Fludarabine Vista Fludara 50 mg powder for solution 1 vial

Fludarabine Vista Fludara 50 mg powder for solution 1 vial

$118.36

Fludarabine Vista aka Fludara 50 mg powder for solution for injection use of antineoplastic therapy. Recommended for treatment chronic lymphocytic leukemia.

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Description

Buy online Fludarabine Vista aka Fludara 50 mg powder for solution for injection or infusion.
Each vial contains 50 mg fludarabine phosphate.
One ml of reconstituted solution contains 25 mg fludarabine phosphate.

Fludarabine Vista aka Fludara FOR INJECTION should be administered under the supervision of a qualified physician experienced in the use of antineoplastic therapy. This drug can severely suppress bone marrow function. When used at high doses in doseranging studies in patients with acute leukemia, was associated with severe neurologic effects, including blindness, coma, and death. This severe central nervous system toxicity occurred in 36% of patients treated with doses approximately four times greater (96 mg/m²/day for 5-7 days) than the recommended dose. Similar severe central nervous system toxicity, including coma, seizures, agitation and confusion, has been reported in patients treated at doses in the range of the dose recommended for chronic lymphocytic leukemia.

INDICATIONS
Treatment of B-cell chronic lymphocytic leukaemia (CLL) in adult patients with sufficient bone marrow reserves.
First line treatment with Fludarabine should only be initiated in adult patients with advanced disease, Rai stages III/IV (Binet stage C), or Rai stages I/II (Binet stage A/B) where the patient has disease related symptoms or evidence of progressive disease.
For the treatment of adult patients with B-cell chronic lymphocytic leukemia (CLL) who have not responded to or whose disease has progressed during treatment with at least one standard alkylating-agent containing regimen. The safety and effectiveness of Fludarabine Vista (Fludara) for injection in previously untreated or non-refractory patients with CLL have not been established.

CONTRAINDICATIONS
Fludarabine Vista (Fludara) for injection is contraindicated in those patients who are hypersensitive to this drug or its components.

  • Renal impairment with creatinine clearance < 30 ml/min;
  • Decompensated haemolytic anaemia;
  • Lactation.

INTERACTION
In a clinical investigation using intravenous Fludara in combination with pentostatin (deoxycoformycin) for the treatment of refractory chronic lymphocytic leukaemia (CLL), there was an unacceptably high incidence of fatal pulmonary toxicity. Therefore, the use of Fludara in combination with pentostatin is not recommended.

Dipyridamole and other inhibitors of adenosine uptake may reduce the therapeutic efficacy of Fludara.

Clinical studies and in vitro experiments showed that during use of Fludarabine Vista in combination with cytarabine the intracellular peak concentration and intracellular exposure of Ara-CTP (active metabolite of cytarabine) increased in leukaemic cells. Plasma concentrations of Ara-C and the elimination rate of Ara-CTP were not affected.

PRECAUTIONS

  • Fludarabine Vista (Fludara) for injection is a potent antineoplastic agent with potentially significant toxic side effects. Patients undergoing therapy should be closely observed for signs of hematologic and nonhematologic toxicity. Periodic assessment of peripheral blood counts is recommended to detect the development of anemia, neutropenia and thrombocytopenia;
  • In patients with impaired state of health, Fludarabine Vista (Fludara) for injection should be given with caution and after careful risk/benefit consideration. This applies especially for patients with severe impairment of bone marrow function (thrombocytopenia, anemia, and/or granulocytopenia), immunodeficiency or with a history of opportunistic infection. Prophylactic treatment should be considered in patients at increased risk of developing opportunistic infections;
  • Fludarabine Vista (Fludara) for injection may reduce the ability to drive or use machines, since fatigue, weakness, visual disturbances, confusion, agitation and seizures have been observed.

SIDE EFFECTS
Very common adverse events include myelosuppression (neutropenia, thrombocytopenia and anemia), fever and chills, fatigue, weakness, infection, pneumonia, cough, nausea, vomiting, and diarrhea. Other commonly reported events include malaise, mucositis and anorexia. Serious opportunistic infections (such as latent viral reactivation, herpes zoster virus, Epstein-Barr virus, and progressive multifocal leukoencephalopathy) have occurred in CLL patients treated with FLUDARA (fludarabine) for injection. Adverse events and those reactions which are more clearly related to the drug are arranged below according to body system.

OVERDOSE
High doses of Fludara have been associated with leukoencephalopathy, acute toxic leukoencephalopathy, or reversible posterior leukoencephalopathy syndrome (RPLS). Symptoms may include headache, nausea and vomiting, seizures, visual disturbances such as vision loss, altered sensorium, and focal neurological deficits. Additional effects may include optic neuritis, and papillitis, confusion, somnolence, agitation, paraparesis/ quadriparesis, muscle spasticity, incontinence, irreversible central nervous system toxicity characterised by delayed blindness, coma, and death. High doses are also associated with severe thrombocytopenia and neutropenia due to bone marrow suppression.

There is no known specific antidote for Fludara overdosage. Treatment consists of drug discontinuation and supportive therapy.

REALESE FORM
Powder for solution for injection or infusion.
White lyophilisate for reconstitution.

STORAGE
Store medicines at room temperature, away from heat and direct light. Do not freeze medicines unless required by package insert. Keep medicines away from children and pets.

Additional information

Weight 150 g
Forms of release

Powders

Volume / Weight

50 mg

Packing

Vial

Manufacturer

Sindan Pharma SRL

Country/Region of Manufacture

Romania

Expiration date

08.2022

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Method of administration
Fludara should be administered under the supervision of a qualified physician experienced in the use of antineoplastic therapy.
It is strongly recommended that Fludara should be only administered intravenously. No cases have been reported in which paravenously administered Fludara led to severe local adverse reactions. However, unintentional paravenous administration must be avoided.

The recommended adult dose of FLUDARA (fludarabine) FOR INJECTION is 25 mg/m² administered intravenously over a period of approximately 30 minutes daily for five consecutive days. Each 5 day course of treatment should commence every 28 days. Dosage may be decreased or delayed based on evidence of hematologic or nonhematologic toxicity. Physicians should consider delaying or discontinuing the drug if neurotoxicity occurs.
The required dose (calculated on the basis of the patient’s body surface area) of the reconstituted solution is drawn up into a syringe. For intravenous bolus injection this dose is further diluted in 10 ml sodium chloride 9 mg/ml (0.9%). Alternatively, for infusion, the required dose drawn up in a syringe may be diluted in 100 ml sodium chloride 9 mg/ml (0.9%) and infused over approximately 30 minutes.
The duration of treatment depends on the treatment success and the tolerability of the drug.
In CLL patients, Fludara should be administered up to the achievement of best response (complete or partial remission, usually 6 cycles) and then the drug should be discontinued.

Patients with renal impairment
Doses should be adjusted for patients with reduced kidney function. If creatinine clearance is between 30 and 70 ml/min, the dose should be reduced by up to 50% and close haematological monitoring should be used to assess toxicity.
Fludara treatment is contraindicated, if creatinine clearance is < 30 ml/min. Patients with hepatic impairment No data are available concerning the use of Fludara in patients with hepatic impairment. In this group of patients, Fludara should be used with caution. Paediatric population The safety and efficacy of Fludara in children below the age of 18 years have not been established. Therefore, Fludara is not recommended for use in children. Older people Since there are limited data for the use of Fludara in older people (> 75 years), caution should be exercised with the administration of Fludara in these patients.
In patients over the age of 65 years, creatinine clearance should be measured.

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