Parenteral Manual

PACLitaxel (NON-FORMULARY)

Disclaimer: Official controlled document is the CHEO online copy. It is the responsibility of user to ensure that any paper copy version is the same as the online version before use.

Alternate Name(s): 
TAXOL
Classification: 
antineoplastic agent - CYTOTOXIC
Original Date: 
June 2010
Revised Date: 
June 2015
Indications: 
  • Treatment of breast, non-small cell lung, and ovarian cancers
  • Investigational use in other tumors

THIS MEDICATION IS TO BE ADMINISTERED BY A CHEMO-TRAINED NURSE. IF THE NURSE IS NOT CHEMO-TRAINED, THEY ARE TO CONTACT THE UNIT NURSE EDUCATOR OR ADVANCED PRACTICE NURSE.

Reconstitution and Stability: 

Following information prepared for Hospira Brand products.

·          Available as 6 mg/mL injectable solution as 5 mL (30 mg), 16.7 mL (100 mg) and 50 mL (300 mg) vials.

·          Store unopened vials at room temperature. Protect from light.  If unopened vials are refrigerated, a precipitate may form which re-dissolves with little or no agitation upon reaching room temperature. Product quality is not affected. If the solution remains cloudy or if an insoluble precipitate is noted, the vial should be discarded.

·          Once punctured, the multi-dose 16.7 mL and 50 mL vials are stable for 28 days at room temperature. Once punctured 5 mL single dose vial should be discarded.

·          Dilute in 250-1000 mL D5W, D5LR, D5NS, or NS to a concentration of 0.3-1.2 mg/mL

·          Excessive agitation, vibration or shaking may induce precipitation and should be avoided.

·          Diluted solution are stable for 48 hours at room temperature when diluted to a concentration of 0.3-1.2 mg/mL in NS or D5W and for 72 hours at room temperature or in the fridge when diluted to a concentration of 0.1-1 mg/mL in NS or D5W.

·          Upon preparation, solutions may show haziness, which is attributed to the formulation vehicle. No significant loss in potency has been noted.

·          Devices with spikes (chemo dispensing pins) should not be used with Paclitaxel vials since they can cause the stopper to collapse resulting in loss of sterile integrity.

Compatibility: 

Solutions Compatible: D5W, D5LR, D5NS, NS

Additive/Buretrol compatibility: none

Y-site compatible: Acyclovir, bleomycin, ceftazidime, ceftriaxone, cyclophosphamide, cytarabine, dexamethasone, diphenhydramine, doxorubicin, etoposide, fluconazole, fluorouracil, furosemide, ganciclovir, gemcitabine, gentamicin, granisetron, heparin, hydrocortisone, hydromorphone, ifosfamide, linezolid, lorazepam, magnesium sulfate, mannitol, meperidine, mesna, methotrexate, metoclopramide, morphine, nalbuphine, ondansetron, potassium chloride, prochlorperazine, ranitidine, sodium bicarbonate, topotecan, vancomycin, vinblastine, vincristine

Incompatible: Amphotericin B, amphotericin B cholesteryl sulfate complex, chlorpromazine, doxorubicin liposome, hydroxyzine, methylprednisolone, mitoxantrone

Administration: 

(For approved routes of administration by nursing personnel, refer to Policy for the Administration of Intravenous Medications.)

Intraperitoneal Infuse over 1-2 hours
SC No
IM No
IV Direct No
IV Intermittent Infusion

Yes, Infusion over 1-3 hours

Administer via DEHP-free tubing and a 0.22 micron in-line filter

Infusion sets should be flushed thoroughly with a compatible diluent prior to use.

Dilute to final concentration of 0.3-1.2 mg/mL in non-PVC bags

Pre-medications required to prevent hypersensitivity reactions

IV Continuous Infusion Yes, as for intermittent infusion except given over 24-96 hours

 

Dosage: 

(For neonatal dosages, refer to Neonatal IV Drug Manual.)

Pediatrics

·          Investigational use: Children's Oncology group protocol AGCT0521

·          135 mg/m2/dose IV every 3 weeks

·          Dose adjustment: refer to protocol for dose adjustment for renal or hepatic toxicities

Adults

·          Initial dose 135-175 mg/m2 IV every 3 weeks, according to protocol

 

Potential hazards of parenteral administration: 

·          Hypersensitivity reaction: commonly occurring in 1st hour of infusion. Occasionally severe. Includes flushing, rash, dyspnea, bradycardia and hypotension. Refer to pre-printed order for monitoring

·          GI: Nausea/vomiting, diarrhea, mucositis

·          Flushing, edema, hypotension/hypertension, Bradycardia, tachycardia, rhythm abnormalities

·          Alopecia (87%), rash (12%)

·          Myelosuppresion

·          Peripheral neuropathy, arthralgia/myalgia, weakness

·          Creatinine, liver function test increased

·          Nail changes

      Vesicant - If extravasation occurs, click HERE for treatment guidelines.   

Notes: 

 

  • Premedication with dexamethasone PO/IV (10 mg/m2, maximum 20 mg) at 12 and 6 hours and 30 minutes prior to start of infusion as well as diphenhydramine IV (1 mg/kg, maximum 50 mg) and ranitidine IV (1 mg/kg, max 50 mg) 30-60 minutes prior to start of infusion
  •  When administered as sequential infusions, taxane derivatives should be administered before platinum derivatives (cisplatin, carboplatin) to limit myelosuppression and to enhance efficacy.
  • Formulations contain dehydrated alcohol; may cause adverse CNS effects.
  • Formulations contain purified Cremophor EL (polyoxyethylated castor oil).  Patients may develop hypersensitivity reactions to the Cremophor EL
  • Sensory neuropathy is almost universal at doses >250 mg/m2; motor neuropathy is uncommon at doses <250 mg/m2. Myopathic effects are common with doses >200 mg/m2, generally occur within 2-3 days of treatment, and resolve over 5-6 days.
  • Intraperitoneal administration of paclitaxel is associated with a higher incidence of chemotherapy related toxicity.
  •  Monitoring includes: CBC with differential and platelets, ECG (in patients with conduction abnormalities), liver function tests.
  • Drug interactions: Paclitaxel is a substrate for CYP3A4 (major) and CYP2C8 (major) and an inducer of CYP3A4 (weak). Consult oncology pharmacy for further information

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