Adverse reactions : תופעות לוואי

4.8.       Undesirable effects

The tolerability of Mycobutin in multiple drug regimens, was assessed in both immunocompetent and immunocompromised patients, suffering from tuberculosis and non-tuberculous mycobacteriosis in long term studies with daily dosages up to 600 mg.
Bearing in mind that Mycobutin was often given in these studies as part of a multidrug regimen it is not always possible to define with certainty a drug-event relationship. Treatment discontinuation was necessary only in a very few cases. Adverse reactions identified through clinical trials or post-marketing surveillance by system organ class (SOC) are listed below in the following frequencies,
 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 and ‘not known’.

MedDRA
Frequency       Undesirable Effects
System Organ Class
Blood and lymphatic       Very            Leukopenia system disorders          common
Common          Anaemia
Uncommon        Pancytopenia
Agranulocytosis
Lymphopenia
Granulocytopenia
Neutropenia
White blood cell count decreased
Neutrophil count decreased
Thrombocytopenia
Platelet count decreased
Common          Rash
       Immune system             Uncommon         Hypersensitivity disorders                                  Bronchospasm
Eosinophilia
Eye disorders             Uncommon         Uveitis
Corneal deposits
Gastrointestinal          Common           Nausea disorders                 Uncommon         Vomiting

Hepatobiliary             Uncommon         Jaundice disorders                                  Hepatic enzyme increased
Skin and                  Uncommon         Skin discolouration subcutaneous tissue disorders
Musculoskeletal and       Common           Myalgia connective tissue         Uncommon         Arthralgia disorders
General disorders and     Common           Pyrexia administration site conditions
Clostridium difficile colitis is a mandated adverse reaction for the pharmacological class; this event was neither observed in the clinical trials nor in the spontaneous reporting for rifabutin.

Anaphylactic shock has occurred with other antibiotics of the same class.

Mild to severe, reversible uveitis has been reported less frequently when Mycobutin is used at 300 mg as monotherapy in MAC prophylaxis, versus Mycobutin in combination with clarithromycin (or other macrolides) for MAC treatment (see section 4.4).
Flu-like syndrome, chest pressure or pain with dyspnoea and rarely hepatitis and haemolysis has been reported.

Anti-tuberculosis drug SCARs.
Anti-tuberculosis drug use may lead to the occurrence of drug reaction with eosinophilia and systemic symptoms (DRESS) as well as other SCARs such as SJS, TEN, and AGEP (see section 4.4).


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