Dosing & Uses
Dosage Forms & Strengths
tablet
- 400mg (Renagel)
- 800mg (Renagel, Renvela)
powder packet for oral suspension
- 800mg (Renvela)
- 2400mg (Renvela)
Serum Phosphorus Regulation
Indicated for the control of serum phosphorus in patients with chronic kidney disease (CKD) who are on dialysis
Initial dose
Not taking phosphate binder
- Serum PO4 >9 mg/dL [2.91 mmol/L]: 1600 mg PO q8hr with meals
- Serum PO4 7.5-9 mg/dL [2.42-2.91 mmol/L]: 1200-1600 mg PO q8hr with meals
- Serum PO4 5.5-7.5 mg/dL [1.78-2.42 mmol/L]: 800 mg PO q8hr with meals
Switching from calcium acetate
- Substitute 800 mg Renagel or Renvela for 667 mg of Ca-acetate
- Substitute 1600 Renvela or Renagel for 1334 mg of Ca-acetate
- Substitute 2400 mg Renvela or Renagel for 2001 mg Ca-acetate
Maintenance dose
- Target goal is serum phosphorus ≤5.5 mg/dL
- Serum PO4 >5.5 mg/dL [>1.78 mmol/L]: Increase dose by 400-800 mg per meal
- Serum PO4 3.5-5.5 mg/dL [1.13-1.78 mmol/L]: Maintain current dose
- Serum PO4 <3.5 mg/dL [1.13 mmol/L] decrease by 400-800 mg per meal
Dose titration
- Titrate dose; increase by 400-800 mg per meal at 2-week intervals as necessary to achieve target serum phosphorus levels
- Based on clinical studies, the average prescribed adult daily dose is ~7.2 g/day
- Highest daily adult dose studied was 14 grams in CKD patients on dialysis
Dosing Considerations
Renagel = Renvela on a per gram basis
Dosage Forms & Strengths
tablet
- 800mg (Renvela)
powder packet for oral suspension
- 800mg (Renvela)
- 2400mg (Renvela)
Serum Phosphorus Regulation
Indicated for the control of serum phosphorus in with chronic kidney disease (CKD) who are on dialysis in children aged ≥6 yr
<6 years: Safety and efficacy not established
See Administration for oral suspension preparation instructions
Initial dose (not taking phosphate binder)
- BSA ≥0.75 to <1.2 m²: 800 mg per meal/snack; titrate up or down by 400 mg-increments
- BSA ≥1.2 m²: 1600 mg per meal/snack; titrate up or down by 800 mg-increments
Interactions
Interaction Checker
No Results
Contraindicated
Serious - Use Alternative
Significant - Monitor Closely
Minor
Adverse Effects
>10%
Vomiting (22%)
Nausea (20%)
Diarrhea (19%)
Dyspepsia (16%)
Nasopharyngitis (14%)
Limb pain (13%)
Pruritus (13%)
Arthralgia (12%)
Bronchitis (11%)
Dyspnea (10%)
Hypertension (10%)
1-10%
Abdominal pain (9%)
Constipation (8%)
Flatulence (8%)
Peritonitis (during peritoneal dialysis: 8%)
Hypercalcemia (5-7%)
Frequency Not Defined
Back pain
Cough
Headache
Pyrexia
Upper respiratory infection
Pruritus
Rash
Intestinal perforation
Fecal impaction
Intestinal obstruction
Postmarketing Reports
Hypersensitivity
Bleeding gastrointestinal ulcers, colitis, ulceration, necrosis
Warnings
Contraindications
Hypersensitivity
Bowel obstruction
Cautions
Caution in dysphagia, GI motility disorders, GI surgery
Cases of bowel obstruction, bleeding gastrointestinal ulcers, colitis, ulceration, necrosis, and perforation reported; inflammatory disorders may resolve upon discontinuation; reevaluate treatment in patients who develop severe gastrointestinal symptoms
Tablets should not be crushed, broken, or chewed (tablets rapidly expand and become a choking hazard)
Dysphagia and esophageal tablet retention reported, in some cases requiring hospitalization and intervention; consider sevelamer oral suspension in patients with history of swallowing disorders
May decrease GI absorption of antiarrhythmic, fat soluble vitamins, folic acid, and antiseizure medications; take medications 1 hour before or 3 hours after sevelamer dose
Monitor serum bicarbonate and chloride levels
Monitor fat soluble vitamin and folic acid levels, especially in pregnancy
Safety/efficacy with dialysis not studied
Pregnancy & Lactation
Pregnancy
Not absorbed systemically following oral administration and maternal use not expected to result in fetal exposure to the drug
May decrease serum levels of fat soluble vitamins and folic acid in pregnant women; consider supplementation
Lactation
Not absorbed systemically by mother following oral administration; breastfeeding is not expected to result in exposure of child to drug
May decrease serum levels of fat soluble vitamins and folic acid in pregnant women; consider supplementation
Pregnancy Categories
A: Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.
B: May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk. C: Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done. D: Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk. X: Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist. NA: Information not available.Pharmacology
Mechanism of Action
Polymeric phosphate binder; decreases serum phosphate concentrations without changing calcium, aluminum, or bicarbonate concentrations
Absorption
No intestinal absorption
Elimination
Excretion: Feces
Administration
Oral Suspension Preparation
Minimum amount of water for suspension
- 400 mg (ie, one-half 800 mg packet): 30 mL
- 800 mg: 30 mL
- 2400 mg: 60 mL
Instruct patients to stir the mixture vigorously (it does not dissolve), resuspend, if necessary, right before administration, and drink the entire preparation within 30 minutes
As an alternative to water, the entire contents of the sachet may be premixed with a small amount of food or beverage and consumed immediately (within 30 minutes) as part of the meal
Do not heat powder for oral suspension (eg, microwave) or add to heated foods or liquids
Images
Patient Handout
Formulary
Adding plans allows you to compare formulary status to other drugs in the same class.
To view formulary information first create a list of plans. Your list will be saved and can be edited at any time.
Adding plans allows you to:
- View the formulary and any restrictions for each plan.
- Manage and view all your plans together – even plans in different states.
- Compare formulary status to other drugs in the same class.
- Access your plan list on any device – mobile or desktop.
