"The European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) has recommended the marketing of selexipag (Uptravi, Actelion Registration Ltd) for the treatment of adults with pulmonary arterial hypertension (PAH)./"...
TEVETEN® has been evaluated for safety in more than 3,300 healthy volunteers and patients worldwide, including more than 1,460 patients treated for more than 6 months, and more than 980 patients treated for 1 year or longer. TEVETEN® was well tolerated at doses up to 1200 mg daily. Most adverse events were of mild or moderate severity and did not require discontinuation of therapy. The overall incidence of adverse experiences and the incidences of specific adverse events reported with eprosartan were similar to placebo.
Adverse experiences were similar in patients regardless of age, gender, or race. Adverse experiences were not dose-related.
In placebo-controlled clinical trials, about 4% of 1,202 patients treated with TEVETEN® discontinued therapy due to clinical adverse experiences, compared to 6.5% of 352 patients given placebo.
Adverse Events Occurring At An Incidence Of 1% Or More Among Eprosartan-treated Patients
The following table lists adverse events that occurred at an incidence of 1% or more among eprosartan-treated patients who participated in placebo-controlled trials of 8 to 13 weeks' duration, using doses of 25 mg to 400 mg twice daily, and 400 mg to 1200 mg once daily. The overall incidence of adverse events reported with TEVETEN® (54.4%) was similar to placebo (52.8%).
Table 1: Adverse Events Reported by ≥ 1% of
Patients Receiving TEVETEN® (eprosartan mesylate) and Were More Frequent on
Eprosartan than Placebo
|Body as a Whole|
|Metabolic and Nutritional|
|Upper respiratory tract infection||8||5|
|Urinary tract infection||1||0|
The following adverse events were also reported at a rate of 1% or greater in patients treated with eprosartan, but were as, or more, frequent in the placebo group: headache, myalgia, dizziness, sinusitis, diarrhea, bronchitis, dependent edema, dyspepsia, and chest pain.
Facial edema was reported in 5 patients receiving eprosartan. Angioedema has been reported with other angiotensin II antagonists.
Rare cases of rhabdomyolysis have been reported in patients receiving angiotensin II receptor blockers.
In addition to the adverse events above, potentially important events that occurred in at least two patients/subjects exposed to eprosartan or other adverse events that occurred in < 1% of patients in clinical studies are listed below. It cannot be determined whether events were causally related to eprosartan:
Resistance Mechanism: herpes simplex, otitis externa, otitis media, upper respiratory tract infection;
Vascular: leg cramps, peripheral ischemia.
Laboratory Test Findings
In placebo-controlled studies, clinically important changes in standard laboratory parameters were rarely associated with administration of TEVETEN®. Patients were rarely withdrawn from TEVETEN® because of laboratory test results.
Creatinine, Blood Urea Nitrogen
Minor elevations in creatinine and in BUN occurred in 0.6% and 1.3%, respectively, of patients taking TEVETEN® and 0.9% and 0.3%, respectively, of patients given placebo in controlled clinical trials. Two patients were withdrawn from clinical trials for elevations in serum creatinine and BUN, and three additional patients were withdrawn for increases in serum creatinine.
Liver Function Tests
Minor elevations of ALAT, ASAT, and alkaline phosphatase occurred for comparable percentages of patients taking TEVETEN® or placebo in controlled clinical trials. An elevated ALAT of > 3.5 x ULN occurred in 0.1% of patients taking TEVETEN® (one patient) and in no patient given placebo in controlled clinical trials. Four patients were withdrawn from clinical trials for an elevation in liver function tests.
A greater than 20% decrease in hemoglobin was observed in 0.1% of patients taking TEVETEN® (one patient) and in no patient given placebo in controlled clinical trials. Two patients were withdrawn from clinical trials for anemia.
A WBC count of ≤ 3.0 x 103/mm³ occurred in 0.3% of patients taking TEVETEN® and in 0.3% of patients given placebo in controlled clinical trials. One patient was withdrawn from clinical trials for leukopenia.
A neutrophil count of ≤ 1.5 x 103/mm³ occurred in 1.3% of patients taking TEVETEN® and in1.4% of patients given placebo in controlled clinical trials. No patient was withdrawn from any clinical trial for neutropenia.
A platelet count of ≤ 100 x 109/L occurred in 0.3% of patients taking TEVETEN® (one patient) and in no patient given placebo in controlled clinical trials. Four patients receiving TEVETEN® in clinical trials were withdrawn for thrombocytopenia. In one case, thrombocytopenia was present prior to dosing with TEVETEN®.
A potassium value of ≥ 5.6 mmol/L occurred in 0.9% of patients taking TEVETEN® and 0.3% of patients given placebo in controlled clinical trials. One patient was withdrawn from clinical trials for hyperkalemia and three for hypokalemia.
Read the Teveten (eprosartan mesylate) Side Effects Center for a complete guide to possible side effects
Dual Blockade Of The Renin-Angiotensin System (RAS)
Dual blockade of the RAS with angiotensin receptor blockers, ACE inhibitors, or aliskiren is associated with increased risks of hypotension, hyperkalemia, and changes in renal function (including acute renal failure) compared to monotherapy. Most patients receiving the combination of two RAS inhibitors do not obtain any additional benefit compared to monotherapy. In general, avoid combined use of RAS inhibitors. Closely monitor blood pressure, renal function and electrolytes in patients on TEVETEN and other agents that affect the RAS.
Do not co-administer aliskiren with TEVETEN in patients with diabetes. Avoid use of aliskiren with TEVETEN in patients with renal impairment (GFR < 60 ml/min).
Eprosartan has been shown to have no effect on the pharmacokinetics of digoxin and the pharmacodynamics of warfarin and glyburide. Thus, no dosing adjustments are necessary during concomitant use with these agents. Because eprosartan is not metabolized by the cytochrome P450 system, inhibitors of CYP450 enzyme would not be expected to affect its metabolism, and ketoconazole and fluconazole, potent inhibitors of CYP3A and 2C9, respectively, have been shown to have no effect on eprosartan pharmacokinetics. Ranitidine also has no effect on eprosartan pharmacokinetics.
Eprosartan (up to 400 mg b.i.d. or 800 mg q.d.) doses have been safely used concomitantly with a thiazide diuretic hydrochlorothiazide). Eprosartan doses of up to 300 mg b.i.d. have been safely used concomitantly with sustained-release calcium channel blockers (sustained-release nifedipine) with no clinically significant adverse interactions.
Non-Steroidal Anti-Inflammatory Agents including Selective Cyclooxygenase-2 Inhibitors (COX-2 Inhibitors)
In patients who are elderly, volume-depleted (including those on diuretic therapy), or with compromised renal function, co-administration of NSAIDs, including selective COX-2 inhibitors, with angiotensin II receptor antagonists, including eprosartan, may result in deterioration of renal function, including possible acute renal failure. These effects are usually reversible. Monitor renal function periodically in patients receiving eprosartan and NSAID therapy.
Increases in serum lithium concentrations and lithium toxicity have been reported during concomitant administration of lithium with angiotensin II receptor agonists. Monitor serum lithium levels during concomitant use.
Read the Teveten Drug Interactions Center for a complete guide to possible interactions
Last reviewed on RxList: 1/19/2016
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