US FDA

First Generic Sevelamer carbonate approved in Malaysia1

Dr Reddy's Sevelamer Carbonate is approved in1

USA Jamaica Australia Malaysia Thailand

 Avoidance of calcium in certain population of Chronic Kidney disease (CKD) patients2,3

Male gender
Older age Vascular calcifications
/Prevalent vascular and/or
valvular calcification*

Risk of Calcifications
Diabetes in Chronic Kidney
disease (CKD)
Post
patient2,3 menopausal

Low bone
turnover Inflammation

*As suggested by Kidney disease improving global outcomes (KDIGO) Clinical Practice Guideline for the Diagnosis, Evaluation, Prevention, and
Treatment of Chronic Kidney Disease - Mineral Bone density (CKD-MBD),baseline calcification is a strong risk factor for ongoing calcification3

Types of phosphate binder4

Effective Pleiotropic effects Accumulation

Calcium-Ac/Carb Yes None Yes

Sevelamer Yes Yes No

Lanthanum Yes None Some

Ca-Mg Yes None Some

Fe-citrate Yes None Yes

Fe-oxyhydroxide Yes None No

Sevelamer is an effective non calcium phosphate binder with no tissue deposition-zero accumulation and has pleiotropic effects4

References
1) Data on file 2) M.Cozzolino, et al., (2011) The treatment of hyperphosphatemia in CKD: calcium based or calcium free phosphate binders. Nephrol Dial Transplant, 26:402–407. 3) Kidney Disease: Improving
Global Outcomes (KDIGO) Clinical Practice Guideline for the Diagnosis, Evaluation, Prevention, and Treatment of Chronic Kidney Disease-Mineral and Bone Disorder (CKD-MBD), Kidney Int Suppl, 2009, vol.
113 (pg. S1-S130) 4) J. Floege,(2016 ). Phosphate binders in chronic kidney disease as systematic review of recent data. Journal of Nephrology, 29,329–340.

Cavsamir® (Sevelamer carbonate) Abridged Prescribing Information

Composition: Cavsamir Tablets: Each film coated tablet contains 800 mg of sevelamer carbonate. Therapeutic indications: Cavsamir is indicated for the control of hyperphosphatemia in adult patients receiving
haemodialysis or peritoneal dialysis. Cavsamir is also indicated for the control of hyperphosphatemia in adult patients with chronic kidney disease not on dialysis with serum phosphorus ≥ 1.78 mmol/l.
Cavsamir should be used within the context of a multiple therapeutic approach, which could include calcium supplement, 1,25-dihydroxy Vitamin D3 or one of its analogues to control the development of renal
bone disease. Dosage and Administration: Starting Dose: One or two 800-mg tab 3 times daily with meals. Because of the rapid disintegration of the carbonate salt tablet and its rapid reaction with the
hydrochloric acid in the stomach, the dosing of sevelamer is anticipated to be similar to that of the hydrochloride salt. Patients Not Taking a Phosphate Binder: Recommended Starting Dose: 800-1600 mg, which
can be administered as 1 or 2 sevelamer 800-mg tablets, with meals based on serum phosphorus level. Contraindications: Cavsamir is contraindicated in patients with hypophosphatemia or bowel obstruction
and in patients with hypersensitivity to the active substance or to any of the excipients. Warnings and Precautions: Sevelamer is currently not recommended for use in adult patients with chronic kidney disease
not on dialysis with serum phosphorus < 1.78 mmol/l. Caution should be exercised when Sevelamer is used in patients with the following disorders: dysphagia, swallowing disorders, severe gastrointestinal
motility disorders including untreated or severe constipation or major gastrointestinal tract surgery. Use with caution in patients with these gastrointestinal disorders. Monitor serum chemistries: Bicarbonate
and chloride levels should be monitored. Pregnancy and Breast-feeding: There are no or limited amount of data from the use of sevelamer in pregnant women. The potential risk to humans is unknown. It is
unknown whether sevelamer/metabolites are excreted in human milk. Adverse Reactions: The most frequently occurring adverse reactions were nausea, vomiting, upper abdominal pain, constipations,
Diarrhoea, dyspepsia, flatulence and abdominal pain. Most of these adverse reactions were mild to moderate in intensity. Packaging: 270 tablets in HDPE bottle pack.
Full information available on request. Please consult full prescribing information before prescribing.

For Healthcare Professionals Only

MY-CO-CAV-300035328-LB-G22-1052

Dr. Reddy's Laboratories Malaysia Sdn. Bhd. (1238154-X)

Unit 10-06, Level 10, Menara MBMR, No.1, Jalan Syed Putra, 58000 Kuala Lumpur Malaysia.
Tel: +603 2276 3229 Fax: +603 2276 3201 Email: info.mys@drreddys.com