Sevelamer
Renagel · ATC code V03AE02
Brand names: Renagel, Sevelamerhydrochlorid Waymade, Karbolamer, Lameris, Lemorin, Perfose, Raneseva, Renadin, Renalamer, Sevaren, Sevyar, Terolam, Velarix
- Key facts
- Active substance
- Sevelamer
- Drug class
- Antihyperkalemic agents
- ATC code
- V03AE02
- Authorisation
- centrally authorised across the EU (EMA)
- Dosage forms
- Renagel 400 mg film-coated tablets · Renagel 800 mg film-coated tablets
- Marketing authorisation holder
- Sanofi Winthrop Industrie
- Information as of
- 2026-10-27
Key facts
Sevelamer (as sevelamer hydrochloride, Renagel) is a calcium-free phosphate binder. It is used to control hyperphosphataemia in adult patients on haemodialysis or peritoneal dialysis.
What it is used for
- Control of hyperphosphataemia in adults receiving haemodialysis or peritoneal dialysis
- Used within a multiple therapeutic approach (e.g. calcium supplements, vitamin D3 or analogues) to control renal bone disease
Dosing
- Renagel 400 mg: recommended starting dose 2.4 g, 3.6 g or 4.8 g per day, based on clinical needs and serum phosphorus
- Renagel 800 mg: recommended starting dose 2.4 g or 4.8 g per day, based on clinical needs and serum phosphorus
- Taken three times per day with meals
- Starting doses by phosphate level and further titration: see the full product information
Contraindications
- Hypersensitivity to sevelamer or any excipient
- Hypophosphataemia
- Bowel obstruction
Important warnings
- Not studied in swallowing disorders, active inflammatory bowel disease, motility disorders (e.g. severe gastroparesis) or after major gastrointestinal surgery: use with caution
- Very rare intestinal obstruction and ileus/subileus; constipation may precede it, so constipated patients should be monitored carefully
- Possible binding of fat-soluble vitamins (A, D, E, K): consider monitoring and supplementation
- Folate deficiency during long-term treatment cannot be excluded
- Contains no calcium: monitor serum calcium; metabolic acidosis should also be considered
Side effects
- Most frequent adverse reactions are gastrointestinal
- Very common: nausea, vomiting
- Common: diarrhoea, dyspepsia, flatulence, upper abdominal pain, constipation
- Very rare: intestinal obstruction, ileus/subileus; postmarketing reports include intestinal perforation, gastrointestinal haemorrhage, diverticulitis
- Acidosis, increased serum chloride, pruritus, rash, hypersensitivity
Interactions
- Ciprofloxacin: bioavailability decreased by approximately 50%; do not take simultaneously
- Anti-arrhythmics and anti-seizure medicines: caution (such patients were excluded from trials)
- Levothyroxine: very rare TSH increases; closer TSH monitoring recommended
- Ciclosporin, mycophenolate mofetil, tacrolimus in transplant patients: reduced levels reported; consider monitoring blood concentrations
- Proton pump inhibitors: very rare increased phosphate levels reported
Pregnancy and breastfeeding
- Pregnancy and breast-feeding: safety not established; use only if clearly needed after careful risk/benefit analysis
- Animal studies showed no evidence of embryo-foetal toxicity
Summary of the official product information, written with AI (Claude, Anthropic) on 2026-10-28. Every number was checked automatically against the original text. Not reviewed by a physician – the full official text is authoritative.
Common questions – ask Medelix
For patients
Package leaflet, verbatim
Authorisation and brand names by country
Medicines with exactly this active-substance composition, as listed in the national registers – alphabetical and without ranking. Whether a product is currently available is not shown here.
EU – centrally authorised (all member states)
- RenagelSanofi Winthrop Industrie · EMEA/H/C/000254
Source: European Medicines Agency (EMA), product information
Germany
- Sevelamerhydrochlorid WaymadeWaymade B.V. · 1 register entry
Source: EMA – Article 57 product data (EU/EEA), as of 2026-10-28
Turkey
- KarbolamerGEN İLAÇ VE SAĞLIK ÜRÜNLERİ SAN. VE TİC. A.Ş. · 1 register entry
- LamerisDAVİVA İLAÇ SAN. VE TİC. A.Ş. · 1 register entry
- LemorinPOLPHARMA SAĞLIK ÜRÜNLERİ SAN. VE TİC. A.Ş. · 2 register entries
- PerfoseVEM İLAÇ SAN. VE TİC. A.Ş. · 1 register entry
- RanesevaHELBA İLAÇ İÇ VE DIŞ SAN. TİC. A.Ş. · 2 register entries
- RenadinDİNÇTAŞ İLAÇ SAN. VE TİC. A.Ş. · 1 register entry
- RenalamerDİNÇSA İLAÇ SAN. VE TİC. A.Ş. · 3 register entries
- SevarenFARMA-TEK İLAÇ SAN. VE TİC. A.Ş. · 1 register entry
- SevyarCELTİS İLAÇ SAN. TİC. A.Ş. · 2 register entries
- TerolamTERRA İLAÇ VE KİMYA SAN. TİC. A.Ş. · 1 register entry
- VelarixABDİ İBRAHİM İLAÇ SAN. VE TİC. A.Ş. · 1 register entry
Source: TİTCK – Ruhsatlı Beşeri Tıbbi Ürünler Listesi, as of 2026-10-16
Brand names in 11 more European countries
- Denmark
- Sevelamerhydrochlorid Waymade
- France
- Chlorhydrate De Sevelamer Waymade
- Greece
- Υδροχλωρικη Σεβελαμερη Waymade
- Iceland
- Renagel
- Ireland
- Sevelamer Hydrochloride Waymade
- Italy
- Sevelamer Waymade
- Liechtenstein
- Renagel
- Netherlands
- Sevelameerhydrochloride Waymade
- Norway
- Renagel
- Romania
- Clorhidrat De Sevelamer Waymade
- Spain
- Hidrocloruro De Sevelámero Waymade
EMA – Article 57 product data (EU/EEA), 2026-10-28
Medelix receives no money from pharmaceutical companies. Brand names are listed alphabetically and without ranking.
Other substances in the same group
Another question about this substance?
Medelix answers clinical questions from guidelines, studies and product information – every claim with its source.
Sources
- European Medicines Agency. Renagel – EPAR, Product Information (OF THE TEXT Detailed information on this medicinal product i). 2026-10-27. https://www.ema.europa.eu/en/documents/product-information/renagel-epar-product-information_en.pdf
- EMA – Article 57 product data (EU/EEA), 2026-10-28. https://www.ema.europa.eu/en/human-regulatory-overview/post-authorisation/data-medicines-iso-idmp-standards-post-authorisation/public-data-article-57-database
- TİTCK – Ruhsatlı Beşeri Tıbbi Ürünler Listesi, 2026-10-16. https://www.titck.gov.tr/dinamikmodul/85
- Wikidata (CC0): ATC V03AE.
Editorial: Medelix editorial team · last updated 2026-10-27 · How these pages are made · Report an error
Source: European Medicines Agency (EMA), product information. Not advertising, not a treatment recommendation. For questions about your own treatment, ask your doctor or pharmacist.