Paclitaxel protein-bound Side Effects

Some side effects of paclitaxel protein-bound may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

For the Consumer

Applies to paclitaxel protein-bound: intravenous powder for injection

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

Call your doctor at once if you have:

• fever, swollen gums, painful mouth sores, pain when swallowing, skin sores, cold or flu symptoms, cough;

• feeling very thirsty or hot, being unable to urinate, heavy sweating, or hot and dry skin;

• pale skin, easy bruising, unusual bleeding (nose, mouth, vagina, or rectum), purple or red pinpoint spots under your skin;

• a light-headed 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.

Common 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.

For Healthcare Professionals

Applies to paclitaxel protein-bound: intravenous powder for injection

Dermatologic

Dermatologic side effects including alopecia (90%) have been reported. Skin abnormalities including generalized rash, maculopapular rash, erythema, pruritus, 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

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.

Myelosuppression has been dose related and reversible.

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, vocal cord paresis, and autonomic neuropathy resulting in paralytic ileus 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. Postmarketing reports have included congestive heart failure and left ventricular dysfunction.

General

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

Musculoskeletal

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.

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

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.

Postmarketing reports have included pneumonitis, interstitial pneumonia, pulmonary embolism and radiation pneumonitis.

Lung fibrosis has been reported as part of the continuing surveillance of paclitaxel injection and may occur following therapy with paclitaxel protein-bound.

Hypersensitivity

The use of paclitaxel protein-bound particles in patients previously exhibiting hypersensitivity to paclitaxel injection or human albumin has not been studied. Patients who experience a severe hypersensitivity reaction to paclitaxel protein-bound particles should not be rechallenged with the drug.

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, increased lacrimation and cystoid macular edema have been reported 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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