Name: Osimert (Osimertinib INN) 80 mg - Oncology Medicine Pharmacy
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Osimert, also known as Osimertinib, is indicated for adults with locally advanced or metastatic non-small cell lung cancer (NSCLC) featuring the epidermal growth factor receptor (EGFR) T790M mutation. This third-generation tyrosine kinase inhibitor selectively targets EGFR mutations, suppressing tumor cell proliferation, angiogenesis, and metastasis. The recommended dosage is 80 mg orally once daily, with or without food, until disease progression or intolerable side effects occur. Caution is advised for potential interactions with drugs affecting cytochrome P450 enzymes, and regular monitoring for adverse reactions like interstitial lung disease/pneumonitis is crucial. Additionally, effective contraception and liver function tests are recommended during treatment, with supportive care recommended in case of overdose.

Indication: Osimert, also known as Osimertinib as per the International Nonproprietary Name (INN), is prescribed for adults with locally advanced or metastatic non-small cell lung cancer (NSCLC) featuring the epidermal growth factor receptor (EGFR) T790M mutation.

Pharmacology: Osimert is a third-generation tyrosine kinase inhibitor (TKI) that selectively targets EGFR-sensitizing mutations and the T790M resistance mutation while sparing wild-type EGFR. This inhibition of EGFR signaling suppresses tumor cell proliferation, angiogenesis, and metastasis in NSCLC with EGFR mutations.

Dosage and Administration: Adults are typically advised to take Osimert orally at a recommended dose of 80 mg once daily, with or without food, until disease progression or intolerable side effects occur. Dosage adjustments may be necessary based on individual patient tolerance.

Interactions: Osimert may interact with drugs affecting cytochrome P450 enzymes, particularly CYP3A4. Avoid co-administration with potent CYP3A4 inhibitors or inducers. Additionally, caution is warranted when combining with drugs prolonging the QT interval or substrates of P-glycoprotein.

Side Effects: Common side effects may include diarrhea, rash, dry skin, nail toxicity, stomatitis, and decreased appetite. Serious adverse reactions could involve interstitial lung disease/pneumonitis, QT prolongation, cardiomyopathy, and ocular disorders like keratitis and cataracts.

Precautions and Warnings:

Regular monitoring for signs of interstitial lung disease/pneumonitis is essential; treatment should be halted if suspected.
Due to the risk of QT prolongation and cardiomyopathy, regular cardiac monitoring is recommended.
Effective contraception is advised during treatment and for at least 6 weeks after the last dose due to embryo-fetal toxicity.
Hepatotoxicity has been observed with Osimert, necessitating routine liver function tests during treatment.

Overdose Effect: In the event of overdose, provide supportive care and closely monitor for adverse reactions. No specific antidote is available; thus, appropriate symptomatic treatment should be initiated as necessary.