Paclitaxel:

• Advanced ovarian cancer (in combination with cisplatin).
• Non–small-cell lung cancer (NSCLC) when potentially curative surgery and/or radiation therapy is not an option.
• Metastatic breast cancer unresponsive to other therapy.
• Node-positive breast cancer when administered sequentially to standard combination chemotherapy that includes doxorubicin.
• Treatment of AIDS-related Kaposi’s sarcoma.

Paclitaxel (albumin-bound):

• Metastatic breast cancer after treatment failure or relapse where therapy included an anthracycline.
• Locally advanced or metastatic NSCLC when potentially curative surgery or radiation therapy is not an option (in combination with carboplatin).
• Metastatic pancreatic adenocarcinoma (in combination with gemcitabine)

Contraindicated in:

• Hypersensitivity to paclitaxel, other taxanes, or castor oil (paclitaxel)
• Severe hypersensitivity to paclitaxel protein-bound particles (paclitaxel protein-bound particles)
• AST >10× upper limit of normal (ULN) or total bilirubin >5× ULN (paclitaxel protein-bound particles)
• Moderate or severe hepatic impairment (pancreatic adenocarcinoma only for paclitaxel protein-bound particles)
• Known alcohol intolerance
• Neutrophil count 1500/mm³ (for patients with ovarian, lung, breast, or pancreatic cancer) or 1000/mm³ (for patients with AIDS-related Kaposi’s sarcoma)
• OB: Pregnancy
• Lactation: Lactation.

Use Cautiously in:

• Moderate or severe hepatic impairment (↓ dose)
• Active infection
• ↓bone marrow reserve
• Women of reproductive potential and men with female partners of reproductive potential
• Pedi: Safety and effectiveness not established in children
• Geri: Older adults may have ↑ risk of adverse reactions.

CV: ECG changes, edema, hypotension, bradycardia.

Derm: alopecia, STEVENS-JOHNSON SYNDROME, TOXIC EPIDERMAL NECROLYSIS.

GI: ↑liver enzymes, diarrhea, mucositis, nausea, vomiting, pancreatitis.

GU: renal failure.

Hemat: anemia, neutropenia, thrombocytopenia.

Local: injection site reactions.

MS: arthralgia, myalgia.

Neuro: peripheral neuropathy, dizziness, headache, seizures.

Resp: cough, dyspnea, interstitial pneumonia, PULMONARY EMBOLISM, PULMONARY FIBROSIS.
Misc: (INCLUDING ANAPHYLAXIS)HYPERSENSITIVITY REACTIONS , SEPSIS.

Drug-Drug:

• CYP3A4 inhibitors, including atazanavir, clarithromycin, itraconazole, ketoconazole, nefazodone, nelfinavir, and ritonavir, may ↑ levels and risk of toxicity; concurrent use should be undertaken with caution.
• CYP3A4 inducers, including carbamazepine, rifampin, and phenytoin, may ↓ levels and ↑ risk of treatment failure; concurrent use should be undertaken with caution.
• Gemfibrozil may ↑ levels and risk of toxicity; concurrent use should be undertaken with caution.
• ↑risk of myelosuppression with other antineoplastics or radiation therapy.
• Myelosuppression ↑ when given after cisplatin.
• May ↑ levels and toxicity of doxorubicin.
• May ↓ antibody response to and ↑ risk of adverse reactions from live-virus vaccines.

Paclitaxel

(Generic available)

• Solution for injection: 6 mg/mL;

Paclitaxel Protein-Bound Particles (albumin-bound)

• Lyophilized powder for injection: 100 mg/vial;

Paclitaxel

• IV (Adults): Previously untreated patients: 175 mg/m² over 3 hr every 3 wk or 135 mg/m² over 24 hr every 3 wk, followed by cisplatin; Previously treated patients: 135 mg/m² or 175 mg/m² over 3 hr every 3 wk.
Breast Cancer
• IV (Adults): Adjuvant treatment of node-positive breast cancer: 175 mg/m² over 3 hr every 3 wk for 4 courses administered sequentially to doxorubicin-containing combination chemotherapy; Failure of initial therapy for metastatic disease or relapse within 6 mo of adjuvant therapy: 175 mg/m² over 3 hr every 3 wk.
NSCLC
• IV (Adults): 135 mg/m² over 24 hr every 3 wk, followed by cisplatin.
AIDS-Related Kaposi’s Sarcoma
• IV (Adults): 135 mg/m² over 3 hr every 3 wk or 100 mg/m² over 3 hr every 2 wk (dose ↓/adjustment may be necessary in patients with advanced HIV infection).

Paclitaxel Protein-Bound Particles (albumin-bound)

• IV (Adults): 260 mg/m² over 30 min every 3 wk.

Taxol

paclitaxel protein-bound particles (Albumin-Bound): Abraxane

• Interferes with the normal cellular microtubule function that is required for interphase and mitosis.

• Death of rapidly replicating cells, particularly malignant ones.

Therapeutic Classification: antineoplastics

Pharmacologic Classification: taxoids

Absorption: IV administration results in complete bioavailability.

Distribution: Cross the placenta.

Protein Binding: 89–98%.

Metabolism/Excretion: Highly metabolized by the liver primarily by the CYP2C8 and CYP3A4 isoenzymes; <10% excreted unchanged in urine.

Half-life: Paclitaxel: 13–52 hr; Paclitaxel protein-bound particles (albumin-bound): 27 hr.

(effect on WBCs)

• Explain purpose of paclitaxel to patient. Advise patient to read Patient Information before starting therapy and periodically during therapy in case of changes.
• Advise patient to notify health care professional immediately of rash, difficulty breathing, or symptoms of hypersensitivity reaction occurs.
• Instruct patient to notify health care professional promptly if fever; chills; cough; hoarseness; sore throat; signs of infection; lower back or side pain; painful or difficult urination; bleeding gums; bruising; petechiae; blood in stools, urine, or emesis; dyspnea; or orthostatic hypotension occurs. Caution patient to avoid crowds and persons with known infections. Instruct patient to use soft toothbrush and electric razor and to avoid falls. Caution patient not to drink alcoholic beverages or to take medication containing aspirin or NSAIDs; may precipitate gastric bleeding.
• May cause dizziness. Caution patient to avoid driving or other activities requiring alertness until response to medication is known.
• Instruct patient to notify health care professional if abdominal pain, yellow skin, weakness, paresthesia, gait disturbances, or joint or muscle aches occur.
• Instruct patient to inspect oral mucosa for redness and ulceration. If mouth sores occur, advise patient to use sponge brush and rinse mouth with water after eating and drinking. Stomatitis usually resolves in 5–7 days.
• Discuss with patient the possibility of hair loss. Complete hair loss usually occurs between days 14 and 21 and is reversible after discontinuation of therapy. Explore coping strategies.
• Instruct patient not to receive any vaccinations without advice of health care professional.
• Advise females of reproductive potential to use a nonhormonal method of contraception during and for at least 6 mo after last dose of therapy and to avoid breastfeeding during and for 2 wk after last dose. Advise male patients with female partners of reproductive potential to use effective contraception during and for at least 3 mo after last dose. May impair fertility in females and males.
• Emphasize the need for periodic lab tests to monitor for side effects.

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