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Lapatinib (Tykerb)

Trade Name : TYKERB

Novartis Pharmaceuticals Corporation

TABLET

Strength 250 mg/1

LAPATINIB DITOSYLATE Kinase Inhibitor [EPC],Protein Kinase Inhibitors [MoA]

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Trade Marks displayed in compliance with provisions of: Trademark Act, 1999 u/s 30 and 30 (1) of "Fair use"

GNH India is WHO GDP and ISO 9001 2015 Certified Pharmaceutical Wholesaler/ Supplier/ Exporters/ Importer from India of Lapatinib (Tykerb) which is also known as TYKERB and Manufactured by Novartis Pharmaceuticals Corporation. It is available in strength of 250 mg/1 per ml. Read more

Lapatinib (Tykerb) is supplied for Tenders/ Emergency imports/ Un - licensed, Specials, Orphan drug/ Name patient line/ RLD supplies/ Reference listed drugs/ Comparator Drug/ Bio-Similar/ Innovator samples For Clinical trials.  Click to know price.     Read less

Packaging and Delivery

Validated Cold Chain Shipment

We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

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We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

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About GNH

We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

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  • No data
  • No data
  • Hepatotoxicity has been observed in clinical trials and postmarketing experience. The hepatotoxicity may be severe and deaths have been reported. Causality of the deaths is uncertain .
  • WARNING: HEPATOTOXICITY
  • See full prescribing information for complete boxed warning.
  • Hepatotoxicity has been observed in clinical trials and postmarketing experience. The hepatotoxicity may be severe and deaths have been reported. Causality of the deaths is uncertain. ()nttttttttt
  • TYKERB is indicated in combination with:
  • TYKERB in combination with an aromatase inhibitor has not been compared to a trastuzumab-containing chemotherapy regimen for the treatment of metastatic breast cancer.
  • TYKERB is a kinase inhibitor indicated in combination with: ()
  • TYKERB in combination with an aromatase inhibitor has not been compared to a trastuzumab-containing chemotherapy regimen for the treatment of metastatic breast cancer.
  • nttttttttttcapecitabine for the treatment of patients with advanced or metastatic breast cancer whose tumors overexpress human epidermal growth factor receptor 2 (HER2) and who have received prior therapy including an anthracycline, a taxane, and trastuzumab.n n : Patients should have disease progression on trastuzumab prior to initiation of treatment with TYKERB in combination with capecitabine.n n
  • nttttttttttletrozole for the treatment of postmenopausal women with hormone receptor-positive metastatic breast cancer that overexpresses the HER2 receptor for whom hormonal therapy is indicated.
  • The recommended dosage of TYKERB for advanced or metastatic breast cancer is 1,250u00a0mg (5 tablets) given orally once daily on Days 1-21 continuously in combination with capecitabine 2,000u00a0mg/m/day (administered orally in 2 doses approximately 12 hours apart) on Days 1-14 in a repeating 21-day cycle. ()
  • The recommended dose of TYKERB for hormone receptor-positive, HER2-positive metastatic breast cancer is 1,500u00a0mg (6 tablets) given orally once daily continuously in combination with letrozole. When TYKERB is coadministered with letrozole, the recommended dose of letrozole is 2.5u00a0mg once daily. ()
  • 2.1n- 12.3
  • 250u00a0mg tablets u2014 oval, biconvex, orange, film-coated with GS XJG debossed on one side.
  • 250u00a0mg tablets ()
  • TYKERB is contraindicated in patients with known severe hypersensitivity (e.g., anaphylaxis) to this product or any of its components.
  • Known severe hypersensitivity (e.g., anaphylaxis) to this product or any of its components. ()
  • No data
  • Decreases in left ventricular ejection fraction (LVEF) have been reported. Confirm normal LVEF before starting TYKERB and continue evaluations during treatment. ()
  • TYKERB has been associated with hepatotoxicity. Monitor liver function tests before initiation of treatment, every 4 to 6 weeks during treatment, and as clinically indicated. Discontinue and do not restart TYKERB if patients experience severe changes in liver function tests. ()
  • Dose reduction in patients with severe hepatic impairment should be considered. (, , )
  • Diarrhea, including severe diarrhea, has been reported during treatment. Manage with antidiarrheal agents, and replace fluids and electrolytes if severe. ()
  • TYKERB has been associated with interstitial lung disease and pneumonitis. Discontinue TYKERB if patients experience severe pulmonary symptoms. ()
  • TYKERB may prolong the QT interval in some patients. Consider electrocardiogram (ECG) and electrolyte monitoring. (, )
  • Severe cutaneous reactions have been reported. Discontinue TYKERB if life-threatening reactions are suspected. ()
  • TYKERB can cause fetal harm. Advise patients of the potential risk to the fetus and to use effective contraception. (, , )
  • The most common (greater than 20%) adverse reactions during treatment with TYKERB plus capecitabine were diarrhea, palmar-plantar erythrodysesthesia, nausea, rash, vomiting, and fatigue. The most common (greater than or equal to 20%) adverse reactions during treatment with TYKERB plus letrozole were diarrhea, rash, nausea, and fatigue. ()n n
  • nttttttttttTo report SUSPECTED ADVERSE REACTIONS, contact Novartis Pharmaceuticals Corporation at 1-888-669-6682 or FDA at 1-800-FDA-1088 or .
  • No data
  • 2.2n- 7.2
  • 2.2n- 7.2
  • No data
  • Lactation: Advise not to breastfeed ()nttttttttt
  • Females and Males of Reproductive Potential: Verify the pregnancy status of females prior to initiation of TYKERB ()
  • There is no known antidote for overdoses of TYKERB. The maximum oral doses of lapatinib that have been administered in clinical trials are 1,800 mg once daily. More frequent ingestion of TYKERB could result in serum concentrations exceeding those observed in clinical trials and could result in increased toxicity. Therefore, missed doses should not be replaced and dosing should resume with the next scheduled daily dose.
  • Asymptomatic and symptomatic cases of overdose have been reported. The doses ranged from 2,500 to 9,000u00a0mg daily and where reported, the duration varied between 1 and 17 days. Symptoms observed include TYKERB-associated events and in some cases sore scalp, sinus tachycardia (with otherwise normal ECG), and/or mucosal inflammation.
  • Because TYKERB is not significantly renally excreted and is highly bound to plasma proteins, hemodialysis would not be expected to be an effective method to enhance the elimination of lapatinib.
  • Treatment of overdose with TYKERB should consist of general supportive measures.
  • Lapatinib is a small molecule and a member of the 4-anilinoquinazoline class of kinase inhibitors. It is present as the monohydrate of the ditosylate salt, with chemical name -(3-chloro-4-{[(3-fluorophenyl)methyl]oxy}phenyl)-6-[5-({[2-(methylsulfonyl)ethyl]amino}methyl)-2-furanyl]-4-quinazolinamine bis(4-methylbenzenesulfonate) monohydrate. It has the molecular formula CHClFNOS (CHOS) HO and a molecular weight of 943.5 g/mol. Lapatinib ditosylate monohydrate has the following chemical structure:
  • Lapatinib is a yellow solid, and its solubility in water is 0.007u00a0mg/mL and in 0.1N HCl is 0.001u00a0mg/mL at 25u00b0C.
  • Each 250u00a0mg tablet of TYKERB contains 405u00a0mg of lapatinib ditosylate monohydrate, equivalent to 398u00a0mg of lapatinib ditosylate or 250u00a0mg lapatinib free base.
  • The inactive ingredients of TYKERB are: Magnesium stearate, microcrystalline cellulose, povidone, sodium starch glycolate. Orange film-coat: FD&C yellow No. 6/sunset yellow FCF aluminum lake, hypromellose, macrogol/PEG 400, polysorbate 80, titanium dioxide.
  • No data
  • No data
  • No data
  • The 250u00a0mg tablets of TYKERB are oval, biconvex, orange, and film-coated with GSu00a0XJG debossed on one side and are available in:
  • Bottles of 150 tablets: NDC 0078-0671-19
  • Store at 25u00b0C (77u00b0F); excursions permitted to 15u00b0C to 30u00b0C (59u00b0F to 86u00b0F) [see USP Controlled Room Temperature].
  • Advise the patient to read the FDA-approved patient labeling (Patient Information).
  • Inform patients of the following:
  • Decreased Left Ventricular Ejection Fraction (LVEF)
  • Hepatotoxicity and Hepatic Impairment
  • Diarrhea
  • Interstitial Lung Disease/Pneumonitis
  • Severe Cutaneous Reactions
  • Drug and Food Interactions
  • Dosing Administration
  • Embryo-Fetal Toxicity
  • Lactation
  • T2018-136
  • No data
  • PRINCIPAL DISPLAY PANEL
  • NDC 0078-0671-19
  • Tykerbn
  • (lapatinib) Tablets
  • 250 mg
  • 150 Tablets
  • R only
  • Store at 25C (77F); excursions permitted to 15 to 30C (59 to 86F).
  • Each tablet contains 398 mg lapatinib ditosylate equivalent to 250 mg lapatinib.
  • Dosage:
  • Important:
  • Novartis

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