Generic Name
Paclitaxel
Brand Names
Paclitaxel Protein-Bound, Abraxane
FDA approval date: March 01, 2004
Classification: Microtubule Inhibitor
Form: Injection
What is Paclitaxel Protein-Bound (Paclitaxel)?
Paclitaxel protein-bound particles for injectable suspension is a microtubule inhibitor indicated for the treatment of: Metastatic breast cancer, after failure of combination chemotherapy for metastatic disease or relapse within 6 months of adjuvant chemotherapy. Prior therapy should have included an anthracycline unless clinically contraindicated.
Approved To Treat
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Brand Information
Paclitaxel protein-bound particles (Paclitaxel protein-bound particles)
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
- Monitor for neutropenia, which may be severe and result in infection or sepsis, it is recommended that frequent [see Warnings and Precautions (
- Perform frequent complete blood cell counts on all patients receiving paclitaxel protein-bound particles for injectable suspension (albumin-bound) [see Contraindications (
1DOSAGE FORMS AND STRENGTHS
For injectable suspension, for intravenous use: white to yellow, sterile lyophilized cake or powder containing 100 mg of paclitaxel formulated as albumin-bound particles in single-dose vial for reconstitution.
2CONTRAINDICATIONS
Paclitaxel protein-bound particles for injectable suspension (albumin-bound) is contraindicated in patients with:
- Baseline neutrophil counts of < 1,500 cells/mm
- A history of severe hypersensitivity reactions to paclitaxel protein-bound particles for injectable suspension (albumin-bound)
3ADVERSE REACTIONS
Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.
The most common adverse reactions (≥ 20%) with single-agent use of paclitaxel protein-bound particles for injectable suspension (albumin-bound) in metastatic breast cancer are alopecia, neutropenia, sensory neuropathy, abnormal ECG, fatigue/asthenia, myalgia/arthralgia, AST elevation, alkaline phosphatase elevation, anemia, nausea, infections, and diarrhea
The most common adverse reactions (≥ 20%) of paclitaxel protein-bound particles for injectable suspension (albumin-bound) in combination with carboplatin for non-small cell lung cancer are anemia, neutropenia, thrombocytopenia, alopecia, peripheral neuropathy, nausea, and fatigue
In a randomized open-label trial of paclitaxel protein-bound particles for injectable suspension (albumin-bound) in combination with gemcitabine for pancreatic adenocarcinoma
3.1Clinical Trials Experience
Metastatic Breast Cancer
Table 6 shows the frequency of important adverse reactions in the randomized comparative trial for the patients who received either single-agent paclitaxel protein-bound particles for injectable suspension (albumin-bound) or paclitaxel injection for the treatment of metastatic breast cancer.
Other Adverse Reactions
Hematologic Disorders
Neutropenia was dose dependent and reversible. Among patients with metastatic breast cancer in the randomized trial, neutrophil counts declined below 500 cells/mm
Infections
Infectious episodes were reported in 24% of the patients treated with paclitaxel protein-bound particles for injectable suspension (albumin-bound). Oral candidiasis, respiratory tract infections and pneumonia were the most frequently reported infectious complications.
Hypersensitivity Reactions (HSRs)
Grade 1 or 2 HSRs occurred on the day of paclitaxel protein-bound particles for injectable suspension (albumin-bound) administration and consisted of dyspnea (1%) and flushing, hypotension, chest pain, and arrhythmia (all <1%). The use of paclitaxel protein-bound particles for injectable suspension (albumin-bound) in patients previously exhibiting hypersensitivity to paclitaxel injection or human albumin has not been studied.
Cardiovascular
Hypotension, during the 30-minute infusion, occurred in 5% of patients. Bradycardia, during the 30-minute infusion, occurred in <1% of patients. These vital sign changes most often caused no symptoms and required neither specific therapy nor treatment discontinuation.
Severe cardiovascular events possibly related to single-agent paclitaxel protein-bound particles for injectable suspension (albumin-bound) occurred in approximately 3% of patients. These events included cardiac ischemia/infarction, chest pain, cardiac arrest, supraventricular tachycardia, edema, thrombosis, pulmonary thromboembolism, pulmonary emboli, and hypertension. Cases of cerebrovascular attacks (strokes) and transient ischemic attacks have been reported.
Electrocardiogram (ECG) abnormalities were common among patients at baseline. ECG abnormalities on study did not usually result in symptoms, were not dose-limiting, and required no intervention. ECG abnormalities were noted in 60% of patients. Among patients with a normal ECG prior to study entry, 35% of all patients developed an abnormal tracing while on study. The most frequently reported ECG modifications were non-specific repolarization abnormalities, sinus bradycardia, and sinus tachycardia.
Respiratory
Dyspnea (12%), cough (7%), and pneumothorax (<1%) were reported after treatment with paclitaxel protein-bound particles for injectable suspension (albumin-bound).
Neurologic
The frequency and severity of sensory neuropathy increased with cumulative dose. Sensory neuropathy was the cause of paclitaxel protein-bound particles for injectable suspension (albumin‑bound) discontinuation in 7/229 (3%) patients. Twenty-four patients (10%) treated with paclitaxel protein-bound particles for injectable suspension (albumin-bound) developed Grade 3 peripheral neuropathy; of these patients, 14 had documented improvement after a median of 22 days; 10 patients resumed treatment at a reduced dose of paclitaxel protein-bound particles for injectable suspension (albumin-bound) and 2 discontinued due to peripheral neuropathy. Of the 10 patients without documented improvement, 4 discontinued the study due to peripheral neuropathy.
No Grade 4 sensory neuropathies were reported. Only one incident of motor neuropathy (Grade 2) was observed in either arm of the controlled trial.
Vision Disorders
Ocular/visual disturbances occurred in 13% of all patients (n=366) treated with paclitaxel protein‑bound particles for injectable suspension (albumin-bound) and 1% were severe. The severe cases (keratitis and blurred vision) were reported in patients who received higher doses than those recommended (300 or 375 mg/m
Arthralgia/Myalgia
The symptoms were usually transient, occurred two or three days after paclitaxel protein-bound particles for injectable suspension (albumin-bound) administration, and resolved within a few days.
Hepatic
Grade 3 or 4 elevations in GGT were reported for 14% of patients treated with paclitaxel protein‑bound particles for injectable suspension (albumin-bound) and 10% of patients treated with paclitaxel injection in the randomized trial.
Renal
Overall 11% of patients experienced creatinine elevation, 1% severe. No discontinuations, dose reductions, or dose delays were caused by renal toxicities.
Other Clinical Events
Nail changes (changes in pigmentation or discoloration of nail bed) have been reported. Edema occurred in 10% of patients; no patients had severe edema. Dehydration and pyrexia were also reported.
Non-Small Cell Lung Cancer
Adverse reactions were assessed in 514 paclitaxel protein-bound particles for injectable suspension (albumin-bound)/carboplatin-treated patients and 524 paclitaxel injection/carboplatin-treated patients receiving first-line systemic treatment for locally advanced (stage IIIB) or metastatic (IV) non-small cell lung cancer (NSCLC) in a multicenter, randomized, open-label trial. Paclitaxel protein-bound particles for injectable suspension (albumin-bound) was administered as an intravenous infusion over 30 minutes at a dose of 100 mg/m
The differences in paclitaxel dose and schedule between the two arms limit direct comparison of dose- and schedule-dependent adverse reactions. Among patients evaluable for adverse reactions, the median age was 60 years, 75% were men, 81% were White, 49% had adenocarcinoma, 43% had squamous cell lung cancer, 76% were ECOG PS 1. Patients in both treatment arms received a median of 6 cycles of treatment.
The following common (≥ 10% incidence) adverse reactions were observed at a similar incidence in paclitaxel protein-bound particles for injectable suspension (albumin-bound) plus carboplatin-treated and paclitaxel injection plus carboplatin-treated patients: alopecia 56%, nausea 27%, fatigue 25%, decreased appetite 17%, asthenia 16%, constipation 16%, diarrhea 15%, vomiting 12%, dyspnea 12%, and rash 10% (incidence rates are for the paclitaxel protein-bound particles for injectable suspension (albumin-bound) plus carboplatin treatment group).
Table 7 provides the frequency and severity of laboratory-detected abnormalities which occurred with a difference of ≥ 5% for all grades (1-4) or ≥ 2% for Grade 3-4 toxicity between paclitaxel protein-bound particles for injectable suspension (albumin-bound) plus carboplatin-treated patients or paclitaxel injection plus carboplatin-treated patients.
Table 8 provides the frequency and severity of adverse reactions, which occurred with a difference of ≥ 5% for all grades (1-4) or ≥ 2% for Grade 3-4 between either treatment group for the 514 paclitaxel protein-bound particles for injectable suspension (albumin-bound) plus carboplatin-treated patients compared with the 524 patients who received paclitaxel injection plus carboplatin.
For the paclitaxel protein-bound particles for injectable suspension (albumin-bound) plus carboplatin treated group, 17/514 (3%) patients developed Grade 3 peripheral neuropathy and no patients developed Grade 4 peripheral neuropathy. Grade 3 neuropathy improved to Grade 1 or resolved in 10/17 patients (59%) following interruption or discontinuation of paclitaxel protein-bound particles for injectable suspension (albumin-bound).
Adenocarcinoma of the Pancreas
Adverse reactions were assessed in 421 patients who received paclitaxel protein-bound particles for injectable suspension (albumin-bound) plus gemcitabine and 402 patients who received gemcitabine for the first-line systemic treatment of metastatic adenocarcinoma of the pancreas in a multicenter, multinational, randomized, controlled, open-label trial. Patients received a median treatment duration of 3.9 months in the paclitaxel protein-bound particles for injectable suspension (albumin-bound)/gemcitabine group and 2.8 months in the gemcitabine group. For the treated population, the median relative dose intensity for gemcitabine was 75% in the paclitaxel protein-bound particles for injectable suspension (albumin-bound)/gemcitabine group and 85% in the gemcitabine group. The median relative dose intensity of paclitaxel protein-bound particles for injectable suspension (albumin-bound) was 81%.
Table 9 provides the frequency and severity of laboratory-detected abnormalities which occurred at a higher incidence for Grades 1-4 (≥ 5%) or for Grade 3-4 (≥ 2%) toxicity in paclitaxel protein-bound particles for injectable suspension (albumin-bound) plus gemcitabine-treated patients.
Table 10 provides the frequency and severity of adverse reactions which occurred with a difference of ≥ 5% for all grades or ≥ 2% for Grade 3 or higher in the paclitaxel protein-bound particles for injectable suspension (albumin-bound) plus gemcitabine-treated group compared to the gemcitabine group.
Additional clinically relevant adverse reactions that were reported in < 10% of the patients with adenocarcinoma of the pancreas who received paclitaxel protein-bound particles for injectable suspension (albumin-bound)/gemcitabine included:
Infections & infestations: oral candidiasis, pneumonia
Vascular disorders: hypertension
Cardiac disorders: tachycardia, congestive cardiac failure
Eye disorders: cystoid macular edema
Peripheral Neuropathy
Grade 3 peripheral neuropathy occurred in 17% of patients who received paclitaxel protein-bound particles for injectable suspension (albumin-bound)/gemcitabine compared to 1% of patients who received gemcitabine only; no patients developed Grade 4 peripheral neuropathy. The median time to first occurrence of Grade 3 peripheral neuropathy in the paclitaxel protein-bound particles for injectable suspension (albumin-bound) arm was 140 days. Upon suspension of paclitaxel protein-bound particles for injectable suspension (albumin-bound) dosing, the median time to improvement from Grade 3 peripheral neuropathy to ≤ Grade 1 was 29 days. Of paclitaxel protein-bound particles for injectable suspension (albumin-bound)-treated patients with Grade 3 peripheral neuropathy, 44% resumed paclitaxel protein-bound particles for injectable suspension (albumin-bound) at a reduced dose.
Sepsis
Sepsis occurred in 5% of patients who received paclitaxel protein-bound particles for injectable suspension (albumin-bound)/gemcitabine compared to 2% of patients who received gemcitabine alone. Sepsis occurred both in patients with and without neutropenia. Risk factors for sepsis included biliary obstruction or presence of biliary stent.
Pneumonitis
Pneumonitis occurred in 4% of patients who received paclitaxel protein-bound particles for injectable suspension (albumin-bound)/gemcitabine compared to 1% of patients who received gemcitabine alone. Two of 17 patients in the paclitaxel protein-bound particles for injectable suspension (albumin-bound) arm with pneumonitis died.
3.2Postmarketing Experience
The following adverse reactions have been identified during postapproval use of paclitaxel protein-bound particles for injectable suspension (albumin-bound) or with paclitaxel injection and may be expected to occur with paclitaxel protein-bound particles for injectable suspension (albumin-bound). Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.
Hypersensitivity Reactions
Severe and sometimes fatal hypersensitivity reactions. Cross-hypersensitivity between paclitaxel protein-bound particles for injectable suspension (albumin-bound) and other taxanes has been reported.
Cardiovascular
Congestive heart failure, left ventricular dysfunction, and atrioventricular block. Most patients were previously exposed to cardiotoxic drugs, such as anthracyclines, or had underlying cardiac history.
Respiratory
Pneumonitis, interstitial pneumonia, and pulmonary embolism.
Radiation pneumonitis in patients receiving concurrent radiotherapy.
Lung fibrosis has been reported with paclitaxel injection.
Neurologic
Cranial nerve palsies and vocal cord paresis, as well as autonomic neuropathy resulting in paralytic ileus.
Vision Disorders
Reduced visual acuity due to cystoid macular edema (CME). After cessation of treatment, CME may improve, and visual acuity may return to baseline. Abnormal visual evoked potentials in patients treated with paclitaxel injection suggest persistent optic nerve damage.
Hepatic
Hepatic necrosis and hepatic encephalopathy leading to death in patients treated with paclitaxel injection.
Gastrointestinal (GI)
Intestinal obstruction, intestinal perforation, pancreatitis, and ischemic colitis. In patients treated with paclitaxel injection, neutropenic enterocolitis (typhlitis) despite the coadministration of G-CSF, alone and in combination with other chemotherapeutic agents.
Injection Site Reaction
Extravasation. Closely monitor the paclitaxel protein-bound particles for injectable suspension (albumin-bound) infusion site for possible infiltration during drug administration
Severe events such as phlebitis, cellulitis, induration, necrosis, and fibrosis have been reported with paclitaxel injection. In some cases, the onset of the injection site reaction occurred during a prolonged infusion or was delayed up to ten days. Recurrence of skin reactions at a site of previous extravasation following administration of paclitaxel injection at a different site has been reported.
Metabolic and Nutritional Disorders
Tumor lysis syndrome.
Other Clinical Events
Skin reactions including generalized or maculopapular rash, erythema, and pruritus
Photosensitivity reactions, radiation recall phenomenon, scleroderma, and in some patients previously exposed to capecitabine, reports of palmar-plantar erythrodysesthesia. Stevens-Johnson syndrome and toxic epidermal necrolysis have been reported.
Conjunctivitis, cellulitis, and increased lacrimation have been reported with paclitaxel injection.
Accidental Exposure
Upon inhalation of paclitaxel, dyspnea, chest pain, burning eyes, sore throat, and nausea have been reported.
Following topical exposure, tingling, burning, and redness have been reported.
4DRUG INTERACTIONS
The metabolism of paclitaxel is catalyzed by CYP2C8 and CYP3A4. Caution should be exercised when administering paclitaxel protein-bound particles for injectable suspension (albumin-bound) concomitantly with medicines known to inhibit or induce either CYP2C8 or CYP3A4.
5OVERDOSAGE
There is no known antidote for paclitaxel protein-bound particles for injectable suspension (albumin-bound) overdosage. The primary anticipated complications of overdosage would consist of bone marrow suppression, sensory neurotoxicity, and mucositis.
6DESCRIPTION
Paclitaxel protein-bound particles for injectable suspension (albumin-bound) is paclitaxel formulated as albumin-bound nanoparticles with a mean particle size of approximately 130 nanometers. Paclitaxel exists in the particles in a non‑crystalline, amorphous state. Paclitaxel is a microtubule inhibitor. The chemical name for paclitaxel is 5β,20-Epoxy- 1,2α,4,7β,10β,13α-hexahydroxytax-11-en-9-one 4,10-diacetate 2-benzoate 13-ester with (2
Paclitaxel is a white to off-white crystalline powder. It is highly lipophilic, insoluble in water, and melts at approximately 206°C to 215°C.
Paclitaxel protein-bound particles for injectable suspension (albumin-bound) is supplied as a white to yellow, sterile, lyophilized cake or powder for reconstitution with 20 mL of 0.9% Sodium Chloride Injection, USP prior to intravenous infusion. Each single-dose vial contains 100 mg of paclitaxel, USP (semi-synthetic) (bound to human albumin) and approximately 900 mg of human albumin (containing sodium caprylate and sodium acetyltryptophanate). Each milliliter (mL) of reconstituted suspension contains 5 mg paclitaxel formulated as albumin-bound particles. Paclitaxel protein-bound particles for injectable suspension (albumin-bound) is free of solvents.
7REFERENCES
- OSHA Hazardous Drugs. OSHA http://www.osha.gov/SLTC/hazardousdrugs/index.html
8HOW SUPPLIED/STORAGE AND HANDLING
Paclitaxel protein-bound particles for injectable suspension (albumin-bound) is a white to yellow, sterile lyophilized cake or powder supplied as:
NDC 69097-398-78 100 mg of paclitaxel in a single-dose vial, individually packaged in a carton.
Store the vials in original cartons at 20ºC to 25ºC (68ºF to 77ºF). Retain in the original package to protect from bright light.
Paclitaxel is a cytotoxic drug. Follow applicable special handling and disposal procedures.
9PATIENT COUNSELING INFORMATION
Advise the patient to read the approved patient labeling(Patient Information).
Severe Myelosuppression
- Patients must be informed of the risk of low blood cell counts and severe and life-threatening infections and instructed to contact their healthcare provider immediately for fever or evidence of infection
Severe Neuropathy
- Patients must be informed that sensory neuropathy occurs frequently with paclitaxel protein-bound particles for injectable suspension (albumin-bound) and patients should advise their healthcare providers of numbness, tingling, pain, or weakness involving the extremities
Pneumonitis
- Instruct patients to contact their healthcare provider immediately for sudden onset of dry persistent cough, or shortness of breath
Severe Hypersensitivity
- Instruct patients to contact their healthcare provider for signs of an allergic reaction, which could be severe and sometimes fatal
Common Adverse Reactions
- Explain to patients that alopecia, fatigue/asthenia, and myalgia/arthralgia occur frequently with paclitaxel protein-bound particles for injectable suspension (albumin-bound)
- Instruct patients to contact their healthcare providers for persistent vomiting, diarrhea, or signs of dehydration
Embryo-Fetal Toxicity
- Paclitaxel protein-bound particles for injectable suspension (albumin-bound) can cause fetal harm. Advise patients to avoid becoming pregnant while receiving this drug. Females of reproductive potential should use effective contraception during treatment with paclitaxel protein-bound particles for injectable suspension (albumin-bound) and for at least six months after the last dose of paclitaxel protein-bound particles for injectable suspension (albumin-bound)
- Advise male patients with female partners of reproductive potential to use effective contraception and avoid fathering a child during treatment with paclitaxel protein-bound particles for injectable suspension (albumin-bound) and for at least three months after the last dose of paclitaxel protein-bound particles for injectable suspension (albumin-bound)
Lactation
- Advise patients not to breastfeed while taking paclitaxel protein-bound particles for injectable suspension (albumin-bound) and for two weeks after receiving the last dose
Infertility
- Advise males and females of reproductive potential that paclitaxel protein-bound particles for injectable suspension (albumin-bound) may impair fertility
Manufactured by:
Cipla Ltd,
Verna Goa,
India
Manufactured for
Cipla USA, Inc.
10 Independence Boulevard, Suite 300
Warren, NJ - 07059
Revised: 02/2022
10PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
NDC 69097-398-78
Rx Only
Paclitaxel Protein-Bound Particles
for Injectable Suspension (albumin-bound)
100 mg per vial
For Intravenous Use only
Functional properties differ from other paclitaxel products.
DO NOT SUBSTITUTE.
Single-Dose Vial
Discard any unused portion.
Cipla
NDC 69097-398-78
Read all sides of carton
Rx Only
Paclitaxel Protein-Bound Particles
for Injectable Suspension (albumin-bound)
100 mg per vial
For Intravenous Use only
Functional properties differ from other paclitaxel products.
DO NOT SUBSTITUTE.
Single-Dose Vial
Discard any unused portion.
Cipla
