- Relevant warnings and precautions regarding severe constipation, bowel obstruction, impaction or abnormal post-operative motility, hepatic impairment, edema/fluid retention, sodium-restriction, renal disease comorbidities, heart failure, QT prolongation, gastric pH, serum potassium, hypokalemia, serum aldosterone, serum bicarbonate, fertility, pregnancy, parturition, breastfeeding, and post-natal development.
- Conditions of clinical use, adverse reactions, drug interactions, and dosing instructions
The product monograph is also available from AstraZeneca Canada Inc. at 1-800-668-6000 (ENGLISH), or 1-800-461-3787 (FRENCH).
- The first 10 g dose significantly reduced serum K+ levels at 1 hour vs. placebo [ZS-003]*
- Median time to normokalemia was 2.2 hours [ZS-004; open-label, uncontrolled]‡ (baseline avg: 5.6; range: 4.1–7.2 mmol/L)
- 88% of patients achieved normal potassium values at 48 hours [ZS-004; open-label, uncontrolled]‡
- 88% of LOKELMA patients had mean serum potassium of ≤5.1 mmol/L in the maintenance phase of the study [ZS-005; days 85-365]††
- ~76% of patients maintained normokalemia [ZS-005; days 8-365]††
* Study ZS-003 (n=753): Two-phase, randomized, double-blind, placebo-controlled trial. Phase 1: Patients randomized to LOKELMA (1.25 g, 2.5 g, 5, g, or 10 g) vs. placebo, TID for 48 hours.
‡ Study ZS-004 (n=258): Open-label, uncontrolled, 48-hour correction phase study of patients with hyperkalemia receiving 10 g of LOKELMA administered 3x daily (TID) for 48 hours. Normokalemia defined as serum K+ of 3.5–5.0 mmol/L.
†† Study ZS-005 (n=751): Open-label, uncontrolled, two-phase, long-term (up to 12 mo.) study. Correction phase: LOKELMA 10 g TID over 72 hrs. Patients normokalemic within 72 hrs (n=746) entered maintenance phase (days 8–365): LOKELMA 5 g QD, titrated in 5 g increments down to 5 g QOD or up to 15 g QD (not a recommended dose) based on titration regimen.
AstraZeneca Canada is providing a financial assistance program designed to help your patients save on their LOKELMA prescription. This program is available at no cost to your patients. The InnoviCares card will cover a portion of the price of LOKELMA. It can be used in conjunction with their private or public health plans and is accepted at 98% of Canadian pharmacies. Patients can sign up for an InnoviCares card online at innovicares.ca.
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LOKELMA (sodium zirconium cyclosilicate) is indicated for treatment of hyperkalemia in adult patients.
Pediatrics (<18 years): Health Canada has not authorized an indication for pediatric use.
- Patients with severe constipation, bowel obstruction or impaction, abnormal postoperative bowel motility
- Increased risk of edema/fluid retention
- Sodium-restricted diets
- Heart failure, hepatic impairment, or renal disease comorbidities
- QT prolongation
- Transient increases in gastric pH, affecting solubility and absorption of co-administered drugs with pH-dependent bioavailability
- Monitor serum potassium when clinically indicated
- Reduced serum aldosterone; increased serum bicarbonate
- No data on human fertility
- No clinical studies in pregnant or lactating women
Reproduction studies in animals did not indicate direct harmful effects on pregnancy, fetal development, parturition or post-natal development. Because animal studies are not always predictive of human response, LOKELMA should only be used during pregnancy if potential benefits justify potential risks. LOKELMA is not systemically absorbed and is not expected to be excreted in breast milk.
Consult the Product Monograph at http://azinfo.ca/lokelma/pm565 for important information relating to adverse reactions, drug interactions, and dosing not discussed in this piece. The Product Monograph is also available by calling AstraZeneca Canada Inc. at 1-800-668-6000 (ENGLISH), or 1-800-461-3787 (FRENCH).
REFERENCE: LOKELMA Product Monograph. AstraZeneca Canada Inc. August 12, 2020
*LOKELMA Product Monograph. AstraZeneca Canada Inc. July 23, 2019
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