epirubicin (Rx)

Brand and Other Names:Ellence, Pharmorubicin
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Dosing & Uses

AdultPediatric

Dosage Forms & Strengths

injectable solution

  • 2mg/mL

powder for reconstitution

  • 50 mg
  • 200 mg

Adjuvant Breast Cancer Treatment

Option 1 (Day 1 dose schedule)

  • Day 1: Epirubicin 100 mg/m² IV, AND 5-fluorouracil 500 mg/m² IV, AND cyclophosphamide 500 mg/m² IV  
  • Repeat q21Days x 6 cycles

Option 2 (Divided dose schedule)

  • First dose divided equally between days 1 & 8: Epirubicin 60 mg/m² IV, AND 5-fluorouracil 500 mg/m² IV, AND
  • Days 1-14: Cyclophosphamide 75 mg/m² PO
  • Repeat q28Days x 6 cycles

Dose Modifications

Adjustment if Total Dose Given on Day 1

  • Administer 75% of Day 1 dose in subsequent cycles if nadir platelet count <50,000/mm³, absolute neutrophil count (ANC) < 250/mm³, neutropenic fever present, grade 3/4 nonhematologic toxicity observed

Divided Dose Adjustment

  • Administer 75% of Day 1 dose on Day 8 if platelet count 75,000-100,000/mm³ and ANC < 1000-1499/mm³
  • Do not administer dose on day 8 if platelet count < 75,000/mm³ and ANC < 1000/mm³

Bone Marrow Dysfunction

  • Consider lower starting dose (75-90 mg/m²)

Renal Impairment

SCr >5 mg/dL [>442 micromoles/L]: Decrease dose by 50%; test cardiac ejection fraction via MUGA before starting treatment

Hepatic Impairment

Billirubin < 1.2 mg/dL: Dose adjustment not necessary

Bilirubin 1.2-3 mg/dL or AST 2-4 x ULN: 50% of recommended starting dose

Bilirubin >3 mg/dL or AST > 4 x ULN: 25% of recommended starting dose (ie, decrease starting dose by 75%)

Severe hepatic impairment: Not recommended

Monitoring

LFTs, CBC, creatinine; multi-gated radionuclide angiography or ECHO

Soft Tissue Sarcoma (Orphan)

epirubicin-conjugated polymer micelles

Orphan designation for treatment of soft tissue sarcoma

Sponsor

  • NanoCarrier Co., Ltd; Chuou 144-15, 226-39 Wakashiba; Kashiwa; Japan

Safety and efficacy not established

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Interactions

Interaction Checker

and epirubicin

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    Contraindicated

      Serious - Use Alternative

        Significant - Monitor Closely

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              Serious - Use Alternative (8)

              • adenovirus types 4 and 7 live, oral

                epirubicin decreases effects of adenovirus types 4 and 7 live, oral by pharmacodynamic antagonism. Avoid or Use Alternate Drug. Immunosuppressives may diminish therapeutic effects of vaccines and increase risk of adverse effects (increased risk of infection). Live-attenuated vaccines should be avoided for at least 3mo after cessation of immunosuppressive therapy.

              • deferiprone

                deferiprone, epirubicin. 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.

              • influenza virus vaccine quadrivalent, adjuvanted

                epirubicin decreases effects of influenza virus vaccine quadrivalent, adjuvanted by pharmacodynamic antagonism. Avoid or Use Alternate Drug. Immunosuppressive drugs may reduce the immune response to influenza vaccine.

              • influenza virus vaccine trivalent, adjuvanted

                epirubicin decreases effects of influenza virus vaccine trivalent, adjuvanted by pharmacodynamic antagonism. Avoid or Use Alternate Drug. Immunosuppressive drugs may reduce the immune response to influenza vaccine.

              • palifermin

                palifermin increases toxicity of epirubicin 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.

              • tofacitinib

                epirubicin, tofacitinib. Either increases toxicity of the other by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.

              • trastuzumab

                trastuzumab, epirubicin. Either increases toxicity of the other by unknown mechanism. Avoid or Use Alternate Drug. Trastuzumab may cause cardiomyopathy. Incidence and severity was highest when used with anthracycline-containing chemotherapy regimens. If possible, avoid anthracycline-based therapy for 7 months after last trastuzumab/hyaluronidase dose. If anthracyclines are used, carefully monitor cardiac function.

              • trastuzumab deruxtecan

                trastuzumab deruxtecan, epirubicin. Either increases toxicity of the other by unknown mechanism. Avoid or Use Alternate Drug. Trastuzumab may cause cardiomyopathy. Incidence and severity was highest when used with anthracycline-containing chemotherapy regimens. If possible, avoid anthracycline-based therapy for 7 months after last trastuzumab/hyaluronidase dose. If anthracyclines are used, carefully monitor cardiac function.

              Monitor Closely (16)

              • acalabrutinib

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

              • belatacept

                belatacept and epirubicin both increase immunosuppressive effects; risk of infection. Use Caution/Monitor.

              • bevacizumab

                bevacizumab, epirubicin. Other (see comment). Use Caution/Monitor. Comment: Potential for increased risk of cardiotoxicity (CHF). Caution is warranted.

              • cholera vaccine

                epirubicin, cholera vaccine. 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.

              • cimetidine

                cimetidine increases levels of epirubicin by decreasing metabolism. Use Caution/Monitor. Cimetidine increased the AUC of epirubicin by 50%. Cimetidine treatment should be stopped during treatment with epirubicin.

              • dengue vaccine

                epirubicin 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

                epirubicin, 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.

              • fingolimod

                epirubicin 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. .

              • hydroxyurea

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

              • meningococcal group B vaccine

                epirubicin decreases effects of meningococcal group B vaccine by pharmacodynamic antagonism. Use Caution/Monitor. Individuals with altered immunocompetence may have reduced immune responses to the vaccine.

              • ofatumumab SC

                ofatumumab SC, epirubicin. 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.

              • olaparib

                epirubicin and olaparib both increase pharmacodynamic synergism. Use Caution/Monitor. Coadministration with other other myelosuppressive anticancer agents, including DNA damaging agents, may potentiate and prolongate the myelosuppressive toxicity.

              • siponimod

                siponimod and epirubicin 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

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

              • trastuzumab

                trastuzumab, epirubicin. 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, epirubicin. 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. .

              Minor (0)

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                Adverse Effects

                >10%

                Alopecia (96%)

                Nausea and vomiting (92%)

                Leukopenia or neutropenia (80%)

                Amenorrhea (72%)

                Anemia (72%)

                Mucositis (59%)

                Thrombocytopenia (49%)

                Lethargy (46%)

                Hot flashes (39%)

                Diarrhea (25%)

                Conjunctivitis (15%)

                1-10%

                Rash (9%)

                Fever (5%)

                Skin changes (5%)

                Anorexia (3%)

                <1%

                Acute lymphoid leukemia

                Acute myelogenous leukemia

                Atrioventricular block

                Esophagitis

                Hyperpigmentation

                Myelodysplastic syndrome

                Frequency Not Defined

                Myocardial toxicity (including CHF)

                Severe myelosuppression

                Risk of secondary AML

                Postmarketing Reports

                Infections and infestations: Sepsis, pneumonia

                Immune system disorders: Anaphylaxis

                Metabolism and nutrition disorders: Dehydration, hyperuricemia

                Vascular disorders: Shock, hemorrhage, embolism arterial, thrombophlebitis, phlebitis

                Respiratory, thoracic and mediastinal disorders: Pulmonary embolism

                Gastrointestinal disorders: Erosions, ulcerations, pain or burning sensation, bleeding, hyperpigmentation of the oral mucosa

                Skin and subcutaneous tissue disorders: Erythema, flushes, skin and nail hyperpigmentation, photosensitivity, hypersensitivity to irradiated skin (radiation-recall reaction), urticaria

                Renal and urinary disorders: Red coloration of urine for 1-2 days after administration

                General disorders and administration site conditions: Fever, chills

                Injury, poisoning and procedural complications: Chemical cystitis (following intravesical administration)

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                Warnings

                Black Box Warnings

                Reduce dosage with impaired hepatic function

                Myelosuppression resulting in serious infection, septic shock, requirement for transfusions, hospitalization, and death may occur

                Administer only under the supervision of physician experienced in the use of cancer chemotherapeutic agents

                Extravasation

                • Severe local tissue necrosis associated with extravasation during administration; administer only by IV route (not IM or SC); immediately terminate the drug and apply ice to the affected area

                Cardiotoxicity

                • Myocardial damage, including acute left ventricular failure can occur; manifested in its most severe form by potentially fatal congestive heart failure (CHF); may occur months to years after treatment discontinued
                • Probability of cardiotoxicity estimated to be 0.9% at a cumulative dose of 550 mg/m², 1.6% at 700 mg/m², and 3.3% at 900 mg/m²
                • Risk of cardiomyopathy is further increased with concomitant cardiotoxic therapy; assess left ventricular ejection fraction (LVEF) before and regularly during and after treatment

                Secondary malignancies

                • Secondary acute myelogenous leukemia (AML) or myelodysplastic syndrome (MDS)
                • More common when given in combination with DNA-damaging antineoplastic agents, patients heavily pretreated with cytotoxic drugs, or with escalated anthracycline doses
                • Cumulative risk of developing treatment-related AML or MDS estimated as 0.27% at 3 years, 0.46% at 5 years, and 0.55% at 8 years

                Contraindications

                Severe hypersensitivity to drug, other anthracyclines, or anthracenediones

                Baseline ANC<1500/mm³

                Cardiomyopathy and/or heart failure, recent MI, or severe arrhythmias

                Severe myocardial insufficiency

                Cumulative dose achieved in previous anthracycline treatment

                Severe persistent drug-induced myelosuppression

                Severe hepatic impairment (Child-Pugh Class C or serum bilirubin level greater than 5 mg/dL)

                Cautions

                Lysis syndrome may occur; evaluate blood uric acid levels, potassium, calcium, phosphate, and creatinine after initial treatment; consider hydration, urine alkalinization, and prophylaxis with allopurinol to minimize potential complications of hyperuricemia and tumor lysis syndrome

                Thrombophlebitis and thromboembolic events, including pulmonary embolism (in some cases fatal) reported with therapy; venous sclerosis may result from an injection into small vessel or from repeated injections into same vein

                Administration of live or live-attenuated vaccines in patients immunocompromised by chemotherapeutic agents may result in serious or fatal infections

                Administration after previous radiation therapy may induce an inflammatory recall reaction at site of irradiation

                Therapy can cause fetal harm; advise patients of potential risk to a fetus and to use effective contraception

                Women of child-bearing potential should be advised to avoid becoming pregnant during treatment and should use effective contraceptive methods

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                Pregnancy & Lactation

                Pregnancy

                Verify pregnancy status in female patients of reproductive potential prior to initiating

                Based on findings from animal studies and mechanism of action, drug can cause fetal harm when administered to a pregnant woman; avoid use during the 1st trimester

                Available human data do not establish presence or absence of major birth defects and miscarriage related to use during the 2nd and 3rd trimesters; there are reports of fetal and/or neonatal cardiotoxicity following in utero exposure to epirubicin

                There have been rare reports of fetal and/or neonatal transient ventricular hypokinesia, transient elevation of cardiac enzymes, and a case of fetal demise from suspected anthracycline-induced cardiotoxicity following in utero exposure to epirubicin in 2nd and/or 3rd trimesters

                Cardiotoxicity is a known risk of anthracycline treatment in adults; monitor fetus and/or neonate for cardiotoxicity and perform testing consistent with community standards of care

                Advise pregnant women and females of reproductive potential of potential risk to a fetus

                Animal data

                • In animal reproduction studies in pregnant rats, drug was embryo-fetal lethal and caused structural abnormalities when administered during organogenesis at doses less than maximum recommended human dose on a body surface area basis

                Contraception

                • Can cause fetal harm in females when administered to a pregnant woman; advise female patients of reproductive potential to use effective contraception during treatment and for 6 months after last dose
                • Based on its mechanism of action and genotoxicity studies, advise male patients with female partners of reproductive potential to use effective contraception during treatment and for 3 months after last dose
                • Advise male patients with pregnant partners to use condoms during treatment and for at least 7 days after last dose

                Infertility

                • Based on clinical findings and animal studies, therapy may impair female fertility and result in amenorrhea; premature menopause can occur; recovery of menses and ovulation is related to age at treatment
                • Based on clinical findings and animal studies in males, therapy may cause oligospermia, azoospermia, and permanent loss of fertility; sperm counts have been reported to return to normal levels in some men; may occur several years after end of therapy

                Lactation

                There are no data on presence of drug in human milk, effects on breastfed child, or on milk production; drug is present in rat milk; when a drug is present in animal milk it is likely the drug will be present in human milk

                Because of potential for serious adverse reactions in breastfed child, advise lactating women not to breastfeed during treatment and for at least 7 days 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

                Anthracycline; intercalates between DNA base pairs and triggers cleavage by topoisomerase II, which results in cytocidal activity

                Inhibits DNA helicase and generates cytotoxic free radicals

                Pharmacokinetics

                Half-Life: 31-35 hr

                Protein Bound: 77%

                Vd: 21-27 L/kg

                Metabolism: Hepatic

                Clearance: 65-69 L/hr

                Excretion: Feces (34-35%) & urine (20-27%)

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                Administration

                IV Incompatibilities

                Additive: Alkaline solutions, heparin, fluorouracil

                Syringe: Fluorouracil, ifosfamide with mesna

                IV Compatibilities

                Additive, Syringe: ifosfamide

                IV Administration

                Administer infuse into tubing of a freely flowing infusion (NS or D5W) over 3-5 min

                Avoid extravasation, associated with severe ulceration & soft tissue necrosis; flush with 5-10 mL of IV solution before & after drug administration

                Extravasation Management

                See Totect

                Storage

                Store refrigerated

                Protect from light

                Solution should be used within 24 hr of penetrating rubber stopper

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                Images

                BRAND FORM. UNIT PRICE PILL IMAGE
                Ellence intravenous
                -
                50 mg/25 mL vial
                epirubicin intravenous
                -
                50 mg/25 mL vial
                epirubicin intravenous
                -
                200 mg/100 mL vial
                epirubicin intravenous
                -
                200 mg/100 mL vial
                epirubicin intravenous
                -
                50 mg/25 mL vial
                epirubicin intravenous
                -
                50 mg/25 mL vial
                epirubicin intravenous
                -
                50 mg vial
                epirubicin intravenous
                -
                50 mg/25 mL vial
                epirubicin intravenous
                -
                50 mg/25 mL vial

                Copyright © 2010 First DataBank, Inc.

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                Patient Handout

                Patient Education
                epirubicin intravenous

                EPIRUBICIN - INJECTION

                (epp-ih-REWB-ih-sin)

                COMMON BRAND NAME(S): Ellence

                WARNING: Epirubicin must be given only by injection slowly into a vein. Do not inject into a muscle or under the skin. If this medication accidentally leaks into the skin/muscle around the injection site, it may cause severe damage. Tell your doctor right away if you notice redness, pain, or swelling at or near the injection site.This medication may rarely cause serious (rarely fatal) heart problems (including heart failure). This may occur both during treatment or months to years after treatment is completed. The risk of heart problems is affected by your dose, medical history (including previous heart disease, radiation treatment to the chest area), and previous use of this and other drugs (including doxorubicin). Tell your doctor right away if you notice symptoms such as fast/slow/irregular heartbeat, shortness of breath, swelling ankles/feet, unusual tiredness, or unusual/sudden weight gain.Epirubicin may cause certain severe blood and bone marrow disorders (low or abnormal red blood cells/white blood cells/platelets). This can affect your body's ability to stop bleeding or fight infection. Tell your doctor right away if you develop unusual tiredness, easy bleeding/bruising, or signs of infection (e.g., fever, chills, persistent sore throat).Very rarely, people with cancer who are treated with this type of medication have developed other cancers (e.g., secondary leukemia). The risk may be increased when this medication is given with certain anti-cancer drugs (especially in high doses) or radiation treatment. Consult your doctor for more details.

                USES: Epirubicin is used to treat breast cancer. It belongs to a class of drugs known as anthracyclines and 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, as directed by your doctor. Dosage is based on your medical condition, body size, and response to treatment.If this medication touches your skin, immediately wash the area well with plenty of water. You may also use soap and water or a mixture of baking soda (sodium bicarbonate) in plenty of water. If this medication gets in your eye, open the eyelids and flush with water for 15 minutes, then seek immediate medical attention.Drink plenty of fluids while using this medication unless otherwise directed by your doctor. Doing so helps decrease the risk of certain side effects (e.g., increased uric acid).

                SIDE EFFECTS: See also Warning section.Nausea, vomiting, diarrhea, abdominal pain, flushing, or skin/nail color changes 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.This medication may cause your urine to turn a reddish color. This is a normal, harmless effect of the drug that usually stops within 2 days after each dose and should not be mistaken for blood in your urine.Temporary hair loss is a common side effect. Normal hair growth should return after treatment has ended.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 you have any serious side effects, including: menstrual changes (e.g., stopped periods), unusual bleeding/bruising (e.g., small red spots on the skin, black/bloody stools, bloody urine, vomit that looks like coffee grounds).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.Severe nausea, vomiting, and diarrhea 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.Epirubicin sometimes causes side effects due to the rapid destruction of cancer cells (tumor lysis syndrome). To lower your risk, your doctor may add a medication and tell you to drink plenty of fluids. Tell your doctor right away if you have symptoms such as: low back/side pain (flank pain), signs of kidney problems (such as painful urination, pink/bloody urine, change in the amount of urine), muscle spasms/weakness.Get medical help right away if you have any very serious side effects, including: chest pain, coughing up blood, sudden pain/swelling/redness usually in the leg.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), trouble breathing, severe dizziness.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 epirubicin, tell your doctor or pharmacist if you are allergic to it; or to other anthracyclines (e.g., doxorubicin); or to anthracenediones (e.g., mitoxantrone); 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), gout, heart disease (e.g., congestive heart failure, recent heart attack, fast/slow/irregular heartbeat), kidney disease, liver disease, radiation treatment (especially to chest area).Do not have immunizations/vaccinations without the consent of your doctor, and avoid contact with people who have recently received oral polio vaccine or flu vaccine inhaled through the nose. Wash your hands well to prevent the spread of infections.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.This medication may make you more sensitive to the sun. Limit your time in the sun. Avoid tanning booths and sunlamps. Use sunscreen and wear protective clothing when outdoors. Tell your doctor right away if you get sunburned or have skin blisters/redness.Before having surgery, tell your doctor or dentist that you are using this medication.Caution is advised when using this drug in the elderly because they may be more sensitive to the effects of the drug.Caution is advised when using this drug in children because they may be more sensitive to the effects of the drug, especially effects on the heart.This medication may affect the production of sperm in males, increasing the risk of fathering a child with birth defects. Men receiving treatment with this drug should use reliable forms of birth control (e.g., condoms). Consult your doctor for details and to discuss effective forms of birth control.This medication can affect menstruation in females and cause premature menopause. Consult your doctor or pharmacist for details.This medication is not recommended for use during pregnancy. It may harm an unborn baby. Women of child-bearing age should use reliable forms of birth control (such as birth control pills, condoms) to prevent pregnancy during treatment and for 6 months after the last dose of epirubicin. Male patients with female partners should use reliable forms of birth control during treatment and for 3 months after the last dose. Male patients with pregnant partners should use condoms during treatment and for at least 7 days after the last dose. If you or your partner become pregnant or think you may be pregnant, tell your doctor right away. Consult your doctor for details and to discuss effective forms of birth control.It is unknown if this drug passes into breast milk. Because of the possible risk to the infant, breast-feeding while using this drug is not recommended and for at least 7 days after the last dose. 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: cimetidine, other drugs that may affect the heart (including trastuzumab, anthracyclines such as doxorubicin).

                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: Lab and/or medical tests (such as complete blood count, liver function tests, certain heart function tests such as LVEF) should be done before you start using this medication and while you are using it. Keep all medical and lab appointments. 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: Not applicable. This medication is given in a clinic and will not be stored at home.

                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 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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                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.
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                NC NOT COVERED – Drugs that are not covered by the plan.
                Code Definition
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                QL Quantity Limits
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                Drugs that have step therapy associated with each prescription. This restriction typically requires that certain criteria be met prior to approval for the prescription.
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