"The U.S. Food and Drug Administration today approved Gazyva (obinutuzumab) for use in combination with chlorambucil to treat patients with previously untreated chronic lymphocytic leukemia (CLL).
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Oforta™ (fludarabine phosphate tablets) for oral use is indicated as a single agent for the treatment of adult patients with B-cell chronic lymphocytic leukemia (CLL) whose disease has not responded to or has progressed during or after treatment with at least one standard alkylating-agent containing regimen. Studies demonstrating clinical benefit such as prolongation of survival or relief of symptoms have not been performed. Studies providing a direct comparison of the clinical efficacy and safety of Oforta™ relative to intravenously administered fludarabine phosphate have not been performed.
DOSAGE AND ADMINISTRATION
Chronic Lymphocytic Leukemia (CLL)
The oral dose of Oforta™ is different than the intravenous fludarabine phosphate dose.
The recommended adult dose of Oforta™ (fludarabine phosphate tablets) is 40 mg/m administered by mouth 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. Oforta™ (fludarabine phosphate tablets) can be taken either on an empty stomach or with food. The tablets have to be swallowed whole with water; they should not be chewed or broken.
The following table provides guidance for determining the number of tablets of Oforta™ (fludarabine phosphate tablets) to be administered based on body surface area (BSA):
TABLE 1: SUGGESTED NUMBER OF TABLETS TO BE ADMINISTERED
|Body Surface Area (BSA)||Calculated Total Dose Equivalent to 40 mg/m2 BSA (rounded up or down to nearest 10 mg)||Total Number of Tablets|
|0.75 - 0.88||30 mg||3|
|0.89 - 1.13||40 mg||4|
|1.14 - 1.38||50 mg||5|
|1.39 - 1.63||60 mg||6|
|1.64 - 1.88||70 mg||7|
|1.89 - 2.13||80 mg||8|
|2.14 - 2.38||90 mg||9|
|2.39 - 2.50||100 mg||10|
A number of clinical settings may predispose to increased toxicity from Oforta™ (fludarabine phosphate tablets) . These include advanced age, renal insufficiency, and bone marrow impairment. Such patients should be monitored closely for excessive toxicity and the dose modified accordingly. The optimal duration of treatment has not been clearly established. It is recommended that three additional cycles of Oforta™ (fludarabine phosphate tablets) be administered following the achievement of a maximal response and then the drug should be discontinued.
Dosage Forms And Strengths
10 mg tablets that are capsule shaped and salmon pink in color, marked on one side with 'LN' in a regular hexagon.
Storage And Handling
Oforta™ (fludarabine phosphate tablets) is supplied in 10 milligram tablets that are film-coated, capsule shaped, salmon pink in color, and marked on one side with 'LN' in a regular hexagon. Each film-coated tablet contains 10 mg fludarabine phosphate. The tablets are supplied in blisters, each blister strip containing 5 tablets. Packages of 15 and 20 tablets are available in child-resistant containers.
NDC 0024-5820-15: 15 - 10 milligram film-coated tablets per container. Each film-coated tablet is packaged in an individual blister package; 5 tablets per blister strip; 3 blister strips packaged in a plastic bottle with a child-resistant container closure; each bottle is packaged in an individual chip-board carton.
NDC 0024-5820-20: 20 - 10 milligram film-coated tablets per container. Each film-coated tablet is packaged in an individual blister package; 5 tablets per blister strip; 4 blister strips packaged in a plastic bottle with a child-resistant container closure; each bottle is packaged in an individual chip-board carton.
Store under normal lighting conditions at 25°C (77°F); excursions permitted to 15-30°C (59-86°F) [see USP controlled room temperature].
Handling And Disposal
Procedures for proper handling and disposal should be considered. Consideration should be given to handling and disposal according to guidelines issued for cytotoxic drugs. Several guidelines on this subject have been published.1-4 Caution should be exercised in the handling of Oforta™ (fludarabine phosphate tablets) . Push tablets through foil to open. Do not remove tablets from individual blisters until immediately prior to taking or administering each scheduled dose. Do not crush tablets. Avoid exposure by direct contact of the skin or mucous membranes or by inhalation. If contact occurs, wash thoroughly with soap and water or wash the eyes immediately with gently flowing water for at least 15 minutes. Consult healthcare provider in case of a skin reaction or if the drug gets in the eyes.
Manufactured for: sanofi-aventis U.S. LLC, Bridgewater, NJ 08807
Last reviewed on RxList: 8/5/2009
This monograph has been modified to include the generic and brand name in many instances.
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