Sevanix

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

Sevanix 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. Sevanix 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. Sevanix treatment also results in a lowering of low-density lipoprotein (LDL) and total serum cholesterol levels.

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

Uses

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

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

How Sevanix works

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

Dosage

Sevanix dosage

Patients not taking a Phosphate Binder: The recommended starting dose of Sevanix is 800 to 1600 mg, which can be administered as two to four 400 mg Sevanix 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 Sevanix:

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

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

Toxicity

Sevanix has been given to normal healthy volunteers in doses of up to 14 grams per day for eight days with no adverse effects. Sevanix 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 Sevanix 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 Sevanix is used in patients with these GI disorders.

Interaction

Sevanix 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: Sevanix 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.

Sevanix 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. Sevanix 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 Sevanix in nursing mothers. Sevanix should be used during breastfeeding only if the potential benefit justifies the potential risks.

Contraindication

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

Acute Overdose

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

Innovators Monograph

You find simplified version here Sevanix

FAQ

What is Sevanix used for?

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

How does a Sevanix work?

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

What are the common side effects of Sevanix?

Sevanix may cause common side effects are include:

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

Is Sevanix safe during pregnancy?

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

Is Sevanix safe during breastfeeding?

Sevanix 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 Sevanix be given?

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

Can Sevanix tablets be crushed?

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

Can I overdose on Sevanix?

If Sevanix 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 Sevanix?

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 Sevanix?

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

Does Sevanix effect my kidney?

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

What happens if I stop taking Sevanix?

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

What is the reason for taking Sevanix with food?

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

Does Sevanix increase calcium?

Sevanix 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 Sevanix?

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

What happens if I miss a dose of Sevanix?

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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