Tykerb Side Effects
Generic Name: lapatinib
Note: This document contains side effect information about lapatinib. Some of the dosage forms listed on this page may not apply to the brand name Tykerb.
Some side effects of Tykerb 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 lapatinib: oral tablet
Along with its needed effects, lapatinib (the active ingredient contained in Tykerb) 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 immediately if any of the following side effects occur while taking lapatinib:Less common
- Difficult or labored breathing
- fast or irregular heartbeat
- severe diarrhea
- shortness of breath
- tightness in the chest
- unusual tiredness or weakness
- Chest pain
- difficulty with swallowing
- general feeling of discomfort or illness
- puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
- skin rash
- thickening of bronchial secretions
Some side effects of lapatinib 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
- Acid or sour stomach
- back pain
- cracked lips
- diarrhea (mild)
- difficulty with swallowing
- dry skin
- pain in the arms or legs
- redness, swelling, or painful skin
- scaling of the skin on the hands and feet
- sores, ulcers, or white spots on the lips, tongue, or the inside of the mouth
- stomach discomfort, upset, or pain
- swelling or inflammation of the mouth
- tingling of the hands and feet
- trouble sleeping
- Loosening of the fingernails
- redness or soreness around the fingernails
For Healthcare Professionals
Applies to lapatinib: oral tablet
All clinical trial data were from trials of lapatinib (the active ingredient contained in Tykerb) in combination with capecitabine.
To report suspected adverse reactions, contact GlaxoSmithKline at 1-888-825-5249 or the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
Gastrointestinal side effects including diarrhea (65%), nausea (44%), vomiting (26%), stomatitis (14%), and dyspepsia (11%) have been reported.
Diarrhea was the most common adverse reaction resulting in discontinuation of study medication.
Hematologic side effects have included laboratory abnormalities in hemoglobin (56%), neutrophils (22%), and platelets (18%).
Dermatologic side effects including palmar plantar erythrodysesthesia (53%) (also called hand-foot syndrome or acral erythema), rash (28%), dry skin (10%), and nail disorders including paronychia have been reported.
Hepatic side effects have included laboratory abnormalities in AST (49%), total bilirubin (45%), and ALT (37%).
Hepatotoxicity may be severe and deaths have been reported. Causality of the deaths is uncertain. The hepatotoxicity may occur days to several months after initiation of treatment. Liver function tests (transaminases, bilirubin, and alkaline phosphatase) should be monitored before initiation of treatment, every 4 to 6 weeks during treatment, and as clinically indicated. If changes in liver function are severe, therapy with lapatinib should be discontinued and patients should not be retreated with lapatinib. If lapatinib is to be administered to patients with severe preexisting hepatic impairment, dose reduction should be considered. In patients who develop severe hepatotoxicity while on therapy, lapatinib should be discontinued and should not be retreated with lapatinib.
Cardiovascular side effects including decreases in left ventricular ejection fraction and QT prolongation have been reported.
Due to potential cardiac toxicity with HER2 (ErbB2) inhibitors, left ventricular ejection fraction (LVEF) was monitored in clinical trials at approximately eight-week intervals. LVEF decreases were defined as signs or symptoms of deterioration in left ventricular cardiac function that are grade 3 (NCI CTCAE), or a 20% decrease in left ventricular cardiac ejection fraction relative to baseline which is below the institution's lower limit of normal. Among 198 patients who received lapatinib/capecitabine combination treatment, three experienced Grade 2 and one had Grade 3 LVEF adverse reactions (NCI CTC 3.0).
The QT prolongation potential of lapatinib was assessed as part of an uncontrolled, open-label dose escalation study in advanced cancer patients. Eighty-one patients received daily doses of lapatinib ranging from 175 mg/day to 1800 mg/day. Serial ECGs were collected on day 1 and day 14 to evaluate the effect of lapatinib on QT intervals. Thirteen of the 81 subjects were found to have either QTcF (corrected QT by the Friedericia method) greater than 480 msec or an increase in QTcF greater than 60 msec by automated machine-read evaluation of ECG. Analysis of the data suggested a relationship between lapatinib concentration and the QTc interval.
Other side effects including mucosal inflammation (15%), pain in the extremity (12%), dyspnea (12%), back pain (11%), and insomnia (10%) have been reported.
Oncologic side effects including genotoxicity have been reported. An impurity in the drug product was genotoxic when tested alone in both in vitro and in vivo assays.
It is recommended that patients be monitored for pulmonary symptoms indicative of interstitial lung disease or pneumonitis. Lapatinib (the active ingredient contained in Tykerb) should be discontinued in patients who experience pulmonary symptoms indicative of interstitial lung disease/pneumonitis which are greater than or equal to grade 3 (NCI CTCAE).
Respiratory side effects have been reported including interstitial lung disease and pneumonitis in monotherapy or in combination with other chemotherapies.
Hypersensitivity side effects including anaphylaxis have been reported.
More about Tykerb (lapatinib)
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