Adriamycin

Name: Adriamycin

Side Effects of Adriamycin

Serious side effects have been reported with Adriamycin. See "Adriamycin Precautions."

Infusion site reactions. Serious infusion site reactions can happen with Adriamycin. Symptoms of infusion reaction may include:

  • pain at injection site
  • skin redness or swelling
  • burning or stinging
  • open skin sores at injection site

Your doctor will watch you closely while you are receiving Adriamycin  and after your infusion for signs of a reaction. You may experience these reactions immediately or within 2 hours of infusion.

Change in the color of your urine. You may have red colored urine for 1 to 2 days after your infusion of Adriamycin. This is normal. Tell your doctor if it does not stop in a few days, or if you see what looks like blood or blood clots in your urine.

Infection. Call your doctor right away if you get any of the following signs of infection:

  • fever (temperature of 100.4 F or greater) chills or shivering
  • cough that brings up mucus
  • burning or pain with urination

Adriamycin may cause lower sperm counts and sperm problems in men. This could affect your ability to father a child and cause birth defects. Men should use effective birth control (contraception) while receiving Adriamycin. Do not have unprotected sexual contact with a female who could become pregnant. Tell your doctor if you do have unprotected sexual contact with a female who could become pregnant. Talk to your doctor if this is a concern for you.

Irreversible amenorrhea or early menopause. Your periods (menstrual cycle) may completely stop when you receive Adriamycin. Your periods may or may not return after you complete your treatment of Adriamycin.

The most common side effects of Adriamycin include:

  • hair loss (alopecia). Your hair may re-grow after your treatment.
  • darkening of your nails or separation of your nails from your nailbed
  • nausea
  • vomiting
  • lack of appetite or increased thirst
  • bruise or bleed more easily
  • abnormal heart beat
  • a secondary cancer may occur when Adriamycin is combined with other chemotherapy agents.
  • mouth sores
  • weight changes
  • stomach (abdominal) pain
  • diarrhea
  • eye problems
  • allergic reactions. Call your doctor right away if you have any of the following symptoms of an allergic reaction:
  • rash
  • flushed face
  • fever
  • hives
  • dizziness or feel faint
  • itching
  • shortness of breath or trouble breathing
  • swelling of your lips or tongue

Tell your doctor or nurse if you have any side effect that bothers you or that does not go away.

These are not all of the possible side effects of Adriamycin. For more information, ask your doctor or pharmacist.

Call your doctor for medical advice about side effects.

Adriamycin Food Interactions

Medicines can interact with certain foods. In some cases, this may be harmful and your doctor may advise you to avoid certain foods. In the case of Adriamycin there are no specific foods that you must exclude from your diet when receiving Adriamycin.

Adriamycin and Lactation

Tell your doctor if you are breastfeeding or plan to breast feed. Adriamycin can pass into your breast milk and harm your baby. You and your doctor should decide if you will receive Adriamycin or breastfeed. You should not do both.

Adriamycin Overdose

Adriamycin is usually administered by a healthcare provider in a medical setting making it unlikely for an overdose to occur. However, if overdose is suspected, seek emergency medical attention.

Other Requirements

Keep all appointments with your doctor and the laboratory. Certain laboratory tests may be required to monitor your body's response to Adriamycin.

What should I discuss with my healthcare provider before receiving Adriamycin (doxorubicin)?

You should not use this medicine if you are allergic to doxorubicin or similar medications (doxorubicin, daunorubicin, epirubicin, idarubicin, mitoxantrone), or if you have:

  • an untreated or uncontrolled infection (including mouth sores);

  • severe liver disease;

  • severe heart problems; or

  • if you have recently had a heart attack.

To make sure doxorubicin is safe for you, tell your doctor if you have:

  • liver or kidney disease;

  • bone marrow suppression;

  • heart disease or a history of heart failure; or

  • if you have been treated before with doxorubicin, daunorubicin, epirubicin, idarubicin, or mitoxantrone.

Tell your doctor about all other cancer medicines or radiation treatments you have received in the past.

Using doxorubicin may increase your risk of developing a bone marrow disease or other types of leukemia later in life. Ask your doctor about your specific risk.

Do not use doxorubicin if you are pregnant. It could harm the unborn baby or cause birth defects. Use birth control to prevent pregnancy while you are using this medicine, whether you are a man or a woman. Doxorubicin use by either parent may cause birth defects.

If you are a woman, you should avoid pregnancy while you are using this medicine and for at least 6 months after your last dose.

If you are a man, use effective birth control if your sexual partner is able to get pregnant. An unborn baby can be harmed if a man fathers the child while he is using doxorubicin. Keep using birth control for at least 6 months after your last dose.

Tell your doctor right away if a pregnancy occurs while either the mother or the father is using doxorubicin.

This medicine may affect fertility (your ability to have children), whether you are a man or a woman. Ask your doctor about your specific risk.

Doxorubicin can pass into breast milk and may harm a nursing baby. You should not breast-feed while you are using doxorubicin.

What other drugs will affect Adriamycin (doxorubicin)?

Other drugs may interact with doxorubicin, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell each of your health care providers about all medicines you use now and any medicine you start or stop using.

Before Using Adriamycin

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Appropriate studies performed to date have not demonstrated pediatric-specific problems that would limit the usefulness of doxorubicin injection in children. However, heart problems are more likely to occur in children younger than 2 years of age, who are usually more sensitive to the effects of doxorubicin injection.

Geriatric

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of doxorubicin injection in the elderly.

Pregnancy

Pregnancy Category Explanation
All Trimesters D Studies in pregnant women have demonstrated a risk to the fetus. However, the benefits of therapy in a life threatening situation or a serious disease, may outweigh the potential risk.

Breast Feeding

Studies in women breastfeeding have demonstrated harmful infant effects. An alternative to this medication should be prescribed or you should stop breastfeeding while using this medicine.

Interactions with Medicines

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are receiving this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.

  • Atazanavir
  • Boceprevir
  • Cobicistat
  • Lopinavir
  • Measles Virus Vaccine, Live
  • Mumps Virus Vaccine, Live
  • Nelfinavir
  • Rotavirus Vaccine, Live
  • Rubella Virus Vaccine, Live
  • Saquinavir
  • Tasonermin
  • Telaprevir
  • Varicella Virus Vaccine

Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

  • Abiraterone
  • Adenovirus Vaccine
  • Amiodarone
  • Amitriptyline
  • Amobarbital
  • Amprenavir
  • Aprepitant
  • Aprobarbital
  • Azathioprine
  • Azithromycin
  • Bacillus of Calmette and Guerin Vaccine, Live
  • Bosentan
  • Bupropion
  • Butabarbital
  • Butalbital
  • Captopril
  • Carbamazepine
  • Carvedilol
  • Ceritinib
  • Chlorpromazine
  • Cholera Vaccine, Live
  • Cinacalcet
  • Ciprofloxacin
  • Cisplatin
  • Clarithromycin
  • Clobazam
  • Clozapine
  • Conivaptan
  • Crizotinib
  • Cyclophosphamide
  • Cyclosporine
  • Darunavir
  • Dasabuvir
  • Delavirdine
  • Desipramine
  • Dexamethasone
  • Dexrazoxane
  • Diltiazem
  • Dronedarone
  • Duloxetine
  • Efavirenz
  • Enzalutamide
  • Erythromycin
  • Etravirine
  • Felodipine
  • Fluconazole
  • Fluoxetine
  • Fluphenazine
  • Fluvoxamine
  • Fosamprenavir
  • Fosaprepitant
  • Fosphenytoin
  • Idelalisib
  • Imatinib
  • Indinavir
  • Influenza Virus Vaccine, Live
  • Itraconazole
  • Ketoconazole
  • Mephobarbital
  • Mercaptopurine
  • Methohexital
  • Miconazole
  • Mifepristone
  • Modafinil
  • Morphine
  • Morphine Sulfate Liposome
  • Nafcillin
  • Nefazodone
  • Nevirapine
  • Nilotinib
  • Oxcarbazepine
  • Paclitaxel
  • Paroxetine
  • Peginterferon Alfa-2b
  • Pentobarbital
  • Phenobarbital
  • Phenytoin
  • Piperaquine
  • Poliovirus Vaccine, Live
  • Posaconazole
  • Quercetin
  • Quinidine
  • Ranolazine
  • Regorafenib
  • Rifabutin
  • Rifampin
  • Rifapentine
  • Ritonavir
  • Secobarbital
  • Simeprevir
  • Smallpox Vaccine
  • Stavudine
  • St John's Wort
  • Telithromycin
  • Terbinafine
  • Thiopental
  • Thioridazine
  • Ticagrelor
  • Tipranavir
  • Tocophersolan
  • Topotecan
  • Trastuzumab
  • Typhoid Vaccine
  • Valspodar
  • Verapamil
  • Voriconazole
  • Warfarin
  • Yellow Fever Vaccine
  • Zidovudine

Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

  • Eltrombopag
  • Sorafenib

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following is usually not recommended, but may be unavoidable in some cases. If used together, your doctor may change the dose or how often you use this medicine, or give you special instructions about the use of food, alcohol, or tobacco.

  • Grapefruit Juice

Other Medical Problems

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

  • Bone marrow problem (eg, drug-induced myelosuppression), severe or
  • Heart attack, recent (within 4 to 6 weeks) or
  • Heart disease, severe or
  • Liver disease, severe—Should not be used in patients with these conditions.
  • Infection—May decrease your body's ability to fight infection.
  • Liver disease, mild—Use with caution. The effects may be increased because of slower removal of the medicine from the body.

How is this medicine (Adriamycin) best taken?

Use Adriamycin as ordered by your doctor. Read all information given to you. Follow all instructions closely.

  • It is given as an infusion into a vein over a period of time.

What do I do if I miss a dose?

  • Call your doctor to find out what to do.

Use in specific populations

Pregnancy

Pregnancy Category D

Risk Summary

Doxorubicin can cause fetal harm when administered to a pregnant woman. Doxorubicin was teratogenic and embryotoxic in rats and rabbits at doses approximately 0.07 times (based on body surface area) the recommended human dose of 60 mg/m2 . If this drug is used during pregnancy, or if the patient becomes pregnant while taking this drug, apprise the patient of the potential hazard to a fetus.

Animal Data

Doxorubicin was teratogenic and embryotoxic at doses of 0.8 mg/kg/day (about 0.07 times the recommended human dose based on body surface area) when administered during the period of organogenesis in rats. Teratogenicity and embryotoxicity were also seen using discrete periods of treatment. The most susceptible was the 6- to 9-day gestation period at doses of 1.25 mg/kg/day and greater. Characteristic malformations included esophageal and intestinal atresia, tracheo-esophageal fistula, hypoplasia of the urinary bladder, and cardiovascular anomalies. Doxorubicin was embryotoxic (increase in embryofetal deaths) and abortifacient at 0.4 mg/kg/day (about 0.07 times the recommended human dose based on body surface area) in rabbits when administered during the period of organogenesis.

Nursing Mothers

Doxorubicin has been detected in the milk of at least one lactating patient [see Clinical Pharmacology (12.3)]. Because of the potential for serious adverse reactions in nursing infants from doxorubicin , a decision should be made whether to discontinue nursing or discontinue the drug, taking into account the importance of the drug to the mother.

Pediatric Use

Based on postmarketing reports, pediatric patients treated with doxorubicin are at risk for developing late cardiovascular dysfunction. Risk factors include young age at treatment (especially < 5 years), high cumulative doses and receipt of combined modality therapy. Long-term periodic cardiovascular monitoring is recommended for all pediatric patients who have received doxorubicin. Doxorubicin, as a component of intensive chemotherapy regimens administered to pediatric patients, may contribute to prepubertal growth failure and may also contribute to gonadal impairment, which is usually temporary.

There are no recommended dose adjustments based on age. Doxorubicin clearance was increased in patients aged 2 years to 20 years as compared to adults, while doxorubicin clearance was similar in children less than 2 years as compared to adults [see Clinical Pharmacology (12.3)].

Geriatric Use

Clinical experience in patients who were 65 years of age and older who received doxorubicin based chemotherapy regimens for metastatic breast cancer showed no overall differences in safety and effectiveness compared with younger patients.

Females and Males of Reproductive Potential

Contraception

Females

Doxorubicin can cause fetal harm when administered during pregnancy. Advise female patients of reproductive potential to use highly effective contraception during treatment with doxorubicin and for 6 months after treatment. Advise patients to contact their healthcare provider if they become pregnant, or if pregnancy is suspected, while taking doxorubicin [see Use in Specific Populations (8.1)].

Males

Doxorubicin may damage spermatozoa and testicular tissue, resulting in possible genetic fetal abnormalities. Males with female sexual partners of reproductive potential should use effective contraception during and for 6 months after treatment [see Nonclinical Toxicology (13.1)].

Infertility

Females

In females of reproductive potential, doxorubicin may cause infertility and result in amenorrhea. Premature menopause can occur. Recovery of menses and ovulation is related to age at treatment [see Nonclinical Toxicology (13.1)].

Males

Doxorubicin may result in oligospermia, azoospermia, and permanent loss of fertility. Sperm counts have been reported to return to normal levels in some men. This may occur several years after the end of therapy.

Hepatic Impairment

The clearance of doxorubicin was reduced in patients with elevated serum bilirubin levels. Reduce the dose of doxorubicin in patients with serum bilirubin levels greater than 1.2 mg/dL [See Dosage and Administration (2.2) and Warnings and Precautions (5.5)].

Doxorubicin is contraindicated in patients with severe hepatic impairment (defined as Child Pugh Class C or serum bilirubin levels greater than 5 mg/dL) [see Contraindications (4)].

For the Consumer

Applies to doxorubicin: intravenous powder for solution, intravenous solution

Along with its needed effects, doxorubicin (the active ingredient contained in Adriamycin) may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor or nurse immediately if any of the following side effects occur while taking doxorubicin:

Less common
  • Cough or hoarseness accompanied by fever or chills
  • darkening or redness of the skin (if you recently had radiation treatment)
  • fast or irregular heartbeat
  • fever or chills
  • joint pain
  • lower back or side pain accompanied by fever or chills
  • pain at the injection site
  • painful or difficult urination accompanied by fever or chills
  • red streaks along the injected vein
  • shortness of breath
  • stomach pain
  • swelling of the feet and lower legs
Rare
  • Black, tarry stools
  • blood in the urine
  • pinpoint red spots on the skin
  • unusual bleeding or bruising

Some side effects of doxorubicin may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common
  • Hair loss, thinning of hair
  • nausea and vomiting
  • sores in the mouth and on the lips
Less common
  • Darkening of the soles, palms, or nails
  • diarrhea

After you stop using this medicine, it may still produce some side effects that need attention. During this period of time, check with your doctor immediately if you notice the following side effects:

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

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