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Abraxane

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Abraxane

Abraxane Side Effects Center

Medical Editor: John P. Cunha, DO, FACOEP

Abraxane (paclitaxel protein-bound particles for Injectable suspension) is used in the treatment of breast cancer. It is a cancer (antineoplastic) medication. Common side effects include nausea, vomiting, diarrhea, mouth sores, headache, muscle/joint pain, numbness/tingling/burning of the hands/feet, weakness, or dizziness.

The recommended dose and regimen for Abraxane is 260 mg/m2 administered intravenously over 30 minutes every 3 weeks. Do not receive "live" vaccines during treatment with Abraxane. Abraxane can interact with many other medications, including other chemotherapy drugs. Tell your doctor all medications you use. Abraxane is not recommended for use during pregnancy. It may harm a fetus. It is recommended men and women use 2 forms of birth control (e.g., condoms, birth control pills) while using this medication and for some time afterwards. If you become pregnant or think you may be pregnant, tell your doctor. It is unknown if this drug passes into breast milk. Because of the possible risk to the infant, breast-feeding while using this drug is not recommended.

Our Abraxane (paclitaxel protein-bound particles) Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What is Patient Information in Detail?

Easy-to-read and understand detailed drug information and pill images for the patient or caregiver from Cerner Multum.

Abraxane in Detail - Patient Information: Side Effects

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have a serious side effect such as:

  • fever, chills, body aches, flu symptoms, sores in your mouth and throat;
  • feeling very thirsty or hot, being unable to urinate, heavy sweating, or hot and dry skin;
  • easy bruising, unusual bleeding (nose, mouth, vagina, or rectum), purple or red pinpoint spots under your skin;
  • pale skin, feeling light-headed or short of breath, rapid heart rate, trouble concentrating;
  • feeling like you might pass out;
  • feeling short of breath (even with mild exertion), swelling, rapid weight gain;
  • chest pain, sudden cough, wheezing, trouble breathing, fast heart rate; or
  • severe skin reaction -- fever, sore throat, swelling in your face or tongue, burning in your eyes, skin pain, followed by a red or purple skin rash that spreads (especially in the face or upper body) and causes blistering and peeling.

Less serious side effects may include:

  • numbness or tingly feeling;
  • muscle or joint pain;
  • nausea, vomiting;
  • diarrhea; or
  • hair loss.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Read the entire detailed patient monograph for Abraxane (Albumin-bound Paclitaxel for Injectable Suspension) »

What is Patient Information Overview?

A concise overview of the drug for the patient or caregiver from First DataBank.

Abraxane Overview - Patient Information: Side Effects

SIDE EFFECTS: See also Warning section.

Nausea, vomiting, diarrhea, mouth sores, headache, muscle/joint pain, numbness/tingling/burning of the hands/feet, weakness, or dizziness may occur. If any of these effects persist or worsen, tell your doctor promptly.

Temporary hair loss may occur. Normal hair growth should return after treatment has ended.

Many people using this medication have serious side effects. However, your doctor has prescribed this drug because he or she has judged that the benefit to you is greater than the risk of side effects. Careful monitoring by your doctor may decrease your risk.

Tell your doctor right away if you have any serious side effects, including: signs of anemia (e.g., unusual tiredness, pale skin), easy bruising/bleeding, fast/slow/irregular heartbeat, pain/redness/swelling/weakness of the arms/legs, calf pain/swelling that is warm to the touch, vision changes.

This medication may infrequently irritate the vein it is given into or leak out of the vein and irritate the area. These effects may cause redness, pain, swelling, discoloration, or unusual skin reactions at the injection site, either while the drug is given or rarely 7 to 10 days later. If this drug has leaked out of a vein and caused a skin reaction in the past, you may rarely have a skin reaction in that same area when the drug is given again, even when it is given into another area. Tell your doctor immediately of any unusual skin/injection site symptoms.

Get medical help right away if any of these rare but very serious side effects occur: chest/jaw/left arm pain, coughing up blood, fainting, weakness on one side of the body, slurred speech, confusion, sudden severe headache.

A very serious allergic reaction to this drug is rare. Do not restart this medication if you have previously stopped using it due to a serious allergic reaction. Get medical help right away if you notice any of the following symptoms of a serious allergic reaction: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing, flushing.

This medication contains albumin that comes from human blood. There is a very small chance that you may get infections from this medication (e.g., viral infections such as hepatitis), even though careful screening of blood donors, special manufacturing processes, and many tests are all used to reduce this risk. Discuss the benefits and risks of treatment with your doctor. Tell your doctor immediately if you develop any of the following: signs of infection (e.g., fever, chills, cough, persistent sore throat), signs of hepatitis (e.g., persistent nausea/vomiting, stomach/abdominal pain, yellowing eyes/skin, dark urine, increasing tiredness).

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

Read the entire patient information overview for Abraxane (Albumin-bound Paclitaxel for Injectable Suspension)»

What is Prescribing information?

The FDA package insert formatted in easy-to-find categories for health professionals and clinicians.

Abraxane FDA Prescribing Information: Side Effects
(Adverse Reactions)

SIDE EFFECTS

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 ABRAXANE 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 ABRAXANE in combination with carboplatin for non-small cell lung cancer are anemia, neutropenia, thrombocytopenia, alopecia, peripheral neuropathy, nausea, and fatigue. The most common serious adverse reactions of ABRAXANE in combination with carboplatin for non-small cell lung cancer are anemia (4%) and pneumonia (3%). The most common adverse reactions resulting in permanent discontinuation of ABRAXANE are neutropenia (3%), thrombocytopenia (3%), and peripheral neuropathy (1%). The most common adverse reactions resulting in dose reduction of ABRAXANE are neutropenia (24%), thrombocytopenia (13%), and anemia (6%). The most common adverse reactions leading to withholding or delay in ABRAXANE dosing are neutropenia (41%), thrombocytopenia (30%), and anemia (16%).

In a randomized open-label trial of ABRAXANE in combination with gemcitabine for pancreatic adenocarcinoma [see Clinical Studies], the most common ( ≥ 20%) selected (with a ≥ 5% higher incidence) adverse reactions of ABRAXANE are neutropenia, fatigue, peripheral neuropathy, nausea, alopecia, peripheral edema, diarrhea, pyrexia, vomiting, decreased appetite, rash, and dehydration. The most common serious adverse reactions of ABRAXANE (with a ≥ 1% higher incidence) are pyrexia (6%), dehydration (5%), pneumonia (4%) and vomiting (4%). The most common adverse reactions resulting in permanent discontinuation of ABRAXANE are peripheral neuropathy (8%), fatigue (4%) and thrombocytopenia (2%). The most common adverse reactions resulting in dose reduction of ABRAXANE are neutropenia (10%) and peripheral neuropathy (6%). The most common adverse reactions leading to withholding or delay in ABRAXANE dosing are neutropenia (16%), thrombocytopenia (12%), fatigue (8%), peripheral neuropathy (15%), anemia (5%) and diarrhea (5%).

Clinical Trials Experience in Metastatic Breast Cancer

Table 6 shows the frequency of important adverse events in the randomized comparative trial for the patients who received either single-agent ABRAXANE or paclitaxel injection for the treatment of metastatic breast cancer.

Table 6: Frequencya of Important Treatment Emergent Adverse Events in the Randomized Metastatic Breast Cancer Study on an Every-3-Weeks Schedule

  Percent of Patients
ABRAXANE 260 mg/m² over 30 min
(n=229)
Paclitaxel Injection 175 mg/m² over 3 hb
(n=225)
Bone Marrow
Neutropenia
   < 2.0 x 109/L 80 82
   < 0.5 x 109/L 9 22
Thrombocytopenia
   < 100 x 109/L 2 3
   < 50 x 109/L < 1 < 1
Anemia
   < 11 g/dL 33 25
   < 8 g/dL 1 < 1
Infections 24 20
Febrile Neutropenia 2 1
Neutropenic Sepsis < 1 < 1
Bleeding 2 2
Hypersensitivity Reactionc
  All 4 12
  Severed 0 2
Cardiovascular
Vital Sign Changes During Administration
  Bradycardia < 1 < 1
  Hypotension 5 5
Severe Cardiovascular Eventsd 3 4
Abnormal ECG
  All Patients 60 52
  Patients with Normal Baseline 35 30
Respiratory
  Cough 7 6
  Dyspnea 12 9
Sensory Neuropathy
  Any Symptoms 71 56
  Severe Symptomsd 10 2
Myalgia / Arthralgia
  Any Symptoms 44 49
  Severe Symptomsd 8 4
Asthenia
  Any Symptoms 47 39
  Severe Symptomsd 8 3
Fluid Retention/Edema
  Any Symptoms 10 8
  Severe Symptomsd 0 < 1
Gastrointestinal
  Nausea
    Any Symptoms 30 22
    Severe Symptomsd 3 < 1
  Vomiting
    Any Symptoms 18 10
    Severe Symptomsd 4 1
  Diarrhea
    Any Symptoms 27 15
    Severe Symptomsd < 1 1
  Mucositis
    Any Symptoms 7 6
    Severe Symptomsd < 1 0
Alopecia 90 94
Hepatic  (Patients with Normal Baseline)
  Bilirubin Elevations 7 7
  Alkaline Phosphatase Elevations 36 31
  AST (SGOT) Elevations 39 32
Injection Site Reaction < 1 1
aBased on worst grade by NCI Common Terminology Criteria for Adverse Events (CTCAE) version 2.
bPaclitaxel injection patients received premedication.
cIncludes treatment-related events related to hypersensitivity (e.g., flushing, dyspnea, chest pain, hypotension) that began on a day of dosing.
dSevere events are defined as at least grade 3 toxicity.

Adverse Event Experiences by Body System

Hematologic Disorders

Neutropenia was dose dependent and reversible. Among patients with metastatic breast cancer in the randomized trial, neutrophil counts declined below 500 cells/mm³ (Grade 4) in 9% of the patients treated with a dose of 260 mg/m² compared to 22% in patients receiving paclitaxel injection at a dose of 175 mg/m² . Pancytopenia has been observed in clinical trials.

Infections

Infectious episodes were reported in 24% of the patients treated with ABRAXANE. 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 ABRAXANE administration and consisted of dyspnea (1%) and flushing, hypotension, chest pain, and arrhythmia (all < 1%). The use of ABRAXANE 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 ABRAXANE 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 ABRAXANE.

Neurologic

The frequency and severity of sensory neuropathy increased with cumulative dose. Sensory neuropathy was the cause of ABRAXANE discontinuation in 7/229 (3%) patients. Twenty-four patients (10%) treated with ABRAXANE 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 ABRAXANE 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 ABRAXANE 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/m²). These effects generally have been reversible.

Arthralgia/Myalgia

The symptoms were usually transient, occurred two or three days after ABRAXANE administration, and resolved within a few days.

Hepatic

Grade 3 or 4 elevations in GGT were reported for 14% of patients treated with ABRAXANE 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.

Clinical Trials Experience in Non-Small Cell Lung Cancer

Adverse reactions were assessed in 514 ABRAXANE/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. ABRAXANE was administered as an intravenous infusion over 30 minutes at a dose of 100 mg/m² on Days 1, 8, and 15 of each 21-day cycle. Paclitaxel injection was administered as an intravenous infusion over 3 hours at a dose of 200 mg/m², following premedication. In both treatment arms carboplatin at a dose of AUC = 6 mg•min/mL was administered intravenously on Day 1 of each 21-day cycle after completion of ABRAXANE/paclitaxel infusion. 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 ABRAXANE plus carboplatintreated 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 ABRAXANE plus carboplatin treatment group).

Table 7 provides the frequency and severity laboratory-detected abnormalities which occurred with a difference of ≥ 5% for all grades (1-4) or ≥ 2% for Grade 3-4 toxicity between ABRAXANE plus carboplatin-treated patients or paclitaxel injection plus carboplatin-treated patients.

Table 7: Selected Hematologic Laboratory-Detected Abnormalities With a Difference of ≥ 5% for grades (1-4) or ≥ 2% for Grade 3-4 Toxicity Between Treatment Groups

  ABRAXANE (100 mg/m² weekly) plus carboplatin Paclitaxel Injection (200 mg/m² every 3 weeks) plus carboplatin
Grades 1-4
(%)
Grade 3-4
(%)
Grades 1-4
(%)
Grade 3-4
(%)
Anemia1,2 98 28 91 7
Neutropenia1,3 85 47 83 58
Thrombocytopenia1,3 68 18 55 9
1508 patients assessed in ABRAXANE/carboplatin-treated group
2514 patients assessed in paclitaxel injection/carboplatin-treated group
3513 patients assessed in paclitaxel injection/carboplatin-treated group

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 ABRAXANE plus carboplatin-treated patients compared with the 524 patients who received paclitaxel injection plus carboplatin.

Table 8: Selected Adverse Reactions with a Difference of ≥ 5% for All Grade Toxicity or ≥ 2% for Grade 3-4 Toxicity Between Treatment Groups

System Organ Class MedDRA v 12.1 Preferred Term ABRAXANE (100 mg/m² weekly) + carboplatin (N=514) Paclitaxel Injection (200 mg/m² every 3 weeks) + carboplatin (N=524)
Grade 1-4 Toxicity
(%)
Grade 3-4 Toxicity
(%)
Grades 1-4 Toxicity
(%)
Grade 3-4 Toxicity
(%)
Nervous system disorders Peripheral neuropathya 48 3 64 12
General disorders and administration site conditions Edema peripheral 10 0 4 < 1
Respiratory thoracic and mediastinal disorders Epistaxis 7 0 2 0
Musculoskeletal and connective Arthralgia 13 < 1 25 2
tissue disorders Myalgia 10 < 1 19 2
aPeripheral neuropathy is defined by the MedDRA Version 14.0 SMQ neuropathy (broad scope).

For the ABRAXANE 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 ABRAXANE.

Clinical Trials Experience in Adenocarcinoma of the Pancreas

Adverse reactions were assessed in 421 patients who received ABRAXANE 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 ABRAXANE/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 ABRAXANE/gemcitabine group and 85% in the gemcitabine group. The median relative dose intensity of ABRAXANE was 81%.

Table 9 provides the frequency and severity of laboratory-detected abnormalities which occurred at a higher incidence for Grades 14 ( ≥ 5%) or for Grade 3-4 ( ≥ 2%) toxicity in ABRAXANE plus gemcitabine-treated patients.

Table 9: Selected Hematologic Laboratory-Detected Abnormalities with a Higher Incidence ( ≥ 5% for Grades 1-4 or ≥ 2% for Grades 3-4 Events) in the ABRAXANE/Gemcitabine Arm

  ABRAXANE(125 mg/m²)/ Gemcitabined Gemcitabine
Grades 1-4
(%)
Grade 3-4
(%)
Grades 1-4
(%)
Grade 3-4
(%)
Neutropeniaa,b 73 38 58 27
Thrombocytopeniab,c 74 13 70 9
a405 patients assessed in ABRAXANE/gemcitabine-treated group
b388 patients assessed in gemcitabine-treated group
c404 patients assessed in ABRAXANE/gemcitabine-treated group
dNeutrophil growth factors were administered to 26% of patients in the ABRAXANE/gemcitabine group.

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 ABRAXANE plus gemcitabine-treated group compared to the gemcitabine group.

Table 10: Selected Adverse Reactions with a Higher Incidence ( ≥ 5% for All Grade Toxicity or ≥ 2% for Grade 3 or Higher Toxicity) in the ABRAXANE/Gemcitabine Arm

System Organ Class Adverse Reaction ABRAXANE (125 mg/m²) and gemcitabine
(N=421)
Gemcitabine
(N=402)
All Grades Grade 3 or Higher All Grades Grade 3 or Higher
General disorders and administration site conditions Fatigue 248 (59%) 77 (18%) 183 (46%) 37 (9%)
Peripheral edema 194 (46%) 13 (3%) 122 (30%) 12 (3%)
Pyrexia 171 (41%) 12 (3%) 114 (28%) 4 (1%)
Asthenia 79 (19%) 29 (7%) 54 (13%) 17 (4%)
Mucositis 42 (10%) 6 (1%) 16 (4%) 1 ( < 1%)
Gastrointestinal disorders Nausea 228 (54%) 27 (6%) 192 (48%) 14 (3%)
Diarrhea 184 (44%) 26 (6%) 95 (24%) 6 (1%)
Vomiting 151 (36%) 25 (6%) 113 (28%) 15 (4%)
Skin and subcutaneous tissue disorders Alopecia 212 (50%) 6 (1%) 21 (5%) 0
Rash 128 (30%) 8 (2%) 45 (11%) 2 ( < 1%)
Nervous system disorders Peripheral neuropathya 227 (54%) 70 (17%) 51 (13%) 3 (1%)
Dysgeusia 68 (16%) 0 33 (8%) 0
Headache 60 (14%) 1 ( < 1%) 38 (9%) 1 ( < 1%)
Metabolism and nutrition disorders Decreased appetite 152 (36%) 23 (5%) 104 (26%) 8 (2%)
Dehydration 87 (21%) 31 (7%) 45 (11%) 10 (2%)
Hypokalemia 52 (12%) 18 (4%) 28 (7%) 6 (1%)
Respiratory, thoracic and mediastinal disorders Cough 72 (17%) 0 30 (7%) 0
Epistaxis 64 (15%) 1 ( < 1%) 14 (3%) 1 ( < 1%)
Infections and infestations Urinary tract infections b 47 (11%) 10 (2%) 20 (5%) 1 ( < 1%)
Musculoskeletal and connective tissue disorders Pain in extremity 48 (11%) 3 (1%) 24 (6%) 3 (1%)
Arthralgia 47 (11%) 3 (1%) 13 (3%) 1 ( < 1%)
Myalgia 44 (10%) 4 (1%) 15 (4%) 0
Psychiatric disorders Depression 51 (12%) 1 ( < 1%) 24 (6%) 0
aPeripheral neuropathy is defined by the MedDRA Version 15.0 Standard MedDRA Query neuropathy (broad scope).
bUrinary tract infections includes the preferred terms of: urinary tract infection, cystitis, urosepsis, urinary tract infection bacterial, and urinary tract infection enterococccal.

Additional clinically relevant adverse reactions that were reported in < 10% of the patients with adenocarcinoma of the pancreas who received ABRAXANE/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 ABRAXANE/gemcitibine 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 ABRAXANE arm was 140 days. Upon suspension of ABRAXANE dosing, the median time to improvement from Grade 3 peripheral neuropathy to ≤ Grade 1 was 29 days. Of ABRAXANE-treated patients with Grade 3 peripheral neuropathy, 44% resumed ABRAXANE at a reduced dose.

Sepsis

Sepsis occurred in 5% of patients who received ABRAXANE/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 ABRAXANE/gemcitabine compared to 1% of patients who received gemcitabine alone. Two of 17 patients in the ABRAXANE arm with pneumonitis died.

Post-Marketing Experience with ABRAXANE and other Paclitaxel Formulations

Unless otherwise noted, the following discussion refers to the adverse reactions that have been identified during post-approval use of ABRAXANE. 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. In some instances, severe events observed with paclitaxel injection may be expected to occur with ABRAXANE.

Hypersensitivity Reactions

Severe and sometimes fatal hypersensitivity reactions have been reported with ABRAXANE. The use of ABRAXANE in patients previously exhibiting hypersensitivity to paclitaxel injection or human albumin has not been studied.

Cardiovascular

There have been reports of congestive heart failure and left ventricular dysfunction with ABRAXANE. Most of the individuals were previously exposed to cardiotoxic drugs, such as anthracyclines, or had underlying cardiac history.

Respiratory

There have been reports of pneumonitis, interstitial pneumonia and pulmonary embolism in patients receiving ABRAXANE and reports of radiation pneumonitis in patients receiving concurrent radiotherapy. Reports of lung fibrosis have been received as part of the continuing surveillance of paclitaxel injection safety and may also be observed with ABRAXANE.

Neurologic

Cranial nerve palsies and vocal cord paresis have been reported, as well as autonomic neuropathy resulting in paralytic ileus.

Vision Disorders

Reports in the literature of abnormal visual evoked potentials in patients treated with paclitaxel injection suggest persistent optic nerve damage. These may also be observed with ABRAXANE.

Reduced visual acuity due to cystoid macular edema (CME) has been reported during treatment with ABRAXANE as well as with other taxanes. After cessation of treatment, CME improves and visual acuity may return to baseline.

Hepatic

Reports of hepatic necrosis and hepatic encephalopathy leading to death have been received as part of the continuing surveillance of paclitaxel injection safety and may occur following ABRAXANE treatment.

Gastrointestinal (GI)

There have been reports of intestinal obstruction, intestinal perforation, pancreatitis, and ischemic colitis following ABRAXANE treatment. There have been reports of neutropenic enterocolitis (typhlitis), despite the coadministration of G-CSF, occurring in patients treated with paclitaxel injection alone and in combination with other chemotherapeutic agents.

Injection Site Reaction

There have been reports of extravasation of ABRAXANE. Given the possibility of extravasation, it is advisable to monitor closely the ABRAXANE infusion site for possible infiltration during drug administration.

Severe events such as phlebitis, cellulitis, induration, necrosis, and fibrosis have been reported as part of the continuing surveillance of paclitaxel injection safety. In some cases the onset of the injection site reaction in paclitaxel injection patients either occurred during a prolonged infusion or was delayed by a week to ten days. Recurrence of skin reactions at a site of previous extravasation following administration of paclitaxel injection at a different site, i.e., "recall”, has been reported.

Other Clinical Events

Skin reactions including generalized or maculopapular rash, erythema, and pruritus have been observed with ABRAXANE. There have been case reports of photosensitivity reactions, radiation recall phenomenon, and in some patients previously exposed to capecitabine, reports of palmar-plantar erythrodysesthesia. Stevens-Johnson syndrome and toxic epidermal necrolysis have been reported.

There have been reports of conjunctivitis, cellulitis, and increased lacrimation with paclitaxel injection.

Accidental Exposure

No reports of accidental exposure to ABRAXANE have been received. However, upon inhalation of paclitaxel, dyspnea, chest pain, burning eyes, sore throat, and nausea have been reported. Following topical exposure, events have included tingling, burning, and redness.

Read the entire FDA prescribing information for Abraxane (Albumin-bound Paclitaxel for Injectable Suspension) »

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