Sevelamero

Sevelamero Uses, Dosage, Side Effects, Food Interaction and all others data.

Sevelamero Hydrochloride is a new treatment for the control of serum phosphorus in patients with chronic kidney disease (CKD) on dialysis. Elevated serum phosphorus levels or uncontrolled hyperphosphatemia leads to development of secondary hyperparathyroidism, renal bone disease, calcification of vascular and nonvascular tissues, and cardiovascular disease. It is a calcium-free and aluminium-free nonabsorbed polymer phosphate binder, it does not cause calcium and aluminium toxicity. When taken with meals it inhibits intestinal absorption of ingested phosphate.

Patients with end-stage renal disease (ESRD) retain phosphorus and can develop hyperphosphatemia. High serum phosphorus can precipitate serum calcium resulting in ectopic calcification. When the product of serum calcium and phosphorus concentrations (Ca x P) exceeds 55 mg2/dL2, there is an increased risk that ectopic calcification will occur. Hyperphosphatemia plays a role in the development of secondary hyperparathyroidism in renal insufficiency. An increase in parathyroid hormone (PTH) levels is characteristic of patients with chronic renal failure. Increased levels of PTH can lead to osteitis fibrosa, a bone disease. A decrease in serum phosphorus may decrease serum PTH levels. Treatment of hyperphosphatemia includes reduction in dietary intake of phosphate, inhibition of intestinal phosphate absorption with phosphate binders, and removal of phosphate with dialysis. Sevelamero taken with meals has been shown to decrease serum phosphorus concentrations in patients with ESRD who are on hemodialysis. In vitro studies have shown that the capsule and tablet formulations bind phosphate to a similar extent. Sevelamero treatment also results in a lowering of low-density lipoprotein (LDL) and total serum cholesterol levels.

Trade Name Sevelamero
Availability Prescription only
Generic Sevelamer
Sevelamer Other Names Sevelamer, Sévélamer, Sevelamero, Sevelamerum
Related Drugs sucralfate, Carafate, Renvela, Auryxia, Velphoro, Renagel
Type
Formula C6H12ClNO
Weight Average: 149.619
Monoisotopic: 149.060741718
Groups Approved
Therapeutic Class Drugs for reduction of serum phosphorus in patients with ESRD
Manufacturer
Available Country
Last Updated: September 19, 2023 at 7:00 am
Sevelamero
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.

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

You find simplified version here Sevelamero

FAQ

What is Sevelamero used for?

Sevelamero is used to control high blood levels of phosphorus in people with chronic kidney disease who are on dialysis .

How does a Sevelamero work?

Sevelamero works by lowers your blood phosphorus levels to help protect your kidneys and bones.

What are the common side effects of Sevelamero?

Sevelamero may cause common side effects are include:

  • diarrhea.
  • vomiting.
  • nausea.
  • stomach pain.
  • gas.
  • heartburn.
  • new or worsening constipation.

Is Sevelamero safe during pregnancy?

Sevelamero products should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. The effect of Sevelamero hydrochloride on the absorption of vitamins and other nutrients has not been studied in pregnant women.

Is Sevelamero safe during breastfeeding?

Sevelamero is not absorbed into the bloodstream, it is not expected to be harmful to a nursing baby.The non-absorbed nature of this drug makes its excretion in human breast milk unlikely. No adequate and controlled studies have been conducted in nursing mothers.

When should Sevelamero be given?

It is usually taken three times a day with meals. Follow the directions on your prescription label carefully.

Can Sevelamero tablets be crushed?

Sevelamero tablets may be crushed and administered via enteral feeding tubes, provided clear instruction on tablet preparation is included.

Can I overdose on Sevelamero?

If Sevelamero is administered by a healthcare provider in a medical setting, it is unlikely that an overdose will occur. However, if overdose is suspected, seek emergency medical attention.

How to use Sevelamero?

Take this medication by mouth as directed by your doctor, usually 3 times daily with meals. Swallow the tablet whole. Do not crush, chew, or split the tablet. The dosage is based on your medical condition, any other medications you take to lower your phosphate levels, and your response to treatment. In children, the dosage is also based on body size.

Can I chew Sevelamero?

Swallow the tablet whole.Do not crush, chew, or split the tablet.

Does Sevelamero effect my kidney?

 Sevelamero lowers phosphorus levels in people with kidney disease on dialysis. Take  with meals.

What happens if I stop taking Sevelamero?

If you stop taking Sevelamero, your phosphate levels may rise again. It is important to keep taking your medicines even if you feel well. Do not stop taking Sevelamero.

What is the reason for taking Sevelamero with food?

Sevelamero should be taken three times a day with meals to help control phosphorus levels in your body. Sevelamero binds to (or holds on to) phosphorus in the foods you eat so your body doesn't absorb as much.

Does Sevelamero increase calcium?

Sevelamero does not contain calcium or metal and is not absorbed, so it does not build up in your body.

How many times a day can I take Sevelamero?

Sevelamero takes 3 times per day with meals. As directed by your doctor.

What happens if I miss a dose of Sevelamero?

Take the missed dose as soon as you remember. Be sure to take the missed dose with food. Skip the missed dose if it is almost time for your next scheduled dose. Do not take extra medicine to make up the missed dose.

*** Taking medicines without doctor's advice can cause long-term problems.
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