Osicent 80

Osicent 80: Each tablet contains a dose of osimertinib mesylate equivalent to 80 mg osimertinib.

Osicent is an epidermal growth factor receptor (EGFR) kinase inhibitor that binds irreversibly to some mutant forms of EGFR. In cultured cells and animal tumor implantation models, osimertinib had anti-tumor effects in non-small cell lung cancer (NSCLC).

Dosage Osicent 80

80 mg orally once a day, with or without food.

Side effects

Among the most common (> 20%) adverse reactions (all classes) observed in people treated with Osicent 80 were diarrhea (42%), rash (41%), dry skin (31%) and brittle nails (25%) ). Serious adverse reactions reported in 2% or more of patients were caused by pneumonia and pulmonary embolism.

Precautionary measures

1. In patients with pneumonitis, Osimertinib should be permanently discontinued.
2. Prolongation of the QTc interval: Electrocardiograms and electrolytes should be monitored in people with a history of or a predisposition to QTc prolongation, or in those taking medications known to increase the QTc interval. Taking Osicent should be stopped and then started again at a reduced dose or completely stopped taking the drug.
3. Cardiomyopathy: Left ventricular ejection fraction (LVEF) should be assessed before starting treatment and then every three months thereafter.
4. Fetal and Fetal Toxicity: Osimertinib may cause harm to the fetus. Women should be educated about the potential risk to the fetus and should use effective contraception during treatment and for 6 weeks after the last dose. Men should be advised to use effective contraception for 4 months after taking the last dose of Osimertinib.

Use during pregnancy and lactation Osicent 80

Based on its mechanism of action and animal data, Osimertinib may cause fetal harm when used by a pregnant woman. There are no data on the use of Osicent in pregnant women. Pregnant women should be apprised of the potential risk to the fetus.

There are no data available on the presence of Osicent in human milk, on the effect on a nursing infant or on milk production. During treatment, a nursing mother is advised not to breastfeed.

Use in pediatrics

The safety and efficacy of Osicent in children has not been established.

Use in geriatrics

No general differences in safety were observed between patients aged 65 and over and under 65 years of age.

Interaction with other medicinal products Osicent 80

Strong inhibitors and inducers of CYP3A

The use of Osicent should be avoided when using strong CYP3A inhibitors, including macrolide antibiotics (for example, telithromycin), antifungal drugs (for example, itraconazole), antiviral agents (for example, ritonavir), nefazodone, since the concomitant use of strong CYP3A inhibitors may increase the plasma concentration. If no other option exists, patients should be monitored more closely for adverse reactions.

The use of Osicent should be avoided when using strong inducers of CYP3A (eg, phenytoin, rifampicin, carbamazepine, St. John's wort), since strong inducers of CYP3A can reduce the plasma concentration of Osimertinib.

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