Adriamycin PFS

DRUG DESCRIPTION

Doxorubicin is a cytotoxic anthracycline antibiotic isolated from cultures of Streptomyces peucetius var. caesius. Doxorubicin consists of a naphthacenequinone nucleus linked through a glycosidic bond at ring atom 7 to an amino sugar, daunosamine. Chemically, doxorubicin hydrochloride is: 5,12-Naphthacenedione, 10-[(3-amino-2,3,6-trideoxy-?-L-lyxo-hexopyranosyl)oxy]-7,8,9,10-tetrahydro-6,8,11-trihydroxy-8-(hydroxylacetyl)-1-methoxy-, hydrochloride (8S-cis)-. The structural formula is as follows:

Adriamycin PFS (Doxorubicin Hydrochloride)Structural Formula Illustration

Doxorubicin binds to nucleic acids, presumably by specific intercalation of the planar anthracycline nucleus with the DNA double helix. The anthracycline ring is lipophilic, but the saturated end of the ring system contains abundant hydroxyl groups adjacent to the amino sugar, producing a hydrophilic center. The molecule is amphoteric, containing acidic functions in the ring phenolic groups and a basic function in the sugar amino group. It binds to cell membranes as well as plasma proteins.

Doxorubicin Hydrochloride for Injection, USP, is a sterile red-orange lyophilized powder.

Doxorubicin Hydrochloride Injection, USP, is a sterile parenteral, isotonic solution.

What are the possible side effects of doxorubicin (Adriamycin)?

If you experience any of the following serious side effects from doxorubicin, contact your doctor immediately:

  • an allergic reaction (including difficulty breathing; closing of the throat; swelling of the lips, tongue, or face; or hives);
  • decreased bone marrow function and blood problems (extreme fatigue; easy bruising or bleeding; black, bloody or tarry stools; or fever, chills, or signs of infection);
  • congestive heart failure (difficulty breathing, fluid retention, chest pain);
  • irregular...

Read All Potential Side Effects and See Pictures of Adriamycin PFS

What are the precautions when taking doxorubicin hydrochloride (Adriamycin PFS)?

Before using doxorubicin, tell your doctor or pharmacist if you are allergic to it; or to lincomycin; 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.

This medication should not be used if you have certain medical conditions. Before using this medicine, consult your doctor or pharmacist if you have: a history of receiving your total maximum dose of any anthracycline-type drug (e.g., doxorubicin, idarubicin, daunorubicin, mitoxantrone), a current infection, low blood cell counts, severe mouth sores (stomatitis), severe liver disease, certain heart problems (e.g., recent heart attack, severe heart failure, severe irregular heartbeat).

Before using...

Read All Potential Precautions of Adriamycin PFS


Adriamycin PFS Consumer (continued)

SIDE EFFECTS: Nausea, vomiting, diarrhea, and loss of appetite may occur. Nausea and vomiting can be severe. In some cases, drug therapy may be needed to prevent or relieve nausea and vomiting. Not eating before your treatment may help relieve vomiting. Changes in diet and lifestyle, such as eating several small meals and limiting activity, may help lessen some of these effects. If any of these effects continue or worsen, notify your doctor or pharmacist.

Doxorubicin may give a reddish color to your urine, tears, and sweat. This effect may start in the first hours after treatment and may last up to several days. This is a normal effect of the drug and should not be mistaken for blood in your urine.

Temporary hair loss may occur. Normal hair growth should return after treatment has ended.

Nail changes (including fungal infections in the nail beds) may rarely occur.

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: cough/hoarseness, persistent diarrhea, redness/flushing of face, eye redness/itching, unusual tiredness, joint pain, pain in the lower back/side/stomach/abdomen, painful/difficult urination, stopped/missed menstrual periods, black/tarry stools, bloody mucus or discharge in stools, fast/irregular heartbeat, shortness of breath, dizziness, swelling of ankles/feet, decreased urination.

Painful sores on the lips, mouth and throat may occur. To decrease the risk, limit hot foods and drinks, brush your teeth carefully, avoid using mouthwash that contains alcohol, and rinse your mouth frequently with cool water.

Get medical help right away if this rare but very serious side effect occurs: chest pain.

Within days to weeks after doxorubicin treatment, a serious skin reaction that looks likes a severe sunburn (radiation recall) may develop on any area of skin that has been previously treated with radiation. Tell your doctor immediately if you develop skin redness, pain, tenderness, swelling, peeling, or blisters. Your doctor may prescribe medication to help your skin heal faster and reduce the swelling. In addition, you should avoid prolonged sun exposure, tanning booths and sunlamps. Use a sunscreen and wear protective clothing when outdoors.

In children, radiation recall may occur in the lungs. Tell the doctor immediately if you notice wheezing or trouble breathing in the child.

A very serious allergic reaction to this drug is unlikely, but seek immediate medical attention if it occurs. Symptoms of a serious allergic reaction may include: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

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.

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 doxorubicin, tell your doctor or pharmacist if you are allergic to it; or to lincomycin; 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.

This medication should not be used if you have certain medical conditions. Before using this medicine, consult your doctor or pharmacist if you have: a history of receiving your total maximum dose of any anthracycline-type drug (e.g., doxorubicin, idarubicin, daunorubicin, mitoxantrone), a current infection, low blood cell counts, severe mouth sores (stomatitis), severe liver disease, certain heart problems (e.g., recent heart attack, severe heart failure, severe irregular heartbeat).

Before using this medication, tell your doctor or pharmacist your medical history, especially of: anemia, gout, heart problems, a certain immune system problem (neutropenia), kidney problems, liver problems, radiation treatment (especially to the chest area), low platelet count (thrombocytopenia).

Do not have immunizations/vaccinations without the consent of your doctor, and avoid contact with people who have recently received oral polio vaccine.

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.

To lower the chance of getting cut, bruised, or injured, use caution with sharp objects like safety razors and nail cutters, and avoid activities such as contact sports. Use a soft-bristle toothbrush to lower the risk of bleeding gums.

Wash your hands well to prevent the spread of infections.

Caution is advised when using this drug in children because they may be more sensitive to the effects of the drug, especially to radiation recall in the lungs, heart problems, or another cancer later on in life. Doxorubicin, in combination with other chemotherapies, may also slow the growth of children before puberty.

This medication is not recommended for use during pregnancy. It may harm an unborn baby. It is recommended that men and women use two effective forms of birth control (e.g., condoms and birth control pills) while being treated with this medication and for some time afterward. Consult your doctor for more details and to discuss reliable forms of birth control.

This medication passes into breast milk. Because of the potential risk to the infant, breast-feeding while using this drug is not recommended. Consult your doctor before breast-feeding.


Adriamycin PFS Patient Information Including Side Effects

Brand Names: Adriamycin

Generic Name: doxorubicin (Pronunciation: DOX oh ROO bi sin)

  • What is doxorubicin (Adriamycin PFS)?
  • What are the possible side effects of doxorubicin (Adriamycin PFS)?
  • What is the most important information I should know about doxorubicin (Adriamycin PFS)?
  • What should I discuss with my healthcare provider before using doxorubicin (Adriamycin PFS)?
  • How should I use doxorubicin (Adriamycin PFS)?
  • What happens if I miss a dose (Adriamycin PFS)?
  • What happens if I overdose (Adriamycin PFS)?
  • What should I avoid while using doxorubicin (Adriamycin PFS)?
  • What other drugs will affect doxorubicin (Adriamycin PFS)?
  • Where can I get more information?

What is doxorubicin (Adriamycin PFS)?

Doxorubicin is a cancer (antineoplastic) medication. Doxorubicin interferes with the growth of cancer cells and slows their growth and spread in the body.

Doxorubicin is used to treat many types of cancer.

Doxorubicin may also be used for purposes other than those listed in this medication guide.

What are the possible side effects of doxorubicin (Adriamycin PFS)?

If you experience any of the following serious side effects from doxorubicin, contact your doctor immediately:

  • an allergic reaction (including difficulty breathing; closing of the throat; swelling of the lips, tongue, or face; or hives);
  • decreased bone marrow function and blood problems (extreme fatigue; easy bruising or bleeding; black, bloody or tarry stools; or fever, chills, or signs of infection);
  • congestive heart failure (difficulty breathing, fluid retention, chest pain);
  • irregular heartbeats;
  • tissue or vein reactions near the site of administration;
  • liver damage (abdominal pain, yellowing of the skin or eyes);
  • severe nausea, vomiting, diarrhea, and loss of appetite;
  • inflamation and sores inside the mouth, throat, or intestines;
  • fever, chills, or other signs of infection;
  • numbness, tingling, or difficult movement of a body part;
  • seizures; or
  • increased levels of uric acid in the body (joint pain and stiffness).

Other, less serious side effects may be more likely to occur. Continue taking doxorubicin and talk to your doctor if you experience:

  • facial flushing during administration;
  • eye irritation or tearing;
  • darkening of the nail beds and skin folds;
  • temporary hair loss; or
  • red colored urine for 1 or 2 days following a dose.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. You may report side effects to FDA at 1-800-FDA-1088.

What is the most important information I should know about doxorubicin (Adriamycin PFS)?

Doxorubicin should only be administered under the supervision of a qualified healthcare provider experienced in the use of cancer chemotherapeutic agents.

Serious side effects have been reported with the use of doxorubicin including: allergic reactions (difficulty breathing; closing of the throat; swelling of the lips, tongue, or face; or hives); severe heart damage with prolonged use; decreased bone marrow function and blood problems (extreme fatigue; easy bruising or bleeding; black, bloody or tarry stools; fever or chills; or signs of infection); severe nausea, vomiting, diarrhea, and loss of appetite; and others. Talk to your doctor about the possible side effects from treatment with doxorubicin.

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