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Veletri

Last reviewed on RxList: 1/4/2019
Veletri Side Effects Center

Last reviewed on RxList 01/04/2019

Veletri (epoprostenol) Powder for Intravenous (IV) Administration is a prostaglandin used to treat pulmonary arterial hypertension (PAH) (WHO Group 1) to improve exercise capacity. Common side effects of Veletri include:

Veletri is administered intravenously and a physician will determine the dose. Veletri may interact with diuretics, drugs to treat high blood pressure, other vasodilators, other antiplatelet drugs, or anticoagulants. Tell your doctor all medications and supplements you use. Tell your doctor if you are pregnant or plan to become pregnant before using Veletri. It is unknown if this drug passes into breast milk. Consult your doctor before breastfeeding. Abrupt withdrawal (including interruptions in drug delivery) or sudden large reductions in dosage of Veletri may result in symptoms associated with rebound pulmonary hypertension.

Our Veletri (epoprostenol) Powder for Intravenous (IV) Administration Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

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Veletri Professional Information

SIDE EFFECTS

Clinical Trials Experience

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.

During clinical trials, adverse events were classified as follows: (1) adverse events during dose initiation and escalation, (2) adverse events during chronic dosing, and (3) adverse events associated with the drug delivery system.

Adverse Events During Dose Initiation And Escalation

During early clinical trials, epoprostenol was increased in 2-ng/kg/min increments until the patients developed symptomatic intolerance. The most common adverse events and the adverse events that limited further increases in dose were generally related to vasodilation, the major pharmacologic effect of epoprostenol. The most common dose-limiting adverse events (occurring in > 1% of patients) were nausea, vomiting, headache, hypotension, and flushing, but also include chest pain, anxiety, dizziness, bradycardia, dyspnea, abdominal pain, musculoskeletal pain, and tachycardia. Table 8 lists the adverse events reported during dose initiation and escalation in decreasing order of frequency.

Table 8: Adverse Events during Dose Initiation and Escalation

Adverse Events Occurring in ≥ 1% of Patients Epoprostenol
(n = 391)
Flushing 58%
Headache 49%
Nausea/vomiting 32%
Hypotension 16%
Anxiety, nervousness, agitation 11%
Chest pain 11%
Dizziness 8%
Bradycardia 5%
Abdominal pain 5%
Musculoskeletal pain 3%
Dyspnea 2%
Back pain 2%
Sweating 1%
Dyspepsia 1%
Hypesthesia/paresthesia 1%
Tachycardia 1%

Adverse Events During Chronic Administration

Interpretation of adverse events is complicated by the clinical features of PAH, which are similar to some of the pharmacologic effects of epoprostenol (e.g., dizziness, syncope). Adverse events which may be related to the underlying disease include dyspnea, fatigue, chest pain, edema, hypoxia, right ventricular failure, and pallor. Several adverse events, on the other hand, can clearly be attributed to epoprostenol. These include hypotension, bradycardia, tachycardia, pulmonary edema, bleeding at various sites, thrombocytopenia, headache, abdominal pain, pain (unspecified), sweating, rash, arthralgia, jaw pain, flushing, diarrhea, nausea and vomiting, flu-like symptoms, anxiety/nervousness, and agitation. In addition, chest pain, fatigue, and pallor have been reported during epoprostenol therapy, and a role for the drug in these events cannot be excluded.

Adverse Events During Chronic Administration For Idiopathic Or Heritable PAH

In an effort to separate the adverse effects of the drug from the adverse effects of the underlying disease, Table 9 lists adverse events that occurred at a rate at least 10% greater on epoprostenol than on conventional therapy in controlled trials for idiopathic or heritable PAH.

Table 9: Adverse Events Regardless of Attribution Occurring in Patients with Idiopathic or Heritable PAH with ≥ 10% Difference between Epoprostenol and Conventional Therapy Alone

Adverse Event Epoprostenol
(n = 52)
Conventional Therapy
(n = 54)
Occurrence More Common With Epoprostenol
General
Chills/fever/sepsis/flu.like symptoms 25% 11%
Cardiovascular
Tachycardia 35% 24%
Flushing 42% 2%
Gastrointestinal
Diarrhea 37% 6%
Nausea/vomiting 67% 48%
Musculoskeletal
Jaw pain 54% 0%
Myalgia 44% 31%
Nonspecific musculoskeletal pain 35% 15%
Neurological
Anxiety/nervousness/tremor 21% 9%
Dizziness 83% 70%
Headache 83% 33%
Hypesthesia, hyperesthesia, paresthesia 12% 2%

Thrombocytopenia has been reported during uncontrolled clinical trials in patients receiving epoprostenol.

Adverse Events During Chronic Administration For PAH/SSD

In an effort to separate the adverse effects of the drug from the adverse effects of the underlying disease, Table 10 lists adverse events that occurred at a rate at least 10% greater on epoprostenol in the controlled trial.

Table 10: Adverse Events Regardless of Attribution Occurring in Patients with PAH/SSD With ≥ 10% Difference Between Epoprostenol and Conventional Therapy Alone

Adverse Event Epoprostenol
(n = 56)
Conventional Therapy
(n = 55)
Cardiovascular
Flushing 23% 0%
Hypotension 13% 0%
Gastrointestinal
Anorexia 66% 47%
Nausea/vomiting 41% 16%
Diarrhea 50% 5%
Musculoskeletal
Jaw pain 75% 0%
Pain/neck pain/arthralgia 84% 65%
Neurological
Headache 46% 5%
Skin and Appendages
Skin ulcer 39% 24%
Eczema/rash/urticaria 25% 4%

Although the relationship to epoprostenol administration has not been established, pulmonary embolism has been reported in several patients taking epoprostenol and there have been reports of hepatic failure.

Adverse Events Attributable To The Drug Delivery System

Chronic infusions of epoprostenol are delivered using a small, portable infusion pump through an indwelling central venous catheter. During controlled PAH trials of up to 12 weeks' duration, the local infection rate was about 18%, and the rate for pain was about 11%. During long-term follow-up, sepsis was reported at a rate of 0.3 infections/patient per year in patients treated with epoprostenol. This rate was higher than reported in patients using chronic indwelling central venous catheters to administer parenteral nutrition, but lower than reported in oncology patients using these catheters. Malfunctions in the delivery system resulting in an inadvertent bolus of or a reduction in epoprostenol were associated with symptoms related to excess or insufficient epoprostenol, respectively.

Post-Marketing Experience

In addition to adverse reactions reported from clinical trials, the following events have been identified during post-approval use of epoprostenol. Because they are reported voluntarily from a population of unknown size, estimates of frequency cannot be made. These events have been chosen for inclusion due to a combination of their seriousness, frequency of reporting, or potential causal connection to epoprostenol.

Blood and Lymphatic: Anemia, hypersplenism, pancytopenia, splenomegaly.

Endocrine and Metabolic: Hyperthyroidism

Read the entire FDA prescribing information for Veletri (Epoprostenol Powder for Intravenous Administration)

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Related Resources for Veletri

© Veletri Patient Information is supplied by Cerner Multum, Inc. and Veletri Consumer information is supplied by First Databank, Inc., used under license and subject to their respective copyrights.

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