Flolan. Potent pulmonary and systemic vasodilator Three major potential pharmacologic actions

Transcription

1 1995 FDA approved for PAH - NYHA functional class III/IV FDA for SPH r/t scleroderma and related disorders 2000 Medicare expanded coverage: cardiac d/o, portal htn, SPH r/t congenital disorders (ASD, Eisenmenger s), HIV, anorexic drug use, RA, MCTD

2 Potent pulmonary and systemic vasodilator Three major potential pharmacologic actions Direct vasodilation of pulmonary & systemic arterial beds Inhibition of platelet aggregation Vascular remodeling

3 Cardiac effects Reduction in right and left ventricular afterload Increase in CO and SV Low doses: vagal mediated bradycardia Higher doses: reflex tachycardia in response to direct vasodilation and hypotension Other pharmacologic effects Bronchodilation Inhibition of gastric secretion Decreased gastric emptying

4 Half life approximately 6 minutes Brief interruption may result in symptoms associated with rebound pulmonary hypertension Dyspnea Dizziness Weakness/loss of strength

5 Candidates for epoprostenol Patients who are non-responders Patients who have not improved on calcium channel blockers, or those who have reached maximum dose Able to care for self independently or has mixing partner Willing/able to take on the life long commitment of continuous drug infusion therapy Insurance pre-approval for drug and supplies Hickman catheter

6 Contraindications CHF due to severe left ventricular systolic dysfunction Pulmonary venous-occlusive disease Known hypersensitivity to epoprostenol or structurally related compounds Patients who develop pulmonary edema during dose-ranging of drug

7 Drug interactions Other drugs may affect BP: diuretics, antihypertensive agents, and other vasodilators Increased chance of bleeding with other antiplatelet agents or anticoagulants

8 Drugs to avoid Aspirin or aspirin products Ibuprofen Pseudoephredrines

9 Adverse reactions during acute dose ranging extreme nausea vomiting headache hypotension extreme flushing chest pain anxiety dizziness bradycardia dyspnea abdominal pain severe musculoskeletal pain tachycardia

10 Common complaints during chronic administration jaw pain flushing diarrhea nausea vomiting long bone pain flu-like symptoms anxiety/nervousness

11 The following reactions are most likely due to pulmonary hypertension and not Flolan: dyspnea fatigue chest pain right ventricular failure pallor

12 Adverse reactions attributable to drug delivery system local infections pain at injections site sepsis (catheter related)

13 Overdosage flushing headache hypotension tachycardia nausea vomiting diarrhea

14 Required tests for Flolan insurance reimbursement Complete H&P documenting dx and progression Cardiac cath report with document PA pressures Echo VQ scan CT of chest (R/O PE) if VQ scan not done Calcium channel blocker statement

15 Infuse only by central line Mix only with special diluent May be infused by peripheral line in an emergent situation In-hospital, new bag hung q 8 hours Flolan is light sensitive

16 Cadd-1 Pump

17 Acute dose ranging: Initial rate 2ng/kg/min Increase by 1-2ng/kg/min q15 minutes until dose limiting side effects are elicited Decreases must be made gradually in 2ng/kg/min decrements q 15 minutes or longer until dose-limiting effects resolve

18 Chronic dosage in-hospital adjustments Increases in the chronic infusion rate are based on persistence, recurrence, or worsening of symptoms Increase 1-2ng/kg/min q 15 minutes to allow assessment of new rate Monitor patient for several hours: standing and supine BP and heart rate

19 Chronic dosage out-patient adjustments Increases or decreases in Flolan not > 2ng/kg/min per visit If > 2ng/kg/min adjustments are necessary, hospitalization may be required to assess tolerance to change

20 Flolan may not be stopped abruptly Sudden large reductions or interruption of drug delivery system may result in symptoms associated with rebound pulmonary hypertension dyspnea dizziness weakness/loss of strength death

21 Developing a Program Brochure for referring MD s and patients Protocols for diagnosis, treatment, including NO, CCB, Flolan Pre-printed Flolan Order Sheet Nursing management protocol Special unit dedicated to epoprostenol delivery Flolan flow sheet Coumadin flow sheet

22 Flow Sheet Example Flolan Flow Sheet Name: Joe Smith Date Flolan initiated: 8/01/01 Dosing Weight: 65 kg Transplant List: NO X YES: 9/01/01 Lung X Heart & Lung Transplant Hospital: NSUH/Manhasset Phone #: Transplant Coordinator: Mary Murphy, NP Date Flolan Dose Concentration? ng/cc Pump cc/24 hours Called into FLOLAN 9/10/01 4 Ng/ Kg/min 5000ng/cc 74 yes DL 10/10/10 6 Ng/ Kg/min 10000ng/cc 56 yes DL Initials

23 Prescribed in ng/kg/min 1mg = 1,000,000 ng

24 Pt Weight Flolan via Hospital Pump Flolan desired dose ng/ kg/ min Flolan concentration ng/ml (3,000, 5,000, 10,000, etc)

25 via Hospital Pump Pt weight 58kg Dose: 16ng/kg/min Hourly dose: 16x58x60=55,680ng/hr

26 via Hospital Pump Flolan concentration: 5,000ng/ml Rate of infusion: Hourly dose Concentration 55,680ng 5,000ng = ml/hr Run pump at 11.1 ml/hr

27 via Hospital Pump Flolan 5,000 ng/ml 16ng/kg/min Pt wt: 58 kg Hourly dose: 55,680ng Run pump at 11.1 ml/hr

28 via Cadd-1 pump Pt weight: Flolan desired dose: ng/ kg/ min x 24h Flolan concentration ng/ml (10,000, 15,000, etc) Pump rate between 45ml/24 hour and 98 ml/24 hour

29 Pt weight: 58kg Flolan via Cadd-1 pump Dose: 16ng/kg/min x 24h 24 hour dose: 16 x 58 x 60 x 24 = 1,336,320 ng

30 via Cadd-1pump Flolan vials =.5mg (500,000 ng) or 1.5 mg (1,500,000 ng) Concentration of Cadd-1 pump: ng/100ml of diluent example: 4 vials of.5mg = (4 x 500,000 ng) = 2,000,000 ng 2,000,000ng 100ml = 20,000 ng/ml

31 via Cadd-1 pump Flolan Concentration: 20,000 ng/ml Rate of Infusion: 24 hour rate concentration 1,3336,320 20,000 = 66.8 ml Run pump at 67 ml/24 hour period

32 via Cadd-1 pump Flolan concentration: 4 vials of.5mg = 2,000,000 ng/100 ml Flolan concentration = 20,000 ng/ml Dose: 16ng/kg/min Pt wt: 58 kg 24 hour dose = 1,336,320ng = 66.8 ml/24 hours Run pump at 67ml/24 hour