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Karvela800 mg
Healthcare Pharmaceuticals Ltd.
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Medicine overview
Indications of Sevel
Sevel is a non-calcium, non-absorbed phosphate-binding agent indicated for the control of serum phosphorus (hyperphosphatemia) in patients with chronic kidney disease (CKD).
- Established/labeled use: Control of serum phosphorus in adults and pediatric patients 6 years of age and older with CKD who are on dialysis (haemodialysis or peritoneal dialysis).
- Guideline-supported/regional use: In some markets, Sevel is also indicated for control of serum phosphorus in adults with CKD not yet on dialysis, when serum phosphorus is significantly elevated, generally alongside dietary phosphate restriction.
- Adjunct role: Sevel is typically used together with calcium supplementation and active vitamin D (or its analogues) as part of a comprehensive plan to manage CKD-mineral and bone disorder; it does not treat the underlying kidney disease itself.
Sevel is not approved for patients without hyperphosphatemia or with normal renal function.
Composition
Each film-coated tablet contains Sevelamer Carbonate as the active ingredient, most commonly available as 800 mg tablets (equivalent to 800 mg sevelamer base). A powder-for-oral-suspension formulation of Sevelamer Carbonate (typically 0.8 g and 2.4 g per sachet) is also available in some markets.
Description
Sevel is a synthetic, non-calcium, non-absorbed polymeric compound that binds dietary phosphate in the gastrointestinal tract, reducing the amount of phosphorus available for absorption into the bloodstream.
It is used as a phosphate-lowering agent in patients whose kidneys can no longer adequately excrete phosphorus, most commonly in advanced chronic kidney disease requiring dialysis. Sevel is supplied as film-coated tablets and, in some markets, as a powder for oral suspension.
Therapeutic Class
Sevel belongs to the therapeutic class of phosphate-binding agents (non-calcium-based phosphate binders), used in the management of hyperphosphatemia associated with chronic kidney disease.
Pharmacology
Sevelamer Carbonate is a polymeric amine that is not absorbed from the gastrointestinal tract. Its multiple amine groups become protonated in the intestine and bind dietary phosphate through ionic and hydrogen bonding, forming a complex that is excreted in the stool.
By reducing intestinal phosphate absorption, Sevelamer Carbonate lowers serum phosphorus concentrations without providing a systemic calcium load, unlike calcium-based binders. Modest reductions in LDL cholesterol have also been observed with sevelamer salts in some studies, though this is not an approved indication.
Dosage & Administration of Sevel
Adults on Dialysis
| Baseline Serum Phosphorus | Starting Dose of Sevel |
|---|---|
| 5.5-7.5 mg/dL (1.8-2.4 mmol/L) | 800 mg three times daily with meals |
| ≥7.5 mg/dL (≥2.4 mmol/L) | 1600 mg three times daily with meals |
The dose of Sevel is then titrated upward or downward by 800 mg per meal at intervals of about 2 weeks, based on serum phosphorus levels, until an acceptable phosphorus level is reached. Average maintenance doses of approximately 6-7 grams per day (in divided doses with meals) are commonly used.
Patients Switching from Sevelamer Hydrochloride
Sevel may be substituted for sevelamer hydrochloride on a gram-for-gram basis, with serum phosphorus monitored to confirm continued control.
Pediatric Patients (6 years and older, on dialysis)
| Body Surface Area (BSA) | Starting Dose of Sevel |
|---|---|
| 0.75-1.2 m² | 800 mg per meal |
| >1.2 m² | 1600 mg per meal |
Doses of Sevel are given three times daily with meals and titrated every 2 weeks initially, based on serum phosphorus response.
Administration Instructions
- Tablets of Sevel must be swallowed whole; do not crush, chew, or split, as this alters how the medicine works in the gut.
- Always take Sevel with meals (or immediately before/after eating); taking it without food substantially reduces its phosphate-binding effect.
- If a powder-for-suspension form of Sevel is prescribed, mix the full contents of the packet with the recommended amount of water and take immediately with a meal.
Administration of Sevel
Sevel tablets should be swallowed whole with meals, three times daily; do not crush, chew, or split. See Dosage & Administration for complete instructions on taking Sevel.
Interaction of Sevel
Sevel can bind to certain oral medications in the gastrointestinal tract and reduce their absorption. Well-documented, clinically significant interactions include:
- Ciprofloxacin: Bioavailability reduced by approximately 50% when taken with Sevel; ciprofloxacin should be taken at least 2 hours before or 6 hours after Sevel.
- Mycophenolate mofetil: Peak concentration is reduced when co-administered with Sevel; mycophenolate mofetil should be taken at least 2 hours before Sevel, with levels monitored in transplant patients.
- Cyclosporine and tacrolimus (transplant patients): Reduced bioavailability has been reported with concurrent Sevel use; blood concentrations of these immunosuppressants should be monitored.
- Levothyroxine: Cases of hypothyroidism have been reported with concurrent use of Sevel; monitor TSH levels closely and consider separating dosing times.
- Other oral medications: For drugs with a narrow therapeutic index, it is prudent to administer the other medication at least 1 hour before or 3 hours after Sevel, unless separation has specifically been shown unnecessary.
No clinically significant interaction has been found between Sevel and digoxin, enalapril, iron, metoprolol, or warfarin at standard doses.
Contraindications
Sevelamer Carbonate is contraindicated in:
- Patients with known hypersensitivity to sevelamer carbonate, sevelamer hydrochloride, or any component of the formulation.
- Patients with bowel obstruction.
Side Effects of Sevel
The most common side effects of Sevel seen in clinical trials are gastrointestinal and generally dose-related:
- Vomiting
- Nausea
- Diarrhea
- Dyspepsia (indigestion)
- Abdominal pain
- Flatulence
- Constipation
Less common but more serious gastrointestinal events have been reported with Sevel and other phosphate-binder resins, including dysphagia, tablet retention in the esophagus, bowel obstruction, bleeding, ulceration, perforation, and colitis; some cases required hospitalization or surgery. Seek prompt medical attention for severe abdominal pain, persistent vomiting, or inability to pass stool or gas while taking Sevel.
Hypersensitivity reactions such as rash and pruritus have been reported post-marketing with Sevel.
Pregnancy & Lactation
Pregnancy: Sevel is not absorbed systemically, so direct fetal drug exposure is not expected; however, data in pregnant women remain limited. Sevel should be used during pregnancy only if clearly needed and if the potential benefit justifies the potential risk; a physician should be consulted before use. Because Sevel can reduce absorption of fat-soluble vitamins and folic acid, supplementation may be advised during pregnancy under physician guidance.
Lactation: As Sevel is not absorbed into the bloodstream, exposure of a breastfeeding infant through milk is not expected; however, use during breastfeeding should still be discussed with a physician, who can weigh individual circumstances and monitor for vitamin deficiency.
Precautions & Warnings
Sevel must always be taken with meals; taking it without food significantly reduces its phosphate-binding effect and therapeutic benefit.
- Swallowing difficulty: Use caution in patients with dysphagia or swallowing disorders, as tablet retention in the esophagus has been reported with Sevel; a powder-for-suspension formulation may be considered where available.
- GI motility disorders / major GI surgery: Use Sevel with caution in patients with significant gastrointestinal motility disorders, active inflammatory bowel disease, or a history of major gastrointestinal tract surgery, as the risk of bowel obstruction with binder resins may be increased (see Contraindications for outright bowel obstruction).
- Fat-soluble vitamin and folate deficiency: Long-term use of Sevel has been associated with reduced levels of vitamins A, D, E, K, and folic acid; periodic monitoring and supplementation may be considered per physician advice, especially with prolonged therapy.
- Drug absorption: See Interactions for medicines whose absorption can be reduced by Sevel and that require dose separation.
- Acid-base status: Because it does not deliver a bicarbonate load (unlike sevelamer hydrochloride), Sevel is generally preferred when acid-base status is a concern, but bicarbonate levels should still be periodically monitored in dialysis patients.
Overdose Effects of Sevel
Because Sevel is not absorbed from the gastrointestinal tract, the risk of systemic toxicity from overdose is low; doses up to 14 grams per day have been studied without a defined maximum tolerated dose. However, excessive doses could theoretically worsen gastrointestinal side effects or contribute to bowel obstruction, particularly in at-risk patients.
If an overdose of Sevel is suspected, or if the patient develops severe abdominal pain, persistent vomiting, or inability to pass stool or gas, seek immediate medical attention or contact a poison control center/emergency services. There is no specific antidote; treatment is supportive.
Storage Conditions
Store Sevel at room temperature (below 30°C), protected from light and moisture. Keep out of reach of children.
Use In Special Populations
Pediatric Use
Sevel is approved for use in pediatric patients 6 years of age and older with chronic kidney disease on dialysis, dosed according to body surface area (see Dosage & Administration). Safety and efficacy of Sevel in children under 6 years of age have not been established. Sevel may be less effective in children under 13 years of age with low baseline serum phosphorus.
Geriatric Use
Dose selection for elderly patients receiving Sevel should generally start at the lower end of the dosing range, reflecting the greater frequency of comorbidities and organ function decline in this age group.
Renal Impairment
Sevel is used specifically in patients with significant renal impairment (chronic kidney disease); because it is not systemically absorbed, no dosage adjustment based on residual renal function itself is required beyond phosphorus-guided titration.
Hepatic Impairment
No specific dosage adjustment of Sevel has been established for hepatic impairment; it has not been extensively studied in this population.
Duration Of Treatment
Sevel is generally used long-term/chronically, for as long as the patient has hyperphosphatemia due to chronic kidney disease requiring dialysis (or, in some markets, pre-dialysis CKD with elevated phosphorus). Treatment duration and dose are periodically reassessed by the physician based on serum phosphorus, calcium, and other laboratory monitoring; Sevel should not be stopped or the dose changed without medical advice.
Reconstitution
For the powder-for-oral-suspension formulation of Sevel (available in some markets), empty the entire contents of one packet into a cup, add the recommended amount of water as specified on the product label, stir well, and drink the entire mixture immediately with a meal. Do not add the powder to hot liquids or heat the suspension, and do not store the reconstituted mixture for later use.
Drug Classes
Phosphate binder; non-calcium, non-absorbed polymeric amine.
Mode Of Action
Sevelamer Carbonate is a non-absorbed polymer containing multiple amine groups that become partially protonated in the intestine. These positively charged amine groups bind negatively charged phosphate ions from food via ionic and hydrogen bonding, forming a complex that is not absorbed and is eliminated in the stool. This reduces the amount of phosphate available for absorption into the blood, lowering serum phosphorus concentrations in patients with chronic kidney disease.
Pediatric Uses
Sevel is approved for the control of serum phosphorus in pediatric patients 6 years of age and older with chronic kidney disease on dialysis. Dosing is based on body surface area (see Dosage & Administration) and titrated according to serum phosphorus response. Sevel has not been shown to be effective in children under 13 years of age with baseline serum phosphorus below 5.6 mg/dL, and safety and efficacy in children under 6 years of age have not been established. Growth, nutritional status, and vitamin levels should be monitored during long-term use of Sevel in children.
Frequently Asked Questions
Q: Why do I need to take Sevel 800 mg Tablet with every meal?
A: Sevel 800 mg Tablet works by binding to phosphate from the food you eat while it is in your stomach and intestines. If you take it without food, there is little or no phosphate for it to bind, so it will not effectively lower your blood phosphorus level. Always take Sevel 800 mg Tablet with a meal or right before/after eating.
Q: Can I crush or chew the Sevel 800 mg Tablet tablets?
A: No. Tablets of Sevel 800 mg Tablet should be swallowed whole. Crushing, chewing, or splitting the tablet can change how it works in the gut and is not recommended unless your physician or pharmacist specifically advises otherwise.
Q: What should I do if I miss a dose of Sevel 800 mg Tablet?
A: Since Sevel 800 mg Tablet only works when taken with food, if you miss a dose simply skip it and take your next dose with your next meal as scheduled. Do not take a double dose to make up for the missed one.
Q: Can Sevel 800 mg Tablet be taken during pregnancy or breastfeeding?
A: Sevel 800 mg Tablet is not absorbed into the bloodstream, so direct exposure of the baby is not expected, but safety data in pregnant and breastfeeding women are limited. Sevel 800 mg Tablet should be used in pregnancy only if clearly needed, when the benefit outweighs the potential risk, and only under a physician's guidance; the same caution applies during breastfeeding. Because Sevel 800 mg Tablet can lower absorption of fat-soluble vitamins and folic acid, your physician may recommend supplements.
Q: What are the most common side effects of Sevel 800 mg Tablet?
A: The most common side effects of Sevel 800 mg Tablet are gastrointestinal: nausea, vomiting, diarrhea, indigestion, abdominal pain, gas, and constipation. These are usually dose-related. Rarely, more serious problems such as difficulty swallowing, tablets getting stuck in the esophagus, or bowel obstruction have been reported; seek prompt medical care for severe abdominal pain, persistent vomiting, or inability to pass stool or gas.
Q: Can I take my other medicines at the same time as Sevel 800 mg Tablet?
A: Sevel 800 mg Tablet can bind to certain oral medicines in the gut and reduce how much of them your body absorbs. For example, ciprofloxacin should be taken at least 2 hours before or 6 hours after Sevel 800 mg Tablet, and mycophenolate mofetil at least 2 hours before it. For other important medicines, it is generally safest to take them 1 hour before or 3 hours after Sevel 800 mg Tablet unless your physician tells you separation is not needed. Always tell your physician or pharmacist about all medicines you take alongside Sevel 800 mg Tablet.
Disclaimer
The information provided is accurate to the best of our knowledge, but it does not replace professional medical advice. We cannot guarantee its completeness or accuracy, and the absence of specific information about a drug should not be taken as an endorsement. We are not responsible for any consequences arising from this information, so please consult a healthcare professional for any concerns or questions.
