Table of Contents
What is YOSPRALA?
YOSPRALA is a combination of aspirin (anti-platelet agent), and omeprazole (proton pump inhibitor (PPI), for patients who require aspirin for preventing cardiovascular and cerebrovascular events for the second time and who are at risk of developing aspirin-associated gastric ulcers.
The aspirin component of YOSPRALA was indicated for:
- reducing the combined risk of death and nonfatal stroke in patients who have had transient ischemia or ischemic stroke 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 death in patients with chronic stable angina pectoris,
- 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:
- reducing the risk of developing aspirin-associated gastric ulcers in patients (age ≥ 55) or documented history of gastric ulcers.
What is the recommended dosage?
- One tablet daily (60 minutes before a meal).
- Do not chew, crush, split, or dissolve the tablet.
- Use the lowest effective dose of YOSPRALA based on the patient’s treatment goals to avoid potential dose-dependent adverse reactions including bleeding.
- If a dose of YOSPRALA is missed, take it as soon as you as remember. Skip the missed dose, If it is almost time for the next dose, then. You can then take the next dose at a regular time. Patients should not take 2 doses at the same time unless advised by their doctor.
- Do not stop taking YOSPRALA suddenly as it could increase the risk of heart attack or stroke.
Dosage forms and strengths:
- 40 mg immediate-release omeprazole/81 mg delayed-release aspirin
- 325 mg delayed-release aspirin/40 mg immediate-release omeprazole
What are the most common adverse reactions to YOSPRALA?
Gastritis, nausea, gastric polyps, diarrhea, and non-cardiac chest pain.
Limitations of Use:
- Not for use as the initial dose of aspirin therapy during the onset of acute myocardial infarction, acute coronary syndrome, or before percutaneous coronary intervention.
- It 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
- History of asthma, urticaria, or other allergic-type reactions after taking aspirin or other NSAIDs.
- Pediatric patients with suspected viral infections because of the risk of Reye’s Syndrome.
- Known hypersensitivity to aspirin, substituted benzimidazoles, omeprazole, or any of the excipients of YOSPRALA.
- Patients receiving rilpivirine-containing products.
WARNINGS AND PRECAUTIONS
- Coagulation Abnormalities: there is a risk of increased bleeding time with aspirin, especially in patients with inherited hemophilia or acquired bleeding disorders.
- Gastrointestinal Adverse Reactions (including bleeding and ulceration): Make sure to monitor for signs and symptoms. Discontinue treatment if bleeding occurs.
- Use of Alcohol may lead to bleeding risk: avoid heavy alcohol use (three or more drinks every day).
- Reduction in Antiplatelet Activity with Clopidogrel due to Interference with CYP2C19 Metabolism: consider other antiplatelet therapy.
- Reduction in Efficacy of Ticagrelor: make sure to avoid the use with the 325/40 strength of YOSPRALA
- Renal Failure: Avoid the use of YOSPRALA in patients with severe renal failure.
- Gastric Malignancy: In adults, response to gastric symptoms does not preclude the presence of gastric malignancy.
- Acute Interstitial Nephritis: was observed in patients taking PPIs.
- Clostridium difficile-Associated Diarrhea: PPI therapy may increase the risk. Use the shortest duration and the lowest dose possible for the treatment.
- Bone Fracture: Long-term PPI therapy may be associated with an increased risk for osteoporosis-related fractures of the hip, wrist, or spine; use the lowest dose and shortest duration of treatment.
- Cutaneous and Systemic Lupus Erythematosus: mostly cutaneous; exacerbation or the onset of existing disease; discontinue YOSPRALA and refer a specialist for evaluation.
- Hepatic Impairment: avoid YOSPRALA in patients with hepatic impairment.
- Vitamin B-12 Deficiency: daily long-term use (longer than 3 years) of PPI may lead to Vitamin B-12 deficiency.
- Hypomagnesemia: This is reported rarely with prolonged treatment with PPIs. Your doctor will monitor your magnesium levels.
- Reduced Effect of Omeprazole with St. John’s Wort or Rifampin: Avoid use.
- Interactions with Diagnostic Investigations for Neuroendocrine Tumors: Increased Chromogranin A (CgA) levels may interfere with investigations for neuroendocrine tumors; temporarily stop YOSPRALA at least 14 days before assessing CgA levels.
- Bone marrow toxicity with methotrexate, especially in the elderly or renally impaired: Use of PPIs may elevate or prolong serum levels of methotrexate or its metabolite possibly leading to toxicity. consider a temporary withdrawal of YOSPRALA, with high dose methotrexate.
- Premature closure of the ductus arteriosus: make sure to avoid the use of YOSPRALA in pregnant women starting at 30 weeks.
- Abnormal Laboratory Tests: Aspirin has been associated with blood urea nitrogen, elevated hepatic enzymes, hyperkalemia, serum creatinine, proteinuria, and prolonged bleeding time.
- Fundic Gland Polyps: the risk of Fundic gland polyps increases with long-term use, especially beyond one year. Try to use the shortest duration of therapy.
The use of NSAIDs, including YOSPRALA, during the third trimester of pregnancy, increases the
risk of premature closure of the fetal ductus arteriosus. Avoid the use of NSAIDs, including YOSPRALA, in pregnant women starting at 30 weeks of gestation.
YOSPRALA may interact with drugs such as:
- Drugs dependent on gastric pH for absorption (e.g., iron salts, mycophenolate mofetil, erlotinib, dasatinib, nilotinib, ketoconazole/itraconazole)
- Heparin and Warfarin
- Oral Hypoglycemics
- Uricosuric Agents (Probenecid)
- Valproic Acid
- Interaction with Secretin Stimulation Test
- False Positive Urine Tests for THC
- CYP2C19 or CYP3A4 Inducers, and
- CYP2C19 or CYP3A4 Inhibitors