Osikin 80 Tablet: Each film coated tablet contains Osimer nib Mesylate INN equivalent to Osimer nib 80 mg.

Osimer nib is indicated for the first-line treatment of pa ents with metasta c non small cell lung cancer (NSCLC) whose tumors have epidermal growth factor receptor (EGFR) exon 19 dele ons or exon 21 L858R muta ons, as detected by an FDA-approved test. Osikin is indicated for the treatment of pa ents with metasta c EGFR T790M muta on-posi ve NSCLC, as detected by an FDA-approved test, whose disease has progressed on or a er EGFR tyrosine kinase inhibitor (TKI) therapy.

The recommended dose of Osimer nib is 80 mg tablet once a day un l disease progression or unacceptable toxicity. Osimer nib can be taken with or without food. If a dose of Osimer nib is missed, do not make up the missed dose and take the next dose as scheduled.

Disperse tablet in 60 ml (2 ounces) of non-carbonated water only. S r un l tablet is dispersed into small pieces (the tablet will not completely dissolve) and swallow immediately. Do not crush, heat, or ultrasonicate during prepara on. Rinse the container with 120 ml to 240 ml (4 to 8 ounces) of water and immediately drink. If administra on via nasogastric tube is required, disperse the tablet as above in 15 ml of non-carbonated water, and then use an addi onal 15 ml of water  to transfer any residues to the syringe. The resul ng 30 ml liquid should be  There is no recommended dose of Osimer nib for pa ents with end stage renal  administered as per the nasogastric tube instruc ons with appropriate water flushes (approximately 30 ml).

Inters  al Lung Disease (ILD)/Pneumoni s: Occurred in 3.3% of pa ents. Permanently discon nue Osikin in pa ents diagnosed with ILD/Pneumoni s.)

• QTc Interval Prolonga on: Monitor electrocardiograms and electrolytes in pa ents who have a history or predisposi on for QTc prolonga on, or those who are taking medica ons that are known to prolong the QTc interval. Withhold then restart at a reduced dose or permanently discon nue Osikin.

• Cardiomyopathy: Occurred in 1.4% of pa ents. Assess le  ventricular ejec on frac on (LVEF) before treatment and then every 3 months therea er.

• Embryo-Fetal Toxicity: Osikin can cause fetal harm. Advise females of  poten al risk to the fetus and to use effec ve contracep on during treatment with Osikin and for 6 weeks a er final dose. Advise males to use effec ve contracep on for 4 months, a er the last dose of Osikin.

None

Osikin 80 Tablet: Each box contains 1x10’s tablets in blister pack.

Strong CYP3A Inhibitors
Avoid concomitant administra on of Osimer nib with strong CYP3A inhibitors, including macrolide an bio cs (e.g., Telithromycin), an fungals (e.g., Itraconazole), an virals (e.g., Ritonavir), Nefazodone, as concomitant use of strong CYP3A inhibitors may increase Osimer nib plasma concentra ons. If no other alterna ve exists, monitor pa ents more closely for adverse reac ons of Osimer nib.

Strong CYP3A Inducers
Avoid concomitant administra on of Osimer nib with strong CYP3A inducers (e.g., Phenytoin, Rifampicin,  Carbamazepine,  St.  John's  Wort)  as  strong  CYP3A  inducers  may  decrease  Osimer nib plasma concentra ons. Effect on other drugs Avoid concomitant administra on of Osimer nib with drugs that are sensi ve substrates of CYP3A, breast cancer resistance protein (BCRP), or CYP1A2 with narrow therapeu c indices, including but not limited to Fentanyl, Cyclosporine, Quinidine, Ergot Alkaloids, Phenytoin, Carbamazepine, as Osimer nib may increase or decrease plasma concentra ons of these drugs.

No Informa on provided.

Do not store above 30⁰ C. Protect from light. Keep out of reach of children.