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In the placebo-controlled trial, incidence of hypersensitivity adverse events was higher when the subjects were treated with sirolimus than if they were given the placebo.
Cardiovascular, Buy phenergan 25 mg neurologic, gastrointestinal, hematologic, and hematologic/reproductive adverse events with sirolimus were reported as follows: hypertension, aortic dissections, renal stones, bleeding from ureter or renal pelvis, thromboembolic and venous thromboembolism, myocardial infarction, coronary artery dissection (for patients taking levodopa), acute thromboembolic stroke, myocardial infarction, thrombosis of the aorta, and stroke (for patients taking sirolimus). One of these patients was given an anticoagulant because of elevated platelet levels before the drug was discontinued.
Drug Interactions
Drugs that inhibit the function of CYP1A1 enzyme may inhibit sirolimus induction and prevent dose optimization. Coadministration of warfarin may also reduce sirolimus response and may be associated with an increase in side effects, including headache, myalgia, and myocardian dysfunction.
Sirolimus has a potential interaction with warfarin, which could result in an increase hepatic toxicity. Therefore, warfarin therapy should be avoided while treating with sirolimus or during the 6-week observation period. For patients currently taking warfarin, sirolimus-containing therapy should be suspended during the 6-week observation period.
In an open-label prospective, multisite study, oral sirolimus caused a rare but serious acute hepatotoxicity called with sirolimus or warfarin (halo), which occurred in 3 of 100 (2%) patients treated with oral sirolimus for Crohn's disease and 2 of 200 (7%) patients treated with oral sirolimus for ulcerative colitis.
Sirolimus treatment was associated with a higher incidence of gastrointestinal bleeding in patients receiving high-dose and extended-release formulations may also elevate the risk of thromboembolic events. Patients with renal or hepatic impairment and patients on other medications may be at an increased risk of thrombotic or hematologic-related events.
Adverse Reactions Observed in at least 1% of Patients Who Received a Dose of 50 or More U/mL (2 treatment days)
There was a higher incidence of gastrointestinal bleeding (16%) and thrombotic events (13%) in sirolimus-treated patients with an oral exposure in excess of 3 mg/day than in those treated with a placebo on an equivalent number of days. There was no statistically significant difference in the incidence of gastrointestinal hemorrhage between the two groups over 5-day time period and no evidence of any difference before or after the dosing interval.
Adverse Events
The following adverse reactions occurred more frequently with sirolimus treatment:
Approximately 1.9% of patients in both sirolimus-treated and placebo groups had at least 1 cardiovascular event in a 24-hour period on or within 72 hours of sirolimus treatment. The incidence at least 1 heart-related event was slightly greater in the sirolimus-treated group at 0 than for the placebo group at 0 days. Slight transient elevations in blood pressure of up to 6 mm Hg occurred in 6% of patients receiving sirolimus (2 to 0.4 mg given with each meal) and 1% of placebo-treated patients, significant hypertension was noted in 6% of sirolimus-treated and 4% placebo-treated patients at the end of study. Patients with a history of an episode angina were excluded from analysis of sirolimus effect (eg, the numbers of patients excluded due to angina are not published). Approximately 1.3% of the sirolimus-treated patients and 1.4% of the placebo-treated patients experienced atlethally-related events with sirolimus (e.g., syncope and transient orthostatic hypotension). Approximately 0.2% of patients treated with sirolimus and 1% of patients treated with placebo experienced at least 1 hematologic-related event. Although patients with a history of allergic rhinitis, anaphylaxis, or asthma were considered to be at a higher risk of anaphylaxis, the incidence hematologous events was similar for both groups at 0 and 12, 24, 48, 72 hours. A case of systemic mastocytosis was observed in 2 patients taking 1 mg of sirolimus per day. There were 2 cases of leukopenia, 1 dose-.
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