Connor Walker, PharmD

, 40 mg and 80 mg capsules (Retevmo, Loxo Oncology), to treat 3 types of tumors—non-small cell lung cancer (NSCLC), medullary thyroid cancer (MTC), and other types of thyroid cancers—in patients whose tumors have an alteration in a specific gene.

 fusion-positive NSCLC, advanced MTC or MTC that has spread, in patients aged 12 years and older who require systemic therapy, and advanced 

 fusion-positive thyroid cancer in patients aged 12 years and older that requires systemic therapy that has stopped responding to radioactive iodine therapy or is not appropriate for radioactive iodine therapy.


In the indication for the treatment of advanced or metastatic RET-mutant MTC, selpercatinib was approved for adult and pediatric patients 12 years of age and older.

Medullary thyroid cancer is a tumor of the parafollicular or C cells in the thyroid gland.

In a study of 143 patients with advanced or metastatic RET-mutant MTC, 55 patients had previously undergone chemotherapy with other approved agents for MTC and 88 patients had not received prior treatment. Complete or partial shrinkage of the tumor was experienced in 69% of the previously treated group, with 76% lasting more than 6 months. In the treatment-naïve group, 73% experienced complete or partial shrinkage of their tumors, with 61% lasting greater than 6 months.


Selpercatinib is a kinase inhibitor that inhibits wild-type RET, multiple other mutated RET isoforms, VEGFR1, and VEGFR3. Selpercatinib has also been shown to inhibit FGFR 1, 2, and 3 at clinically achievable higher concentrations.




Selpercatinib can be taken with or without food, but patients should avoid co-administering selpercatinib with a proton pump inhibitor. Capsules should be swallowed whole. Do not crush or chew.


Selpercatinib is dosed based on body weight.

For patients weighing less than 50 kg, 120 mg every 12 hours.

Patients weighing 50 kg or more, 160 mg every 12 hours.

Dose should be reduced in those patients with severe hepatic impairment.


The most common AEs in patients taking selpercatinib were dry mouth, hypertension, fatigue, diarrhea, constipation, rash, and edema.

Common laboratory abnormalities include elevated AST/ALT, elevated glucose, elevated creatinine, elevated alkaline phosphatase, decreased albumin, decreased calcium, decreased leukocytes, decreased sodium and decreased platelet count.





Selpercatinib caused hypertension in approximately 35% of patients. Health care providers should properly control patients’ blood pressure before starting selpercatinib. Blood pressure should be monitored after 1 week of starting therapy and at least monthly thereafter.

Selpercatinib was shown to cause concentration-dependent QT interval prolongation. Health care providers should monitor those patients most at risk of developing QTc prolongation. Potassium, magnesium, and calcium levels should be corrected before starting selpercatinib.

Due to the risk of serious hepatic AEs, health care providers should monitor their patient’s AST and ALT prior to beginning selpercatinib, every 2 weeks during the first 3 months of use, and then monthly thereafter.

Health care providers should monitor patients for signs of hypersensitivity to selpercatinib. Should hypersensitivity occur, selpercatinib should be withheld and corticosteroids should be initiated.

Once hypersensitivity event has resolved, selpercatinib can be resumed at a reduced dose and increased each week as tolerated. Should hypersensitivity occur a second time, selpercatinib should be permanently discontinued.



VEGF inhibitors are known to impair wound healing to various degrees, therefore patients taking selpercatinib should avoid taking the medication for at least 7 days prior to surgery. Selpercatinib should be held for at least 2 weeks after surgery and until the wound is adequately healed.

Rare cases of hemorrhagic events have also been shown with selpercatinib, including 3 patient fatalities. Selpercatinib should be permanently discontinued in patients exhibiting signs of severe hemorrhage.


There are currently no available data on selpercatinib use in pregnant women to appropriately informdrug associated risk. When studied in pregnant rats, selpercatinib showed embryolethality and malformations at exposure levels that were approximately equal to those of human exposure at the dose of 160 mg twice daily.

Patients are advised not to breastfeed while taking selpercatinib as there are no data regarding the presence of the medication or its metabolites in human milk. Women should wait 1 week after their last dose to begin breastfeeding.



Connor Walker, PharmD, is a clinical pharmacist at Yale New Haven Health


1. Drug Trial Snapshots: Retevmo. U.S. Food and Drug Administration. Accessed May 18, 2022. https://www.fda.gov/drugs/development-approval-process-drugs/drug-trials-snapshots-retevmo

2. Retevmo Prescribing information. January 2021. Accessed May 18, 2022


https://uspl.lilly.com/retevmo/retevmo.html#pi

https://www.fda.gov/news-events/press-announcements/fda-approves-first-therapy-patients-lung-and-thyroid-cancers-certain-genetic-mutation-or-fusion

Articles

Selpercatinib (Retevmo, Loxo Oncology) is FDA-approved to treat 3 types of tumors—metastatic RET fusion-positive non-small cell lung cancer, advanced medullary thyroid cancer (MTC) or MTC that has spread, and advanced RET fusion-positive thyroid cancer.

Oncology Overview: Selpercatinib in the Treatment of Medullary Thyroid Cancer

Up to 30% of adults experience insomnia, and pharmacists need to know how to identify this condition that many patients think is normal and do not discuss.

Insomnia is not just difficulty falling asleep but also refers to difficulty staying asleep and early morning awakenings with trouble falling back asleep.

 Regardless of the type of insomnia, this condition can have significant consequences for patients. Chronic illness, difficulty concentrating, and irritability are just a few problems that may occur in those who suffer from insomnia.

Insomnia can be difficult to spot. In our fast-paced society, everyone seems to have difficulty sleeping from time to time. Insomnia is chronically underreported

 and patients may rarely seek help, because the condition is often viewed as benign and inconsequential.

When patients were asked about reasons for not seeking treatment, the 5 most common answers were as follows

I did not recognize the difficulty with sleep was an illness.

I have developed my own treatments or ways of coping.

I thought difficulty with sleep was an expected response to a life situation.

I thought it was something I should be strong enough to manage myself.

I thought the problem would get better by itself.

A 2019 study assessed the likelihood that community pharmacists would offer counseling when patients purchase OTC sleep aids. It found that pharmacists rarely questioned patients’ medical history or symptoms during the sale. Most often, pharmacists provided only the recommended dose and administration time—information that patients can read on the label. They never offered information to patients regarding proper lifestyle and sleep habits.

 The study shines light on an obvious lack of adequate counseling in the community setting. As the most accessible health care providers, community pharmacists can be a vital resource for patients with insomnia. Knowing the risk factors for insomnia (

) can prompt pharmacists to identify those who may be struggling.

One key area is for pharmacists to identify patients who may be experiencing insomnia as an adverse effect (AE) of a medication.

 Prescription medications are widely used across the United States, with nearly 60% of adults reporting daily use, and certain classes can cause insomnia as an AE (

Proper sleep habits can help ensure a better night’s sleep. Habits such as background noise, excessive blue light before bedtime, irregular bedtimes, and staying up late can negatively affect sleep quality.

 Pharmacists should screen patients struggling with insomnia to determine whether the cause of their sleep problems stems from poor sleep habits. Asking open-ended questions can help gather information regarding sleep habits.

How often do you use alcohol, nicotine, or other stimulants before going to bed?

How often do you use a cell phone or tablet or watch television before bedtime?

The CDC recommends multiple tips for improving sleep habits. These include making sure the bedroom is set up for optimal sleep with a comfortable temperature (cooler is better) and dim lights, and is free from excessive noise. Avoiding alcohol, large meals, and stimulants before bedtime and being consistent with a bedtime routine are also critical.

Pharmacists can identify insomnia and offer the necessary interventions to combat its repercussions. Provided there is a proper assessment and patient counseling, insomnia is treatable by both pharmacologic and nonpharmacologic means. Most often patients will not say they are suffering from insomnia, so it is crucial that pharmacists use contextual clues and maintain an empathetic, questioning attitude when assisting patients. Knowing what to look for and asking the proper questions can allow pharmacists to make a difference in patients’ sleep quality.

, is a multispecialty clinical pharmacist at Yale New Haven Health in Connecticut.

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6. Torrens Darder I, Argüelles-Vázquez R, Lorente-Montalvo P, Torrens-Darder MDM, Esteva M. Primary care is the frontline for help-seeking insomnia patients. 

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7. Patel D, Steinberg J, Patel P. Insomnia in the elderly: a review. 

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8. Stinson K, Tang NK, Harvey AG. Barriers to treatment seeking in primary insomnia in the United Kingdom: a cross-sectional perspective. 

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9. Do D. Trends in the use of medications with insomnia side effects and the implications for insomnia among US adults. 

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10. Bonnet MH, Arand DL. Risk factors, comorbidities, and consequences
of insomnia in adults. UpToDate. Updated April 15, 2022. Accessed April
26, 2022. https://www.uptodate.com/contents/risk-factors-comorbidities-and-consequences-of-insomnia-in adults?search=drugs%20causing%20insomnia&source=search_result&selected Title=1~150&usage_ type=default&display_rank=1#H1582169839

11. Chung KF, Lee CT, Yeung WF, Chan MS, Chung EW, Lin WL. Sleep hygiene education as a treatment of insomnia: a systematic review and meta-analysis. 

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12. Tips for better sleep. CDC. Updated July 15, 2016. Accessed April 11, 2022. https://www.cdc.gov/sleep/about_sleep/sleep_hygiene.html

Pharmacists must communicate more than drugs and dosages and offer counseling on lifestyle and sleep habits.