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CERUBIDINE is a brand name for Daunorubicin, supplied as a powder for solution. The medicine, its uses, side effects and dosage are the same regardless of brand.
Verbatim from this product's HC label. Tap a section to expand.
At the start of treatment, the patient may experience anorexia, nausea and vomiting. These are transient effects and generally do not require an interruption of treatment. Antiemetics may help relieve vomiting. Abdominal pain, constipation or diarrhea, alopecia, rash, petechiae or purpura may be observed during therapy.
Some cases of thrombocytopenia and anemia have been reported during the first or second week of treatment. These phenomena are transient and corrective measures such as blood or platelet transfusions are rarely required. During the aplastic phase, cases of localized infection have occurred, particularly in the buccal cavity and pharynx.
Septicemia not responsive to antibiotics has also been reported. Some cases of cardiopathy attended by congestive heart failure, rhythm abnormalities, electrical modifications and indications of cardiac insufficiency have been observed in patients receiving a cumulative dose exceeding 30 mg/kg.
In young patients, the urine occasionally acquires a red tint. This coloration is due to the presence of CERUBIDINE® and its metabolites and has no clinical significance. During treatment with combinations of CERUBIDINE® with other antileukemic agents, there have been occurrences of myalgia and neuropathy.
These symptoms, already associated with the use of other agents, have not been directly attributed to CERUBIDINE®. Secondary leukaemias have been reported in patients treated with daunorubicin combination with other antineoplastics.
In every patient bone marrow function will be depressed by treatment with daunorubicin and in a variable proportion of cases, severe aplasia will develop. The consequence may include severe infection and opportunistic infection. Serious infection is a very common risk (including sepsis, septic shock and pneumonia), which sometimes can be fatal.
Tumour lysis syndrome has been observed during daunorubicin treatment. Cases of colitis, neutropenic enterocolitis (typhlitis), enterocolitis have been reported. Page 5 of 9 PHARMACOLOGY Daunorubicin inhibits the synthesis of nucleic acids; its effect on desoxyribonucleic acid is particularly rapid and marked.
Ribonucleic acid is more gradually affected. It appears that the action of the drug is the result of the formation of a complex with desoxyribonucleic acid in the cell nucleus; this blocks the site of action of the polymerases and gives daunorubicin a cytostatic activity.
Daunorubicin displays an immunosuppressive action as demonstrated by the inhibition of the production of heterohemagglutinins, by the prolongation of tolerance of skin grafts in mice and by the marked reduction of systemic lesions and arthritis provoked by Freund’s complete adjuvant in the rat.
) daunorubicin does not decrease the number of immunologically active splenic cells in the mouse. Daunorubicin has no effect on respiration or cellular glycolysis up to elevated concentrations which would inhibit cell growth. 6 mcg/mL.
CERUBIDINE must not be administered to patients who exhibit myocardial lesions or to those above 75 years of age (See WARNINGS and PRECAUTIONS). WARNINGS & PRECAUTIONS Infections should be treated before the start of daunorubicin therapy.
If during daunorubicin treatment a patient becomes febrile (regardless of the neutrophil count), treatment with broad spectrum antibiotics should be initiated. CERUBIDINE® induces medullary aplasia and leukopenia. It is therefore imperative that patients be protected against infection during the period of aplasia.
Daunorubicin treatment may lead to hyperuricaemia as a consequence of tumour lysis syndrome at the start of therapy. The increase in uric acid in the blood due to leukocyte degradation can be controlled by administering allopurinol and liquids to stimulate urine excretion.
Caution must be exercised in patients with renal insufficiency. Cases of colitis, enterocolitis and neutropenic enterocolitis (typhlitis) have been observed in patients treated with daunorubicin. Treatment discontinuation and prompt appropriate medical management are recommended.
CERUBIDINE® can cause tissue necrosis, thus great care must be taken to inject the product directly into the vein. When CERUBIDINE® is employed in association with other anticancer agents, the dosage of each should be reduced so as to minimize the total toxic effect.
Some instances of cardiotoxicity leading to congestive heart failure may be observed when a cumulative dose of 25 mg/kg has been reached; in general, this dose must not be exceeded except in certain desperate cases where 30 mg/kg can be administered.
Likewise, because of possible cardiotoxicity, the drug must not be administered to patients who exhibit myocardial lesions or to those above 75 years of age. Before initiating treatment with CERUBIDINE®, physical examination, appropriate x-rays and ECG should be performed and repeated at regular intervals thereafter, particularly when the cumulative dose has reached 15 mg/kg.
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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It exerts an antiviral effect on the herpes and on the vaccine viruses of the desoxyribonucleic acid group, but not on the polio or influenza virus of the ribonucleic acid group. In vivo, in the mouse, chicken and rabbit, daunorubicin provides a variable anti-tumor activity on grafted tumors and on tumors which appear either spontaneously or as a result of a virus.
C. for 6 days. P. C. route, against solid sarcomas when treatment is instituted immediately after the graft. C. route in the rabbit. P. route, reduces the weight of the spleen by 55% and prolongs the life of the animal by 25%. , daunorubicin is also extremely effective in lymphoblastic leukemia and demonstrates a good effect on C 1498 myeloid leukemia.
P. route in L 1210 leukemia and Rauscher leukemia. V. of daunorubicin does not produce any significant changes in arterial pressure and no effects were observed on the ECG or pulse. However, the same dose in the dog under pentobarbital anesthesia with atropine, produces an immediate and sustained (4 to 20 hours) reduction (10%) of cardiac rhythm, but without appreciably affecting the contracting force of the right ventricle, the blood pressure, or respiratory rate and amplitude.
The drug exerts no clear effect on the sympathetic and parasympathetic systems. Daunorubicin is inactive when administered orally. Page 6 of 9 TERATOGENICITY STUDIES No teratological effects have been observed in the chicken embryo, even at embryotoxic doses.
C. daily did not interfere with gestation or produce any teratogenic effects. V. induced 66% and 100% abortions respectively; in some fetuses, abnormalities which could not be attributed to drug, were observed. 5 and 25 mg/kg in the rat.
The animals usually died from the third post-drug day. No particular toxic symptoms were observed, except that the animals languished in a state of profound torpor. V. for 3 months in the rabbit did not produce mortality. The appearance and […]
It is also recommended that CERUBIDINE® be employed only as a treatment to induce a remission, and not as maintenance therapy. Page 4 of 9 ADVERSE REACTIONS At the start of treatment, the patient may experience anorexia, nausea and vomiting.
These are transient effects and generally do not require an interruption of treatment. Antiemetics may help relieve vomiting. Abdominal pain, constipation or diarrhea, alopecia, rash, petechiae or purpura may be observed during therapy.
Some cases of thrombocytopenia and anemia have been reported during the first or second week of treatment. These phenomena are transient and corrective measures such as blood or platelet transfusions are rarely required. During the aplastic phase, cases of localized infection have occurred, particularly in the buccal cavity and pharynx.
Septicemia not responsive to antibiotics has also been reported. Some cases of cardiopathy attended by congestive heart failure, rhythm abnormalities, electrical modifications and indications of cardiac insufficiency have been observed in patients receiving a cumulative dose exceeding 30 mg/kg.
In young patients, the urine occasionally acquires a red tint. This coloration is due to the presence of CERUBIDINE® and its metabolites and has no clinical significance. During treatment with combinations of CERUBIDINE® with other antileukemic agents, there have been occurrences of myalgia and neuropathy.
These symptoms, already associated with the use of other agents, have not been directly attributed to CERUBIDINE®. Secondary leukaemias have been reported in patients treated with daunorubicin combination with other antineoplastics.
In every patient bone marrow function will be depressed by treatment with daunorubicin and in a variable proportion of cases, severe aplasia will develop. The consequence may include severe infection and opportunistic infection. Serious infection is a very common risk (including sepsis, septic shock and pneumonia), which sometimes can be fatal.
Tumour lysis syndrome has been observed during daunorubicin treatment. Cases of colitis, neutropenic enterocolitis (typhlitis), enterocolitis have been reported. Page 5 of 9 PHARMACOLOGY Daunorubicin inhibits the synthesis of nucleic acids; its effect on desoxyribonucleic acid is particularly rapid and marked.
Ribonucleic acid is more gradually affected. It appears that the action of the drug is the result of the formation of a complex with desoxyribonucleic acid in the cell nucleus; this blocks the site of action of the polymerases and gives daunorubicin a cytostatic activity.
Daunorubicin displays an immunosuppressive action as demonstrated by the inhibition of the production of heterohemagglutinins, by the prolongation of tolerance of skin grafts in mice and by the marked reduction of systemic lesions and arthritis provoked by Freund’s complete adjuvant in the rat.
) daunorubicin does not decrease the number of immunologically active splenic cells in the mouse. Daunorubicin has no effect on respiration or cellular glycolysis up to elevated concentrations which would inhibit cell growth. 6 mcg/mL.
It exerts an antiviral effect on the herpes and on the vaccine viruses of the desoxyribonucleic acid group, but not on the polio or influenza virus of the ribonucleic acid group. In vivo, in the mouse, chicken and rabbit, daunorubicin provides a variable anti-tumor activity on grafted tumors and on tumors which appear either spontaneously or as a result of a virus.
C. for 6 days. P. route, daunorubicin is effective against […]