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PACLITAXEL is a brand name for Paclitaxel, supplied as a powder for suspension. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: Paclitaxel Powder for Injectable Suspension Nanoparticle, Albumin-bound Paclitaxel is indicated for: • the treatment of metastatic breast cancer. • the first-line treatment of metastatic adenocarcinoma of the pancreas, in combination with gemcitabine. Paclitaxel Powder for Injectable Suspension Nanoparticle,…
Verbatim from this product's HC label. Tap a section to expand.
5 Missed Dose 08/2024 7 WARNINGS AND PRECAUTIONS, Reproductive Health: Female and Male Potential 08/2024 TABLE OF CONTENTS Sections or subsections that are not applicable at the time of authorization are not listed. RECENT MAJOR LABEL CHANGES .............................................................................................
2 TABLE OF CONTENTS ............................................................................................................... 2 PART I: HEALTH PROFESSIONAL INFORMATION .......................................................................
4 1 INDICATIONS .................................................................................................................. 1 Pediatrics ....................................................................................................................
2 Geriatrics .................................................................................................................... 4 2 CONTRAINDICATIONS .....................................................................................................
4 3 SERIOUS WARNINGS AND PRECAUTIONS BOX ................................................................ 5 4 DOSAGE AND ADMINISTRATION .................................................................................... 1 Dosing Considerations ................................................................................................
2 Recommended Dose and Dosage Adjustment ........................................................... 3 Reconstitution .......................................................................................................... 4 Administration ..........................................................................................................
5 Missed Dose ............................................................................................................. 13 5 OVERDOSAGE ...............................................................................................................
13
and 4 DOSAGE AND ADMINISTRATION). Hepatic/Biliary/Pancreatic In the randomized controlled trials, patients were excluded for elevated baseline serum bilirubin. Exposure and toxicity of paclitaxel can increase with hepatic impairment.
Patients with hepatic impairment may be at increased risk of toxicity, particularly from myelosuppression; such patients should be closely monitored for development of profound myelosuppression. Paclitaxel Powder for Injectable Suspension Nanoparticle, Albumin-bound Paclitaxel is not recommended in patients that have total bilirubin > 5 x ULN or AST > 10 x ULN.
5 x ULN and AST < 10 x ULN). The starting dose should be reduced for patients with moderate or severe hepatic impairment (see 4 DOSAGE AND ADMINISTRATION). Immune Very rare occurrences of severe hypersensitivity reactions, including anaphylactic reactions with fatal outcome have been reported.
Patients who experience a severe hypersensitivity reaction to Paclitaxel Powder for Injectable Suspension Nanoparticle, Albumin-bound Paclitaxel should not be re-challenged with the drug. The use of paclitaxel powder for injectable suspension nanoparticle, albumin-bound paclitaxel in patients exhibiting hypersensitivity to paclitaxel or human albumin has not been studied.
Infection Sepsis was reported in 5% of patients with or without neutropenia who received paclitaxel powder for injectable suspension nanoparticle, albumin-bound paclitaxel in combination with gemcitabine. Complications due to the underlying pancreatic cancer, especially biliary PACLitaxel Powder for Injectable Suspension Nanoparticle, Albumin-bound Paclitaxel Page 16 of 58 obstruction or presence of biliary stent, were identified as significant contributing factors.
If a patient becomes febrile (regardless of neutrophil count), initiate treatment with broad spectrum antibiotics. For febrile neutropenia, withhold Paclitaxel Powder for Injectable Suspension Nanoparticle, Albumin-bound Paclitaxel and gemcitabine until fever resolves and ANC ≥ 1500, then resume treatment at reduced dose levels (see 4 DOSAGE AND ADMINISTRATION).
Injection Site Reactions Injection site reactions can occur with Paclitaxel Powder for Injectable Suspension Nanoparticle, Albumin-bound Paclitaxel. Given the possibility of extravasation, it is advisable to closely monitor the infusion site for possible infiltration during drug administration.
Monitoring and Laboratory Tests In order to monitor the occurrence of bone marrow suppression, primarily neutropenia, which may be severe and result in infection, it is recommended that frequent peripheral blood cell counts be performed on all patients receiving Paclitaxel Powder for Injectable Suspension Nanoparticle, Albumin-bound Paclitaxel.
Patients should not be retreated with subsequent cycles of Paclitaxel Powder for Injectable Suspension Nanoparticle, Albumin-bound Paclitaxel until neutrophils recover to a level > 1,500 cells/mm3 and platelets recover to a level > 100,000 cells/mm3 (see 4 DOSAGE AND ADMINISTRATION).
Neurologic Sensory neuropathy occurs frequently with Paclitaxel Powder for Injectable Suspension Nanoparticle, Albumin-bound Paclitaxel. The occurrence of grade 1 or 2 sensory neuropathy does not generally require dose modification.
When Paclitaxel Powder for Injectable Suspension Nanoparticle, Albumin-bound Paclitaxel is used as monotherapy, if grade 3 sensory neuropathy develops, treatment should be withheld until resolution to grade 1 or 2 followed by a dose reduction for all subsequent courses of Paclitaxel Powder for Injectable Suspension Nanoparticle, Albumin-bound Paclitaxel (see 4 DOSAGE AND ADMINISTRATION).
For combination use of Paclitaxel Powder for Injectable Suspension Nanoparticle, Albumin-bound Paclitaxel and gemcitabine, if grade 3 or higher peripheral neuropathy develops, withhold Paclitaxel Powder for Injectable Suspension Nanoparticle, Albumin-bound Paclitaxel treatment until resolution to ≤ Grade 1 and resume at a reduced dose for all subsequent courses of Paclitaxel Powder for Injectable Suspension Nanoparticle, Albumin-bound Paclitaxel.
The median time to first occurrence of Grade 3 peripheral neuropathy was 140 days, and the median time to improvement from Grade 3 peripheral neuropathy to Grade 0 or 1 was 29 days. Of the patients with treatment interrupted due to peripheral neuropathy, 44% (31/70 patients) were able to resume paclitaxel powder for injectable suspension nanoparticle, albumin-bound paclitaxel at a reduced dose.
No patients treated with paclitaxel powder for injectable suspension nanoparticle, albumin-bound paclitaxel / gemcitabine had Grade 4 peripheral neuropathy (see 4 DOSAGE AND ADMINISTRATION). PACLitaxel Powder for Injectable Suspension Nanoparticle, Albumin-bound Paclitaxel Page 17 of 58 Ophthalmologic There have been reports of reduced visual acuity due to cystoid macular edema (CME) during treatment with paclitaxel powder for injectable suspension nanoparticle, albumin-bound paclitaxel as well as with other taxanes.
5 Post-Market Adverse Reactions). Patients with visual impairment during Paclitaxel Powder for Injectable Suspension Nanoparticle, Albumin-bound Paclitaxel treatment should seek a prompt and complete ophthalmologic examination. Paclitaxel Powder for Injectable Suspension Nanoparticle, Albumin-bound Paclitaxel should be discontinued if a CME diagnosis is confirmed.
Renal The use of paclitaxel powder for injectable suspension nanoparticle, albumin-bound paclitaxel has not been adequately studied in patients with severe renal impairment or end stage renal disease (estimated creatinine clearance <30 mL/min).
In the randomized controlled trials, patients […]
, Reproductive Health: Female and Male Potential 08/2024 TABLE OF CONTENTS Sections or subsections that are not applicable at the time of authorization are not listed. RECENT MAJOR LABEL CHANGES .............................................................................................
2 TABLE OF CONTENTS ............................................................................................................... 2 PART I: HEALTH PROFESSIONAL INFORMATION .......................................................................
4 1 INDICATIONS .................................................................................................................. 1 Pediatrics ....................................................................................................................
2 Geriatrics .................................................................................................................... 4 2 CONTRAINDICATIONS .....................................................................................................
4 3 SERIOUS WARNINGS AND PRECAUTIONS BOX ................................................................ 5 4 DOSAGE AND ADMINISTRATION .................................................................................... 1 Dosing Considerations ................................................................................................
2 Recommended Dose and Dosage Adjustment ........................................................... 3 Reconstitution .......................................................................................................... 4 Administration ..........................................................................................................
5 Missed Dose ............................................................................................................. 13 5 OVERDOSAGE ...............................................................................................................
13 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING .................................. 13 7 WARNINGS AND PRECAUTIONS .................................................................................... 1 Special Populations...................................................................................................
1 Pregnant Women ..................................................................................................... 2 Breast-feeding ..........................................................................................................
3 Pediatrics .................................................................................................................. 4 Geriatrics ..................................................................................................................
19 PACLitaxel Powder for Injectable Suspension Nanoparticle, Albumin-bound Paclitaxel Page 3 of 58 8 ADVERSE REACTIONS .................................................................................................... 1 Adverse Reaction Overview ......................................................................................
2 Clinical Trial Adverse Reactions ................................................................................ 3 Less Common Clinical Trial Adverse Reactions ......................................................... 5 Post-Market Adverse Reactions ...............................................................................
32 9 DRUG INTERACTIONS ................................................................................................... 2 Drug Interactions Overview ......................................................................................
4 Drug-Drug Interactions ............................................................................................. 5 Drug-Food Interactions.............................................................................................
6 Drug-Herb Interactions ............................................................................................. 7 Drug-Laboratory Test Interactions............................................................................ 34 10 CLINICAL PHARMACOLOGY ...........................................................................................
1 Mechanism of Action ................................................................................................ 2 Pharmacodynamics ..................................................................................................
3 Pharmacokinetics ..................................................................................................... 34 11 STORAGE, STABILITY AND DISPOSAL.............................................................................
37 12 SPECIAL HANDLING INSTRUCTIONS .............................................................................. 38 PART II: SCIENTIFIC INFORMATION ........................................................................................
39 13 PHARMACEUTICAL INFORMATION ............................................................................... 39 14 CLINICAL TRIALS ...........................................................................................................
1 Clinical Trials by Indication ....................................................................................... 39 Metastatic Breast Carcinoma .............................................................................................
39 Metastatic Pancreatic Cancer ............................................................................................ 43 15 MICROBIOLOGY ............................................................................................................
47 16 NON-CLINICAL TOXICOLOGY […]
• Paclitaxel powder for injectable suspension nanoparticle, albumin-bound paclitaxel is contraindicated in patients who are hypersensitive to this drug or to any ingredient in the PACLitaxel Powder for Injectable Suspension Nanoparticle, Albumin-bound Paclitaxel Page 5 of 58 formulation, including any non-medicinal ingredient, or component of the container.
For a complete listing of ingredients, see 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING. • Paclitaxel Powder for Injectable Suspension Nanoparticle, Albumin-bound Paclitaxel is contraindicated in patients who have baseline neutrophil counts of < 1,500 cells/mm3 on day 1 of each treatment cycle.
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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