Paclitaxel Protein Bound

Paclitaxel protein-bound is a cancer medicine that interferes with the growth and spread of cancer cells in the body.

Paclitaxel protein-bound is used in the treatment of breast cancer, lung cancer, and pancreatic cancer.

Paclitaxel protein-bound is sometimes given with other cancer medicines.

Paclitaxel protein-bound may also be used for purposes not listed in this medication guide.

You should not receive paclitaxel protein-bound if you have a very low white blood cell count.

You should not receive paclitaxel protein-bound if you are allergic to it, or if you have:

• a low white blood cell count; or
• severe liver disease.

To make sure paclitaxel protein-bound is safe for you, tell your doctor if you have:

• liver disease;
• kidney disease;
• heart disease, heart rhythm disorder; or
• bone marrow suppression.

Do not use paclitaxel protein-bound if you are pregnant. It could harm the unborn baby. Use effective birth control to prevent pregnancy during treatment.

Use birth control to prevent pregnancy while you are receiving this medicine, whether you are a man or a woman. Paclitaxel protein-bound use by either parent may cause birth defects. Follow your doctor's instructions about how long to prevent pregnancy after your treatment ends.

It is not known whether this medicine passes into breast milk or if it could harm a nursing baby. You should not breast-feed while you are receiving paclitaxel protein-bound.

• Tell all of your health care providers that you take this medicine. This includes your doctors, nurses, pharmacists, and dentists.
• Avoid driving and doing other tasks or actions that call for you to be alert until you see how paclitaxel affects you.
• Very bad and sometimes deadly allergic side effects have rarely happened. Talk with your doctor.
• Other drugs may be given before this medicine to help avoid side effects.
• You may have more chance of getting an infection. Wash hands often. Stay away from people with infections, colds, or flu.
• You may bleed more easily. Be careful and avoid injury. Use a soft toothbrush and an electric razor.
• If you have upset stomach, throwing up, loose stools (diarrhea), or are not hungry, talk with your doctor. There may be ways to lower these side effects.
• This medicine is made from human plasma (part of the blood) and may have viruses that may cause disease. This medicine is screened, tested, and treated to lower the chance that it carries an infection. Talk with the doctor.
• Talk with your doctor before getting any vaccines. Use with paclitaxel may either raise the chance of an infection or make the vaccine not work as well.
• Talk with your doctor before you drink alcohol or use other drugs and natural products that slow your actions.
• If you are 65 or older, use this medicine with care. You could have more side effects.
• Do not father a child while taking paclitaxel.
• If you are a man and have sex with a female who could get pregnant, protect her from pregnancy. Use birth control that you can trust.
• Use birth control that you can trust to prevent pregnancy while taking this medicine.
• This medicine may cause harm to the unborn baby if you take it while you are pregnant. If you are pregnant or you get pregnant while taking paclitaxel, call your doctor right away.

Use this medicine as ordered by your doctor. Read all information given to you. Follow all instructions closely.

• It is given as an infusion into a vein over a period of time.

What do I do if I miss a dose?

• Call your doctor to find out what to do.

• If your symptoms or health problems do not get better or if they become worse, call your doctor.
• Do not share your drugs with others and do not take anyone else's drugs.
• Keep a list of all your drugs (prescription, natural products, vitamins, OTC) with you. Give this list to your doctor.
• Talk with the doctor before starting any new drug, including prescription or OTC, natural products, or vitamins.
• Keep all drugs in a safe place. Keep all drugs out of the reach of children and pets.
• Check with your pharmacist about how to throw out unused drugs.
• Some drugs may have another patient information leaflet. Check with your pharmacist. If you have any questions about paclitaxel (protein bound), please talk with your doctor, nurse, pharmacist, or other health care provider.
• If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.

This information should not be used to decide whether or not to take this medicine or any other medicine. Only the healthcare provider has the knowledge and training to decide which medicines are right for a specific patient. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about paclitaxel. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to this medicine. This information is not specific medical advice and does not replace information you receive from the healthcare provider. You must talk with the healthcare provider for complete information about the risks and benefits of using paclitaxel.

Review Date: October 4, 2017

(pac li TAKS el PROE teen bownd)

Plasma paclitaxel exposure is increased in patients with hepatic impairment. Patients with moderate (bilirubin >1.5 to ≤3 times ULN and AST ≤10 times ULN) or severe (bilirubin >3 to ≤5 times ULN) hepatic impairment had ~20% increase in AUC compared to patients with normal hepatic function.

Dosage adjustment for hepatic impairment at treatment initiation:

Breast cancer (every 3 week regimen):

Mild impairment (AST ≤10 times ULN and bilirubin >1 to ≤1.5 times ULN): No dosage adjustment necessary.

Moderate impairment (AST ≤10 times ULN and bilirubin >1.5 to ≤3 times ULN): Reduce dose to 200 mg/m2; may increase up to 260 mg/m2 if the reduced dose is tolerated for 2 cycles

Severe impairment:

AST ≤10 times ULN and bilirubin >3 to ≤5 times ULN: Reduce dose to 200 mg/m2; may increase up to 260 mg/m2 in subsequent cycles if the reduced dose is tolerated for 2 cycles

AST >10 times ULN or bilirubin >5 times ULN: Use is not recommended (has not been studied).

Non-small cell lung cancer (NSCLC) regimen:

Mild impairment (AST ≤10 times ULN and bilirubin >1 to ≤1.5 times ULN): No dosage adjustment necessary.

Moderate impairment (AST ≤10 times ULN and bilirubin >1.5 to ≤3 times ULN): Reduce dose to 80 mg/m2; may increase up to 100 mg/m2 in subsequent cycles if the reduced dose is tolerated for 2 cycles

Severe impairment:

AST ≤10 times ULN and bilirubin >3 to ≤5 times ULN: Reduce dose to 80 mg/m2; may increase up to 100 mg/m2 in subsequent cycles if the reduced dose is tolerated for 2 cycles

AST >10 times ULN or bilirubin >5 times ULN: Use is not recommended (has not been studied).

Pancreatic adenocarcinoma:

Mild impairment (AST ≤10 times ULN and bilirubin >1 to ≤1.5 times ULN): No dosage adjustment necessary.

Moderate impairment (AST ≤10 times ULN and bilirubin >1.5 to ≤3 times ULN): Use is not recommended.

Severe impairment:

AST ≤10 times ULN and bilirubin >3 to ≤5 times ULN: Use is not recommended.

AST >10 times ULN or bilirubin >5 times ULN: Use is not recommended.

Dosage adjustment for hepatic impairment during treatment: AST >10 times ULN or bilirubin >5 times ULN: Withhold treatment

Frequency may vary based on indication and/or concomitant therapy.

>10%:

Cardiovascular: ECG abnormality (60%; 35% in patients with a normal baseline), peripheral edema (10% to 46%)

Central nervous system: Peripheral sensory neuropathy (71%; grades 3/4: 10%; dose dependent; cumulative), fatigue (25% to 59%), peripheral neuropathy (48% to 54%; grade 3: 3% to 17%), headache (14%), depression (12%)

Dermatologic: Alopecia (50% to 90%), skin rash (10% to 30%)

Endocrine & metabolic: Dehydration (21%), increased gamma-glutamyl transferase (grades 3/4: 14%), hypokalemia (12%)

Gastrointestinal: Nausea (27% to 54%; grades 3/4: 3% to 6%), diarrhea (15% to 44%; grades 3/4: ≤6%), decreased appetite (17% to 36%), vomiting (12% to 36%; grades 3/4: 4% to 6%), constipation (16%), dysgeusia (16%)

Genitourinary: Urinary tract infection (11%)

Hematologic & oncologic: Anemia (33% to 98%; grades 3/4: 1% to 28%), neutropenia (73% to 85%; grades 3/4: 34% to 47%), thrombocytopenia (2% to 74%; grades 3/4: <1% to 18%), bone marrow depression (dose-related)

Hepatic: Increased serum AST (39%), increased serum alkaline phosphatase (36%)

Infection: Infection (24%; primarily included oral candidiasis, respiratory tract infection, and pneumonia)

Neuromuscular & skeletal: Weakness (16% to 47%; severe: 8%), musculoskeletal pain (10% to 44%; myalgia/arthralgia), limb pain (11%)

Ophthalmic: Visual disturbance (13%; severe [keratitis, blurred vision]: 1%)

Renal: Increased serum creatinine (11%; severe 1%)

Respiratory: Cough (7% to 17%), epistaxis (7% to 15%), dyspnea (12%)

Miscellaneous: Fever (41%)

1% to 10%:

Cardiovascular: Edema (10%), cardiac failure (<10%), hypotension (5%), significant cardiovascular event (grades 3/4: 3%; included chest pain, cardiac arrest, supraventricular tachycardia, thrombosis, pulmonary thromboembolism, pulmonary emboli, and hypertension)

Gastrointestinal: Mucositis (7% to 10%; grades 3/4: ≤1%)

Hematologic & oncologic: Hemorrhage (2%), febrile neutropenia (2%)

Hepatic: Increased serum bilirubin (7%)

Hypersensitivity: Hypersensitivity reaction (4%, includes anaphylactic reactions, chest pain, dyspnea, flushing, hypotension; severe: <1%)

Infection: Sepsis (5%)

Ophthalmic: Cystoid macular edema (<10%)

Respiratory: Pneumonitis (4%)

<1% (Limited to important or life-threatening): Atrioventricular block, autonomic neuropathy, bradycardia, cardiac arrhythmia, cerebrovascular accident, cranial nerve palsy, embolism, hepatic encephalopathy, hepatic necrosis, intestinal obstruction, intestinal perforation, ischemic colitis, ischemic heart disease, left ventricular dysfunction, maculopapular rash, myocardial infarction, neutropenic sepsis, optic nerve damage (rare), palmar-plantar erythrodysesthesia (in patients previously exposed to capecitabine), pancreatitis, pancytopenia, paralytic ileus, peripheral motor neuropathy, pneumonia, pneumothorax, pulmonary embolism, radiation pneumonitis (with concurrent radiation therapy), radiation recall phenomenon, skin photosensitivity, Stevens-Johnson syndrome, thrombosis, toxic epidermal necrolysis, transient ischemic attacks, ventricular dysfunction, vocal cord paralysis

You should not receive paclitaxel protein-bound if you are allergic to it, or if you have:

• a low white blood cell count; or

• severe liver disease.

To make sure paclitaxel protein-bound is safe for you, tell your doctor if you have:

• liver disease;

• kidney disease;

• heart disease, heart rhythm disorder; or

• bone marrow suppression.

Do not use paclitaxel protein-bound if you are pregnant. It could harm the unborn baby. Use effective birth control to prevent pregnancy during treatment.

Use birth control to prevent pregnancy while you are receiving this medicine, whether you are a man or a woman. Paclitaxel protein-bound use by either parent may cause birth defects. Follow your doctor's instructions about how long to prevent pregnancy after your treatment ends.

It is not known whether this medicine passes into breast milk or if it could harm a nursing baby. You should not breast-feed while you are receiving paclitaxel protein-bound.

Paclitaxel protein-bound can be harmful if it gets in your eyes, mouth, or nose, or on your skin. If skin contact occurs, wash the area with soap and water or rinse the eyes thoroughly with plain water.

This medicine can pass into body fluids (urine, feces, vomit). For at least 48 hours after you receive a dose, avoid allowing your body fluids to come into contact with your hands or other surfaces. Caregivers should wear rubber gloves while cleaning up a patient's body fluids, handling contaminated trash or laundry or changing diapers. Wash hands before and after removing gloves. Wash soiled clothing and linens separately from other laundry.