The package insert of the medicine Citostal

the package insert of the medicine Citostal. Therapeutic class of Antineoplastic. Active principles Lomustina.

what For?

CITOSTAL is indicated as therapy in palliative care in association with other treatment modalities or in combinations established with other chemotherapeutic agents approved in the following neoplasms:
Brain tumors – primary or metastatic, in patients who have already received surgical treatment and / or radioterapêutico appropriate.

Hodgkin’s Disease – as therapy-secondary
Other tumors – CITOSTAL has been employed in combination with other therapeutic agents, only after other conventional methods have failed.

Contraindications

When should I not use?

CITOSTAL should not be administered to individuals who have demonstrated a previous hypersensitivity to this drug.

Side Effects

What are the evils that can cause me?

Gastrointestinal
Nausea and vomiting may occur approximately 3 to 6 hours after an oral dose and usually persisting for at least 24 hours. Can reduce the frequency and duration of these side effects through the use of antiemetics prior to administration of the drug and administering the patients on fasting.

Haematological toxicities
Toxicity the most frequent and serious CITOSTAL is the mielodepressão delayed. Usually occurs 4 to 6 weeks after drug administration and is dose related. Thrombocytopenia occurs approximately 4 weeks after administration and persists for 1 or 2 weeks. Leukopenia occurs at 5 to 6 weeks after a dose of CITOSTAL and persists for 1 or 2 weeks. Approximately 65% of patients receiving 130mg/m 2 exhibit leukopenia below 5000 leukocytes/mm 3, and 36% have leukopenia below 3000 leukocytes/mm 3. The thrombocytopenia is usually more severe than leukopenia. However, both can be toxicities limiting the dose.

CITOSTAL can produce mielodepressão cumulative, manifested through rates of depression, or depression more prolonged after repeated doses.

The occurrence of acute leukemia and dysplasias spinal cord has been recorded in patients on prolonged treatment with nitrosuréias.

Anemia also occurs, but is less frequent and severe than thrombocytopenia or leukopenia.

Pulmonary Toxicity
Pulmonary toxicity carcterizada by pulmonary infiltrates and/or fibrosis has rarely been reported with the use of CITOSTAL. The onset of toxicity occurs after an interval of six months or more since the beginning of the treatment with a cumulative dose of CITOSTAL generally larger than 1100mg/m 2. There is one report of pulmonary toxicity with a cumulative dose of only 600mg.

Fibrosis lung delayed onset occurring up to 15 years after treatment have been observed with intracranial tumors who received nitrosuréias during his childhood and early adolescence.

Other toxicities
Has been reported rarely; stomatitis, alopecia, and anemia. The reactions neurological disorders such as disorientation, lethargy, ataxia, and dysarthria have been observed in some patients receiving CITOSTAL. However it is not clarified the relationship with the medication in these patients.

Nephrotoxicity
Abnormalities of the kidney consisting of reduction in size of the kidneys, azotemia is progressive and renal failure have been reported in patients who have received high cumulative dose after prolonged therapy with the CITOSTAL and other nitrosuréias. Occasionally, also have been reported cases of alteracões kidney in patients receiving doses total lower.

Hepatotoxicity
A kind reversible hepatic toxicity, manifested by increased levels of transaminases, alkaline phosphatase, and bilirrubinas have been reported in a small percentage of patients receiving CITOSTAL.

DOSAGE AND ADMINISTRATION
The recommended dose of CITOSTAL in children and adults is 130mg/m 2 orally as a single dose every 6 weeks. In individuals with medullar compromised, the dosage should be reduced to 100mg/m 2 every 6 weeks.

you should Not administer another cycle of treatment, until the recovery of bone marrow to an acceptable level (platelets > 100.000/mm 3; white blood cells > 4.000/mm 3).

complete blood count should be monitored weekly, and new cycles should not be repeated before 6 weeks because the toxicity haematological is delayed and cumulative. Doses subsequent to the initial dose should be adjusted according to the haematological response of the patient to the previous dose. The following schema is suggested as a guide for the adjustment of the dose to be administered:
The NADIR AFTER the PREVIOUS DOSE PERCENTAGE OF the PREVIOUS DOSE TO BE ADMI
NISTRADA
LEUKOCYTES, PLATELETS
> 4.000 > 100.000 100%
3.000 – 3.999 75.000 – 99.000 100%
2.000 – 2.999 25.000 – 74.999 70%
< 2.000 < a 25,000-50%
When CITOSTAL is used in combination with drugs mielodepressivas, the doses should be adjusted accordingly.

Warnings and Precautions

what should I know before using?

CITOSTAL should be prescribed by professionals with experience in the use of antineoplastic agents.

The toxic effect most common and serious CITOSTAL is depression spinal delayed, notably thrombocytopenia and leukopenia, which may contribute to bleeding and serious infections in patients already committed.

blood counts should be monitored weekly for at least 6 weeks after a dose (see ADVERSE REACTIONS). At the recommended dose, the cycles of CITOSTAL should not be conducted with greater frequency than every 6 weeks.

The toxiucidade core of the CITOSTAL is cumulative and therefore dosage adjustment must be considered based on the blood counts from previous dose (see dose adjustment in the table “DOSAGE AND ADMINISTRATION”).

care Should be taken when administering the CITOSTAL the patients with the number of platelets, leukocytes or erythrocytes circulating owners. (see “DOSAGE AND ADMINISTRATION”).

The pulmonary toxicity of CITOSTAL seems to be related to the dose (see “backlash”).

The prolonged use of nitrosuréias has been reported to be probably associated with the development of malignancies secondary.

The tests of kidney and liver functions should be periodically monitored (see “backlash”).

Use during pregnancy
The safe use of CITOSTAL during pregnancy is not established. CITOSTAL is embriotóxico and teratogenic in rats and embriotóxico in rabbits in doses equivalent to those employed in human beings. If this drug is used during pregnancy or if the patient becomes pregnant while taking this drug, the patient should be informed of the potential risk to the fetus. Women with potential to become pregnant should be advised to avoid pregnancy.

Carcinogenesis, Mutagênese and Fertility
CITOSTAL is carcinogenic in rats and mice, producing a marked increase in the incidence of tumours at doses close to those used clinically.

therapy with nitrosuréias has the potential carcinogen.It has been reported the occurrence of acute leukemia and dysplasias spinal cord in patients treated with nitrosuréias.

CITOSTAL also affects fertility in male rats at doses somewhat higher than the human dose.

Use in lactation
It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk and the occurrence with CITOSTAL of serious adverse events in babies being breastfed, you should choose to stop breastfeeding or the administration of the drug, taking into account the importance of the drug to the mother.

Introduction

Citostal is presented in vials with 5 capsules. each capsule contains 10 or 40 mg lomustina(ccnu).

Laboratory

Bristol-Myers Squibb Pharma EEIG

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