Generic Name: Epirubicin Brand Name(s): Epirubicin.

Uses

What is Epirubicin used for?

Epirubicin is commonly 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 should I take Epirubicin?

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. Therefore, 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. If you become pregnant or think you may be pregnant, tell your doctor right away. Women of child-bearing age and men using this medication should use reliable forms of birth control (such as birth control pills, condoms) to prevent pregnancy. 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.

How do I store Epirubicin?

Store refrigerated between 2ºC and 8ºC (36ºF and 46ºF). Do not freeze. Protect from light.

Storage of the solution for injection at refrigerated conditions can result in the formation of a gelled product.  This gelled product will return to a slightly viscous to mobile solution after 2 to a maximum of 4 hours equilibration at controlled room temperature (15ºC to 25ºC).  Solution for injection should be used within 24 hours after removal from refrigeration.

If you need to store this medicine at home, talk with your doctor, nurse, or pharmacist about how to store it.

Precautions & warnings

What should I know before using Epirubicin?

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. Therefore, 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. If you become pregnant or think you may be pregnant, tell your doctor right away. Women of child-bearing age and men using this medication should use reliable forms of birth control (such as birth control pills, condoms) to prevent pregnancy. 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.

Is it safe during pregnancy or breast-feeding?

There are no adequate studies in women for determining risk when using this Epirubicin during pregnancy or while breastfeeding. Please always consult with your doctor to weigh the potential benefits and risks before taking this Epirubicin. This Epirubicin is pregnancy risk category D according to the US Food and Drug Administration (FDA).

FDA pregnancy risk category reference below:

  • A=No risk,
  • B=No risk in some studies,
  • C=There may be some risk,
  • D=Positive evidence of risk,
  • X=Contraindicated,
  • N=Unknown

Side effects

What side effects can occur from Epirubicin?

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 your doctor has prescribed this medication because he or she 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 a loss of too much body water (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.

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.

Not everyone experiences these side effects. There may be some side effects not listed above. If you have any concerns about a side-effect, please consult your doctor or pharmacist.

Interactions

What drugs may interact with Epirubicin?

Some products that may interact with this drug include: cimetidine, other drugs that may affect the heart (including trastuzumab, anthracyclines such as doxorubicin).

Epirubicin may interact with other drugs that you are currently taking, which can change how your drug works or increase your risk for serious side effects. To avoid any potential drug interactions, you should keep a list of all the drugs you are using (including prescription drugs, nonprescription drugs and herbal products) and share it with your doctor and pharmacist. For your safety, do not start, stop, or change the dosage of any drugs without your doctor’s approval.

Does food or alcohol interact with Epirubicin?

Epirubicin may interact with food or alcohol by altering the way the drug works or increase the risk for serious side effects. Please discuss with your doctor or pharmacist any potential food or alcohol interactions before using this drug.

What health conditions may interact with Epirubicin?

Epirubicin may interact with your health condition. This interaction may worsen your health condition or alter the way the drug works. It is important to always let your doctor and pharmacist know all the health conditions you currently have.

Dosage

The information provided is not a substitute for any medical advice. You should ALWAYS consult with your doctor or pharmacist before using this Epirubicin.

What is the dose of Epirubicin for an adult?

Usual Adult Dose for Breast Cancer – Adjuvant

For use as a component of adjuvant therapy in patients with evidence of axillary node tumor involvement following resection of primary breast cancer:

Starting Dose: 100 to 120 mg/m2 by intravenous infusion every 3 to 4 weeks. The total dose may either be given on Day 1 of each cycle or divided equally and given on Days 1 and 8 of each cycle.

Renal Dose Adjustments

Although no specific dosage adjustments are available, lower doses should be considered in patients with severe renal impairment (serum creatinine >5 mg/dL).

Liver Dose Adjustments

If a patient has a bilirubin of 1.2 to 3 mg/dL or AST 2 to 4 times the upper limit of normal, then they should receive 1/2 of the normally recommended starting dose.

If a patient has a bilirubin >3 mg/dL or AST >4 times the upper limit of normal, then they should receive 1/4 of the normally recommended starting dose

Dose Adjustments

Consideration should be given to administration of lower starting doses (75 to 90 mg/m2) for heavily pretreated patients, patients with preexisting bone marrow depression, or in the presence of neoplastic bone marrow infiltration.

Dosage adjustments after the first treatment cycle should be made based on both hematologic and nonhematologic toxicities Patients experiencing nadir platelet counts <50,000/mm3, absolute neutrophil counts <250/mm3, neutropenic fever, of grades 3/4 nonhematologic toxicity should have the day 1 dose in subsequent cycles reduced to 75% of the Day 1 dose given in the current cycle. Day 1 chemotherapy in subsequent courses of treatment should be delayed until platelet counts are >=100,000/mm3, absolute neutrophil counts are >=1500/mm3, and nonhematologic toxicities have recovered to <=grade 1.

For patients receiving a divided dose (day 1 and day 8), the day 8 dose should be 75% of day 1 if platelet counts are 75,000 to 100,000/mm3 and the absolute neutrophil count is 1000 to 1499/mm3. If day 8 platelet counts are <75,000/mm3 , absolute neutrophil counts are <1000/mm3, or grade 3/4 nonhematologic toxicity has occurred, the day 8 dose should be omitted.

Precautions

Epirubicin is not recommended for use in patients with a baseline neutrophil count <1500 cells /mm3, severe myocardial insufficiency, recent myocardial infarction, severe arrhythmias, previous treatment with anthracyclines up to the maximum cumulative dose, or severe hepatic dysfunction.

Before initiating therapy with epirubicin, patients should be recovered from any acute toxicities (such as stomatitis, neutropenia, thrombocytopenia, and generalized infections) from prior cytotoxic treatments.

Assessment of blood counts, serum levels of total bilirubin, AST, creatinine, and cardiac function as measured by left ventricular ejection function (LVEF) are recommended before and during treatment with epirubicin.

Extra care is recommended in monitoring toxicity when administered to female patients >=70 years old.

Other Comments

In clinical trials, the patients administered the 120 mg/m2 regimen also received prophylactic antibiotic therapy with trimethoprim-sulfamethoxazole or a fluoroquinolone.

What is the dose of Epirubicin for a child?

The dosage has not been established in pediatric patients. It may be unsafe for your child. It is always important to fully understand the safety of the drug before using. Please consult with your doctor or pharmacist for more information.

How is Epirubicin available?

Epirubicin is available in the following dosage forms and strengths:

  • Intravenous Solution

What should I do in case of an emergency or overdose?

In case of an emergency or an overdose, call your local emergency services or go to your nearest emergency room.

What should I do if I miss a dose?

If you miss a dose of Epirubicin, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and take your regular dose as scheduled. Do not take a double dose.

Hello Health Group does not provide medical advice, diagnosis or treatment.

Sources

Review Date: January 25, 2018 | Last Modified: January 25, 2018

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