pharmacopeia
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/api/v1/drug/paclitaxel

Boxed warning

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. Anaphylaxis and severe hypersensitivity reactions characterized by dyspnea and hypotension requiring treatment, angioedema, and generalized urticaria have occurred in 2 to 4% of patients receiving paclitaxel in clinical trials. Fatal reactions have occurred in patients despite premedication. All patients should be pretreated with corticosteroids, diphenhydramine, and H 2 antagonists (see DOSAGE AND ADMINISTRATION ). Patients who experience severe hypersensitivity reactions to paclitaxel should not be rechallenged with the drug. Paclitaxel therapy should not be given to patients with solid tumors who have baseline neutrophil counts of less than 1,500 cells/mm 3 and should not be given to patients with AIDS-related Kaposi's sarcoma if the baseline neutrophil count is less than 1,000 cells/mm 3 . 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 paclitaxel.

Mechanism of action

Sourced from openFDA

Mechanism-of-action classes: beta Tubulin Interactions; Immunologic Adjuvants.

Indications

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  • Paclitaxel Injection, USP is indicated as subsequent therapy for the treatment of advanced carcinoma of the ovary. As first-line therapy, Paclitaxel Injection, USP is indicated in combination with cisplatin.

Contraindications

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  • Paclitaxel is contraindicated in patients who have a history of hypersensitivity reactions to paclitaxel or other drugs formulated in polyoxyl 35 castor oil. Paclitaxel should not be used in patients with solid tumors who have baseline neutrophil counts of <1,500 cells/mm 3 or in patients with AIDS-related Kaposi's sarcoma with baseline neutrophil counts of <1,000 cells/mm 3 .contraindicated

Dosage & administration

Sourced from openFDA

DOSAGE & ADMINISTRATION Note: Contact of the undiluted concentrate with plasticized PVC equipment or devices used to prepare solutions for infusion is not recommended. In order to minimize patient exposure to the plasticizer DEHP [di-(2-ethylhexyl)phthalate], which may be leached from PVC infusion bags or sets, diluted paclitaxel solutions should be stored in bottles (glass, polypropylene) or plastic bags (polypropylene, polyolefin) and administered through polyethylene-lined administration sets. All patients should be premedicated prior to paclitaxel administration in order to prevent severe hypersensitivity reactions. Such premedication may consist of dexamethasone 20 mg PO administered approximately 12 and 6 hours before paclitaxel, diphenhydramine (or its equivalent) 50 mg I.V. 30 to 60 minutes prior to paclitaxel, and cimetidine (300 mg) or ranitidine (50 mg) I.V. 30 to 60 minutes before paclitaxel. For patients with carcinoma of the ovary the following regimen is recommended (see CLINICAL STUDIES, Ovarian Carcinoma ): For previously untreated patients with carcinoma of the ovary, one of the following recommended regimens may be given every 3 weeks. In selecting the appropriate regimen, differences in toxicities should be considered (see TABLE 11 in ADVERSE REACTIONS, Disease-Specific Adverse Event Experiences) . Paclitaxel administered intravenously over 3 hours at a dose of 175 mg/m 2 followed by cisplatin at a dose of 75 mg/m 2 ;or Paclitaxel administered intravenously over 24 hours at a dose of 135 mg/m 2 followed by cisplatin at a dose of 75 mg/m 2 .

Warnings & precautions

Sourced from openFDA

Anaphylaxis and severe hypersensitivity reactions characterized by dyspnea and hypotension requiring treatment, angioedema, and generalized urticaria have occurred in 2 to 4% of patients receiving paclitaxel in clinical trials. Fatal reactions have occurred in patients despite premedication. All patients should be pretreated with corticosteroids, diphenhydramine, and H 2 antagonists. (see DOSAGE AND ADMINISTRATION ). Patients who experience severe hypersensitivity reactions to paclitaxel should not be rechallenged with the drug. Bone marrow suppression (primarily neutropenia) is dose-dependent and is the dose-limiting toxicity. Neutrophil nadirs occurred at a median of 11 days. Paclitaxel should not be administered to patients with baseline neutrophil counts of less than 1,500 cells/mm 3 (<1,000 cells/mm 3 for patients with KS). Frequent monitoring of blood counts should be instituted during paclitaxel treatment. Patients should not be re-treated with subsequent cycles of paclitaxel until neutrophils recover to a level >1,500 cells/mm 3 (>1,000 cells/mm 3 for patients with KS) and platelets recover to a level >100,000 cells/mm 3 . Severe conduction abnormalities have been documented in <1% of patients during paclitaxel therapy and in some cases requiring pacemaker placement. If patients develop significant conduction abnormalities during paclitaxel infusion, appropriate therapy should be administered and continuous cardiac monitoring should be performed during subsequent therapy with paclitaxel.

Adverse reactions

Sourced from openFDA

Pooled Analysis of Adverse Event Experiences from Single-Agent Studies Data in the following table are based on the experience of 812 patients (493 with ovarian carcinoma and 319 with breast carcinoma) enrolled in 10 studies who received single-agent Paclitaxel Injection. Two hundred and seventy-five patients were treated in 8, Phase 2 studies with paclitaxel doses ranging from 135 to 300 mg/m 2 administered over 24 hours (in 4 of these studies, G-CSF was administered as hematopoietic support). Three hundred and one patients were treated in the randomized Phase 3 ovarian carcinoma study which compared 2 doses (135 or 175 mg/m 2 ) and 2 schedules (3 or 24 hours) of paclitaxel. Two hundred and thirty-six patients with breast carcinoma received paclitaxel (135 or 175 mg/m 2 ) administered over 3 hours in a controlled study. TABLE 10.

Use in specific populations

Sourced from openFDA

Pregnancy (See WARNINGS section).

Overdosage

Sourced from openFDA

There is no known antidote for paclitaxel overdosage. The primary anticipated complications of overdosage would consist of bone marrow suppression, peripheral neurotoxicity, and mucositis. Overdoses in pediatric patients may be associated with acute ethanol toxicity (see PRECAUTIONS, Pediatric Use ).

Approval history

Sourced from openFDA
  • Jan 25, 2002ANDAANDA075184Teva Pharms
  • May 8, 2002ANDAANDA076131Hospira
  • Jan 7, 2005NDANDA021660Bristol-myers
  • Nov 27, 2006ANDAANDA077574Fresenius Kabi Usa
  • Sep 29, 2011ANDAANDA091540Natco Pharma Usa
  • Aug 23, 2016ANDAANDA207326Gland
  • Jul 27, 2022NDANDA211875Am Regent
  • May 11, 2023NDANDA216338Teva Pharms Inc

FAERS reports

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Reference statistics only. FAERS reports are voluntarily submitted and are not incidence rates, safety signals, or causal evidence. Counts reflect reporting volume — how often a reaction was reported, not how often it occurs. For decision-grade use, consult openFDA and the FAERS Public Dashboard directly.
95,870 total reports matchedLatest report Share = reports listing the reaction ÷ total matched reports. Rows can sum to >100% because a single report often lists multiple reactions.
  1. 1Nausea5,3995.6%
  2. 2Neutropenia5,3295.6%
  3. 3Diarrhoea5,0625.3%
  4. 4Dyspnoea5,0365.3%
  5. 5Off Label Use5,0295.2%
  6. 6Anaemia4,7084.9%
  7. 7Death4,4034.6%
  8. 8Malignant Neoplasm Progression4,1604.3%
  9. 9Fatigue4,1354.3%
  10. 10Pyrexia3,8404.0%
  11. 11Neuropathy Peripheral3,8314.0%
  12. 12Disease Progression3,7944.0%
  13. 13Vomiting3,7493.9%
  14. 14Febrile Neutropenia3,6323.8%
  15. 15Myelosuppression3,2803.4%

Literature

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Recent PubMed references pinned to Paclitaxel as a MeSH major topic. Citations link to pubmed.ncbi.nlm.nih.gov.

Clinical trials

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The 10 most recently updated of 6,025 ClinicalTrials.gov registrations naming Paclitaxel as an intervention. Registration is not evidence of efficacy or safety — reference crosswalk only.

Frequently asked questions

How does Paclitaxel work?
Mechanism-of-action classes: beta Tubulin Interactions; Immunologic Adjuvants.
What is Paclitaxel used for?
According to FDA labeling, Paclitaxel carries indications including: Paclitaxel Injection, USP is indicated as subsequent therapy for the treatment of advanced carcinoma of the ovary. As first-line therapy, Paclitaxel Injection, USP is indicated in combination with cisplatin.. This is a reference summary of labeled uses, not medical advice or a treatment recommendation.
What class of drug is Paclitaxel?
Paclitaxel is classified as Taxanes, Microtubule Inhibitor, beta Tubulin Interactions, Immunologic Adjuvants, Decreased Mitosis, Microtubule Inhibition.
What are the brand names for Paclitaxel?
Paclitaxel is marketed under brand names including Abraxane.
What are the contraindications for Paclitaxel?
Paclitaxel labeling lists contraindications including: Paclitaxel is contraindicated in patients who have a history of hypersensitivity reactions to paclitaxel or other drugs formulated in polyoxyl 35 castor oil. Paclitaxel should not be used in patients with solid tumors who have baseline neutrophil counts of <1,500 cells/mm 3 or in patients with AIDS-related Kaposi's sarcoma with baseline neutrophil counts of <1,000 cells/mm 3 .. Always consult the full prescribing information and a clinician.
Note. Data for paclitaxel is illustrative MVP content compiled from public sources. pharmacopeia is for educational and informational use only and is not a substitute for professional medical advice.

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