Paclitaxel
Looking up MedlinePlus…
From MedlinePlus, U.S. National Library of Medicine
Boxed warning
WARNING: SEVERE MYELOSUPPRESSION Do not administer Paclitaxel Protein-Bound Particles for Injectable Suspension (albumin-bound) therapy to patients who have baseline neutrophil counts of less than 1,500 cells/mm 3 . [see Contraindications ( 4 )] . Monitor for neutropenia, which may be severe and result in infection or sepsis, [see Warnings and Precautions ( 5.1 , 5.3 )] . Perform frequent complete blood cell counts on all patients receiving Paclitaxel Protein-Bound Particles for Injectable Suspension (albumin-bound) [see Contraindications ( 4 ), Warnings and Precautions ( 5.1 , 5.3 )]. WARNING: SEVERE MYELOSUPPRESSION See full prescribing information for complete boxed warning.
Do not administer Paclitaxel Protein-Bound Particles for Injectable Suspension (albumin-bound) therapy to patients with baseline neutrophil counts of less than 1,500 cells/mm 3 . ( 4 ) Monitor for neutropenia, which may be severe and result in infection or sepsis. ( 5.1 , 5.3 ) Perform frequent complete blood cell counts on all patients receiving Paclitaxel Protein-Bound Particles for Injectable Suspension (albumin-bound). ( 5.1 , 5.3 )
Microtubule Inhibitor
Dosing in kidney impairment
Renal Impairment No adjustment of the starting Paclitaxel Protein-Bound Particles for Injectable Suspension (albumin-bound) dose is required for patients with mild to moderate renal impairment (estimated creatinine clearance 30 to <90 mL/min) [see Clinical Pharmacology] . There are insufficient data to permit dosage recommendations in patients with severe renal impairment or end stage renal disease (estimated creatinine clearance <30 mL/min).
Dosing in liver impairment
Dosage Modifications for Hepatic Impairment For patients with moderate or severe hepatic impairment, reduce the starting dose of Paclitaxel Protein-Bound Particles for Injectable Suspension (albumin-bound) as shown in Table 1. [See table below.]
| AST Levels | BilirubinLevels | Paclitaxel Protein-Bound Particles for Injectable Suspension (albumin-bound) Dosea | ||||
| MBC | NSCLCc | Adenocarcinoma of Pancreasc | ||||
| Moderate | <10 x ULN | AND | >1.5 to ≤3 x ULN | 200 mg/m2b | 80 mg/m2b | not recommended |
| Severe | <10 x ULN | AND | >3 to ≤5 x ULN | 200 mg/m2b | 80 mg/m2b | not recommended |
| >10 x ULN | OR | >5 x ULN | not recommended | not recommended | not recommended | |
| AST = Aspartate Aminotransferase; MBC = Metastatic Breast Cancer; NSCLC = Non-Small Cell Lung Cancer; ULN = Upper limit of normal. | ||||||
| a Dosage recommendations are for the first course of therapy. The need for further dose adjustments in subsequent courses should be based on individual tolerance. | ||||||
| b A dose increase to 260 mg/m2 for patients with metastatic breast cancer or 100 mg/m2 for patients with non-small cell lung cancer in subsequent courses should be considered if the patient tolerates the reduced dose for two cycles. | ||||||
| c Patients with bilirubin levels above the upper limit of normal were excluded from clinical trials for pancreatic or lung cancer. | ||||||
Preparation and administration
Prepare this dose
Your numbers for paclitaxel. Take vial strength, diluent, and limits from the label below.
Enter a dose to see draw volume, final concentration, and rates.
Important Administration Instructions DO NOT SUBSTITUTE FOR OR WITH OTHER PACLITAXEL FORMULATIONS. Paclitaxel Protein-Bound Particles for Injectable Suspension (albumin-bound) has different dosage and administration instructions from other paclitaxel products. Closely monitor the infusion site for extravasation or drug infiltration during administration.
Limiting the infusion of Paclitaxel Protein-Bound Particles for Injectable Suspension (albumin-bound) to 30 minutes may reduce the risk of infusion-related reactions [see Adverse Reactions] . Consider premedication in patients who have had prior hypersensitivity reactions to Paclitaxel Protein-Bound Particles for Injectable Suspension (albumin-bound).
Do not re-challenge patients who experience a severe hypersensitivity reaction to Paclitaxel Protein-Bound Particles for Injectable Suspension (albumin-bound) [see Contraindications and Warnings and Precautions] .
Preparation for Intravenous Administration Paclitaxel Protein-Bound Particles for Injectable Suspension (albumin-bound) is a hazardous drug. Follow applicable special handling and disposal procedures. 1 The use of gloves is recommended. If Paclitaxel Protein-Bound Particles for Injectable Suspension (albumin-bound) (lyophilized cake or reconstituted suspension) contacts the skin, wash the skin immediately and thoroughly with soap and water.
Following topical exposure to paclitaxel, events may include tingling, burning, and redness. If Paclitaxel Protein-Bound Particles for Injectable Suspension (albumin-bound) contacts mucous membranes, the membranes should be flushed thoroughly with water. Paclitaxel Protein-Bound Particles for Injectable Suspension (albumin-bound) is supplied as a sterile lyophilized powder for reconstitution before use.
Read the entire preparation instructions prior to reconstitution. 1. Aseptically, reconstitute each vial by injecting 20 mL of 0.9% Sodium Chloride Injection, USP. 2. Slowly inject the 20 mL of 0.9% Sodium Chloride Injection, USP, over a minimum of 1 minute, using the sterile syringe to direct the solution flow onto the INSIDE WALL OF THE VIAL. 3.
DO NOT INJECT the 0.9% Sodium Chloride Injection, USP, directly onto the lyophilized cake as this will result in foaming. 4. Once the injection is complete, allow the vial to sit for a minimum of 5 minutes to ensure proper wetting of the lyophilized cake/powder. 5. Gently swirl and/or invert the vial slowly for at least 2 minutes until complete dissolution of any cake/powder occurs.
Avoid generation of foam. 6. If foaming or clumping occurs, stand solution for at least 15 minutes until foam subsides. Each mL of the reconstituted formulation will contain 5 mg/mL paclitaxel. The reconstituted suspension should be milky and homogenous without visible particulates. If particulates or settling are visible, the vial should be gently inverted again to ensure complete resuspension prior to use.
Discard the reconstituted suspension if precipitates are observed. Discard any unused portion. Calculate the exact total dosing volume of 5 mg/mL suspension required for the patient and slowly withdraw the dosing volume of the reconstituted suspension from the vial(s) into a syringe: Dosing volume (mL)=Total dose (mg)/5 (mg/mL).
Inject the appropriate amount of reconstituted Paclitaxel Protein-Bound Particles for Injectable Suspension (albumin-bound) into an empty, sterile intravenous bag [plasticized polyvinyl chloride (PVC) containers, PVC or non-PVC type intravenous bag]. The use of specialized DEHP-free solution containers or administration sets is not necessary to prepare or administer Paclitaxel Protein-Bound Particles for Injectable Suspension (albumin-bound) infusions.
The use of medical devices containing silicone oil as a lubricant (i.e., syringes and intravenous bags) to reconstitute and administer Paclitaxel Protein-Bound Particles for Injectable Suspension (albumin-bound) may result in the formation of proteinaceous strands. Visually inspect the reconstituted Paclitaxel Protein-Bound Particles for Injectable Suspension (albumin-bound) suspension in the intravenous bag prior to administration.
Discard the reconstituted suspension if proteinaceous strands, particulate matter, or discoloration are observed. 1
Stability Stability of Reconstituted Suspension in the Vial Reconstituted Paclitaxel Protein-Bound Particles for Injectable Suspension (albumin-bound) in the vial should be used immediately, but may be refrigerated at 2°C to 8°C (36°F to 46°F) for a maximum of 24 hours if necessary. If not used immediately, each vial of reconstituted suspension should be replaced in the original carton to protect it from light.
Discard any unused portion. Stability of Reconstituted Suspension in the Infusion Bag The suspension for infusion when prepared as recommended in an infusion bag should be used immediately, but may be refrigerated at 2°C to 8°C (36°F to 46°F) and protected from light for a maximum of 24 hours. The total combined refrigerated storage time of reconstituted Paclitaxel Protein-Bound Particles for Injectable Suspension (albumin-bound) in the vial and in the infusion bag is 24 hours.
This may be followed by storage in the infusion bag at ambient temperature (approximately 25°C) and lighting conditions for a maximum of 4 hours. Discard any unused portion.
| 1. Aseptically, reconstitute each vial by injecting 20 mL of 0.9% Sodium Chloride Injection, USP.2. Slowly inject the 20 mL of 0.9% Sodium Chloride Injection, USP, over a minimum of 1 minute, using the sterile syringe to direct the solution flow onto the INSIDE WALL OF THE VIAL.3. DO NOT INJECT the 0.9% Sodium Chloride Injection, USP, directly onto the lyophilized cake as this will result in foaming.4. Once the injection is complete, allow the vial to sit for a minimum of 5 minutes to ensure proper wetting of the lyophilized cake/powder.5. Gently swirl and/or invert the vial slowly for at least 2 minutes until complete dissolution of any cake/powder occurs. Avoid generation of foam.6. If foaming or clumping occurs, stand solution for at least 15 minutes until foam subsides. |
Drug interactions
Check paclitaxel against a medication listLabel text (2 paragraphs)
Use caution when concomitantly administering Paclitaxel Protein-Bound Particles for Injectable Suspension (albumin-bound) with inhibitors or inducers of either CYP2C8 or CYP3A4. ( 7 )
7.1 Effect of Other Drugs on Paclitaxel Protein-Bound Particles for Injectable Suspension The metabolism of paclitaxel is catalyzed by CYP2C8 and CYP3A4. Caution should be exercised when administering protein bound paclitaxel concomitantly with medicines known to inhibit or induce either CYP2C8 or CYP3A4 [see Clinical Pharmacology ( 12.3 )] .
Contraindications
Paclitaxel Protein-Bound Particles for Injectable Suspension (albumin-bound) is contraindicated in patients with: Baseline neutrophil counts of <1,500 cells/mm 3 [see Warnings and Precautions ( 5.1 )] A history of severe hypersensitivity reactions to protein bound paclitaxel [see Warnings and Precautions ( 5.5 )] Neutrophil counts of <1,500 cells/mm 3 . ( 4 ) Severe hypersensitivity reactions to protein bound paclitaxel. ( 4 )
Pregnancy and lactation
Pregnancy
8.1 Pregnancy Risk Summary Based on its mechanism of action and findings in animals, Paclitaxel Protein-Bound Particles for Injectable Suspension (albumin-bound) can cause fetal harm when administered to a pregnant woman [see Clinical Pharmacology ( 12.1 )] . There are no available human data on Paclitaxel Protein-Bound Particles for Injectable Suspension (albumin-bound) use in pregnant women to inform the drug-associated risk.
In animal reproduction studies, administration of paclitaxel formulated as albumin-bound particles to pregnant rats during the period of organogenesis resulted in embryo-fetal toxicity at doses approximately 2% of the daily maximum recommended human dose on a mg/m 2 basis (see Data) . Advise females of reproductive potential of the potential risk to a fetus. The background rate of major birth defects and miscarriage is unknown for the indicated population. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively.
Data Animal Data In embryo-fetal development studies, intravenous administration of paclitaxel formulated as albumin-bound particles to rats during pregnancy, on gestation days 7 to 17 at doses of 6 mg/m 2 (approximately 2% of the daily maximum recommended human dose on a mg/m 2 basis) caused embryo-fetal toxicities, as indicated by intrauterine mortality, increased resorptions (up to 5-fold), reduced numbers of litters and live fetuses, reduction in fetal body weight, and increase in fetal anomalies. Fetal anomalies included soft tissue and skeletal malformations, such as eye bulge, folded retina, microphthalmia, and dilation of brain ventricles.
For breastfeeding, also see LactMed (National Library of Medicine), which summarizes milk levels and infant effects.
Supply and cost
Drug shortage status
Recalls (last 24 months)
Therapeutic equivalence (Orange Book)
Price ladder
Not the price at the counterThese are not what a patient pays at the pharmacy counter. They are what pharmacies, health plans, and government buyers pay, before manufacturer rebates. A patient's cost depends on their insurance (copay, coinsurance, or deductible) or the pharmacy's cash price.