Adriamycin

Adriamycin is a prescription medication used to treat certain types of cancer in adults and children including breast cancer, lung cancer, and ovarian cancer.  Adriamycin belongs to a group of drugs called anthracyclines, which slow and stop the growth of cancer cells.

This medication comes in an injectable form and is given by injection into a vein (intravenously) by a healthcare provider.

Common side effects of Adriamycin include hair loss, nausea, and vomiting.

Adriamycin is a prescription medication used in combination with other medications to treat:

• Bedford Laboratories

• Pharmacia, Inc.

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 the 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 nail bed
• nausea
• vomiting
• lack of appetite or increased thirst
• bruise or bleed more easily
• abnormal heartbeat
• 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.

Tell your doctor about all the medicines you take including prescription and non-prescription medicines, vitamins, and herbal supplements. Especially tell your doctor if you take:

• Paclitaxel
• progesterone (Provera, Depo-Provera)
• Verapamil
• cyclosporine (Neoral, Sandimmune)
• cytarabine (DepoCyt)
• cyclophosphamide (Cytoxan)
• phenobarbital
• phenytoin (Dilantin)
• streptozocin (Zanosar)
• saquinavir

This is not a complete list of Adriamycin drug interactions. Ask your doctor or pharmacist for more information.

Adriamycin may cause serious side effects including:

• Heart problems. Adriamycin may cause heart problems that may lead to death. These problems can happen during your treatment or months to years after stopping treatment. In some cases heart problems are irreversible. Your chance of heart problems is higher if you:
  • already have heart problems
  • have a history of radiation therapy or are currently receiving radiation therapy to your chest
  • have had treatment with certain other anti-cancer medicines
  • take other medicines that can affect your heart

Tell your doctor if you get any of these symptoms of heart problems:

• shortness of breath
• cough
• swelling of your feet and ankles
• fast heartbeat

Your doctor should do tests to check your heart before, during, and after your treatment with Adriamycin.

• Secondary cancers. Some people who have received Adriamycin have developed acute myelogenous leukemia (AML) or myelodysplastic syndrome (MDS). Your chance of developing a secondary cancer is higher if you receive Adriamycin along with other anti-cancer medicines or with radiation therapy.
• Decreased blood cell counts. Adriamycin can cause a severe decrease in neutrophils (a type of white blood cells important in fighting in bacterial infections), red blood cells (blood cells that carry oxygen to the tissues), and platelets (important for clotting and to control bleeding). Your doctor will check your blood cell count during your treatment with Adriamycin and after you have stopped your treatment.

Do not receive Adriamycin if:

• your blood cell counts are too low: platelets (which help your blood to clot), red blood cells (which help to carry iron and oxygen throughout your body), and white blood cells (which help to fight infection)
• you have a severe liver problem
• you have had a recent heart attack or have severe heart problems
• you have had previous treatment with Adriamycin or certain other anticancer medicines and received the maximum dose allowed
• you are allergic to certain other anti-cancer medicines, Adriamycin hydrochloride, or any other ingredient in Adriamycin.

Talk to your doctor before receiving Adriamycin if you have any of the conditions listed above.

Avoid receiving live vaccines during treatment with Adriamycin. Talk to your doctor to find out which vaccines are safe for you while receiving Adriamycin.

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.

Before you receive Adriamycin, tell your doctor if you:

• have heart problems
• have had radiation treatment or currently receiving radiation therapy
• are over the age of 50
• have liver problems
• plan to receive any vaccines
• have any other medical conditions
• are pregnant or breastfeeding

Tell your doctor about all the medicines you take, including prescription and non-prescription medicines, vitamins, and herbal supplements. Adriamycin can interact with other medicines. Do not start any new medicine before you talk with the doctor that prescribed Adriamycin.

Tell your doctor if you are pregnant or plan to become pregnant.

Adriamycin can harm your unborn baby. Women who may become pregnant should use effective birth control (contraception). Talk to your doctor about the best way to prevent pregnancy while receiving Adriamycin.

Tell your doctor if you are breastfeeding or plan to breastfeed.

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.

• Your doctor will prescribe Adriamycin in an amount that is right for you.
• Adriamycin will be given to you by intravenous (IV) infusion into your vein.
• Your doctor will do regular blood tests to check for side effects of Adriamycin.
• Before receiving Adriamycin you may receive other medicines to prevent or treat side effects.
• Caregivers of children receiving Adriamycin should take precautions (such as wearing latex gloves) to prevent contact with the patient’s urine and other body fluids for at least 5 days after each treatment.

Liposomal formulation (Lipodox):

• Breast Cancer/Ovarian cancer: 50 mg/m2 once every 4 weeks
• AIDS-KS patients: 20 mg/m2 once every 3 weeks

Liposomal formulation (Doxil):

• Ovarian Cancer: 50 mg/m2 once every 4 weeks. A minimum of 4 courses is recommended.

Adriamycin (doxorubicin) formulation:

• The most commonly used dose schedule, when used as a single agent, is 60 to 75 mg/m2 as a single injection. It is given at 21-day intervals.
•  When used in combination with other chemotherapy drugs, the most commonly used dosage is 40 to 60 mg/m2 every 21 to 28 days.
• The NSABP B-15 study: the combination dosage regimen of Adriamycin 60 mg/m2 and cyclophosphamide 600 mg/m2 was done on day 1 of each 21-day treatment cycle. Four cycles of treatment were completed.

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

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

WARNINGS

1. Severe local tissue necrosis will occur if there is extravasation during administration. Adriamycin must not be given by the intramuscular or subcutaneous route.
2. Myocardial toxicity manifested in its most severe form by potentially fatal congestive heart failure (CHF) may occur either during therapy or months to years after termination of therapy. The probability of developing impaired myocardial function based on a combined index of signs, symptoms and decline in left ventricular ejection fraction (LVEF) is estimated to be 1 to 2% at a total cumulative dose of 300 mg/m2 of Adriamycin, 3 to 5% at a dose of 400 mg/m2, 5 to 8% at 450 mg/m2 and 6 to 20% at 500 mg/m2. The risk of developing CHF increases rapidly with increasing total cumulative doses of Adriamycin in excess of 400 mg/m2. Risk factors (active or dormant cardiovascular disease, prior or concomitant radiotherapy to the mediastinal/pericardial area, previous therapy with other anthracyclines or anthracenediones, concomitant use of other cardiotoxic drugs) may increase the risk of cardiac toxicity. Cardiac toxicity with Adriamycin may occur at lower cumulative doses whether or not cardiac risk factors are present. Pediatric patients are at increased risk for developing delayed cardiotoxicity.
3. Secondary acute myelogenous leukemia (AML) or myelodysplastic syndrome (MDS) have been reported in patients treated with anthracyclines, including Adriamycin. The occurrence of refractory secondary AML or MDS is more common when anthracyclines are given in combination with DNA-damaging anti-neoplastic agents or radiotherapy, when patients have been heavily pretreated with cytotoxic drugs, or when doses of anthracyclines have been escalated. The rate of developing secondary AML or MDS has been estimated in an analysis of 8563 patients with early breast cancer treated in 6 studies conducted by the National Surgical Adjuvant Breast and Bowel Project (NSABP), including NSABP B-15. Patients in these studies received standard doses of Adriamycin and standard or escalated doses of cyclophosphamide (AC) adjuvant chemotherapy and were followed for 61,810 patient years. Among 4483 such patients who received conventional doses of AC, 11 cases of AML or MDS were identified, for an incidence of 0.32 cases per 1000 patient years (95% CI, 0.16 to 0.57) and a cumulative incidence at 5 years of 0.21% (95% CI, 0.11 to 0.41%). In another analysis of 1474 patients with breast cancer who received adjuvant treatment with Adriamycin-containing regimens in clinical trials conducted at University of Texas M.D. Anderson Cancer Center,the incidence was estimated at 1.5% at 10 years. In both experiences, patients who received regimens with higher cyclophosphamide dosages, who received radiotherapy, or who were aged 50 or older had an increased risk of secondary AML or MDS. Pediatric patients are also at risk of developing secondary AML.
4. Dosage should be reduced in patients with impaired hepatic function.
5. Severe myelosuppression may occur.
6. Adriamycin should be administered only under the supervision of a physician who is experienced in the use of cancer chemotherapeutic agent.