Ventavis

Drug overview for VENTAVIS (iloprost):

Generic name: ILOPROST (EYE-loe-prost)
Drug class: Vasodilators
Therapeutic class: Cardiovascular Therapy Agents

Iloprost, a synthetic analog of prostacyclin (PGI2), is a vasodilator and platelet-aggregation inhibitor.

No enhanced Uses information available for this drug.

DRUG IMAGES

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The following indications for VENTAVIS (iloprost) have been approved by the FDA:

Indications:
Pulmonary arterial hypertension

Professional Synonyms:
Hypertensive pulmonary arterial disease
Pulmonary hypertensive arterial disease

Dosing information for VENTAVIS
DRUG LABEL	DOSING TYPE	DOSING INSTRUCTIONS
VENTAVIS 10 MCG/1 ML SOLUTION	Maintenance	Adults inhale 0.5 milliliter (5 mcg) via nebulizer by inhalation route 6 times per day
VENTAVIS 20 MCG/1 ML SOLUTION	Maintenance	Adults inhale 0.25 milliliter (5 mcg) via nebulizer by inhalation route 6 times per day

The following drug interaction information is available for VENTAVIS (iloprost):

Contraindicated
Severe
Moderate

There are 0 contraindications.

There are 0 severe interactions.

There are 2 moderate interactions. The clinician should assess the patient’s characteristics and take action as needed. Actions required for moderate interactions include, but are not limited to, discontinuing one or both agents, adjusting dosage, altering administration.

Drug Interaction	Drug Names
Tizanidine/Selected Antihypertensives SEVERITY LEVEL: 3-Moderate Interaction: Assess the risk to the patient and take action as needed. MECHANISM OF ACTION: Tizanidine is an alpha-2 agonist. Concurrent use with antihypertensive agents may result in additive effects on blood pressure.(1) CLINICAL EFFECTS: Concurrent use of antihypertensives and tizanidine may result in hypotension.(1) PREDISPOSING FACTORS: None determined. PATIENT MANAGEMENT: Patients receiving concurrent therapy should be monitored for hypotension. The risk of hypotension may be decreased by careful titration of tizanidine dosages and monitoring for hypotension prior to dose advancement. Counsel patients about the risk of orthostatic hypotension.(1) DISCUSSION: Severe hypotension has been reported following the addition of tizanidine to existing lisinopril therapy.(2-4)	TIZANIDINE HCL, ZANAFLEX
Apomorphine/Selected Antihypertensives and Vasodilators SEVERITY LEVEL: 3-Moderate Interaction: Assess the risk to the patient and take action as needed. MECHANISM OF ACTION: Apomorphine causes dose-dependent decreases in blood pressure. Concurrent use with antihypertensive agents may result in additive effects on blood pressure.(1) CLINICAL EFFECTS: Concurrent use of antihypertensives and apomorphine may result in orthostatic hypotension with or without dizziness, nausea, or syncope.(1) PREDISPOSING FACTORS: The risk of orthostatic hypotension may be increased during dose escalation of apomorphine and in patients with renal or hepatic impairment.(1) PATIENT MANAGEMENT: Patients receiving concurrent therapy should be monitored for hypotension. Counsel patients about the risk of orthostatic hypotension.(1) DISCUSSION: Healthy volunteers who took sublingual nitroglycerin (0.4 mg) concomitantly with apomorphine experienced a mean largest decrease in supine systolic blood pressure (SBP) of 9.7 mm Hg and in supine diastolic blood pressure (DBP) of 9.3 mm Hg, and a mean largest decrease in standing SBP and DBP of 14.3 mm Hg and 13.5 mm Hg, respectively. The maximum decrease in SBP and DBP was 65 mm Hg and 43 mm Hg, respectively. When apomorphine was taken alone, the mean largest decrease in supine SBP and DBP was 6.1 mm Hg and 7.3 mm Hg, respectively, and in standing SBP and DBP was 6.7 mm Hg and 8.4 mm Hg, respectively.(1)	APOKYN, APOMORPHINE HCL, ONAPGO

Drug Interaction

Drug Names

Tizanidine/Selected Antihypertensives

SEVERITY LEVEL: 3-Moderate Interaction: Assess the risk to the patient and take action as needed.

MECHANISM OF ACTION: Tizanidine is an alpha-2 agonist. Concurrent use with antihypertensive agents may result in additive effects on blood pressure.(1)

CLINICAL EFFECTS: Concurrent use of antihypertensives and tizanidine may result in hypotension.(1)

PREDISPOSING FACTORS: None determined.

PATIENT MANAGEMENT: Patients receiving concurrent therapy should be monitored for hypotension. The risk of hypotension may be decreased by careful titration of tizanidine dosages and monitoring for hypotension prior to dose advancement. Counsel patients about the risk of orthostatic hypotension.(1)

DISCUSSION: Severe hypotension has been reported following the addition of tizanidine to existing lisinopril therapy.(2-4)

TIZANIDINE HCL, ZANAFLEX

Apomorphine/Selected Antihypertensives and Vasodilators

SEVERITY LEVEL: 3-Moderate Interaction: Assess the risk to the patient and take action as needed.

MECHANISM OF ACTION: Apomorphine causes dose-dependent decreases in blood pressure. Concurrent use with antihypertensive agents may result in additive effects on blood pressure.(1)

CLINICAL EFFECTS: Concurrent use of antihypertensives and apomorphine may result in orthostatic hypotension with or without dizziness, nausea, or syncope.(1)

PREDISPOSING FACTORS: The risk of orthostatic hypotension may be increased during dose escalation of apomorphine and in patients with renal or hepatic impairment.(1)

PATIENT MANAGEMENT: Patients receiving concurrent therapy should be monitored for hypotension. Counsel patients about the risk of orthostatic hypotension.(1)

DISCUSSION: Healthy volunteers who took sublingual nitroglycerin (0.4 mg) concomitantly with apomorphine experienced a mean largest decrease in supine systolic blood pressure (SBP) of 9.7 mm Hg and in supine diastolic blood pressure (DBP) of 9.3 mm Hg, and a mean largest decrease in standing SBP and DBP of 14.3

mm Hg and 13.5 mm Hg, respectively. The maximum decrease in SBP and DBP was 65 mm Hg and 43 mm Hg, respectively.

When apomorphine was taken alone, the mean largest decrease in supine SBP and DBP was 6.1 mm Hg and 7.3 mm Hg, respectively, and in standing SBP and DBP was 6.7

mm Hg and 8.4 mm Hg, respectively.(1)

APOKYN, APOMORPHINE HCL, ONAPGO

The following contraindication information is available for VENTAVIS (iloprost):

Overview
Contraindicated
Severe
Moderate

Drug contraindication overview.

*None.

There are 1 contraindications. Absolute contraindication.

Contraindication List
Lactation

There are 2 severe contraindications. Adequate patient monitoring is recommended for safer drug use.

Severe List
Hypotension
Pulmonary edema

There are 2 moderate contraindications. Clinically significant contraindication, where the condition can be managed or treated before the drug may be given safely.

Moderate List
Bronchospastic pulmonary disease
Chronic obstructive pulmonary disease

The following adverse reaction information is available for VENTAVIS (iloprost):

Overview
Severe
Less Severe

Adverse reaction overview.

Adverse effects reported at least 3% more frequently with iloprost than with placebo include vasodilation (flushing), cough, headache, trismus, insomnia, nausea, hypotension, vomiting, increased alkaline phosphatase, flu syndrome, back pain, tongue pain, palpitations, syncope, increased gamma-glutamyl transferase (GGT), muscle cramps, hemoptysis, and pneumonia.

There are 12 severe adverse reactions.

More Frequent	Less Frequent
Abnormal hepatic function tests	Pneumonia

Rare/Very Rare
Bronchospastic pulmonary disease Chest pain Chronic heart failure Dyspnea Hypersensitivity drug reaction Paroxysmal supraventricular tachycardia Peripheral edema Renal failure Supraventricular tachycardia Thrombocytopenic disorder

There are 22 less severe adverse reactions.

More Frequent	Less Frequent
Back pain Cough Cramps Flu-like symptoms Headache disorder Hypotension Insomnia Nausea Palpitations Syncope Trismus Vasodilation of blood vessels Vomiting	Hemoptysis Sore tongue

Rare/Very Rare
Diarrhea Dizziness Dysgeusia Epistaxis Mouth irritation Nasal congestion Skin rash

The following precautions are available for VENTAVIS (iloprost):

Pediatric
Pregnant
Lactation
Geriatric

Safety and efficacy of iloprost have not been established in pediatric patients.

Contraindicated

None

Severe Precaution

None

Management or Monitoring Precaution

None

A drug-associated risk of adverse maternal or fetal outcomes has not been demonstrated in limited case reports and case series of iloprost. Available animal data are conflicting. Untreated pulmonary arterial hypertension (PAH) in pregnancy increases the risk for maternal heart failure, stroke and death, miscarriage, preterm delivery, low birthweight infants, and stillbirth.

Iloprost is distributed into milk in rats; it is not known whether the drug is distributed into human milk. When a drug is present in animal milk, it is likely the drug will be present in human milk. Because of the potential for severe adverse effects in nursing infants, advise women not to breastfeed during treatment.

Clinical studies of iloprost did not include sufficient numbers of patients 65 years of age and older to determine whether geriatric patients respond differently than younger patients. In general, dosage should be titrated carefully in geriatric patients. The greater frequency of decreased hepatic, renal, and/or cardiac function and of concomitant disease and drug therapy observed in the elderly should be considered.

Pulmonary arterial hypertension
I27.0	Primary pulmonary hypertension
I27.21	Secondary pulmonary arterial hypertension