Sevelamer Carbonate

V03A - All other therapeutic products ATC V03AE02 Small molecule approved 2007 Oral

JFDA label: Renvela 800mg F.C Tab

Mechanism of Action

— Unknown

Indications

Approved

Control of serum phosphorous

Contraindications

Source: Lexicomp

Additional contraindications (not in US labeling): Hypophosphatemia Absolute
Hypersensitivity to sevelamer or any component of the formulation Absolute
bowel obstruction Absolute

Adverse Reactions

Very Common >10%Common 1–10%Uncommon 0.1–1% Rare 0.01–0.1%Very Rare <0.01%Not Known

Metabolism and nutrition disorders (2)

Very Common Metabolic acidosis; adults: Frequency not defined)

Common Hypercalcemia

Gastrointestinal disorders (8)

Very Common diarrhea · dyspepsia · nausea · Vomiting

Common Abdominal pain · constipation · flatulence · peritonitis

Dosing

Source: Lexicomp

Note: The dosing of sevelamer carbonate and sevelamer hydrochloride are similar; when switching from one product to another, the same dose (on a mg per mg basis) should be utilized. Control of serum phosphorous: Oral: Patients not taking a phosphate binder: Initial: 800 to 1,600 mg 3 times daily with meals; the initial dose may be based on serum phosphorous levels: >5.5 mg/dL to ≥7.5 mg/dL to ≥9 mg/dL: 1,600 mg 3 times daily Maintenance dose adjustment based on serum phosphorous concentration (goal range of 3.5 to 5.5 mg/dL; maximum dose studied was equivalent to 13 g/day [sevelamer hydrochloride] or 14 g/day [sevelamer carbonate]): >5.5 mg/dL: Increase by 400 to 800 mg per meal at 2-week intervals 3.5 to 5.5 mg/dL: Maintain current dose Dosage adjustment when switching between phosphate-binder products: 667 mg of calcium acetate is equivalent to ~800 mg sevelamer (carbonate or hydrochloride) Conversion based on dose per meal: Calcium acetate 667 mg: Convert to 800 mg Renagel/Renvela Calcium acetate 1,334 mg: Convert to 1,600 mg as Renagel/Renvela (800 mg tablets x 2) or 1,200 mg as Renagel (400 mg tablets x 3) Calcium acetate 2,001 mg: Convert to 2,400 mg as Renagel/Renvela (800 mg tablets x 3) or 2,000 mg as Renagel (400 mg tablets x 5)

(For additional information see "Sevelamer: Pediatric drug information") Control of serum phosphorous: Sevelamer carbonate (Renvela): Children ≥6 years and Adolescents: Oral: Patients not taking a phosphate binder: Initial: 800 to 1,600 mg 3 times daily with meals; dose based on body surface area: BSA ≥0.75 to 2: 800 mg per meal; titrate as needed by 400 mg per dose at 2 week intervals. BSA ≥1.2 m2: 1,600 mg per meal; titrate as needed by 800 mg per dose at 2 week intervals.

Refer to adult dosing.

There are no dosage adjustments provided in the manufacturer's labeling (has not been studied).

There are no dosage adjustments provided in the manufacturer's labeling.

Warnings & Precautions

Source: Lexicomp

Gastrointestinal effects

Bowel obstruction and perforation have been reported. Dysphagia and esophageal tablet retention have also been reported with the tablet formulation; consider change to suspension formulation in patients with a history of swallowing disorders Disease-related concerns:

Gastrointestinal disease

Use with caution in patients with gastrointestinal disorders including dysphagia, swallowing disorders, severe gastrointestinal motility disorders (including severe constipation), or major gastrointestinal surgery. Concurrent drug therapy issues:

Drug-drug interactions

Potentially significant interactions may exist, requiring dose or frequency adjustment, additional monitoring, and/or selection of alternative therapy. Consult drug interactions for more detailed information

Vitamins

May cause reductions in vitamin D, E, K, or folic acid absorption. Dosage form specific issues:

Tablets

Should not be taken apart or chewed; broken or crushed tablets will rapidly expand in water/saliva and may be a choking hazard.

Pregnancy & Lactation

Pregnancy

FDA category C

Adverse events have been observed in animal reproduction studies. Sevelamer is not absorbed systemically; however, it may cause a reduction in the absorption of fat soluble vitamins and folic acid.

Lactation

Sevelamer is not absorbed systemically; however, it may cause a reduction in the absorption of fat soluble vitamins and folic acid.

Monitoring

Clinical pearl	Serum chemistries, including bicarbonate and chloride Serum calcium and phosphorus: Frequency of measurement may be dependent upon the presence and magnitude of abnormalities, the rate of progression of CKD, and the use of treatments for CKD-mineral and bone disorders (KDIGO, 2009): CKD stage 3: Every 6-12 months CKD stage 4: Every 3-6 months CKD stage 5 and 5D: Every 1-3 months Periodic 24-hour urinary calcium and phosphorus; magnesium; alkaline phosphatase every 12 months or more frequently in the presence of elevated PTH; creatinine, BUN, albumin; intact parathyroid hormone (iPTH) every 3-12 months depending on CKD severity

Clinical pearl

Serum chemistries, including bicarbonate and chloride Serum calcium and phosphorus: Frequency of measurement may be dependent upon the presence and magnitude of abnormalities, the rate of progression of CKD, and the use of treatments for CKD-mineral and bone disorders (KDIGO, 2009): CKD stage 3: Every 6-12 months CKD stage 4: Every 3-6 months CKD stage 5 and 5D: Every 1-3 months Periodic 24-hour urinary calcium and phosphorus; magnesium; alkaline phosphatase every 12 months or more frequently in the presence of elevated PTH; creatinine, BUN, albumin; intact parathyroid hormone (iPTH) every 3-12 months depending on CKD severity

Biology & Pharmacokinetics

Pharmacokinetics

Drug–drug interactions (34, DDInter)

Interacting drug	Severity	Management
Erdafitinib	major
Calcifediol	moderate
Calcitriol	moderate
Cholecalciferol	moderate
Cinoxacin	moderate
Ciprofloxacin	moderate
Cyclosporine	moderate
Delafloxacin	moderate
Dihydrotachysterol	moderate
Doxercalciferol	moderate
Enoxacin	moderate
Ergocalciferol	moderate
Gatifloxacin	moderate
Gemifloxacin	moderate
Grepafloxacin	moderate
Levofloxacin	moderate
Levothyroxine	moderate
Liothyronine	moderate
Liotrix	moderate
Lomefloxacin	moderate
Moxifloxacin	moderate
Mycophenolate mofetil	moderate
Mycophenolic acid	moderate
Nalidixic acid	moderate
Norfloxacin	moderate
Ofloxacin	moderate
Paricalcitol	moderate
Phylloquinone	moderate
Sparfloxacin	moderate
Tacrolimus	moderate
Thyroid, porcine	moderate
Trovafloxacin	moderate
Vitamin A	moderate
Vitamin E	moderate

Registered Products (1)

Brand	Form / strength	Pack	Agent	Citizen (JOD)
Renvela 800mg F.C Tab	Film-Coated Tablet 800 mg	180 tab	Ulfa Pharma Co.	71.680