Class: Biological Therapy

Generic Name: Osimertinib

Trade Name: Tagrisso™

For which conditions is this drug approved? Tagrisso is a kinase inhibitor used to treat patients with metastatic epidermal growth factor receptor (EGFR) T790M mutation-positive non-small cell lung cancer (NSCLC) whose cancer has progressed on or after EGFR tyrosine kinase inhibitor therapy.

What is the mechanism of action? Some non-small cell lung cancer cells express certain EGFR mutations. Therefore, researchers have designed Tagrisso to specifically target and bind to these particular mutations. Once binding has occurred, these cancer cells are killed.

How is Tagrisso typically given (administered)? Tagrisso is taken orally once per day. It can be taken with or without food and should not be double-dosed if a dose is missed.

What are the most common side effects of treatment with Tagrisso?

• Diarrhea
• Rash
• Dry skin
• Nail toxicity

What are some of the less common but potentially serious side effects of Tagrisso?

• Pneumonia
• QTc interval prolongation
• Pulmonary embolus
• Interstitial lung disease including pneumonitis
• Cerebrovascular accidents/infarctions

This is not a complete list of side effects. Some patients may experience other side effects that are not listed here. Patients may wish to discuss with their physician the other less common side effects of this drug, some of which may be serious.

Some side effects may require medical attention. Other side effects do not require medical attention and may go away during treatment. Patients should check with their physician about any side effects that continue or are bothersome.

What can patients do to help alleviate or prevent discomfort and side effects?

• Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

 Are there any special precautions patients should be aware of before starting treatment?

• Patients should inform their physician if they are pregnant, breastfeeding or planning a family in the near future. This drug may cause birth defects. It is important to use some kind of birth control while undergoing treatment and for a period of time following treatment.
• Patients should not breastfeed while undergoing treatment with Tagrisso.
• Patients with congenital long QTc syndrome, congestive heart failure, electrolyte abnormalities, or those who are taking medications known to prolong the QTc interval require periodic monitoring of electrocardiograms and electrolytes.
• Patients diagnosed with interstitial lung disease or pneumonitis must permanently discontinue use of Tagrisso.

What is a package insert?

A package insert is required by the FDA and contains a summary of the essential scientific information needed for the safe and effective use of the drug for healthcare providers and consumers. A package insert typically includes information regarding specific indications, administration schedules, dosing, side effects, contraindications, results from some clinical trials, chemical structure, pharmacokinetics and metabolism of the specific drug. By carefully reviewing the package insert, you will get the most complete and current information about how to safely use this drug. If you do not have the package insert for the drug you are using, your pharmacist or physician may be able to provide you with a copy.

Important Limitations of Use

The information provided above on the drug you have selected is provided for your information only and is not a substitute for consultation with an appropriate medical doctor. We are providing this information solely as a courtesy and, as such, it is in no way a recommendation as to the safety, efficacy or appropriateness of any particular drug, regimen, dosing schedule for any particular cancer, condition, or patient nor is it in any way to be considered medical advice. Patients should discuss the appropriateness of a particular drug or chemotherapy regimen with their physician.

As with any printed reference, the use of particular drugs, regimens and drug dosages may become out-of-date over time, since new information may have been published and become generally accepted after the latest update to this printed information. Please keep in mind that health care professionals are fully responsible for practicing within current standards, avoiding use of outdated regimens, employing good clinical judgment in selecting drugs and/or regimens, in calculating doses for individual patients, and verifying all dosage calculations.

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