Renvela

Renvela
^®(sevelamer carbonate) is indicated for the control of serum phosphorus in adults and children 6 years of age and older with chronic kidney disease (CKD) on dialysis.

• Starting dose of Renvela is 0.8 or 1.6 grams administered orally three times per day with meals based on serum phosphorus levels for adult patients and based on body surface area (BSA) category for pediatric patients. (
  
  
  2.1 General Dosing Information

  Starting Dose for Adult Patients Not Taking a Phosphate Binder.

  The recommended starting dose of Renvela is 0.8 to 1.6 g taken orally with meals based on serum phosphorus level. Table 1 provides recommended starting doses of Renvela for adult patients not taking a phosphate binder.

  Table 1: Starting Dose for Adult Dialysis Patients Not Taking a Phosphate Binder

  Serum Phosphorus	Renvela
  >5.5 and <7.5 mg/dL	0.8 g three times daily with meals
  ≥7.5 mg/dL	1.6 g three times daily with meals

  Dose Titration for Adult Patients Taking Renvela

  . Titrate the Renvela dose by 0.8 g three times per day with meals at two-week intervals as necessary to achieve target serum phosphorus levels. Based on clinical studies, the average prescribed adult daily dose of sevelamer carbonate is approximately 7.2 g per day. The highest daily adult dose of sevelamer carbonate studied was 14 grams in CKD patients on dialysis.

  Starting Dose for Pediatric Patients Not Taking a Phosphate Binder.

  The recommended starting dose for pediatric patients 6 years of age and older is 0.8 to 1.6 g taken three times per day with meals based on the patient's body surface area (BSA) category; see Table 2.

  Table 2: Recommended Starting Dosage and Titration Increment Based on Pediatric Patient's Body Surface Area (m²)

  BSA (m2)	Starting Dose Per Meal/Snack	Titration Increases/Decreases Per Dose
  ≥0.75 to <1.2	0.8 g	Titrate by 0.4 g
  ≥1.2	1.6 g	Titrate by 0.8 g

  Dose Titration for Pediatric Patients Taking Renvela.

  Titrate the Renvela dose as needed to achieve target levels at two-week intervals based on BSA category, as shown in Table 2.

  Switching from Sevelamer Hydrochloride Tablets.

  For adult patients switching from sevelamer hydrochloride tablets to sevelamer carbonate tablets or powder, use the same dose in grams.

  Switching between Sevelamer Carbonate Tablets and Powder.

  Use the same dose in grams.

  Switching from Calcium Acetate

  . Table 3 gives recommended starting doses of Renvela based on a patient's current calcium acetate dose.

  Table 3: Starting Dose for Dialysis Patients Switching from Calcium Acetate to Renvela

  Calcium Acetate 667 mg (Tablets per meal)	Renvela
  1 tablet	0.8 g
  2 tablets	1.6 g
  3 tablets	2.4 g
  )
  
• Titrate by 0.8 g per meal in two-week intervals for adult patients as needed to obtain serum phosphorus target. (
  
  
  2.1 General Dosing Information

  Starting Dose for Adult Patients Not Taking a Phosphate Binder.

  The recommended starting dose of Renvela is 0.8 to 1.6 g taken orally with meals based on serum phosphorus level. Table 1 provides recommended starting doses of Renvela for adult patients not taking a phosphate binder.

  Table 1: Starting Dose for Adult Dialysis Patients Not Taking a Phosphate Binder

  Serum Phosphorus	Renvela
  >5.5 and <7.5 mg/dL	0.8 g three times daily with meals
  ≥7.5 mg/dL	1.6 g three times daily with meals

  Dose Titration for Adult Patients Taking Renvela

  . Titrate the Renvela dose by 0.8 g three times per day with meals at two-week intervals as necessary to achieve target serum phosphorus levels. Based on clinical studies, the average prescribed adult daily dose of sevelamer carbonate is approximately 7.2 g per day. The highest daily adult dose of sevelamer carbonate studied was 14 grams in CKD patients on dialysis.

  Starting Dose for Pediatric Patients Not Taking a Phosphate Binder.

  The recommended starting dose for pediatric patients 6 years of age and older is 0.8 to 1.6 g taken three times per day with meals based on the patient's body surface area (BSA) category; see Table 2.

  Table 2: Recommended Starting Dosage and Titration Increment Based on Pediatric Patient's Body Surface Area (m²)

  BSA (m2)	Starting Dose Per Meal/Snack	Titration Increases/Decreases Per Dose
  ≥0.75 to <1.2	0.8 g	Titrate by 0.4 g
  ≥1.2	1.6 g	Titrate by 0.8 g

  Dose Titration for Pediatric Patients Taking Renvela.

  Titrate the Renvela dose as needed to achieve target levels at two-week intervals based on BSA category, as shown in Table 2.

  Switching from Sevelamer Hydrochloride Tablets.

  For adult patients switching from sevelamer hydrochloride tablets to sevelamer carbonate tablets or powder, use the same dose in grams.

  Switching between Sevelamer Carbonate Tablets and Powder.

  Use the same dose in grams.

  Switching from Calcium Acetate

  . Table 3 gives recommended starting doses of Renvela based on a patient's current calcium acetate dose.

  Table 3: Starting Dose for Dialysis Patients Switching from Calcium Acetate to Renvela

  Calcium Acetate 667 mg (Tablets per meal)	Renvela
  1 tablet	0.8 g
  2 tablets	1.6 g
  3 tablets	2.4 g
  )
  
• Titrate based on BSA category for pediatric patients in two-week intervals for 6 weeks and then every 4 weeks as needed to obtain serum phosphorus target. (
  
  
  2.1 General Dosing Information

  Starting Dose for Adult Patients Not Taking a Phosphate Binder.

  The recommended starting dose of Renvela is 0.8 to 1.6 g taken orally with meals based on serum phosphorus level. Table 1 provides recommended starting doses of Renvela for adult patients not taking a phosphate binder.

  Table 1: Starting Dose for Adult Dialysis Patients Not Taking a Phosphate Binder

  Serum Phosphorus	Renvela
  >5.5 and <7.5 mg/dL	0.8 g three times daily with meals
  ≥7.5 mg/dL	1.6 g three times daily with meals

  Dose Titration for Adult Patients Taking Renvela

  . Titrate the Renvela dose by 0.8 g three times per day with meals at two-week intervals as necessary to achieve target serum phosphorus levels. Based on clinical studies, the average prescribed adult daily dose of sevelamer carbonate is approximately 7.2 g per day. The highest daily adult dose of sevelamer carbonate studied was 14 grams in CKD patients on dialysis.

  Starting Dose for Pediatric Patients Not Taking a Phosphate Binder.

  The recommended starting dose for pediatric patients 6 years of age and older is 0.8 to 1.6 g taken three times per day with meals based on the patient's body surface area (BSA) category; see Table 2.

  Table 2: Recommended Starting Dosage and Titration Increment Based on Pediatric Patient's Body Surface Area (m²)

  BSA (m2)	Starting Dose Per Meal/Snack	Titration Increases/Decreases Per Dose
  ≥0.75 to <1.2	0.8 g	Titrate by 0.4 g
  ≥1.2	1.6 g	Titrate by 0.8 g

  Dose Titration for Pediatric Patients Taking Renvela.

  Titrate the Renvela dose as needed to achieve target levels at two-week intervals based on BSA category, as shown in Table 2.

  Switching from Sevelamer Hydrochloride Tablets.

  For adult patients switching from sevelamer hydrochloride tablets to sevelamer carbonate tablets or powder, use the same dose in grams.

  Switching between Sevelamer Carbonate Tablets and Powder.

  Use the same dose in grams.

  Switching from Calcium Acetate

  . Table 3 gives recommended starting doses of Renvela based on a patient's current calcium acetate dose.

  Table 3: Starting Dose for Dialysis Patients Switching from Calcium Acetate to Renvela

  Calcium Acetate 667 mg (Tablets per meal)	Renvela
  1 tablet	0.8 g
  2 tablets	1.6 g
  3 tablets	2.4 g
  )
  

Tablets: 800 mg white oval, film-coated, compressed tablets, engraved with RV800 on one side

Powder: 0.8 g and 2.4 g pale-yellow powder packaged in an opaque, foil-lined, heat-sealed packets

Sevelamer carbonate is not absorbed systemically following oral administration and maternal use is not expected to result in fetal exposure to the drug.

• Serious cases of dysphagia, bowel obstruction, bleeding gastrointestinal ulcers, colitis, ulceration, necrosis, and perforation have been associated with sevelamer use, some requiring hospitalization and surgery. (
  
  
  5.1 Gastrointestinal Adverse Events

  Patients with dysphagia, swallowing disorders, severe gastrointestinal (GI) motility disorders, including severe constipation, or major GI tract surgery were not included in the Renvela clinical studies.

  Cases of dysphagia and esophageal tablet retention have been reported in association with use of the tablet formulation of sevelamer, some requiring hospitalization and intervention. Consider using sevelamer suspension in patients with a history of swallowing disorders.

  Cases of bowel obstruction, bleeding gastrointestinal ulcers, colitis, ulceration, necrosis, and perforation have also been reported with sevelamer use

  [see Adverse Reactions (6.2)]

  . Inflammatory disorders may resolve upon Renvela discontinuation. Treatment with Renvela should be re-evaluated in patients who develop severe gastrointestinal symptoms.
  )