This Site Is Intended For US Healthcare Professionals Only

This Site Is Intended For US Healthcare Professionals Only

Get your patients to goal

*Not actual patients

For patients like Joe, with established CVD, Global Guidelines suggest they need to lower their LDL-C below 70 mg/dL


JOE*, 59 yrs

History of unstable angina

*Not an actual patient. Results may vary by dose and individual response. Dosage of Roszet should be individualized based on indication, LDL-C levels, and risk for cardiovascular events.

LIPID PROFILE

CURRENT LDL-C 97 mg/dL
Pretreatment LDL-C 194 mg/dL
HDL-C 45 mg/dL
TG 120 mg/dL
BMI 29

CURRENT TREATMENTS

High intensity statin

Clopidogrel 75 mg

Enalapril 5 mg

KNOW YOUR OPTIONS

Expected drops from pretreatment LDL-C of 194 mg/dL1

Roszet can provide powerful

66% LDL-C Reduction

with 20mg/10mg dose

For patients like Donna, with comorbidities and high 10-year risk score, Global Guidelines suggest they need to lower their LDL-C below 70 mg/dL


LIPID PROFILE

CURRENT LDL-C 88 mg/dL
Pretreatment LDL-C 196 mg/dL
HDL-C 35 mg/dL
TG 128 mg/dL
BMI 29

CURRENT TREATMENTS

Rosuvastatin 20mg

Losartan/HCT 100mg/12.5mg

Dapagliflozin 10mg

metformin 500mg

KNOW YOUR OPTIONS

Expected drops from pretreatment LDL-C of 196 mg/dL1

‡ Values estimated based on LDL-C reduction for rosuvastatin 20 mg from Roszet PI

DONNA*, 59 yrs

Hypertension,

Type 2 diabetes

ASCVD risk score PCE > 20%

*Not an actual patient. Results may vary by dose and individual response. Dosage of Roszet should be individualized based on indication, LDL-C levels, and risk for cardiovascular events.

Roszet can provide powerful

66% LDL-C Reduction

with 20mg/10mg dose

For patients like Kevin, with comorbidities and high risk, Global Guidelines suggest they need to lower their LDL-C below 70 mg/dL


KEVIN*, 49 yrs

Diabetes for > 10 yrs

Hypertension

ASCVD risk score PCE >14%

*Not an actual patient. Results may vary by dose and individual response. Dosage of Roszet should be individualized based on indication, LDL-C levels, and risk for cardiovascular events.

LIPID PROFILE

CURRENT LDL-C 99 mg/dL
Pretreatment LDL-C 206 mg/dL
HDL-C 30 mg/dL
TG 125 mg/dL
BMI 27

CURRENT TREATMENTS

Rosuvastatin 10mg

Sitagliptin 50mg

Metformin 1000 mg

Valsartan/HCT 160mg/2.5mg

KNOW YOUR OPTIONS

Expected drop pretreatment LDL-C of 206 mg/dL1

‡ Values estimated based on LDL-C reduction for rosuvastatin 10 mg from Roszet PI

Roszet can provide powerful

64% LDL-C Reduction

with 10mg/10mg dose

For patients like Susan, with previous cardiovascular event, Global Guidelines suggest they need to lower their LDL-C below 70 mg/dL


LIPID PROFILE

CURRENT LDL-C 88 mg/dL
Pretreatment LDL-C 176 mg/dL
HDL-C 30 mg/dL
TG 115 mg/dL
BMI 27

CURRENT TREATMENTS

High intensity statin

Metoprolol 100 mg

Aspirin 100 mg

KNOW YOUR OPTIONS

Expected drops from pretreatment LDL-C of 176 mg/dL1

SUSAN*, 63 yrs

Hypertension

Prior MI

*Not an actual patient. Results may vary by dose and individual response. Dosage of Roszet should be individualized based on indication, LDL-C levels, and risk for cardiovascular events.

Roszet can provide powerful

64% LDL-C Reduction

with 10mg/10mg dose

For patients like Michael, with very high LDL-C, Global Guidelines suggest they need to lower their LDL-C to below 100 mg/dL


MICHAEL*, 60 yrs

Very high LDL-C

* Not an actual patient. Results may vary by dose and individual response. Dosage of Roszet should be individualized based on indication, LDL-C levels, and risk for cardiovascular events.

LIPID PROFILE

CURRENT LDL-C 112 mg/dL
Pretreatment LDL-C 233 mg/dL
HDL-C 30 mg/dL
TG 100 mg/dL
BMI 25

CURRENT TREATMENTS

Rosuvastatin 10mg

KNOW YOUR OPTIONS

Expected drops from current LDL-C of 112 mg/dL5

‡ Values estimated based on LDL-C reduction for rosuvastatin 10 mg from rosuvastatin PI

Data from the ACTE trial shows that,

for patients on rosuvastatin 10 mg,

Roszet can provide powerful incremental

24% LDL-C Reduction

with 10mg/10mg dose vs 6% with doubling dose of rosuvastatin

For patients like Raj, with moderate CV risk plus other factors, Global Guidelines suggest they need to lower their LDL-C to below 100 mg/dL


LIPID PROFILE

CURRENT LDL-C 109 mg/dL
Pretreatment LDL-C 227 mg/dL
HDL-C 25 mg/dL
TG 125 mg/dL
BMI 31

CURRENT TREATMENTS

Rosuvastatin 10 mg

KNOW YOUR OPTIONS

Expected drops from current LDL-C of 109 mg/dL5

‡ Values estimated based on LDL-C reduction for rosuvastatin 10 mg from rosuvastatin PI

RAJ*, 58 yrs

South Asian ethnicity

Metabolic syndrome

ASCVD risk score PCE >14%

*Not an actual patient. Results may vary by dose and individual response. Dosage of Roszet should be individualized based on indication, LDL-C levels, and risk for cardiovascular events. Asian patients can have increased rosuvastatin plasma concentrations. Consider the risk/benefit when treating Asian patients not adequately controlled at doses upto 20 mg/10 mg once daily’

Data from the ACTE trial shows that,

for patients on rosuvastatin 10 mg,

Roszet can provide powerful incremental

24% LDL-C Reduction

with 10mg/10mg dose vs 6% with doubling dose of rosuvastatin

1. Roszet (rosuvastatin and ezetimibe) Prescribing Information; Morristown, NJ; Althera Pharmaceuticals.

5. Bays HE, et al. Safety and efficacy of ezetimibe added on to rosuvastatin 5 or 10 mg versus up-titration of rosuvastatin in patients with hypercholesterolemia (the ACTE Study). Am J Cardiol 2011;108:523-30.

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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
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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