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Ventavis

Last reviewed on RxList: 7/2/2019
Ventavis Side Effects Center

Last reviewed on RxList 7/2/2019

Ventavis (iloprost) Inhalation Solution is a synthetic prostacyclin that works by opening blood vessels in the lungs used as an inhalant to treat pulmonary arterial hypertension (PAH). Common side effects of Ventavis Inhalation Solution include nausea, vomiting, diarrhea, headache, dizziness, jaw tightness or pain, muscle spasms of the jaw, tongue pain, trouble chewing or speaking, flushing (warmth, redness, or tingly feeling), trouble sleeping (insomnia), increased cough, muscle cramps, back pain, or altered sense of taste.

Ventavis is inhaled using either of two pulmonary drug delivery devices: the I-neb AAD System or the Prodose AAD System. The first inhaled dose should be 2.5 mcg (as delivered at the mouthpiece). If this dose is well tolerated, dosing is increased to 5.0 mcg and maintained at that dose; otherwise maintain the dose at 2.5 mcg. Ventavis should be taken 6 to 9 times per day (no more than once every 2 hours). Other drugs may interact with Ventavis. Tell your doctor all medications and supplements you use. During pregnancy, Ventavis should be used only when prescribed. It is unknown if this drug passes into breast milk. Consult your doctor before breastfeeding.

Our Ventavis (iloprost) 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.

QUESTION

COPD (chronic obstructive pulmonary disease) is the same as adult-onset asthma. See Answer
Ventavis Consumer Information

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have a serious side effect such as:

  • feeling like you might pass out;
  • pounding heartbeats or fluttering in your chest;
  • coughing up blood;
  • unusual bleeding (nosebleeds, bleeding gums);
  • fever, chills, cough with yellow or green mucus;
  • chest tightness, stabbing chest pain, wheezing, feeling short of breath; or
  • anxiety, sweating, pale skin, severe shortness of breath, wheezing, gasping for breath, cough with foamy mucus, chest pain, fast or uneven heart rate.

Less serious side effects may include:

  • flushing (warmth, redness, or tingly feeling);
  • increased cough;
  • nausea, vomiting, diarrhea;
  • headache, dizziness;
  • muscle cramps, back pain;
  • sleep problems (insomnia);
  • tongue pain, jaw tightness or pain, trouble chewing or speaking; or
  • altered sense of taste.

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.

Read the entire detailed patient monograph for Ventavis (Iloprost)

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Ventavis Professional Information

SIDE EFFECTS

Clinical Studies 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.

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. Forty patients completed 12 months of open-label treatment with iloprost.

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

Table 1: Adverse Events in Phase 3 Clinical Trial

Adverse Event Ventavis
n = 101
Placebo
n = 102
Placebo subtracted
%
Vasodilation (flushing) 27 9 18
Cough increased 39 26 13
Headache 30 20 10
Trismus 12 3 9
Insomnia 8 2 6
Nausea 13 8 5
Hypotension 11 6 5
Vomiting 7 2 5
Alk phos increased 6 1 5
Flu syndrome 14 10 4
Back pain 7 3 4
Tongue pain 4 0 4
Palpitations 7 4 3
Syncope 8 5 3
GGT increased 6 3 3
Muscle cramps 6 3 3
Hemoptysis 5 2 3
Pneumonia 4 1 3

Pre-marketing serious adverse events reported with the use of inhaled Ventavis and not shown in Table 1 include congestive heart failure, chest pain, supraventricular tachycardia, dyspnea, peripheral edema, and kidney failure.

In a small clinical trial (the STEP trial) [see Clinical Studies], safety trends in patients receiving concomitant bosentan and Ventavis were consistent with those observed in the larger experience of the Phase 3 study in patients receiving only Ventavis or bosentan.

Adverse Events With Higher Doses

In a study in healthy subjects (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 subjects. 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 patients with a history of hyperreactive airways [see WARNINGS AND PRECAUTIONS]. Bleeding events most commonly reported as epistaxis and hemoptysis were observed on Ventavis treatment [see DRUG INTERACTIONS]. Cases of thrombocytopenia, dizziness, diarrhea, mouth and tongue irritation, nasal congestion, dysgeusia, hypersensitivity, and rash have also been reported with the use of Ventavis.

Read the entire FDA prescribing information for Ventavis (Iloprost)

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

QUESTION

COPD (chronic obstructive pulmonary disease) is the same as adult-onset asthma. See Answer

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