Very common side effects (may occur in more than 1 in 10 patients)
- Diarrhea;
- Stomatitis (inflammation of the oral cavity);
- Rash;
- Dry skin;
- Paronychia (nail bed alterations, nail bed inflammation, nail bed tenderness, nail color change, nail alteration, nail dystrophy, nail infection).
Common side effects (may occur in more than 1 in 100 patients)
- Liver toxicity;
- Reduced heart rate.
Rare side effects (may occur in more than 1 in 10,000 patients)
- Pneumonia: Your doctor should be contacted in the event of an acute and/or unexplained onset or worsening dyspnea, cough, fever.
How to take Osimertinib
The commercially available tablets are 40 mg or 80 mg. The recommended dose is 80 mg once a day. The intake schedule is independent of food. Osimertinib should be swallowed whole with water at the same time each day and should not be crushed, divided or chewed. If there are difficulties in swallowing, the tablet can be dissolved (without breaking it) into 50 mL of non-carbonated water, it must be mixed until dispersed and drunk immediately. Add another half glass of water to make sure no residue remains and drink immediately. You should not eat grapefruit or grapefruit derivatives during treatment with osimertinib which could reduce its effectiveness.
Pharmacokinetic interactions
It is recommended to avoid using the following medicines which could reduce the effectiveness of osimertinib:
- Phenytoin, carbamazepine or phenobarbital – used for seizures or convulsions;
- Rifabutin or rifampicin – used for the treatment of tuberculosis (TB);
- St. John’s wort (Hypericum perforatum) – an herbal medicine used for the treatment of depression.
Osimertinib may reduce the effectiveness of the following medicines and / or increase the side effects:
- Warfarin – used for blood clots;
- Phenytoin and S-mephenytoin – used for seizures or convulsions;
- Alfentanil, fentanyl and other painkillers used for operations;
- Rosuvastatin – used to lower the cholesterol level;
- Oral contraceptive pill – used to prevent pregnancy.
Fertility, pregnancy and lactation
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine. It is recommended that women do not become pregnant and men should refrain from generating children during treatment with Osimertinib, as Osimertinib may harm the baby.
If there is a possibility that the person taking this medicine may become pregnant or become a father, he/she must use a valid contraceptive method for the duration of the treatment and for at least 90 days after completion of the therapy, as oral contraceptives may not be effective if taken in conjunction with Osimertinib.
List of excipients
Mannitol, microcrystalline cellulose, hydroxypropyl cellulose, sodium stearyl fumarate, polyvinyl alcohol, titanium dioxide, macrogol 3350, talc, yellow iron oxide (E 172), red iron oxide (E 172), black iron oxide (E 172).
Insights
– Therapies for patients with EGFR
– Osimertinib mutation: how the therapeutic strategy changes in patients with EGFR gene mutation
