Paclitaxel

Paclitaxel is used to treat various types of cancer. It is a cancer chemotherapy drug that works by slowing or stopping cancer cell growth.

• Paclitaxel is available under the following different brand names: Taxol.

Dosage Forms and Strengths

Injectable solution

• 6 mg/mL

Dosage Considerations – Should be Given as Follows:

Ovarian Cancer

• Premedicate to prevent hypersensitivity reactions (e.g., dexamethasone, diphenhydramine, H2 blockers)
• Previously untreated: 175 mg/m² intravenously (IV) over 3 hours every 3 weeks (follow with cisplatin), OR
• 135 mg/m² IV over 24 hours every 3 weeks (follow with cisplatin)
• Previously treated: Various regimens exist: 135-175 mg/m² IV over 3 hours every 3 weeks

Breast Cancer

• Node positive (adjuvant chemotherapy): 175 mg/m² intravenously (IV) over 3 hours every 3 weeks 4 times (with doxorubicin-containing regimen)
• Metastatic Disease (failure of initial chemotherapy or relapse within 6 months following adjuvant chemotherapy): 175 mg/m² IV over 3 hours every 3 weeks

Non-small Cell Lung Cancer

• 135 mg/m² intravenously (IV) over 24 hours every 3 weeks (follow with cisplatin)

AIDS-related Kaposi's Sarcoma (2nd-line Treatment)

• 135 mg/m² intravenously (IV) over 3 hours every 3 weeks; OR
• 100 mg/m² IV over 3 hours every 2 weeks

Pancreatic Cancer (Off-label)

• Investigational: 125 mg/m² intravenously (IV) with gemcitabine

Dosage Modifications

• If baseline PMN is less than 1500/m³, do not re-treat until PMN greater than 1500/m³ and platelet count greater than 100,000/m³
• If severe neutropenia occurs (PMN less than 500/m³ for 7 days), reduce subsequent doses by 20%
• Renal impairment: No dosage adjustment is required
• Pediatric: Safety and efficacy not established

Hepatic Impairment

With solid carcinomas and not Kaposi sarcoma

24-hr infusion

• AST/ALT less than 2 times upper limit of normal (ULN) and bilirubin up to 1.5 mg/dL: 135 mg/m² over 24 hours
• AST/ALT 2 to 10 times ULN and bilirubin up to 1.5 mg/dL: 100 mg/m² over 24 hours
• AST/ALT less than 10 times ULN and bilirubin 1.6-7.5 mg/dL: 50 mg/m² over 24 hours
• AST/ALT 10 times ULN or greater OR bilirubin greater than 7.5 mg/dL: Do not administer

3-hr infusion

• AST/ALT less than 10 times upper limit of normal (ULN) and bilirubin less than 1.25 times ULN: 175 mg/m² over 3 hours
• AST/ALT less than 10 times ULN and bilirubin 1.26-2 times ULN: 135 mg/m² over 3 hours
• AST/ALT less than 10 times ULN and bilirubin 2.01-5 times ULN: 90 mg/m² over 3 hours
• AST/ALT 10 times ULN or greater OR bilirubin greater than 5 times ULN: Do not administer

Other Indications and Uses

• Off-label: head/neck cancer, small-cell lung cancer, upper gastrointestinal (GI) adenocarcinoma, hormone-refractory prostate cancer, non-Hodgkin lymphoma (NHL), urothelium transitional cell carcinoma, stage IIB-IV melanoma

Common side effects of paclitaxel include:

• Low white blood cell count (neutropenia, leukopenia)
• Hair loss
• Anemia
• Joint pain
• Muscle pain
• Diarrhea
• Nausea/vomiting
• Opportunistic infections
• Numbness and tingling in extremities
• Low blood platelet count (thrombocytopenia)
• Hypersensitivity
• Renal impairment
• Low blood pressure (hypotension)
• Increased blood pressure
• Fever
• Flushing (skin warmth or redness)
• Constipation
• Mouth sores (mucositis)
• Weakness
• Darkening of your skin or nails
• Dizziness
• Drowsiness
• Injection site reactions (pain, swelling, or skin color changes)

Less common side effects of paclitaxel include:

• Slow heart rate
• Grand mal seizures
• Cardiac conduction abnormalities

Other side effects of paclitaxel include:

• Fever
• Dehydration
• Pancytopenia
• Congestive heart failure
• Left ventricular dysfunction
• Stevens-Johnson syndrome, toxic epidermal necrolysis, and extravasation

This is not a complete list of side effects and other serious side effects may occur. Call your doctor for information and medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

If your doctor has directed you to use this medication, your doctor or pharmacist may already be aware of any possible drug interactions and may be monitoring you for them. Do not start, stop, or change the dosage of any medicine before checking with your doctor, health care provider, or pharmacist first.

• Paclitaxel has no known severe interactions with other drugs.
• Serious interactions of paclitaxel include:
  • adenovirus types 4 and 7 live, oral
  • eluxadoline
  • idarubicin
  • idelalisib
  • influenza virus vaccine trivalent, adjuvanted
  • ivacaftor
  • nefazodone
  • palifermin
  • quinidine
• Paclitaxel has moderate interactions with at least 98 different drugs.
• Paclitaxel has mild interactions with at least 81 different drugs.

This document does not contain all possible interactions. Therefore, before using this product, tell your doctor or pharmacist of all the products you use. Keep a list of all your medications with you, and share the list with your doctor and pharmacist. Check with your physician if you have health questions or concerns.

Warnings

• Paclitaxel should be administered under the supervision of an experienced cancer chemotherapy physician in a facility equipped to diagnose and manage complications.
• Paclitaxel is contraindicated in patients with solid tumor who have baseline neutrophil counts less than 1500 cells/m³ and in patients with AIDS-related Kaposi sarcoma who have baseline neutrophil counts less than 1000 cells/m³; perform frequent peripheral blood counts to monitor for the occurrence of bone marrow suppression, primarily neutropenia, which may result in infection.
• Fatal anaphylaxis and severe hypersensitivity reactions characterized by shortness of breath (dyspnea) and low blood pressure (hypotension) requiring treatment, skin swelling (angioedema), and generalized hives (urticarial) have occurred in patients despite premedication.
• Pretreat all patients with corticosteroids, diphenhydramine, and H2 antagonists.
• Do not re-challenge patients who experience severe hypersensitivity reactions to the drug.
• This medication contains paclitaxel. Do not take Taxol if you are allergic to paclitaxel or any ingredients contained in this drug.
• Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center immediately.

Contraindications

• Hypersensitivity to paclitaxel or castor oil
• Pregnancy
• Solid tumor w/baseline PMN less than 1500 cells/m³
• AIDS-related Kaposi's sarcoma with baseline PMN less than 1000 cells/m³

Effects of Drug Abuse

• None

Short-Term Effects

• See "What Are Side Effects Associated with Using Paclitaxel?"

Long-Term Effects

• See "What Are Side Effects Associated with Using Paclitaxel?"

Cautions

• Irritant.
• Concomitant radiation therapy.
• Elderly.
• Avoid pregnancy.
• May increase the risk of cardiac dysfunction if received in conjunction with trastuzumab or anthracyclines.

Pregnancy and Lactation

• Use paclitaxel during pregnancy only in LIFE-THREATENING emergencies when no safer drug is available. There is positive evidence of human fetal risk.
• It is not known if paclitaxel is excreted in breast milk; do not nurse.