Maacy Brochure flow plan.pptx

MAACY Brochure Flow Plan Medical Data and Outline PAH Facts PAH is uncommon relative to other forms of PH, with an estimated prevalence of 15 to 50 per million Globally.1 &2 1. 2. 3. 4. 5. 6. PAH incidence 6 in USA and Europe. 3 IPAH was the most common subtype (50– 60% of all cases).4 Affec...

MAACY Brochure Flow Plan Medical Data and Outline PAH Facts PAH is uncommon relative to other forms of PH, with an estimated prevalence of 15 to 50 per million Globally.1 &2 1. 2. 3. 4. 5. 6. PAH incidence 6 in USA and Europe. 3 IPAH was the most common subtype (50– 60% of all cases).4 Affects twice as many females as males.5 and predominantly recognized in younger females.5 Humbert M., Sitbon O., Chaouart A., et al. Pulmonary arterial hypertension in France. Am J Resp Crit Care Med. 2006;173(9):1023–1030. Peacock A.J., Murphy M.F., McMurray J.J.V., Caballero L., Stewart S. An epidemiological study of pulmonary arterial hypertension. Eur Respir J. 2007;30(1):104–109. Strange G, Playford D, Stewart S, et al. Pulmonary hypertension: prevalence and mortality in the Armadale echocardiography cohort. Heart 2012;98:1805-11. 10.1136/heartjnl-2012-301992 ERS 2022 guideline Hoeper M.M., Huschen D., Ghofrani H.A., et al. Elderly patients diagnosed with idiopathic pulmonary arterial hypertension: results from the COMPERA registry. Int J Cardiol. 2013;168(2):871–880. Advisory board conducted by march 2023 The prevalence of PAH in Saudi Arabia is still unknown although the numbers of patients found till now are 750 patient.6 PAH Common Cause Common causes of PAH include: • Idiopathic • Heritable • Drug-induced • Connective tissue disease • Congenital heart disease–associated. 1. 10 Schermuly R.T., Ghofrani H.A., Wilkins M.R., Grimminger F. Mechanisms of disease: pulmonary arterial hypertension. Nat Rev Cardiol. 2011;8:443. PAH Diagnosis I. Symptoms of PAH 1. 2022 ERS MAIN PAH report . II. Past Medical History III. Family History IV. Physical Examination PAH Diagnosis V. Investigation Hemodynamic parameters Echocardiography 6MWD Right catheterization Link each one with the ERS PAH 2022 main report 1. 2022 ERS MAIN PAH report . PAH Severity and Risk Assessment World Health Organization classification of functional status of patients with pulmonary hypertension 2015 ESC/ERS Threestrata, risk-assessment tool 2015 ESC/ERS Fourstrata, riskassessment tool Link each one with the risk chart related with animation 1. 2023 ERS main report . MAACY Approved Indication is an endothelin receptor antagonist (ERA) indicated for the treatment of pulmonary arterial hypertension (PAH, WHO Group I) to reduce the risks of disease progression and hospitalization for PAH. 1. WHO Group 1 refers to pulmonary arterial hypertension (PAH), which is caused when the arteries in the lungs become narrowed, thickened or stiff. The right side of the heart must work harder to push blood through these narrowed arteries. This extra stress can cause the heart to lose its ability to pump enough blood through the lungs to meet the needs of Maacy Summary of Product Characteristics. the rest of the body. There are several types of PAH. Idiopathic PAH (IPAH) is PAH that occurs without a clear cause. Heritable PAH (HPAH) is linked to genes that are inherited from family members. PAH can also develop in association with other medical conditions including congenital heart disease, liver disease, HIV and connective tissue diseases — such as scleroderma and lupus. Add illustration here that can easily deliver the exact positioning of Maacy approved indications PAH can even be associated with past or present drug use, such as the use of methamphetami ne or certain diet pills. Macitentan Mechanism Of Action Decreases mean pulmonary arterial pressure without affecting systemic blood pressure, decreased pulmonary arterial hypertrophy, and right ventricular remodeling 1. Opsumit™ (macitentan) 10 mg film-coated tablet [product monograph]. Laval (QC): Actelion Pharmaceuticals Canada Inc; Nov 1, 2013. Benefits of Macitentan Advanced Positioning of Macitentan Improve Survival Rate Improve Functionality Improve Quality of life Decrease in Hospitalization PAH Management Guidelines PAH Management Guidelines Make a pop up link for the 3 tables 16,17 & 18 Seraphin Study A 15 month, multicenter, double‐blind, parallel‐group study, placebo-controlled, event-driven, A total of 742 patients aged from 12 years and older randomized in parallel groups 1:1:1, One group takes Placebo only, Second group takes 3mg Macitentan once daily, Third group takes 10mg Macitentan once daily. Study Design Stratified, randomized, double-blind, parallelgroupnumber studyof patients recruited in a trial on Largest PAH ever 242 250 742 Patients Use it as on the Reference Tab 250 Seraphin OL Extension Study Study Design A 9‐year, multicenter.(Survival study) A 36 Month multicenter, double‐blind, parallel‐group study, placebo-controlled, event-driven. (Combination therapy, A total of 550 patients aged from 12 years and older divided between two study groups: First group: 242 patients in the survival study, Second group: 306 patients in the study of the combinational therapy with Macitentan Long-term safety/survival set (n=242) Use it as on the Reference Tab 742 patients 250 Patient Seraphin OL Serap hin 242 Patient 250 Patient Randomized to Macitentan 10 mg Randomized to Macitentan 3 mg Randomized to Placebo 182 entered the OL and received Macitentan 10 MG 185 entered the OL and initiated Macitentan 10 MG 183 entered the OL and initiated Macitentan 10 MG Prematurely discontinued study (n=94) Due to: • Death (56) • Adverse event (16) • Admin (14) • Withdrawal of treatment (6) • Lost to follow (1) • Withdrawal of consent (1) 88 Patient Completed OL Study drug OL Safety Set (n=550) Prematurely discontinued study (n=97) Due to: • Death (50) • Adverse event (19) • Admin (15) • Withdrawal of treatment (6) • Lost to follow (3) • Withdrawal of consent (1) • Use of forbidden drug (1) 88 Patient • Unknown reason (2) Completed OL Study drug Prematurely discontinued study (n=81) Due to: • Death (37) • Adverse event (29) • Admin (11) • Withdrawal of treatment (1) • Withdrawal of consent (2) • Treatment failure (1) 102 Patient Completed OL Study drug Improve Survival Rate Seraphin Study Maacy reduce the risk of Morbidity and Mortality in patients with PAH • Primary Outcome:  Macitentan significantly reduced the risk of the first morbidity and mortality event by 45% Based on Seraphin Study Decrease in Hospitalization Seraphin Study Maacy reduce the risk of Hospitalization in patients with PAH • Secondary Outcome:  Macitentan significantly reduced death due to PAH or hospitalization by 50% Based on Seraphin Study Seraphin Study Maacy improve the WHO FC in patients with PAH Improve in Functionality • Secondary Outcome: Change to the baseline to month 6 in WHO FC  Patients on Macitentan 10mg had greater chance to improve FC Status by 74% Improve in Quality of Life • Secondary Outcome: Exercise capacity  Macitentan significantly increased the 6-minute walk distance by 22 Based on Seraphin Study Improve Survival Rate Seraphin OL Extension Study The Use of Maacy offers averagely survival. 5.9 Years 5.9 years of Based on Seraphin OL Extension Study Decrease in Hospitalization Seraphin OL Extension Study • Primary Outcome:  Macitentan 10mg combination therapy decreases the rate events by 38% more than placebo combination with background therapy  Patients receiving the Macitentan 10mg combination therapy had a reduction in the risk of being hospitalized for PAH of 37.4% Based on Seraphin OL Extension Study Improve in Quality of Life Based on Seraphin OL Extension Study Seraphin OL Extension Study • Secondary Outcome:  Patients receiving the Macitentan 10mg combination therapy had a increase in the 6-Minute Walk Distance by 17.9M vs a decrease by 7.8M in the placebo combination therapy Macitentan combination therapy significantly increased the 6-minute walk distance by Meter vs placebo combination therapy 25.9 Maacy Doses Maacy Dosage: • 10 MG Once Daily Maacy Use in Special Population Pregnant Women • • Do not take Maacy if you are pregnant or trying to get pregnant. Maacy can cause serious birth defects if taken while pregnant. Women who are able to get pregnant must have negative pregnancy tests: • • • • Before starting Maacy Each month while taking Maacy For 1 month after stopping Maacy Your doctor will decide when you should take pregnancy tests. Lactating Women • You should not breastfeed if you take Maacy It is not known if Maacy passes into your breast milk. Talk to your doctor about the best way to feed your baby. Female Pediatric Patients • If you are the parent or caregiver of a female child who started taking Maacy before reaching puberty, check with your child regularly for any signs of puberty. Your child may reach puberty before having her first menstrual period. Talk to your doctor if you think your child is showing signs of puberty or if you have any questions about the signs of puberty. MAACY 10 mg Maacy BI • Maacy comes in the form of film-coated tablets. Each film-coated tablet contains macitentan 10 mg. They are white in color, round-shaped, biconvex, and free from physical defects. The tablets are debossed with an 'M' on one side and '10' on the other side. DOSAGE AND ADMINSTRATION: • The recommended dose of Maacy is one 10 mg tablet, taken once a day. Swallow the whole tablet with a glass of water; do not chew or break the tablet. You can take Maacy with or without food. It is best to take the tablet at the same time each day. INDICATIONS: •Maacy, as monotherapy or in combination, is indicated for the long-term treatment of pulmonary arterial hypertension (PAH) in adult patients classified as WHO Functional Class (FC) II to III. • Its efficacy has been demonstrated in a PAH population, including idiopathic and heritable PAH, PAH associated with connective tissue disorders, and PAH associated with corrected simple congenital heart disease. OVERDOSE & MISSED DOSES: • If you have taken more tablets than you have been told to take, you may experience headache, nausea, or vomiting. Ask your doctor for advice. • If you forget to take Maacy , take a dose as soon as you remember, then continue to take your tablets at the usual times. Do not take a double dose to make up for a forgotten tablet. DO NOT TAKE MAACY: • if you are allergic to Macitentan, soya or any of the other ingredients of this medicine. • if you are pregnant, if you are planning to become pregnant, or if you could become pregnant because you are not using reliable birth control (contraception). • if you are breastfeeding. • if you have liver disease or if you have very high levels of liver enzymes in your blood. Talk to your doctor, who will decide whether this medicine is suitable for you. If any of these apply to you, please tell your doctor. SPECIAL WARNING AND PRECAUTIONS: • Before taking Maacy, it is important to consult your doctor or pharmacist. Your doctor may recommend blood tests, which will be conducted before starting treatment with Maacy and periodically during the course of treatment. These tests will assess whether you have anemia (a reduced number of red blood cells) and monitor the proper functioning of your liver. If you experience symptoms of anemia, such as dizziness, fatigue, weakness, a fast heart rate, palpitations, or pallor, it is important to inform your doctor. Similarly, if you notice any signs suggesting liver dysfunction, including nausea, vomiting, fever, abdominal pain, jaundice (yellowing of the skin or eyes), dark-colored urine, itching, unusual tiredness or fatigue, or flu-like symptoms (joint and muscle pain with fever), you should promptly notify your doctor. If you have kidney problems, it is crucial to discuss this with your doctor before using Maacy. In patients with kidney problems, Maacy may further reduce blood pressure and cause a decrease in hemoglobin levels. Additionally, in patients with pulmonary veno-occlusive disease (obstruction of the lung veins), the use of medications for the treatment of PAH, including Maacy, may lead to pulmonary edema. If you experience symptoms of pulmonary edema while taking Maacy, such as a sudden and significant increase in breathlessness and low oxygen levels, it is important to inform your doctor immediately. Your doctor may conduct additional tests and determine the most suitable treatment regimen for you. CHILDREN AND ADOLESCENTS: • Do not give this medicine to children and adolescents below 18 years because Maacy has not been tested in children. ELDERLY: • There is limited experience with Maacy in patients older than 75 years. Maacy should be used with caution in this age group. OTHER MEDICINES AND MAACY: Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicine. Maacy can affect other medicines. If you take Maacy together with other medicines including those listed below, the effects of Maacy or the other medicines might be altered. Please talk to your doctor or pharmacist if you are taking any of the following medicines: • rifampicin, clarithromycin, telithromycin, ciprofloxacin, erythromycin (antibiotics used to treat infections), • phenytoin (a medicine used to treat seizures), • carbamazepine (used to treat depression and epilepsy),• St. John’s Wort (an herbal preparation used to treat depression), • ritonavir, saquinavir (used to treat HIV infections), • nefazodone (used to treat depression), • ketoconazole (except shampoo), fluconazole, miconazole, itraconazole, voriconazole (medicines used against fungal infections) • amiodarone (to control the heartbeat) • cyclosporine (used to prevent organ rejection after transplant) • diltiazem, verapamil (to treat high blood pressure or specific heart problems). DRIVING AND USING MACHINES: Maacy can cause side effects such as headaches and hypotension, and the symptoms of your condition can also make you less fit to drive. LACTOSE INTOLERANCE: Maacy contains lactose (a type of sugar). If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product. PREGNANCY: If you are pregnant, think you may be pregnant, or are planning to have a baby, it is important to seek advice from your doctor before taking this medicine. Maacy may cause harm to unborn babies conceived before, during, or shortly after treatment. • If there is a possibility of pregnancy, it is recommended to use a reliable form of contraception while taking Maacy. Discuss this with your doctor. • Do not take Maacy if you are pregnant or planning to become pregnant. • If you become pregnant or suspect that you may be pregnant while taking Maacy, or within one month after stopping Maacy, it is crucial to consult your doctor immediately. If you are a woman who could become pregnant, your doctor may ask you to take a pregnancy test before starting Maacy and regularly (once a month) while taking Maacy. BREAST-FEEDING: It is unknown whether Maacy is transferred into breast milk. Do not breastfeed while you are taking Maacy. If you are