cetuximab (Rx)

Brand and Other Names:Erbitux
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Dosing & Uses

AdultPediatric

Dosage Forms & Strengths

injectable solution

  • 2mg/mL (50mL, 100mL single use vials)

KRAS Wild-type, EGFR Expressing Metastatic Colorectal Cancer

Indicated for KRAS mutation-negative (wild-type), epidermal growth factor receptor (EGFR)-expressing colorectal cancer (CRC) as determine by FDA-approved tests

Indications

  • Indicated in combination with FOLFIRI (irinotecan, fluorouracil, leucovorin) for first-line treatment
  • Indicated in combination with irinotecan in patients refractory to irinotecan-based chemotherapy
  • Indicated as a single agent in failed oxaliplatin- and irinotecan-based chemotherapy or in patients intolerant to irinotecan

Weekly dosage

  • Initial dose: 400 mg/m2 IV x 1 dose  
  • Subsequent doses: 250 mg/m2/week until disease progression or unacceptable toxicity

Biweekly dosage

  • Initial and subsequent doses: 500 mg/m2 IV q2Weeks until disease progression or unacceptable toxicity

BRAF V600E Mutation-Positive Metastatic Colorectal Cancer

Indication in combination with encorafenib for metastatic colorectal cancer (CRC) with a BRAF V600E mutation (as determine by FDA-approved test) after prior therapy

Initial: 400 mg/m2 IV x 1 dose

Subsequent doses: 250 mg/m2/week until disease progression or unacceptable toxicity

See encorafenib drug monograph for recommended dosing information

Advanced Squamous Cell Carcinoma of Head & Neck

Indications

  • Indicated in combination with radiation therapy for initial treatment of local or regional cancer
  • Indicated in combination with platinum-based therapy with 5-FU for first-line treatment of patients with recurrent locoregional disease or metastatic form
  • Indicated as monotherapy in patients with recurrent or metastatic carcinoma for whom prior platinum-based therapy failed

Weekly dosage

  • Initial dose: 400 mg/m2 IV x 1 dose
  • Subsequent doses: 250 mg/m2/week until disease progression or unacceptable toxicity
  • With radiation: Initiate 1 week prior to beginning radiation therapy, continue qWeek x 6-7 weeks

Biweekly dosage

  • Initial dose and subsequent doses: 500 mg/m2 IV q2Weeks until disease progression or unacceptable toxicity

Dosage modifications

Infusion-related reactions

  • Grade 1 or 2: Reduce infusion rate by 50%
  • Grade 3 or 4: Immediately and permanently, discontinue cetuximab
  • Serious infusion reactions, requiring medical intervention and/or hospitalization: Immediately and permanently discontinued

Dermatologic toxicities and infectious sequelae (eg, acneiform rash, mucocutaneous disease)

  • First occurrence, Grade 3-4: Delay infusion 1-2 weeks; if condition improves, continue at 250 mg/m² if no improvement, discontinue cetuximab
  • Second occurrence, Grade 3-4: Delay infusion 1-2 weeks; if condition improves, continue at 200 mg/m² if no improvement, discontinue cetuximab
  • Third occurrence, Grade 3-4: Delay infusion 1-2 weeks; if condition improves, continue at 150 mg/m² if no improvement, discontinue cetuximab
  • Fourth occurrence: Discontinue cetuximab

Pulmonary toxicity

  • Acute onset or worsening pulmonary symptoms: Delay infusion 1-2 weeks; if condition improves, continue at the dose that was being administered at the time of occurrence
  • If no improvement in 2 weeks or interstitial lung disease (ILD) is confirmed, discontinue cetuximab

Dosing Considerations

Limitation of use: Not indicated for treatment of Ras mutant colorectal cancer or when the results of the Ras mutation tests are unknown

Premedication

  • Premedicate with an H1 antagonist (eg, diphenhydramine 50 mg) IV 30-60 min before first dose; administer premedication subsequent doses based upon clinical judgment and presence/severity of prior infusion reactions

Safety and efficacy not established

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Adverse Effects

Adverse effects listed are all grades of severity unless indicated otherwise

>10% (Monotherapy)

Rash/desquamation (95%)

Fatigue (91%)

Nausea (64%)

Other pain (59%)

Dry skin (57%)

Constipation (53%)

Dyspnea (49%)

Pruritus (47%)

Sensory neuropathy (45%)

Diarrhea (42%)

Vomiting (40%)

Headache (38%)

Infections with neutropenia (38%)

Other dermatology (35%)

Stomatitis (32%)

Fatigue (31%)

Nail changes (31%)

Insomnia (27%)

Fever (25%)

Other gastrointestinal (22%)

Infusion reactions (18%)

Confusion (18%)

Other pain, Grade 3 or 4 (18%)

Rigors or chills (16%)

Dyspnea, Grade 3 or 4 (16%)

Rash/desquamation, Grade 3 or 4 (16%)

Anxiety (14%)

Depression (14%)

Dehydration (13%)

Mouth dryness (12%)

Other gastrointestinal, Grade 3 or 4 (12%)

Infections with neutropenia, Grade 3 or 4 (11%)

>10% (Combination Therapy)

Acne-like rash (86%)

Diarrhea (66%)

Neutropenia (49%)

Rash (44%)

Stomatitis (31%)

Anorexia (30%)

Pyrexia (26%)

Acneform dermatitis (26%)

Paronychia (20%)

Palmar-plantar erythrodysesthesia syndrome (19%)

Skin fissure (19%)

Conjunctivitis (18%)

Acne-like rash, Grade 3 or 4 (18%)

Diarrhea, Grade 3 or 4 (16%)

Dyspepsia (16%)

Decreased weight (15%)

Infusion-related reaction (14%)

Acne (14%)

Pruritus (14%)

1-10% (Monotherapy)

Taste disturbance (10%)

Nausea (6%)

Confusion, Grade 3 or 4 (6%)

Vomiting, Grade 3 or 4 (5%)

Bone pain (4%)

Infusion reactions, Grade 3 or 4 (3%)

Fever, Grade 3 or 4 (3%)

Constipation, Grade 3 or 4 (3%)

Arthralgia, Grade 3 or 4 (3%)

Diarrhea, Grade 3 or 4 (2%)

Pruritus, Grade 3 or 4 (2%)

Headache, Grade 3 or 4 (2%)

Rigors or chills, Grade 3 or 4 (1%)

Stomatitis, Grade 3 or 4 (1%)

1-10% (Combination Therapy)

Rash, Grade 3 or 4 (9%)

Acneform dermatitis, Grade 3 or 4 (5%)

Palmar-plantar erythrodysesthesia syndrome, Grade 3 or 4 (4%)

Stomatitis, Grade 3 or 4 (3%)

Anorexia, Grade 3 or 4 (3%)

Acne, Grade 3 or 4 (2%)

Skin fissures, Grade 3 or 4 (2%)

Infusion-related reactions, Grade 3 or 4 (1%)

Decreased weight, Grade 3 or 4 (1%)

Pyrexia, Grade 3 or 4 (1%)

Postmarketing Reports

Aseptic meningitis

Mucosal inflammation

Stevens-Johnson syndrome

Toxic epidermal necrolysis

Life-threatening and fatal bullous mucocutaneous disease

Pulmonary embolism

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Warnings

Black Box Warnings

Infusion reactions

  • Severe infusion reactions occurred with this agent in ~3% of patients in clinical trials, with fatal outcome reported in less than 1 in 1000
  • Immediately interrupt and permanently discontinue cetuximab infusion for serious infusion reactions (see Dosage Modifications)

Cardiopulmonary arrest

  • Cardiopulmonary arrest and/or sudden death occurred in 2% (4/208) of patients with squamous cell carcinoma of the head and neck treated with radiation therapy and cetuximab
  • Closely monitor serum electrolytes, including serum magnesium, potassium, and calcium, during and after cetuximab therapy

Contraindications

None

Cautions

Use in colorectal cancer only with confirmed KRAS mutation-negative (wild-type); confirm Ras mutation status in tumor specimens prior to initiating therapy

Risk of cardiopulmonary arrest and sudden death (see Black Box Warnings); carefully consider use with radiation therapy or platinum-based therapy with fluorouracil in patients with squamous cell carcinoma of the head and neck (SCCHN) with a history of coronary artery disease, congestive heart failure, or arrhythmias; monitor serum electrolytes, including serum magnesium, potassium, and calcium, during and after therapy

Increases risk of electrolyte depletion, especially hypomagnesemia; hypomagnesemia and accompanying electrolyte abnormalities can occur days to months after initiating therapy; monitor patients weekly during treatment for hypomagnesemia; hypomagnesemia of any grade reported in 4% of patients receiving cetuximab, carboplatin, and fluorouracil; monitor patients weekly during and for at least 8 wk following completion of therapy; replete electrolytes as necessary

Risk of anaphylactic reactions may increase in patients with a history of tick bites, red meat allergy, or in the presence of IgE antibodies directed against galactose-α-1,3-galactose (alpha-gal); consider testing patients for alpha-gal IgE antibodies using FDA-cleared methods prior to initiating therapy; negative results for alpha-gal antibodies do not rule out the risk of severe infusion reactions

Risk of infusion reactions; monitor patients following infusion; discontinue therapy for serious infusion reactions (see Black Box Warnings); premedicate with a histamine-1 (H1) receptor antagonist; monitor patients for at least 1 hour following each infusion, in a setting with resuscitation equipment and other agents necessary to treat anaphylaxis; in patients requiring treatment for infusion reactions, monitor for more than 1 hr to confirm resolution of the reaction; interrupt the infusion and upon recovery, resume the infusion at a slower rate or permanently discontinue therapy based on severity

Mucocutaneous adverse reactions may occur; limit sun exposure; wear sunscreen and hats

Dermatologic toxicities (eg, life-threatening and fatal bullous mucocutaneous disease with blisters, erosions, skin sloughing, acneiform rash, skin drying and fissuring, paronychial inflammation, infectious sequelae [eg, Streptococcal aureus sepsis, abscess formation, cellulitis, blepharitis, conjunctivitis, keratitis/ulcerative keratitis with decreased visual acuity, cheilitis], hypertrichosis); monitor for inflammatory or infectious sequelae

Withhold, reduce dose or permanently discontinue therapy based on severity of acneiform rash or mucocutaneous disease

Increased incidence of grade 3-4 mucositis, radiation recall syndrome, acneiform rash, cardiac events, and electrolyte disturbances when used in combination with radiation and cisplatin; coadministration did not improve progression-free survival

Interstitial lung disease reported; interrupt treatment for acute onset or worsen of pulmonary symptoms; monitor patients for signs and symptoms of pulmonary toxicity

Increased tumor progression, increased mortality, or lack of benefit in patients with Ras-mutant metastatic colorectal cancer (mCRC)

Fetal harm may occur when administered to a pregnant woman (see Pregnancy)

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Pregnancy & Lactation

Pregnancy

Based on findings from animal studies and its mechanism of action, cetuximab can cause fetal harm when administered to pregnant women

There are no available data in pregnant women; advise pregnant women of the potential risk to a fetus

Verify pregnancy status in females of reproductive potential prior to initiating treatment

Animal data

  • In an animal reproduction study, IV administration of cetuximab once weekly to pregnant cynomolgus monkeys during the period of organogenesis resulted in an increased incidence of embryo lethality and abortion
  • Disruption or depletion of EGFR in animal models results in impairment of embryo-fetal development including effects on placental, lung, cardiac, skin, and neural development
  • Human IgG is known to cross the placental barrier; therefore, cetuximab may be transmitted from the mother to the developing fetus

Contraception

  • Advise females of reproductive potential to use effective contraception during treatment and for 2 months after last dose

Infertility

  • Based on animal studies, cetuximab may impair fertility in females of reproductive potential

Lactation

There is no information regarding the presence of drug in human milk, the effects on the breastfed infant, or the effects on milk production

Human IgG antibodies can be excreted in human milk

Due to potential for serious adverse reactions in breastfed infants, advise women not to breastfeed during treatment and for 2 months after last dose

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

Recombinant humanized monoclonal antibody

Binds specifically to the EGF receptor (EGFR, HER1, c-ErbB-1) on both normal and tumor cells

Competitively inhibits the binding of EGF NS other ligands, such as TGF-alpha

Blocks phosphorylation and activation of receptor-associated kinases, resulting in inhibition of cell growth, induction of apoptosis, NS decreased matrix metalloproteinase ns VEGF production

Absorption

AUC: Increased in a greater than dose proportional manner as dose increased from 20 to 400 mg/m²

Peak Plasma Concentration

  • Following a 2 hr infusion of 400 mg/m²: 184 mcg/mL (range: 92-327 mcg/mL)
  • Following a 1 hr infusion of 250 mg/m²: 140 mcg/mL (range 120-170 mcg/mL)

Distribution

Vd: 2-3 L/m²

Elimination

Half-life: 114 hr (range 75-188 hr); 97 hr (range 41-213 hr), following 400 mg/sq.meter IV over 2 hr

Clearance: Decreased from 0.08 to 0.02 L/hr/sq.meter as dose increased from 20 to 200 mg/m² plateaus at doses >200 mg/m²

Pharmacogenomics

Colorectal cancer

  • Colorectal cancer expressing with KRAS wild-type respond more favorably to regimens that include anti-EGFR antibodies (cetuximab, panitumumab); whereas, the presence of KRAS mutation (codon 12 or 13) showed an absence of biological and clinical activity for the anti-EGFR antibody treatment
  • Strongly recommended that patients with metastatic CRC who are being considered for treatment with anti-EGFR antibody therapy should be tested for the presence of a KRAS mutation prior to the administration of therapy (NCCN guidelines)

Non-small cell lung cancer (investigational)

  • Presence of EGFR mutations does not appear to predict response to treatment with the EGFR monoclonal antibody cetuximab, but clinical trials have been conflicting
  • An ongoing study is underway to examine prospectively whether high EGFR protein expression can be used as a predictor of treatment response to cetuximab

Genetic testing laboratories

  • The following companies are currently offering KRAS mutation status testing
  • Clarient, Inc. (http://www.clarientinc.com)
  • Caris Diagnostics (http://www.carisdx.com)
  • DxS (http://www.dxsdiagnostics.com)
  • Genzyme Genetics (http://www.genzymegenetics.com)
  • LabCorp (http://www.labcorp.com)
  • Response Genetics (http://www.responsegenetics.com)
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Administration

IV Preparation

Do not shake or dilute

Discard unused portion after 8 hr at room temperature or 12 hr if refrigerated

IV Administration

Do not administer as an IV push or bolus

Administer via infusion pump or syringe pump IV infusion

Do not administer as an IV push or bolus

Administer via infusion pump or syringe pump IV infusion through low-protein-binding 0.22-micrometer inline filter

Infusion time

  • 400 mg/m2- or 500 mg/m2-dose: Infuse over 2 hr
  • 250 mg/m2-dose: Infuse over 1 hr
  • Not to exceed 10 mg/min
Squamous cell carcinoma of head and neck
  • Complete administration 1 hr prior to platinum-based therapy with fluorouracil
  • With radiation: Complete administration 1 hr before radiation therapy
CRC
  • Complete administration 1 hr prior to irinotecan or FOLFIRI

Premedication

Before first dose: Premedicate with an H1 antagonist (eg, diphenhydramine 50 mg) IV 30-60 min

Subsequent doses: Administer premedication subsequent doses based upon clinical judgment and presence/severity of prior infusion reactions

Storage

Unused vials

  • Refrigerate at 2-8°C (36-46°F); do not freeze
  • Increased particulate formation may occur at temperatures ≤0°C

Prepared infusions

  • Refrigerate at 2-8°C (36-46°F) for up to 12 hr OR
  • Store at room temperature (20-25°C [68-77°F]) for up to 8 hr
  • Discard any remaining solution in the infusion container after 8 hr at room temperature or after 12 hr refrigerated
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Images

BRAND FORM. UNIT PRICE PILL IMAGE
Erbitux intravenous
-
100 mg/50 mL vial
Erbitux intravenous
-
200 mg/100 mL vial

Copyright © 2010 First DataBank, Inc.

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Patient Handout

Patient Education
cetuximab intravenous

CETUXIMAB - INJECTION

(se-TUX-i-mab)

COMMON BRAND NAME(S): Erbitux

WARNING: Severe (sometimes fatal) reactions have occurred in people while receiving cetuximab. Your risk may be higher if you have a history of tick bites or have a severe allergic reaction to meat (such as beef, pork). Before receiving cetuximab, tell your doctor if you have either of these conditions. Your doctor will carefully monitor you during and for at least one hour after your infusion. Tell your doctor right away if you have shortness of breath, hoarseness, itching, or dizziness. Your doctor may stop treatment with this medication if you have a severe reaction.Rare deaths due to heart problems (cardiopulmonary arrest) or sudden death have occurred in people with head and neck cancer treated with cetuximab. Before starting treatment with this medication, tell your doctor if you have a history of heart disease (such as heart failure, irregular heartbeat, previous heart attack). Get medical help right away if you develop chest/jaw/left arm pain, shortness of breath, or unusual sweating. Your doctor will order certain blood tests (including magnesium, calcium, and potassium) during and after your treatment to monitor and help decrease your risk for heart problems.

USES: Cetuximab is used to treat a certain type of cancer of the colon (large intestine) or rectum. This medication is also used to treat head and neck cancer. Cetuximab works by slowing or stopping the growth of cancer cells. It binds to a certain protein (epidermal growth factor receptor-EGFR) in some tumors. Cetuximab is a man-made protein (monoclonal antibody).

HOW TO USE: Cetuximab is given by injection into a vein as directed by your doctor, usually once every week or every 2 weeks by a healthcare professional. Another drug (such as diphenhydramine) may be given before you receive cetuximab to lessen the chance of certain side effects. The dosage is based on your medical condition, body size, and response to treatment.A healthcare professional should watch you for at least 1 hour after your infusion is finished to make sure you do not have an infusion reaction. (See Warning section). If you experience a severe infusion reaction, your infusion will be stopped and your doctor may decide to stop further treatments.

SIDE EFFECTS: See also Warning section.Nausea, vomiting, constipation, diarrhea, headache, stomachache, backache, fever/chills, trouble sleeping, weight loss, fatigue, drowsiness, eye redness/itching, nail changes, dry skin, and mouth/throat sores may occur. Nausea and vomiting can be quite severe. In some cases, drug therapy may be necessary to prevent or relieve nausea and vomiting. Not eating before your treatment may help relieve vomiting. Changes in diet such as eating several small meals or limiting activity may help lessen some of these effects. If any of these effects last or get worse, tell your doctor or pharmacist promptly.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.An acne-like rash may occur. Depending on how severe this rash is, your doctor may delay your cetuximab treatment, lower your dose, treat the rash with antibiotics, or stop treatment with cetuximab to decrease this potentially serious side effect.Tell your doctor right away if you have any serious side effects, including: confusion, depression, swelling of hands/feet/lower legs, dehydration, signs of serious infection (such as high fever, chills, persistent sore throat), signs of kidney problems (such as change in the amount of urine), decreased vision, severe dizziness, fast/slow/irregular heartbeat, severe muscle spasms.Rarely, very serious lung problems may occur. Get medical help right away if you develop: trouble breathing, chest pain.A very serious allergic reaction to this drug is rare. However, get medical help right away 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: See also Warning section.Before receiving cetuximab, tell your doctor or pharmacist if you are allergic to it, or if you have a severe allergy to meat (such as beef, pork), 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: lung disease, radiation therapy, heart disease (e.g., coronary artery disease, congestive heart failure, arrhythmias), tick bites.This drug may make you drowsy. Alcohol or marijuana (cannabis) can make you more drowsy. Do not drive, use machinery, or do anything that needs alertness until you can do it safely. Limit alcoholic beverages. Talk to your doctor if you are using marijuana (cannabis).Sunlight may worsen any skin reactions that may occur while you are using this drug. Avoid prolonged sun exposure, tanning booths, and sunlamps during treatment and for 2 months after your last treatment with cetuximab. Use a sunscreen and wear protective clothing when outdoors.This medication is not recommended for use during pregnancy. It may harm an unborn baby. Consult your doctor for more details and to discuss the use of reliable forms of birth control (such as condoms, birth control pills) while using this medication and for 2 months after the end of treatment.Based on information from related drugs, cetuximab may pass into breast milk. Because of potential harm to the infant, breast-feeding is not recommended while using cetuximab and for 2 months after the end of treatment. 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.

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: Medical tests and regular physical exams should be performed to check for side effects. Laboratory tests should be performed before giving cetuximab to check for the EGFR protein on your tumor. Certain laboratory tests (e.g., calcium, magnesium, potassium levels) will be performed from time to time while you are being treated with cetuximab and up to 8 weeks after your last infusion. Consult your doctor for more details. Keep all scheduled medical appointments.

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

STORAGE: Not applicable. This medication is given in a hospital or clinic and will not be stored at home.

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

Adding plans allows you to compare formulary status to other drugs in the same class.

To view formulary information first create a list of plans. Your list will be saved and can be edited at any time.

Adding plans allows you to:

  • View the formulary and any restrictions for each plan.
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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.