Lanib

Lanib tablets are categorized as anti-neoplastic agent, which is orally active drug used for treating breast cancer.
Lanib tablets are comes under biological category which is targeted chemotherapy.
Lanib tablets are classified as;
1. Tyrosine kinase prohibitor
2. Stop the HER2/neu& epidermal growth factor receptor activity
3. Targeted therapy
4. Signal transduction prohibitor
Lanib 250mg tablets containing 250mg of Lapatinib as an active substance.
Lanib is a synthetic oral tablet, chemically classified as quinazoline with strong anti-cancer effect.

Lapatinib

Lanib

250mg

BDR





PRESCRIBING INFORMATION

Lanib consist of Lapatinib is primarily indicated for advanced breast cancer.
Lanib is used in combination with;
Capecitabine with Lanib tablets are usually indicated for the treatment of metastatic breast cancer patients in whose cancer cells expressed with EGFR 2 (HER2) and patients may already receive an anthracycline, taxane& Transtuzumab.
The major demerit of Lanib:
Patients should be produce advancement of disease during Transtuzumab therapy, prior initiation of Lanib with Capecitabine. Lanib tablet with letrozole is involved in the therapy of post menopausal women suffered with hormone receptor positive advanced breast cancer that contains HER 2 receptors.
Lanib concurrent with Aromatase inhibitors have not been correlates to Transtuzumab chemotherapy drug for breast cancer therapy.

MECHANISM OF ACTION

Chemically Lapatinib is categorized as 4-anilinoquinazoline derivative, which expels anti-cancer activity by prohibiting intracellular tyrosine kinase domains of EFGR & HER type 2. The ErbB driven tumor cell production has been prohibited by Lapatinib. This growth factor receptor present on cell surface of tumors which may leads to cause cell death.



ADME PROPERTIES

The absorption of Lanib is incomplete and insufficient, the maximum plasma concentration time of Lapatinib occurs relatively 4 hours after drug intake. The steady state reaches within 6 to 7 days

Lapatinib is largely bounds to human plasma protein like albumin & alpha glycoprotein nearly 99%.

Lapatinib is a substrate of P-gp& BCRP and undergoes intensive metabolism by using CYPP3A4 & CYP3A5 with lesser contribution of CYP2C19 & CYP2C8.

Lanib in single dose reaches half life time in 14.2 hours and repeated dosing reaches in 24 hours. Elimination occurs via feces & urine.




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drug
Brand Lanib
Ingredients Lapatinib
Strength 250mg
Manufactured BDR
Rating


In HER2 positive advanced breast cancer:

The recommended dose of Lanib is 1250mg should be administered orally as a single dose on day 1 to 21repeatedly combined with Capecitabine 2000mg/m2/day (should be taken orally in 2 doses relatively 12 hours apart) on day 1 to 14 in continuous 21 day cycle. Totally 5 tablets of Lanib should be taken at a time as whole.
In hormone receptor positive HER 2 positive advance breast cancer:
The prescribed dose is 1500mg should be administered orally as a single dose by combining with letrozole.
The prescribed dose of letrozole is 2.5mg as a once a day.
In these total 6 tablets of Lanib should be administered as such.
Dose alteration:
Cardiac events:
In patients with reduction of left ventricular ejection fraction with grade 2, treatment with Lanib should be discontinued. In this condition, the dose of Lanib should be initiated with 1000mg/day in combination with Capecitabine; whereas in combination with letrozole the dose of Lanib restated with 1250mg/day after 2 weeks, if LVEF turns to normal.
Hepatic impairment:
For patient with severe hepatic impairment, the dose reduced from 1250mg/day to 750mg/day or from 1500mg/day to 1000mg/day.
Diarrhea:
Lanib tablets should be restarted once the severity of diarrhea may reduced to grade I. permanently discontinued if diarrhea is persists.
Concurrent use of CYP3A4 inhibitors:
Lanib should not be combined with CYP3A4 inhibitors; because of elevation of plasma concentration of Lapatinib occurs. For eradicate this effect, the dose of Lanib should be reduced to 500mg/day.
Concurrent use of CYP3A4 inducers:
In this combinational study, the dose of Lanib should be elevate from 1250mg/day to 4500mg/day or from 1500mg/day to 5500mg/day.
In other toxicity:
Postpone or stop the Lanib therapy may happens, in case of developing higher grade of toxicities which is greater than or equal to grade II.
Lanib use in combination with Capecitabine should be resume at lower doses 1000mg/day and whereas in combination with letrozole should be resume at lower dose of 1250mg/day.
Lanib tablets should be taken without food; administer 1 hour earlier or 2 hours after the food uptake.
Capecitabine should be administered with food or taken within 30 minutes after ingestion of food.

OVER DOSAGE

The doses of Lanib ranges from 2500mg to 9000mg daily, the duration of therapy should be varied between 1 & 17 days. Symptoms occurred during over dose of Lanib are; Sore scalp, sinus tachycardia & mucosal inflammation. Patients should be providing with supportive measures. Hemodialysis is not an effective method for overcoming the over dosage condition of Lanib.

SIDE EFFECTS

Diarrhea, Nausea, Vomiting, Stomatitis, Back pain, Dyspnea, Insomnia, Elevation of hemoglobulin, platelets, neutrophils, Increase in AST & ALT, bilirubin, Alopecia, Pruritus, Nail disorders, Asthenia, Headache, Epistaxis, Reduction of left ventricular ejection fraction, Liver toxicity, Interstitial lung disease, Anaphylactic reactions, Stevens Johnson syndrome, Ventricular arrhythmias, QT prolongation

Reduction in left ventricular ejection fraction:
Caution should be taken while using Lanib in patient with LVEF The virulence of LVEF should be decreased within first 12 weeks of treatment Before starting the therapy with Lanib, patient must be examining thoroughly if suspected with LVEF or not.

Liver damage:
Increasing level of AST, ALT or bilirubin may leads to liver injury To prevent this condition, periodic LFT should be maintained

Diarrhea:
Severe diarrhea may lead to dehydration causes death also; if patient do not recover from this severity must discontinue with this therapy.

Interstitial lung disease:
Patient should be monitored with pulmonary symptoms and provide supportive measures. On severe condition, treatment should be interrupt or discontinue

QT prolongation:
Monitor ECG periodically Provide substituent for this adverse condition Hypokalemia and hypomagnesemia correction should be takes place.

DRUG- DRUG INTERACTION

Lanib tablets are inhibition of CYP3A4, CYP2C8 & P-gp drug transporters; weak inhibitor of CYP3A4.
The dose reduction of these concurrent uses of substrate drug should be advised, while allowing Lanib combined with drugs metabolized by CYP3A4, CYP2C8 or P-gp.
Midazolam:
use with Lanib, increases the exposure of Midazolam
Paclitaxel:
Increase in paclitaxel exposure occurs while concomitant with Lanib
Digoxin: Serum digoxin concentration should be examined periodically before starting the concomitant use. If digoxin level in serum is greater than 1.2ng/ml, then the dose of digoxin reduced taken with half.
Ketoconazole with Lanib, the dose reduced to 200mg as two times a day for 7 days.
Carbamazepine with Lanib, the dose of carbamazepine at 100mg as two times a day for 3 days & 200mg for two times a day for 17 days, the exposure of Lanib reduced to 72%.
While combining Lanib with P-gp inhibitors causes increasing the concentration of Lapatinib
Without regard to esomeprazole a proton pump inhibitor, taken as 40mg as a single dose for 7 days, did not result in significant reduction in Lapatinib steady state.



A hypersensitivity reaction occurs in patients who are contraindicated to the component present in Lanib tablet.

Pregnancy category: D
Lanib should not be used in pregnancy condition
Breast feeding should not be allowed
The potency of Lanib has not been evaluated in pediatric patients.
In both renal & hepatic impairment patients, caution should be taken while using this medication

Lanib carton should be kept at 25°C (77°F). Keep the carton free from moisture, heat or light

Missed dose should be skipped and follow the regular dosing schedule for avoiding adverse conditions. If missed dose occurs, it should not be resume and continue the next schedule.

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