Quest for the right Drug
וואקיקס 4.5 מ"ג WAKIX 4.5 MG (PITOLISANT AS HYDROCHLORIDE)
תרופה במרשם
תרופה בסל
נרקוטיקה
ציטוטוקסיקה
צורת מתן:
פומי : PER OS
צורת מינון:
טבליות מצופות פילם : FILM COATED TABLETS
עלון לרופא
מינוניםPosology התוויות
Indications תופעות לוואי
Adverse reactions התוויות נגד
Contraindications אינטראקציות
Interactions מינון יתר
Overdose הריון/הנקה
Pregnancy & Lactation אוכלוסיות מיוחדות
Special populations תכונות פרמקולוגיות
Pharmacological properties מידע רוקחי
Pharmaceutical particulars אזהרת שימוש
Special Warning עלון לרופא
Physicians Leaflet
Adverse reactions : תופעות לוואי
4.8 Undesirable effects Narcolepsy with or without cataplexy Summary of the safety profile The most frequent adverse drug reactions (ADRs) reported with pitolisant were insomnia (8.4%), headache (7.7%), nausea (4.8%), anxiety (2.1%), irritability (1.8%), dizziness (1.4%), depression (1.3%), tremor (1.2%), sleep disorders (1.1%), fatigue (1.1%), vomiting (1.0%), vertigo (1.0%), dyspepsia (1.0%), weight increase (0.9%), abdominal pain upper (0.9%). The most serious ADRs are abnormal weight decrease (0.09%) and abortion spontaneous (0.09%). Tabulated list of adverse reactions The following adverse reactions have been reported with pitolisant during clinical studies in narcolepsy and other indications and are listed below as MedDRA preferred term by system organ class and frequency; frequencies are defined as: very common (≥1/10), common (≥1/100 to <1/10), uncommon (≥ 1/1,000 to <1/100), rare (≥1/10,000 to <1/1,000), very rare (<1/10,000); within each frequency group, adverse reactions are presented in order of decreasing seriousness: Common Uncommon Rare Metabolism and nutrition Decreased appetite Anorexia disorders Increased appetite Hyperphagia Fluid retention Appetite disorder Psychiatric disorders Insomnia Agitation Abnormal behaviour Anxiety Hallucination Confusional state Irritability Hallucination visual, Depressed mood Depression auditory Excitability Sleep disorder Affect lability Obsessive thoughts Abnormal dreams Dysphoria Dyssomnia Hypnopompic Middle insomnia hallucination Initial insomnia Depressive symptom Terminal insomnia Hypnagogic Nervousness hallucination Tension Mental impairment Apathy Nightmare Restlessness Panic Attack Libido decreased Libido increased Suicidal ideation Nervous system disorders Headache Dyskinesia Loss of consciousness Dizziness Balance disorder Tension headache Tremor Cataplexy Memory impairment Disturbance in attention Poor sleep quality Dystonia On and off phenomenon Hypersomnia Migraine Psychomotor hyperactivity Restless Legs Syndrome Somnolence Epilepsy Bradykinesia Paresthesia Eye disorders Visual acuity reduced Blepharospasm Ear and labyrinth disorders Vertigo Tinnitus Cardiac disorders Extrasystoles Bradycardia Vascular disorders Hypertension Hypotension Hot flush Respiratory, thoracic and Yawning mediastinal disorders Gastrointestinal disorders Nausea Dry mouth Abdominal distension Vomiting Abdominal pain Dysphagia Dyspepsia Diarrhoea Flatulence Abdominal discomfort Odynophagia Abdominal pain upper Enterocolitis Constipation Gastrooesophageal reflux disease Gastritis Gastrointestinal pain Hyperacidity Paraesthesia oral Stomach discomfort Skin and subcutaneous Erythema Toxic skin eruption tissue disorders Pruritus Photosensitivity Rash Hyperhidrosis Sweating Musculoskeletal and Arthralgia Neck pain connective tissue disorders Back pain Musculoskeletal chest Muscle rigidity pain Muscular weakness Musculoskeletal pain Myalgia Pain in extremity Renal and urinary disorders Pollakiuria Pregnancy, puerperium and Abortion spontaneous perinatal conditions Reproductive system and Metrorrhagia breast disorders General disorders and Fatigue Asthenia Pain administration site Chest Pain Night sweats conditions Feeling Abnormal Sense of oppression Malaise Oedema Peripheral oedema Investigations Weight increased Creatine Weight decreased phosphokinase Hepatic enzymes increased increased Electrocardiogram QT General physical prolonged condition abnormal Heart rate increased Electrocardiogram Gamma- repolarisation glutamyltransferase abnormality increased Electrocardiogram T wave inversion Description of selected adverse reactions Headache and insomnia During clinical studies, episodes of headache and insomnia have been reported (7.7 % to 8.4%). Most of these adverse reactions were mild to moderate. If symptoms persist a reduced daily dose or discontinuation should be considered. Gastric disorders Gastric disorders caused by hyperacidity have been reported during clinical studies in 3.5% of the patients receiving pitolisant. These effects were mostly mild to moderate. If they persist a corrective treatment with proton pump inhibitor could be initiated. Obstructive sleep apnoea (OSA) Summary of the safety profile The most frequent adverse reactions are headache 12.4%, insomnia (all types) 8.9%, nausea 3.3%, anxiety 2.2%, abdominal pain 2.8%, vertigo 1.7% and diarrhoea 1%. Tabulated list of adverse reactions The following adverse reactions have been reported with pitolisant during clinical studies are listed below as MedDRA preferred term by system organ class and frequency; frequencies are defined as: very common (≥1/10), common (≥1/100 to <1/10), uncommon (≥ 1/1,000 to <1/100), rare (≥1/10,000 to <1/1,000), very rare (<1/10,000); within each frequency group, adverse reactions are presented in order of decreasing seriousness: Very Common Common Uncommon Infections and infestations Herpes zoster; Viral upper respiratory; tract infection. Blood and lymphatic system Alanine disorders aminotransferase increased; Blood cholesterol increased; Blood pressure increased Blood triglycerides increased; Hepatic enzyme increased; Transaminase increased Metabolism and nutrition Alcohol disorders intolerance; Increased appetite; Hypoglycaemia; Weight decreased; Weight increased Psychiatric disorders Insomnia (all types) Confusional Anxiety disorders arousal; Sleep disorders Depressed mood disorders and disturbances; Fear; Irritability; Nervousness disorders; Libido disorders; Panic reaction; Withdrawal syndrome Nervous system disorders Headache Circadian rhythm sleep disorder; Dizziness; Dysgeusia; Psychomotor hyperactivity; Migraine; Sleep paralysis Hypotonia Eye disorders Dry eye; Photopsia Ear and labyrinth disorders Vertigo Tinnitus Cardiac disorders Atrioventricular block first degree; Palpitations; Tachycardia; Ventricular extrasystoles; Electrocardiogram QT prolonged; Heart rate increased Vascular disorders Hypertension Hot flush Respiratory, thoracic and Yawning Cough; mediastinal disorders Nocturnal dyspnoea Gastrointestinal disorders Nausea/vomiting; Constipation; Abdominal pain and discomfort Dry mouth; Diarrhoea Enterocolitis; Faeces discoloured ;Gastrointestinal disorders; Breath odour; Flatulence; Rectal haemorrhage; Salivary hypersecretion Skin and subcutaneous tissue Rash; disorders Hyperhidrosis, Pruritus Erythema; Cold sweat; Night sweats; Solar dermatitis Musculoskeletal and Limb discomfort; connective tissue disorders Muscle spasms; Myalgia; Arthralgia; Tendonitis Renal and urinary disorders Pollakiuria General disorders and Pain and Discomfort Asthenia; administration site conditions Pyrexia; Thirst Description of selected adverse reactions Headache and insomnia During clinical studies in OSA indication, episodes of headache and insomnia have been reported (12.4 % and 8.9%) more frequently in women (headache and insomnia) and in elderly (insomnia) patients. Most of these adverse reactions were mild to moderate (see section 4.2). Dosing should be adjusted accordingly. Gastric disorders Gastric disorders presumably caused by hyperacidity have been reported during clinical studies in 3.5% of the patients receiving pitolisant. Higher rates of nausea are reported in women. These effects were mostly mild to moderate. If they persist, a corrective treatment with proton pump inhibitor could be initiated. Patients with low/normal Body Mass Index (BMI) (<25) Headache, insomnia, nausea and anxiety have been reported in higher rates in patients with low/normal BMI. Dosing should be adjusted accordingly. Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Any suspected adverse events should be reported to the Ministry of Health according to the National Regulation by using an online form: https://sideeffects.health.gov.il
פרטי מסגרת הכללה בסל
א. התרופה תינתן לשיפור עירנות בחולי נרקולפסיה בחולים העונים על אחד מאלה:1. נרקולפסיה מלווה בקטפלקסיה2. נרקולפסיה ללא קטפלקסיה, כקו טיפול שניב. התכשיר לא יינתן בשילוב Solriamfetol ג. מתן התרופה ייעשה לפי מרשם של רופא מומחה בנוירולוגיה או רופא מומחה במעבדת שינה.
מסגרת הכללה בסל
התוויות הכלולות במסגרת הסל
התוויה | תאריך הכללה | תחום קליני | Class Effect | מצב מחלה |
---|---|---|---|---|
א. התרופה תינתן לשיפור עירנות בחולי נרקולפסיה בחולים העונים על אחד מאלה: 1. נרקולפסיה מלווה בקטפלקסיה 2. נרקולפסיה ללא קטפלקסיה, כקו טיפול שני ב. התכשיר לא יינתן בשילוב Solriamfetol ג. מתן התרופה ייעשה לפי מרשם של רופא מומחה בנוירולוגיה או רופא מומחה במעבדת שינה. | 01/02/2023 | נוירולוגיה | נרקולפסיה, Narcolepsy | |
שיפור עירנות בחולי נרקולפסיה בחולי נרקולפסיה ללא קטפלקסיה, כקו טיפול שני | 03/02/2022 | נוירולוגיה | נרקולפסיה, Narcolepsy | |
שיפור עירנות בחולי נרקולפסיה מלווה בקטפלקסיה | 30/01/2020 | נוירולוגיה | נרקולפסיה, Narcolepsy |
שימוש לפי פנקס קופ''ח כללית 1994
לא צוין
תאריך הכללה מקורי בסל
30/01/2020
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וואקיקס 4.5 מ"ג