sevelamer (Rx)

Brand and Other Names:Renagel, Renvela
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Dosing & Uses

AdultPediatric

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
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Interactions

Interaction Checker

and sevelamer

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            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

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            Warnings

            Contraindications

            Hypersensitivity

            Bowel obstruction

            Cautions

            Caution in dysphagia, GI motility disorders, GI surgery

            Bowel obstruction and perforation reported

            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 fat soluble vitamin and folic acid levels, especially in pregnancy

            Safety/efficacy with dialysis not studied

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            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.

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            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

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            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

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            Formulary

            FormularyPatient Discounts

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            The above information is provided for general informational and educational purposes only. Individual plans may vary and formulary information changes. Contact the applicable plan provider for the most current information.

            Tier Description
            1 This drug is available at the lowest co-pay. Most commonly, these are generic drugs.
            2 This drug is available at a middle level co-pay. Most commonly, these are "preferred" (on formulary) brand drugs.
            3 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs.
            4 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
            5 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
            6 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
            NC NOT COVERED – Drugs that are not covered by the plan.
            Code Definition
            PA Prior Authorization
            Drugs that require prior authorization. This restriction requires that specific clinical criteria be met prior to the approval of the prescription.
            QL Quantity Limits
            Drugs that have quantity limits associated with each prescription. This restriction typically limits the quantity of the drug that will be covered.
            ST Step Therapy
            Drugs that have step therapy associated with each prescription. This restriction typically requires that certain criteria be met prior to approval for the prescription.
            OR Other Restrictions
            Drugs that have restrictions other than prior authorization, quantity limits, and step therapy associated with each prescription.
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            Medscape prescription drug monographs are based on FDA-approved labeling information, unless otherwise noted, combined with additional data derived from primary medical literature.