The words of which the initial letter is capitalized have meanings defined under the following conditions. The following definitions shall have the same meaning regardless of whether they appear in singular or in plural.
Account means a unique account created for You to access our Service or parts of our Service.
Business, for the purpose of the CCPA (California Consumer Privacy Act), refers to the Company as the legal entity that collects Consumers' personal information and determines the purposes and means of the processing of Consumers' personal information, or on behalf of which such information is collected and that alone, or jointly with others, determines the purposes and means of the processing of consumers' personal information, that does business in the State of California.
Company (referred to as either "the Company", "We", "Us" or "Our" in this Agreement) refers to Althera Pharmaceuticals LLC, with its offices at 89 Headquarters Plaza, STE 1448, Morristown NJ 07960, United States.
Consumer, for the purpose of the CCPA (California Consumer Privacy Act), means a natural person who is a California resident. A resident, as defined in the law, includes (1) every individual who is in the USA for other than a temporary or transitory purpose, and (2) every individual who is domiciled in the USA who is outside the USA for a temporary or transitory purpose.
Cookies are small files that are placed on Your computer, mobile device or any other device by a website, containing the details of Your browsing history on that website among its many uses.
Country refers to: United States with its state location in New Jersey.
Device means any device that can access the Service such as a computer, a cellphone or a digital tablet.
Do Not Track (DNT) is a concept that has been promoted by US regulatory authorities, in particular the U.S. Federal Trade Commission (FTC), for the Internet industry to develop and implement a mechanism for allowing internet users to control the tracking of their online activities across websites.
Personal Data is any information that relates to an identified or identifiable individual. For the purposes of the CCPA, Personal Data means any information that identifies, relates to, describes or is capable of being associated with, or could reasonably be linked, directly or indirectly, with You.
Sale, for the purpose of the CCPA (California Consumer Privacy Act), means selling, renting, releasing, disclosing, disseminating, making available, transferring, or otherwise communicating orally, in writing, or by electronic or other means, a Consumer's personal information to another business or a third party for monetary or other valuable consideration.
Service refers to the Website.
Service Provider means any natural or legal person who processes the data on behalf of the Company. It refers to third-party companies or individuals employed by the Company to facilitate the Service, to provide the Service on behalf of the Company, to perform services related to the Service or to assist the Company in analyzing how the Service is used.
Third-party Social Media Service refers to any website or any social network website through which a User can log in or create an account to use the Service.
Usage Data refers to data collected automatically, either generated by the use of the Service or from the Service infrastructure itself (for example, the duration of a page visit).
Website refers to roszet.com, roszethcp.com accessible from www.roszet.com, or www. roszethcp.com or other websites hosted by the Company.
You means the individual accessing or using the Service, or the company, or other legal entity on behalf of which such individual is accessing or using the Service, as applicable.
3.0 Types of Data Collected
3.1 Personal Data
While using Our Service, We may ask You to provide Us with certain personally identifiable information that can be used to contact or identify You. Personally identifiable information may include, but is not limited to:
Email address, First name and last name, Phone number, Address, State, Province, ZIP/Postal code, City, Usage Data
3.2 Usage Data
Usage Data is collected automatically when using the Service.
Usage Data may include information such as Your Device's Internet Protocol address (e.g. IP address), browser type, browser version, the pages of our Service that You visit, the time and date of Your visit, the time spent on those pages, unique device identifiers and other diagnostic data.
When You access the Service by or through a mobile device, We may collect certain information automatically, including, but not limited to, the type of mobile device You use, Your mobile device unique ID, the IP address of Your mobile device, Your mobile operating system, the type of mobile Internet browser You use, unique device identifiers and other diagnostic data.
We may also collect information that Your browser sends whenever You visit our Service or when You access the Service by or through a mobile device.
3.3 Tracking Technologies and Cookies
Flash Cookies. Certain features of our Service may use local stored objects (or Flash Cookies) to collect and store information about Your preferences or Your activity on our Service. Flash Cookies are not managed by the same browser settings as those used for Browser Cookies. For more information on how You can delete Flash Cookies, please read "Where can I change the settings for disabling, or deleting local shared objects?" available at https://helpx.adobe.com/flash-player/kb/disable-local-shared-objects-flash.html#main_Where_can_I_change_the_settings_for_disabling__or_deleting_local_shared_objects_
Web Beacons. Certain sections of our Service and our emails may contain small electronic files known as web beacons (also referred to as clear gifs, pixel tags, and single-pixel gifs) that permit the Company, for example, to count users who have visited those pages or opened an email and for other related website statistics (for example, recording the popularity of a certain section and verifying system and server integrity).
Cookies can be "Persistent" or "Session" Cookies. Persistent Cookies remain on Your personal computer or mobile device when You go offline, while Session Cookies are deleted as soon as You close Your web browser. You can learn more about cookies here: All About Cookies by TermsFeed.
We use both Session and Persistent Cookies for the purposes set out below:
Necessary / Essential Cookies
Type: Session Cookies
Administered by: Us
Purpose: These Cookies are essential to provide You with services available through the Website and to enable You to use some of its features. They help to authenticate users and prevent fraudulent use of user accounts. Without these Cookies, the services that You have asked for cannot be provided, and We only use these Cookies to provide You with those services.
Cookies Policy / Notice Acceptance Cookies
Type: Persistent Cookies
Administered by: Us
Type: Persistent Cookies
Administered by: Us
Purpose: These Cookies allow us to remember choices You make when You use the Website, such as remembering your login details or language preference. The purpose of these Cookies is to provide You with a more personal experience and to avoid You having to re-enter your preferences every time You use the Website.
Tracking and Performance Cookies
Type: Persistent Cookies
Administered by: Third-Parties
Purpose: These Cookies are used to track information about traffic to the Website and how users use the Website. The information gathered via these Cookies may directly or indirectly identify you as an individual visitor. This is because the information collected is typically linked to a pseudonymous identifier associated with the device you use to access the Website. We may also use these Cookies to test new pages, features or new functionality of the Website to see how our users react to them.
4.0 How we may use or store your Data
4.1 Use of Your Personal Data
The Company may use Personal Data for the following purposes:
To provide and maintain our Service, including to monitor the usage of our Service.
To manage Your Account: to manage Your registration as a user of the Service. The Personal Data You provide can give You access to different functionalities of the Service that are available to You as a registered user.
For the performance of a contract: the development, compliance and undertaking of the purchase contract for the products, items or services You have purchased or of any other contract with Us through the Service.
To contact You: To contact You by email, telephone calls, SMS, or other equivalent forms of electronic communication, such as a mobile application's push notifications regarding updates or informative communications related to the functionalities, products or contracted
services, including the security updates, when necessary or reasonable for their implementation.
To provide You with news, special offers and general information about other goods, services and events which we offer that are similar
to those that you have already purchased or enquired about unless You have opted not to receive such information.
To manage Your requests: To attend and manage Your requests to Us.
For business transfers: We may use Your information to evaluate or conduct a merger, divestiture, restructuring, reorganization, dissolution, or other sale or transfer of some or all of Our assets, whether as a going concern or as part of bankruptcy, liquidation, or similar proceeding, in which Personal Data held by Us about our Service users is among the assets transferred.
For other purposes: We may use Your information for other purposes, such as data analysis, identifying usage trends, determining the effectiveness of our promotional campaigns and to evaluate and improve our Service, products, services, marketing and your experience.
We may share Your personal information in the following situations:
With Service Providers: We may share Your personal information with Service Providers to monitor and analyze the use of our Service, to show advertisements to You to help support and maintain Our Service, to contact You.
For business transfers: We may share or transfer Your personal information in connection with, or during negotiations of, any merger, sale of Company assets, financing, or acquisition of all or a portion of Our business to another company.
With business partners: We may share Your information with Our business partners to offer You certain products, services or promotions.
With Your consent: We may disclose Your personal information for any other purpose with Your consent.
4.2 Retention of Your Personal Data
The Company will also retain Usage Data for internal analysis purposes. Usage Data is generally retained for a shorter period of time, except when this data is used to strengthen the security or to improve the functionality of Our Service, or We are legally obligated to retain this data for longer time periods.
4.3 Transfer of Your Personal Data
Your information, including Personal Data, is processed at the Company's operating offices and in any other places where the parties involved in the processing are located. It means that this information may be transferred to — and maintained on — computers located outside of Your state, province, country or other governmental jurisdiction where the data protection laws may differ than those from Your jurisdiction.
4.4 Disclosure of Your Personal Data
4.4.1 Business Transactions
4.4.2 Law enforcement
Under certain circumstances, the Company may be required to disclose Your Personal Data if required to do so by law or in response to valid requests by public authorities (e.g. a court or a government agency).
4.4.3 Other legal requirements
The Company may disclose Your Personal Data in the good faith belief that such action is necessary to:
Comply with a legal obligation
Protect and defend the rights or property of the Company
Prevent or investigate possible wrongdoing in connection with the Service
Protect the personal safety of Users of the Service or the public
Protect against legal liability
4.4.4 Security of Your Personal Data
The security of Your Personal Data is important to Us, but remember that no method of transmission over the Internet, or method of electronic storage is 100% secure. While We strive to use commercially acceptable means to protect Your Personal Data, We cannot guarantee its absolute security.
5.0 Detailed Information on the Processing of Your Personal Data
The Service Providers We use may have access to Your Personal Data. These third-party vendors collect, store, use, process and transfer information about Your activity on Our Service in accordance with their Privacy Policies.
We may use third-party Service providers to monitor and analyze the use of our Service.
Google Analytics is a web analytics service offered by Google that tracks and reports website traffic. Google uses the data collected to track and monitor the use of our Service. This data is shared with other Google services. Google may use the collected data to contextualize and personalize the ads of its own advertising network.
For more information on the privacy practices of Google, please visit the Google Privacy & Terms web page: https://policies.google.com/privacy.
5.2 Advertising We may use Service Providers to show advertisements to You to help support and maintain Our Service.
Google AdSense & Double Click Cookie
You may opt out of the use of the DoubleClick Cookie for interest-based advertising by visiting the Google Ads Settings web page: http://www.google.com/ads/preferences/
5.3 Email Marketing We may use Your Personal Data to contact You with newsletters, marketing or promotional materials and other information that may be of interest to You. You may opt-out of receiving any, or all, of these communications from Us by following the unsubscribe link or instructions provided in any email We send or by contacting Us.
We may use Email Marketing Service Providers to manage and send emails to You.
6.0 CCPA Privacy
6.1 Categories of Personal Information Collected
We collect information that identifies, relates to, describes, references, is capable of being associated with, or could reasonably be linked, directly or indirectly, with a particular Consumer or Device. The following is a list of categories of personal information which we may collect or may have been collected from California residents within the last twelve (12) months.
Please note that the categories and examples provided in the list below are those defined in the CCPA. This does not mean that all examples of that category of personal information were in fact collected by Us, but reflects our good faith belief to the best of our knowledge that some of that information from the applicable category may be and may have been collected. For example, certain categories of personal information would only be collected if You provided such personal information directly to Us.
Category A: Identifiers.
Examples: A real name, alias, postal address, unique personal identifier, online identifier, Internet Protocol address, email address, account name, driver's license number, passport number, or other similar identifiers.
Category B: Personal information categories listed in the California Customer Records statute (Cal. Civ. Code § 1798.80(e)).
Examples: A name, signature, Social Security number, physical characteristics or description, address, telephone number, passport number, driver's license or state identification card number, insurance policy number, education, employment, employment history, bank account number, credit card number, debit card number, or any other financial information, medical information, or health insurance information. Some personal information included in this category may overlap with other categories.
Category C: Protected classification characteristics under California or federal law.
Examples: Age (40 years or older), race, color, ancestry, national origin, citizenship, religion or creed, marital status, medical condition, physical or mental disability, sex (including gender, gender identity, gender expression, pregnancy or childbirth and related medical conditions), sexual orientation, veteran or military status, genetic information (including familial genetic information).
Category D: Commercial information.
Examples: Records and history of products or services purchased or considered.
Category E: Biometric information.
Examples: Genetic, physiological, behavioral, and biological characteristics, or activity patterns used to extract a template or other identifier or identifying information, such as, fingerprints, faceprints, and voiceprints, iris or retina scans, keystroke, gait, or other physical patterns, and sleep, health, or exercise data.
Category F: Internet or other similar network activity.
Examples: Interaction with our Service or advertisement.
Category G: Geolocation data.
Examples: Approximate physical location.
Category H: Sensory data.
Examples: Audio, electronic, visual, thermal, olfactory, or similar information.
Category I: Professional or employment-related information.
Examples: Current or past job history or performance evaluations.
Category J: Non-public education information (per the Family Educational Rights and Privacy Act (20 U.S.C. Section 1232g, 34 C.F.R. Part 99)).
Examples: Education records directly related to a student maintained by an educational institution or party acting on its behalf, such as grades, transcripts, class lists, student schedules, student identification codes, student financial information, or student disciplinary records.
Category K: Inferences drawn from other personal information.
Examples: Profile reflecting a person's preferences, characteristics, psychological trends, predispositions, behavior, attitudes, intelligence, abilities, and aptitudes.
Under CCPA, personal information does not include:
Publicly available information from government records
Deidentified or aggregated consumer information
Information excluded from the CCPA's scope, such as:
Health or medical information covered by the Health Insurance Portability and Accountability Act of 1996 (HIPAA) and the California Confidentiality of Medical Information Act (CMIA) or clinical trial data
Personal Information covered by certain sector-specific privacy laws, including the Fair Credit Reporting Act (FRCA), the Gramm-Leach-Bliley Act (GLBA) or California Financial Information Privacy Act (FIPA), and the Driver's Privacy Protection Act of 1994
6.2 Sources of Personal Information
We obtain the categories of personal information listed above from the following categories of sources:
Directly from You. For example, from the forms You complete on our Service, preferences You express or provide through our Service.
Indirectly from You. For example, from observing Your activity on our Service.
Automatically from You. For example, through cookies We or our Service Providers set on Your Device as You navigate through our Service.
From Service Providers. For example, third-party vendors to monitor and analyze the use of our Service, third-party vendors to provide advertising on our Service, or other third-party vendors that We use to provide the Service to You.
6.3 Use of Personal Information for Business Purposes or Commercial Purposes
We may use or disclose personal information We collect for "business purposes" or "commercial purposes" (as defined under the CCPA), which may include the following examples:
To operate our Service and provide You with our Service.
To provide You with support and to respond to Your inquiries, including to investigate and address Your concerns and monitor and improve our Service.
To fulfill or meet the reason You provided the information. For example, if You share Your contact information to ask a question about our Service, We will use that personal information to respond to Your inquiry.
To respond to law enforcement requests and as required by applicable law, court order, or governmental regulations.
As described to You when collecting Your personal information or as otherwise set forth in the CCPA.
For internal administrative and auditing purposes.
To detect security incidents and protect against malicious, deceptive, fraudulent or illegal activity, including, when necessary, to prosecute those responsible for such activities.
Please note that the examples provided above are illustrative and not intended to be exhaustive. For more details on how we use this information, please refer to the "Use of Your Personal Data" section.
6.4 Disclosure of Personal Information for Business Purposes or Commercial Purposes
We may use or disclose and may have used or disclosed in the last twelve (12) months the following categories of personal information for business or commercial purposes:
Category A: Identifiers
Category B: Personal information categories listed in the California Customer Records statute (Cal. Civ. Code § 1798.80(e))
Category F: Internet or other similar network activity
Please note that the categories listed above are those defined in the CCPA. This does not mean that all examples of that category of personal information were in fact disclosed, but reflects our good faith belief to the best of our knowledge that some of that information from the applicable category may be and may have been disclosed.
When We disclose personal information for a business purpose or a commercial purpose, We enter a contract that describes the purpose and requires the recipient to both keep that personal information confidential and not use it for any purpose except performing the contract.
6.5 Sale of Personal Information
As defined in the CCPA, "sell" and "sale" mean selling, renting, releasing, disclosing, disseminating, making available, transferring, or otherwise communicating orally, in writing, or by electronic or other means, a consumer's personal information by the business to a third party for valuable consideration. This means that We may have received some kind of benefit in return for sharing personal information, but not necessarily a monetary benefit.
Please note that the categories listed below are those defined in the CCPA. This does not mean that all examples of that category of personal information were in fact sold, but reflects our good faith belief to the best of our knowledge that some of that information from the applicable category may be and may have been shared for value in return.
We may sell and may have sold in the last twelve (12) months the following categories of personal information:
Category A: Identifiers
Category B: Personal information categories listed in the California Customer Records statute (Cal. Civ. Code § 1798.80(e))
Category F: Internet or other similar network activity
6.6 Share of Personal Information
We may share Your personal information identified in the above categories with the following categories of third parties:
Our business partners
Third party vendors to whom You or Your agents authorize Us to disclose Your personal information in connection with products or services We provide to You
6.7 Sale of Personal Information of Minors Under 16 Years of Age
We do not sell the personal information of Consumers We actually know are less than 16 years of age, unless We receive affirmative authorization (the "right to opt-in") from either the Consumer who is between 13 and 16 years of age, or the parent or guardian of a Consumer less than 13 years of age. Consumers who opt-in to the sale of personal information may opt-out of future sales at any time. To exercise the right to opt-out, You (or Your authorized representative) may submit a request to Us by contacting Us.
If You have reason to believe that a child under the age of 13 (or 16) has provided Us with personal information, please contact Us with sufficient detail to enable Us to delete that information.
6.8 Your Rights under the CCPA
The CCPA provides California residents with specific rights regarding their personal information. If You are a resident of California, You have the following rights:
The right to notice. You have the right to be notified which categories of Personal Data are being collected and the purposes for which the Personal Data is being used.
The right to request. Under CCPA, You have the right to request that We disclose information to You about Our collection, use, sale, disclosure for business purposes and share of personal information. Once We receive and confirm Your request, We will disclose to You:
The categories of personal information We collected about You
The categories of sources for the personal information We collected about You
Our business or commercial purpose for collecting or selling that personal information
The categories of third parties with whom We share that personal information
The specific pieces of personal information We collected about You
If we sold Your personal information or disclosed Your personal information for a business purpose, We will disclose to You:
The categories of personal information categories sold
The categories of personal information categories disclosed
The right to say no to the sale of Personal Data (opt-out). You have the right to direct Us to not sell Your personal information. To submit an opt-out request please contact Us.
The right to delete Personal Data. You have the right to request the deletion of Your Personal Data, subject to certain exceptions. Once We receive and confirm Your request, We will delete (and direct Our Service Providers to delete) Your personal information from our records, unless an exception applies. We may deny Your deletion request if retaining the information is necessary for Us or Our Service Providers to:
Complete the transaction for which We collected the personal information, provide a good or service that You requested, take actions reasonably anticipated within the context of our ongoing business relationship with You, or otherwise perform our contract with You.
Detect security incidents, protect against malicious, deceptive, fraudulent, or illegal activity, or prosecute those responsible for such activities.
Debug products to identify and repair errors that impair existing intended functionality.
Exercise free speech, ensure the right of another consumer to exercise their free speech rights, or exercise another right provided for by law.
Comply with the California Electronic Communications Privacy Act (Cal. Penal Code § 1546 et. seq.).
Engage in public or peer-reviewed scientific, historical, or statistical research in the public interest that adheres to all other applicable ethics and privacy laws, when the information's deletion may likely render impossible or seriously impair the research's achievement, if You previously provided informed consent.
Enable solely internal uses that are reasonably aligned with consumer expectations based on Your relationship with Us.
Comply with a legal obligation.
Make other internal and lawful uses of that information that are compatible with the context in which You provided it.
The right not to be discriminated against. You have the right not to be discriminated against for exercising any of Your consumer's rights, including by:
Denying goods or services to You
Charging different prices or rates for goods or services, including the use of discounts or other benefits or imposing penalties
Providing a different level or quality of goods or services to You
Suggesting that You will receive a different price or rate for goods or services or a different level or quality of goods or services
6.9 Exercising Your CCPA Data Protection Rights
In order to exercise any of Your rights under the CCPA, and if You are a California resident, You can contact Us:
By email: firstname.lastname@example.org
Only You, or a person registered with the California Secretary of State that You authorize to act on Your behalf, may make a verifiable request related to Your personal information.
Your request to Us must:
Provide sufficient information that allows Us to reasonably verify You are the person about whom We collected personal information or an authorized representative
Describe Your request with sufficient detail that allows Us to properly understand, evaluate, and respond to it
We cannot respond to Your request or provide You with the required information if We cannot:
Verify Your identity or authority to make the request
And confirm that the personal information relates to You
We will disclose and deliver the required information free of charge within 45 days of receiving Your verifiable request. The time period to provide the required information may be extended once by an additional 45 days when reasonable necessary and with prior notice.
Any disclosures We provide will only cover the 12-month period preceding the verifiable request's receipt.
For data portability requests, We will select a format to provide Your personal information that is readily useable and should allow You to transmit the information from one entity to another entity without hindrance.
6.10 Do Not Sell My Personal Information
You have the right to opt-out of the sale of Your personal information. Once We receive and confirm a verifiable consumer request from You, we will stop selling Your personal information. To exercise Your right to opt-out, please contact Us.
The Service Providers we partner with (for example, our analytics or advertising partners) may use technology on the Service that sells personal information as defined by the CCPA law. If you wish to opt out of the use of Your personal information for interest-based advertising purposes and these potential sales as defined under CCPA law, you may do so by following the instructions below.
Please note that any opt out is specific to the browser You use. You may need to opt out on every browser that You use.
You can opt out of receiving ads that are personalized as served by our Service Providers by following our instructions presented on the Service:
The NAI's opt-out platform: http://www.networkadvertising.org/choices/
The EDAA's opt-out platform http://www.youronlinechoices.com/
The DAA's opt-out platform: http://optout.aboutads.info/?c=2&lang=EN
The opt out will place a cookie on Your computer that is unique to the browser You use to opt out. If you change browsers or delete the cookies saved by your browser, You will need to opt out again.
6.12 Mobile Devices
Your mobile device may give You the ability to opt out of the use of information about the apps You use in order to serve You ads that are targeted to Your interests:
"Opt out of Interest-Based Ads" or "Opt out of Ads Personalization" on Android devices
"Limit Ad Tracking" on iOS devices
You can also stop the collection of location information from Your mobile device by changing the preferences on Your mobile device.
7.0 "Do Not Track" Policy as Required by California Online Privacy Protection Act (CalOPPA)
Our Service does not respond to Do Not Track signals. However, some third party websites do keep track of Your browsing activities. If You are visiting such websites, You can set Your preferences in Your web browser to inform websites that You do not want to be tracked. You can enable or disable DNT by visiting the preferences or settings page of Your web browser.
8.0 Children's Privacy
Our Service does not address anyone under the age of 13. We do not knowingly collect personally identifiable information from anyone under the age of 13. If You are a parent or guardian and You are aware that Your child has provided Us with Personal Data, please contact Us. If We become aware that We have collected Personal Data from anyone under the age of 13 without verification of parental consent, We take steps to remove that information from Our servers.
If We need to rely on consent as a legal basis for processing Your information and Your country requires consent from a parent, We may require Your parent's consent before We collect and use that information.
9.0 Your California Privacy Rights (California's Shine the Light law)
Under California Civil Code Section 1798 (California's Shine the Light law), California residents with an established business relationship with us can request information once a year about sharing their Personal Data with third parties for the third parties' direct marketing purposes.
If you'd like to request more information under the California Shine the Light law, and if You are a California resident, You can contact Us using the contact information provided below.
10.0 California Privacy Rights for Minor Users (California Business and Professions Code Section 22581)
California Business and Professions Code section 22581 allow California residents under the age of 18 who are registered users of online sites, services or applications to request and obtain removal of content or information they have publicly posted.
To request removal of such data, and if You are a California resident, You can contact Us using the contact information provided below, and include the email address associated with Your account.
Be aware that Your request does not guarantee complete or comprehensive removal of content or information posted online and that the law may not permit or require removal in certain circumstances.
11.0 Links to Other Websites
We have no control over and assume no responsibility for the content, privacy policies or practices of any third party sites or services.
13.0 Contact Us
By email: email@example.com
Important Safety Information
Indications and Usage
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.
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