Quest for the right Drug

|

נוקספיל 100 מ"ג טבליות עמידות בקיבה NOXAFIL 100 MG GASTRO-RESISTANT TABLETS (POSACONAZOLE)

תרופה במרשם תרופה בסל נרקוטיקה ציטוטוקסיקה

צורת מתן:

פומי : PER OS

צורת מינון:

אין פרטים : GASTRO RESISTANT TABLETS

Adverse reactions : תופעות לוואי

4.8   Undesirable effects

Summary of the safety profile
Safety data mainly derive from studies with the oral suspension.
The safety of posaconazole oral suspension has been assessed in > 2,400 patients and healthy volunteers enrolled in clinical studies and from post-marketing experience. The most frequently reported serious related adverse reactions included nausea, vomiting, diarrhoea, pyrexia, and increased bilirubin.

Posaconazole tablets
The safety of posaconazole tablet has been assessed in 104 healthy volunteers and 230 patients enrolled in a clinical study of antifungal prophylaxis.


The tablet formulation was investigated in AML and MDS patients and those after HSCT with or at risk for Graft versus Host Disease (GVHD) only. Maximum duration of exposure to the tablet formulation was shorter than with the oral suspension. Plasma exposure resulting from the tablet formulation was higher than observed with the oral suspension. A higher incidence of adverse reactions cannot be ruled out.

The safety of posaconazole tablets has been assessed in 230 patients enrolled in the pivotal clinical study. Patients were enrolled in a non-comparative pharmacokinetic and safety study of posaconazole tablets when given as antifungal prophylaxis. Patients were immunocompromised with underlying conditions including haematological malignancy, neutropenia post-chemotherapy, GVHD, and post HSCT. Posaconazole therapy was given for a median duration of 28 days. Twenty patients received 200 mg daily dose and 210 patients received 300 mg daily dose (following twice daily dosing on
Day 1 in each cohort).

The safety of posaconazole tablet has been assessed in 336 patients and healthy volunteers enrolled in clinical studies. The safety profile of tablets was similar to that of the oral suspension.

Tabulated list of adverse reactions
Within the organ system classes, adverse reactions are listed under headings of frequency using the following categories: 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); not known (cannot be estimated from the available data).

Table 2. Adverse reactions by body system and frequency reported in clinical studies and/or post-marketing use*
Blood and lymphatic system disorders

Common:                                neutropenia
Uncommon:                              thrombocytopenia, leukopenia, anaemia, eosinophilia, lymphadenopathy, splenic infarction
Rare:                                  haemolytic uraemic syndrome, thrombotic thrombocytopenic purpura, pancytopenia, coagulopathy, haemorrhage
Immune system disorders
Uncommon:                              allergic reaction
Rare:                                  hypersensitivity reaction


Endocrine disorders
Rare:                                  adrenal insufficiency, blood gonadotropin decreased, pseudoaldosteronism
Metabolism and nutrition disorders
Common:                            electrolyte imbalance, anorexia, decreased appetite, hypokalaemia, hypomagnesaemia
Uncommon:                          hyperglycaemia, hypoglycaemia

Psychiatric disorders
Uncommon:                              abnormal dreams, confusional state, sleep disorder Rare:                                  psychotic disorder, depression Nervous system disorders
Common:                                paraesthesia, dizziness, somnolence, headache, dysgeusia Uncommon:                              convulsions, neuropathy, hypoaesthesia, tremor, aphasia, insomnia
Rare:                                  cerebrovascular accident, encephalopathy, peripheral neuropathy, syncope
Eye disorders
Uncommon:                              blurred vision, photophobia, visual acuity reduced 

Rare:                            diplopia, scotoma
Ear and labyrinth disorder
Rare:                            hearing impairment
Cardiac disorders
Uncommon:                        long QT syndrome§, electrocardiogram abnormal§, palpitations, bradycardia, supraventricular extrasystoles,
tachycardia
Rare:                            torsade de pointes, sudden death, ventricular tachycardia, cardio-respiratory arrest, cardiac failure, myocardial infarction
Vascular disorders
Common:                          hypertension
Uncommon:                        hypotension, vasculitis
Rare:                            pulmonary embolism, deep vein thrombosis 
Respiratory, thoracic and mediastinal disorders
Uncommon:                        cough, epistaxis, hiccups, nasal congestion, pleuritic pain, tachypnoea
Rare:                            pulmonary hypertension, interstitial pneumonia, pneumonitis Gastrointestinal disorders
Very Common:                     nausea
Common:                          vomiting, abdominal pain, diarrhoea, dyspepsia, dry mouth, flatulence, constipation, anorectal discomfort
Uncommon:                        pancreatitis, abdominal distension, enteritis, epigastric discomfort, eructation, gastroesophageal reflux disease,
oedema mouth
Rare:                            gastrointestinal haemorrhage, ileus
Hepatobiliary disorders
Common:                          liver function tests raised (ALT increased, AST increased, bilirubin increased, alkaline phosphatase increased, GGT increased)
Uncommon:                        hepatocellular damage, hepatitis, jaundice, hepatomegaly, cholestasis, hepatic toxicity, hepatic function abnormal
Rare:                            hepatic failure, hepatitis cholestatic, hepatosplenomegaly, liver tenderness, asterixis
Skin and subcutaneous tissue disorders
Common:                          rash, pruritis
Uncommon:                        mouth ulceration, alopecia, dermatitis, erythema, petechiae Rare:                            Stevens Johnson syndrome, vesicular rash Not known                        photosensitivity reaction§
Musculoskeletal and connective tissue disorders
Uncommon:                        back pain, neck pain, musculoskeletal pain, pain in extremity Renal and urinary disorders
Uncommon:                        acute renal failure, renal failure, blood creatinine increased Rare:                            renal tubular acidosis, interstitial nephritis Reproductive system and breast disorders
Uncommon:                        menstrual disorder
Rare:                            breast pain
General disorders and administration site conditions
Common:                          pyrexia (fever), asthenia, fatigue
Uncommon:                        oedema, pain, chills, malaise, chest discomfort, drug intolerance, feeling jittery, mucosal inflammation
Rare:                                           tongue oedema, face oedema Investigations
Uncommon:                                       altered medicine levels, blood phosphorus decreased, chest x- ray abnormal
* Based on adverse reactions observed with all Noxafil presentations.
§
See section 4.4.


Description of selected adverse reactions
Hepatobiliary disorders
During post-marketing surveillance of posaconazole oral suspension, severe hepatic injury with fatal outcome has been reported (see section 4.4).

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

1. התרופה תינתן לטיפול במקרים האלה: א. אספרגילוזיס חודרנית לאחר כשל ב-AMPHOTERICIN B או ITRACONAZOLE או VORICONAZOLE; ב. פוסריוזיס בחולים רפרקטורים או שאינם יכולים לקבל טיפול ב-AMPHOTERICIN B; ג. כרומובלסטומיקוזיס ומיצטומה בחולים רפרקטורים או שאינם יכולים לקבל טיפול ב-ITRACONAZOLE; ד. Coccidioidomycosis בחולים רפרקטורים או שאינם יכולים לקבל טיפול ב-AMPHOTERICIN B, ITRACONAZOLE או FLUCONAZOLE. ה. Zygomycosis (Mucor) בחולים רפרקטורים או שאינם יכולים לקבל טיפול אחר ו. ו. מניעת זיהומים פטרייתיים חודרניים במושתלי מח עצם המטופלים בטיפול המדכא את מערכת החיסון עבור GVHD (מחלת שתל נגד מאחסן)  2. הטיפול בתרופה יעשה לפי מרשם של רופא מומחה במחלות זיהומיות.
שימוש לפי פנקס קופ''ח כללית 1994 לא צוין
תאריך הכללה מקורי בסל 01/03/2008
הגבלות לא צוין

רישום

156 42 34550 00

מחיר

0 ₪

מידע נוסף

עלון מידע לרופא

13.04.22 - עלון לרופא 07.09.23 - עלון לרופא 24.08.24 - עלון לרופא

עלון מידע לצרכן

24.12.17 - עלון לצרכן 13.04.22 - עלון לצרכן אנגלית 13.04.22 - עלון לצרכן עברית 04.08.22 - עלון לצרכן ערבית 07.09.23 - עלון לצרכן אנגלית 07.09.23 - עלון לצרכן עברית 14.11.23 - עלון לצרכן ערבית 24.08.24 - עלון לצרכן אנגלית 24.08.24 - עלון לצרכן עברית 26.09.24 - עלון לצרכן ערבית 16.08.20 - החמרה לעלון 11.01.21 - החמרה לעלון 19.10.21 - החמרה לעלון 01.03.22 - החמרה לעלון 13.04.22 - החמרה לעלון 24.08.24 - החמרה לעלון

לתרופה במאגר משרד הבריאות

נוקספיל 100 מ"ג טבליות עמידות בקיבה

קישורים נוספים

RxList WebMD Drugs.com