TAXOL (paclitaxel) Injection is a clear, colorless to slightly yellow viscous solution. It is supplied as a nonaqueous solution intended for dilution with a suitable parenteral fluid prior to intravenous infusion. TAXOL is available in 30 mg (5 mL), 100 mg (16.7 mL), and 300 mg (50 mL) multidose vials. Each mL of sterile nonpyrogenic solution contains 6 mg paclitaxel, 527 mg of purified Cremophor® EL (polyoxyethylated castor oil) and 49.7% (v/v) dehydrated alcohol, USP.

Paclitaxel is a natural product with antitumor activity. TAXOL (paclitaxel) is obtained via a semi-synthetic process from Taxus baccata. The chemical name for paclitaxel is 5?,20-Epoxy-l,2?,4,7?,10?,13?-hexahydroxytax-l l-en-9-one 4,10-diacetate 2-benzoate 13-ester with (2R,3S)-N-benzoyl-3-phenylisoserine.

Paclitaxel has the following structural formula:

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

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 infrequently 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.

Many people using this medication 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 of side 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 infrequently 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 immediately of any unusual skin/injection site symptoms.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

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

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

PRECAUTIONS: Before using paclitaxel, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients (such as polyoxyethylated castor oil), which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

This medication should not be used if you have certain medical conditions. Before using this medicine, consult your doctor or pharmacist if you have: a very low white blood cell count.

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

This drug may make you dizzy or drowsy. Do not drive, use machinery, or do any activity that requires alertness until you are sure you can perform such activities safely. Limit alcoholic beverages.

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 immediately.

This medication is not recommended for use during pregnancy. It may harm an unborn baby. Consult your doctor for more details and to discuss reliable forms of birth control. It is recommended that men and women use 2 effective forms of birth control (e.g., condoms, birth control pills) while using this medication and for some time afterwards. If you become pregnant or think you may be pregnant, tell your doctor immediately.

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.