Totect
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Totect
Totect Side Effects Center
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
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 ) »
Additional Totect Information
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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