7.2 Digoxin
In 19 healthy subjects receiving 2.4 grams of sevelamer hydrochloride three times a day with meals for 2 days, sevelamer did not alter the pharmacokinetics of a single dose of digoxin.

In 18 healthy subjects receiving 9.6 grams of sevelamer carbonate once daily, sevelamer did not alter the pharmacokinetics of a single dose of digoxin.

7.3 Warfarin
In 14 healthy subjects receiving 2.4 g of sevelamer hydrochloride three times a day with meals, sevelamer did not alter the pharmacokinetics of a single dose of warfarin.

In 14 healthy subjects receiving 9.6 grams of sevelamer carbonate once daily with meal, sevelamer did not alter the pharmacokinetics of a single dose of warfarin.

7.4 Enalapril
In 28 healthy subjects a single 2.4 gram dose of sevelamer hydrochloride did not alter the pharmacokinetics of a single dose of enalapril.

7.5 Metoprolol
In 31 healthy subjects a single 2.4 gram dose of sevelamer hydrochloride did not alter the pharmacokinetics of a single dose of metoprolol.

7.6 Iron
In 23 healthy subjects, a single 2.8 gram dose of sevelamer hydrochloride did not alter the absorption of a single oral dose of iron as 200 mg exsiccated ferrous sulfate tablet.

7.7 Other Concomitant Drug Therapy
There are no empirical data on avoiding drug interactions between Renvela and most concomitant drugs. During postmarketing experience, very rare cases of increased thyroid stimulating hormone (TSH) levels have been reported in patients co-administered sevelamer hydrochloride and levothyroxine. Monitor TSH levels and signs of hypothyroidism in patients receiving both medications.

When administering an oral medication where a reduction in the bioavailability of that medication would have a clinically significant effect on its safety or efficacy, there is no information that suggests a dosing regimen that would be universally appropriate for all drugs. One may, however, administer the drug one hour before or three hours after Renvela, and when important, monitor blood levels of the drug. Patients taking anti-arrhythmic medications for the control of arrhythmias and anti-seizure medications for the control of seizure disorders were excluded from the clinical trials.

8 USE IN SPECIFIC POPULATIONS
8.1 Pregnancy
Pregnancy Category C: There are no adequate and well-controlled studies in pregnant women. Sevelamer products should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

The effect of sevelamer hydrochloride on the absorption of vitamins and other nutrients has not been studied in pregnant women. Requirements for vitamins and other nutrients are increased in pregnancy. In pregnant rats given doses of sevelamer hydrochloride during organogenesis, reduced or irregular ossification of fetal bones, probably due to a reduced absorption of fat-soluble vitamin D, occurred at a dose approximately equal to the maximum clinical trial dose of 13 g on a body surface area basis. In pregnant rabbits given oral doses of sevelamer hydrochloride by gavage during organogenesis, an increase of early resorptions occurred at dose approximately twice the maximum clinical trial dose on a body surface area basis [see Nonclinical Toxicology (13.2) ] .

8.2 Labor and Delivery
No sevelamer hydrochloride treatment-related effects on labor and delivery were seen in animal studies [see Noncl