Hello i’m dr. ron val cassini i’m a pulmonologist and contract consultant in denver i work at national jewish health in denver colorado and i’m a paid speaker for synovium pharmaceuticals thank you for joining me for today’s presentation nebulizer ivana are for moderate our trait inhalation solution for copd this promotional non cme program presented on behalf of
Synovium pharmaceuticals is intended only for us healthcare professionals involved in the treatment of patients with copd the information contained herein is intended for general information purposes only it is not a substitute for your professional medical advice and judgement this presentation reviews appropriate initiation or adjustment of maintenance therapy
For copd as well as the clinical data for nebulizer ivana are from all rural tartrate inhalation solution a nebulizer treatment option for copd indication rivana are for manarola tartrate inhalation solution is a long-acting beta to adrenergic agonist or laba indicated for the long-term twice daily morning and evening maintenance treatment a bronchoconstriction in
Patients with chronic obstructive pulmonary disease copd including chronic bronchitis and or emphysema pravana is for use by nebulization only important limitations pravana is not indicated to treat acute deteriorations of copd and it’s not indicated to treat asthma important safety information warning asthma related death long-acting beta to adrenergic agonists
Or labas increased the risk of asthma related death data from a large placebo controlled us study that compared the safety of another lava salmeterol or placebo added to usual asthma therapy showed an increase in asthma related deaths in patients receiving salmeterol this finding was salmeterol is considered a class effective labas including hour for moderate the
Active ingredient in bravano the safety and efficacy of revonnah in patients with asthma have not been established ravana is not into for the treatment of asthma ravana is a long-acting maness therapy used in controlling symptoms of copd in adults long-acting bronchodilators are preferred over short-acting bronchodilators as maintenance therapy l’abbé medicines
Such as bravano may treat symptoms like wheezing cough chest tightness and shortness of breath gold recommendations state that routine follow-up is essential in patients with copd to determine when to modify therapy follow-up visits should also include a discussion of current therapeutic regimens and symptoms particularly any new or worsening symptoms at each
Visit inquire about changes and symptoms since the last visit transitioning to nebulizer therapy may be appropriate for some patients and bravano should not be initiated in patients with acutely deteriorating copd or potentially life-threatening episodes of copd or used as rescue therapy for acute episodes of bronchospasm acute symptoms should be treated with an
Inhaled short-acting beta-2 agonist ravana has taken every 12 hours and is supplied in a single strength 15 micrograms of are from otter all equivalent to 22 micrograms of rf moderate heart rate as to ml’s of a sterile solution ravana is delivered in 115 microgram unit dose filed twice daily morning and evening and is administered by oral inhalation by a standard
Jet nebulizer with a face mask or mouthpiece connected to an air compressor each treatment with pravana takes an average of five to ten minutes with regular tidal breathing ravana should not be used more often at higher doses than recommended or in conjunction with other medications containing lavas as an overdose may result patients who have been taking inhaled
Short-acting beta-2 agonist on a regular basis should be instructed to discontinue their regular use and to use them only for symptomatic relief for acute respiratory symptoms clinic clinically significant cardiovascular effects and fatalities have been reported in association with excessive use of inhaled sympathomimetic drugs patients using bravo no should not
Use another medicine containing a lava for any reason patients were randomized after a two-week single blind placebo run in period the primary endpoint was the mean percentage change from baseline prior to the first dose at week zero in morning trough fev1 over 12 weeks all patients including those in placebo group received rescue albuterol and supplemental petrow
Priam for use as needed throughout the trial except within 6 hours of their pft visit in an additional study an ad hoc analysis of 212 copd patients showed that the majority 56% n equals 118 had greater than or equal to 100 ml improvement in troth fev1 at week 12 pool data from two identical 12-week double-blind double dummy placebo-controlled randomized multicenter
Trials trials a and b assessing the efficacy and tolerability of pravana 15 micrograms twice daily n equals 288 versus placebo n equals 293 in patients with copd all lavas including bhuvana are contraindicated in patients with asthma without use of a long-term asthma control medication bravano is also contraindicated in patients with a history of hypersensitivity
To are from auto all race make for montréal or to any of the ingredients now i’ll discuss the clinical data for bravano in this clinical trial bravano significantly improved bronchodilation over the 12 hours following dosing pooled data from two identical 12-week double-blind double dummy placebo controlled multicenter trials trials a and b assessing the efficacy
Of tolerability of pravana 15 micrograms twice daily n equals 288 versus placebo n equals 293 in patients with copd showed significant and consistent bronchodilation over 12 hours with few troughs so meter was an active comparator and there was no statistically significant difference between the bravano and salmeterol treatment groups for the primary efficacy
Endpoint overall efficacy of ravana was made tane throughout the 12-week trial duration some tolerance to the bronchodilator affective ravana was observed after six weeks of dosing at the end of the dosing interval although the fev1 improvement remains statistically significant this was not accompanied by other clinical manifestations of tolerance in two
Identical 12-week double-blind double dummy placebo-controlled randomized multicenter trials assessing the efficacy and tolerability of bravano n equals 285 versus placebo n equals to 89 in patients with copd ravana reduced the need for rescue medication ravana reduced patient reported daily use of both albuterol and if atropine by 37% versus 2 percent and 9%
For placebo respectively from baseline as reported on synovial generated copd questionnaire data are pooled from clinical trials a and b over 12 weeks these data are not controlled for multiplicity please keep in mind that bhuvana is not indicated to treat acute deterioration of copd and is not indicated to treat asthma ravana should not be used in conjunction
With other inhaled medications containing long-acting beta 2 agonist patients who have been taking inhaled short-acting beta-2 agonist example leave albuterol on a regular basis should be instructed to discontinue the regular use of these products and use them only for the symptomatic relief of acute symptoms immediate hypersensitivity reactions may occur with
Pravana and if signs occur discontinue immediately an institute alternative therapy as with other inhaled beta-2 agonist pravana can produce paradoxical bronchospasm that may be life-threatening if paradoxical bronchospasm occurs ravana should be discontinued immediately an alternative therapy instituted in the same analysis of data from two identical 12-week
Double-blind doubledown a placebo controlled randomized multicenter trials trials a and b patients taking bravano experienced a 19% increase in mean number of symptom free nights per week over the 12-week study period versus nine percent for placebo compared with baseline as reported on sanofi and generated copd questionnaire data are pooled from clinical trials
A and b over 12 weeks these data are not controlled for multiplicity ravana should not be swallowed as the intended effects on the lungs will not be obtained ravana is only for oral inhalation via a standard jet nebulizer connected to an air compressor in addition to clinical efficacy ravana offers an established safety profile in two 12-week pivotal trials the
Low incidence of cardiovascular adverse events was comparable to a placebo ravana like other beta-2 agonist can produce a clinically significant cardiovascular effect in some patients as measured by increases in pulse rate systolic or diastolic blood pressure and/or symptoms ravana should be used with caution and patients with cardiovascular disorders especially
Coronary insufficiency cardiac arrhythmias and hypertension beta-2 adrenergic agonists may produce significant hypokalemia in some patients in these two trials the five most common adverse events with frequency greater than or equal to two percent in patients taking ravana and occurring more frequently than with pressley bow were paying eight percent versus five
Percent chest pain seven percent versus six percent back pain six percent versus two percent diarrhea six percent versus 4% and sinusitis five percent versus four percent as with other beta-2 agonist ravana should be used with caution and patients treated with additional adrenergic drugs non potassium sparing diuretics and beta blockers bravano like all medicines
Containing sympathomimetic amines should be used with caution in patients with convulsive disorders thyrotoxicosis diabetes mellitus ketoacidosis and in patients who are unusually responsive to sympathomimetic enemies in this 52 week double-blind randomized placebo-controlled safety trial with patients with moderate to severe copd the primary endpoint was time
To either respiratory death or first copd exacerbation related hospitalization which ever occurred first the event had to be a death or hospitalization for which the patient’s respiratory status was predominant and or inciting contributor as determined by the clinical investigator the objective of the trial was to demonstrate that the risk of respiratory death
Or copd exacerbation related hospitalization for patients treated with pravana was not greater than 40% more than the risk for patients treated with placebo a total of 841 patients with copd were randomized 422 bravada and 421 to placebo of the randomized patients 255 61% in the bravano group and 211 50% in the placebo group completed one year of treatment the
Trial objective was met demonstrating that copd patients treated with bhuvana are not at an increased risk of respiratory death or copd exacerbation related hospitalizations compared to placebo as with other beta-2 agonist bravano should be administered with extreme caution to patients being treated with monoamine oxidase inhibitors tricyclic antidepressants or
Drugs known to prolong the qt c interval because these agents may potentiate the action of adrenergic agonist on the cardiovascular system synovium profile ww synovium profile calm /bo vana is designed to inform health care providers about pravana how it works and its benefits it also allows offices to request synovium product samples as well as online practice and
Patient materials you are encouraged to report negative side effects of prescription drugs to the fda visit wwf/e a gov forward slash medwatch or call one 800 ft a one zero eight eight for additional information please see full prescribing information including boxed warning and medication guide for bhuvana @ww synovium profile comm /ro vana synovium has developed a
Program for patients and their caregivers called synovium answers it’s a support resource that can answer medical and insurance quest about bravano help patients find a pharmacy or connect them to copd advocacy groups this concludes our discussion of copd and bhuvana so now i’d like to cover the important safety information we may have already covered some of this
During the presentation but it’s here for your reference indication bravano ar from montréal tartrate inhalation solution is a long-acting beta to adrenergic agonist lava indicated for the long term twice daily morning and evening maintenance treatment of bronchoconstriction in patients with chronic obstructive pulmonary disease copd including chronic bronchitis
And or emphysema ravana is for use by nebulization only what are some important limitations ravana is not indicated to treat acute deterioration of copd and is not indicated to treat asthma important safety information warning asthma related death long-acting beta to adrenergic agonist lavas increased the risk of asthma related death data from a large placebo
Controlled us study that compared the safety of another lava salmeterol or placebo added to usual asthma therapy showed an increase in asthma related deaths in patients receiving some meter all this finding was salmeterol is considered a class effect of lavas including our montréal the active ingredient ingredient in bravano the safety and efficacy of ravana in
Patients with asthma have not been established ravana is not indicated for the treatment of asthma all lavas including ravana are contraindicated in patients with asthma without use of a long-term asthma control medication ravana is also contraindicated in patients with a history of hypersensitivity to r4 mater all racemate from adderall or to any of the ingredients
Bravano should not be initiated in patients with acutely deteriorating copd or potentially life-threatening episodes of copd or as rescue therapy for acute episodes of bronchospasm acute symptoms should be treated with an inhaled short-acting beta-2 agonist bravano should not be used more often at higher doses than recommended or in conjunction with other medications
Containing lavas as an overdose may result patients who have been taking inhaled short-acting beta-2 agonist on a regular basis should be instructed to discontinue the regular use and to use them only for symptomatic relief for acute respiratory symptoms clinically significant cardiovascular effects and fatalities have been reported in association with excessive use
Of inhaled sympathomimetic drugs patients using bhuvana should not use another medicine containing alaba for any reason immediate hypersensitivity reactions may occur with bhuvana if signs occurred discontinue immediately and institute alternative therapy as with other inhaled beta-2 agonists bravano can produce paradoxical bronchospasm that may be life-threatening
If paradoxical bronchospasm occurs ravana should be discontinued immediately an alternative therapy instituted ravana like other beta-2 agonists can produce a clinically significant cardiovascular effect in some patients as measured by increases in pulse rate systolic or diastolic blood pressure and/or symptoms ravana should be used with caution in patients with
Cardiovascular disorders especially coronary insufficiency cardiac arrhythmias and hypertension beta-2 adrenergic agonist may produce significant hyperkalemia in some patients as with other beta-2 agonist bravano should be administered with extreme caution to patients being treated with monoamine oxidase inhibitors tricyclic antidepressants or drugs known to
Prolong the qt c interval because these agents may potentiate the action of adrenergic agonist on the cardiovascular system as with other beta-2 agonist ravana should be used with caution and patients treated with additional adrenergic drugs non potassium sparing diuretics and beta blockers ravana like all medicines containing pama medicare means should be used
With caution in patients with convulsive disorders thyrotoxicosis diabetes mellitus ketoacidosis and in patients who are unusually responsive to some fátima medicare means the overall efficacy of bravano was maintained throughout the 12-week trial duration some tolerance to the bronchodilator affective ravana was observed after six weeks of dosing at the end of
The dosing interval although the fev1 improvement remains statistically significant this was not accompanied by other clinical manifestations of tolerance the five most common adverse events reported with frequency greater than or equal to two percent in patients taking bravano and occurring more frequently than in patients taking placebo were paying 8% versus 5%
Chest pain 7% versus 6 percent back pain 6% vs. 2% diarrhea 6% versus 4% and sinusitis 5% versus 4% bravano should not be swallowed as the intended effects on the lungs will not be obtained ravana is only for the oral inhalation by a standard jet nebulizer connected to an air compressor you are encouraged to report negative side effects of prescription drugs to
The fda visit wwf/e a gov forward slash medwatch or call one 800 ft a one zero eight eight for additional information please see full prescribing information including boxed warning and medication guide for bhuvana at wwdc nova and profile comm ford / ravana thank you for taking the time to listen to this presentation i hope the information has been helpful thank you
Transcribed from video
Nebulized BROVANA arformoterol tartrate Inhalation Solution for COPD By Touch Medical Media Services
