Tyverb (lapatinib) is used to treat patients with advanced breast cancer that has been shown to be "expressing" large amounts of HER2. This means that the cancer produces a specific protein called HER2 (also known as ErbB2) in large quantities on the surface of the tumour cells. Tyverb is used in the following ways:
In combination with capecitabine when the cancer is advanced or metastatic and got worse following previous treatment including an anthracycline and a taxane, and following treatment of the patient’s metastatic disease with trastuzumab.
In combination with trastuzumab for advanced or metastatic cancer that does not respond to hormones (hormone receptor-negative disease), and which got worse when previously treated with a combination of trastuzumab and other cancer medicines (chemotherapy).
In combination with an aromatase inhibitor in women who have been through the menopause, when the cancer is metastatic and responds to hormones. This combination is used in women who do not currently need to receive standard chemotherapy to treat their cancer.
This information is based on the European Summary of Product Characteristics. The prescribing information in your country may vary; please consult your local prescribing information and/or contact your local Novartis representative.
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Important Safety Information for Tyverb (lapatinib)
Special populations:Children Safety and efficacy not established. Elderly (>65 years): Limited data. No overall differences in the safety or efficacy on the basis of age were observed. Renal impairment: No dose adjustment required. Severe hepatic impairment: Caution and dose reduction.
Contraindications: Hypersensitivity to any of the ingredients.
Warnings and precautions:Cardiac toxicity: Caution in patients with conditions that could impair left ventricular function. Baseline and on treatment monitoring of LVEF. LVEF should be within the institutions normal limits prior to treatment initiation. Caution in patients who have or may develop prolongation of QTc. Interstitial Lung Disease and Pneumonitis: Monitoring for pulmonary symptoms indicative of interstitial lung disease/pneumonitis. Hepatotoxicity: Liver function tests monitoring before initiation of treatment, every four to six weeks during treatment, and as clinically indicated. Dose reduction in patients with severe pre-existing hepatic impairment. Discontinue in patients who develop severe hepatotoxicity. Patients should not be retreated with lapatinib. Diarrhea: Early identification and prompt treatment is recommended. If diarrhoea persists beyond 24 hours with fever or Grade 3 or 4 neutropenia, interrupt or discontinue treatment. Severe cutaneous reactions have been reported. Discontinue treatment if erythema multiforme or lifethreatening reactions such as, Stevens-Johnson syndrome, or toxic epidermal necrolysis are suspected.
Women of child-bearing potential: Use adequate contraception and avoid becoming pregnant.
Pregnancy: Only if expected benefit justifies potential risk to the fetus.
Adverse drug reactions:Monotherapy:Very common (≥10%): anorexia, diarrhea, which may lead to dehydration, nausea, vomiting, rash, fatigue. Common (1 to 10%): decreased left ventricular ejection fraction, nail disorders including paronychia. Uncommon (0.1 to 1%): interstitial lung disease/pneumonitis, hyperbilirubinemia, hepatotoxicity. Rare (0.01 to 0.1%): hypersensitivity reactions including anaphylaxis. Additional adverse reactions observed when lapatinib is used in combination with: Capecitabine: Very common (≥10%): dyspepsia, dry skin, stomatitis, constipation, abdominal pain, palmar-plantar erythrodysesthesia, mucosal inflammation, pain in extremity, back pain, insomnia. Common (1 to 10%): headache. Paclitaxel: Very common (≥10%): neutropenia, leukopenia, anemia, neuropathy peripheral, myalgia. Letrozole: Very common (≥10%): epistaxis, alopecia, dry skin.
For a complete list of ADRs, consult full prescribing information.
Interactions:Caution in combination with known inhibitors and inducers of CYP3A4 (e.g. ketoconazole, itraconazole or grapefruit juice; rifampin, carbamazepine, or phenytoin). In patients pre-treated with a proton pump inhibitor (esomeprazole). Concurrently with orally administered medications with narrow therapeutic windows that are substrates of CYP3A4, CYP2C8 Pgp and Breast Cancer Resistance Protein (BCRP), With paclitaxel. With irinotecan. With docetaxel which increased the occurrence of docetaxel-induced neutropenia. It cannot be excluded that lapatinib will affect the pharmacokinetics of substrates of BCRP (e.g. topotecan) and OATP1B1 (e.g. rosuvastatin). Food interaction, take at least one hour before or one hour after food.