Sevelamer is a medication primarily used to lower high blood phosphate levels in patients with chronic kidney disease (CKD) who are on dialysis. It works by binding to phosphate in the food you eat, preventing it from being absorbed into your bloodstream. This helps to reduce the buildup of phosphate in the blood, which can occur when the kidneys are not functioning properly.
High levels of phosphate in the blood can lead to complications such as bone and cardiovascular problems in CKD patients. Sevelamer helps to manage these complications by controlling phosphate levels.
Renvela or Sevelamer inhibits phosphate absorption from the intestinal lumen. It is, therefore, used to treat hyperphosphatemia (high phosphate levels in the blood) in patients with chronic kidney disease. It is specifically useful in patients with normal or high calcium levels since it does not affect serum calcium, bicarbonate and aluminum levels. Sevelamer/ Renvela has a phosphate binding capacity as follows:
- 400 mg of sevelamer (Renvela) binds to 32 mg of phosphate
- 800 mg of sevelamer (Renvela) binds to 64 mg of phosphate
Sevelamer Dose in Adults
Sevelamer Dose in hyperphosphatemia:
For patients not already taking a phosphate binder:
- Start with 800 to 1,600 mg of sevelamer three times a day with meals.
- The starting dose depends on the level of phosphorus in the blood:
- If phosphorus is between 5.5 to less than 7.5 mg/dL, start with 800 mg three times a day.
- If phosphorus is between 7.5 to less than 9 mg/dL, start with 1,200 to 1,600 mg three times a day.
- If phosphorus is 9 mg/dL or higher, start with 1,600 mg three times a day.
- Adjust the dose based on phosphorus levels:
- If phosphorus is above 5.5 mg/dL, increase the dose by 400 to 800 mg per meal every two weeks.
- If phosphorus is within the goal range of 3.5 to 5.5 mg/dL, keep the current dose.
- If phosphorus is below 3.5 mg/dL, decrease the dose by 400 to 800 mg per meal.
When switching between phosphate binder products:
- 667 mg of calcium acetate is about equal to 800 mg of sevelamer.
- Convert the dose based on the number of tablets per meal:
- For example, if you were taking 667 mg of calcium acetate, switch to 800 mg of sevelamer.
- If you were taking 1,334 mg of calcium acetate, switch to 1,600 mg of sevelamer (either two 800 mg tablets or three 400 mg tablets).
- If you were taking 2,001 mg of calcium acetate, switch to 2,400 mg of sevelamer (either three 800 mg tablets or five 400 mg tablets).
Sevelamer Dose in Children
Sevelamer for Hyperphosphatemia in children:
Sevelamer Carbonate (Renvela):
- For Children ≥6 years and Adolescents:
- If not already taking a phosphate binder, the initial dose depends on body surface area (BSA):
- BSA ≥0.75 to <1.2 m²: Start with 800 mg three times daily with meals; adjust every two weeks by adding 400 mg per dose as needed.
- BSA ≥1.2 m²: Start with 1,600 mg three times daily with meals; adjust every two weeks by adding 800 mg per dose as needed.
- If not already taking a phosphate binder, the initial dose depends on body surface area (BSA):
- When switching from calcium acetate to sevelamer carbonate:
- 667 mg of calcium acetate is about equal to 800 mg of sevelamer carbonate.
- Convert the dose based on the number of tablets per meal:
- For example, if you were taking 667 mg of calcium acetate, switch to 800 mg of sevelamer carbonate.
- If you were taking 1,334 mg of calcium acetate, switch to 1,600 mg of sevelamer carbonate.
- If you were taking 2,001 mg of calcium acetate, switch to 2,400 mg of sevelamer carbonate.
Sevelamer Hydrochloride (Renagel):
- For Infants ≥10 months and Children <2 years:
- The final dose varies but typically ranges around 140 ± 86 mg/kg/day (5.38 ± 3.24 g/day). The initial dose is based on prior phosphate binder dose and serum phosphorus concentrations.
- For Children ≥2 years and Adolescents:
- Start with 400 or 800 mg three times daily with meals.
- Adjust the dose monthly in 1,200 mg/day increments to target phosphorus level. The final mean range is around 140 to 163 mg/kg/day (5.38 to 6.7 g/day).
- When switching from calcium acetate to sevelamer hydrochloride:
- 667 mg of calcium acetate is about equal to 800 mg of sevelamer.
- Convert the dose based on the number of tablets per meal, similar to the carbonate form.
Pretreatment with Sevelamer:
- For Oral and Enteral Nutrition:
- Take 800 mg of sevelamer (in tablets or powder form).
- Add it to up to 400 mL of breast milk, 100 mL of infant formula, tube feeding, or cow's milk.
- Let it sit for 10 minutes, then separate the liquid from the sediment at the bottom.
- Studies have shown significant reductions in phosphate levels: more than 85% in breast milk, 42% in cow's milk, 48% in tube feeding, and 68% in infant formula.
Pregnancy Risk Factor C
- Sevelamer doesn't get absorbed into the body, but it might affect how the body absorbs certain vitamins like fat-soluble vitamins and folic acid.
- That means moms taking sevelamer might need extra vitamins to make up for what's not being absorbed properly.
Sevelamer use during breastfeeding
- Sevelamer doesn't get into the bloodstream, so it's unlikely to pass to a breastfeeding baby through breast milk.
- However, it could affect how the mother's body absorbs vitamins like fat-soluble vitamins and folic acid, which are important for both mom and baby.
- This might mean the mom needs extra vitamin supplements to make sure she and her baby get enough of these nutrients.
Sevelamer Dose in Renal Disease:
- The manufacturer's labeling doesn't include any specific dosage adjustments for people with kidney problems because it hasn't been studied yet.
Sevelamer Dose in Liver Disease:
- The manufacturer's labeling doesn't offer any specific dosage adjustments for individuals with liver problems.
Common side effects of sevelamer (Renvela):
- Endocrine & metabolic:
- Metabolic acidosis
- Gastrointestinal:
- Vomiting, nausea, diarrhea, and dyspepsia.
Sevelamer Less common side effects:
- Gastrointestinal:
- Abdominal pain, constipation, flatulence, and peritonitis
Contraindications to Sevelamer (Renvela) include:
- In addition to hypersensitivity to sevelamer or its components and bowel obstruction, Canadian labeling includes additional contraindications not found in US labeling, such as hypophosphatemia and active mucosal injury like necrosis, perforation, ulcerative colitis, and gastrointestinal bleeding.
- These contraindications highlight conditions where the use of sevelamer may not be safe or suitable for the patient.
Warnings and Precautions
Gastrointestinal effects:
- Sevelamer can have gastrointestinal effects, including reports of bowel obstruction and perforation.
- The tablet form has been associated with dysphagia (difficulty swallowing) and tablet retention in the esophagus.
- For patients with a history of swallowing disorders, switching to the suspension formulation may be considered to reduce the risk of these complications.
Gastrointestinal Disease:
- Sevelamer should be used cautiously in individuals with gastrointestinal disorders, such as dysphagia, swallowing difficulties, severe gastrointestinal motility disorders (like severe constipation), or those who have undergone major gastrointestinal surgery.
- These conditions may increase the risk of complications or affect how the medication is absorbed and should be taken into consideration when prescribing sevelamer.
Monitor Serum chemistries including the following:
Serum Chemistries
- Bicarbonate and Chloride: These levels in the blood should be checked regularly.
Serum Calcium, Phosphorus, and Parathyroid Hormone (PTH)
- CKD Stage G3a to G3b:
- Serum calcium and phosphate: Every 6 to 12 months
- PTH: Frequency depends on baseline level and CKD progression
- CKD Stage G4:
- Serum calcium and phosphate: Every 3 to 6 months
- PTH: Every 6 to 12 months
- CKD Stage G5 and G5D:
- Serum calcium and phosphate: Every 1 to 3 months
- PTH: Every 3 to 6 months
Other Measures
- Periodic 24-hour urinary calcium and phosphorus
- Magnesium and alkaline phosphatase every 12 months or more frequently with elevated PTH
- Creatinine, BUN, and albumin
- Intact parathyroid hormone (iPTH) every 3 to 12 months depending on CKD severity
How to take Sevelamer?
Powder for Oral Suspension:
- Preparation: Mix the directed amount of powder with water as indicated for the packet size.
- Alternatively, the entire content of the packet can be premixed with a small amount of food or beverage (avoid heating or adding to hot foods or liquids).
- Consumption: Consume the prepared suspension immediately or within 30 minutes.
- For oral suspension in water, it may need to be resuspended right before drinking.
Tablets:
- Administration: Swallow the tablets whole.
- Do Not: Do not crush, chew, or break the tablets.
Mechanism of action of Sevelamer:
- Sevelamer, which is a polymeric compound, works by binding phosphate in the intestines.
- This binding action helps limit the absorption of phosphate into the bloodstream, leading to decreased levels of phosphate in the blood.
- Importantly, sevelamer achieves this without affecting the concentrations of calcium, aluminum, or bicarbonate in the body.
Onset of Action:
- Reduction in serum phosphorus levels typically occurs within 1 to 2 weeks after starting sevelamer treatment. This information is supported by studies conducted in 1997 (Burke, Chertow).
Absorption:
- Sevelamer is not absorbed into the bloodstream, meaning it stays within the gastrointestinal tract and does not enter the systemic circulation.
Sevelamer International brands:
- ACCEL-Sevelamer
- Eurolamer
- Inophos
- Invela
- Lameraseve
- Postiline
- Renagel
- Renosev
- Renvela
- Sevel
- Tasermity
Sevelamer Brands in Pakistan:
|
Sevelamer HCl [Tabs 400 mg] |
|
|
Renavel |
Genome Pharmaceuticals (PVT) LTD. |
Sevelamer is a medication primarily used to lower high blood phosphate levels in patients with chronic kidney disease (CKD) who are on dialysis. It works by binding to phosphate in the food you eat, preventing it from being absorbed into your bloodstream. This helps to reduce the buildup of phosphate in the blood, which can occur when the kidneys are not functioning properly.
High levels of phosphate in the blood can lead to complications such as bone and cardiovascular problems in CKD patients. Sevelamer helps to manage these complications by controlling phosphate levels.
Renvela or Sevelamer inhibits phosphate absorption from the intestinal lumen. It is, therefore, used to treat hyperphosphatemia (high phosphate levels in the blood) in patients with chronic kidney disease. It is specifically useful in patients with normal or high calcium levels since it does not affect serum calcium, bicarbonate and aluminum levels. Sevelamer/ Renvela has a phosphate binding capacity as follows:
- 400 mg of sevelamer (Renvela) binds to 32 mg of phosphate
- 800 mg of sevelamer (Renvela) binds to 64 mg of phosphate
Sevelamer Dose in Adults
Sevelamer Dose in hyperphosphatemia:
For patients not already taking a phosphate binder:
- Start with 800 to 1,600 mg of sevelamer three times a day with meals.
- The starting dose depends on the level of phosphorus in the blood:
- If phosphorus is between 5.5 to less than 7.5 mg/dL, start with 800 mg three times a day.
- If phosphorus is between 7.5 to less than 9 mg/dL, start with 1,200 to 1,600 mg three times a day.
- If phosphorus is 9 mg/dL or higher, start with 1,600 mg three times a day.
- Adjust the dose based on phosphorus levels:
- If phosphorus is above 5.5 mg/dL, increase the dose by 400 to 800 mg per meal every two weeks.
- If phosphorus is within the goal range of 3.5 to 5.5 mg/dL, keep the current dose.
- If phosphorus is below 3.5 mg/dL, decrease the dose by 400 to 800 mg per meal.
When switching between phosphate binder products:
- 667 mg of calcium acetate is about equal to 800 mg of sevelamer.
- Convert the dose based on the number of tablets per meal:
- For example, if you were taking 667 mg of calcium acetate, switch to 800 mg of sevelamer.
- If you were taking 1,334 mg of calcium acetate, switch to 1,600 mg of sevelamer (either two 800 mg tablets or three 400 mg tablets).
- If you were taking 2,001 mg of calcium acetate, switch to 2,400 mg of sevelamer (either three 800 mg tablets or five 400 mg tablets).
Sevelamer Dose in Children
Sevelamer for Hyperphosphatemia in children:
Sevelamer Carbonate (Renvela):
- For Children ≥6 years and Adolescents:
- If not already taking a phosphate binder, the initial dose depends on body surface area (BSA):
- BSA ≥0.75 to <1.2 m²: Start with 800 mg three times daily with meals; adjust every two weeks by adding 400 mg per dose as needed.
- BSA ≥1.2 m²: Start with 1,600 mg three times daily with meals; adjust every two weeks by adding 800 mg per dose as needed.
- If not already taking a phosphate binder, the initial dose depends on body surface area (BSA):
- When switching from calcium acetate to sevelamer carbonate:
- 667 mg of calcium acetate is about equal to 800 mg of sevelamer carbonate.
- Convert the dose based on the number of tablets per meal:
- For example, if you were taking 667 mg of calcium acetate, switch to 800 mg of sevelamer carbonate.
- If you were taking 1,334 mg of calcium acetate, switch to 1,600 mg of sevelamer carbonate.
- If you were taking 2,001 mg of calcium acetate, switch to 2,400 mg of sevelamer carbonate.
Sevelamer Hydrochloride (Renagel):
- For Infants ≥10 months and Children <2 years:
- The final dose varies but typically ranges around 140 ± 86 mg/kg/day (5.38 ± 3.24 g/day). The initial dose is based on prior phosphate binder dose and serum phosphorus concentrations.
- For Children ≥2 years and Adolescents:
- Start with 400 or 800 mg three times daily with meals.
- Adjust the dose monthly in 1,200 mg/day increments to target phosphorus level. The final mean range is around 140 to 163 mg/kg/day (5.38 to 6.7 g/day).
- When switching from calcium acetate to sevelamer hydrochloride:
- 667 mg of calcium acetate is about equal to 800 mg of sevelamer.
- Convert the dose based on the number of tablets per meal, similar to the carbonate form.
Pretreatment with Sevelamer:
- For Oral and Enteral Nutrition:
- Take 800 mg of sevelamer (in tablets or powder form).
- Add it to up to 400 mL of breast milk, 100 mL of infant formula, tube feeding, or cow's milk.
- Let it sit for 10 minutes, then separate the liquid from the sediment at the bottom.
- Studies have shown significant reductions in phosphate levels: more than 85% in breast milk, 42% in cow's milk, 48% in tube feeding, and 68% in infant formula.
Pregnancy Risk Factor C
- Sevelamer doesn't get absorbed into the body, but it might affect how the body absorbs certain vitamins like fat-soluble vitamins and folic acid.
- That means moms taking sevelamer might need extra vitamins to make up for what's not being absorbed properly.
Sevelamer use during breastfeeding
- Sevelamer doesn't get into the bloodstream, so it's unlikely to pass to a breastfeeding baby through breast milk.
- However, it could affect how the mother's body absorbs vitamins like fat-soluble vitamins and folic acid, which are important for both mom and baby.
- This might mean the mom needs extra vitamin supplements to make sure she and her baby get enough of these nutrients.
Sevelamer Dose in Renal Disease:
- The manufacturer's labeling doesn't include any specific dosage adjustments for people with kidney problems because it hasn't been studied yet.
Sevelamer Dose in Liver Disease:
- The manufacturer's labeling doesn't offer any specific dosage adjustments for individuals with liver problems.
Common side effects of sevelamer (Renvela):
- Endocrine & metabolic:
- Metabolic acidosis
- Gastrointestinal:
- Vomiting, nausea, diarrhea, and dyspepsia.
Sevelamer Less common side effects:
- Gastrointestinal:
- Abdominal pain, constipation, flatulence, and peritonitis
Contraindications to Sevelamer (Renvela) include:
- In addition to hypersensitivity to sevelamer or its components and bowel obstruction, Canadian labeling includes additional contraindications not found in US labeling, such as hypophosphatemia and active mucosal injury like necrosis, perforation, ulcerative colitis, and gastrointestinal bleeding.
- These contraindications highlight conditions where the use of sevelamer may not be safe or suitable for the patient.
Warnings and Precautions
Gastrointestinal effects:
- Sevelamer can have gastrointestinal effects, including reports of bowel obstruction and perforation.
- The tablet form has been associated with dysphagia (difficulty swallowing) and tablet retention in the esophagus.
- For patients with a history of swallowing disorders, switching to the suspension formulation may be considered to reduce the risk of these complications.
Gastrointestinal Disease:
- Sevelamer should be used cautiously in individuals with gastrointestinal disorders, such as dysphagia, swallowing difficulties, severe gastrointestinal motility disorders (like severe constipation), or those who have undergone major gastrointestinal surgery.
- These conditions may increase the risk of complications or affect how the medication is absorbed and should be taken into consideration when prescribing sevelamer.
Monitor Serum chemistries including the following:
Serum Chemistries
- Bicarbonate and Chloride: These levels in the blood should be checked regularly.
Serum Calcium, Phosphorus, and Parathyroid Hormone (PTH)
- CKD Stage G3a to G3b:
- Serum calcium and phosphate: Every 6 to 12 months
- PTH: Frequency depends on baseline level and CKD progression
- CKD Stage G4:
- Serum calcium and phosphate: Every 3 to 6 months
- PTH: Every 6 to 12 months
- CKD Stage G5 and G5D:
- Serum calcium and phosphate: Every 1 to 3 months
- PTH: Every 3 to 6 months
Other Measures
- Periodic 24-hour urinary calcium and phosphorus
- Magnesium and alkaline phosphatase every 12 months or more frequently with elevated PTH
- Creatinine, BUN, and albumin
- Intact parathyroid hormone (iPTH) every 3 to 12 months depending on CKD severity
How to take Sevelamer?
Powder for Oral Suspension:
- Preparation: Mix the directed amount of powder with water as indicated for the packet size.
- Alternatively, the entire content of the packet can be premixed with a small amount of food or beverage (avoid heating or adding to hot foods or liquids).
- Consumption: Consume the prepared suspension immediately or within 30 minutes.
- For oral suspension in water, it may need to be resuspended right before drinking.
Tablets:
- Administration: Swallow the tablets whole.
- Do Not: Do not crush, chew, or break the tablets.
Mechanism of action of Sevelamer:
- Sevelamer, which is a polymeric compound, works by binding phosphate in the intestines.
- This binding action helps limit the absorption of phosphate into the bloodstream, leading to decreased levels of phosphate in the blood.
- Importantly, sevelamer achieves this without affecting the concentrations of calcium, aluminum, or bicarbonate in the body.
Onset of Action:
- Reduction in serum phosphorus levels typically occurs within 1 to 2 weeks after starting sevelamer treatment. This information is supported by studies conducted in 1997 (Burke, Chertow).
Absorption:
- Sevelamer is not absorbed into the bloodstream, meaning it stays within the gastrointestinal tract and does not enter the systemic circulation.
Sevelamer International brands:
- ACCEL-Sevelamer
- Eurolamer
- Inophos
- Invela
- Lameraseve
- Postiline
- Renagel
- Renosev
- Renvela
- Sevel
- Tasermity
Sevelamer Brands in Pakistan:
|
Sevelamer HCl [Tabs 400 mg] |
|
|
Renavel |
Genome Pharmaceuticals (PVT) LTD. |
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