Generic drug of the therapeutic class: Rheumatology
active ingredients: Febuxostat
laboratory: Menarini France
box of 2 blister packs of 14
All forms
Indication
Treatment of chronic hyperuricemia in cases where urate deposition has already occurred (including history or presence of tophi and / or gouty arthritis).
ADENURIC is indicated in adults.
Dosage ADENURIC 80 mg film-coated tablet box of 2 blister packs of 14
Treatment of chronic hyperuricemia in cases where urate deposition has already occurred (including history or presence of tophi and / or gouty arthritis).
ADENURIC is indicated in adults.
Against indications
Hypersensitivity to the active substance or to any of the excipients listed under Composition (see also section 4.8 ).
Adenuric side effects
Summary of the security profile
The most commonly reported adverse reactions in clinical studies (4, 072 patients treated with at least one dose of 10 mg to 300 mg) and post-marketing experience include gout, abnormal liver function, diarrhea, nausea, headaches, rashes and edema. These adverse effects were generally of mild or moderate severity. Few serious hypersensitivity reactions to febuxostat, some of which were associated with systemic symptoms, were observed after marketing.
Tabulated list of adverse effects
Common side effects (≥ 1/100 to <1/10), infrequent (≥ 1/1000 to <1/100), and rare (≥ 1/10 000 to <1/1000), occurring in patients treated by febuxostat are mentioned below.
In each frequency group, the adverse effects are presented in order of decreasing severity.
Table 1: Adverse Events in Phase III Studies, Long-Term and Post-marketing Extension Studies
Blood and lymphatic system disorders | Rare Pancytopenia , thrombocytopenia |
Immune system disorders | Rare Anaphylactic reaction *, drug hypersensitivity * |
Endocrine disorders | Rare Increased blood serum |
Eye disorders | Rare Blurry vision |
Metabolism and nutrition disorders | Frequent *** Crisis of gout Rare Diabetes mellitus, hyperlipidemia, decreased appetite, weight Rare Weight loss, increased appetite, anorexia |
Psychiatric disorders | Rare Decreased libido, insomnia Rare Nervousness |
Nervous system disorders | Frequent Headache Rare Dizziness, paresthesia, hemiparesis, somnolence, taste alteration, hypoesthesia, hyposmia |
Hearing and labyrinth disorders | Rare tinnitus |
Heart conditions | Rare Atrial fibrillation, palpitations, ECG abnormalities |
Vascular disorders | Rare Hypertension, flushing, hot flushes |
Respiratory disorders | Rare Dyspnoea, bronchitis, upper respiratory infections, cough |
Gastrointestinal disorders | Frequent Diarrhea **, nausea Rare Abdominal pain, abdominal distension, gastrooeophageal reflux, vomiting, dry mouth, dyspepsia, constipation, frequent bowel movements, flatulence, gastrointestinal discomfort Rare Pancreatitis, ulceration of the mouth |
Hepatobiliary disorders | Frequent Abnormal liver function ** Rare Chole lithiasis Rare Hepatitis, jaundice *, liver injury * |
Skin and tissue disorders subcutaneous | Frequent Eruptions (including various types of eruptions reported with a lower frequency, see below) Rare Dermatitis, urticaria, pruritus, discolouration of the skin, skin lesions, petechia, macular rash, maculopapular rash, papular rash Rare Toxic epidermal necrolysis (Lyell syndrome) *, Stevens-Johnson syndrome *, angioedema *, hypersensitivity syndrome medications with eosinophilia and systemic symptoms (DRESS syndrome) *, generalized rash (severe) *, erythema, exfoliative eruption, follicular rash, vesicular rash, pustular rash, itchy rash *, erythematous rash, morbilliform rash, alopecia, hyperhydrosis. |
Musculoskeletal and systemic disorders | Rare Arthralgia, arthritis, myalgia, musculoskeletal pain, muscle weakness, muscle spasms, contracture Muscular bursitis Rare Rhabdomyoly se *, joint stiffness, musculoskeletal stiffness |
Kidney disorders and pathways urinary | Rare Renal insufficiency, renal lithiasis, hematuria, pollakiuria, proteinuria Rare Tubulointerstitial nephritis *, urgent urination |
Disorders of the reproductive system and breasts | Rare Erectile dysfunction |
General disorders and abnormalities at the administration site | Frequent Edema Rare Fatigue, chest pain, discomfort in the chest Rare Thirst |
Changes in biological parameters | Rare Increase in amylase, decreased platelet count, decreased white blood cell count, decreased lymphocyte count, increased serum creatinine, reduced hemoglobin, increased uremia, increased triglyceride levels, increased cholesterolemia, decreased hematocrit, increased lactate dehydrogenase in the blood, increased serum potassium Rare Increased blood glucose, increased activated partial thromboplastin time, reduced red blood cells, increased alkaline phosphatase in the blood |
* treatment-related adverse effects from post-market data
** The combined results of phase 3 studies have shown non-infectious diarrhea and liver function abnormalities more frequent in patients treated concomitantly with colchicine.
*** See Pharmacodynamic properties for the incidence of gout attacks in randomized, controlled phase III studies.
Description of specific adverse events
Rare severe hypersensitivity reactions to febuxostat, including Stevens-Johnson syndrome, toxic epidermal necrolysis (Lyell syndrome), and anaphylactic reaction / shock have been observed post-marketing. Stevens-Johnson syndrome and toxic epidermal necrolysis are characterized by a progressive skin rash, accompanied by bubbles or mucosal lesions and eye irritation. Hypersensitivity reactions to febuxostat may be associated with the following symptoms: skin reactions characterized by an infiltrated maculopapular rash, generalized or exfoliative rash, but also cutaneous lesions, facial edema, fever, abnormalities of the skin. blood tests such as thrombocytopenia and eosinophilia, and involvement of a single organ or multiple organ (liver and kidneys including tubulointerstitial nephritis) (see Warnings and Precautions for Use section ).
The gout attacks were frequently observed shortly after the start of treatment and during the first few months. Subsequently, the frequency of gout attacks decreases over time. Prophylaxis of gout flares is recommended (see sections Posology and method of administration and Warnings and precautions for use ).
Reporting of suspected adverse reactions
The reporting of suspected adverse reactions after authorization of the drug is important. It allows continuous monitoring of the benefit / risk ratio of the drug. Health professionals report any suspected adverse reactions via the national reporting system - see Annex V.
