Aurlumyn (iloprost tromethamine)

If a dose-limiting adverse reaction (e.g., headache, flushing, jaw pain, myalgia, nausea, vomiting) occurs during administration of iloprost at the starting dose, the infusion should be discontinued; re-initiation of the infusion can be attempted after the event resolves or is treated. If a dose-limiting adverse reaction occurs that cannot be tolerated by the patient, then decrease the dosage in a stepwise manner by 0.5 ng/kg/min every 30 minutes, until a tolerated dosage is reached.

If the infusion is stopped at any point for a dose-limiting adverse event, the infusion can be reinitiated at a previously tolerated dose/infusion rate once the event has resolved. The maximum tolerated dose should be maintained for the remaining 6-hour daily infusion.

Administer iloprost as a continuous IV infusion over 6 hours each day for up to a maximum of 8 consecutive days. The IV infusion should be administered through a peripheral line or peripherally inserted central catheter using an infusion pump. Use an infusion set with an in-line 0.22- or 0.2-micron filter. The infusion pump used to administer iloprost should (1) be able to deliver rates of 0.1 to 99.9 mL per hour, (2) adjust infusion rates with increments of 0.1 mL per hour, (3) be accurate to within 5% of the programmed rate, and (4) be positive pressure-driven (continuous or pulsatile). The reservoir and infusion line set should be made of polyvinyl chloride (PVC).

Iloprost (Aurlumyn(R)) is commercially available as a 100 mcg/mL solution in single-dose vials; the drug should be diluted prior to administration.

Avoid inadvertent administration of a bolus dose. Do not flush the catheter without withdrawing residual drug from the catheter system. Discard any unused portion.

Do not mix or administer iloprost with any other medications or solutions.

Unopened vials of iloprost are stable until the date indicated on the package when stored at 20-25oC, with excursions permitted to 15-30oC. The unopened vial should be kept in the carton and not exposed to direct sunlight. Do not freeze.

No dosing information is available for this tab.

No dosing information is available for this tab.

Iloprost is metabolized principally via beta-oxidation of the carboxyl side chain. Its metabolite, tetranor-iloprost, is considered to be inactive. Metabolism via cytochrome P-450 (CYP) isoenzymes is minor.

There are no contraindication interactions for this drug.

There are no severe interactions for this drug.

Moderate Interaction: Assess the risk to the patient and take action as needed.

Selected Antihypertensives And Vasodilators/Apomorphine

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)

Selected Antihypertensives/Tizanidine

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)

*None

• Lactation

• Child-pugh class B hepatic impairment
• Child-pugh class C hepatic impairment
• Disease of liver
• Hypotension

There are no moderate contraindications for this drug.

The most common adverse effects of iloprost include headache, flushing, palpitations/tachycardia, nausea, vomiting, dizziness, and hypotension.

Less Frequent

• Injection site sequelae

Rare or Very Rare

• Chronic heart failure
• Dyspnea
• Seizure disorder

More Frequent

• Dizziness
• Flushing
• Headache disorder
• Hyperhidrosis
• Hypotension
• Nausea
• Orthostatic hypotension
• Tachycardia
• Vasodilation of blood vessels
• Vomiting

Less Frequent

• Acute abdominal pain
• Agitation
• Anorexia
• Arthralgia
• Diarrhea
• Drowsy
• Erythema
• Fatigue
• Hyperesthesia
• Indifference
• Jaw pain
• Myalgia
• Nervousness
• Pain
• Paresthesia
• Sedation
• Sensation of warmth
• Syncope
• Trismus
• Vertigo

Rare or Very Rare

• Cough
• Cramps

No enhanced messaging available.

Safety and efficacy in pediatric patients have not been established.

There are no available data with iloprost injection during pregnancy to evaluate for a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes. There are limited published cases of inhaled iloprost use during pregnancy, primarily during the second and third trimesters; no drug-associated risk of adverse maternal or fetal outcomes has been identified from these cases. In animal reproductive studies, administration of continuous IV iloprost to rats during organogenesis at doses 2-times the maximum recommended human dose resulted in adverse developmental outcomes.

There are no data on the presence of iloprost in human milk, the effects on the breastfed infant, or the effects on milk production. Iloprost is present in rat milk. When a drug is present in animal milk, it is likely that the drug will be present in human milk. Because of the potential for serious adverse reactions, advise women not to breastfeed during treatment with iloprost.

The manufacturer makes no specific dosage recommendations for geriatric patients. In general, dose selection in these patients should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy.

Clinical studies of iloprost did not include sufficient numbers of patients 65 years of age and older to determine whether they respond differently than younger patients. Other reported clinical experience with iloprost has not identified differences in responses between geriatric and younger patients.