KLOR-CON, Potassium Chloride Form

Potassium chloride for oral solution (Klor-Con® Powder) is a potassium salt supplement.
FDA Approved Indication(s) Klor-Con Powder is indicated for the treatment and prophylaxis of hypokalemia with or without metabolic alkalosis, in patients for whom dietary management with potassium-rich foods or diuretic dose reduction is insufficient.
Policy/Criteria Provider must submit documentation (such as office chart notes, lab results or other clinical information) supporting that member has met all approval criteria.
It is the policy of health plans affiliated with Centene Corporation® that Klor-Con Powder is medically necessary when the following criteria are met:
I. Initial Approval Criteria
A. Hypokalemia (must meet all):

1. Diagnosis of hypokalemia;

2. Member must use oral capsule and tablet formulation (see Appendix B) of potassium salts, unless clinically significant adverse effects are experienced or all are contraindicated;

   3. Dose does not exceed 200 mEq per day. Approval duration: 12 months B. Other diagnoses/indications (must meet 1 or 2):
   4. If this drug has recently (within the last 6 months) undergone a label change (e.g., newly approved indication, age expansion, new dosing regimen) that is not yet reflected in this policy, refer to one of the following policies (a or b): a. For drugs on the formulary (commercial, health insurance marketplace), the no coverage criteria policy for the relevant line of business: HIM.PA.33 for health insurance marketplace; or b. For drugs NOT on the formulary (commercial, health insurance marketplace), the non-formulary policy for the relevant line of business: HIM.PA.103 for health insurance marketplace; or
   5. If the requested use (e.g., diagnosis, age, dosing regimen) is NOT specifically listed under section III (Diagnoses/Indications for which coverage is NOT authorized) AND Page 1 of 5

   CLINICAL POLICY Potassium Chloride for Oral Solution criterion 1 above does not apply, refer to the off-label use policy for the relevant line of business: HIM.PA.154 for health insurance marketplace. II. Continued Therapy A. Hypokalemia (must meet all):

   1. Member meets one of the following (a or b): a. Currently receiving medication via Centene benefit or member has previously met initial approval criteria; b. Member is currently receiving medication and is enrolled in a state and product with continuity of care regulations (refer to state specific addendums for CC.PHARM.03A and CC.PHARM.03B);
3. Member is responding positively to therapy;

4. If request is for a dose increase, new dose does not exceed 200 mEq per day. Approval duration: 12 months B. Other diagnoses/indications (must meet 1 or 2):

   1. If this drug has recently (within the last 6 months) undergone a label change (e.g., newly approved indication, age expansion, new dosing regimen) that is not yet reflected in this policy, refer to one of the following policies (a or b): a. For drugs on the formulary (commercial, health insurance marketplace), the no coverage criteria policy for the relevant line of business: HIM.PA.33 for health insurance marketplace; or b. For drugs NOT on the formulary (commercial, health insurance marketplace), the non-formulary policy for the relevant line of business: HIM.PA.103 for health insurance marketplace; or
   2. If the requested use (e.g., diagnosis, age, dosing regimen) is NOT specifically listed under section III (Diagnoses/Indications for which coverage is NOT authorized) AND criterion 1 above does not apply, refer to the off-label use policy for the relevant line of business: HIM.PA.154 for health insurance marketplace. III. Diagnoses/Indications for which coverage is NOT authorized:
      A. Non-FDA approved indications, which are not addressed in this policy, unless there is sufficient documentation of efficacy and safety according to the off label use policies – HIM.PA.154 for health insurance marketplace or evidence of coverage documents. IV. Appendices/General Information Appendix A: Abbreviation/Acronym Key ER: extended release
      FDA: Food and Drug Administration Appendix B: Therapeutic Alternatives
      This table provides a listing of preferred alternative therapy recommended in the approval criteria. The drugs listed here may not be a formulary agent for all relevant lines of business and may require prior authorization.
      Page 2 of 5

   CLINICAL POLICY Potassium Chloride for Oral Solution Drug Name Dosing Regimen potassium chloride ER capsule (8/10 mEq) Capsule may be taken apart and sprinkled on food. potassium chloride ER tablet (8/10/20 mEq) (Klor-Con® ER

   • 8/10 mEq; K-Tab® ER - 8/10/20 mEq) Treatment of hypokalemia: • Adults: Typical doses range from 40 to 100 mEq/day in 2 to 5 divided doses; limit doses to 40 mEq per dose • Pediatric patients: 2 to 4 mEq/kg/day in divided doses not to exceed 1 mEq/kg as a single dose or 20 mEq, whichever is lower; if deficits are severe or ongoing losses are great, consider intravenous therapy Maintenance or prophylaxis of hypokalemia: • Adults: Typical dose is 20 mEq per day
     • Pediatric patients: Typical dose is 1 mEq/kg/day Treatment of hypokalemia:
     • Adults: Typical dose range is 40-100 mEq per day Maintenance or prophylaxis of hypokalemia:
     • Adults: Typical dose range is 20 mEq per day Dose Limit/ Maximum Dose Adults: 40 mEq/dose Pediatrics: 1 mEq/kg/dose or 20 mEq/dose whichever is lower Adults: 40 mEq/dose potassium chloride ER tablet micro- dispersible (10/15/20 mEq) (Klor-Con® M10/15/20) Treatment of potassium depletion: • Adults: Doses of 40 to 100 mEq per day or more are used Prevention of hypokalemia: • Adults: Doses are typically in the range of 20 mEq per day Adults: 20 mEq/dose Therapeutic alternatives are listed as Brand name® (generic) when the drug is available by brand name only and generic (Brand name®) when the drug is available by both brand and generic. Appendix C: Contraindications/Boxed Warnings • Contraindication(s): concomitant use with potassium sparing diuretics • Boxed warning(s): none reported V. Dosage and Administration
     Dosing Regimen Indication Dilute prior to administration. Monitor serum potassium and adjust dosage accordingly. If serum potassium concentration is < 2.5 mEq/L, use IV potassium instead of PO supplementation. Treatment of hypokalemia Maximum Dose • Adults: Initial doses range from 40 to 100 mEq/day in 2 to 5 divided doses. • Pediatrics (birth to 16 years old): 2 to 4 mEq/kg/day in divided doses; if deficits Adults:
     40 mEq/dose 200 mEq/day
     Pediatrics:
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   CLINICAL POLICY Potassium Chloride for Oral Solution Indication Dosing Regimen are severe or ongoing losses are great, consider IV therapy.
   Maintenance or prophylaxis of hypokalemia • Adults: Typical dose is 20 mEq/day. • Pediatrics (birth to 16 years old): typical dose is 1 mEq/kg/day. Maximum Dose 1 mEq/kg/dose or 40 mEq whichever is lower 100 mEq/day
   Adults: 200 mEq/day Pediatrics: 3 mEq/kg/day VI. Product Availability
   Packet: 1.5 g of potassium chloride providing potassium 20 mEq and chloride 20 mEq VII.