IMPORTANT SAFETY INFORMATION ABOUT ARTIVeda™
WARNING
- When pregnancy is detected, discontinue ARTIVeda™ as soon as possible.
- Drugs that act directly on the renin-angiotensin system can cause injury to or death of the developing fetus.
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ARTIVeda™ contains perindopril arginine, an angiotensin converting enzyme inhibitor, and amlodipine, a dihydropyridine calcium channel blocker, and is indicated for the treatment of hypertension, to lower blood pressure. Prestalia may be used in patients whose blood pressure is not adequately controlled on monotherapy. Prestalia may also be used as initial therapy in patients likely to need multiple drugs to achieve blood pressure goals. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. These benefits have been seen in controlled trials of antihypertensive drugs from a wide variety of pharmacologic classes, including amlodipine and the ACE inhibitor class to which perindopril principally belongs. There are no controlled trials demonstrating risk reduction with Prestalia.
Prestalia is contraindicated in patients with hereditary or idiopathic angioedema, with or without previous angiotensin converting enzyme (ACE) inhibitor treatment, and in patients who are hypersensitive to perindopril, to ACE inhibitors, or to amlodipine. Rare cases of angioedema, including intestinal angioedema, have been reported in patients treated with ACE inhibitors. Do not co-administer aliskiren with ACE inhibitors, including Prestalia, in patients with diabetes.
Worsening angina and acute myocardial infarction can develop after starting or increasing the dose of Prestalia, particularly in patients with severe obstructive coronary artery disease. In patients at risk of excessive hypotension, start Prestalia therapy under close medical supervision. Follow patients closely for the first 2 weeks of treatment and whenever the dose of Prestalia is increased or a diuretic is added or its dose increased. Monitor renal function periodically in patients treated with Prestalia. Consider withholding or discontinuing therapy in patients who develop a clinically significant decrease in renal function.
The most common adverse events associated with Prestalia include peripheral edema, cough, headache, and dizziness.
SIDE EFFECTS
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OTHER RISKS
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OTHER IMPORTANT SAFETY INFORMATION ABOUT ARTIVeda™
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About Oncotelic
Oncotelic is an immuno-oncology company dedicated to the development of first in class RNA therapeutics as well as small molecule drugs against cancer and infectious diseases. OT-101, the lead immuno-oncology drug candidate of Oncotelic, is a first-in-class anti-TGF-βRNA therapeutic that exhibited single agent activity in relapsed/refractory cancer patients in clinical trial settings. OT-101 also has activity against SARS-CoV-2. Mateon/Oncotelic is seeking to leverage its deep expertise in drug development to improve treatment outcomes and survival of cancer patients with a special emphasis on rare pediatric cancers. Mateon has rare pediatric designation for DIPG (OT-101), melanoma (CA4P), and AML (OXi4503).
IMPORTANT LINKS
Our Office
Oncotelic Corporate Headquarters
29397 Agoura Road, Suite 107
Agoura Hills, CA 91301
(650) 635 7000 (main)
(650) 635 7001 (fax)
ir@oncotelic.com