Fosfamer Special Precautions

The safety and efficacy of Sevelamer Carbonate in patients with dysphagia, swallowing disorders, severe gastrointestinal motility disorders including severe constipation or major gastrointestinal tract surgery have not been established. Consequently, caution should be exercised when Sevelamer Carbonate is used in patients with these disorders.
Sevelamer Carbonate treatment should be reevaluated in patients who develop severe constipation or other severe gastrointestinal symptoms.
Uncommon case reports of difficulty swallowing the tablet have been reported. Many of these cases involved patients with contributing co-morbid conditions affecting the ability to swallow including swallowing disorders or oroesophageal abnormalities. Caution should be exercised when the tablets are used in these patients. Consider using powder for oral suspension in patients with a history of difficulty swallowing.
Patients with CKD may develop low vitamin A, D, E and K levels, depending on dietary intake and the severity of their disease. Treatment with Sevelamer in preclinical studies, approximately at the equivalent of 6-10 times the maximum clinical trial dose, has been shown to reduce the absorption of vitamins D, E and K, and folic acid. Therefore, in patients not taking supplemental vitamins but on Sevelamer, serum vitamin A, D, and E levels and vitamin K status should be assessed regularly.
Abuse and Dependence: There have been no reports of abuse or dependence of Sevelamer Carbonate or Sevelamer hydrochloride in patients. Since Sevelamer is not absorbed, the risk of abuse or dependence is low.
Driving a Vehicle or Performing Other Hazardous Tasks: No effects on ability to drive and use machines have been observed.