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 suspension

Along with its needed effects, paclitaxel protein-bound may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor or nurse immediately if any of the following side effects occur while taking paclitaxel protein-bound:

More common
  • Black, tarry stools
  • bloating or swelling of the face, arms, hands, lower legs, or feet
  • blurred or double vision
  • chest pain
  • chills
  • cough
  • fever
  • loss of taste
  • lower back or side pain
  • painful or difficult urination
  • pale skin
  • rapid weight gain
  • sneezing
  • sore mouth, tongue, or throat
  • tightness in the chest
  • tingling of the hands or feet
  • troubled breathing with exertion
  • ulcers, sores, or white spots in the mouth
  • unusual bleeding or bruising
  • unusual weight gain or loss
  • unusual tiredness or weakness
Less common
  • Anxiety
  • bleeding
  • blood in the urine or stools
  • burning, tingling, numbness or pain in the hands, arms, feet, or legs
  • confusion
  • difficulty with swallowing
  • dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position
  • fast, pounding, slow, or irregular heartbeat or pulse
  • general feeling of discomfort or illness
  • inability to move the arms, legs, or facial muscles
  • inability to speak
  • pain in the chest, groin, or legs, especially the calves
  • pinpoint red spots on the skin
  • rapid, shallow breathing
  • sensation of pins and needles
  • severe, sudden headache
  • skin itching, rash, or redness
  • slurred or slow speech
  • stabbing pain
  • sudden loss of coordination
  • sudden, severe weakness or numbness in the arms or legs
  • sudden, unexplained shortness of breath
  • sweating
  • swelling of the face, throat, or tongue
  • thickening of bronchial secretions
  • trouble thinking or walking

Some side effects of paclitaxel protein-bound may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common
  • Cracked lips
  • decreased appetite
  • diarrhea
  • difficulty with moving
  • headache
  • lack or loss of strength
  • loss of hair
  • muscle pain or stiffness
  • nausea
  • pain in the joints
  • swelling
  • vomiting
Less common
  • Bleeding, blistering, burning, coldness, discoloration of the skin, a feeling of pressure, hives, infection, inflammation, itching, lumps, numbness, pain, rash, redness, scarring, soreness, stinging, swelling, tenderness, tingling, ulceration, or warmth at the injection site
Rare
  • Nail changes

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, left ventricular dysfunction and atrioventricular block.

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%), sepsis, and neutropenic sepsis 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%).

Disclaimer: Every effort has been made to ensure that the information provided is accurate, up-to-date and complete, but no guarantee is made to that effect. In addition, the drug information contained herein may be time sensitive and should not be utilized as a reference resource beyond the date hereof. This material does not endorse drugs, diagnose patients, or recommend therapy. This information is a reference resource designed as supplement to, and not a substitute for, the expertise, skill , knowledge, and judgement of healthcare practitioners in patient care. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate safety, effectiveness, or appropriateness for any given patient. Drugs.com does not assume any responsibility for any aspect of healthcare administered with the aid of materials provided. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the substances you are taking, check with your doctor, nurse, or pharmacist.

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