Medicinal Products

EPOPROSTENOL INTSEL CHIMOS 1.5 mg

Flolan Generic Drug
Therapeutic class: Cardiology and angiology
active ingredients: Epoprostenol
laboratory: Intsel-Chimos

Powder and solvent for solution for injection
Box of 1 bottle of powder + 50 ml solvent bottle
All forms

Indication

EPOPROSTENOL INTSEL CHIMOS 1.5 mg, powder and solvent for solution for injection is indicated for the long-term continuous infusion of pulmonary arterial hypertension (PAH):

· Idiopathic pulmonary arterial hypertension - familial or sporadic,

· Pulmonary arterial hypertension associated with systemic collagenosis.

In patients with functional clinical stage III or IV (New York Heart Association severity scale).

As an indication, before considering the initiation of a long-term treatment with EPOPROSTENOL INTSEL CHIMOS 1.5 mg, powder and solvent for solution for injection, patients potentially responding to oral vasodilators may be identified by a vasodilatation test. in acute which will be best achieved using nitric oxide by inhalation.

EPOPROSTENOL INTSEL CHIMOS 1.5 mg, powder and solvent for solution for injection should only be prescribed in specialist pulmonary departments with an intensive care unit and an invasive cardiological exploration unit to ensure a specialized assessment. and monitoring by a team trained in the management of patients with pulmonary arterial hypertension and the use of EPOPROSTENOL INTSEL CHIMOS 1.5 mg powder and solvent for solution for injection.

Dosage EPOPROSTENOL INTSEL CHIMOS 1.5 mg Powder and solvent for solution for injection Box of 1 vial of powder + vial of solvent of 50 ml

Recommended dosage in adults:

· Vasodilatation test in acute:
This test is only of interest to detect patients responding to oral vasodilators (such as calcium channel blockers) and in no case epoprostenol responders in long-term administration (the indication of which is justified only in patients with non-responders to the acute test). It can easily be replaced by an inhaled nitric oxide (NO) test, simpler and without systemic repercussions.
The product can be administered either peripherally or centrally.
The infusion will be initiated at a rate of 2 ng / kg / min, then increased in increments of 2 ng / kg / min every 15 minutes or less frequently, until the onset of limiting pharmacological effects, the most common of which are nausea, vomiting, headache, hypotension or tachycardia.
As an indication, in clinical trials, the maximum dose administered to acute patients without such effects was on average 8.6 ± 0.3 ng / kg / min.

· Continuous infusion in the long run:
For long-term infusion, the diluted product will be administered via a central venous catheter. The infusion rate of epoprostenol will be adjusted under medical supervision.

o Initial dose:
The infusion will be started at a rate of 1 ng / kg / min and then increased in steps of 1 ng / kg / min every 12 to 24 hours depending on the tolerance, up to a dosage of 10 ng / kg / min. The dosage will then be increased from 1 ng / kg / min every 15 days to a dose of 16 ng / kg / min.

o Adjustment of doses infused during long-term treatment:
Epoprostenol doses will be increased depending on recurrence or worsening of symptoms of pulmonary arterial hypertension, on the objectivation of a decrease in exercise tolerance on repeated (6 min) walk tests and on hemodynamic parameters.
The occurrence of adverse events related to an overdose should consider the reduction of epoprostenol doses.

o Modalities and conditions for dose increase during long-term infusion:
The symptoms of pulmonary arterial hypertension may gradually return during treatment. In general, they respond well to small dose increases of epoprostenol.
When signs of pulmonary arterial hypertension increase, the infused dose will be increased in increments of 1 ng / kg / min at sufficiently long time intervals (1 to 4 weeks) to allow evaluation of the clinical response.
Infusion rates should be re-evaluated at regular intervals. As an indication, during clinical trials, the dose increase was an average of 1 ng / kg / min per month, but the variability was considerable.

o Terms and conditions for dose reduction during long-term infusion:
The occurrence of clinical signs suggestive of overdosage or too high cardiac output (dyspnea, fatigue, weight loss, tachycardia, vomiting) may require reducing the dose of epoprostenol infused. This phenomenon sometimes disappears without dosage adjustment and it is often difficult to differentiate these symptoms from signs suggestive of insufficient treatment, hence the need for clinical and hemodynamic monitoring.
Dose reduction should be done incrementally, in increments of 2 ng / kg / min, every 15 minutes or more, until the limiting effects in relation to the administered dose are resolved.

The dose reduction must be done gradually in steps.

Abrupt discontinuation of epoprostenol infusion or significant and / or sudden reduction in infusion rate should be avoided due to the potential for potentially life-threatening rebound effects.

· Use in the elderly:
Clinical studies with EPOPROSTENOL INTSEL CHIMOS 1.5 mg powder and solvent for solution for injection have not included an adequate number of patients over 65 years of age to determine whether the efficacy and safety of EPOPROSTENOL INTSEL CHIMOS 1.5 mg, powder and solvent for solution for injection differed from those observed in younger subjects.
Nevertheless, in this population, the choice of a dosage should be careful, because of a greater risk of hepatic, renal and cardiac dysfunction, as well as associated pathologies or treatments.

In children: in the absence of sufficient data concerning the treatment of PAH in children with EPOPROSTENOL INTSEL CHIMOS 1.5 mg, powder and solvent for solution for injection, it is the physician's responsibility to weigh the expected benefit of the treatment. by EPOPROSTENOL INTSEL CHIMOS 1.5 mg, powder and solvent for solution for injection and the risk incurred by the patient in the absence of this treatment.

In the newborn: in the absence of sufficient data concerning the treatment of the newborn with EPOPROSTENOL INTSEL CHIMOS 1.5 mg, powder and solvent for solution for injection, it is up to the doctor to weigh the expected benefit of EPOPROSTENOL INTSEL CHIMOS 1, 5 mg, powder and solvent for solution for injection in view of the risk incurred by the patient in the absence of this treatment and the existing therapeutic alternatives.

Administration mode:

Intravenous infusion.

For long-term intravenous infusion, EPOPROSTENOL INTSEL CHIMOS 1.5 mg powder and solvent for solution for injection will be administered via a central catheter using an ambulatory infusion pump.

· The ambulatory pump must:

o be small and of low weight;

o allow rate adjustments in increments of 1 ng / kg / min;

o have an alarm for obstructions, infusion and battery unloading;

o allow an accuracy of at least 6% compared to the programmed flow rate;

o operate by positive pressure (continuous or pulsatile); the interval between relapses should not exceed 3 minutes at the rates used for administration of EPOPROSTENOL INTSEL CHIMOS 1.5 mg, powder and solvent for solution for injection.

The tank must be made of polyvinyl chloride, polypropylene or glass.
As an indication, the infusion pumps used in the clinical trials were: CADD-1 HFX 5, 100 (Pharmacia Deltec), Walk-Med 410C (Medfusion, Inc.) and Auto Syringe AS2F (Baxter Healthcare) and Graseby MS32.
In order to avoid possible interruptions in the administration of the drug, the patient must be able to access an emergency pump and intravenous infusion equipment.
EPOPROSTENOL INTSEL CHIMOS 1.5 mg, powder and solvent for solution for injection should not be mixed with other solutes, a multi-lumen catheter should be used if other intravenous treatments are routinely administered.

· Preparation of a solution of EPOPROSTENOL INTSEL CHIMOS 1.5 mg, powder and solvent for solution for injection for infusion:
Reconstituted solutions, prepared in real time, should not be used for more than 12 hours when administered at room temperature (between + 15 ° C and + 25 ° C). They should not be exposed to temperatures above 25 ° C and should be kept out of direct light.
Before use at room temperature, the reconstituted solutions of EPOPROSTENOL INTSEL CHIMOS 1.5 mg, powder and solvent for solution for injection may be stored in the refrigerator at + 2 ° C to + 8 ° C for a period not exceeding 24 hours. In this case they should not be used for more than 8 hours when administered at room temperature.
Before administration, the reconstituted solution will be inspected. A discolouration or the presence of particles must prohibit its administration.

· Calculation of the infusion rate:
The perfusion rate Δ (ml / h) will be calculated using the following formula:

Δ (ml / h) = [D (ng / kg / min) x P (kg) x 60 min]

________________________

[F (ng / ml) x 1 (h)]


D represents the prescribed dose of epoprostenol expressed in ng / kg / min.
P represents the body weight of the patient expressed in kg.
F represents the concentration of epoprostenol expressed in ng / ml and calculated on the basis of the following formula: F (ng / ml) = Q (ng) / VD (ml) where VD represents the dilution volume of the solvent expressed in ml and Q the amount of epoprostenol expressed in ng.
As an indication, the concentrations (F) of epoprostenol most frequently used in the treatment of PAHP are:

o 10, 000 ng / ml = 1 vial with 0.5 mg epoprostenol, reconstituted and diluted in 50 ml;

o 20 000 ng / ml = 2 vials with 0.5 mg epoprostenol, reconstituted and diluted in 50 ml;

o 30 000 ng / ml = 3 vials with 0.5 mg epoprostenol or 1 vial with 1.5 mg epoprostenol, reconstituted and diluted in 50 ml;

o 40 000 ng / ml = 4 vials with 0.5 mg epoprostenol or 1 vial with 1.5 mg epoprostenol + 1 vial with 0.5 mg epoprostenol, reconstituted and diluted in 50 ml.

Against indications

This medicine is contraindicated:

· If hypersensitivity to epoprostenol or any of the excipients;

· In patients with congestive heart failure due to severe left ventricular dysfunction;

· If there is suspicion of veno-occlusive disease on history, clinical examination, thoracic CT and bronchoalveolar lavage, or pulmonary edema (clinical or radiological) ) when starting treatment with epoprostenol.

Adverse effects Epoprostenol Intsel Chimos

Reported adverse reactions are listed below by organ class. Frequencies are defined as: very common (> 1/10), frequent (> 1/100, 1/1000, 1/10 000, <1/1000), very rare (<1/10 000), y including isolated cases.

The events mentioned with an indefinite frequency correspond to those reported by spontaneous notification since the commercialization.

Infections and infestations

Frequent: Sepsis, sepsis.

Blood and lymphatic system disorders

Frequent: Thrombocytopenia, various bleeding.

Metabolism and nutrition disorders

Not known:

Increased blood sugar

Psychiatric disorders

Common: Anxiety, nervousness.

Not known: Agitation.

Nervous system disorders

Very common: Headache.

Heart conditions

Common: Tachycardia (Cases have been reported in response to administration of epoprostenol at doses ≤ 5 nanograms / kg / min).

Bradycardia, sometimes accompanied by orthostatic hypotension, has occurred in healthy volunteers at doses> 5 nanograms / kg / min.

Hypotension.

Vascular disorders

Very common: facial flush.

Gastrointestinal disorders

Very common: Nausea, vomiting, diarrhea.

Common: Abdominal colic, sometimes reported as abdominal discomfort.

Skin and subcutaneous tissue disorders

Common: Rash.

Not known: Photosensitivity.

Musculoskeletal and systemic disorders

Very common: Jaw pain.

Common: Arthralgia.

Not known: Lower limb pain.

General disorders and administration site conditions

Very common: Pain (site not specified)

Frequent: Edema of the lower extremities often associated with ascites whose origin is not always clearly established, chest pain, pain at the injection site.

Rare: Local infection.

Very rare: chest tightness, redness at the site of administration, occlusion of intravenous catheter, feeling of weariness.

Not known: Flu-like syndrome, shortness of breath, dizziness, vertigo.

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