Deltyba Adverse Reactions

Summary of the safety profile: The most frequently observed adverse drug reactions in patients treated with delamanid + Optimised Background Regimen (OBR) (i.e. incidence >10%) are nausea (32.9%), vomiting (29.9%), headache (28.4%), sleep disorders and disturbances (28.2%), dizziness (22.4%), gastritis (15.9%) and decreased appetite (13.1%).
Tabulated list of adverse reactions: The list of adverse drug reactions and frequencies are based on the results from 2 double-blind placebo controlled clinical trials and on spontaneous reports. The adverse drug reactions are listed by MedDRA System Organ Class and Preferred Term. Within each System Organ Class, adverse reactions are listed under frequency categories of 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 (cannot be estimated from the available data). Within each frequency grouping, adverse reactions are presented in order of decreasing seriousness. (See table.)

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Description of selected adverse reactions: ECG QT interval prolongation: In patients receiving 200 mg delamanid total daily dose in the phase 2 and 3 trials, the mean placebo corrected increase in QTcF from baseline ranged from 4.7 - 7.6 ms at 1 month and 5.3 ms - 12.1 ms at 2 months, respectively. The incidence of a QTcF interval >500 ms ranged from 0.6% (1/161) - 2.1% (7/341) in patients receiving delamanid 200 mg total daily dose versus 0% (0/160) - 1.2% (2/170) of patients receiving placebo + OBR, while the incidence of QTcF change from baseline >60ms ranged from 3.1% (5/161) - 10.3% (35/341) in patients receiving delamanid 200 mg total daily dose versus 0% (0/160) - 7.1% (12/170) in patients receiving placebo.
Palpitations: For patients receiving delamanid + OBR in the phase 2 and 3 trials, the frequency was 7.9% (frequency category common) in comparison to a frequency of 6.7% in patients receiving placebo + OBR.
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. If the patient experience any adverse reactions after taking the drug, he or she should report the events to healthcare professional immediately for appropriate follow up.