Paclitaxel (Conventional)

• 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 (conventional), 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 con VEN sha nal)

There are no dosage adjustments provided in the manufacturer’s labeling. The following have been recommended:

CrCl <50 mL/minute: Adults: No dosage adjustment is necessary (Aronoff 2007).

Hemodialysis: Paclitaxel may be used in cancer patients on hemodialysis and because paclitaxel is not dialyzable, it may be used either before or after hemodialysis (Janus 2010).

Dosage modification for toxicity (solid tumors, including ovary, breast, and lung carcinoma): Courses of paclitaxel should not be repeated until the neutrophil count is ≥1,500/mm3 and the platelet count is ≥100,000/mm3; reduce dosage by 20% for patients experiencing severe peripheral neuropathy or severe neutropenia (neutrophil <500/mm3 for a week or longer)

Dosage modification for immunosuppression in advanced HIV disease: Paclitaxel should not be given to patients with HIV if the baseline or subsequent neutrophil count is <1000 cells/mm3. Additional modifications include: Reduce dosage of dexamethasone in premedication to 10 mg orally; reduce dosage by 20% in patients experiencing severe peripheral neuropathy or severe neutropenia (neutrophil <500/mm3 for a week or longer); initiate concurrent hematopoietic growth factor (G-CSF) as clinically indicated

Dilute for infusion in 250 to 1,000 mL D5W, D5LR, D5NS, or NS to a concentration of 0.3 to 1.2 mg/mL, use a non-PVC container (glass or polyethylene). Chemotherapy dispensing devices (eg, Chemo Dispensing Pin) should not be used to withdraw paclitaxel from the vial; closed system transfer devices may not be compatible with undiluted paclitaxel.

IV: Infuse over 3 or 24 hours (depending on indication/protocol); some off-label protocols use a 1-hour infusion. Infuse through a 0.22-micron in-line filter and polyethylene-lined (non-PVC) administration set. When administered as a part of a combination chemotherapy regimen, sequence of administration may vary by regimen; refer to specific protocol for sequence recommendation.

Premedication with dexamethasone (20 mg orally or IV at 12 and 6 hours before the dose; reduce to 10 mg with advanced HIV disease), diphenhydramine (50 mg IV 30 to 60 minutes prior to the dose), and cimetidine 300 mg, famotidine 20 mg, or ranitidine 50 mg (IV 30 to 60 minutes prior to the dose) is recommended.

Irritant with vesicant-like properties; avoid extravasation. Ensure proper needle or catheter position prior to administration.

Extravasation management: If extravasation occurs, stop infusion immediately and disconnect (leave cannula/needle in place); gently aspirate extravasated solution (do NOT flush the line); remove needle/cannula; initiate antidote (hyaluronidase); remove needle/cannula; elevate extremity. Information conflicts regarding the use of warm or cold compresses (Perez Fidalgo, 2012; Polovich, 2009).

Hyaluronidase: If needle/cannula still in place: Administer 1 to 6 mL (150 units/mL) into existing IV line; usual dose is 1 mL for each 1 mL of extravasated drug; if needle/cannula has been removed, inject subcutaneously in a clockwise manner around area of extravasation; may repeat several times over the next 3 to 4 hours (Ener, 2004).

Intraperitoneal (off-label route): Solution was prepared in warmed saline and infused as rapidly as possible through an implantable intraperitoneal catheter (Armstrong, 2006).

Percentages reported with single-agent therapy.

>10%:

Cardiovascular: Flushing (28%), ECG abnormality (14% to 23%), edema (21%), hypotension (4% to 12%)

Central nervous system: Peripheral neuropathy (42% to 70%; grades 3/4: ≤7%)

Dermatologic: Alopecia (87%), skin rash (12%)

Gastrointestinal: Nausea (≤52%), vomiting (≤52%), diarrhea (38%), mucositis (17% to 35%), stomatitis (15%; most common at doses >390 mg/m2), abdominal pain (with intraperitoneal administration)

Hematologic & oncologic: Neutropenia (78% to 98%; grade 4: 14% to 75%; onset: 8 to 10 days; median nadir: 11 days; recovery: 15 to 21 days), leukopenia (90%; grade 4: 17%), anemia (47% to 90%; grades 3/4: 2% to 16%), thrombocytopenia (4% to 20%; grades 3/4: 1% to 7%), hemorrhage (14%)

Hepatic: Increased serum alkaline phosphatase (22%), increased serum AST (19%)

Hypersensitivity: Hypersensitivity reaction (31% to 45%; grades 3/4: ≤2%)

Infection: Infection (15% to 30%)

Local: Injection site reaction (erythema at injection site, skin discoloration at injection site, swelling at injection site, tenderness at injection site: 13%)

Neuromuscular & skeletal: Arthralgia (≤60%), myalgia (≤60%), weakness (17%)

Renal: Increased serum creatinine (observed in Kaposi sarcoma patients only: 18% to 34%, severe: 5% to 7%)

1% to 10%:

Cardiovascular: Bradycardia (3%), tachycardia (2%), hypertension (1%), cardiac arrhythmia (1%), syncope (1%), venous thrombosis (1%)

Dermatologic: Changes in nails (2%)

Hematologic & oncologic: Febrile neutropenia (2%)

Hepatic: Increased serum bilirubin (7%)

Respiratory: Dyspnea (2%)

<1% (Limited to important or life-threatening): Anaphylaxis, ataxia, atrial fibrillation, atrioventricular block, back pain, brain disease (neurological), cardiac conduction disturbance, cardiac failure, cellulitis, chills, conjunctivitis, dehydration, desquamation, enterocolitis, exacerbation of scleroderma, fibrosis at injection site, hepatic encephalopathy, hepatic necrosis, increased lacrimation, induration at injection site, intestinal obstruction, intestinal perforation, interstitial pneumonitis, ischemic colitis, ischemic heart disease, maculopapular rash, malaise, myocardial infarction, neutropenic enterocolitis, ototoxicity (tinnitus and hearing loss), pancreatitis, paralytic ileus, phlebitis, pneumonitis, pruritus, pulmonary embolism, pulmonary fibrosis, radiation recall phenomenon, radiation pneumonitis, renal insufficiency, seizure, skin edema (diffuse), skin necrosis, skin sclerosis, Stevens-Johnson syndrome, supraventricular tachycardia, thickening of skin, toxic epidermal necrolysis, typhlitis (neutropenic), ventricular tachycardia (asymptomatic), visual disturbance (scintillating scotomata)

CBC with differential and platelet count, liver and kidney function; monitor for hypersensitivity reactions, vital signs (frequently during the first hour of infusion), continuous cardiac monitoring (patients with conduction abnormalities); monitor infusion site during infusion.

• Discuss specific use of drug and side effects with patient as it relates to treatment. (HCAHPS: During this hospital stay, were you given any medicine that you had not taken before? Before giving you any new medicine, how often did hospital staff tell you what the medicine was for? How often did hospital staff describe possible side effects in a way you could understand?)

• Patient may experience mouth sores or hair loss. Have patient report immediately to prescriber signs of infection, signs of liver problems (dark urine, fatigue, lack of appetite, nausea, abdominal pain, light-colored stools, vomiting, or jaundice), signs of bleeding (vomiting blood or vomit that looks like coffee grounds; coughing up blood; hematuria; black, red, or tarry stools; bleeding from the gums; abnormal vaginal bleeding; bruises without a reason or that get bigger; or any severe or persistent bleeding) signs of kidney problems (urinary retention, hematuria, change in amount of urine passed, or weight gain), shortness of breath, edema, severe dizziness, passing out, angina, tachycardia, flushing, abnormal heartbeat, bradycardia, severe headache, severe abdominal pain, severe nausea, vomiting, severe diarrhea, severe muscle pain, severe joint pain, burning or numbness feeling, severe loss of strength and energy, vision changes, or severe injection site redness, burning, edema, pain or irritation (HCAHPS).

• Educate patient about signs of a significant reaction (eg, wheezing; chest tightness; fever; itching; bad cough; blue skin color; seizures; or swelling of face, lips, tongue, or throat). Note: This is not a comprehensive list of all side effects. Patient should consult prescriber for additional questions.

Intended Use and Disclaimer: Should not be printed and given to patients. This information is intended to serve as a concise initial reference for health care professionals to use when discussing medications with a patient. You must ultimately rely on your own discretion, experience, and judgment in diagnosing, treating, and advising patients.