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J. Iverson Riddle Developmental Center
Patient Education Monograph
IMPORTANT NOTE: THE FOLLOWING INFORMATION IS INTENDED TO SUPPLEMENT, NOT SUBSTITUTE FOR, THE
EXPERTISE AND JUDGEMENT OF YOUR PHYSICIAN, PHARMACIST OR OTHER HEALTHCARE PROFESSIONAL. IT
SHOULD NOT BE CONSTRUED TO INDICATE THAT USE OF THE DRUG IS SAFE, APPROPRIATE, OR EFFECTIVE FOR
YOU. CONSULT YOUR HEALTHCARE PROFESSIONAL BEFORE USING THIS DRUG.
PACLITAXEL PROTEIN-BOUND - INJECTION
USES: This medication is used to treat advanced breast cancer. Paclitaxel is a cancer chemotherapy drug that works
by slowing or stopping cancer cell growth.
HOW TO USE: Read the Patient Information Leaflet available from your pharmacist before you start using paclitaxel.
If you have any questions, consult 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. Dosage is based on your medical condition, body size, and response to
treatment.
MISSED DOSE: For the best possible benefit, it is important to receive each scheduled dose of this medication as
directed. If you miss a dose, contact your doctor or pharmacist immediately to establish a new dosing schedule.
STORAGE: Not applicable. This medication is given in a clinic and will not be stored at home.
SIDE EFFECTS: 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 persist or worsen, tell your
doctor promptly.
• Temporary hair loss may occur. Normal hair growth should return after treatment has ended.
• 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, 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 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.
• Get medical help right away if any of these rare but very serious side effects occur: chest/jaw/left arm
pain, coughing up blood, fainting, weakness on one side of the body, slurred speech, confusion, sudden
severe headache.
• A very serious allergic reaction to this drug is rare. Do not restart this medication if you have previously
stopped using it due to a serious allergic reaction. Get medical help right away if you notice
any of the following symptoms of a serious allergic reaction: rash, itching/swelling (especially of the
face/tongue/throat), severe dizziness, trouble breathing, flushing.
• This medication contains albumin that comes from human blood. There is a very small chance that you
may get infections from this medication (e.g., viral infections such as hepatitis), even though careful
screening of blood donors, special manufacturing processes, and many tests are all used to reduce this
risk. Discuss the benefits and risks of treatment with your doctor. Tell your doctor immediately if you
develop any of the following: signs of infection (e.g., fever, chills, cough, persistent sore throat), signs
of hepatitis (e.g., persistent nausea/vomiting, stomach/abdominal pain, yellowing eyes/skin, dark urine,
increasing tiredness).
• This is not a complete list of possible side effects. If you notice other effects not listed above, contact
your doctor or pharmacist.
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• 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 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.
• 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. 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.
• 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, breastfeeding
while using this drug is not recommended. Consult your doctor before breast-feeding.
DRUG INTERACTIONS: 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.
• Some products that may interact with this drug include: other drugs that may decrease bone marrow
function (e.g., azathioprine, trimethoprim/sulfamethoxazole), drugs affecting liver enzymes that remove
paclitaxel from your body (such as azole antifungals including ketoconazole, macrolide antibiotics including
erythromycin, rifamycins including rifabutin, St. John’s wort, certain anti-seizure medicines
including carbamazepine).
• This medication can affect the removal of other medications from your body, which may affect how they
work. Examples of affected drugs include buspirone, eletriptan, felodipine, some benzodiazepines (such
as midazolam, triazolam), some drugs used to treat erectile dysfunction (such as sildenafil), some statin
drugs (such as lovastatin, simvastatin), among others.
NOTES: Laboratory and/or medical tests (e.g., complete blood counts) should be performed periodically to monitor
your progress or check for side effects. Consult your doctor for more details.
OVERDOSE: If overdose is suspected, contact your local poison control center or emergency room immediately. US
residents can call the US National Poison Hotline at 1-800-222-1222. Canada residents can call a provincial poison
control center.
WARNING: 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
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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 immediately if you develop any signs of infection (e.g., fever, chills, cough,
persistent sore throat, 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. Therefore, this product should not
be substituted for or used with any other forms of paclitaxel.
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