What precautions should be taken when handling Osimertinib?

jnspharma

Osimertinib (brand name Tagrisso®) is an oral medication used in the treatment of certain types of non-small cell lung cancer. While it comes in tablet form and is often taken at home, it is a potent chemotherapy agent, and appropriate precautions should be taken during its handling and administration to minimize potential exposure, particularly for caregivers and healthcare professionals.

Here's a comprehensive overview of precautions when handling Osimertinib:

1. Personal Protection for Caregivers and Healthcare Professionals:

Gloves: If a caregiver is preparing the dose or handling the tablets, they should consider wearing disposable gloves. This is especially important when dissolving tablets or in situations where skin contact with the medication is likely. Gloves help prevent skin absorption, which is a potential route of exposure for hazardous drugs.

Hand Hygiene: Always wash hands thoroughly with soap and water before and after handling Osimert 80 mg (Osimertinib), even if gloves were worn. This helps remove any residual medication and prevents accidental ingestion or transfer to other surfaces.

Avoid Direct Contact: Whenever possible, avoid direct skin contact with the tablets. Pour pills directly from the container into the cap, a small cup, or directly into the patient's hand.

No Crushing, Chewing, or Cutting: Osimertinib tablets should not be crushed, chewed, or cut. This can release drug particles into the air, increasing the risk of inhalation and skin exposure. If the patient has difficulty swallowing, the tablet can be dispersed in water, as described below.

2. Preparation and Administration:

Dissolving Tablets (if necessary): For patients who have difficulty swallowing whole tablets, Osimertinib can be dissolved in plain drinking water.

Place the tablet in a quarter glass of plain drinking water (approximately 50-60 mL or 2 ounces).

Stir until the tablet is dispersed into small pieces. The tablet will not completely dissolve.

Drink the liquid immediately.

Rinse the empty glass with additional water (e.g., 120-240 mL or 4-8 ounces) and drink it right away to ensure the full dose is taken.

Important: Do not use carbonated water or any other liquids to dissolve the tablet. Do not heat the mixture or use ultrasound.

Nasogastric (NG) Tube Administration: Specific instructions exist for administering Osimertinib via an NG tube. Healthcare professionals should consult the complete prescribing information for detailed guidance, which typically involves dissolving the tablet in a smaller volume of water (e.g., 15 mL) and flushing the tube afterwards to ensure the full dose is delivered.

Dosing Accuracy: Always ensure the correct amount of medication is being taken as prescribed. Do not take more or less than the prescribed dose.

Consistency: Take Osimertinib at approximately the same time each day, with or without food, as directed by the healthcare provider.

3. Storage and Disposal:

Original Container: Store Osimertinib in its original, labeled container at room temperature and in a dry location.
Child and Pet Safety: Keep the medication containers out of reach of children and pets to prevent accidental ingestion.
Disposal of Unused Medication: Do not flush unused medication down the toilet or throw it in the trash. Ask your oncology team or pharmacist for guidance on proper disposal methods for unused or expired medication. Hazardous drugs like Osimertinib require specific disposal protocols to prevent environmental contamination.

4. Special Considerations for Pregnancy, Breastfeeding, and Reproductive Health:

Embryo-Fetal Toxicity: Osimertinib can cause significant harm to an unborn baby, including birth defects and miscarriage.

For Women: Females of reproductive potential must have a negative pregnancy test before starting treatment and use effective contraception during treatment and for at least 6 weeks after the last dose.

For Men: Male patients with female partners of reproductive potential should use effective contraception during treatment and for at least 4 months after the last dose, as the drug may pass into sperm. Even if menstruation stops or sperm production is believed to be affected, fertility can still exist.

Breastfeeding: Do not breastfeed while taking Osimertinib and for two weeks after the last dose, as it is not known if the medication passes into breast milk and could harm the infant.

5. Occupational Exposure Precautions (for healthcare settings):

While Osimertinib is an oral tablet, when manipulated (e.g., if a tablet is broken, crushed, or dissolved), it can become a higher risk for occupational exposure through skin contact or inhalation of dust. In healthcare settings, hazardous drug handling guidelines (such as those from NIOSH) should be followed. This typically includes:

Engineering Controls: Using a fume hood or other ventilated enclosure when manipulating tablets (e.g., dissolving).

Personal Protective Equipment (PPE): Beyond gloves, gowns and eye protection may be recommended, especially if there's a risk of splashing during dissolution or if handling powdered forms in a research setting.

Spill Management: Have procedures in place for managing accidental spills, including appropriate cleanup materials and PPE.
By adhering to these precautions, the risks associated with handling Osimertinib can be significantly minimized, ensuring both patient safety and the safety of those involved in its administration and care. Always consult with your healthcare provider or pharmacist for specific instructions and any concerns you may have.