In view of the potential impact of bisphosphonates, including Zometa, on renal function, the lack of clinical safety data in patients with severe renal impairment (in clinical trials defined as serum creatinine ≥ 400 µmol/ l or ≥ 4.5 mg/ dl for patients with TIH and ≥ 265 µmol/ l or ≥ 3.0 mg/ dl for patients with cancer and bone metastases, respectively) at baseline and only limited pharmacokinetic data in patients with severe renal impairment at baseline (creatinine clearance < 30 ml/ min), the use of Zometa is not recommended in patients with severe renal impairment.