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Zinecard

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Zinecard

Zinecard Side Effects Center

Medical Editor: John P. Cunha, DO, FACOEP

Zinecard (dexrazoxane) is used in women who are receiving doxorubicin for metastatic breast cancer. It is a cardioprotective agent that is used to protect the heart from harmful side effects caused by doxorubicin. This medication is available in generic form. Common side effects include nausea, vomiting, loss of appetite, trouble swallowing, diarrhea, temporary hair loss, or pain/irritation at the injection site. Because this medication is used with another medication, it may be difficult to tell which side effects it causes.

The dose of Zinecard depends on the dose of doxorubicin. The recommended dosage ratio of Zinecard:doxorubicin is 10:1 (e.g., 500 mg/mē Zinecard:50 mg/mē doxorubicin). Zinecard may interact with fluorouracil, or cyclophosphamide. Tell your doctor all medications and supplements you use. During pregnancy, Zinecard should be used only when prescribed. This drug passes into breast milk and could have undesirable effects on a nursing infant. Consult your doctor before breastfeeding.

Our Zinecard (dexrazoxane) 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.

Zinecard in Detail - Patient Information: Side Effects

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

Tell your doctor at once if you have any of these serious side effects:

  • fever, chills, body aches, flu symptoms, sores in your mouth and throat;
  • easy bruising, unusual bleeding (nose, mouth, vagina, or rectum), purple or red pinpoint spots under your skin; or
  • bruising, swelling, warmth, redness, oozing, or bleeding of any surgical incision.

Less serious side effects may include:

  • swelling in your hands or feet;
  • hair loss;
  • nausea, vomiting, diarrhea, loss of appetite;
  • sore throat, trouble swallowing;
  • dizziness, tired feeling; or
  • pain, swelling, or redness where the medicine was injected.

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.

Read the entire detailed patient monograph for Zinecard (Dexrazoxane) »

What is Patient Information Overview?

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

Zinecard Overview - Patient Information: Side Effects

SIDE EFFECTS: Pain at the injection site may occur. If this effect persists or worsens, tell your doctor or pharmacist promptly.

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: signs of infection (such as fever, persistent sore throat), easy bruising/bleeding.

Very rarely, people with cancer who have been treated with this medication have developed other cancers (such as leukemia, lymphoma). Consult your doctor for more details.

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 Zinecard (Dexrazoxane)»

What is Prescribing information?

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

Zinecard FDA Prescribing Information: Side Effects
(Adverse Reactions)

SIDE EFFECTS

ZINECARD at a dose of 500 mg/m² has been administered in combination with FAC in randomized, placebo-controlled, double-blind studies to patients with metastatic breast cancer. The dose of doxorubicin was 50 mg/m² in each of the trials. Courses were repeated every three weeks, provided recovery from toxicity had occurred. Table 3 below lists the incidence of adverse experiences for patients receiving FAC with either ZINECARD or placebo in the breast cancer studies. Adverse experiences occurring during courses 1 through 6 are displayed for patients receiving ZINECARD or placebo with FAC beginning with their first course of therapy (columns 1 and 3, respectively). Adverse experiences occurring at course 7 and beyond for patients who received placebo with FAC during the first six courses and who then received either ZINECARD or placebo with FAC are also displayed (columns 2 and 4, respectively).

Table 3

EXPERIENCE FAC + ZINECARD FAC + PLACEBO
Courses 1-6
N =413
Courses ≥ 7
N = 102
Courses 1-6
N =458
Course ≥ 7
N = 99
Alopecia 94 100 97 98
Nausea 77 51 84 60
Vomiting 59 42 72 49
Fatigue/Malaise 61 48 58 55
Anorexia 42 27 47 38
Stomatitis 34 26 41 28
Fever 34 22 29 18
Infection 23 19 18 21
Diarrhea 21 14 24 7
Pain on injection 12 13 3 0
Sepsis 17 12 14 9
Neurotoxicity 17 10 13 5
Streaking/ Erythema 5 4 4 2
Phlebitis 6 3 3 5
Esophagitis 6 3 7 4
Dysphagia 8 0 10 5
Hemorrhage 2 3 2 1
Extravasation 1 3 1 2
Urticaria 2 2 2 0
Recall Skin Reaction 1 1 2 0

The adverse experiences listed above are likely attributable to the FAC regimen with the exception of pain on injection that was observed mainly on the ZINECARD arm.

Myelosuppression

Patients receiving FAC with ZINECARD experienced more severe leukopenia, granulocytopenia, and thrombocytopenia at nadir than patients receiving FAC without ZINECARD, but recovery counts were similar for the two groups of patients.

Hepatic and Renal

Some patients receiving FAC + ZINECARD or FAC + placebo experienced marked abnormalities in hepatic or renal function tests, but the frequency and severity of abnormalities in bilirubin, alkaline phosphatase, BUN, and creatinine were similar for patients receiving FAC with or without ZINECARD.

Read the entire FDA prescribing information for Zinecard (Dexrazoxane) »

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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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