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Totect

Last reviewed on RxList: 11/28/2016
Totect Side Effects Center

Medical Editor: John P. Cunha, DO, FACOEP

Last reviewed on RxList 6/8/2016

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. Totect 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, diarrhea, loss of appetite). Other side effects of Totect include:

  • swelling in your hands or feet
  • hair loss
  • sore throat
  • trouble swallowing
  • dizziness
  • tired feeling, or
  • injection site reactions (pain, swelling, or redness)

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 m�. 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.

Totect Consumer Information

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 )

Totect Professional Information

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 )

Related Resources for Totect

© Totect Patient Information is supplied by Cerner Multum, Inc. and Totect Consumer information is supplied by First Databank, Inc., used under license and subject to their respective copyrights.

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