EPIRUBICIN

Damage to skin: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.

Heart Problems: This medication may infrequently result in serious (rarely fatal) heart problems (including heart failure). This may occur both during treatment or months to years after treatment is completed.

Blood and Bone marrow disorders: 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.

Cancer: 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.

Before starting treatment with this medication, tell your doctor if you have liver problems. Your dose may need to be adjusted.

If any of the following side effects occur while taking epirubicin, check with your doctor or nurse immediately:

More common

• Black, tarry stools
• bleeding, redness, or ulcers in the mouth or throat
• chest pain
• cough or hoarseness
• fever or chills
• lower back or side pain
• pain or burning in the mouth or throat
• painful or difficult urination
• shortness of breath
• sore throat
• sores, ulcers, or white spots in the mouth or on the lips
• swollen glands
• unusual bleeding or bruising
• unusual tiredness or weakness

Less common

• Blood in the urine or stools
• pinpoint red spots on the skin
• red streaks along the injected vein

If any of the following symptoms of overdose occur while taking epirubicin, get emergency help immediately:

Symptoms of overdose

• Abdominal or stomach swelling or tenderness
• high fever
• stomach pain
• swelling of the lining of the mouth, nose, or throat
• vomiting

Some of the side effects that can occur with epirubicin may not need medical attention:

More common

• Absent, missed, or irregular menstrual periods
• burning, dry, or itching eyes
• diarrhea
• discharge or excessive tearing
• feeling of warmth
• hair loss or thinning of the hair
• nausea
• redness of the face, neck, arms, and occasionally, upper chest
• redness, pain, or swelling of the eye, eyelid, or inner lining of the eyelid
• stopping of menstrual bleeding
• sudden sweating
• unusual drowsiness, dullness, tiredness, weakness, or feeling of sluggishness

Less common

• Changes in the skin
• loss of appetite
• weight loss

Rare

• Darkening of the soles, palms, or nails

After you stop taking this drug, it is possible that you may still experience side effects that need medical attention. If you notice any of the following side effects check with your doctor immediately:

• Fast or irregular heartbeat
• shortness of breath
• swelling of the abdomen or stomach, feet, and lower legs

 Precautions

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.

• Medical History: Before using this medication, tell your doctor or pharmacist if you had: 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).
• Immunization: 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.
• 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.
• Sensitivity to the sun: This medication may make you more sensitive to the sun. Avoid prolonged sun exposure, tanning booths, and sunlamps. Use a sunscreen and wear protective clothing when outdoors.
• Birth defects: 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).
• Menstruation: This medication can affect menstruation in females and cause premature menopause. Consult your doctor or pharmacist for details.

Pregnancy Risk: Category D.  This medication is not recommended for use during pregnancy. It may harm an unborn baby.

Breastfeeding: 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.

Interactions

• 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 overdose is suspected, contact a poison control center or emergency room immediately.

Notes

Laboratory and/or medical tests (e.g., complete blood count, liver function tests, certain heart function tests such as LVEF) should be performed periodically to monitor your progress or check for side effects. Consult your doctor for more details.

Missed Dose

For the best possible benefit, it is important to receive each scheduled dose of this medication as directed. If you miss a dose, contact your doctor to establish a new dosing schedule.

Storage

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

Brands

Available Brands:

Also marketed as