown, consider a dose reduction for patients on ROSZET therapy with unexplained persistent proteinuria and/or hematuria during routine urinalysis testing.
HbA1c and Fasting Serum Glucose: Increases in HbA1c and fasting serum glucose levels have been reported with statins, including rosuvastatin. Based on clinical trial data with rosuvastatin, in some instances these increases may exceed the threshold for the diagnosis of diabetes mellitus.
Adverse Reactions: Most frequent adverse reactions (incidence >2% and greater than placebo) for rosuvastatin in clinical trials are: headache, nausea, myalgia, asthenia, dizziness, asthenia, constipation, and abdominal pain. Other adverse reactions reported in clinical studies were hypersensitivity (including rash, pruritus, urticaria, and angioedema), and pancreatitis. For ezetimibe co-administered with a statin most frequent adverse reactions (incidence >2% and greater than statin alone) are nasopharyngitis, myalgia, upper respiratory tract infection, arthralgia, diarrhea, back pain, influenza, pain in extremity, and fatigue. For ezetimibe monotherapy most frequent adverse reactions (incidence >2% and greater than placebo) are upper respiratory tract infection, diarrhea, arthralgia, sinusitis, pain in extremity, fatigue and influenza.
There have been rare post marketing reports of cognitive impairment (e.g., memory loss, forgetfulness, amnesia, memory impairment, confusion) associated with statin use, including ROSZET. These cognitive issues have been reported for all statins. The reports are generally nonserious, and reversible upon statin discontinuation.
Drug Interactions:
Gemfibrozil or Cyclosporin: Avoid concomitant use with ROSZET.
Antivirals: Avoid concomitant use or adjust dose of ROSZET.
Darolutamide: Do not exceed ROSZET 5 mg/10 mg once daily.
Regorafenib: Do not exceed ROSZET 10 mg/10 mg once daily.
Fenofibrates, Niacin, Colchicine: Consider risks and benefits of concomitant use with ROSZET.
Warfarin: Obtain INR before ROSZET initiation and monitor INR during ROSZET initiation or dosage adjustment.
Use in Specific Populations: Discontinue ROSZET when pregnancy is recognized as it may cause fetal harm. Breastfeeding is not recommended during treatment with ROSZET.
Please see full Prescribing Information for ROSZET
test
Important Safety Information
Indications and Usage
ROSZET 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.
Important Safety Information
Contraindications: ROSZET is contraindicated in patients with active liver disease or decompensated cirrhosis, and hypersensitivity to any component of this product.
Myopathy and Rhabdomyolysis: ROSZET may cause myopathy (muscle pain, tenderness, or weakness with creatine kinase [CK] above ten times the upper limit of normal) and rhabdomyolysis. Acute kidney injury secondary to myoglobinuria and rare fatalities have occurred as a result of rhabdomyolysis with statins, including rosuvastatin.
Risk factors for myopathy include age 65 years or greater, uncontrolled hypothyroidism, renal impairment, concomitant use with certain other drugs including other lipid-lowering therapies, and higher ROSZET dosage; Asian patients on ROSZET may be at higher risk for myopathy. The myopathy risk is greater in patients taking ROSZET 40 mg/10 mg daily compared with lower ROSZET dosages.
The concomitant use of ROSZET with cyclosporine or gemfibrozil is not recommended. ROSZET dosage modifications are recommended for patients taking certain anti-viral medications, darolutamide, and regorafenib. Niacin, fibrates, and colchicine may also increase the risk of myopathy and rhabdomyolysis.
Discontinue ROSZET if markedly elevated CK levels occur or myopathy is diagnosed or suspected. Muscle symptoms and CK increases may resolve if ROSZET is discontinued. Instruct patients to promptly report any unexplained muscle pain, tenderness or weakness, particularly if accompanied by malaise or fever.
Immune-Mediated Necrotizing Myopathy: There have been rare reports of immune-mediated necrotizing myopathy (IMNM), an autoimmune myopathy, associated with statin use. IMNM is characterized by: proximal muscle weakness and elevated serum creatine kinase, which persist despite discontinuation of statin treatment; positive anti-HMG CoA reductase antibody; muscle biopsy showing necrotizing myopathy; and improvement with immunosuppressive agents. Treatment with immunosuppressive agents may be required. Consider risk of IMNM carefully prior to initiation of a different statin. If therapy is initiated with a different statin, monitor for signs and symptoms of IMNM.
Hepatic Dysfunction: Increases in serum transaminases have occurred with rosuvastatin. Consider liver enzyme testing before ROSZET initiation and thereafter, when clinically indicated. There have been rare post marketing reports of fatal and non-fatal hepatic failure in patients taking statins, including rosuvastatin. Patients who consume substantial quantities of alcohol and/or have a history of liver disease may be at increased risk for hepatic injury. If serious hepatic injury with clinical symptoms and/or hyperbilirubinemia or jaundice occurs, promptly discontinue ROSZET.
Proteinuria and Hematuria: Dipstick-positive proteinuria and microscopic hematuria were observed among rosuvastatin treated patients. These findings were more frequent in patients taking rosuvastatin 40 mg, when compared to lower doses of rosuvastatin or comparator statins, though it was generally transient and was not associated with worsening renal function. Although the clinical significance of this finding is unknown, consider a dose reduction for patients on ROSZET therapy with unexplained persistent proteinuria and/or hematuria during routine urinalysis testing.
HbA1c and Fasting Serum Glucose: Increases in HbA1c and fasting serum glucose levels have been reported with statins, including rosuvastatin. Based on clinical trial data with rosuvastatin, in some instances these increases may exceed the threshold for the diagnosis of diabetes mellitus.
Adverse Reactions: Most frequent adverse reactions (incidence >2% and greater than placebo) for rosuvastatin in clinical trials are: headache, nausea, myalgia, asthenia, dizziness, asthenia, constipation, and abdominal pain. Other adverse reactions reported in clinical studies were hypersensitivity (including rash, pruritus, urticaria, and angioedema), and pancreatitis. For ezetimibe co-administered with a statin most frequent adverse reactions (incidence >2% and greater than statin alone) are nasopharyngitis, myalgia, upper respiratory tract infection, arthralgia, diarrhea, back pain, influenza, pain in extremity, and fatigue. For ezetimibe monotherapy most frequent adverse reactions (incidence >2% and greater than placebo) are upper respiratory tract infection, diarrhea, arthralgia, sinusitis, pain in extremity, fatigue and influenza.
There have been rare post marketing reports of cognitive impairment (e.g., memory loss, forgetfulness, amnesia, memory impairment, confusion) associated with statin use, including ROSZET. These cognitive issues have been reported for all statins. The reports are generally nonserious, and reversible upon statin discontinuation.
Drug Interactions:
Gemfibrozil or Cyclosporin: Avoid concomitant use with ROSZET.
Antivirals: Avoid concomitant use or adjust dose of ROSZET.
Darolutamide: Do not exceed ROSZET 5 mg/10 mg once daily.
Regorafenib: Do not exceed ROSZET 10 mg/10 mg once daily.
Fenofibrates, Niacin, Colchicine: Consider risks and benefits of concomitant use with ROSZET.
Warfarin: Obtain INR before ROSZET initiation and monitor INR during ROSZET initiation or dosage adjustment.
Use in Specific Populations: Discontinue ROSZET when pregnancy is recognized as it may cause fetal harm. Breastfeeding is not recommended during treatment with ROSZET.
Please see full Prescribing Information for ROSZET