Section 4.2 (Posology and method of administration) - No dose adjustment of temsirolimus is recommended for patients with advanced renal cell carcinoma and mild to moderate hepatic impairment.  For patients with RCC and severe hepatic impairment, the recommended dose is 10mg IV once a week (baseline platelets >100).  See also Section 4.4 (Special warnings and precautions for use).

Section 4.8 (Undesirable effects) - common: venous thromboembolism (including DVT, pulmonary embolus including fatal outcomes, thrombosis).

Section 5.2 (Pharmacokinetic properties) - Temsirolimus and sirolimus pharmacokinetics have been investigated in an open-label, dose-escalation study in 112 patients with advanced malignancies and either normal or impaired hepatic function. See SPC for full details.