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

Roszet Savings Programs

Roszet is available and affordable for a wide number of patients.

Eligible patients can
     self-pay for Roszet at


† Per month indicates 30-day supply. Additional details, including eligibility and Terms and Conditions, are available at Walgreens and Duane Reade pharmacies. Offer subject to change.

Most Commercially
     Insured patients* can get
     Roszet for a Preferred
     Brand Tier price


*Not for Medicare or other government insured patients. Available at participating pharmacies. Offer is subject to change at any time. See details, including eligibility and Terms and Conditions, below.



Eligibility Criteria/ Terms and Conditions for Roszet Savings Program for Commercially Insured Patients:

By using the Roszet Savings Program, eligible commercially insured patients confirm that they understand and agree to comply with the following terms and conditions of this offer:

  • Eligibility Exclusions: This offer is not valid for any person eligible for reimbursement of prescriptions, in whole or in part, by any federal, state, or other governmental programs, including, but not limited to Medicare, Medicaid, TRICARE, Veterans Administrations or Department of Defense health coverage, CHAMPUS, the Puerto Rico Government Health Insurance Plan or any other federal or state health care programs.
  • The Savings Program is only valid for use with Roszet. Savings will be automatically applied at participating pharmacies when patient is eligible, and transaction can be processed through Althera’s preferred vendor for pharmacy claims processing. No other purchase necessary.
  • This offer is valid for eligible patients with commercial insurance, as confirmed through Althera’s preferred vendor for pharmacy claims processing, as long as the patient's insurance does not cover the full cost of the prescription up to the program thresholds.
  • This offer is valid only in the United States (including the District of Columbia, Puerto Rico, Guam and the U.S. Virgin Islands) and only at participating retail pharmacies. Participating pharmacies subject to change without notice.
  • Savings limitations apply. Patient is responsible for all additional costs and expenses after savings limits are reached, including additional copayment and coinsurance amounts. Eligible commercially insured patients may pay as low as $45 per 30 day supply. However, some patients may pay more than $45 for a 30 day supply depending on insurance coverage, eligibility and pharmacy used.
  • This offer can only be applied to the cost of an eligible Roszet prescription and not toward ancillary services or treatment costs.
  • This offer is not valid where prohibited, taxed, or otherwise restricted.
  • This offer is not valid for any person who is 65 years or older without commercial insurance. You must be 18 years of age or older to redeem this offer for yourself or a minor.
  • This Savings Program and offer are not health insurance.
  • This offer is not valid with other offers.
  • Althera Pharmaceuticals reserves the right to rescind, revoke, terminate or amend this offer at any time, without notice.
  • If you have questions, please contact us using the Contact Us form available here.

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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