mitomycin (Rx)

Brand and Other Names:Mitomycin C, Mutamycin
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Dosing & Uses

AdultPediatric

Dosage Forms & Strengths

powder for injection

  • 5mg
  • 20mg
  • 40mg

Stomach Cancer, Pancreas Cancer

20 mg/m² IV q6-8Weeks  

Anal Carcinoma (Off-label)

10 mg/m² as IV bolus days 1-29; not to exceed 20 mg/dose

Dosage Modification

for SI units: count in US units x10^6/L

Full dose if

  • Leukocytes >3000/mm³
  • Platelets >75 x 10^3/mm³

Give 70% if

  • Leukocytes: 2000-2999/mm³
  • Platelets: 25-74.999 x 10^3/mm³

Give 50% if

  • Leukocytes <2000/mm³
  • Platelets <25 x 10^3/mm³

Renal Impairment

Serum creatinine >1.7 mg/dL: Avoid use

CrCl <10 mL/min: Decrease dose by 25%

CAPD: Decrease dose by 25%

Monitor

CBC, LFTs, renal function

Do not repeat dose until WBC >4000/mm³ and Plts >100,000/mm³

Dosing Considerations

Always use in combination with other antineoplastics

Discontinue if progression continues after 2 courses

Safety and efficacy not established

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Interactions

Interaction Checker

and mitomycin

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              Serious - Use Alternative (8)

              • bacitracin

                mitomycin and bacitracin both increase nephrotoxicity and/or ototoxicity. Avoid or Use Alternate Drug. Avoid concurrent use of bacitracin with other nephrotoxic drugs

              • deferiprone

                deferiprone, mitomycin. Either increases toxicity of the other by pharmacodynamic synergism. Avoid or Use Alternate Drug. Avoid use of deferiprone with other drugs known to be associated with neutropenia or agranulocytosis; if an alternative is not possible, monitor absolute neutrophil count more frequently.

              • erdafitinib

                erdafitinib will increase the level or effect of mitomycin by P-glycoprotein (MDR1) efflux transporter. Avoid or Use Alternate Drug. If coadministration unavoidable, separate administration by at least 6 hr before or after administration of P-gp substrates with narrow therapeutic index.

              • lasmiditan

                lasmiditan increases levels of mitomycin by P-glycoprotein (MDR1) efflux transporter. Avoid or Use Alternate Drug.

              • palifermin

                palifermin increases toxicity of mitomycin by Other (see comment). Avoid or Use Alternate Drug. Comment: Palifermin should not be administered within 24 hrbefore, during infusion of, or within 24 hr after administration of antineoplastic agents. Coadministration of palifermin within 24 hr of chemotherapy resulted in increased severity and duration of oral mucositis.

              • sotorasib

                sotorasib will decrease the level or effect of mitomycin by P-glycoprotein (MDR1) efflux transporter. Avoid or Use Alternate Drug. If use is unavoidable, refer to the prescribing information of the P-gp substrate for dosage modifications.

              • tepotinib

                tepotinib will increase the level or effect of mitomycin by P-glycoprotein (MDR1) efflux transporter. Avoid or Use Alternate Drug. If concomitant use unavoidable, reduce the P-gp substrate dosage if recommended in its approved product labeling.

              • voxelotor

                mitomycin will decrease the level or effect of voxelotor by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug. Voxelotor is primarily metabolized by CYP3A4. Avoid coadministration with moderate or strong CYP3A4 inducers. If unable to avoid coadministration, increase voxelotor dose (see Dosage Modifications).

              Monitor Closely (33)

              • acalabrutinib

                acalabrutinib, mitomycin. Either increases toxicity of the other by pharmacodynamic synergism. Use Caution/Monitor. Coadministration may increase risk of myelosuppressive effects.

              • berotralstat

                berotralstat will increase the level or effect of mitomycin by P-glycoprotein (MDR1) efflux transporter. Use Caution/Monitor. Monitor or titrate P-gp substrate dose if coadministered.

              • bosutinib

                bosutinib increases levels of mitomycin by P-glycoprotein (MDR1) efflux transporter. Use Caution/Monitor.

              • cholera vaccine

                mitomycin decreases effects of cholera vaccine by immunosuppressive effects; risk of infection. Modify Therapy/Monitor Closely. Immunosuppressive therapies, including irradiation, antimetabolites, alkylating agents, cytotoxic drugs and corticosteroids (used in greater than physiologic doses), may reduce the immune response to cholera vaccine.

              • crizotinib

                crizotinib increases levels of mitomycin by P-glycoprotein (MDR1) efflux transporter. Use Caution/Monitor.

              • dengue vaccine

                mitomycin decreases effects of dengue vaccine by immunosuppressive effects; risk of infection. Use Caution/Monitor. Immunosuppressive therapies (eg, irradiation, antimetabolites, alkylating agents, cytotoxic drugs, corticosteroids [greater than physiologic doses]) may reduce immune response to dengue vaccine.

              • denosumab

                mitomycin, denosumab. Other (see comment). Use Caution/Monitor. Comment: Caution should be taken in patients on concomitant immunosuppressants or with impaired immune systems because of increased risk for serious infections.

              • elagolix

                elagolix will increase the level or effect of mitomycin by P-glycoprotein (MDR1) efflux transporter. Use Caution/Monitor.

              • eliglustat

                eliglustat increases levels of mitomycin by P-glycoprotein (MDR1) efflux transporter. Modify Therapy/Monitor Closely. Monitor therapeutic drug concentrations, as indicated, or consider reducing the dosage of the P-gp substrate and titrate to clinical effect.

              • fingolimod

                mitomycin increases effects of fingolimod by immunosuppressive effects; risk of infection. Modify Therapy/Monitor Closely. Concomitant therapy is expected to increase the risk of immunosuppression. Use caution when switching patients from long-acting therapies with immune effects. .

              • fostamatinib

                fostamatinib will increase the level or effect of mitomycin by P-glycoprotein (MDR1) efflux transporter. Use Caution/Monitor. Concomitant use of fostamatinib may increase concentrations of P-gp substrates. Monitor for toxicities of the P-gp substrate drug that may require dosage reduction when given concurrently with fostamatinib.

              • glecaprevir/pibrentasvir

                glecaprevir/pibrentasvir will increase the level or effect of mitomycin by P-glycoprotein (MDR1) efflux transporter. Use Caution/Monitor.

              • hydroxyurea

                mitomycin, hydroxyurea. Other (see comment). Use Caution/Monitor. Comment: Combination may increase risk of myelosuppression.

              • istradefylline

                istradefylline will increase the level or effect of mitomycin by P-glycoprotein (MDR1) efflux transporter. Use Caution/Monitor. Istradefylline 40 mg/day increased peak levels and AUC of P-gp substrates in clinical trials. Consider dose reduction of sensitive P-gp substrates.

              • ivacaftor

                ivacaftor increases levels of mitomycin by P-glycoprotein (MDR1) efflux transporter. Use Caution/Monitor. Ivacaftor and its M1 metabolite has the potential to inhibit P-gp; may significantly increase systemic exposure to sensitive P-gp substrates with a narrow therapeutic index.

              • lomitapide

                lomitapide increases levels of mitomycin by P-glycoprotein (MDR1) efflux transporter. Modify Therapy/Monitor Closely. Consider reducing dose when used concomitantly with lomitapide.

              • lonafarnib

                lonafarnib will increase the level or effect of mitomycin by P-glycoprotein (MDR1) efflux transporter. Modify Therapy/Monitor Closely. Lonafarnib is a weak P-gp inhibitor. Monitor for adverse reactions if coadministered with P-gp substrates where minimal concentration changes may lead to serious or life-threatening toxicities. Reduce P-gp substrate dose if needed.

              • ofatumumab SC

                ofatumumab SC, mitomycin. Either increases effects of the other by immunosuppressive effects; risk of infection. Use Caution/Monitor. Consider the risk of additive immune system effects when coadministering immunosuppressive therapies with coadministration. When switching from therapies with immune effects, take into account the duration and mechanism of action of these therapies when initiating ofatumumab SC.

              • ponatinib

                ponatinib increases levels of mitomycin by P-glycoprotein (MDR1) efflux transporter. Use Caution/Monitor.

              • sarecycline

                sarecycline will increase the level or effect of mitomycin by P-glycoprotein (MDR1) efflux transporter. Use Caution/Monitor. Monitor for toxicities of P-gp substrates that may require dosage reduction when coadministered with P-gp inhibitors.

              • siponimod

                siponimod and mitomycin both increase immunosuppressive effects; risk of infection. Use Caution/Monitor. Caution if coadministered because of additive immunosuppressive effects during such therapy and in the weeks following administration. When switching from drugs with prolonged immune effects, consider the half-life and mode of action of these drugs to avoid unintended additive immunosuppressive effects.

              • sipuleucel-T

                mitomycin decreases effects of sipuleucel-T by pharmacodynamic antagonism. Modify Therapy/Monitor Closely.

              • stiripentol

                stiripentol will increase the level or effect of mitomycin by P-glycoprotein (MDR1) efflux transporter. Modify Therapy/Monitor Closely. Consider reducing the dose of P-glycoprotein (P-gp) substrates, if adverse reactions are experienced when administered concomitantly with stiripentol.

              • tenofovir DF

                mitomycin, tenofovir DF. Either increases toxicity of the other by nephrotoxicity and/or ototoxicity. Use Caution/Monitor.

                mitomycin increases levels of tenofovir DF by decreasing renal clearance. Use Caution/Monitor.

              • trastuzumab

                trastuzumab, mitomycin. Either increases toxicity of the other by immunosuppressive effects; risk of infection. Use Caution/Monitor. Neutropenia or febrile neutropenia incidence were increased when trastuzumab was coadministered with myelosuppressive chemotherapy. .

              • trastuzumab deruxtecan

                trastuzumab deruxtecan, mitomycin. Either increases toxicity of the other by immunosuppressive effects; risk of infection. Use Caution/Monitor. Neutropenia or febrile neutropenia incidence were increased when trastuzumab was coadministered with myelosuppressive chemotherapy. .

              • tucatinib

                tucatinib will increase the level or effect of mitomycin by P-glycoprotein (MDR1) efflux transporter. Use Caution/Monitor. Consider reducing the dosage of P-gp substrates, where minimal concentration changes may lead to serious or life-threatening toxicities.

              • vemurafenib

                vemurafenib increases levels of mitomycin by P-glycoprotein (MDR1) efflux transporter. Use Caution/Monitor.

              • vinblastine

                vinblastine increases toxicity of mitomycin by unknown mechanism. Use Caution/Monitor. Acute shortness of breath and severe bronchospasm have occurred following use of vinca alkaloids in patients who had previously or simultaneously received mitomycin. .

              • vincristine

                vincristine increases toxicity of mitomycin by unknown mechanism. Use Caution/Monitor. Risk of severe bronchospasm and dyspnea. D/C mitomycin 2 wks prior to vinblastine Tx.

              • vincristine liposomal

                vincristine liposomal increases toxicity of mitomycin by unknown mechanism. Use Caution/Monitor. Risk of severe bronchospasm and dyspnea. D/C mitomycin 2 wks prior to vinblastine Tx.

              • vinorelbine

                mitomycin, vinorelbine. Either increases toxicity of the other by pharmacodynamic synergism. Use Caution/Monitor. Acute shortness of breath and severe bronchospasm have occurred following use of vinca alkaloids in patients who had previously or simultaneously received mitomycin. .

              • zidovudine

                mitomycin, zidovudine. Either increases toxicity of the other by pharmacodynamic synergism. Use Caution/Monitor. Increased risk of myelosuppression.

              Minor (0)

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                Adverse Effects

                >10%

                Hemolytic uremic syndrome (≤15%)

                Myelosuppression (64%)

                Nausea/vomiting (14%)

                Fever (14%)

                1-10%

                Stomatitis (4%)

                Increased serum creatinine (2%)

                Mucous membrane toxicity (4%)

                Frequency Not Defined

                Fatigue

                Pulmonary toxicity

                Dyspnea

                Cystitis

                Interstitial fibrosis

                Nephrotoxicity

                Amenorrhea

                Alopecia

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                Warnings

                Black Box Warnings

                The drug should be administered under the supervision of an experienced cancer chemotherapy physician in a facility equipped to manage complications

                Bone marrow suppression, notably thrombocytopenia and leucopenia, may contribute to overwhelming infections in an already compromised patient

                Hemolytic uremic syndrome may occur with monotherapy or combination therapy and usually occurs with doses >60 mg. Blood product transfusion may exacerbate symptoms

                Contraindications

                Hypersensitivity

                Thrombocytopenia, coagulation disorders, bleeding diathesis

                Cautions

                Vesicant

                Avoid use in renal impairment (SCr >1.7 mg/dL [150.3 umol/L])

                Chicken pox, recent

                Bladder fibrosis/contraction reported

                Herpes zoster

                Acute respiratory distress syndrome reported when used in combination with other types of chemotherapy maintained at FIO2 concentrations >50% preoperatively

                Avoid pregnancy

                Increased prevalence of Heart Failure observed when used in conjunction with anthracyclines

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                Pregnancy & Lactation

                Pregnancy Category: D

                Lactation: Not known if excreted in breast milk, do not nurse

                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

                Crosslinks DNA, preventing replication and transcription

                Pharmacokinetics

                Half-life: 48 min

                Vd: 16-56 L/m²

                Metabolism: Liver

                Clearance: 201-810 mL/min/m²

                Excretion: Urine (10%)

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                Administration

                IV Incompatibilities

                Solution: D5W

                Additive: bleomycin

                Y-site: aztreonam, cefepime, etoposide PO4, filgrastim, gemcitabine, piperacillin/tazobactam, sargramostim, topotecan, vinorelbine

                IV Compatibilities

                Solution: LR, NS

                Additive: dexamethasone Na-phosphate, heparin, hydrocortisone Na-succinate

                Syringe: bleomycin, cisplatin, cyclophosphamide, doxorubicin, droperidol, fluorouracil, furosemide, heparin, leucovorin, methotrexate, metoclopramide, vinblastine, vincristine

                Y-site: amifostine, bleomycin, cisplatin, cyclophosphamide, doxorubicin, droperidol, fluorouracil, furosemide, granisetron, heparin, leucovorin, melphalan, methotrexate, metoclopramide, ondansetron, teniposide, thiotepa, vinblastine, vincristine

                IV Preparation

                Reconstitute with SWI to a concentration of 0.5 mg/mL

                Standard dilution

                • IV push: dose/syringe (concentration is 0.5 mg/mL); maximum syringe size for IVP is a 30 mL syringe & syringe should be <75% full
                • IVPB: dose/100 mL NS

                IV Administration

                Vesicant

                Administer slow IV push by central line only

                Flush with 5-10 mL of IV solution before & after drug administration

                IVPB infusion should be closely monitored for adequate vein patency

                Extravasation Management

                Frequently causes necrosis

                Plastic surgeon may be required

                Storage

                Store intact vials of lyophilized powder at RT

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                Images

                BRAND FORM. UNIT PRICE PILL IMAGE
                mitomycin intravenous
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                40 mg vial
                mitomycin intravenous
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                20 mg vial
                mitomycin intravenous
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                20 mg vial
                mitomycin intravenous
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                5 mg vial
                mitomycin intravenous
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                40 mg vial
                mitomycin intravenous
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                20 mg vial
                mitomycin intravenous
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                5 mg vial
                mitomycin intravenous
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                40 mg vial
                Mutamycin intravenous
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                40 mg vial
                Mutamycin intravenous
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                20 mg vial
                Mutamycin intravenous
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                5 mg vial

                Copyright © 2010 First DataBank, Inc.

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                Patient Handout

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                Patient Education
                mitomycin intravenous

                MITOMYCIN - INJECTION

                (MYE-toe-MYE-sin)

                COMMON BRAND NAME(S): Mutamycin

                WARNING: Mitomycin may cause serious blood and bone marrow disorders (e.g., low red blood cells/white blood cells/platelets). These problems can affect your body's ability to stop bleeding or fight infection. Tell your doctor right away if you develop easy bleeding/bruising or signs of an infection (e.g., fever, chills, persistent sore throat).This drug may cause a certain serious, sometimes fatal side effect (hemolytic uremic syndrome). This condition may result in anemia, low platelet counts, and kidney problems. Blood transfusions may make the symptoms worse. Tell your doctor right away if you have any of the following signs: pink/bloody urine or change in the amount of urine.

                USES: Mitomycin is used to treat various types of cancer (such as stomach/pancreas cancer). It works by slowing or stopping the growth of cancer cells.

                HOW TO USE: This medication is given by injection into a vein by a health care professional. Dosage is based on your medical condition, body size, and response to treatment.

                SIDE EFFECTS: See also Warning section.Nausea, vomiting, stomach/abdominal pain, or loss of appetite may occur. Nausea and vomiting can be severe. In some cases, your doctor may prescribe medication to prevent or relieve nausea and vomiting. Eating several small meals, not eating before treatment, or limiting activity may help lessen some of these effects. If these effects persist or worsen, tell your doctor or pharmacist promptly.Severe nausea and vomiting may rarely cause dehydration. Contact your doctor promptly if you notice any symptoms of dehydration such as unusual decreased urination, unusual dry mouth/increased thirst, lack of tears, dizziness/lightheadedness, or pale/wrinkled skin.Temporary hair loss may occur. Normal hair growth should return after treatment has ended.People using this medication may have serious side effects. However, you have been prescribed this drug because your doctor has judged that the benefit to you is greater than the risk of side effects. Careful monitoring by your doctor may decrease your risk.Tell your doctor right away if you have any serious side effects, including: unusual bleeding/bruising (e.g., small red spots on the skin, black/bloody stools, vomit that looks like coffee grounds), numbness/tingling feelings, unusual tiredness/weakness.Pain or sores in the mouth and throat may occur. Brush your teeth gently/carefully, avoid using mouthwash that contains alcohol, and rinse your mouth frequently with cool water mixed with baking soda or salt. It may also be best to eat soft, moist foods.If this medication accidentally leaks into the skin/muscle around the injection site, it may cause severe damage. Symptoms may occur both during treatment or weeks to months after receiving a dose. Tell your doctor right away if you notice redness, pain, or swelling at or near the injection site.A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any of the following symptoms of a serious allergic reaction: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing (especially with cough).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 using mitomycin, 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: blood/bleeding disorders (e.g., anemia, low blood cell counts), current infection, kidney disease, liver disease, radiation treatment.Do not have immunizations/vaccinations without the consent of your doctor. Avoid contact with people who have recently received live vaccines (such as flu vaccine inhaled through the nose).To lower your risk of getting cut, bruised, or injured, use caution with sharp objects like razors and nail cutters, and avoid activities such as contact sports.Before having surgery, tell your doctor or dentist that you are using this medication.This medication is not recommended for use during pregnancy. It may harm an unborn baby. If you become pregnant or think you may be pregnant, tell your doctor right away. To avoid pregnancy, both males and females using this drug should use reliable form(s) of birth control (e.g., birth control pills, condoms) during treatment. Consult your doctor for details and to discuss effective forms of birth control.It is not known whether this drug passes into breast milk. Because of the possible risk to the infant, breast-feeding while using this drug is not recommended. Consult your doctor before breast-feeding.

                DRUG INTERACTIONS: 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: other anti-cancer drugs (especially vinca alkaloids such as vinblastine).

                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: Laboratory and/or medical tests (e.g., complete blood counts, kidney function tests) should be performed periodically to monitor your progress or check for side effects. Consult your doctor for more details.

                MISSED DOSE: It is important to get each dose of this medication as scheduled. If you miss a dose, ask your doctor or pharmacist right away for a new dosing schedule.

                STORAGE: Consult the product instructions and your pharmacist for storage details. 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.

                MEDICAL ALERT: Your condition can cause complications in a medical emergency. For information about enrolling in MedicAlert, call 1-888-633-4298 (US) or 1-800-668-1507 (Canada).

                Information last revised September 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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                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.
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                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
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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.