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Adriamycin PFS

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Adriamycin PFS

Adriamycin PFS Side Effects Center

Medical Editor: John P. Cunha, DO, FACOEP

Adriamycin PFS (doxorubicin hydrochloride) Injection is used to treat many types of cancer. It is a cancer (antineoplastic) medication. The brand name Adriamycin PFS is discontinued in the U.S. Generic forms may be available. Common side effects include nausea and vomiting (may be severe), diarrhea, and loss of appetite. This drug may give a reddish color to urine, tears, and sweat that 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.

Doxorubicin is given intravenously under physician supervision. Dose is determined by clinical factors. Tell your doctor if you have had previous treatment with doxorubicin, doxorubicin liposomal, daunorubicin, daunorubicin liposomal, idarubicin, or mitoxantrone. Doxorubicin may interact with paclitaxel, progesterone, verapamil, cyclosporine, cyclophosphamide, phenobarbital, phenytoin, streptozocin, or "live" vaccines. Tell your doctor all medications you use. Doxorubicin is not recommended for use during pregnancy. It may harm a fetus. Men and women should use two 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 to discuss 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.

Our Adriamycin PFS (doxorubicin hydrochloride) Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

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.

What is Patient Information in Detail?

Easy-to-read and understand detailed drug information and pill images for the patient or caregiver from Cerner Multum.

Adriamycin PFS in Detail - Patient Information: Side Effects

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Tell your caregivers at once if you have a serious side effect such as:

  • pain, burning, irritation, or skin changes where the injection was given;
  • feeling short of breath, even with mild exertion;
  • swelling, rapid weight gain (especially in your face and midsection);
  • nausea, upper stomach pain, itching, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes);
  • fast, slow, or uneven heartbeats;
  • anxiety, sweating, severe shortness of breath, wheezing, gasping for breath;
  • chest pain, sudden cough, cough with foamy mucus, rapid breathing, coughing up blood;
  • nausea, upper stomach pain, itching, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes);
  • lower back pain, blood in your urine, urinating less than usual or not at all;
  • numbness or tingly feeling around your mouth, weak pulse, overactive reflexes, confusion, fainting;
  • muscle weakness, tightness, or contraction;
  • fever, chills, body aches, flu symptoms, sores in your mouth and throat;
  • pale skin, feeling light-headed or short of breath, rapid heart rate, trouble concentrating; or
  • easy bruising, unusual bleeding (nose, mouth, vagina, or rectum), purple or red pinpoint spots under your skin.

Less serious side effects may include:

  • missed menstrual periods;
  • darkening of your skin or nails;
  • temporary hair loss;
  • feeling weak or tired;
  • mild nausea, diarrhea; or
  • eye redness, puffy eyelids.

This is not a complete list of side effects and others may occur. Tell your doctor about any unusual or bothersome side effect. You may report side effects to FDA at 1-800-FDA-1088.

Read the entire detailed patient monograph for Adriamycin PFS (Doxorubicin hydrochloride) »

What is Patient Information Overview?

A concise overview of the drug for the patient or caregiver from First DataBank.

Adriamycin PFS Overview - Patient Information: Side Effects

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 you have any very serious side effects, including: 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 rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: 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.

Read the entire patient information overview for Adriamycin PFS (Doxorubicin hydrochloride)»

What is Prescribing information?

The FDA package insert formatted in easy-to-find categories for health professionals and clinicians.

Adriamycin PFS FDA Prescribing Information: Side Effects
(Adverse Reactions)

SIDE EFFECTS

Dose limiting toxicities of therapy are myelosuppression and cardiotoxicity. Other reactions reported are:

Cardiotoxicity - (See WARNINGS.)

Cutaneous- Reversible complete alopecia occurs in most cases. Hyperpigmentation of nailbeds and dermal creases, primarily in pediatric patients, and onycholysis have been reported in a few cases. Radiation recall reaction has occurred with doxorubicin administration. Rash, itching, or photosensitivity may occur.

Gastrointestinal-Acute nausea and vomiting occurs frequently and may be severe. This may be alleviated by antiemetic therapy. Mucositis (stomatitis and esophagitis) may occur within 5 to 10 of beginning therapy, and most patients recover from this adverse event within another 5 to 10 days. The effect may be severe leading to ulceration and represents a site of origin for severe infections. The dosage regimen consisting of administration of doxorubicin on three successive days results in greater incidence and severity of mucositis. Ulceration and necrosis of the colon, especially the cecum, may occur leading to bleeding or severe infections which can be fatal. This reaction has been reported in patients with acute non-lymphocytic leukemia treated with a 3-day course of doxorubicin combined with cytarabine. Anorexia, abdominal pain, dehydration, diarrhea, and hyperpigmentation of the oral mucosa have been occasionally reported.

Hematologic - (See WARNINGS.)

Hypersensitivity - Fever, chills and urticaria have been reported occasionally. Anaphylaxis may occur. A case of apparent cross sensitivity to lincomycin has been reported.

Neurological- Peripheral neurotoxicity in the form of local-regional sensory and/or motor disturbances have been reported in patients treated intra-arterially with doxorubicin, mostly in combination with cisplatin. Animal studies have demonstrated seizures and coma in rodents and dogs treated with intra-carotid doxorubicin. Seizures and coma have been reported in patients treated with doxorubicin in combination with cisplatin or vincristine.

Ocular - Conjunctivitis, keratitis, and lacrimation occur rarely.

Other - Malaise/asthenia have been reported.

Adverse Reactions in Patients with Early Breast Cancer Receiving Doxorubicin-Containing Adjuvant Therapy: Safety data were collected from approximately 2300 women who participated in a randomized, open-label trial (NSABP B-15) evaluating the use of AC versus CMF in the treatment of early breast cancer involving axillary lymph nodes. In the safety analysis, the follow-up data from all patients receiving AC were combined (N=1492 evaluable patients) and compared with data from patients receiving conventional CMF (i.e., oral cyclophosphamide; N=739 evaluable patients). The most relevant adverse events reported in this study are provided in Table 2.

Table 2. Relevant Adverse Events in Patients with Early Breast Cancer Involving Axillary Lymph Nodes

  AC* Conventional CMF
  N=1492 N=739
Treatment administration
  Mean number of cycles 3.8 5.5
  Total cycles 5676 4068
Adverse events, % of patients
  Leukopenia    
  Grade 3 (1,000-1,999 /mm3) 3.4 9.4
  Grade 4 (<1000 /mm3) 0.3 0.3
Thrombocytopenia
  Grade 3 (25,000-49,999 /mm3) 0 0.3
  Grade 4 (<25,000 /mm3) 0.1 0
  Shock, sepsis 1.5 0.9
  Systemic infection 2.4 1.2
Nausea and vomiting
  Nausea only 15.5 42.8
  Vomiting ≤ 12 hours 34.4 25.2
  Vomiting >12 hours 36.8 12.0
  Intractable 4.7 1.6
  Alopecia 92.4 71.4
  Partial 22.9 56.3
  Complete 69.5 15.1
Weight loss
  5-10% 6.2 5.7
  >10% 2.4 2.8
Weight gain
  5-10% 10.6 27.9
  >10% 3.8 14.3
Cardiac function
  Asymptomatic 0.2 0.1
  Transient 0.1 0
  Symptomatic 0.1 0
  Treatment-related death 0 0
* Includes pooled data from patients who received either AC alone for 4 cycles, or who were treated with AC for 4 cycles followed by 3 cycles of CMF

Read the entire FDA prescribing information for Adriamycin PFS (Doxorubicin hydrochloride) »

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Adriamycin PFS - User Reviews

Adriamycin PFS User Reviews

Now you can gain knowledge and insight about a drug treatment with Patient Discussions.

Here is a collection of user reviews for the medication Adriamycin PFS sorted by most helpful. Patient Discussions FAQs

Report Problems to the Food and Drug Administration

 

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.


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