Paclitaxel

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Generic Name: Paclitaxel Brand Name(s): Generics only. No brands available.

Uses

What is Paclitaxel used for?

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

How should I take Paclitaxel?

This medication is given by injection into a vein by a health care professional. It is given on a schedule as directed by your doctor. Dosage is based on your medical condition, body size, and response to treatment.

How do I store Paclitaxel?

Store the vials in original cartons between 20° to 25°C (68° to 77°F). Retain in the original package to protect from light. If you need to store paclitaxel (conventional) at home, talk with your doctor, nurse, or pharmacist about how to store it.

There may be different brands of Paclitaxel that may have different storage needs. It is important to always check the product package for instructions on storage, or ask your pharmacist. For safety, you should keep all medicines away from children and pets.

You should not flush Paclitaxel down the toilet or pour them into a drain unless instructed to do so. It is important to properly discard this product when it is expired or no longer needed. Consult your pharmacist for more details about how to safely discard your product.

Precautions & warnings

What should I know before using Paclitaxel?

Before using this medication, tell your doctor or pharmacist your medical history, especially of: blood disorders (e.g., low white blood cell count), decreased bone marrow function, current infections, heart problems (e.g., fast/slow/irregular heartbeat), low or high blood pressure, liver disease.

This drug may make you dizzy or drowsy. Alcohol or marijuana can make you more dizzy or drowsy. Do not drive, use machinery, or do anything that needs alertness until you can do it safely. Limit alcoholic beverages. Talk to your doctor if you are using marijuana.

Do not have immunizations/vaccinations without the consent of your doctor, and avoid contact with people who have recently received polio vaccine by mouth or flu vaccine inhaled through the nose.

Since this medication can increase your risk of developing serious infections, wash your hands well to prevent the spread of infections. Avoid contact with people who have illnesses that may spread to others (e.g., flu, chickenpox).

To lower the chance of getting cut, bruised, or injured, use caution with sharp objects like safety razors and nail cutters, and avoid activities such as contact sports.

Caution is advised when using this drug in children because it contains alcohol. Children may be more sensitive to the side effects of alcohol, especially drowsiness and confusion.

Caution is advised when using this drug in the elderly because they may be more sensitive to its side effects, especially the decrease in bone marrow function and numbness/tingling/burning of the hands/feet.

Men using this medication should not plan to father a child while receiving treatment. This medication may affect sperm production in men and increase the risk of harm to the unborn baby. Therefore, reliable forms of birth control should be used during treatment and for some time afterwards. Consult your doctor for more details. If your partner becomes pregnant while you are using this medication, tell your doctor right away.

This medication is not recommended for use during pregnancy. It may harm an unborn baby. It is important that men and women using this medication use reliable forms of birth control (such as condoms, birth control pills) while using this medication. If you become pregnant or think you may be pregnant, tell your doctor right away.

It is not known if this drug passes into breast milk. Because of the possible risk to the infant, breast- feeding while using this drug is not recommended. Consult your doctor before breast-feeding.

Is it safe during pregnancy or breast-feeding?

There are no adequate studies in women for determining risk when using this Paclitaxel during pregnancy or while breastfeeding. Please always consult with your doctor to weigh the potential benefits and risks before taking Paclitaxel. Paclitaxel is pregnancy risk category D according to the US Food and Drug Administration (FDA).

FDA pregnancy risk category reference below:

  • A=No risk,
  • B=No risk in some studies,
  • C=There may be some risk,
  • D=Positive evidence of risk,
  • X=Contraindicated,
  • N=Unknown

Side effects

What side effects can occur from Paclitaxel?

Nausea, vomiting, diarrhea, mouth sores, muscle/joint pain, numbness/tingling/burning of the hands/feet, flushing, dizziness, or drowsiness may occur. If any of these effects persist or worsen, tell your doctor promptly.

Temporary hair loss may occur. Normal hair growth should return after treatment has ended.

This medication may rarely cause changes to your blood pressure and heart rate. You should be closely monitored for these changes during the infusion of this medication. Tell your doctor promptly if you have increasing dizziness, headache, or a fast/slow/irregular heartbeat.

People using this medication may have serious side effects. However, your doctor has prescribed this drug because he or she has judged that the benefit to you is greater than the risk ofside effects. Careful monitoring by your doctor may decrease your risk.

Tell your doctor right away if you have any serious side effects, including: signs of anemia (e.g., unusual tiredness, pale skin), easy bruising/bleeding, fainting, confusion, pain/redness/swelling/weakness of the arms/legs, calf pain/swelling that is warm to the touch, coughing up blood, persistent nausea/vomiting, stomach/abdominal pain, yellowing eyes/skin, dark urine, vision/hearing changes, seizures.

This medication may rarely irritate the vein it is given into or leak out of the vein and irritate the area. These effects may cause redness, pain, swelling, discoloration, or unusual skin reactions at the injection site, either while the drug is given or rarely 7 to 10 days later. If this drug has leaked out of a vein and caused a skin reaction in the past, you may rarely have a skin reaction in that same area when the drug is given again, even when it is given into another area. Tell your doctor right away of any unusual skin/injection site symptoms.

Not everyone experiences these side effects. There may be some side effects not listed above. If you have any concerns about a side-effect, please consult your doctor or pharmacist.

Interactions

What drugs may interact with Paclitaxel?

Some products that may interact with this drug include: other drugs that may decrease bone marrow function (e.g., azathioprine, trimethoprim/sulfamethoxazole).

Tell your doctor or pharmacist if you are taking other products that cause drowsiness such as opioid pain or cough relievers (such as codeine, hydrocodone), alcohol, marijuana, drugs for sleep or anxiety (such as alprazolam, lorazepam, zolpidem), muscle relaxants (such as carisoprodol, cyclobenzaprine), or antihistamines (such as cetirizine, diphenhydramine).

Check the labels on all your medicines (such as allergy or cough-and-cold products) because they may contain ingredients that cause drowsiness. Ask your pharmacist about using those products safely.

Paclitaxel may interact with other drugs that you are currently taking, which can change how your drug works or increase your risk for serious side effects. To avoid any potential drug interactions, you should keep a list of all the drugs you are using (including prescription drugs, nonprescription drugs and herbal products) and share it with your doctor and pharmacist. For your safety, do not start, stop, or change the dosage of any drugs without your doctor’s approval.

Does food or alcohol interact with Paclitaxel?

Paclitaxel may interact with food or alcohol by altering the way the drug works or increase the risk for serious side effects. Please discuss with your doctor or pharmacist any potential food or alcohol interactions before using this drug.

What health conditions may interact with Paclitaxel?

Paclitaxel may interact with your health condition. This interaction may worsen your health condition or alter the way the drug works. It is important to always let your doctor and pharmacist know all the health conditions you currently have.

Dosage

The information provided is not a substitute for any medical advice. You should ALWAYS consult with your doctor or pharmacist before using this Paclitaxel.

What is the dose of Paclitaxel for an adult?

Usual Adult Dose for Ovarian Cancer

For previously untreated patients with cancer of the ovary:

175 mg/m2 IV over 3 hours every 3 weeks followed by cisplatin

OR

135 mg/m2 IV over 24 hours every 3 weeks followed by cisplatin

For patients previously treated for cancer of the ovary:

175 mg/m2 IV over 3 hours every 3 weeks

OR

135 mg/m2 IV over 3 hours every 3 weeks

Comment:

-All patients should be premedicated prior to receiving this drug to prevent severe hypersensitivity reactions. Consult the manufacturer product information or local protocol for premedication guidelines.

Uses: As subsequent therapy for the treatment of advanced carcinoma of the ovary; as first-line therapy in combination with cisplatin

Usual Adult Dose for Breast Cancer

After failure of initial chemotherapy for metastatic disease or relapse within 6 months of adjuvant chemotherapy:

175 mg/m2 IV over 3 hours every 3 weeks

Comment:

-All patients should be premedicated prior to receiving this drug to prevent severe hypersensitivity reactions. Consult the manufacturer product information or local protocol for premedication guidelines.

Use: For the treatment of breast cancer after failure of combination chemotherapy for metastatic disease or relapse within 6 months of adjuvant chemotherapy; prior therapy should have included an anthracycline unless clinically contraindicated

Usual Adult Dose for Breast Cancer – Adjuvant

For adjuvant treatment of node-positive breast cancer:

175 mg/m2 IV over 3 hours every 3 weeks for 4 courses administered sequentially to doxorubicin-containing chemotherapy

Comment:

-All patients should be premedicated prior to receiving this drug to prevent severe hypersensitivity reactions. Consult the manufacturer product information or local protocol for premedication guidelines.

Use: For the adjuvant treatment of node-positive breast cancer administered sequentially to standard doxorubicin-containing combination chemotherapy

Usual Adult Dose for Non-Small Cell Lung Cancer

135 mg/m2 IV over 24 hours followed by cisplatin every 3 weeks

Comment:

-All patients should be premedicated prior to receiving this drug to prevent severe hypersensitivity reactions. Consult the manufacturer product information or local protocol for premedication guidelines.

Use: For the first-line treatment of non-small cell lung cancer in combination with cisplatin in patients who are not candidates for potentially curative surgery and/or radiation therapy

Usual Adult Dose for Kaposi’s Sarcoma

For patients with AIDS-Related Kaposi’s Sarcoma:

135 mg/m2 IV over 3 hours every 3 weeks

OR

100 mg/m2 IV over 3 hours every 2 weeks

Note: In patients with advanced HIV disease:

1) Reduce the dose of dexamethasone as one of the premedication drugs (consult the manufacturer product information).

2) Initiate or repeat treatment with this drug only if the neutrophil count is at least 1000 cells/mm3.

3) Reduce the dose of subsequent courses of this drug by 20% for patients who experience severe neutropenia (a neutrophil count less than 500 cells/mm3 for a week or longer).

4) Initiate concomitant hematopoietic growth factor (G-CSF) as clinically indicated.

Comment:

-All patients should be premedicated prior to receiving this drug to prevent severe hypersensitivity reactions. Consult the manufacturer product information or local protocol for premedication guidelines.

Use: For the second-line treatment of AIDS-related Kaposi’s sarcoma

Liver Dose Adjustments

Dose adjustments for liver impairment:

24-hour infusion:

-Transaminase levels less than 2 x ULN and bilirubin levels less than or equal to 1.5 mg/dL: 135 mg/m2 IV

-Transaminase levels 2 to less than 10 x ULN and bilirubin levels less than or equal to 1.5 mg/dL: 100 mg/m2 IV

-Transaminase levels less than 10 x ULN and bilirubin levels 1.6 to 7.5 mg/dL: 50 mg/m2 IV

-Transaminase levels greater than or equal to 10 x ULN or bilirubin levels greater than 7.5 mg/dL: Use is not recommended

3-hour infusion:

-Transaminase levels less than 10 x ULN and bilirubin levels less than or equal to 1.25 x ULN: 175 mg/m2 IV

-Transaminase levels less than 10 x ULN and bilirubin levels 1.26 to 2 x ULN: 135 mg/m2 IV

-Transaminase levels less than 10 x ULN and bilirubin levels 2.01 to 5 x ULN: 90 mg/m2 IV

-Transaminase levels greater than or equal to 10 x ULN or bilirubin levels greater than 5 x ULN: Use is not recommended

Dose Adjustments

-For patients with solid tumors (ovary, breast, and NSCLC): Courses should not be repeated until the neutrophil count is at least 1500 cells/mm3 and the platelet count is at least 100,000 cells/mm3.

-This drug should not be given to patients with AIDS-related Kaposi’s sarcoma if the baseline or subsequent neutrophil count is less than 1000 cells/mm3.

-Patients who experience severe neutropenia (neutrophil less than 500 cells/mm3 for a week or longer) or severe peripheral neuropathy during therapy should have the dosage reduced by 20% for subsequent courses.

-The incidence of neurotoxicity and the severity of neutropenia increase with dose.

Other Comments

Administration advice:

-This drug should be administered using an in-line filter with a microporous membrane of less than or equal to 0.22 microns.

Storage requirements:

-Consult the manufacturer product information.

Reconstitution/preparation techniques:

-Consult the manufacturer product information.

IV compatibility:

-Consult the manufacturer product information.

General:

-All patients should be premedicated with corticosteroids, antihistamines and H2-receptor antagonists prior to receiving this drug to prevent severe hypersensitivity reactions. Consult the manufacturer product information or local protocol for premedication guidelines.

Monitoring:

-Because of the possibility of extravasation, it is advisable to monitor the infusion site for possible infiltration during administration.

-Dose adjustments based on hepatic function may be necessary.

What is the dose of Paclitaxel for a child?

The dosage has not been established in pediatric patients. It may be unsafe for your child. It is always important to fully understand the safety of the drug before using. Please consult with your doctor or pharmacist for more information.

How is Paclitaxel available?

Paclitaxel is available in the following dosage forms and strengths:

  • Intravenous solution

What should I do in case of an emergency or overdose?

In case of an emergency or an overdose, call your local emergency services or go to your nearest emergency room.

What should I do if I miss a dose?

If you miss a dose of Paclitaxel, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and take your regular dose as scheduled. Do not take a double dose.

Hello Health Group does not provide medical advice, diagnosis or treatment.

Sources

Review Date: April 11, 2018 | Last Modified: April 11, 2018

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