LoTax^™ is a generic formulation of paclitaxel, the active ingredient of the potent anticancer drug Taxol.^® Paclitaxel has demonstrated a significant effectiveness against ovarian, breast, and a number of other cancers in clinical trials and use. Paclitaxel works by stabilizing microtubules and preventing unregulated cell mitosis or division. Paclitaxel thus holds the promise of being a very effective chemotherapeutic agent for a variety of cancers. Paclitaxel has been cited as one of the most important anticancer therapeutic discoveries of the last 30 years.

LoTax^™ is a clear colorless to slightly yellow viscous solution intended for dilution with a suitable parenteral fluid prior to intravenous infusion. LoTax^™ is available in 5-milliliter single-dose vials containing 30 milligrams of paclitaxel. Each milliliter of sterile nonpyrogenic solution contains 6 milligrams of paclitaxel, 527 milligrams Cremophor™ EL (polyoxyethylated castor oil) and 49.7% (v/v) dehydrated alcohol, USP.

Paclitaxel is a natural product with potent anticancer activity. The chemical name for paclitaxel is 5ß, 20-epoxy-1,2a,4,7ß, 10ß, 13a-hexahydroxytax-11-en-9-one, 4,10-diacetate 2-benzoate 13-ester with (2R, 3S)-N-benzoyl-3-phenylisoserine.

Paclitaxel is a white to off-white crystalline powder with the empirical formula C₄₇H₅₁NO₁₄ and a molecular weight of 853.9. This natural compound is highly hydrophobic, insoluble in water, and melts at around 216-217°C.

WARNING
LoTax™ (paclitaxel) is not approved by the United States Food and Drug Administration for human use. LoTax™ is being developed as a generic version of Taxol.^® As such all warnings related to Taxol^® and listed in the Physician’s Desk Reference should be heeded. This warning is as follows.

“Taxol^® (paclitaxel) should be administered under the supervision of a physician experienced in the use of cancer chemotherapeutic agents. Appropriate management of complications is possible only when adequate diagnostic and treatment facilities are readily available. Severe hypersensitivity reactions characterized by dyspnea and hypotension requiring treatment, angioedema, and generalized urticaria have occurred in 2% of patients receiving Taxol.^® One of these reactions was fatal in a patient treated without premedication in a Phase I study. Patients receiving Taxol^® should be pretreated with corticosteroids, diphenhydramine, and H2 antagonists to prevent these reactions . . . Patients who experience severe hypersensitivity reactions to Taxol^® should not be rechallenged with the drug.

Taxol^® therapy should not be given to patients with baseline neutrophil counts of less than 1.500 cells/mm3. In order to monitor the occurrence of bone marrow suppression, primarily neutropenia, which may be severe and result in infection. It is recommended that frequent peripheral blood cell counts be performed on all patients receiving Taxol.^® ”

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