Wirkstoffe & Arzneimittelsicherheit

Nebenwirkungen · Steglatro

Steglatro 5 mg film-coated tablets Steglatro 15 mg film-coated tablets · Abschnitt 4.8 · PDF-Seite 9

HOS-137650 · Präparat HOS-098083

Uncommon Dysuria, Blood creatinine increased/Glomerular filtration rate decreased† Reproductive system and breast disorders Common Vulvovaginal pruritus General disorders and administration site conditions Common Thirst§ Investigations Common Serum lipids changed¶, Haemoglobin increased**, BUN increased¶¶ * See section 4.4. † See subsections below for additional information. ‡ Includes: pollakiuria, micturition urgency, polyuria, urine output increased, and nocturia. § Includes: thirst and polydipsia. ¶ Mean percent changes from baseline for ertugliflozin 5 mg and 15 mg versus placebo, respectively, were low-density lipoprotein cholesterol (LDL-C) 5.8% and 8.4% versus 3.2%; total cholesterol 2.8% and 5.7% versus 1.1%; however, high-density lipoprotein cholesterol (HDL-C) 6.2% and 7.6% versus 1.9%. Median percent changes from baseline for ertugliflozin 5 mg and 15 mg versus placebo, respectively, were triglycerides -3.9% and -1.7% versus 4.5%. ** The proportion of subjects having at least 1 increase in haemoglobin > 2.0 g/dL was higher in the ertugliflozin 5 mg and 15 mg groups (4.7% and 4.1%, respectively) compared to the placebo group (0.6%). ¶¶ The proportion of subjects having any occurrence of blood urea nitrogen (BUN) values ≥ 50% increase and value >upper limit of normal (ULN) was numerically higher in the ertugliflozin 5 mg group and higher in the 15 mg group (7.9% and 9.8%, respectively) relative to the placebo group (5.1%). a Adverse reactions were identified through post-marketing surveillance.

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