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Totect

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Totect

Totect Side Effects Center

Medical Editor: John P. Cunha, DO, FACOEP

Totect (dexrazoxane for injection) protects the heart and other tissues from harmful side effects caused by certain cancer medications and is used to reduce serious tissue injury if doxorubicin or a similar cancer chemotherapy medication has leaked out of the vein into the surrounding tissue. It can help prevent the need for surgery to repair the tissue damage. Many of the side effects reported with Totect are the same as those reported with cancer chemotherapy drugs, and are probably caused by the chemotherapy (such as nausea, vomiting, loss of appetite). Pain at the injection site may also occur.

The individual dosage of Totect is based on calculation of the Body Surface Area (BSA) up to a maximum dose of 2000 mg (each on Day 1 and 2) and 1000 mg (Day 3), corresponding to a BSA of 2 mē. Totect may interact with fluorouracil, and cyclophosphamide. Tell your doctor all medications and supplements you use. During pregnancy, Totect should be used only when prescribed. It may harm a fetus. It is unknown if this drug passes into breast milk. Because this drug may have undesirable effects on a nursing infant, breastfeeding while using Totect is not recommended.

Our Totect (dexrazoxane for injection) 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.

Totect 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 Totect (Dexrazoxane for Injection, Intravenous Infusion Only ) »

What is Patient Information Overview?

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

Totect Overview - Patient Information: Side Effects

SIDE EFFECTS: Many of the side effects reported with dexrazoxane treatment are the same as those reported with cancer chemotherapy drugs, and are probably caused by the chemotherapy (such as nausea, vomiting, loss of appetite). Pain at the injection site may also occur. If any side effects persist or worsen, 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 regularly 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 Totect (Dexrazoxane for Injection, Intravenous Infusion Only )»

What is Prescribing information?

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

Totect FDA Prescribing Information: Side Effects
(Adverse Reactions)

SIDE EFFECTS

Clinical Trials Experience

Because clinical trials are conducted under widely varying conditions, the adverse reaction rates observed cannot be directly compared to rates in other trials and may not reflect the rates observed in clinical practice.

In the clinical studies, Totect® was administered to patients also receiving chemotherapeutic agents for cancer, and the adverse reaction profile reflects the combination of Totect®, underlying disease, and already administered chemotherapy. The adverse reaction data reflect exposure to Totect® in 80 patients who received the first dose, 72 patients who received two doses, and 69 patients who received all three doses. Table 1 summarizes adverse reactions occurring with ≥ 5% frequency.

Table 1 : Adverse Reactions Occurring at ≥ 5% Frequency

MedDRA System Organ Class (SOC) and Preferred term Study 1 and 2 Combined (All causalities)
N=80 (%)
Total number of patients with at least one event 68 (85)
General disorders and administration site conditions 46 (58)
  Pyrexia 17 (21)
  Injection site pain/injection site discomfort 13 (16)
  Fatigue 10 (13)
  Edema peripheral 8 (10)
  Injection site phlebitis 5 (6)
Gastrointestinal disorders 44 (55)
  Nausea 34 (43)
  Vomiting 15 (19)
  Diarrhea 9 (11)
  Abdominal pain 5 (6)
  Constipation 5 (6)
Infections and infestations 24 (30)
  Postoperative infection 13 (16)
Nervous system disorders 19 (24)
  Dizziness 9 (11)
  Headache 5 (6)
Skin and subcutaneous disorders 14 (18)
  Alopecia 11 (14)
Respiratory, thoracic and mediastinal disorders 13 (16)
  Dyspnea 6 (8)
  Pneumonia 5 (6)
  Cough 4(5)
Vascular disorders 12 (15)
Blood and lymphatic system disorders 11 (14)
  Anemia 5 (6)
Psychiatric disorders 11 (14)
  Depression 6 (8)
  Insomnia 4 (5)
Musculoskeletal and connective tissue disorders 10 (13)
Metabolism and nutrition disorders 8 (10)
  Anorexia 4 (5)
Cardiac disorders 4 (5)

Neutropenia and febrile neutropenia each occurred in 2.5% of patients.

Table 2 summarizes laboratory adverse events from studies 1 and 2.

Table 2: Laboratory Adverse Reactions

CTCAE version 3 Term CTC grade 3
N (%)
CTC grade 4
N (%)
CTC grade 2 to 4
N (%)
Hematologic:
Decreased hemoglobin 2 (3) 0 34 (43)
Decreased WBC 20 (25) 16 (20) 58 (73)
Decreased neutrophils 17 (22) 19 (24) 48 (61)
Decreased platelets 17 (21) 0 21 (26)
Hepatic:
Increased bilirubin 1 (2) 0 6 (11)
Increased AST 1 (1) 1 (1) 21 (28)
Increased ALT 1 (1) 4 (5) 17 (22)
Increased alkaline phosphatase 0 0 3 (4)
Increased LDH 0 0 1 (5)
Metabolic:
Increased creatinine 1 (2) 1 (2) 8 (14)
Decreased sodium 4 (5) 1 (1) 5 (6)
Increased calcium total 1 (2) 1 (2) 4 (7)

Read the entire FDA prescribing information for Totect (Dexrazoxane for Injection, Intravenous Infusion Only ) »

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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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