Medicinal Products

ADENURIC 120 mg

Generic drug of the therapeutic class: Rheumatology
active ingredients: Febuxostat
laboratory: Menarini France

Coated tablet
box of 2 blister packs of 14
All forms

Indication

ADENURIC is indicated for the 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 for the prevention and treatment of hyperuricemia in adult patients treated with chemotherapy for hematological malignancies and at intermediate risk or at high risk for Tumor Lysis Syndrome (TLS).

ADENURIC is indicated in adults.

Dosage ADENURIC 120 mg film-coated tablet box of 2 blister packs of 14

ADENURIC is indicated for the 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 for the prevention and treatment of hyperuricemia in adult patients treated with chemotherapy for hematological malignancies and at intermediate risk or at high risk for Tumor Lysis Syndrome (TLS).

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 in gout patients were droplet attacks, abnormal liver function, diarrhea, nausea, headache, 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

Frequent (≥ 1/100 to <1/10), infrequent (≥ 1/1000 to <1/100), and rare (≥ 1/10 000 to <1/1000) adverse reactions in treated patients by febuxostat are mentioned below. Frequencies are based on studies and after marketing in patients with gout.

In each frequency group, the adverse effects are presented in order of decreasing severity.

Table 1: Adverse effects in phase 3 studies, long-term and post-marketing extension studies in patients with gout.

Hematologic disorders and lymphatic system

Rare

Pancytopenia, thrombocytopenia

System conditions

immune

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 hearing disorders

labyrinth

Rare

tinnitus

Heart conditions

Rare

Atrial fibrillation, palpitations, ECG abnormalities, left branch block (see section Tumor Lysis Syndrome), sinus tachycardia (see section Tumor Lysis Syndrome)

Vascular disorders

Rare

Hypertension, flushing, flushing, bleeding (see section Tumor Lysis Syndrome)

Respiratory disorders

Rare

Dyspnoea, bronchitis, upper respiratory infections, cough

Gastrointestinal disorders

Frequent

Diarrhea **, nausea

Rare

Abdominal pain, abdominal distension, gastroesophageal 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

cholelithiasis

Rare

Hepatitis, jaundice *, liver injury *

Skin and subcutaneous tissue disorders

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) *, syndrome

Stevens-Johnson *, angiodem *, drug hypersensitivity syndrome with eosinophilia and systemic symptoms (DRESS syndrome) *, generalized rash (severe) *, erythema, exfoliative eruption, follicular rash, vesicular rash,

pustular rash, itchy rash *, rash

erythematous, morbilliform rash, alopecia, hyperhydrosis

Musculoskeletal and systemic disorders

Rare

Arthralgia, arthritis, myalgia, musculoskeletal pain, muscle weakness, muscle spasms, contracture

Muscular bursitis

Rare

Rhabdomyolysis *, joint stiffness, muscular stiffness

skeletal

Renal and urinary disorders

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, decrease in platelet count, decrease in white blood cells, decrease

number of lymphocytes, increased serum creatinine, decreased hemoglobin, increased uremia, increased triglyceride, increased cholesterol, decreased hematocrit, increased lactate dehydrogenase in the blood, increased kalemia

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-marketing data.

* The combined results of phase 3 studies have shown non-infectious diarrhea and more frequent liver function abnormalities in patients treated concomitantly with colchicine.

*** See Pharmacodynamic properties for the incidence of gout attacks in randomized, controlled phase 3 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 ).

Tumor Lysis Syndrome

Tolerance Profile Summary

In the pivotal FLORENCE (FLO-01) phase 3, randomized, double-blind study, comparing febuxostat to allopurinol (346 patients undergoing chemotherapy for hematologic malignancies and at intermediate risk or at high risk of TLS), only 22 (6.4%) of all patients experienced adverse events, ie 11 (6.4%) patients in each treatment group. The majority of adverse events were mild or moderate.

In total, the FLORENCE study does not show any particular problem of tolerance in addition to that already known with ADENURIC in the treatment of gout, with the exception of the following three adverse effects (listed above in Table 1). ).

Heart conditions:

Uncommon: left branch block, sinus tachycardia.

Vascular disorders:

Uncommon: haemorrhage.

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.

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