colesevelam (Rx)

Brand and Other Names:WelChol
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Dosing & Uses

AdultPediatric

Dosage Forms & Strengths

tablet

  • 625mg

powder for oral suspension

  • 3.75g/packet

Hyperlipidemia

Indicated as adjunctive therapy to diet and exercise to reduce elevated low-density lipoprotein cholesterol (LDL-C) in adults with primary hyperlipidemia

Tablet: 1.875 g (3 tablets) PO q12hr or 3.75 g (6 tablets) PO qDay

Oral suspension: 1.875 g (½ packet) PO q12hr or 3.75 g (1 packet) PO qDay

Type 2 Diabetes Mellitus

Indicated as adjunctive therapy to improve of glycemic control in adults

Tablet: 1.875 g (3 tablets) PO q12hr or 3.75 g (6 tablets) PO qDay

Oral suspension: 1.875 g (½ packet) PO q12hr or 3.75 g (1 packet) PO qDay

Dosing Considerations

Obtain lipid panel, including triglycerides (TG) levels and non-HDL-C, before starting treatment; contraindicated in patients with TG levels >500 mg/dL

Limitations of use

  • Should not be used for treatment of type 1 diabetes or diabetic ketoacidosis
  • Effect of colesevelam on cardiovascular morbidity and mortality not determined
  • Not studied
    • Type 2 diabetes in combination with a dipeptidyl peptidase 4 inhibitor
    • Fredrickson Type I, III, IV, and V dyslipidemia

Dosage Forms & Strengths

tablet

  • 625mg

powder for oral suspension

  • 3.75g/packet

Heterozygous Familial Hypercholesterolemia

Indicated to reduce LDL-C levels in boys and postmenarchal girls (10-17 years) with heterozygous familial hypercholesterolemia (HeFH) who are unable to reach LDL-C target levels despite an adequate trial of dietary therapy and lifestyle modification

<10 years: Safety and efficacy not established

10-17 years

  • Tablet: 1.875 g (3 tablets) PO q12hr or 3.75 g (6 tablets) PO qDay
  • Oral suspension: 1.875 g (½ packet) PO q12hr or 3.75 g (1 packet) PO qDay
  • Due to tablet size, oral suspension is recommended for use in the pediatric population

Dosing Considerations

Obtain lipid panel, including triglycerides (TG) levels and non-HDL-C, before starting treatment; contraindicated in patients with TG levels >500 mg/dL

Limitations of use

  • Should not be used for treatment of type 1 diabetes or diabetic ketoacidosis
  • Effect of colesevelam on cardiovascular morbidity and mortality not determined
  • Not studied
    • Type 2 diabetes in combination with a dipeptidyl peptidase 4 inhibitor
    • Fredrickson Type I, III, IV, and V dyslipidemia
    • Children <10 years or in premenarchal girls
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Interactions

Interaction Checker

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        Significant - Monitor Closely

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              Serious - Use Alternative (0)

                Monitor Closely (23)

                • cholic acid

                  colesevelam will decrease the level or effect of cholic acid by drug binding in GI tract. Use Caution/Monitor. Take cholic acid at least 1 hr before or 4-6 hr (or as great an interval as possible) after a bile acid binding resin.

                • cyclosporine

                  colesevelam decreases levels of cyclosporine by drug binding in GI tract. Use Caution/Monitor. Concomitant administration decreases cyclosporine absorption; however, absorption is not reduced when cyclosporine is administered 4 hr before colesevelam.

                • doxercalciferol

                  colesevelam decreases levels of doxercalciferol by inhibition of GI absorption. Applies only to oral form of both agents. Use Caution/Monitor. (Vitamin D analog).

                • fosphenytoin

                  colesevelam will decrease the level or effect of fosphenytoin by Mechanism: inhibition of GI absorption. Applies only to oral form of both agents. Modify Therapy/Monitor Closely. Administer fosphenytoin at least 4 hr before colesevelam

                • glimepiride

                  colesevelam decreases levels of glimepiride by drug binding in GI tract. Use Caution/Monitor. Concomitant administration decreases glimepiride absorption; however, absorption is not reduced when glimepiride is administered 4 hr before colesevelam.

                • glipizide

                  colesevelam decreases levels of glipizide by drug binding in GI tract. Use Caution/Monitor. Concomitant administration decreases glipizide absorption; however, absorption is not reduced when glipizide is administered 4 hr before colesevelam.

                • glyburide

                  colesevelam decreases levels of glyburide by drug binding in GI tract. Use Caution/Monitor. Concomitant administration decreases glyburide absorption; however, absorption is not reduced when glyburide is administered 4 hr before colesevelam.

                • levonorgestrel oral/ethinylestradiol/ferrous bisglycinate

                  colesevelam decreases levels of levonorgestrel oral/ethinylestradiol/ferrous bisglycinate by Other (see comment). Modify Therapy/Monitor Closely. Comment: Colesevelam, a bile acid sequestrant, given together with a combined hormonal contraceptives (CHCs), has been shown to significantly decrease the AUC of ethinyl estradiol (EE). Oral contraceptives containing ethinyl estradiol should be administered at least 4 hours before the colesevelam dose.

                • levothyroxine

                  colesevelam decreases levels of levothyroxine by drug binding in GI tract. Use Caution/Monitor. Concomitant administration decreases levothyroxine absorption; however, absorption is not reduced when levothyroxine is administered 4 hr before colesevelam.

                • liothyronine

                  colesevelam will decrease the level or effect of liothyronine by Mechanism: inhibition of GI absorption. Applies only to oral form of both agents. Modify Therapy/Monitor Closely. Administer thyroid hormones at least 4 hr before colesevelam. Elevated thyroid-stimulating hormone (TSH) in patients receiving thyroid hormone.

                • lomitapide

                  colesevelam decreases levels of lomitapide by drug binding in GI tract. Use Caution/Monitor. Separate lomitapide and administration of bile acid sequestrants by at least 4 hours; bile acid sequestrants can interfere with the absorption of oral medications.

                • metformin

                  colesevelam increases levels of metformin by pharmacodynamic antagonism. Use Caution/Monitor.

                • norethindrone

                  colesevelam decreases levels of norethindrone by drug binding in GI tract. Use Caution/Monitor. Administer oral contraceptives containing norethindrone/ethinyl estradiol at least 4 hr before colesevelam to avoid decreased absorption.

                • obeticholic acid

                  colesevelam will decrease the level or effect of obeticholic acid by drug binding in GI tract. Modify Therapy/Monitor Closely. Administer obeticholic acid at least 4 hr before or 4 hr after taking a bile acid binding resins.

                • odevixibat

                  colesevelam will decrease the level or effect of odevixibat by drug binding in GI tract. Modify Therapy/Monitor Closely. Administer bile acid sequestrants 4 hr before or after odevixibat.

                • olmesartan

                  colesevelam decreases levels of olmesartan by drug binding in GI tract. Use Caution/Monitor. Concomitant administration decreases levothyroxine absorption; however, absorption is not reduced when levothyroxine is administered 4 hr before colesevelam.

                • omadacycline

                  colesevelam will decrease the level or effect of omadacycline by inhibition of GI absorption. Applies only to oral form of both agents. Modify Therapy/Monitor Closely. Monitor for decreased effects of tetracyclines if coadministered with a bile acid sequestrant. Separate doses 2 or more hours if these agents are used concomitantly.

                • paricalcitol

                  colesevelam decreases levels of paricalcitol by inhibition of GI absorption. Applies only to oral form of both agents. Use Caution/Monitor. (Vitamin D analog).

                • phenytoin

                  colesevelam will decrease the level or effect of phenytoin by Mechanism: inhibition of GI absorption. Applies only to oral form of both agents. Modify Therapy/Monitor Closely. Administer phenytoin at least 4 hr before colesevelam

                • sarecycline

                  colesevelam will decrease the level or effect of sarecycline by inhibition of GI absorption. Applies only to oral form of both agents. Modify Therapy/Monitor Closely. Monitor for decreased effects of tetracyclines if coadministered with a bile acid sequestrant. Separate doses by 2 or more hours if coadministered.

                • thyroid desiccated

                  colesevelam will decrease the level or effect of thyroid desiccated by Mechanism: inhibition of GI absorption. Applies only to oral form of both agents. Modify Therapy/Monitor Closely. Administer thyroid hormones at least 4 hr before colesevelam. Elevated thyroid-stimulating hormone (TSH) in patients receiving thyroid hormone.

                • vitamin D

                  colesevelam will decrease the level or effect of vitamin D by Other (see comment). Use Caution/Monitor. Bile acid sequestrants may decrease the absorption of fat-soluble vitamins. Administer vitamin supplementation at least 4 hours prior to colesevelam.

                • warfarin

                  colesevelam will decrease the level or effect of warfarin by Mechanism: inhibition of GI absorption. Applies only to oral form of both agents. Modify Therapy/Monitor Closely. Administer warfarin at least 4 hr before colesevelam. Monitor INR frequently during colesevelam initiation or discontinuance.

                Minor (4)

                • chenodiol

                  colesevelam decreases levels of chenodiol by inhibition of GI absorption. Applies only to oral form of both agents. Minor/Significance Unknown.

                • ursodiol

                  colesevelam decreases effects of ursodiol by pharmacodynamic antagonism. Minor/Significance Unknown.

                • verapamil

                  colesevelam decreases levels of verapamil by inhibition of GI absorption. Applies only to oral form of both agents. Minor/Significance Unknown. (Sustained release form of verapamil).

                • vitamin K1 (phytonadione)

                  colesevelam decreases levels of vitamin K1 (phytonadione) by inhibition of GI absorption. Applies only to oral form of both agents. Minor/Significance Unknown. (Vitamin K).

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                Adverse Effects

                >10%

                Constipation (6.5-11%)

                1-10%

                Dyspepsia (2.8-8.3%)

                Headache (3.9-7.6%)

                Nasopharyngitis (5.4-6.2%)

                Upper respiratory tract infection (4.9%)

                Nausea (4.2%)

                Influenza (3.8%)

                Nausea (2.6-3.8%)

                Accidental injury (3.7%)

                Asthenia (3.6%)

                Hypoglycemia (3.4%)

                Pharyngitis (3.2%)

                Flu syndrome (3.2%)

                Rhinitis (3.2%)

                Fatigue (3.9%)

                Hypertension (2.6%)

                Creatine phosphokinase increase (2.3%)

                Rhinitis (2.3%)

                Vomiting (2.3%)

                Back pain (2.3%)

                Myalgia (2.1%)

                Postmarketing Reports

                Gastrointestinal: Bowel obstruction (in patients with a history of bowel obstruction or resection), dysphagia or esophageal obstruction (occasionally requiring medical intervention), fecal impaction, pancreatitis, abdominal distension, exacerbation of hemorrhoids, and increased transaminases

                Laboratory abnormalities: Hypertriglyceridemia

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                Warnings

                Contraindications

                Serum TG concentrations >500 mg/dL

                History of hypertriglyceridemia-induced pancreatitis

                History of bowel obstruction

                Cautions

                Tablets can cause dysphagia or esophageal obstruction due to size; for patients with difficulty swallowing tablets use oral suspension

                May increase serum TG concentrations, hypertriglyceridemia can cause acute pancreatitis

                Secondary causes of hyperlipidemia must be ruled out before therapy is initiated

                Postmarketing cases of bowel obstruction have occurred; not recommended in gastroparesis (constipating effects); instruct patients to promptly discontinue therapy and seek medical attention if severe abdominal pain or severe constipation occurs

                May exacerbate preexisting constipation (initiate therapy at lower dosage in patients with history of constipation)

                Seek prompt medical attention if symptoms of acute pancreatitis occur (e.g., severe abdominal pain with or without nausea and vomiting)

                Phenylalanine can be harmful to patients with phenylketonuria (PKU); before prescribing oral suspension to a patient with PKU, consider combined daily amount of phenylalanine from all sources, including oral suspension

                Drug interactions overview

                • May reduce absorption of some drugs and nutrients; administer drugs with known interactions or narrow therapeutic index 4 hr before colesevelam
                • Bile acid sequestrants may decrease absorption of fat-soluble vitamins; administer vitamin at least 4 hr prior to colesevelam
                • In vivo drug interactions studies showed a decrease in exposure of ethinyl estradiol, norethindrone, olmesartan, and sulfonylureas when coadministered with colesevelam; also showed increase in metformin ER when coadministered colesevelam
                • Adverse reactions resulting from coadministration with colesevelam
                  • Increased seizure activity or decreased phenytoin levels in patients receiving phenytoin
                  • Reduced INR in patients receiving warfarin therapy; monitor INR
                  • Elevated thyroid-stimulating hormone (TSH) in patients receiving thyroid hormone replacement therapy; administer thyroid hormone replacement therapy 4 hr prior to colesevelam
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                Pregnancy & Lactation

                Pregnancy

                There are no adequate and well-controlled studies of colesevelam hydrochloride use in pregnant women

                In the postmarketing setting, there have been reports of pregnancy and a causal association with congenital anomalies has not been established

                Animal data

                • In animal reproduction studies, no evidence of either maternal or fetal toxicity was found in rats or rabbits exposed to colesevelam hydrochloride during the period of fetal organogenesis at 8 and 5 times, respectively, the maximum recommended human dose (MRHD) of 3.75 g/day, based on body surface area (mg/m2)

                Contraception

                • Coadministration with colesevelam and oral contraceptives may reduce efficacy of oral contraceptives; advise patients to take oral contraceptives at least 4 hr prior to taking therapy

                Lactation

                Not absorbed systemically by mother following oral administration, and breastfeeding is not expected to result in exposure of child to drug

                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

                Forms complex with bile acids that is not absorbed through intestine; inhibits enterohepatic reuptake of intestinal bile salts, and this, in turn, increases fecal loss of bile salt-bound LDL and consequently reduces serum cholesterol in patients with primary hypercholesterolemia

                Absorption

                Colesevelam HCl is a hydrophilic, water-insoluble polymer not hydrolyzed by digestive enzymes and is not absorbed

                Distribution

                Distribution is limited to the gastrointestinal tract

                Metabolism

                Not metabolized systemically and does not interfere with systemic drug-metabolizing enzymes (eg, CYP450)

                Elimination

                Excretion: Urine (0.05%)

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                Administration

                Oral Administration

                Tablet: Take with meals and plenty of liquid; use oral suspension if patient has difficulty swallowing tablets (eg, pediatric patients)

                Oral suspension: Empty packet in 4-8 oz of water, fruit juice, or diet soft drink and stir; drink with meal(s); do not take oral suspension in dry form

                May be coadministered with statins or administered at separate times; monitor lipid levels within 4-6 weeks after initiation

                Storage

                Store at 25°C (77°F); excursions permitted to 15-30°C (59-86°F)

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                Images

                BRAND FORM. UNIT PRICE PILL IMAGE
                WelChol oral
                -
                3.75 gram powder
                WelChol oral
                -
                625 mg tablet
                colesevelam oral
                -
                625 mg tablet
                colesevelam oral
                -
                3.75 gram powder
                colesevelam oral
                -
                3.75 gram powder
                colesevelam oral
                -
                625 mg tablet
                colesevelam oral
                -
                625 mg tablet
                colesevelam oral
                -
                625 mg tablet
                colesevelam oral
                -
                625 mg tablet

                Copyright © 2010 First DataBank, Inc.

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                Patient Handout

                Patient Education
                colesevelam oral

                COLESEVELAM - ORAL

                (KOE-le-SEV-e-lam)

                COMMON BRAND NAME(S): Welchol

                USES: This medication is used along with a proper diet and exercise to lower cholesterol in people with high levels of cholesterol in the blood. Lowering cholesterol decreases the risk of heart disease and helps prevent strokes and heart attacks.Colesevelam is also used along with a proper diet and exercise to lower high blood sugar in people with type 2 diabetes. Controlling high blood sugar helps prevent kidney damage, blindness, nerve problems, loss of limbs, and sexual function problems. Proper control of diabetes may also lessen your risk of a heart attack or stroke.Colesevelam belongs to a class of drugs called bile acid-binding resins. Bile acid is a natural substance the liver makes by using cholesterol. This medication works by removing bile acid from the body. This causes the liver to make more bile acid by using cholesterol, which reduces cholesterol levels in the blood. It is not known how colesevelam works in lowering blood sugar.

                HOW TO USE: Take this medication by mouth with a meal, usually 1 to 2 times daily or as directed by your doctor. Take the tablet form with a liquid (such as water, milk). If you have trouble swallowing the tablet, talk to your doctor about switching to the powder form of this medication.If you are using the powder form of this medication, pour the contents of one packet into a glass. Add one cup (8 ounces/240 milliliters) of water, fruit juice, or diet soda. Stir the mixture well and drink all of it. Do not take the powder without mixing it in liquid.Take this medication regularly to get the most benefit from it. To help you remember, take it at the same time(s) each day.It may take several weeks before you get the full benefit of this drug.Colesevelam may decrease the absorption of other products you may be taking. Some examples include cyclosporine, glipizide, glimepiride, glyburide, levothyroxine, and phenytoin, as well as birth control pills that contain ethinyl estradiol and norethindrone. Take other medications as directed by your doctor, usually at least 4 hours before taking your colesevelam dose. Ask your pharmacist if you are not sure when to take your medications.

                SIDE EFFECTS: Constipation and upset stomach may occur. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.To prevent constipation, eat dietary fiber, drink enough water, and exercise. You may also need to take a laxative. Ask your pharmacist which type of laxative is right for you.Remember that this medication has been prescribed because your doctor has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.Tell your doctor right away if any of these unlikely but serious side effects occur: nausea/vomiting, stomach/abdominal pain, trouble swallowing, unusual bleeding/bruising.This medication does not usually cause low blood sugar (hypoglycemia). Low blood sugar may occur if this drug is prescribed with other diabetes medications, or if you do not consume enough calories from food, or if you do unusually heavy exercise.Symptoms of low blood sugar include sudden sweating, shaking, fast heartbeat, hunger, blurred vision, dizziness, or tingling hands/feet. It is a good habit to carry glucose tablets or gel to treat low blood sugar. If you don't have these reliable forms of glucose, rapidly raise your blood sugar by eating a quick source of sugar such as table sugar, honey, or candy, or drink fruit juice or non-diet soda. Tell your doctor right away about the reaction and the use of this product. To help prevent low blood sugar, eat meals on a regular schedule, and do not skip meals. Check with your doctor or pharmacist to find out what you should do if you miss a meal.Symptoms of high blood sugar (hyperglycemia) include thirst, increased urination, confusion, drowsiness, flushing, rapid breathing, and fruity breath odor. If these symptoms occur, tell your doctor right away. Your dosage may need to be increased.A very serious allergic reaction to this drug is rare. However, seek immediate medical attention if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.In the US -Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch.In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

                PRECAUTIONS: Before taking colesevelam, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.Before using this medication, tell your doctor or pharmacist your medical history, especially of: pancreatitis (caused by high triglyceride levels), high triglyceride levels, trouble swallowing, stomach/intestinal disorders (such as constipation, blockage, gastroparesis), recent major intestinal surgery, hemorrhoids.Because this drug can interfere with the absorption of certain vitamins (such as vitamins A, D, E, K) when used for a long period of time, your doctor may direct you to take a multivitamin supplement. Take the multivitamin at least 4 hours before taking your colesevelam dose.The powder form of this medication may contain aspartame. If you have phenylketonuria (PKU) or any other condition that requires you to restrict your intake of aspartame (or phenylalanine), consult your doctor or pharmacist about using this medication safely.Tell your doctor if you are pregnant before using this medication.This medication is unlikely to pass into breast milk or harm a nursing infant. Consult your doctor before breast-feeding.

                DRUG INTERACTIONS: See also How to Use section.Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval.Some products that may interact with this drug include: raloxifene, warfarin.Beta-blocker medications (such as metoprolol, propranolol, glaucoma eye drops such as timolol) may prevent the fast/pounding heartbeat you would usually feel when your blood sugar falls too low (hypoglycemia). Other symptoms of low blood sugar, such as dizziness, hunger, or sweating, are unaffected by these drugs.Many drugs can affect your blood sugar, making it harder to control. Before you start, stop, or change any medication, talk with your doctor or pharmacist about how the medication may affect your blood sugar. Check your blood sugar regularly as directed and share the results with your doctor. Tell your doctor right away if you have symptoms of high or low blood sugar. (See also Side Effects section.) Your doctor may need to adjust your diabetes medication, exercise program, or diet.

                OVERDOSE: If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center.

                NOTES: Do not share this medication with others.Lab and/or medical tests (such as blood cholesterol levels, blood sugar) should be done while you are taking this medication. Keep all medical and lab appointments. Consult your doctor for more details.Lifestyle changes that may help this medication work better include exercising, stopping smoking, and eating a low-cholesterol/low-fat diet. Consult your doctor for more details.Attend a diabetes education program to learn more about how to manage your diabetes with medications, diet, exercise, and regular medical exams.Learn the symptoms of high and low blood sugar and how to treat low blood sugar. Check your blood sugar regularly as directed and share the results with your doctor.

                MISSED DOSE: If you miss a dose, take it as soon as you remember with a meal. If it is near the time of the next dose, skip the missed dose. Take your next dose at the regular time. Do not double the dose to catch up.

                STORAGE: Store at room temperature away from light and moisture. Do not store in the bathroom. Keep all medications away from children and pets.Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company.

                Information last revised August 2021. Copyright(c) 2021 First Databank, Inc.

                IMPORTANT: HOW TO USE THIS INFORMATION: This is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate for you. This information is not individual medical advice and does not substitute for the advice of your health care professional. Always ask your health care professional for complete information about this product and your specific health needs.

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                Tier Description
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