Not reported in available sources.

No clinically relevant differences in glycaemic efficacy were observed between men and women; reductions in HbA1c were similar across gender subgroups.

No sex- or gender-specific dose adjustments are required; the recommended adult dose for women is 25 mg alogliptin once daily, with renal dose adjustments based on kidney function rather than sex.

Dose adjustments in women are based on renal function, not sex. For mild renal impairment (CrCl >50 to ≤80 mL/min), no adjustment is needed; for moderate impairment (CrCl ≥30 to ≤50 mL/min), the dose is reduced to 12.5 mg once daily; for severe impairment (CrCl <30 mL/min) or end-stage renal disease requiring dialysis, the dose is reduced to 6.25 mg once daily.

No sex-specific differences in adverse reactions were identified in the available sources.

Across 13 studies involving 9,405 patients with type 2 diabetes mellitus, overall incidences of adverse events, serious adverse events, and discontinuations were comparable between alogliptin (25 mg and 12.5 mg), active control, and placebo; the most common adverse reaction with 25 mg alogliptin was headache. No adverse reactions were classified as very common (≥1/10). Common adverse reactions (≥1/100 to <1/10) included upper respiratory tract infections, nasopharyngitis, hypoglycaemia, headache, abdominal pain, gastroesophageal reflux disease, diarrhoea, pruritus, and rash. Important serious or clinically significant adverse reactions (frequency not known) included acute pancreatitis, hepatic dysfunction including hepatic failure, hypersensitivity reactions (including anaphylactic reactions and angioedema), exfoliative skin conditions such as Stevens‑Johnson syndrome and erythema multiforme, urticaria, bullous pemphigoid, and interstitial nephritis. Pooled analyses showed overall hypoglycaemia rates were low and similar or lower with alogliptin 25 mg compared to active control or placebo, with severe hypoglycaemia rare (0.1%).

There are no data on the use of alogliptin in pregnant women. Animal studies do not indicate harmful effects with respect to reproductive toxicity, but as a precautionary measure its use during pregnancy should be avoided. It is unknown whether alogliptin is excreted in human milk; a decision should be made to discontinue breast-feeding or discontinue therapy, considering the benefit for the child and the woman.

No human data are available on the effects of alogliptin on female fertility; animal studies showed no adverse effects on fertility.