In Summary

Commonly reported side effects of paclitaxel protein-bound include: infection, severe peripheral sensory neuropathy, bone marrow depression, neutropenia, alopecia, anemia, and peripheral sensory neuropathy. Other side effects include: hypersensitivity reaction. See below for a comprehensive list of adverse effects.

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

Very common (10% or more): Alopecia (90%), rash

Common (1% to 10%): Nail disorder, pruritus, dry skin, erythema, nail pigmentation/discoloration, skin hyperpigmentation, onycholysis, nail changes

Uncommon (0.1% to 1%): Nail bed tenderness, urticaria, skin pain, photosensitivity reaction, pigmentation disorder, pruritic rash, skin disorder, hyperhidrosis, onychomadesis, erythematous rash, generalized rash, dermatitis, night sweats, maculopapular rash, vitiligo, hypotrichosis, nail discomfort, generalized pruritus, macular rash, papular rash, skin lesion, swollen face

Very rare (less than 0.01%): Stevens-Johnson syndrome, toxic epidermal necrolysis (TEN)

Hematologic

Very common (10% or more): Neutropenia (up to 82%), anemia (up to 25%), leukopenia, thrombocytopenia, lymphopenia, bone marrow suppression

Common (1% to 10%): Febrile neutropenia

Rare (less than 0.1%): Pancytopenia

Nervous system

Very common (10% or more): Peripheral neuropathy, neuropathy, hypoesthesia, paresthesia

Common (1% to 10%): Peripheral sensory neuropathy, headache, dysgeusia, dizziness, peripheral motor neuropathy, ataxia, sensory disturbance, somnolence

Uncommon (0.1% to 1%): Polyneuropathy, areflexia, dyskinesia, hyporeflexia, neuralgia, sensory loss, syncope, postural dizziness, neuropathic pain, tremor, abnormal gait

Cardiovascular

Very common (10% or more): Abnormal ECG (60%) including abnormal ECG in patients with a normal baseline (35%)

Common (1% to 10%): Tachycardia, arrhythmia, supraventricular tachycardia, flushing, hot flushes, hypertension, lymphedema, peripheral edema, chest pain

Uncommon (0.1% to 1%): Hypotension, peripheral coldness, orthostatic hypotension, chest discomfort, increased blood pressure

Rare (less than 0.1%): Bradycardia, cardiac arrest, left ventricular dysfunction, congestive heart failure, atrioventricular block, thrombosis

Musculoskeletal

Very common (10% or more): Arthralgia/myalgia (44%)

Common (1% to 10%): Pain in extremity, bone pain, back pain, muscle cramps, limb pain, rigors

Uncommon (0.1% to 1%): Chest wall pain, muscular weakness, neck pain, groin pain, muscle spasms, musculoskeletal pain, flank pain, limb discomfort, muscle weakness

Hepatic

Very common (10% or more): AST (SGOT) elevations (39%), alkaline phosphatase elevations (36%), gamma-glutamyl transpeptidase (GGT) elevations (14%) patients

Common (1% to 10%): Bilirubin elevations

Uncommon (0.1% to 1%): Hepatomegaly

Rare (less than 0.1%): Hepatic necrosis, hepatic encephalopathy

Gastrointestinal

Very common (10% or more): Nausea (30%), diarrhea (26%), vomiting (18%), constipation, stomatitis

Common (1% to 10%): Abdominal pain, abdominal distension, upper abdominal pain, dyspepsia, gastroesophageal reflux disease, oral hypoesthesia, mucosal inflammation

Uncommon (0.1% to 1%): Dysphagia, flatulence, glossodynia, dry mouth, gingival pain, esophagitis, lower abdominal pain, mouth ulceration, oral pain, rectal hemorrhage

Rare (less than 0.1%): Intestinal obstruction, intestinal perforation, pancreatitis, ischemic colitis, neutropenic enterocolitis

Other

Very common (10% or more): Fatigue, asthenia, pyrexia

Common (1% to 10%): Vertigo, pain, edema, weakness, decreased performance status, malaise, lethargy, hyperpyrexia

Uncommon (0.1% to 1%): Ear pain, tinnitus

Respiratory

Common (1% to 10%): Upper respiratory tract infection, sinusitis, interstitial pneumonitis, dyspnea, epistaxis, pharyngolaryngeal pain, cough, rhinitis, rhinorrhea

Uncommon (0.1% to 1%): Nasopharyngitis, pneumonia, productive cough, exertional dyspnea, sinus congestion, decreased breath sounds, pleural effusion, allergic rhinitis, hoarseness, nasal congestion, nasal dryness, wheezing, pulmonary emboli, pulmonary thromboembolism

Hypersensitivity

Very common (10% or more): Hypersensitivity (up to 12%)

Rare (less than 0.1%): Severe hypersensitivity

Local

Uncommon (0.1% to 1%): Swelling, injection site reaction

Rare (0.01% to 0.1%): Extravasation

Ocular

Common (1% to 10%): Increased lacrimation, blurred vision, dry eye, keratoconjunctivitis sicca, madarosis

Uncommon (0.1% to 1%): Eye irritation, eye pain, abnormal vision, reduced visual acuity, conjunctivitis, visual disturbance, eye pruritus, keratitis

Rare (less than 0.1%): Cystoid macular edema

Genitourinary

Common (1% to 10%): Urinary tract infection

Uncommon (0.1% to 1%): Dysuria, pollakiuria, hematuria, nocturia, polyuria, urinary incontinence, breast pain

Metabolic

Very common (10% or more): Anorexia

Common (1% to 10%): Dehydration, hypokalemia, weight loss, increased alanine aminotransferase, increased aspartate aminotransferase, increased gamma-glutamyltransferase, decreased hematocrit, decreased red blood cell count, increased blood alkaline phosphatase

Uncommon (0.1% to 1%): Hypophosphatasemia, fluid retention, hypoalbuminemia, polydipsia, hyperglycemia, hypocalcemia, hypoglycemia, hyponatremia, weight gain, increased blood lactate dehydrogenase, increased blood creatinine, increased blood glucose, increased blood phosphorus, decreased blood potassium, increased bilirubin

Oncologic

Uncommon (0.1% to 1%): Metastatic pain, tumor necrosis

Psychiatric

Common (1% to 10%): Insomnia, depression, anxiety

Uncommon (0.1% to 1%): Restlessness

Immunologic

Very common (10% or more): Infections (up to 24%)

Common (1% to 10%): Febrile neutropenia, folliculitis, candidiasis, influenza-like illness

Uncommon (0.1% to 1%): Neutropenic sepsis, oral candidiasis, cellulitis, herpes simplex, viral infection, catheter-related infection, fungal infection, herpes zoster, injection site infection, sepsis, neutropenic sepsis