Abraxane Side Effects

Please note - some side effects for Abraxane may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA at http://www.fda.gov/medwatch/ or 1-800-FDA-1088 (1-800-332-1088).

Side Effects of Abraxane - for the Consumer

Abraxane

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome when using Abraxane:

Cough; diarrhea; general feeling of discomfort; hair loss; mild discomfort, redness, or swelling at the injection site; mild joint or muscle pain; nausea; numbness, tingling, or burning of your arms, hands, legs, or feet; redness and/or sores on the mouth or lips; unusual weakness or tiredness; vomiting.

Severe allergic reactions (rash; hives; difficulty swallowing or breathing; tightness in the chest; flushing; swelling of the mouth, face, lips, tongue, or throat; hoarseness); blistering, swelling, redness, severe pain, or open sores on your skin or at the injection site; change in the amount of urine produced; chest pain; fast, slow, or irregular heartbeat; flu-like symptoms (fever, chills, sore throat); pale appearance; redness, swelling, or tenderness in the calf; severe joint or muscle pain; severe nausea, vomiting or diarrhea; severe numbness, tingling, or burning in the arms, hands, legs, or feet; severe stomach pain; swelling of arms, hands, legs, or feet; sudden or severe dizziness, lightheadedness, or headache; unusual bruising or bleeding; vision changes or blurred vision.

Abraxane Side Effects - for the Professional

Abraxane

The following table 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.

Myelosuppression and sensory neuropathy were dose related.

Adverse Event Experiences by Body System

Unless otherwise noted, the following discussion refers to the primary safety database of 229 patients with metastatic breast cancer treated with single-agent Abraxane® in the randomized controlled trial. The frequency and severity of important adverse events for the study are presented above in tabular form. In some instances, rare severe events observed with paclitaxel injection may be expected to occur with Abraxane.

Neutropenia, the most important hematologic toxicity, 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.

In the randomized metastatic breast cancer study, infectious episodes were reported in 24% of the patients treated with a dose of 260 mg/m2 given as a 30-minute infusion. Oral candidiasis, respiratory tract infections and pneumonia were the most frequently reported infectious complications. Febrile neutropenia was reported in 2% of patients in the Abraxane arm and 1% of patients in the paclitaxel injection arm.

Thrombocytopenia was uncommon. In the randomized metastatic breast cancer study, bleeding episodes were reported in 2% of the patients in each treatment arm.

Anemia (Hb <11 g/dL) was observed in 33% of patients treated with Abraxane in the randomized trial and was severe (Hb <8 g/dL) in 1% of the cases. Among all patients with normal baseline hemoglobin, 31% became anemic on study and 1% had severe anemia.

In the randomized controlled metastatic breast cancer study, 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.

During postmarketing surveillance, rare occurrences of severe 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. Patients who experience a severe hypersensitivity reaction to Abraxane should not be rechallenged with the drug.

Hypotension, during the 30-minute infusion, occurred in 5% of patients in the randomized metastatic breast cancer trial. 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 in the randomized trial. These events included 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 rarely.

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 in the metastatic breast cancer randomized trial. 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.

Reports of dyspnea (12%) and cough (6%) were reported after treatment with Abraxane in the randomized trial. Rare reports (<1%) of pneumothorax were reported after treatment with Abraxane. Rare reports of interstitial pneumonia, lung fibrosis, and pulmonary embolism have been received as part of the continuing surveillance of paclitaxel injection safety and may occur following Abraxane treatment. Rare reports of radiation pneumonitis have been received in paclitaxel injection patients receiving concurrent radiotherapy. There is no experience with the use of Abraxane with concurrent radiotherapy.

The frequency and severity of neurologic manifestations were influenced by prior and/or concomitant therapy with neurotoxic agents.

In general, the frequency and severity of neurologic manifestations were dose-dependent in patients receiving single-agent Abraxane®. In the randomized trial, sensory neuropathy was observed in 71% of patients (10% severe) in the Abraxane arm and in 56% of patients (2% severe) in the paclitaxel injection arm. The frequency of sensory neuropathy increased with cumulative dose. Sensory neuropathy was the cause of Abraxane discontinuation in 7/229 (3%) patients in the randomized trial. In the randomized comparative study, 24 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 incidences of grade 4 sensory neuropathies were reported in the clinical trial. Only one incident of motor neuropathy (grade 2) was observed in either arm of the controlled trial.

Cranial nerve palsies have been reported during postmarketing surveillance of Abraxane. Because these events have been reported during clinical practice, true estimates of frequency cannot be made and a causal relationship to the events has not been established.

Reports of autonomic neuropathy resulting in paralytic ileus have been received as part of the continuing surveillance of paclitaxel injection safety.

Ocular/visual disturbances occurred in 13% of all patients (n=366) treated with Abraxane in single arm and randomized trials and 1% were severe. The severe cases (keratitis and blurred vision) were reported in patients in a single arm study who received higher doses than those recommended (300 or 375 mg/m2). These effects generally have been reversible. However, rare reports in the literature of abnormal visual evoked potentials in patients treated with paclitaxel injection have suggested persistent optic nerve damage.

Forty-four percent of patients treated in the randomized trial experienced arthralgia/myalgia; 8% experienced severe symptoms. The symptoms were usually transient, occurred two or three days after Abraxane® administration, and resolved within a few days.

Among patients with normal baseline liver function treated with Abraxane in the randomized trial, 7%, 36%, and 39% had elevations in bilirubin, alkaline phosphatase, and AST (SGOT), respectively. 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.

Rare 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.

Overall 11% of patients experienced creatinine elevation, 1% severe. No discontinuations, dose reductions, or dose delays were caused by renal toxicities.

Nausea/vomiting, diarrhea, and mucositis were reported by 33%, 27%, and 7% of Abraxane treated patients in the randomized trial.

Rare reports of intestinal obstruction, intestinal perforation, pancreatitis, and ischemic colitis have been received as part of the continuing surveillance of paclitaxel injection safety and may occur following Abraxane treatment. Rare reports of neutropenic enterocolitis (typhlitis), despite the coadministration of G-CSF, were observed in patients treated with paclitaxel injection alone and in combination with other chemotherapeutic agents.

Injection site reactions have occurred infrequently with Abraxane and were mild in the randomized clinical trial. 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 rarely.

Rare reports of more severe events such as phlebitis, cellulitis, induration, skin exfoliation, necrosis, and fibrosis have been received 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.

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

Asthenia was reported in 47% of patients (8% severe) treated with Abraxane® in the randomized trial. Asthenia included reports of asthenia, fatigue, weakness, lethargy and malaise.

Rare cases of cardiac ischemia/infarction and thrombosis/embolism possibly related to Abraxane treatment have been reported. Alopecia was observed in almost all of the patients. Nail changes (changes in pigmentation or discoloration of nail bed) were uncommon. Edema (fluid retention) was infrequent (10% of randomized trial patients); no patients had severe edema.

The following rare adverse events have been reported as part of the continuing surveillance of paclitaxel injection safety and may occur following Abraxane treatment: skin abnormalities related to radiation recall as well as reports of Stevens-Johnson syndrome, toxic epidermal necrolysis, conjunctivitis, and increased lacrimation. As part of the continuing surveillance of Abraxane, skin reactions including generalized or maculo-papular rash, erythema, and pruritis have been observed. Additionally, there have been case reports of photosensitivity reactions, radiation recall phenomenon, and in some patients previously exposed to capecitabine, reports of palmar-plantar erythrodysaesthesiae. Because these events have been reported during clinical practice, true estimates of frequency cannot be made and a causal relationship to the events has not been established.

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.

Side Effects by Body System

Dermatologic

Dermatologic side effects including alopecia (90%) have been reported. Skin abnormalities including generalized rash, maculopapular rash, erythema, pruritis, Stevens-Johnson syndrome, and toxic epidermal necrolysis have been reported rarely as part of the continuing surveillance of paclitaxel injection and may occur following therapy with paclitaxel protein-bound particles. Additionally, there have been case reports of photosensitivity reactions, radiation recall phenomenon, and in some patients previously exposed to capecitabine, reports of palmar-plantar erythrodysesthesia.

Hematologic

Myelosuppression has been dose related and reversible.

Hematologic side effects have been reported including neutropenia less than 2.0 x 10(9)/L (80%) and less than 0.5 x 10(9)/L (9%), anemia less than 11 g/L (33%) and less than 8 g/L (1%), and thrombocytopenia less than 100 x 10(9)/L (2%) and less than 50 x 10(9)/L (less than 1%). Febrile neutropenia (2%) and bleeding (2%) have also been reported.

Nervous system

Nervous system side effects have been reported such as any symptoms of sensory neuropathy (71%) including severe symptoms of sensory neuropathy (10%). Cranial nerve palsies have been reported during postmarketing surveillance.

Sensory neuropathy has been dose related. The frequency and severity of neurologic manifestations were also influenced by prior and/or concomitant therapy with neurotoxic agents.

Cardiovascular

The most frequently reported ECG modifications were nonspecific repolarization abnormalities, sinus bradycardia, and sinus tachycardia.

Cardiovascular side effects have been reported such as abnormal ECG (60%) including abnormal ECG in patients with a normal baseline (35%). Hypotension (5%), severe cardiovascular events (3%), and bradycardia (less than 1%) have also been reported. The severe cardiovascular events included chest pain, cardiac arrest, supraventricular tachycardia, edema, thrombosis, pulmonary thromboembolism, pulmonary emboli, and hypertension. Cases of stroke and transient ischemic attacks have been reported rarely.

General

General side effects have been reported such as any symptoms of asthenia (47%) including severe asthenia (8%) and fluid retention/edema (10%).

Musculoskeletal

Musculoskeletal side effects have been reported such as any symptoms of myalgia/arthralgia (44%) including severe symptoms of myalgia/arthralgia (8%).

Symptoms of myalgia/arthralgia were usually transient, occurred two or three days after the administration of paclitaxel protein-bound particles, and resolved within a few days.

Hepatic

Hepatic side effects including AST (SGOT) elevations (39%), alkaline phosphatase elevations (36%), and bilirubin elevations (7%) have been reported. Grade 3 or 4 elevations in gamma-glutamyl transpeptidase (GGT) were reported in 14% of patients.

Hepatic necrosis and hepatic encephalopathy leading to death have been reported rarely as part of the continuing surveillance of paclitaxel injection and may occur following therapy with paclitaxel protein-bound particles.

Gastrointestinal

Gastrointestinal side effects have been reported such as any symptoms of nausea (30%) including severe nausea (3%), any diarrhea (26%) including severe diarrhea (less than 1%), any vomiting (18%) including severe vomiting (4%), and any mucositis (7%) including severe mucositis (less than 1%). Oral candidiasis has also been reported.

Intestinal obstruction, intestinal perforation, pancreatitis, ischemic colitis, and neutropenic enterocolitis have been reported rarely as part of the continuing surveillance of paclitaxel injection and may occur following therapy with paclitaxel protein-bound particles.

Other

Other side effects including infections (24%) have been reported. Nail changes (changes in pigmentation or discoloration of the nail bed) were uncommon.

Respiratory

Respiratory side effects including dyspnea (12%), cough (6%), respiratory tract infections, and pneumonia have been reported. Pneumothorax has been reported rarely.

Interstitial pneumonia, lung fibrosis, pulmonary embolism, and radiation pneumonitis have been reported rarely as part of the continuing surveillance of paclitaxel injection and may occur following therapy with paclitaxel protein-bound particles.

Hypersensitivity

Hypersensitivity side effects including hypersensitivity reactions (4%) which consisted of dyspnea, flushing, hypotension, chest pain, and arrhythmia have been reported.

During postmarketing surveillance, rare occurrences of severe hypersensitivity reactions have been reported with paclitaxel protein-bound particles.

Local

Local side effects have included mild injection site reactions (1%). The recurrence of skin reactions at a site of previous extravasation following administration of paclitaxel injection at a different site (recall) has been reported rarely.

Phlebitis, cellulitis, induration, skin exfoliation, necrosis, and fibrosis have been reported rarely as part of the continuing surveillance of paclitaxel injection.

Because of the possibility of extravasation, close monitoring of the infusion site for possible infiltration during drug administration is recommended.

Ocular

Ocular side effects have been reported such as ocular/visual disturbances (13%) including severe ocular/visual disturbances (1%). The severe cases (keratitis and blurred vision) were reported in patients who received higher doses in a single arm study than the doses currently recommended.

Conjunctivitis and increased lacrimation have been reported rarely as part of the continuing surveillance of paclitaxel injection and may occur following therapy with paclitaxel protein-bound particles.

Renal

Renal side effects have been reported such as elevated creatinine levels (11%) including severely elevated creatinine levels (1%).

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