Paclitaxel (Page 15 of 15)

Preparation and Administration Precautions

Procedures for proper handling and disposal of anticancer drugs should be considered. Several guidelines on this subject have been published.1-4 To minimize the risk of dermal exposure, always wear impervious gloves when handling vials containing paclitaxel Injection. If paclitaxel solution contacts the skin, wash the skin immediately and thoroughly with soap and water. Following topical exposure, events have included tingling, burning, and redness. If paclitaxel contacts mucous membranes, the membranes should be flushed thoroughly with water. Upon inhalation, dyspnea, chest pain, burning eyes, sore throat, and nausea have been reported.

Given the possibility of extravasation, it is advisable to closely monitor the infusion site for possible infiltration during drug administration (see PRECAUTIONS, Injection Site Reaction section).

Preparation for Intravenous Administration

Paclitaxel must be diluted prior to infusion. Paclitaxel should be diluted in 0.9% Sodium Chloride Injection, USP; 5% Dextrose Injection, USP; 5% Dextrose and 0.9% Sodium Chloride Injection, USP or 5% Dextrose in Ringer’s Injection to a final concentration of 0.3 to 1.2 mg/mL. The solutions are physically and chemically stable for up to 27 hours at ambient temperature (approximately 25°C) and room lighting conditions. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration whenever solution and container permit.

Upon preparation, solutions may show haziness, which is attributed to the formulation vehicle. No significant losses in potency have been noted following simulated delivery of the solution through I.V. tubing containing an in-line (0.22 micron) filter.

Data collected for the presence of the extractable plasticizer DEHP [di-(2-ethylhexyl) phthalate] show that levels increase with time and concentration when dilutions are prepared in PVC containers. Consequently, the use of plasticized PVC containers and administration sets is not recommended.

Paclitaxel solutions should be prepared and stored in glass, polypropylene, or polyolefin containers. Non-PVC containing administration sets, such as those which are polyethylene-lined, should be used.

Paclitaxel should be administered through an in-line filter with a microporous membrane not greater than 0.22 microns. Use of filter devices such as IVEX-2® filters which incorporate short inlet and outlet PVC-coated tubing has not resulted in significant leaching of DEHP.

The Chemo Dispensing Pin™ device or similar devices with spikes should not be used with vials of paclitaxel since they can cause the stopper to collapse resulting in loss of sterile integrity of the paclitaxel solution.

Stability

Unopened vials of Paclitaxel Injection, USP are stable until the date indicated on the package when stored between 20° to 25°C (68° to 77°F), in the original package. Neither freezing nor refrigeration adversely affects the stability of the product. Upon refrigeration components in the paclitaxel vial may precipitate, but will redissolve upon reaching room temperature with little or no agitation. There is no impact on product quality under these circumstances. If the solution remains cloudy or if an insoluble precipitate is noted, the vial should be discarded. Solutions for infusion prepared as recommended are stable at ambient temperature (approximately 25°C) and lighting conditions for up to 27 hours.

HOW SUPPLIED

Paclitaxel Injection, USP is supplied as follows:

NDC Paclitaxel Injection, USP (6 mg per mL) Package Factor
70860-215-68 300 mg per 50 mL Multi-Dose Vial 1 vial per carton

Storage Conditions

Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.]

Protect from light. Retain in carton until time of use.

Handling and Disposal

See DOSAGE AND ADMINISTRATION: Preparation and Administration Precautions.

Sterile, Nonpyrogenic, Preservative-free. The container closure is not made with natural rubber latex.

REFERENCES

  1. NIOSH Alert: Preventing occupational exposures to antineoplastic and other hazardous drugs in healthcare settings. 2004. U.S. Department of Health and Human Services, Public Health Service, Centers for Disease Control and Prevention, National Institute for Occupational Safety and Health, DHHS (NIOSH) Publication No. 2004165.
  2. OSHA Technical Manual, TED 1-0.15A, Section VI: Chapter 2. Controlling occupational exposure to hazardous drugs. OSHA, 1999. http://www.osha.gov/dts/osta/otm/otm_vi/otm_vi_2.html.
  3. American Society of Health-System Pharmacists. ASHP guidelines on handling hazardous drugs. Am J Health-Syst Pharm. 2006; 63:1172-1193.
  4. Polovich M, White JM, Kelleher LO, eds. 2005. Chemotherapy and biotherapy guidelines and recommendations for practice. 2nd ed. Pittsburgh, PA: Oncology Nursing Society.

*DaunoXome® is a registered trademark of Gilead Sciences, Inc.
DOXIL® is a registered trademark of ALZA Corporation.
IVEX-2® is a registered trademark of the Millipore Corporation.
Chemo Dispensing Pin™ is a trademark of B. Braun Medical Incorporated.

novaplusTM +
Mfd. for Athenex
Schaumburg, IL 60173 (USA)
Made in India
Novaplus is a registered trademark of Vizient, Inc.

February 2019

PATIENT INFORMATION

Paclitaxel Injection, USP

Read this patient information leaflet before you start taking paclitaxel. There may be new information. This information does not take the place of talking to your healthcare provider about your medical condition or your treatment.

What is the most important information I should know about paclitaxel?

Paclitaxel can cause serious side effects including death.

Serious allergic reactions (anaphylaxis) can happen in people who receive paclitaxel.

Anaphylaxis is a serious medical emergency that can lead to death and must be treated right away.

Tell your healthcare provider right away if you have any of these signs of an allergic reaction:

  • trouble breathing
  • sudden swelling of your face, lips, tongue, throat, or trouble swallowing
  • hives (raised bumps) or rash

Your healthcare provider will give you medicines to lessen your chance of having an allergic reaction.

What is paclitaxel?

Paclitaxel is a prescription medicine used to treat some forms of:

  • ovarian cancer
  • breast cancer
  • lung cancer
  • Kaposi’s sarcoma

It is not known if paclitaxel is safe or effective in children.

Who should not receive paclitaxel?

Do not receive paclitaxel if:

  • you are allergic to any of the ingredients in paclitaxel. See the end of this leaflet for a complete list of ingredients in paclitaxel.
  • are allergic to medicines containing polyoxyethylated castor oil.
  • you have low white blood cell counts.

What should I tell my healthcare provider before receiving paclitaxel?

Before receiving paclitaxel, tell your healthcare provider about all your medical conditions, including if you:

  • have liver problems
  • have heart problems
  • are pregnant or plan to become pregnant. paclitaxel can harm your unborn baby. Talk to your healthcare provider if you are pregnant or plan to become pregnant.
  • are breast-feeding or plan to breast-feed. It is not known if paclitaxel passes into your breast milk. You and your healthcare provider should decide if you will receive paclitaxel or breast-feed.

Tell your healthcare provider about all the medicines you take, including prescription and non-prescription medicines, vitamins, and herbal supplements.

Know the medicines you take. Keep a list of them and show it to your healthcare provider and pharmacist when you get a new medicine.

How will I receive paclitaxel?

  • Paclitaxel is injected into a vein (intravenous [IV] infusion) by your healthcare provider.

Your healthcare provider will do certain tests while you receive paclitaxel.

What are the possible side effects of paclitaxel?

Tell your healthcare provider right away if you have:

  • severe stomach pain
  • severe diarrhea

The most common side effects of paclitaxel include:

  • low red blood cell count (anemia) feeling weak or tired
  • hair loss
  • numbness, tingling, or burning in your hands or feet (neuropathy)
  • joint and muscle pain
  • nausea and vomiting
  • hypersensitivity reaction — trouble breathing; sudden swelling of your face, lips, tongue, throat, or trouble swallowing; hives (raised bumps) or rash
  • diarrhea
  • mouth or lip sores (mucositis)
  • infections — if you have a fever (temperature above 100.4°F) or other sign of infection, tell your healthcare provider right away
  • swelling of your hands, face, or feet
  • bleeding events
  • irritation at the injection site
  • low blood pressure (hypotension)

Tell your healthcare provider if you have any side effect that bothers you or that does not go away.

These are not all the possible side effects of paclitaxel. For more information, ask your healthcare provider or pharmacist.

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

General information about the safe and effective use of paclitaxel.

Medicines are sometimes prescribed for purposes other than those listed in a patient information leaflet. Do not use paclitaxel for a condition for which it was not prescribed.

Do not give paclitaxel to other people, even if they have the same symptoms that you have. It may harm them.

This patient information leaflet summarizes the most important information about paclitaxel. If you would like more information, talk with your healthcare provider. You can ask your pharmacist or healthcare provider for information about paclitaxel that is written for health professionals.

What are the ingredients in paclitaxel?

Active ingredient: paclitaxel.

Inactive ingredients include: Polyoxyl 35 castor oil, NF and dehydrated alcohol, USP and Citric Acid, USP.

What is cancer?

Under normal conditions, the cells in your body divide and grow in an orderly, controlled way. Cell division and growth are necessary for the human body to perform its functions and to repair itself, when necessary. Cancer cells are different from normal cells because they are not able to control their own growth. The reasons for this abnormal growth are not yet fully understood. A tumor is a mass of unhealthy cells that are dividing and growing fast and in an uncontrolled way. When a tumor invades surrounding healthy body tissue, it is known as a malignant tumor. A malignant tumor can spread (metastasize) from its original site to other parts of the body if not found and treated early.

novaplusTM +
Mfd. for Athenex
Schaumburg, IL 60173 (USA)
Made in IndiaNovaplus is a registered trademark of Vizient, Inc.

February 2019

PACKAGE LABEL — PRINCIPAL DISPLAY PANEL — Vial Label

NDC 70860-215-68

Paclitaxel Injection, USP

300 mg per 50 mL (6 mg per mL)

Rx only

Caution: Dilution required prior to Intravenous Infusion

Caution: Cytotoxic Agent

50 mL Multi-Dose Vial

PACKAGE LABEL – PRINCIPAL DISPLAY PANEL – Vial Label
(click image for full-size original)
PACLITAXEL paclitaxel injection, solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:70860-215
Route of Administration INTRAVENOUS DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
paclitaxel (paclitaxel) paclitaxel 6 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
polyoxyl 35 castor oil
alcohol
anhydrous citric acid
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:70860-215-68 1 VIAL in 1 CARTON contains a VIAL
1 50 mL in 1 VIAL This package is contained within the CARTON (70860-215-68)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA207326 11/30/2019
Labeler — Athenex Pharmaceutical Division, LLC. (080318964)

Revised: 03/2017 Athenex Pharmaceutical Division, LLC.

All MedLibrary.org resources are included in as near-original form as possible, meaning that the information from the original provider has been rendered here with only typographical or stylistic modifications and not with any substantive alterations of content, meaning or intent.

This site is provided for educational and informational purposes only, in accordance with our Terms of Use, and is not intended as a substitute for the advice of a medical doctor, nurse, nurse practitioner or other qualified health professional.

Privacy Policy | Copyright © 2021. All Rights Reserved.