sodium zirconium cyclosilicate (Rx)

Brand and Other Names:Lokelma
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Dosing & Uses

AdultPediatric

Dosage Forms & Strengths

powder for oral suspension

  • 5g/packet
  • 10g/packet

Hyperkalemia

Indicated for hyperkalemia

Initial: 10 g PO TID for up to 48 hr

Maintenance

  • 10 g PO qDay
  • May titrate based on serum potassium level and desired target range at intervals of 1 week or longer and in increments of 5 g
  • Dosing may range from 5 g every other day to 15 g qDay); not to exceed 15 g/day

Dosage Modifications

Patients on chronic hemodialysis

  • Starting dose: 5 g PO qDay on nondialysis days
  • If potassium >6.5 mEq/L, consider starting at 10 g PO qDay on nondialysis days
  • Monitor serum potassium and adjust dose based on predialysis serum potassium after the long interdialytic interval and desired target range
  • During initiation and after a dose adjustment, assess serum potassium after 1 week
  • Maintenance dose: 5-15 g PO qDay on nondialysis days
  • Discontinue or decrease dose if serum potassium falls below desired target range based on the predialysis value after the long interdialytic interval, or if clinically significant hypokalemia develops

Dosing Considerations

Not to be used as an emergency treatment for life-threatening hyperkalemia because of its delayed onset of action

Monitor serum potassium and adjust dose based on the serum potassium level and desired target range

Decrease or discontinue dose if serum potassium is below desired target range

Safety and efficacy not been established

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Interactions

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                Monitor Closely (47)

                • acalabrutinib

                  sodium zirconium cyclosilicate will decrease the level or effect of acalabrutinib by increasing gastric pH. Applies only to oral form of both agents. Modify Therapy/Monitor Closely. Check specific recommendations for drugs that exhibit pH-dependent solubility that may affect their systemic exposure and efficacy. In general, administer drugs at least 2 hr before or after sodium zirconium cyclosilicate.

                • amphetamine

                  sodium zirconium cyclosilicate will increase the level or effect of amphetamine by increasing gastric pH. Applies only to oral form of both agents. Modify Therapy/Monitor Closely. Check specific recommendations for drugs that exhibit pH-dependent solubility that may affect their systemic exposure and efficacy. In general, administer drugs at least 2 hr before or after sodium zirconium cyclosilicate. Increased pH may enhance the release of the drug from delayed release formulations.

                • atazanavir

                  sodium zirconium cyclosilicate will decrease the level or effect of atazanavir by increasing gastric pH. Applies only to oral form of both agents. Modify Therapy/Monitor Closely. Check specific recommendations for drugs that exhibit pH-dependent solubility that may affect their systemic exposure and efficacy. In general, administer drugs at least 2 hr before or after sodium zirconium cyclosilicate.

                • atorvastatin

                  sodium zirconium cyclosilicate will increase the level or effect of atorvastatin by increasing gastric pH. Applies only to oral form of both agents. Modify Therapy/Monitor Closely. Separate administration by at least 2 hr. Medications that are weak acids (eg, atorvastatin) are more readily absorbed with elevated gastric pH.

                • axitinib

                  sodium zirconium cyclosilicate will decrease the level or effect of axitinib by increasing gastric pH. Applies only to oral form of both agents. Modify Therapy/Monitor Closely. Check specific recommendations for drugs that exhibit pH-dependent solubility that may affect their systemic exposure and efficacy. In general, administer drugs at least 2 hr before or after sodium zirconium cyclosilicate.

                • bosutinib

                  sodium zirconium cyclosilicate will decrease the level or effect of bosutinib by increasing gastric pH. Applies only to oral form of both agents. Modify Therapy/Monitor Closely. Check specific recommendations for drugs that exhibit pH-dependent solubility that may affect their systemic exposure and efficacy. In general, administer drugs at least 2 hr before or after sodium zirconium cyclosilicate.

                • cefditoren

                  sodium zirconium cyclosilicate will decrease the level or effect of cefditoren by increasing gastric pH. Applies only to oral form of both agents. Modify Therapy/Monitor Closely. Check specific recommendations for drugs that exhibit pH-dependent solubility that may affect their systemic exposure and efficacy. In general, administer drugs at least 2 hr before or after sodium zirconium cyclosilicate.

                • cefpodoxime

                  sodium zirconium cyclosilicate will decrease the level or effect of cefpodoxime by increasing gastric pH. Applies only to oral form of both agents. Modify Therapy/Monitor Closely. Check specific recommendations for drugs that exhibit pH-dependent solubility that may affect their systemic exposure and efficacy. In general, administer drugs at least 2 hr before or after sodium zirconium cyclosilicate.

                • cefuroxime

                  sodium zirconium cyclosilicate will decrease the level or effect of cefuroxime by increasing gastric pH. Applies only to oral form of both agents. Modify Therapy/Monitor Closely. Check specific recommendations for drugs that exhibit pH-dependent solubility that may affect their systemic exposure and efficacy. In general, administer drugs at least 2 hr before or after sodium zirconium cyclosilicate.

                • clopidogrel

                  sodium zirconium cyclosilicate will decrease the level or effect of clopidogrel by increasing gastric pH. Applies only to oral form of both agents. Modify Therapy/Monitor Closely. Clopidogrel active metabolite may be decreased. Separate administration by at least 2 hr.

                • crizotinib

                  sodium zirconium cyclosilicate will decrease the level or effect of crizotinib by increasing gastric pH. Applies only to oral form of both agents. Modify Therapy/Monitor Closely. Check specific recommendations for drugs that exhibit pH-dependent solubility that may affect their systemic exposure and efficacy. In general, administer drugs at least 2 hr before or after sodium zirconium cyclosilicate.

                • cysteamine

                  sodium zirconium cyclosilicate will decrease the level or effect of cysteamine by increasing gastric pH. Applies only to oral form of both agents. Modify Therapy/Monitor Closely. Check specific recommendations for drugs that exhibit pH-dependent solubility that may affect their systemic exposure and efficacy. In general, administer drugs at least 2 hr before or after sodium zirconium cyclosilicate.

                • dabigatran

                  sodium zirconium cyclosilicate will decrease the level or effect of dabigatran by increasing gastric pH. Applies only to oral form of both agents. Modify Therapy/Monitor Closely. Separate administration by at least 2 hr.

                • dabrafenib

                  sodium zirconium cyclosilicate will decrease the level or effect of dabrafenib by increasing gastric pH. Applies only to oral form of both agents. Modify Therapy/Monitor Closely. Check specific recommendations for drugs that exhibit pH-dependent solubility that may affect their systemic exposure and efficacy. In general, administer drugs at least 2 hr before or after sodium zirconium cyclosilicate.

                • dasatinib

                  sodium zirconium cyclosilicate will decrease the level or effect of dasatinib by increasing gastric pH. Applies only to oral form of both agents. Modify Therapy/Monitor Closely. Check specific recommendations for drugs that exhibit pH-dependent solubility that may affect their systemic exposure and efficacy. In general, administer drugs at least 2 hr before or after sodium zirconium cyclosilicate.

                • dexmethylphenidate

                  sodium zirconium cyclosilicate will increase the level or effect of dexmethylphenidate by increasing gastric pH. Applies only to oral form of both agents. Modify Therapy/Monitor Closely. Check specific recommendations for drugs that exhibit pH-dependent solubility that may affect their systemic exposure and efficacy. In general, administer drugs at least 2 hr before or after sodium zirconium cyclosilicate. Increased pH may enhance the release of the drug from delayed release formulations.

                • dextroamphetamine

                  sodium zirconium cyclosilicate will increase the level or effect of dextroamphetamine by increasing gastric pH. Applies only to oral form of both agents. Modify Therapy/Monitor Closely. Check specific recommendations for drugs that exhibit pH-dependent solubility that may affect their systemic exposure and efficacy. In general, administer drugs at least 2 hr before or after sodium zirconium cyclosilicate. Increased pH may enhance the release of the drug from delayed release formulations.

                • erlotinib

                  sodium zirconium cyclosilicate will decrease the level or effect of erlotinib by increasing gastric pH. Applies only to oral form of both agents. Modify Therapy/Monitor Closely. Check specific recommendations for drugs that exhibit pH-dependent solubility that may affect their systemic exposure and efficacy. In general, administer drugs at least 2 hr before or after sodium zirconium cyclosilicate.

                • ferric maltol

                  sodium zirconium cyclosilicate will decrease the level or effect of ferric maltol by increasing gastric pH. Applies only to oral form of both agents. Modify Therapy/Monitor Closely. Check specific recommendations for drugs that exhibit pH-dependent solubility that may affect their systemic exposure and efficacy. In general, administer drugs at least 2 hr before or after sodium zirconium cyclosilicate.

                • ferrous fumarate

                  sodium zirconium cyclosilicate will decrease the level or effect of ferrous fumarate by increasing gastric pH. Applies only to oral form of both agents. Modify Therapy/Monitor Closely. Check specific recommendations for drugs that exhibit pH-dependent solubility that may affect their systemic exposure and efficacy. In general, administer drugs at least 2 hr before or after sodium zirconium cyclosilicate.

                • ferrous gluconate

                  sodium zirconium cyclosilicate will decrease the level or effect of ferrous gluconate by increasing gastric pH. Applies only to oral form of both agents. Modify Therapy/Monitor Closely. Check specific recommendations for drugs that exhibit pH-dependent solubility that may affect their systemic exposure and efficacy. In general, administer drugs at least 2 hr before or after sodium zirconium cyclosilicate.

                • ferrous sulfate

                  sodium zirconium cyclosilicate will decrease the level or effect of ferrous sulfate by increasing gastric pH. Applies only to oral form of both agents. Modify Therapy/Monitor Closely. Check specific recommendations for drugs that exhibit pH-dependent solubility that may affect their systemic exposure and efficacy. In general, administer drugs at least 2 hr before or after sodium zirconium cyclosilicate.

                • fosamprenavir

                  sodium zirconium cyclosilicate will decrease the level or effect of fosamprenavir by increasing gastric pH. Applies only to oral form of both agents. Modify Therapy/Monitor Closely. Check specific recommendations for drugs that exhibit pH-dependent solubility that may affect their systemic exposure and efficacy. In general, administer drugs at least 2 hr before or after sodium zirconium cyclosilicate.

                • furosemide

                  sodium zirconium cyclosilicate will increase the level or effect of furosemide by increasing gastric pH. Applies only to oral form of both agents. Modify Therapy/Monitor Closely. Separate administration by at least 2 hr. Medications that are weak acids (eg, furosemide) are more readily absorbed with elevated gastric pH.

                • gefitinib

                  sodium zirconium cyclosilicate will decrease the level or effect of gefitinib by increasing gastric pH. Applies only to oral form of both agents. Modify Therapy/Monitor Closely. Check specific recommendations for drugs that exhibit pH-dependent solubility that may affect their systemic exposure and efficacy. In general, administer drugs at least 2 hr before or after sodium zirconium cyclosilicate.

                • gemifloxacin

                  sodium zirconium cyclosilicate will decrease the level or effect of gemifloxacin by increasing gastric pH. Applies only to oral form of both agents. Modify Therapy/Monitor Closely. Check specific recommendations for drugs that exhibit pH-dependent solubility that may affect their systemic exposure and efficacy. In general, administer drugs at least 2 hr before or after sodium zirconium cyclosilicate.

                • glyburide

                  sodium zirconium cyclosilicate will increase the level or effect of glyburide by increasing gastric pH. Applies only to oral form of both agents. Modify Therapy/Monitor Closely. Check specific recommendations for drugs that exhibit pH-dependent solubility that may affect their systemic exposure and efficacy. In general, administer drugs at least 2 hr before or after sodium zirconium cyclosilicate.

                • indinavir

                  sodium zirconium cyclosilicate will decrease the level or effect of indinavir by increasing gastric pH. Applies only to oral form of both agents. Modify Therapy/Monitor Closely. Check specific recommendations for drugs that exhibit pH-dependent solubility that may affect their systemic exposure and efficacy. In general, administer drugs at least 2 hr before or after sodium zirconium cyclosilicate.

                • itraconazole

                  sodium zirconium cyclosilicate will decrease the level or effect of itraconazole by increasing gastric pH. Applies only to oral form of both agents. Modify Therapy/Monitor Closely. Check specific recommendations for drugs that exhibit pH-dependent solubility that may affect their systemic exposure and efficacy. In general, administer drugs at least 2 hr before or after sodium zirconium cyclosilicate.

                • ketoconazole

                  sodium zirconium cyclosilicate will decrease the level or effect of ketoconazole by increasing gastric pH. Applies only to oral form of both agents. Modify Therapy/Monitor Closely. Check specific recommendations for drugs that exhibit pH-dependent solubility that may affect their systemic exposure and efficacy. In general, administer drugs at least 2 hr before or after sodium zirconium cyclosilicate.

                • ledipasvir/sofosbuvir

                  sodium zirconium cyclosilicate will decrease the level or effect of ledipasvir/sofosbuvir by increasing gastric pH. Applies only to oral form of both agents. Modify Therapy/Monitor Closely. Check specific recommendations for drugs that exhibit pH-dependent solubility that may affect their systemic exposure and efficacy. In general, administer drugs at least 2 hr before or after sodium zirconium cyclosilicate.

                • mesalamine

                  sodium zirconium cyclosilicate will decrease the level or effect of mesalamine by increasing gastric pH. Applies only to oral form of both agents. Modify Therapy/Monitor Closely. Check specific recommendations for drugs that exhibit pH-dependent solubility that may affect their systemic exposure and efficacy. In general, administer drugs at least 2 hr before or after sodium zirconium cyclosilicate.

                • methylphenidate

                  sodium zirconium cyclosilicate will increase the level or effect of methylphenidate by increasing gastric pH. Applies only to oral form of both agents. Modify Therapy/Monitor Closely. Check specific recommendations for drugs that exhibit pH-dependent solubility that may affect their systemic exposure and efficacy. In general, administer drugs at least 2 hr before or after sodium zirconium cyclosilicate. Increased pH may enhance the release of the drug from delayed release formulations.

                • mycophenolate

                  sodium zirconium cyclosilicate will decrease the level or effect of mycophenolate by increasing gastric pH. Applies only to oral form of both agents. Modify Therapy/Monitor Closely. Check specific recommendations for drugs that exhibit pH-dependent solubility that may affect their systemic exposure and efficacy. In general, administer drugs at least 2 hr before or after sodium zirconium cyclosilicate.

                • nelfinavir

                  sodium zirconium cyclosilicate will decrease the level or effect of nelfinavir by increasing gastric pH. Applies only to oral form of both agents. Modify Therapy/Monitor Closely. Check specific recommendations for drugs that exhibit pH-dependent solubility that may affect their systemic exposure and efficacy. In general, administer drugs at least 2 hr before or after sodium zirconium cyclosilicate.

                • neratinib

                  sodium zirconium cyclosilicate will decrease the level or effect of neratinib by increasing gastric pH. Applies only to oral form of both agents. Modify Therapy/Monitor Closely. Check specific recommendations for drugs that exhibit pH-dependent solubility that may affect their systemic exposure and efficacy. In general, administer drugs at least 2 hr before or after sodium zirconium cyclosilicate.

                • nilotinib

                  sodium zirconium cyclosilicate will decrease the level or effect of nilotinib by increasing gastric pH. Applies only to oral form of both agents. Modify Therapy/Monitor Closely. Check specific recommendations for drugs that exhibit pH-dependent solubility that may affect their systemic exposure and efficacy. In general, administer drugs at least 2 hr before or after sodium zirconium cyclosilicate.

                • pazopanib

                  sodium zirconium cyclosilicate will decrease the level or effect of pazopanib by increasing gastric pH. Applies only to oral form of both agents. Modify Therapy/Monitor Closely. Check specific recommendations for drugs that exhibit pH-dependent solubility that may affect their systemic exposure and efficacy. In general, administer drugs at least 2 hr before or after sodium zirconium cyclosilicate.

                • ponatinib

                  sodium zirconium cyclosilicate will decrease the level or effect of ponatinib by increasing gastric pH. Applies only to oral form of both agents. Modify Therapy/Monitor Closely. Check specific recommendations for drugs that exhibit pH-dependent solubility that may affect their systemic exposure and efficacy. In general, administer drugs at least 2 hr before or after sodium zirconium cyclosilicate.

                • posaconazole

                  sodium zirconium cyclosilicate will decrease the level or effect of posaconazole by increasing gastric pH. Applies only to oral form of both agents. Modify Therapy/Monitor Closely. Check specific recommendations for drugs that exhibit pH-dependent solubility that may affect their systemic exposure and efficacy. In general, administer drugs at least 2 hr before or after sodium zirconium cyclosilicate.

                • prasugrel

                  sodium zirconium cyclosilicate will decrease the level or effect of prasugrel by increasing gastric pH. Applies only to oral form of both agents. Modify Therapy/Monitor Closely. Check specific recommendations for drugs that exhibit pH-dependent solubility that may affect their systemic exposure and efficacy. In general, administer drugs at least 2 hr before or after sodium zirconium cyclosilicate.

                • raltegravir

                  sodium zirconium cyclosilicate will increase the level or effect of raltegravir by increasing gastric pH. Applies only to oral form of both agents. Modify Therapy/Monitor Closely. Check specific recommendations for drugs that exhibit pH-dependent solubility that may affect their systemic exposure and efficacy. In general, administer drugs at least 2 hr before or after sodium zirconium cyclosilicate.

                • rilpivirine

                  sodium zirconium cyclosilicate will decrease the level or effect of rilpivirine by increasing gastric pH. Applies only to oral form of both agents. Modify Therapy/Monitor Closely. Check specific recommendations for drugs that exhibit pH-dependent solubility that may affect their systemic exposure and efficacy. In general, administer drugs at least 2 hr before or after sodium zirconium cyclosilicate.

                • risedronate

                  sodium zirconium cyclosilicate, risedronate. increasing gastric pH. Applies only to oral form of both agents. Modify Therapy/Monitor Closely. Check specific recommendations for drugs that exhibit pH-dependent solubility that may affect their systemic exposure and efficacy. In general, administer drugs at least 2 hr before or after sodium zirconium cyclosilicate.

                • tolbutamide

                  sodium zirconium cyclosilicate will increase the level or effect of tolbutamide by increasing gastric pH. Applies only to oral form of both agents. Modify Therapy/Monitor Closely. Check specific recommendations for drugs that exhibit pH-dependent solubility that may affect their systemic exposure and efficacy. In general, administer drugs at least 2 hr before or after sodium zirconium cyclosilicate.

                • velpatasvir

                  sodium zirconium cyclosilicate will decrease the level or effect of velpatasvir by increasing gastric pH. Applies only to oral form of both agents. Modify Therapy/Monitor Closely. Check specific recommendations for drugs that exhibit pH-dependent solubility that may affect their systemic exposure and efficacy. In general, administer drugs at least 2 hr before or after sodium zirconium cyclosilicate.

                • warfarin

                  sodium zirconium cyclosilicate will increase the level or effect of warfarin by increasing gastric pH. Applies only to oral form of both agents. Modify Therapy/Monitor Closely. Separate administration by at least 2 hr. Medications that are weak acids (eg, warfarin) are more readily absorbed with elevated gastric pH.

                Minor (0)

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                  Adverse Effects

                  >10%

                  Edema (4.4-16.1%)

                  1-10%

                  Hypokalemia (4.1%)

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                  Warnings

                  Contraindications

                  None

                  Cautions

                  Avoid with severe constipation or bowel obstruction or impaction, including abnormal postoperative bowel motility disorders; safety and efficacy not studied in these patients and may be ineffective and may worsen GI conditions

                  Each 5-g dose of sodium zirconium cyclosilicate contains ~400 mg of sodium; in clinical trials, mild-to-moderate edema was more commonly seen in patients treated with 15 g qDay; monitor for signs of edema, particularly in patients who should restrict their sodium intake or are prone to fluid overload (eg, heart failure, renal disease); increase diuretic dose as needed

                  This agent has radio-opaque properties and, therefore, may give the appearance typical of an imaging agent during abdominal X-ray procedures

                  Edema

                  • Each 5 g contains ~400 mg of sodium, but the extent of absorption by the patient is unknown
                  • Edema was observed in clinical trials and was generally mild to moderate in severity and was more commonly seen in patients treated with 15 g once daily
                  • Monitor for signs of edema, particularly in patients who should restrict their sodium intake or are prone to fluid overload (eg, heart failure, renal disease)
                  • Advise patients to adjust dietary sodium, if appropriate
                  • Increase dose of diuretics as needed

                  Hypokalemia in patients on chronic hemodialysis

                  • Patients on hemodialysis may be prone to acute illness that can increase the risk of hypokalemia (eg, illnesses associated with decreased oral intake, diarrhea)
                  • Consider adjusting dose based on potassium levels in these settings

                  Drug interactions overview

                  • Transient changes of gastric pH
                    • Sodium zirconium cyclosilicate transiently increases gastric pH, which can change the absorption of coadministered drugs that exhibit pH-dependent solubility, potentially leading to altered efficacy or safety of these drugs when coadministered
                    • In general, other oral medications whose solubility is pH-dependent should be administered at least 2 hr before or after sodium zirconium cyclosilicate
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                  Pregnancy

                  Pregnancy

                  Not absorbed systemically following oral administration and maternal use is not expected to result in fetal exposure to the drug

                  Lactation

                  Not absorbed systemically following oral administration, and breastfeeding is not expected to result in exposure to the child

                  Pregnancy Categories

                  A: Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.

                  B: May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.

                  C: Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.

                  D: Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk.

                  X: Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist.

                  NA: Information not available.

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                  Pharmacology

                  Mechanism of Action

                  Potassium binder; nonabsorbed zirconium silicate that preferentially captures potassium in exchange for hydrogen and sodium

                  It increases fecal potassium excretion through binding of potassium in the lumen of the GI tract; binding of potassium reduces the free potassium concentration in the GI lumen, thereby lowering serum potassium level

                  Absorption

                  In a clinical study in patients with hyperkalemia in which zirconium concentrations were measured in the urine and blood, zirconium concentrations were similar in treated and untreated patients

                  Excretion

                  A vivo mass balance study in rats showed the drug was recovered in the feces with no evidence of systemic absorption

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                  Administration

                  Oral Administration

                  Empty the entire contents of the packet(s) into a drinking glass containing ~3 tablespoons of water or more if desired

                  Stir well and drink immediately

                  If powder still remains in the drinking glass, add water, stir, and drink immediately; repeat until no powder remains to ensure the entire dose is taken

                  Storage

                  Packets: Store at 15-30°C (59-86°F)

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                  Images

                  BRAND FORM. UNIT PRICE PILL IMAGE
                  Lokelma oral
                  -
                  5 gram powder
                  Lokelma oral
                  -
                  10 gram powder
                  Lokelma oral
                  -
                  10 gram powder
                  Lokelma oral
                  -
                  5 gram powder
                  Lokelma oral
                  -
                  5 gram powder
                  Lokelma oral
                  -
                  10 gram powder

                  Copyright © 2010 First DataBank, Inc.

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                  Formulary

                  FormularyPatient Discounts

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                  The above information is provided for general informational and educational purposes only. Individual plans may vary and formulary information changes. Contact the applicable plan provider for the most current information.

                  Tier Description
                  1 This drug is available at the lowest co-pay. Most commonly, these are generic drugs.
                  2 This drug is available at a middle level co-pay. Most commonly, these are "preferred" (on formulary) brand drugs.
                  3 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs.
                  4 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
                  5 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
                  6 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
                  NC NOT COVERED – Drugs that are not covered by the plan.
                  Code Definition
                  PA Prior Authorization
                  Drugs that require prior authorization. This restriction requires that specific clinical criteria be met prior to the approval of the prescription.
                  QL Quantity Limits
                  Drugs that have quantity limits associated with each prescription. This restriction typically limits the quantity of the drug that will be covered.
                  ST Step Therapy
                  Drugs that have step therapy associated with each prescription. This restriction typically requires that certain criteria be met prior to approval for the prescription.
                  OR Other Restrictions
                  Drugs that have restrictions other than prior authorization, quantity limits, and step therapy associated with each prescription.
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                  Medscape prescription drug monographs are based on FDA-approved labeling information, unless otherwise noted, combined with additional data derived from primary medical literature.