Lokelma Adverse Reactions

Clinical trials: The safety profile of Lokelma was evaluated in clinical trials involving 1760 patients with 507 patients exposed for one year.
The most commonly reported adverse reaction was oedema related events which were reported by 5.7% LOKELMA patients; 1.7, 2.7, 5.2, and 14.3% of patients randomised to placebo, LOKELMA 5 g, 10 g, or 15 g once daily up to one month, respectively. Fifty-three percent were managed with initiating a diuretic or adjusting a diuretic dose; the remainder did not require treatment. In longer-term uncontrolled trials in which most patients were maintained on doses <15 g once daily, adverse reactions of oedema (oedema, generalized oedema and peripheral oedema) were reported in 8% to 11% of patients.
In clinical trials, 4.1% of LOKELMA patients developed hypokalaemia with a serum potassium value less than 3.5 mmol/L, which was resolved with dose adjustment or discontinuation of LOKELMA.
In 2 clinical trials with open label exposure of LOKELMA up to 1 year in 874 subjects, the following events were reported as related by investigators: gastrointestinal events [constipation (2.9%), diarrhea (0.9%), abdominal pain/distension (0.5%), nausea (1.6%) and vomiting (0.5%)]; and hypersensitivity reactions [rash (0.3%) and pruritus (0.1%)]. These events were mild to moderate in nature, none were reported as serious and were generally resolved while the patient continued treatment. Due to the open label study design, a causal relationship between these events and Lokelma cannot be definitively established.
Tabulated list of adverse reactions: The following convention was used for frequency of adverse drug reactions: 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). (See Table 3.)

Click on icon to see table/diagram/image