Drug Interaction:
None reported
Indication:
Chronic lymphocytic leukemia.
Fludarabine was approved by FDA in April 1991
Approved by (DCI) Drug Controller GENERAL - India For Marketing
(Ref- IDMA Publication)
Name of Drug Indication Date of Approval
Fludarabine Phosphate Anti-cancer 26-06-1999
Adverse Reaction:
Fever, chills, fatigue, infection, pain, weakness, parethesia, headache, visual disturbance, cough, pneumonia, dyspnea, sinusitis, nausea, vomiting, anorexia, stomatitis, GI bleeding
Contra-Indications:
Hypersens to the drug Special precaution: Monitoring the patients hematologic profile. Hetatologic toxicity- closely observe patients of hematologic and nonhematologic toxicity.
Dosages/ Overdosage Etc:
Fludarabine was approved by FDA in April 1991
Indications:
Chronic lymphocytic leukemia.
Dosage:
Usual dose 25mg/m2 administered over a period of about 30 minutes daily for 5 consecutive days.
Patient Information:
Ref - USP PDI Vol II 17th Edition (1997)
1.Allergies-
Tell your doctor if you are have ever had any unusual or allergic reaction to
fludarabine.
2.Pregnancy-
It is best to use some kind of birth control birth control while receiving
fludarabine
3. Breast-feeding-
Not known whether fludarabine passes into breast milk. Because
fludarbine may cause serious side effects , breast feeding is not generally
recommended.
4.Children-
There is no specific information comparing fludarabne in children with
use in other age groups.
5.Older adults-
Fludarabine is not expected to cause different side effects or problems
in older people than it does in younger adults
6. Other medicines-
When you are receiving fludarabine it is especially important that your doctor
know if you taking any of the following-
Amphotericin B
Azathioprine
Chloramphenicol
Colchicine or
Flucytosine or
Ganciclovir
Pilcamycin
Zidovudine - if you have been treated with radiation or cancer medicine -
Fludarabine may increase the effects of these medicines
7. Other medical problems-
The presence of other medical problems may affect the use of fludarabine.
Make sure you tell your doctor if you have any other medical problems
especially-
Chicken pox or exposure of
Herpes Zoster - risk of severe disease affecting different parts of the body
Gout or
Kidney stones -fludarabine may increase the levels of uric acid, which
can cause gout or kidney stones.
Kidney disease - effects of fludarabine may be increased because of slower
removal from the body
Pharmacology/ Pharmacokinetics:
Pharmacology:
Fluadarabine is a fluorinated nucleotide analog of the antiviral agent vidarabine that is relatively resistent to deamination by adenosine deaminase.
Pharmacokinetics:
Fludarabine is rapidly converted to the active 2-fluoroara-A, within minutes after IV infusion. Total body clearance is inversely correlated with serum creatinine,suggesting renal elimination of the compound.
Pregnancy and lactation:
Pregnancy:
Avoid women of child bearing potential to avoid becoming pregnant.
Lactation:
Excercise caution and decide whether to discontinue the drug or discontinue nursing, depending on the importance of the drug to the mother.
Manufacturer Details