iloprost (Ventavis)

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Trade Name: Ventavis

Following information is meant for : Wholesalers, Suppliers, Exporters, Doctors, CROs, Comparator Supplies, Hospitals, MOH Tender Supplies, Generic, Brand, Cooperate Sourcing, India, Institutional Buyers.

Manufacturer: Actelion Pharmaceuticals US, Inc.

Presentation: SOLUTION, HUMAN PRESCRIPTION DRUG

Strength: 0.01 mg/mL

Storage and handling

ILOPROST Prostacycline [EPC],Prostaglandins I [CS]

Disclaimer:

These products are NOT FOR SALE in US territories. We offer them for Exports outside of US Territories to Trade Professionals or patients with a valid prescription.
Trademark shown are property of their respective owners and GNH India does not lay any claim on them.

No data

VENTAVIS is indicated for the treatment of pulmonary arterial hypertension (PAH) (WHO Group 1) to improve a composite endpoint consisting of exercise tolerance, symptoms (NYHA Class), and lack of deterioration. Studies establishing effectiveness included predominately patients with NYHA Functional Class IIIu2013IV symptoms and etiologies of idiopathic or heritable PAH (65%) or PAH associated with connective tissue diseases (23%) .
VENTAVIS is a prostacyclin mimetic indicated for the treatment of pulmonary arterial hypertension (PAH) (WHO Group 1) to improve a composite endpoint consisting of exercise tolerance, symptoms (NYHA Class), and lack of deterioration. Studies establishing effectiveness included predominately patients with NYHA Functional Class III-IV symptoms and etiologies of idiopathic or heritable PAH (65%) or PAH associated with connective tissue diseases (23%). ().

VENTAVIS is intended to be inhaled using the I-nebu00ae AADu00ae System. Patients should receive 6 to 9 doses (inhalations) per day (minimum of 2 hours between doses during waking hours) as follows:

1 mL ampules in two concentrations: 10 mcg/mL and 20 mcg/mL.
1 mL ampules in two concentrations: 10 mcg/mL and 20 mcg/mL ().

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Hypotension leading to syncope has been observed. Monitor vital signs while initiating VENTAVIS. VENTAVIS should not be administered in patients with systolic blood pressure below 85 mmHg ().
Pulmonary venous hypertension: Discontinue if pulmonary edema is present ().
May cause bronchospasm: Patients with a history of hyperreactive airway disease may be more sensitive ().
Avoid contact with skin and eyes and ingestion ().

Most common (u22653% placebo adjusted) adverse reactions are vasodilation (flushing), cough increased, headache, trismus, insomnia, nausea, hypotension, vomiting, alkaline phosphatase increased, flu syndrome, back pain, tongue pain, palpitations, syncope, GGT increased, muscle cramps, hemoptysis, and pneumonia ().n n n

No data

VENTAVIS has the potential to increase the hypotensive effect of vasodilators and antihypertensive agents ().
There is a potential for increased risk of bleeding, particularly in patients maintained on anticoagulants ().

No data

Hepatic impairment: In patients with Child-Pugh Class B or C hepatic impairment, consider increasing the dosing interval (e.g., 3-4 hours between doses depending on the patient's response at the end of the dose interval) (, ).
Lactation: Advise not to breastfeed ().

Cases of overdose have been reported. Frequently observed symptoms following overdose are dizziness, headache, flushing, nausea, jaw pain or back pain. Hypotension, vomiting, and diarrhea are possible. A specific antidote is not known. Interruption of the inhalation session, monitoring, and symptomatic measures are recommended.

VENTAVIS (iloprost) Inhalation Solution is a clear, colorless, sterile solution containing iloprost formulated for inhalation via the I-nebu00ae AADu00ae (Adaptive Aerosol Delivery) System. VENTAVIS is supplied in 1 mL single-use glass ampules containing either 10 mcg/mL or 20 mcg/mL.
For the 10 mcg/mL solution, one mL of the solution contains 0.01 mg iloprost and also contains 0.81 mg ethanol, approximately 0.51 mg hydrochloric acid (for pH adjustment to 8.1) in water for injection, 9.0 mg sodium chloride, and 0.121 mg tromethamine.
For the 20 mcg/mL solution, one mL of the solution contains 0.02 mg iloprost and also contains 1.62 mg ethanol, approximately 0.76 mg hydrochloric acid (for pH adjustment to 8.4) in water for injection, 9.0 mg sodium chloride, and 0.242 mg tromethamine.
The solution contains no preservatives.
The chemical name for iloprost is (E)-(3a, 4, 5, 6a)-hexahydro-5-hydroxy-4-[()-(3,4)-3-hydroxy-4-methyl-1-octen-6-ynyl]-u0394-pentalenevaleric acid. Iloprost consists of a mixture of the 4R and 4S diastereoisomers at a ratio of approximately 53:47. Iloprost is an oily substance, which is soluble in methanol, ethanol, ethyl acetate, acetone, and pH 7 buffer, sparingly soluble in buffer pH 9, and very slightly soluble in distilled water, buffer pH 3, and buffer pH 5. The molecular formula of iloprost is CHO. Its relative molecular weight is 360.49. The structural formula is shown below:

No data

Iloprost was not mutagenic in bacterial and mammalian cells in the presence or absence of extrinsic metabolic activation. Iloprost did not cause chromosomal aberrations in human lymphocytes and was not clastogenic in NMRI/SPF mice. There was no evidence of a tumorigenic effect of iloprost clathrate (13% iloprost by weight) in Sprague-Dawley rats dosed orally for up to 8 months at doses of up to 125 mg/kg/day (C of 45 ng/mL serum), followed by 16 months at 100 mg/kg/day, or in Crl:CD-1u00ae(ICR)BR albino mice dosed orally for up to 24 months at doses of up to 125 mg/kg/day (C of 156 ng/mL serum). The recommended clinical dosage regimen for iloprost (5 mcg) affords a serum C of 0.16 ng/mL. Fertility of males or females was not impaired in Han-Wistar rats at intravenous doses up to 1 mg/kg/day.

A randomized, double-blind, multi-center, placebo-controlled trial was conducted in 203 adult patients (inhaled iloprost: n = 101; placebo: n = 102) with NYHA Class III or IV PAH (WHO Group 1); idiopathic in 53%, associated with connective tissue disease, including CREST and scleroderma, in 17%, or associated with anorexigen use in 2%) or PAH related to chronic thromboembolic disease (WHO Group 4; 28%). Inhaled iloprost (or placebo) was added to patients' current therapy, which could have included anticoagulants, vasodilators (e.g., calcium channel blockers), diuretics, oxygen, and digoxin, but not PGI (prostacyclin or its analogs) or endothelin receptor antagonists. Patients received 2.5 or 5.0 mcg of iloprost by repeated inhalations 6 to 9 times per day during waking hours. The mean age of the entire study population was 52 years and 68% of the patients were female. The majority of patients (59%) were NYHA Class III. The baseline 6-minute walk test values reflected a moderate exercise limitation (the mean was 332 meters for the iloprost group and 315 meters for the placebo group). In the iloprost group, the median daily inhaled dose was 30 mcg (range of 12.5 to 45 mcg/day). The mean number of inhalations per day was 7.3. Ninety percent of patients in the iloprost group never inhaled study medication during the nighttime.
The primary efficacy endpoint was clinical response at 12 weeks, a composite endpoint defined by: a) improvement in exercise ability (6-minute walk test) by at least 10% versus baseline evaluated 30 minutes after dosing, b) improvement by at least one NYHA class versus baseline, and c) no death or deterioration of pulmonary hypertension. Deterioration required two or more of the following criteria: 1) refractory systolic blood pressure < 85 mmHg, 2) worsening of right heart failure with cardiac edema, ascites, or pleural effusion despite adequate background therapy, 3) rapidly progressive cardiogenic hepatic failure (e.g., leading to an increase of GOT or GPT to > 100 U/L, or total bilirubin u2265 5 mg/dL), 4) rapidly progressive cardiogenic renal failure (e.g., decrease of estimated creatinine clearance to u2264 50% of baseline), 5) decrease in 6-minute walking distance by u2265 30% of baseline value, 6) new long-term need for i.v. catecholamines or diuretics, 7) cardiac index u2264 1.3 L/min/m, 8) CVP u2265 22 mmHg despite adequate diuretic therapy, and 9) SVO u2264 45% despite nasal O therapy.
Although effectiveness was seen in the full population (response rates for the primary composite endpoint of 17% and 5%; p = 0.007), there was inadequate evidence of benefit in patients with pulmonary hypertension associated with chronic thromboembolic disease (WHO Group 4); the results presented are therefore those related to patients with PAH (WHO Group 1). The response rate for the primary efficacy endpoint among PAH patients was 19% for the iloprost group, compared with 4% for the placebo group (p = 0.0033). All three components of the composite endpoint favored iloprost (Figure 1).
Figure 1: Composite Primary Endpoint for PAH Patients (WHO Group 1)
The absolute change in 6-minute walk distance (Figure 2) measured (using all available data and no imputation) 30 minutes after inhalation among patients with PAH was greater in the iloprost group compared to the placebo group at all time points. At Week 12, the placebo-corrected difference was 40 meters (p < 0.01). When walk distance was measured immediately prior to inhalation, the improvement compared to placebo was approximately 60% of the effect seen at 30 minutes after inhalation.
Figure 2: Change (Mean u00b1 SEM) in 6-Minute Walk Distance 30 Minutes Post-inhalation in PAH Patients (WHO Group 1).
The effect of VENTAVIS in various subgroups is shown in Table 2.
Hemodynamic assessments obtained at Week 12 before inhalation in both groups (at least 2 hours after a previous dose, trough) and after inhalation in the iloprost group (approximately 15 minutes after a dose, peak), are shown in Table 3. The relationship between hemodynamic changes and clinical effects is unknown.
In a small, randomized, double-blind, placebo-controlled study (the STEP trial), 34 patients treated with bosentan 125 mg bid for at least 16 weeks tolerated the addition of inhaled iloprost (up to 5 mcg 6 to 9 times per day during waking hours). The mean daily inhaled dose was 27 mcg and the mean number of inhalations per day was 5.6.

VENTAVIS (iloprost) Inhalation Solution is supplied in cartons of 30 u00d7 1 mL clear glass single-use ampules as follows:
1 mL ampule containing iloprost 10 mcg per mL (NDC 66215-302-00), carton of 30 (NDC 66215-302-30)
1 mL ampule containing iloprost 20 mcg per mL (NDC 66215-303-00), carton of 30 (NDC 66215-303-30)
STORAGE
Store at 20 u2013 25 C (68 u2013 77 u00b0F)
Excursions permitted to 15 u2013 30 C (59 u2013 86 F)
[See USP Controlled Room Temperature]
Keep out of reach of children.

Advise patients to read the FDA-approved patient labeling (Patient Information).
Advise patients that they may have a fall in blood pressure with VENTAVIS, so they may become dizzy or even faint. They should stand up slowly when they get out of a chair or bed. If fainting gets worse, patients should consult their physicians about dose adjustment.
Advise patients that VENTAVIS should be inhaled at intervals of not less than 2 hours and that the acute benefits of VENTAVIS may not last 2 hours. Thus, patients may want to adjust times of administration to cover planned activities.

Manufactured for:
Made in Germany
u00a9 2004 - 2019 Actelion Pharmaceuticals US, Inc.JN20210115

No data

Patient Instructions for Using VENTAVIS
To take VENTAVIS, you will need to use the I-neb Adaptive Aerosol Delivery (AAD) System. This system is used to give you the right dose of VENTAVIS. You should not use other systems to take VENTAVIS, as other systems may not give you the amount of VENTAVIS you need.
Do not use VENTAVIS until your doctor has showed you how to use this system the right way.
With the I-neb System, you will receive two medicine chambers (one with a red latch and one with a purple latch) and two color-matching dosing discs to use with the 10 micrograms per 1 mL of VENTAVIS.
I-neb System Medication Chamber
You should use the red dosing disc with the red latched medicine chamber (gives you a 2.5 microgram dose). You should use the purple dosing disc with the purple-latched medicine chamber (gives you a 5 microgram dose). n
If you are using the I-neb System and usually have long treatment times, your doctor may ask you to switch to a third medicine chamber (one with a gold latch). The medicine chamber with the gold latch and matching dosing disc are only for use with the 20 micrograms per 1 mL ampule of VENTAVIS. You should use the gold dosing disc with the gold latched medicine chamber (gives you a 5 microgram dose.).
Do not change the medicine chamber and dosing disc in your I-neb System without talking to your doctor.
Do not put any medicines other than VENTAVIS in your I-neb System.
To Use VENTAVIS:
Open the small glass bottle (ampule) of VENTAVIS by using either an ampule breaker or a rubber pad. Use either the ampule breaker or the rubber pad. You do not need to use both methods to open a VENTAVIS ampule.
When using an ampule breaker:
Step 1.
Step 2.
Step 3.
When using a rubber pad:
Step 1.
Step 2.
Step 3.
Step 4.
I-neb System
Step 5.
Keep both the ampule and the pipette out of the reach of children.
Step 6.
The I-neb System allows you to stop your treatment for up to ten minutes with no effect on the final dose you get. If your treatment is stopped for more than ten minutes, the I-neb System will reset itself. If that happens,n
Step 7.
Step 8.
Step 9.
Rx onlyRevised: 01/2021
Manufactured for:Actelion Pharmaceuticals US, Inc.a Janssen Pharmaceutical CompanySouth San Francisco, CA 94080, USA
Made in Germany
u00a9 2004 - 2019 Actelion Pharmaceuticals US, Inc.JN20210115

NDC 66215-302-30
VENTAVISn (iloprost) INHALATION SOLUTION
10 mcg/1 mL
Contents: 30 single-use ampules. Each single-use glass ampule contains 1 mL (10 mcg) of the solution to be added to the nebulizer medication chamber. Each mL of the aqueous solution contains 0.01 mg iloprost, 0.81 mg ethanol, 0.121 mg tromethamine, 9.0 mg sodium chloride, and approximately 0.51 mg hydrochloric acid (for pH adjustment to 8.1) in water for injection. The sterile solution contains no preservatives.
Dosage and Administration: See enclosed full prescribing information.
Storage: Store at 20u201325u00b0C (68u201377u00b0F); excursions permitted to 15u201330u00b0C (59u201386u00b0F) [See USP Controlled Room Temperature]
KEEP OUT OF THE REACH OF CHILDREN
ACTELION

NDC 66215-303-30
VENTAVISn (iloprost) INHALATION SOLUTION
20 mcg/1 mL
Each inhalation session requires one single-use ampule.
Contents: 30 single-use ampules. Each single-use glass ampule contains 1 mL (20 mcg) of the solution to be added to the I-neb AAD medication chamber. Each mL of the aqueous solution contains 0.02 mg iloprost, 1.62 mg ethanol, 0.242 mg tromethamine, 9.0 mg sodium chloride, and approximately 0.76 mg hydrochloric acid (for pH adjustment to 8.4) in water for injection. The sterile solution contains no preservatives.
Dosage and Administration: See enclosed full prescribing information.
Storage: Store at 20u201325u00b0C (68u201377u00b0F); excursions permitted to 15u201330u00b0C (59u201386u00b0F) [See USP Controlled Room Temperature]
KEEP OUT OF THE REACH OF CHILDREN
ACTELION

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GNH India is WHO GDP and ISO 9001 2015 Certified Pharmaceutical Wholesaler, Supplier, Exporters from India of iloprost (Ventavis) which is also known as Ventavis and Manufactured by Actelion Pharmaceuticals US, Inc.. It is available in strength of 0.01 mg/mL.

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