Yosprala

YOSPRALA- aspirin and omeprazole tablet, film coated
Genus Lifesciences Inc.

1 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.
  • Do not substitute YOSPRALA with the single-ingredient products of aspirin and omeprazole.

2 DOSAGE AND ADMINISTRATION

2.1 Recommended Dosage

  • Take one tablet daily.
  • YOSPRALA is available in combinations that contain 81 mg or 325 mg of aspirin. Generally 81 mg of aspirin has been accepted as an effective dose for secondary cardiovascular prevention. Providers should consider the need for 325 mg and refer to current clinical practice guidelines.

2.2 Administration Instructions

  • Take YOSPRALA once daily at least 60 minutes before a meal.
  • The tablets are to be swallowed whole with liquid. Do not split, chew, crush or dissolve the tablet.
  • Use the lowest effective dose of YOSPRALA based on the individual patient’s treatment goals and to avoid potential dose dependent adverse reactions including bleeding.
  • If a dose of YOSPRALA is missed, advise patients to take it as soon as it is remembered. If it is almost time for the next dose, skip the missed dose. Take the next dose at the regular time. Patients should not take 2 doses at the same time unless advised by their doctor.
  • Do not stop taking YOSPRALA suddenly as this could increase the risk of heart attack or stroke.

3 DOSAGE FORMS AND STRENGTHS

Oval, blue-green, film-coated, delayed-release tablets for oral administration containing either:

  • 81 mg delayed-release aspirin and 40 mg immediate-release omeprazole, printed with 81/40, or
  • 325 mg delayed-release aspirin and 40 mg immediate-release omeprazole, printed with 325/40.

4 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.
  • YOSPRALA is contraindicated in patients with known hypersensitivity to aspirin, omeprazole, substituted benzimidazoles, or to any of the excipients in the formulation [see Warnings and Precautions (5.8), Adverse Reactions (6.2)].
  • Proton pump inhibitor (PPI)–containing products, including YOSPRALA, are contraindicated in patients receiving rilpivirine-containing products [see Drug Interactions (7)].

5 WARNINGS AND PRECAUTIONS

5.1 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.

5.2 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.

Serious GI adverse reactions reported in the clinical trials of YOSPRALA were: gastric ulcer hemorrhage in one of the 521 patients treated with YOSPRALA and duodenal ulcer hemorrhage in one of the 524 patients treated with enteric-coated aspirin. In addition, there were two cases of intestinal hemorrhage, one in each treatment group, and one patient treated with YOSPRALA experienced obstruction of the small bowel.

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.

5.3 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.

5.4 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 [see Drug Interactions (7), Clinical Pharmacology (12.3)].

5.5 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 [see Drug Interactions (7)].

5.6 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. [see Use in Specific Populations (8.6), Clinical Pharmacology (12.3)].

5.7 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.

5.8 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 [see Contraindications (4)].

5.9 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 (CDAD), especially in hospitalized patients. This diagnosis should be considered for diarrhea that does not improve [see Adverse Reactions (6.2)].

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

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