Privacy Policy

Introduction

Welcome to Genuslifesciences.com. This site is owned by Genus Lifesciences. (the Company). At Genus Lifesciences, we respect the privacy of our website visitors. We protect and control the collection, use and disclosure of personal information of individuals that visit this website, in accordance with applicable Canadian privacy laws; Federal and State laws and governmental regulations in the United States; and laws concerning the protection of personal information in the EU, including the Data Protection Act 1998. This Privacy Policy summarizes our personal information management practices for this website. By visiting this website, you consent to the collection, use and disclosure of your personal information as described in this Privacy Statement. Genus Lifesciences reserves the right to modify the terms and conditions of this Privacy Statement at any time, and such modifications will be effective immediately upon posting of the modified Privacy Statement on this website. Please check back periodically, and especially before you provide any personally identifiable information. Your continued use of this Website is deemed to be acceptance of this Privacy Policy.

Your use of this website is also subject to our Legal Notice.

Children Under the Age of 13

Our websites are not intended for children under 13 years of age. No one under age 13 may provide any Personal Data to our websites or the Company. We do not knowingly collect Personal Data from children under 13. If you are under 13, do not use or provide any information on our websites or provide any Personal Data or other information about yourself to us, including your name, address, telephone number, email address, or any screen name or user name you may use. If we learn we have collected or received Personal Data from a child under 13 without verification of parental consent, we will delete that information.

Information We Collect and How We Collect It

Like many websites, this site collects information from its visitors. Some of the information that you submit may be personally identifiable information. Generally speaking, personally identifiable information means information that can be used to identify an individual, including information such as your name, address, e-mail address, personal health information, and other information, such as resume or employment-related information that you may choose to voluntarily provide to Genus Lifesciences by e-mail or through this website.

Genus Lifesciences may collect personal information from you when you voluntarily provide it through your access and use of this website. For example, we may collect your personal information through this website when you choose to: (i) participate in online contests, surveys or polls, or request e-mail updates; (ii) provide us with feedback or send us an e-mail through the Contact Us section; (iii) register for interactive portions of this website that may be offered; or (iv) submit an online job or community support application to us. By providing your personal information to us electronically, you consent to the collection, use and disclosure of your personal information as described in this Privacy Policy.

As you navigate through a website, including ours, certain information also can be passively collected (that is, gathered without your actively providing the information) using various technologies and means, such as Internet Protocol (IP) addresses, cookies, internet tags and navigational data collection. Our servers automatically log information about visits to our website in the normal course of establishing and maintaining web connections. Server logs record statistical information, such as visitors’ IP addresses, type of operating systems, time and duration of visit, web pages requested, and identify categories of visitors by items such as domains and browser types. These statistics are reported in aggregate form to us and are used to improve our website and ensure that it provides the optimal web experience for visitors. We do not link server log information to any other data, in a way that would enable us to identify individual visitors. However, we may review server logs for security purposes, for example, to detect intrusions into our network. The possibility therefore exists that server log data, which contains visitors’ IP addresses, could in instances of criminal malfeasance be used to trace and identify individuals. In such instances, raw data logs would be shared with appropriate investigative bodies authorized to investigate such breaches of security.

How We Use Information of Visitors to Our Websites

We use personal information for the purposes for which you provide it to us, and as permitted or required by law. In particular, we use personal information that you provide electronically for purposes that include: (i) administering online contests, promotions, surveys or polls in which you choose to participate; (ii) processing your requests for, and sending you, e-mail updates and any other information you have requested about our products and services; (iii) responding to your feedback, questions and comments about us and our products and services; (iv) completing and administering your registration for interactive portions of our website; (v) evaluating, processing and responding to your online job or community support applications, and retaining such applications for present and future consideration; (vi) understanding how we can improve the website and our products and services; and (vii) assessing website use and traffic.

We may disclose your personally identifiable information to other Genus affiliates worldwide that agree to treat it in accordance with this Privacy Policy. Some of these affiliates may be located outside of Canada; United States or the EU and, as such, they are subject to foreign laws including laws that may require disclosure of personal information to foreign government authorities. In addition, we may disclose your personally identifiable information where required by applicable laws, court orders, or government regulations.

Whenever we process Personal Data, we take reasonable steps to ensure that your Personal Data is kept accurate and up-to date for the purposes for which it was collected. We will provide you with the ability to object to the processing of your Personal Data if such processing is not reasonably required for a legitimate business purpose as described in this policy or our compliance with law. In the case of electronic direct marketing, we will provide you with a method to opt out of receiving further marketing materials or with a method to opt in if required by law.

Data Security

We take reasonable steps to protect your personally identifiable information as you transmit your information from your computer to our site and to protect such information from loss, misuse, and unauthorized access, disclosure, alteration, or destruction. You should keep in mind that no Internet transmission is ever 100% secure or error-free. In particular, e-mail sent to or from this site may not be secure, and you should therefore take special care in deciding what information you send to us via e-mail. Moreover, where you use passwords, ID numbers, or other special access features on this site, it is your responsibility to safeguard them.

Accessing and Correcting Your Information

If you wish to contact us regarding our use of your Personal Data or object to the processing of your Personal Data, please email us at Info@GenusLifesciences.com. If you contact us, please note the name of the website where you provided the information, as well as the specific information you would like us to correct, update or delete plus a proper identification of you. Requests to delete personal data will be subject to any applicable legal and ethical reporting or document filing or retention obligations imposed on us.

Use of Cookies

As with many other websites, our site makes use of session and permanent “cookie” technology. Cookies are small text files that contain a unique identification number that is automatically deposited on a visitor’s computer. This information helps us determine, in the aggregate, the total number of visitors to the site on an ongoing basis and the types of Internet browsers (e.g. Safari, Google Chrome, Mozilla Firefox, or Internet Explorer) and operating systems (e.g. Windows or MacOS) used by our visitors. This information is used to facilitate and enhance your online visits. We do not cross-reference the information automatically collected through “cookies” with any type of personal information that is voluntarily offered on or through this website.

The use of cookie technology is common on the Internet, and many Internet browsers are initially configured to accept cookies automatically. If you would prefer not to accept cookies, you can set your Internet browser to notify you when your computer is receiving a cookie or to refuse cookies automatically. To re-adjust your Internet browser’s cookie options, please refer to the instruction documentation of your particular browser, or seek online assistance.

Links to External Websites

This site may contain links or references to other websites. Please be aware that we do not control, and we do not assume any responsibility for, such other websites and that this Privacy Policy does not apply to those websites. We encourage you to read the Privacy Policy of every website you visit.

Contact Information

If you have any concerns about our Privacy Policy or your data, please contact us at Info@GenusLifesciences.com.

Indications and Usage

Yosprala, a combination of aspirin and omeprazole, is indicated for patients who require aspirin for secondary prevention of cardiovascular and cerebrovascular events and who are at risk of developing aspirin-associated gastric ulcers.

The aspirin component of Yosprala is indicated for:

  • Reducing the combined risk of death and nonfatal stroke in patients who have had ischemic stroke or transient ischemia of the brain due to fibrin platelet emboli
  • Reducing the combined risk of death and nonfatal MI in patients with a previous MI or unstable angina pectoris
  • Reducing the combined risk of MI and sudden death in patients with chronic stable angina pectoris
  • Use in patients who have undergone revascularization procedures (Coronary Artery Bypass Graft [CABG] or Percutaneous Transluminal Coronary Angioplasty [PTCA]) when there is a pre-existing condition for which aspirin is already indicated

The omeprazole component of Yosprala is indicated for decreasing the risk of developing aspirin-associated gastric ulcers in patients at risk for developing aspirin-associated gastric ulcers due to age ( 55) or documented history of gastric ulcers.

Limitations of Use:
  • Yosprala contains a delayed-release formulation of aspirin and it is not for use as the initial dose of aspirin therapy during onset of acute coronary syndrome, acute myocardial infarction, or before percutaneous coronary intervention (PCI), for which immediate-release aspirin therapy is appropriate
  • Yosprala has not been shown to reduce the risk of gastrointestinal bleeding due to aspirin
  • Yosprala is not interchangeable with the individual components of aspirin and omeprazole
Important Safety Information
Contraindications

Yosprala is contraindicated in:

  • Patients with known allergy to aspirin and other nonsteroidal anti-inflammatory drug products (NSAIDs) and in patients with the syndrome of asthma, rhinitis, and nasal polyps. Aspirin may cause severe urticaria, angioedema, or bronchospasm (asthma)
  • Pediatric patients with suspected viral infections, with or without fever, because of the risk of Reye’s syndrome with concomitant use of aspirin in certain viral illnesses
  • Patients with known hypersensitivity to aspirin, omeprazole, substituted benzimidazoles, or to any of the excipients in the formulation
  • Proton pump inhibitor (PPI)–containing products, including Yosprala, are contraindicated in patients receiving rilpivirine-containing products
Warnings and Precautions
Coagulation Abnormalities

Even low doses of aspirin can inhibit platelet function leading to an increase in bleeding time. This can adversely affect patients with inherited (hemophilia) or acquired (liver disease or vitamin K deficiency) bleeding disorders. Monitor patients for signs of increased bleeding.

Gastrointestinal Adverse Reactions

Aspirin is associated with serious gastrointestinal (GI) adverse reactions, including inflammation, bleeding ulceration and perforation of the upper and lower GI tract. Other adverse reactions with aspirin include stomach pain, heartburn, nausea, and vomiting.

Although minor upper GI symptoms, such as dyspepsia, are common and can occur anytime during therapy, monitor patients for signs of ulceration and bleeding, even in the absence of previous GI symptoms. Inform patients about the signs and symptoms of GI adverse reactions.

If active and clinically significant bleeding from any source occurs in patients receiving Yosprala, discontinue treatment.

Bleeding Risk with Use of Alcohol

Counsel patients who consume three or more alcoholic drinks every day about the bleeding risks involved with chronic, heavy alcohol use while taking Yosprala.

Interaction with Clopidogrel

Avoid concomitant use of Yosprala with clopidogrel. Clopidogrel is a prodrug. Inhibition of platelet aggregation by clopidogrel is entirely due to an active metabolite. The metabolism of clopidogrel to its active metabolite can be impaired by use with concomitant medications, such as omeprazole, that interfere with CYP2C19 activity. Co-administration of clopidogrel with 80-mg omeprazole reduces the pharmacological activity of clopidogrel, even when administered 12 hours apart. When using Yosprala, consider alternative anti-platelet therapy.

Interaction with Ticagrelor

Maintenance doses of aspirin above 100 mg reduce the effectiveness of ticagrelor in preventing thrombotic cardiovascular events. Avoid concomitant use of ticagrelor with the 325-mg/40-mg tablet strength of Yosprala.

Renal Failure

Avoid Yosprala in patients with severe renal failure (glomerular filtration rate less than 10 mL/minute). Regular use of aspirin is associated in a dose-dependent manner with an increased risk of chronic renal failure. Aspirin use decreases glomerular filtration rate and renal blood flow especially with patients with pre-existing renal disease.

Presence of Gastric Malignancy

In adults, response to gastric symptoms with Yosprala does not preclude the presence of gastric malignancy. Consider additional gastrointestinal follow-up and diagnostic testing in adult patients who experience gastric symptoms during treatment with Yosprala or have a symptomatic relapse after completing treatment. In older patients, also consider an endoscopy.

Acute Interstitial Nephritis

Acute interstitial nephritis has been observed in patients taking PPIs including omeprazole. Acute interstitial nephritis may occur at any point during PPI therapy and is generally attributed to an idiopathic hypersensitivity reaction. Discontinue Yosprala if acute interstitial nephritis develops.

Clostridium difficile-Associated Diarrhea

Published observational studies suggest that PPI-containing therapy like Yosprala may be associated with an increased risk of Clostridium difficile-associated diarrhea, especially in hospitalized patients. This diagnosis should be considered for diarrhea that does not improve.

Use the lowest dose and shortest duration of Yosprala appropriate to the condition being treated.

Bone Fracture

Several published observational studies suggest that PPI therapy may be associated with an increased risk for osteoporosis-related fractures of the hip, wrist, or spine. The risk of fracture was increased in patients who received high-dose, defined as multiple daily doses, and long-term PPI therapy (a year or longer). Use the lowest dose and shortest duration of Yosprala therapy appropriate to the condition being treated.

Cutaneous and Systemic Lupus Erythematosus

Cutaneous lupus erythematosus (CLE) and systemic lupus erythematosus (SLE) have been reported in patients taking PPIs, including omeprazole. These events have occurred as both new onset and an exacerbation of existing autoimmune disease. The majority of PPI-induced lupus erythematous cases were CLE.

Avoid administration of PPIs for longer than medically indicated. If signs or symptoms consistent with CLE or SLE are noted in patients receiving Yosprala, discontinue the drug and refer the patient to the appropriate specialist for evaluation. Most patients improve with discontinuation of the PPI alone in 4 to 12 weeks.

Hepatic Impairment

Long-term moderate to high doses of aspirin may result in elevations in serum ALT levels. These abnormalities resolve rapidly with discontinuation of aspirin. Systemic exposure to omeprazole is increased in patients with hepatic impairment. Avoid Yosprala in patients with any degree of hepatic impairment.

Cyanocobalamin (Vitamin B12) Deficiency

Daily treatment with any acid-suppressing medications over a long period of time (eg, longer than 3 years) may lead to malabsorption of cyanocobalamin (vitamin B12) caused by hypo- or achlorhydria. This diagnosis should be considered if clinical symptoms consistent with cyanocobalamin deficiency are observed in patients treated with Yosprala.

Hypomagnesemia

Hypomagnesemia, symptomatic and asymptomatic, has been reported rarely in patients treated with PPIs for at least three months, in most cases after a year of therapy. Serious adverse events include tetany, arrhythmias, and seizures. In most patients, treatment of hypomagnesemia required magnesium replacement and discontinuation of the PPI. For patients expected to be on prolonged treatment or who take Yosprala with medications such as digoxin or drugs that may cause hypomagnesemia (eg, diuretics), consider monitoring magnesium levels prior to initiation of Yosprala and periodically during treatment.

Reduced Effect of Omeprazole with St. John’s Wort or Rifampin

Drugs which induce the CYP2C19 or CYP3A4 (such as St. John’s Wort or rifampin) can substantially decrease concentrations of omeprazole. Avoid concomitant use of Yosprala with St. John’s Wort or rifampin.

Interactions with Diagnostic Investigations for Neuroendocrine Tumors

Serum chromogranin A (CgA) levels increase secondary to omeprazole-induced decreases in gastric acidity. The increased CgA level may cause false positive results in diagnostic interventions for neuroendocrine tumors. Temporarily discontinue treatment with Yosprala at least 14 days before assessing CgA levels and consider repeating the test if initial CgA levels are high. If serial tests are performed (eg, for monitoring), the same commercial laboratory should be used for testing, as reference ranges between tests may vary.

Interaction with Methotrexate

Literature suggests that concomitant use of PPIs with methotrexate (primarily at high dose) may elevate and prolong serum levels of methotrexate and/or its metabolite, possibly leading to methotrexate toxicities. In high-dose methotrexate administration, a temporary withdrawal of Yosprala may be considered in some patients.

Premature Closure of Fetal Ductus Arteriosus

NSAIDs including aspirin, may cause premature closure of the fetal ductus arteriosus. Avoid use of NSAIDs, including Yosprala, in pregnant women starting at 30 weeks of gestation (third trimester).

Abnormal Laboratory Tests

Aspirin has been associated with elevated hepatic enzymes, blood urea nitrogen and serum creatinine, hyperkalemia, proteinuria, and prolonged bleeding time.

Adverse Reactions

Most common adverse reactions in adults (incidence 2% and more common in Yosprala treated patients) are: gastritis, nausea, diarrhea, gastric polyps, and non-cardiac chest pain. Less common adverse reactions were 2 patients with upper GI bleeding (gastric or duodenal) and 2 patients with lower GI bleeding (hematochezia and large intestinal hemorrhage) and one additional patient experienced obstruction in the small bowel.

Drug Interactions

See the full prescribing information for the complete list of drugs with clinically important drug interactions and interaction with diagnostics when administered concomitantly with Yosprala and instructions for preventing or managing them.

Use in Specific Populations
  • Pregnancy: Use during the third trimester of pregnancy increases the risk of premature closure of the fetal ductus arteriosus. Avoid use of Yosprala in pregnant women starting at 30 weeks of gestation (third trimester)
  • Lactation: Breastfeeding not recommended

To report SUSPECTED ADVERSE EVENTS, contact Genus Lifesciences at 1 - 833-967-7725(1-833-YOS-PRAL) or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

Please click here for full Prescribing Information.

READ MORE
Indications and Usage

Yosprala, a combination of aspirin and omeprazole, is indicated for patients who require aspirin for secondary prevention of cardiovascular and cerebrovascular events and who are at risk of developing aspirin-associated gastric ulcers.

The aspirin component of Yosprala is indicated for:

  • Reducing the combined risk of death and nonfatal stroke in patients who have had ischemic stroke or transient ischemia of the brain due to fibrin platelet emboli
  • Reducing the combined risk of death and nonfatal MI in patients with a previous MI or unstable angina pectoris
  • Reducing the combined risk of MI and sudden death in patients with chronic stable angina pectoris
  • Use in patients who have undergone revascularization procedures (Coronary Artery Bypass Graft [CABG] or Percutaneous Transluminal Coronary Angioplasty [PTCA]) when there is a pre-existing condition for which aspirin is already indicated

The omeprazole component of Yosprala is indicated for decreasing the risk of developing aspirin-associated gastric ulcers in patients at risk for developing aspirin-associated gastric ulcers due to age ( 55) or documented history of gastric ulcers.

Limitations of Use:
  • Yosprala contains a delayed-release formulation of aspirin and it is not for use as the initial dose of aspirin therapy during onset of acute coronary syndrome, acute myocardial infarction, or before percutaneous coronary intervention (PCI), for which immediate-release aspirin therapy is appropriate
  • Yosprala has not been shown to reduce the risk of gastrointestinal bleeding due to aspirin
  • Yosprala is not interchangeable with the individual components of aspirin and omeprazole
READ MORE
READ MORE
Important Safety Information
Contraindications

Yosprala is contraindicated in:

  • Patients with known allergy to aspirin and other nonsteroidal anti-inflammatory drug products (NSAIDs) and in patients with the syndrome of asthma, rhinitis, and nasal polyps. Aspirin may cause severe urticaria, angioedema, or bronchospasm (asthma)
  • Pediatric patients with suspected viral infections, with or without fever, because of the risk of Reye’s syndrome with concomitant use of aspirin in certain viral illnesses
  • Patients with known hypersensitivity to aspirin, omeprazole, substituted benzimidazoles, or to any of the excipients in the formulation
  • Proton pump inhibitor (PPI)–containing products, including Yosprala, are contraindicated in patients receiving rilpivirine-containing products
Warnings and Precautions
Coagulation Abnormalities

Even low doses of aspirin can inhibit platelet function leading to an increase in bleeding time. This can adversely affect patients with inherited (hemophilia) or acquired (liver disease or vitamin K deficiency) bleeding disorders. Monitor patients for signs of increased bleeding.

Gastrointestinal Adverse Reactions

Aspirin is associated with serious gastrointestinal (GI) adverse reactions, including inflammation, bleeding ulceration and perforation of the upper and lower GI tract. Other adverse reactions with aspirin include stomach pain, heartburn, nausea, and vomiting.

Although minor upper GI symptoms, such as dyspepsia, are common and can occur anytime during therapy, monitor patients for signs of ulceration and bleeding, even in the absence of previous GI symptoms. Inform patients about the signs and symptoms of GI adverse reactions.

If active and clinically significant bleeding from any source occurs in patients receiving Yosprala, discontinue treatment.

Bleeding Risk with Use of Alcohol

Counsel patients who consume three or more alcoholic drinks every day about the bleeding risks involved with chronic, heavy alcohol use while taking Yosprala.

Interaction with Clopidogrel

Avoid concomitant use of Yosprala with clopidogrel. Clopidogrel is a prodrug. Inhibition of platelet aggregation by clopidogrel is entirely due to an active metabolite. The metabolism of clopidogrel to its active metabolite can be impaired by use with concomitant medications, such as omeprazole, that interfere with CYP2C19 activity. Co-administration of clopidogrel with 80-mg omeprazole reduces the pharmacological activity of clopidogrel, even when administered 12 hours apart. When using Yosprala, consider alternative anti-platelet therapy.

Interaction with Ticagrelor

Maintenance doses of aspirin above 100 mg reduce the effectiveness of ticagrelor in preventing thrombotic cardiovascular events. Avoid concomitant use of ticagrelor with the 325-mg/40-mg tablet strength of Yosprala.

Renal Failure

Avoid Yosprala in patients with severe renal failure (glomerular filtration rate less than 10 mL/minute). Regular use of aspirin is associated in a dose-dependent manner with an increased risk of chronic renal failure. Aspirin use decreases glomerular filtration rate and renal blood flow especially with patients with pre-existing renal disease.

Presence of Gastric Malignancy

In adults, response to gastric symptoms with Yosprala does not preclude the presence of gastric malignancy. Consider additional gastrointestinal follow-up and diagnostic testing in adult patients who experience gastric symptoms during treatment with Yosprala or have a symptomatic relapse after completing treatment. In older patients, also consider an endoscopy.

Acute Interstitial Nephritis

Acute interstitial nephritis has been observed in patients taking PPIs including omeprazole. Acute interstitial nephritis may occur at any point during PPI therapy and is generally attributed to an idiopathic hypersensitivity reaction. Discontinue Yosprala if acute interstitial nephritis develops.

Clostridium difficile-Associated Diarrhea

Published observational studies suggest that PPI-containing therapy like Yosprala may be associated with an increased risk of Clostridium difficile-associated diarrhea, especially in hospitalized patients. This diagnosis should be considered for diarrhea that does not improve.

Use the lowest dose and shortest duration of Yosprala appropriate to the condition being treated.

Bone Fracture

Several published observational studies suggest that PPI therapy may be associated with an increased risk for osteoporosis-related fractures of the hip, wrist, or spine. The risk of fracture was increased in patients who received high-dose, defined as multiple daily doses, and long-term PPI therapy (a year or longer). Use the lowest dose and shortest duration of Yosprala therapy appropriate to the condition being treated.

Cutaneous and Systemic Lupus Erythematosus

Cutaneous lupus erythematosus (CLE) and systemic lupus erythematosus (SLE) have been reported in patients taking PPIs, including omeprazole. These events have occurred as both new onset and an exacerbation of existing autoimmune disease. The majority of PPI-induced lupus erythematous cases were CLE.

Avoid administration of PPIs for longer than medically indicated. If signs or symptoms consistent with CLE or SLE are noted in patients receiving Yosprala, discontinue the drug and refer the patient to the appropriate specialist for evaluation. Most patients improve with discontinuation of the PPI alone in 4 to 12 weeks.

Hepatic Impairment

Long-term moderate to high doses of aspirin may result in elevations in serum ALT levels. These abnormalities resolve rapidly with discontinuation of aspirin. Systemic exposure to omeprazole is increased in patients with hepatic impairment. Avoid Yosprala in patients with any degree of hepatic impairment.

Cyanocobalamin (Vitamin B12) Deficiency

Daily treatment with any acid-suppressing medications over a long period of time (eg, longer than 3 years) may lead to malabsorption of cyanocobalamin (vitamin B12) caused by hypo- or achlorhydria. This diagnosis should be considered if clinical symptoms consistent with cyanocobalamin deficiency are observed in patients treated with Yosprala.

Hypomagnesemia

Hypomagnesemia, symptomatic and asymptomatic, has been reported rarely in patients treated with PPIs for at least three months, in most cases after a year of therapy. Serious adverse events include tetany, arrhythmias, and seizures. In most patients, treatment of hypomagnesemia required magnesium replacement and discontinuation of the PPI. For patients expected to be on prolonged treatment or who take Yosprala with medications such as digoxin or drugs that may cause hypomagnesemia (eg, diuretics), consider monitoring magnesium levels prior to initiation of Yosprala and periodically during treatment.

Reduced Effect of Omeprazole with St. John’s Wort or Rifampin

Drugs which induce the CYP2C19 or CYP3A4 (such as St. John’s Wort or rifampin) can substantially decrease concentrations of omeprazole. Avoid concomitant use of Yosprala with St. John’s Wort or rifampin.

Interactions with Diagnostic Investigations for Neuroendocrine Tumors

Serum chromogranin A (CgA) levels increase secondary to omeprazole-induced decreases in gastric acidity. The increased CgA level may cause false positive results in diagnostic interventions for neuroendocrine tumors. Temporarily discontinue treatment with Yosprala at least 14 days before assessing CgA levels and consider repeating the test if initial CgA levels are high. If serial tests are performed (eg, for monitoring), the same commercial laboratory should be used for testing, as reference ranges between tests may vary.

Interaction with Methotrexate

Literature suggests that concomitant use of PPIs with methotrexate (primarily at high dose) may elevate and prolong serum levels of methotrexate and/or its metabolite, possibly leading to methotrexate toxicities. In high-dose methotrexate administration, a temporary withdrawal of Yosprala may be considered in some patients.

Premature Closure of Fetal Ductus Arteriosus

NSAIDs including aspirin, may cause premature closure of the fetal ductus arteriosus. Avoid use of NSAIDs, including Yosprala, in pregnant women starting at 30 weeks of gestation (third trimester).

Abnormal Laboratory Tests

Aspirin has been associated with elevated hepatic enzymes, blood urea nitrogen and serum creatinine, hyperkalemia, proteinuria, and prolonged bleeding time.

Adverse Reactions

Most common adverse reactions in adults (incidence 2% and more common in Yosprala treated patients) are: gastritis, nausea, diarrhea, gastric polyps, and non-cardiac chest pain. Less common adverse reactions were 2 patients with upper GI bleeding (gastric or duodenal) and 2 patients with lower GI bleeding (hematochezia and large intestinal hemorrhage) and one additional patient experienced obstruction in the small bowel.

Drug Interactions

See the full prescribing information for the complete list of drugs with clinically important drug interactions and interaction with diagnostics when administered concomitantly with Yosprala and instructions for preventing or managing them.

Use in Specific Populations
  • Pregnancy: Use during the third trimester of pregnancy increases the risk of premature closure of the fetal ductus arteriosus. Avoid use of Yosprala in pregnant women starting at 30 weeks of gestation (third trimester)
  • Lactation: Breastfeeding not recommended
READ MORE