RENVELA 800 MG — DIN 02354586

What is RENVELA?

RENVELA 800 MG contains SEVELAMER CARBONATE : 800 MG. It is listed in the Health Canada Drug Product Database under DIN 02354586, held by SANOFI-AVENTIS CANADA INC, supplied as TABLET for ORAL administration. Health Canada currently lists it as marketed, status dated 24-Jul-2014. Nexara Health is a licensed Canadian wholesale distributor (DEL 3-002896-A) and can source this product for hospitals, pharmacies and clinics. Availability and lead time are confirmed per order.

What is RENVELA used for?

RENVELA (sevelamer carbonate) is indicated for the control of hyperphosphatemia in adult and pediatric patients (≥6 years of age and a Body Surface Area (BSA) of ≥0.75 m²) with end-stage renal disease (ESRD) undergoing dialysis.

Authorized indication as written in the Health Canada product monograph. For healthcare professionals and licensed purchasers; this is not medical advice.

How is it administered?

RENVELA (sevelamer carbonate) is available as tablets or powder for oral suspension. The formulation administered may be based on patient preference; however, a mixture of tablets and powder is not recommended. In the pediatric study, children with a BSA ≥0.75 to <1.2 m² were administered only the powder formulation. As tablets may present a choking hazard to small children, RENVELA powder for oral suspension is recommended for children with a BSA <1.2 m². RENVELA tablets should not be bitten, chewed or broken apart prior to dosing. RENVELA should be taken with meals, since its action is to bind ingested phosphate. When administering any other medication where a reduction in the bioavailability of that medication would have a clinically significant effect on safety or efficacy, the physician should consider monitoring blood levels or dosing that medicine apart from RENVELA to prevent GI binding (at least one hour before or three hours after RENVELA). Monitor serum phosphorus, and adjust the dose of RENVELA based on the desired target range. Tablets: RENVELA 800 mg tablets should be taken three times per day with meals at a dosage based on individual patient requirements to control serum phosphate levels. Powder for oral suspension: RENVELA 0.8 g or 2.4 g powder sachets should be taken three times per day with meals. RENVELA powder sachets can be combined to achieve the required dose to control serum phosphate levels. The recommended amount of water per sachet must be used for reconstitution. Adults (≥18 years of age): Starting dose for patients not using another phosphate binder: If initial serum phosphorus is > 1.8 and < 2.4 mmol/L, take 1 tablet (2.4 grams/day) or 0.8 g powder (2.4 grams/day) three times a day with meals. If initial serum phosphorus is ≥ 2.4 mmol/L, take 2 tablets (4.8 grams/day) or 1.6 g powder (4.8 grams/day) three times a day with meals. For patients previously on sevelamer hydrochloride, RENVELA should be given on a gram for gram basis with monitoring of serum phosphorus levels. Dose adjustments should be done every 1 to 3 weeks by increasing one tablet per meal (3 tablets per day) or 0.8 grams of powder per meal (2.4 grams per day) until desired serum levels are met. The total dose should be divided according to the meal portion during the day. Pediatric patients (6 - <18 years of age): Recommended starting dose is based on the patient's Body Surface Area (BSA) category. For BSA ≥0.75 to <1.2 m², dose is 0.8 g powder three times daily. For BSA ≥1.2 m², dose is 1.6 g powder or tablets three times daily. Titration increases/decreases by 0.4 g three times daily for BSA ≥0.75 to <1.2 m², and by 0.8 g three times daily for BSA ≥1.2 m². RENVELA should be taken three times per day with meals and/or snacks. If a pediatric patient eats less than 3 meals/snacks per day, RENVELA should only be given per meal/snack and not on an empty stomach. Dose adjustments should be performed in two-week intervals for the first 6 weeks, and then every 4 weeks as needed. Reconstitution of Sevelamer Powder for Oral Suspension: The entire contents of each 0.8 g or 2.4 g sachet should be placed in a cup and mixed thoroughly with the amount of water specified in Table 5 (30 mL for 0.4g/0.8g, 60 mL for 2.4g). The powder does not dissolve. Multiple sachets may be mixed at once. For increments of 0.4 g, use one half of a 0.8 g sachet. As an alternative to water, the powder may be mixed with a small amount of cold beverage or food (e.g. 120 mL per 0.8 g or 2.4 g powder sachet) or added to lukewarm foods after cooking (up to 50°C). Do not heat RENVELA powder or add to hot (>50°C) foods or liquids. RENVELA powder preparations made with water or food should be entirely consumed within 30 min after preparation. Tablets should be swallowed intact. Missed Dose: If a dose is forgotten, it should be skipped. Double dosing is not advisable.

Included because it drives pack selection and wastage. Consult the monograph.

Contraindications

RENVELA (sevelamer carbonate) is contraindicated in patients with hypophosphatemia, bowel obstruction, or known active mucosal injury such as necrosis, perforation, ulcerative colitis or gastrointestinal bleeding. It is also contraindicated in patients hypersensitive to sevelamer or one of the other ingredients in the product.

Warnings and precautions

Serious cases of dysphagia, bowel obstruction, and perforation have been associated with RENVELA use, some requiring hospitalization and surgery. Patients with renal insufficiency may develop hypocalcemia; serum calcium levels should be monitored and elemental calcium supplemented if necessary. Caution should be exercised to avoid hypophosphatemia. Rare serious cases of difficulty swallowing RENVELA tablets have been reported, especially in patients with co-morbid conditions affecting swallowing. Powder for oral suspension should be considered for patients with a history of difficulty swallowing and in pediatric patients. Sevelamer binds to bile acids and prevents cholesterol absorption. The safety and efficacy of RENVELA in patients with renal disease not undergoing dialysis has not been established. Cases of dysphagia and esophageal tablet retention have been reported. Cases of bowel obstruction (ileus, subileus) and perforation have also been reported, with constipation potentially being a preceding symptom. Patients with dysphagia, swallowing disorders, severe GI motility disorders (including severe constipation), or major GI tract surgery were not included in clinical studies, and caution should be exercised in these patients. Treatment should be re-evaluated if severe constipation or other severe GI symptoms develop. Cases of serious inflammatory disorders of the gastrointestinal tract (including hemorrhage, perforation, ulceration, necrosis, colitis, and colonic/cecal mass) associated with sevelamer crystals have been reported. Inflammatory disorders may resolve upon RENVELA discontinuation. Treatment discontinuation should be considered in patients who develop severe gastrointestinal symptoms.