Sevelamero

Uses

Sevelamero Hydrochloride is used for the reduction of serum phosphorus in patients with end-stage renal disease (ESRD).

Sevelamero is also used to associated treatment for these conditions: Hyperphosphataemia

How Sevelamero works

Sevelamero prevents hyperphosphatemia by binding to dietary phosphate in the gut, preventing its absorption and thus decreasing serum parathyroid hormone levels.

Dosage

Sevelamero dosage

Patients not taking a Phosphate Binder: The recommended starting dose of Sevelamero is 800 to 1600 mg, which can be administered as two to four 400 mg Sevelamero tablets, with meals based on serum phosphorus level. Renophos 400 Recommendation for the patients with hyperphosphatemia is given below-

Starting dose of Renophos for dialysis patients not taking any phosphate binder:

• Serum Phosphorus >5.5 and <7.5 mg/dL: 800 mg (2 tablets) three times daily with meals
• Serum Phosphorus ≥7.5 and <9.0 mg/dL: 1200 mg (3 tablets) three times daily with meals
• Serum Phosphorus ≥9.0 mg/dL: 1600 mg (4 tablets) three times daily with meals

Starting dose for dialysis patients switching from calcium acetate to Sevelamero:

• Calcium Acetate 667 mg (1 tablet): Sevelamero 800 mg (2 tablets)
• Calcium Acetate 1334 mg (2 tablets): Sevelamero 1200 mg (3 tablets)
• Calcium Acetate 2001 mg (3 tablets): Sevelamero 2000 mg (5 tablets)

Dose titration guideline:

• Serum Phosphorus >5.5 mg/dL: Increase 400 mg (1 tablet) per meal at 2 week intervals
• Serum Phosphorus 3.5-5.5 mg/dL: Maintain current dose
• Serum Phosphorus <3.5 mg/dL: Decrease 400 mg (1 tablet) per meal

Dose titration for all patients taking Sevelamero: Dosage should be adjusted based on the serum phosphorus concentration with a goal of lowering serum phosphorus to 5.5 mg/dl or less. The dose may be increased or decreased by one tablet per meal at two week intervals as necessary.

Side Effects

Sevelamero may cause dyspepsia, peritonitis, diarrhea, nausea, constipation, pruritus, abdominal distension, vomiting, fatigue, anorexia, arthralgia and less commonly ileus, bowel obstruction and bowel perforation.

Toxicity

Sevelamero has been given to normal healthy volunteers in doses of up to 14 grams per day for eight days with no adverse effects. Sevelamero has been given in average doses up to 13 grams per day to hemodialysis patients. There are no reported overdosages of sevelamer in patients. Since sevelamer is not absorbed, the risk of systemic toxicity is low.

Precaution

The safety and efficacy of Sevelamero in patients with dysphagia, swallowing disorders, severe GI motility disorders including severe constipation, or major GI tract surgery have not been established. Caution should be exercised when Sevelamero is used in patients with these GI disorders.

Interaction

Sevelamero has been studied in human drug-drug interaction studies with ciprofloxacin, digoxin, warfarin, enalapril, metoprolol and iron.

Food Interaction

• Take with food.

[Moderate] ADJUST DOSING INTERVAL: Sevelamero may decrease the oral bioavailability of concomitantly administered drugs. While clinical data are lacking for most drugs, the intestinal absorption of some may be impaired due to sevelamer's binding capabilities.

MANAGEMENT: As a precaution, drugs that can be adversely affected by alterations in blood levels should be administered 1 hour before or 3 hours after sevelamer.

Sevelamero multivitamins interaction

[Moderate] ADJUST DOSING INTERVAL: Bile acid sequestrants and the phosphate binder, sevelamer, can decrease the absorption of fat-soluble vitamins A, D, E, and K.

In non-clinical safety studies, rats administered colesevelam at doses greater than 30-fold the projected human clinical dose developed hemorrhage in association with vitamin K deficiency.

In a crossover study involving healthy subjects, coadministration of sevelamer with calcitriol resulted in a significant reduction in bioavailability for calcitriol (calcitriol with sevelamer vs calcitriol alone: AUC 137 pg*h
Oral vitamin supplements should be administered at least 4 hours before colesevelam and either 1 hour before or 4 to 6 hours after other bile acid sequestrants and sevelamer.

Sevelamero Drug Interaction

Moderate: multivitamin with iron, multivitamin, levothyroxine, cholecalciferolUnknown: aspirin, aspirin, docusate, apixaban, epoetin alfa, omega-3 polyunsaturated fatty acids, insulin glargine, insulin glargine, furosemide, metoprolol, metoprolol, polyethylene glycol 3350, insulin aspart, cinacalcet, acetaminophen, ondansetron

Sevelamero Disease Interaction

Major: gastrointestinal diseaseModerate: dysphagia, renal disease

Elimination Route

Not absorbed following oral administration, however no absorption studies have been performed in patients with renal disease. Sevelamero may bind to dietary phosphates and prevent its gastrointestinal absorption when sevelamer is administered in combination with food.

Pregnancy & Breastfeeding use

Pregnancy Category C. No adequate and controlled studies have been conducted using Sevelamero in nursing mothers. Sevelamero should be used during breastfeeding only if the potential benefit justifies the potential risks.

Contraindication

Sevelamero is contraindicated in patients with hypophosphatemia or bowel obstruction and in patients with known hypersensitivity to Sevelamero hydrochloride or any of its constituents.

Acute Overdose

Over dosages of Sevelamero in patients was never reported. Since Sevelamero is not absorbed, the risk of systemic toxicity is low.

Innovators Monograph

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