Ventavis Side Effects

Generic Name: iloprost

Please note - some side effects for Ventavis may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA at http://www.fda.gov/medwatch/ or 1-800-FDA-1088 (1-800-332-1088).

Side Effects of Ventavis - for the Consumer

Ventavis

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome when using Ventavis:

Back pain; cough; dizziness; flu-like symptoms; flushing; headache; increased cough; muscle cramps; nausea; sleeplessness; tongue pain; vomiting.

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); bleeding gums; chest pain; coughing up blood; decreased urination; fainting; fast or irregular heartbeat; flu-like symptoms; lock jaw; nosebleed; pneumonia; pounding in the chest; shortness of breath; swelling of the arms or legs; unusual sweating; wheezing.

Ventavis Side Effects - for the Professional

Ventavis

Pre-marketing experiences

Pre-marketing safety data on Ventavis were obtained from 215 patients with pulmonary arterial hypertension receiving iloprost in two 12-week clinical trials and two long-term extensions. Patients received inhaled Ventavis for periods of from 1 day to more than 3 years. The median number of weeks of exposure was 15 weeks. Forty patients completed 12 months of open-label treatment with iloprost.

The following table shows adverse events reported by at least 4 iloprost patients and reported at least 3% more frequently for iloprost patients than placebo patients in the 12-week placebo-controlled study.

Pre-marketing serious adverse events reported with the use of inhaled iloprost and not shown in Table 3 include congestive heart failure, chest pain, supraventricular tachycardia, dyspnea, peripheral edema, and kidney failure.

In a small clinical trial (the STEP trial, see CLINICAL TRIALS), safety trends in patients receiving concomitant bosentan and iloprost were consistent with those observed in the larger experience of the Phase 3 study in patients receiving only iloprost.

Adverse events with higher doses

In a study in healthy volunteers (n=160), inhaled doses of iloprost solution were given every 2 hours, beginning with 5 mcg and increasing up to 20 mcg for a total of 6 dose inhalations (total cumulative dose of 70 mcg) or up to the highest dose tolerated in a subgroup of 40 volunteers. There were 13 subjects (32%) who failed to reach the highest scheduled dose (20 mcg). Five were unable to increase the dose because of (mild to moderate) transient chest pain/discomfort/tightness, usually accompanied by headache, nausea, and dizziness. The remaining 8 subjects discontinued for other reasons.

POSTMARKETING EXPERIENCE

The following adverse reactions have been identified during the postapproval use of Ventavis. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.

Cases of bronchospasm and wheezing have been reported, particularly in susceptible patients with hyperreactive airways, such as patients with comorbid diseases affecting the airways. Cases of epistaxis and gingival bleeding have been reported within one month of starting iloprost treatment. Cases of dizziness and diarrhea have also been reported with the use of Ventavis.

Side Effects by Body System

Cardiovascular

Cardiovascular side effects have included congestive heart failure, chest pain, supraventricular tachycardia, peripheral edema, vasodilation (flushing), hypotension, palpitations and syncope.

Gastrointestinal

Gastrointestinal side effects have included nausea and vomiting. Postmarketing experience has included diarrhea.

Hepatic

Hepatic side effects have included increased GGT (gamma-glutamyltranspeptidase) and alkaline phosphatase levels.

Musculoskeletal

Musculoskeletal side effects have included muscle cramps, back pain, tongue pain and trismus.

Nervous system

Nervous system side effects have included headache, dizziness and insomnia.

Renal

Renal side effects have included kidney failure.

Respiratory

Respiratory side effects have included hemoptysis, pneumonia, dyspnea and increased cough. Postmarketing experience has included cases of bronchospasm and wheezing, particularly in susceptible patients with hyperreactive airways.

General

General side effects have included flu syndrome.

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