SEVELAMER CARBONATE FOR ORAL SUSPENSION- sevelamer carbonate powder, for suspension
Dr. Reddys Laboratories Inc
Sevelamer carbonate for oral suspension is indicated for the control of serum phosphorus in adults and children 6 years of age and older with chronic kidney disease (CKD) on dialysis.
Starting Dose for Adult Patients Not Taking a Phosphate Binder. The recommended starting dose of sevelamer carbonate is 0.8 to 1.6 grams taken orally with meals based on serum phosphorus level.
Table 1 provides recommended starting doses of sevelamer carbonate for adult patients not taking a phosphate binder.
Table 1. Starting Dose for Adult Dialysis Patients Not Taking a Phosphate Binder
|Serum Phosphorus||Sevelamer Carbonate|
|> 5.5 and and < 7.5 mg/dL||0.8 grams three times daily with meals|
|≥7.5 mg/dL||1.6 grams three times daily with meals|
Dose Titration for Adult Patients Taking Sevelamer Carbonate. Titrate the sevelamer carbonate dose by 0.8 grams three times per day with meals at two-week intervals as necessary to achieve target serum phosphorus levels. Based on clinical studies, the average prescribed adult daily dose of sevelamer carbonate is approximately 7.2 grams per day. The highest daily adult dose of sevelamer carbonate studied was 14 grams in CKD patients on dialysis.
Starting Dose for Pediatric Patients Not Taking a Phosphate Binder. The recommended starting dose for pediatric patients 6 years of age and older is 0.8 g to 1.6 g taken three times per day with meals based on the patient’s body surface area (BSA) category; see Table 2.
Table 2: Recommended Starting Dosage and Titration Increment Based on Pediatric Patient’s Body Surface Area (m2)
|BSA (m 2 )||Starting Dose Per Meal/Snack||Titration Increases /Decreases Per Dose|
|≥0.75 to <1.2||0.8 g||Titrate by 0.4 g|
|≥1.2||1.6 g||Titrate by 0.8 g|
Dose Titration for Pediatric Patients Taking sevelamer carbonate. Titrate the sevelamer carbonate dose as needed to achieve target levels at two-week intervals based on BSA category, as shown in Table 2.
Switching from Sevelamer Hydrochloride Tablets. For adult patients switching from sevelamer hydrochloride tablets to sevelamer carbonate tablets or powder, use the same dose in grams.
Switching between Sevelamer Carbonate Tablets and Powder. Use the same dose in grams.
Switching from Calcium Acetate. Table 3 gives recommended starting doses of sevelamer carbonate based on a patient’s current calcium acetate dose.
Table 3. Starting Dose for Dialysis Patients Switching from Calcium Acetate to Sevelamer carbonate
|Calcium Acetate 667 mg (Tablets per meal)||Sevelamer Carbonate|
|1 tablet||0.8 grams|
|2 tablets||1.6 grams|
|3 tablets||2.4 grams|
Sevelamer carbonate powder is available in 0.8 or 2.4 grams packets. Place the sevelamer carbonate powder in a cup and suspend in the amount of water described in Table 4.
Table 4. Sevelamer Carbonate Powder Preparation Instructions
|Amount of Sevelamer Carbonate Powder||Minimum Amount of Water for Dose Preparation (either ounces, mL or tablespoon)|
Instruct patients to stir the mixture vigorously (it does not dissolve), resuspend, if necessary, right before administration, and drink the entire preparation within 30 minutes.
As an alternative to water, the entire contents of the packet may be pre-mixed with a small amount of food or beverage and consumed immediately (within 30 minutes) as part of the meal. Do not heat sevelamer carbonate powder (e.g., microwave) or add to heated foods or liquids.
Powder: 0.8 grams and 2.4 grams off white to pale yellow color powder packaged in an opaque, foil lined, heat sealed packets.
Sevelamer carbonate for oral suspension is contraindicated in patients with bowel obstruction.
Sevelamer carbonate for oral suspension is contraindicated in patients with known hypersensitivity to sevelamer carbonate, sevelamer hydrochloride, or to any of the excipients.
Patients with dysphagia, swallowing disorders, severe gastrointestinal (GI) motility disorders, including severe constipation, or major GI tract surgery were not included in the sevelamer carbonate clinical studies.
Cases of dysphagia and esophageal tablet retention have been reported in association with use of the tablet formulation of sevelamer, some requiring hospitalization and intervention. Consider using sevelamer suspension in patients with a history of swallowing disorders.
Cases of bowel obstruction, bleeding gastrointestinal ulcers, colitis, ulceration, necrosis, and perforation have also been reported with sevelamer use [see Adverse Reactions (6.2)]. Inflammatory disorders may resolve upon sevelamer discontinuation. Treatment with sevelamer should be re-evaluated in patients who develop severe gastrointestinal symptoms.
In preclinical studies in rats and dogs, sevelamer hydrochloride, which contains the same active moiety as sevelamer carbonate, reduced vitamins D, E, and K (coagulation parameters) and folic acid levels at doses of 6 to 10 times the recommended human dose. In short-term clinical trials, there was no evidence of reduction in serum levels of vitamins. However, in a one-year clinical trial, 25-hydroxyvitamin D (normal range 10 to 55 ng/mL) fell from 39 ± 22 ng/mL to 34 ± 22 ng/mL (p<0.01) with sevelamer hydrochloride treatment. Most (approximately 75%) patients in sevelamer hydrochloride clinical trials were receiving vitamin supplements.
Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.
There are limited clinical trial data on the safety of sevelamer carbonate. However, because it contains the same active ingredient as the hydrochloride salt, the adverse event profiles of the two salts are expected to be similar. In a cross-over study in hemodialysis patients with treatment durations of eight weeks each and no washout, and another cross-over study in hemodialysis patients, with treatment durations of four weeks each and no washout between treatment periods, the adverse reactions on sevelamer carbonate powder were similar to those reported for sevelamer hydrochloride.
In a parallel design study of sevelamer hydrochloride with treatment duration of 52 weeks, adverse reactions reported for sevelamer hydrochloride (n=99) were similar to those reported for the active-comparator group (n=101). Overall adverse reactions among those treated with sevelamer hydrochloride occurring in > 5% of patients included: vomiting (22%), nausea (20%), diarrhea (19%), dyspepsia (16%), abdominal pain (9%), flatulence (8%) and constipation (8%). A total of 27 patients treated with sevelamer and 10 patients treated with comparator withdrew from the study due to adverse reactions.
Based on studies of 8 to 52 weeks, the most common reason for withdrawal from sevelamer hydrochloride was gastrointestinal adverse reactions (3% to 16%).
In 143 peritoneal dialysis patients studied for 12 weeks using sevelamer hydrochloride, most common adverse reactions were similar to adverse reactions observed in hemodialysis patients. The most frequently occurring treatment emergent serious adverse reaction was peritonitis (8 reactions in 8 patients [8%] in the sevelamer group and 2 reactions in 2 patients [4%] on active-control). Thirteen patients (14%) in the sevelamer group and 9 patients (20%) in the active-control group discontinued, mostly for gastrointestinal adverse reactions.
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