Abraxane 100 mg intravenous suspension

Generic name:
Paclitaxel protein-bound - injection

Pronunciation
(pack-lih-TAX-el)

Brand name(s)
Abraxane

This medication may often cause a serious blood disorder (decreased bone marrow function leading to a low number of white blood cells). This effect can lower your body's ability to fight an infection. Your doctor will monitor you closely and check your blood often during treatment. If your white blood cell count is too low, you should not receive this medication. Tell your doctor right away if you develop any signs of infection (such as sore throat that doesn't go away, fever, chills, cough, painful/difficult urination).

This medication contains a form of paclitaxel that is bound to a human protein called albumin. This product acts differently in the body than other forms of paclitaxel. This product should not be substituted for or used with any other forms of paclitaxel.

This medication is used to treat certain cancers (including breast, lung, and pancreatic cancer). Paclitaxel belongs to a class of drugs known as chemotherapy drugs. It works by slowing or stopping the growth of cancer cells.

Read the Patient Information Leaflet if available from your pharmacist before you start using paclitaxel and each time you receive a dose. If you have any questions, ask your doctor or pharmacist.

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. The dosage is based on your medical condition, body size, lab tests, and response to treatment.

See also Warning section.

Nausea, vomiting, diarrhea, mouth sores, headache, muscle/joint pain, numbness/tingling/burning of the hands/feet, weakness, or dizziness may occur. If any of these effects last or get worse, tell your doctor promptly.

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

People using this medication may have serious side effects. However, you have been prescribed this drug because your doctor 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 (such as unusual tiredness, pale skin)
• easy bruising/bleeding
• fast/slow/irregular heartbeat
• pain/redness/swelling/weakness of the arms/legs
• calf pain/swelling that is warm to the touch
• vision changes

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.

Get medical help right away if you have any very serious side effects, including:

• chest/jaw/left arm pain
• coughing up blood
• fainting
• weakness on one side of the body
• trouble speaking
• confusion
• sudden severe headache

A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including:

• rash
• itching/swelling (especially of the face/tongue/throat)
• severe dizziness
• trouble breathing

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 or at www.fda.gov/medwatch.

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

Before using paclitaxel, tell your doctor or pharmacist if you are allergic to it; or to similar drugs (taxane-type drugs such as docetaxel, cabazitaxel); or to products containing human albumin; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of:

• blood disorders (such as low white blood cell count)
• decreased bone marrow function
• current infections
• heart problems (such as fast/slow/irregular heartbeat)
• high or low blood pressure
• liver disease

This drug may make you dizzy. Alcohol or marijuana (cannabis) can make you more dizzy. 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 (cannabis).

Tell your health care professional that you are using paclitaxel before having any immunizations/vaccinations. Avoid contact with people who have recently received live vaccines (such as flu vaccine inhaled through the nose).

Paclitaxel can make you more likely to get infections or may make current infections worse. Stay away from anyone who has an infection that may easily spread (such as chickenpox, COVID-19, measles, flu). Talk to your doctor if you have been exposed to an infection or for more details.

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.

Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).

This medication is made from human blood. Even though the blood is carefully tested, and this medication goes through a special manufacturing process, there is an extremely small chance that you may get infections from the medication (for example, viruses such as hepatitis). Consult your doctor or pharmacist for more information.

Older adults may be more sensitive to the side effects of this drug.

Tell your doctor if you are pregnant or plan to become pregnant. You should not become pregnant while using paclitaxel. Paclitaxel may harm an unborn baby. Your doctor should order a pregnancy test before you start this medication. Women using this medication should ask about reliable forms of birth control during treatment and for at least 6 months after the last dose. Men using this medication should ask about reliable forms of birth control during treatment and for some time after the last dose. If you or your partner becomes pregnant, talk to your doctor right away about the risks and benefits of this medication.

It is unknown if this drug passes into breast milk. Because of the possible risk to the infant, breastfeeding is not recommended while using this drug and for 2 weeks after the last dose. Consult your doctor before breastfeeding.

Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval.

If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call 1-800-222-1222. Canada residents can call 1-844-764-7669.

Lab and/or medical tests (such as complete blood counts) should be done while you are using this medication. Keep all medical and lab appointments. Consult your doctor for more details.

It is important to get each dose of this medication as scheduled. If you miss a dose, ask your doctor or pharmacist right away for a new dosing schedule.

Not applicable. This medication is given in a clinic and will not be stored at home.

Your condition can cause complications in a medical emergency. For information about enrolling in MedicAlert, call 1-888-633-4298 (US) or 1-800-668-1507 (Canada).

HOW TO USE THIS INFORMATION: This is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate for you. This information is not individual medical advice and does not substitute for the advice of your health care professional. Always ask your health care professional for complete information about this product and your specific health needs.