paclitaxel

Contraindicated in:

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

Use Cautiously in:

Moderate or severe hepatic impairment (↓ dose);
Active infection;
↓bone marrow reserve;
Rep: 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.

Adv. Reactions/Side Effects ⬆ ⬇

CV: ECG changes, edema, hypotension, bradycardia

Derm: alopecia, STEVENS-JOHNSON SYNDROME (SJS), TOXIC EPIDERMAL NECROLYSIS (TEN)

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: HYPERSENSITIVITY REACTIONS (INCLUDING ANAPHYLAXIS), SEPSIS

Interactions ⬆ ⬇

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 effectiveness; 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 risk of toxicity of doxorubicin.
May ↓ antibody response to and ↑ risk of adverse reactions from live-virus vaccines.

Availability ⬆ ⬇

Paclitaxel

(Generic available)

Solution for injection: 6 mg/mL

Paclitaxel Protein-Bound Particles (Albumin-Bound)

Lyophilized powder for injection: 100 mg/vial

Route/Dosage ⬆ ⬇

Paclitaxel

Ovarian Cancer
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.

Hepatic Impairment

IV (Adults 24-hr infusion): Transaminase levels <2 times ULN and bilirubin levels ≤1.5 mg/dL: 135 mg/m² over 24 hr. Transaminase levels 2–<10 times ULN and bilirubin levels ≤1.5 mg/dL: 100 mg/m² over 24 hr. Transaminase levels <10 times ULN and bilirubin levels 1.6–7.5 mg/dL: 50 mg/m² over 24 hr. Transaminase levels ≥10 times ULN or bilirubin levels >7.5 mg/dL: Avoid use.

Hepatic Impairment

IV (Adults 3-hr infusion): Transaminase levels <10 times ULN and bilirubin levels ≤1.25 times ULN: 175 mg/m² over 3 hr. Transaminase levels <10 times ULN and bilirubin levels 1.26–2 times ULN: 135 mg/m² over 3 hr. Transaminase levels <10 times ULN and bilirubin levels 2.01–5 times ULN: 90 mg/m² over 3 hr. Transaminase levels ≥10 times ULN or bilirubin levels >5 times ULN: Avoid use.
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.

Hepatic Impairment

IV (Adults 3-hr infusion): Transaminase levels <10 times ULN and bilirubin levels ≤1.25 times ULN: 175 mg/m² over 3 hr. Transaminase levels <10 times ULN and bilirubin levels 1.26–2 times ULN: 135 mg/m² over 3 hr. Transaminase levels <10 times ULN and bilirubin levels 2.01–5 times ULN: 90 mg/m² over 3 hr. Transaminase levels ≥10 times ULN or bilirubin levels >5 times ULN: Avoid use.
Non-Small Cell Lung Cancer
IV (Adults ): 135 mg/m² over 24 hr every 3 wk, followed by cisplatin.

Hepatic Impairment

IV (Adults 24-hr infusion): Transaminase levels <2 times ULN and bilirubin levels ≤1.5 mg/dL: 135 mg/m² over 24 hr. Transaminase levels 2–<10 times ULN and bilirubin levels ≤1.5 mg/dL: 100 mg/m² over 24 hr. Transaminase levels <10 times ULN and bilirubin levels 1.6–7.5 mg/dL: 50 mg/m² over 24 hr. Transaminase levels ≥10 times ULN or bilirubin levels >7.5 mg/dL: Avoid use.
AIDS-Related Kaposi 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).

Hepatic Impairment

IV (Adults 3-hr infusion): Transaminase levels <10 times ULN and bilirubin levels ≤1.25 times ULN: 175 mg/m² over 3 hr. Transaminase levels <10 times ULN and bilirubin levels 1.26–2 times ULN: 135 mg/m² over 3 hr. Transaminase levels <10 times ULN and bilirubin levels 2.01–5 times ULN: 90 mg/m² over 3 hr. Transaminase levels ≥10 times ULN or bilirubin levels >5 times ULN: Avoid use.

Paclitaxel Protein-Bound Particles (Albumin-Bound)

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

Hepatic Impairment

IV (Adults ): AST levels <10 times ULN and bilirubin levels 1.51–3 times ULN: 200 mg/m² over 30 min every 3 wk; may ↑ to 260 mg/m² for the 3rd course based on individual tolerance; AST levels <10 times ULN and bilirubin levels 3.01–5 times ULN: 200 mg/m² over 30 min every 3 wk; may ↑ to 260 mg/m² for the 3rd course based on individual tolerance; AST levels >10 times ULN or bilirubin levels >5 times ULN: Avoid use.
Non-Small Cell Lung Cancer
IV (Adults ): 100 mg/m² over 30 min on Days 1, 8, and 15 of each 21-day cycle.

Hepatic Impairment

IV (Adults ): AST levels <10 times ULN and bilirubin levels 1.51–3 times ULN): 80 mg/m² over 30 min on Days 1, 8, and 15 of each 21-day cycle; may ↑ to 100 mg/m² for the 3rd course based on individual tolerance; AST levels <10 times ULN and bilirubin levels 3.01–5 times ULN: 80 mg/m² over 30 min on Days 1, 8, and 15 of each 21-day cycle; may ↑ to 100 mg/m² for the 3rd course based on individual tolerance; AST levels >10 times ULN or bilirubin levels >5 times ULN): Avoid use.
Pancreatic Adenocarcinoma
IV (Adults ): 125 mg/m² over 30–40 min on Days 1, 8, and 15 of each 28-day cycle.

Hepatic Impairment

IV (Adults ): Moderate or severe hepatic impairment: Avoid use.

US Brand Names ⬆ ⬇

PACLitaxel: ~~Taxol,~~

PACLitaxel protein-bound particles (albumin-bound): Abraxane

Action ⬆ ⬇

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

Therapeutic effects:

Death of rapidly replicating cells, particularly malignant ones.

Classifications ⬆ ⬇

Therapeutic Classification: antineoplastics

Pharmacologic Classification: taxoids

Pharmacokinetics ⬆ ⬇

Absorption: IV administration results in complete bioavailability.

Distribution: Widely distributed to tissues.

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.

Time/Action Profile ⬆ ⬇

(effect on WBCs)

ROUTE	ONSET	PEAK	DURATION
IV	unknown	11 days	3 wk

Patient/Family Teaching ⬆ ⬇

Explain purpose and side effects of medication. Advise patient to read Patient Information before starting therapy.
Advise patient to notify health care provider of all Rx or OTC medications, vitamins, or herbal products being taken and to consult health care provider before taking other medications.
Advise patient to notify health care provider immediately of rash, difficulty breathing, or symptoms of hypersensitivity reaction occurs.
Instruct patient to notify health care provider 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 provider 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 after 14–21 days and is reversible after discontinuation of therapy. Explore coping strategies.
Instruct patient not to receive any vaccinations without advice of health care provider.
Rep: Advise women of reproductive potential to use a nonhormonal method of contraception during therapy and for ≥6 mo after last dose of therapy and to avoid breastfeeding during therapy and for 2 wk after last dose. Advise men with female partners of reproductive potential to use effective contraception during therapy and for ≥3 mo after last dose. May impair fertility in women and men.

section name header

Indications ⬇

Contraind./Precautions ⬆ ⬇

Adv. Reactions/Side Effects ⬆ ⬇

Interactions ⬆ ⬇

Availability ⬆ ⬇

Route/Dosage ⬆ ⬇

US Brand Names ⬆ ⬇

Action ⬆ ⬇

Classifications ⬆ ⬇

Pharmacokinetics ⬆ ⬇

Time/Action Profile ⬆ ⬇

Patient/Family Teaching ⬆ ⬇

Pronunciation ⬆