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Class: Biological therapy
Generic Name: selpercatinib- LOXO-292
Trade Name: Retevmo™

How is Retevmo used? Retevmo is approved for the treatment of patients with:

• RET fusion-positive non-small cell lung cancer (NSCLC),

• Advanced or metastatic RET-mutant medullary thyroid cancer who are 12 years of age or older and require systemic treatment or

• Advanced or metastatic RET fusion-positive thyroid cancer who are 12 years of age or older, require systemic therapy and are radioactive iodine-refractory.

What is the mechanism of action? Retevmo is a kinase inhibitor that targets cancers with genomic alterations in the RET kinase. Retevmo works by inhibiting overactive RET signaling which leads to uncontrolled cell growth in certain cancers. Genomic alterations in the RET kinase have been identified in ~2% of NSCLC, 10-20% of papillary and other thyroid cancers, and approximately 60% of medullary thyroid cancer.

How is Retevmo given (administered)? Retevmo is administered orally.

How are patients monitored? Patients will usually have scheduled meetings with their healthcare provider while they are being treated with Retevmo. Typically, blood will be drawn to check levels of blood cells and to monitor functions of some organ systems. Patients may also undergo physical examinations, scans or other measures to assess side effects and response to therapy.

What are the common (occur in 20% or more of patients) side effects of treatment with Retevmo?

· Increased levels of liver enzymes

· Increased blood sugar levels

· Decrease in white blood cell count

· Decreased protein levels in the blood

· Decreased calcium levels in the blood

· Dry mouth

· Diarrhea

· Changes in kidney function test

· High blood pressure

· Tiredness

· Arm, leg, hands and/or feet swelling

· Platelet count decreases

· Cholesterol level increases

· Rash

· Decreased sodium levels in the blood

· Constipation

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

· Liver problems

· High blood pressure

· Heart rhythm changes

· Bleeding problems

· Allergic reactions

· Risk of wound healing problems

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

• Pay careful attention to the physician’s instructions and inform the physician of any side effects.

• Maintain adequate rest and nutrition.

• Wear sunscreen and protective clothing and try to minimize sun exposure.

• Drink plenty of fluids. (Patients should ask their physician about the amount of liquid to consume during a day.)

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• If possible, avoid large crowds or people who are sick or not feeling well, as this drug may leave some patients susceptible to infection.

• Wash hands often to reduce the risk of infection.

• Eat small meals frequently to help alleviate nausea.

• Avoid activities that may cause injury or bruising.

• Use a soft toothbrush and an electric razor to prevent cuts on the mouth or skin.

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. Also, patients may want to talk to their physician if they are considering having children in the future, since some drugs may cause fertility problems.

· It is important that patients inform their physician of any pre-existing conditions such as liver problems, high blood pressure, heart problems, bleeding problems as these may worsen during treatment with Retevmo.

· Patients should inform their healthcare provider if they have had or plan on having surgery as Retevmo can impair wound healing.

· Patients should inform their physician of any other medication they are taking (whether prescription or over-the-counter, including vitamins, herbs, etc.) as they may interfere with treatment.

· Patients should check with their physician before starting any new drug or nutritional supplement. Patients should avoid St. John’s wort, proton pump inhibitors, H2 receptor antagonists and antacids while taking Retevmo.

· Patients should inform their physician of any known drug or food allergies or any reactions to medications they have experienced in the past.

When should patients notify their physician?

· Yellowing of skin or whites of the eyes (jaundice)

· Dark urine

· Sleepiness

· Bleeding/bruising

· Loss of appetite

· Nausea or vomiting

· Pain on the upper right side of your stomach

· Confusion

· Headaches

· Shortness of breath

· Dizziness

· Chest pain

· Loss of consciousness

· Fainting

· Heart palpitations

· Blood in vomit, stools or urine

· Unusual bleeding

· Change in speech

· Symptoms of allergic reaction (fever, rash, muscle or join pain)

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.

Updated June 19, 2020