OSIMERTINIB 40MG

Tagrisso 40mg (osimertinib) is a kinase inhibitor, it is an oral, comes under third generation drug Tagrisso 40mg is an irreversible epidermal growth factor receptor tyrosine kinase inhibitor Tagrisso 40mg selectively prohibits both EGFR-TKI sensitizing and EFGR T790M resistance mutations Tagrisso 40mg is first line therapy in patients with EGFR mutated non-small cell lung cancer

osimertinib

40mg

30 tablets




INDICATION

First line indication is;
Respiratory carcinoma
Thoracic carcinoma
Tagrisso 40 mg is mainly indicated for;
Patient with advanced or metastatic non-small cell lung cancer with epidermal growth factor receptor exon 19 deletions as detected by FDA
• First line treatment of EGFR mutation positive metastatic non small cell lung cancer
• Previously treated EGFR T790M mutation positive metastatic non small cell lung cancer

Mechanism of action

Tagrisso 40 mg (osimertinib) is classified as tyrosine kinase inhibitor of epidermal growth factor receptor which is present on the surface of tumor cells
Tagrisso 40mg is non reversibly merge with mutant form of EGFR at 9 folds than wild type
Prohibits EGFR sensitizing mutations exon 19 Del and L858R
Leads to prohibits mutated EGFR with T790M resistance mutation
Finally, lower activity against wild type EGFR



Pharmacokinetic

The peak plasma time of drug Tagrisso 40 mgb is 6 hours

Human plasma protein bound: 95% Volume of distribution: 918L

The main metabolic pathway of drug Tagrisso 40mg
Oxidation
Dealkylation
The metabolites are circulating in blood has;
AZ7550
AZ5104

The terminal half life time is 48 hours
Clearance: 14.3 L/hr
The route of excretion of metabolites occur through feces 68% and urine 14% and 2% as unchanged form



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osimeritinib-40mg
Ingredients Osimertinib
Strength 40mg
Pack 30 tablets
Rating

Tagrisso available in the strength of; 40mg
80mg Non-small cell lung cancer, metastatic first line (EGFR exon 19 del):
The recommended dose of Tagrisso 40mg is 80mg should be taken as a single dose
It should be administered orally with or without food
Non-small cell lung cancer metastatic previously treated:
80mg should be taken as orally for once a day
Combination with strong CYP3A4 inducers:
Avoid concomitant with strong CYP3A4 inducers
In case of co administration, increase the dose of Tagrisso as 160mg. it should be taken as a single dose
Then decreased the dose of Tagrisso to 80mg 3 weeks after discontinuation of CYP3A4 inducers
If patient is not able to take tablet orally, Tagrisso tablets should be dispersed into 60ml non-carbonated water and drink immediately
In pediatric:
The safety and efficacy of the Tablet Tagrisso 40mg in pediatric patient has not been established
Dosage adjustment:
In pulmonary:
Interstitial lung disease or pneumonitis: permanently discontinue Tagrisso 40mg
QT interval greater than 500 msec on 2 ECGsb: withhold the Tagrisso 40mg until QTc is less than 481 msec then continue the drug as 40mg
In cardiac:
QT prolongation causes life threatening conditions: stop Tagrisso 40mg
Congestive heart failure, asymptomatic left ventricular dysfunction: stop Tagrisso 40mg
If adverse reaction:
Grade 3: stop the drug for 3 weeks
If improvement to Grade 0-2 within 3 weeks: continue at 40mg
No improvement: discontinue the drug

Side effects

Tagrisso 40mg causes;
>10%:
Lymphopenia, thrombocytopenia, anemia, diarrhea, rash, neutropenia, hypomagnesemia, hyponatremia, dry skin, nail toxicity, fatigue, hypoglycemia, eye disorders, loss of appetite, cough, nausea, stomatitis, constipation, Pruritus, vomiting
1-10%:
Back pain, headache, hypokalemia, Lymphopenia, venous thromboembolism, pneumonia, interstitial lung disease, QT prolongation, neutropenia, hyponatremia, hypomagnesemia, loss of appetite
<1% :
Keratitis, nausea, vomiting, rash, back pain, thrombocytopenia Increased AST, ALT Hyperbilirubinaemia.This are the tagrisso side effects.

Precautions

While taking Tagrisso 40mg, care should be taken to avoid these conditons :
Tagrisso 40 mg causes interstitial lung disease in this condition the drug should be permanently discontinued
QT prolongation
Cardiomyopathy, keratitis
Embryo fetal toxicity.
Non-clinical toxicology :
Carcinogenesis, mutagenesis, impairment of fertility
Bone marrow depression like Lymphopenia thrombocytopenia, neutropenia, anemia
Ocular toxicity
Pulmonary toxicity
Fertility effects
Gastrointestinal toxicity.

DRUG – DRUG INTERACTION

  • Concomitant of Tagrisso 40mg with CYP3A4 inducers: may cause decreased exposure to Tagrisso 40mg leads to reduce the efficacy
  • CYP3A4 inducers: phenytoin, carbamazepine, Phenobarbital
  • Co administration of Tagrisso 40mg with BCRP: cause increased in exposure to BCRP substrates to increase the toxicity
  • BCRP substrates: rosuvastatin, sulfasalazine, topotecan
  • Some list of drugs :
    BCG vaccine, Bosentan, Chloramphenicol, CYP3A4 inducers, Dabrafenib, Deferiprione, Denosumab, Enzalutamide, QT prolongating agents, promazine, probucol, vaccines, ketaconazole, voriconazole, rifampin, ritonavir

Contraindications

Hypersensitivity reaction occurs while patients are in tolerated to the components present




Tagrisso 40mg causes embryo fetal toxicity, it is not recommended in pregnancy condition

Breast feeding is not recommended

Store at 25°C(77°F)excursions are permitted between 25°C and 30°C (59°F and 86°F).
Keep away from moisture, heat and light

Generally Tagrisso 40mg tablets have serious ill effects, if patient fails to take the dose of Pomalidomide, must consult with well practiced oncologist and get the suggestion
Otherwise the missed dose should be skipped and follow the regular schedule
Pomalid tablet is generally take as once daily per day
Do not double the dose .


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