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Retevmo (Oral)

Generic Name: selpercatinib (Oral route)

Commonly used brand name(s)

In the U.S.

  • Retevmo

Available Dosage Forms:

  • Capsule

Therapeutic Class: Antineoplastic Agent

Pharmacologic Class: Tyrosine Kinase Inhibitor

Uses for Retevmo

Selpercatinib is used to treat metastatic (cancer that has already spread) non-small cell lung cancer (NSCLC) in patients whose tumors have RET fusion-positive genes. Your doctor will perform a test to check for the RET gene fusion before you use this medicine.

Selpercatinib is also used to treat advanced or metastatic (cancer that has already spread) medullary thyroid cancer (MTC) in patients whose tumors have abnormal RET (RET-mutant) genes. Your doctor will perform a test to check for the abnormal RET gene before you use this medicine.

Selpercatinib is also used to treat advanced or metastatic (cancer that has already spread) thyroid cancer in patients whose tumors have RET fusion-positive genes. Your doctor will perform a test to check for the RET gene fusion before you use this medicine. It is used in patients who needs a medicine by mouth or injection and have received radioactive iodine but did not work.

Selpercatinib belongs to the group of medicines called antineoplastics (cancer medicines). It works by interfering with the growth of cancer cells, which are eventually destroyed.

This medicine is available only with your doctor's prescription.

Before using Retevmo

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Appropriate studies have not been performed on the relationship of age to the effects of selpercatinib to treat non-small cell lung cancer in the pediatric population. Safety and efficacy have not been established.

Appropriate studies performed to date have not demonstrated pediatric-specific problems that would limit the usefulness of selpercatinib to treat medullary thyroid cancer and thyroid cancer in children 12 years of age and older. Safety and efficacy have not been established in children younger than 12 years of age.

Geriatric

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of selpercatinib in the elderly.

Breastfeeding

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Interactions with medicines

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.

  • Bepridil
  • Cisapride
  • Dronedarone
  • Fluconazole
  • Ketoconazole
  • Mesoridazine
  • Pimozide
  • Piperaquine
  • Posaconazole
  • Saquinavir
  • Sparfloxacin
  • Terfenadine
  • Thioridazine
  • Ziprasidone

Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

  • Alfentanil
  • Alfuzosin
  • Aluminum Carbonate, Basic
  • Aluminum Hydroxide
  • Aluminum Phosphate
  • Amiodarone
  • Amisulpride
  • Amitriptyline
  • Anagrelide
  • Apalutamide
  • Apomorphine
  • Aprepitant
  • Aripiprazole
  • Aripiprazole Lauroxil
  • Arsenic Trioxide
  • Asenapine
  • Astemizole
  • Atazanavir
  • Azithromycin
  • Bedaquiline
  • Boceprevir
  • Bosentan
  • Buprenorphine
  • Buserelin
  • Calcium Carbonate
  • Carbamazepine
  • Cenobamate
  • Ceritinib
  • Chloroquine
  • Chlorpromazine
  • Cimetidine
  • Ciprofloxacin
  • Citalopram
  • Clarithromycin
  • Clofazimine
  • Clomipramine
  • Clozapine
  • Cobicistat
  • Conivaptan
  • Crizotinib
  • Cyclobenzaprine
  • Cyclosporine
  • Dabrafenib
  • Dasatinib
  • Degarelix
  • Delamanid
  • Desipramine
  • Deslorelin
  • Deutetrabenazine
  • Dexlansoprazole
  • Dihydroergotamine
  • Dihydroxyaluminum Aminoacetate
  • Dihydroxyaluminum Sodium Carbonate
  • Diltiazem
  • Disopyramide
  • Dofetilide
  • Dolasetron
  • Domperidone
  • Donepezil
  • Doxepin
  • Droperidol
  • Ebastine
  • Efavirenz
  • Encorafenib
  • Entrectinib
  • Enzalutamide
  • Ergotamine
  • Eribulin
  • Erythromycin
  • Escitalopram
  • Esomeprazole
  • Etravirine
  • Famotidine
  • Felbamate
  • Fentanyl
  • Fingolimod
  • Flecainide
  • Flibanserin
  • Fluoxetine
  • Formoterol
  • Foscarnet
  • Fosnetupitant
  • Fosphenytoin
  • Fostemsavir
  • Galantamine
  • Gatifloxacin
  • Gemifloxacin
  • Glasdegib
  • Gonadorelin
  • Goserelin
  • Granisetron
  • Halofantrine
  • Haloperidol
  • Histrelin
  • Hydroquinidine
  • Hydroxychloroquine
  • Hydroxyzine
  • Ibutilide
  • Idelalisib
  • Iloperidone
  • Imatinib
  • Imipramine
  • Indinavir
  • Inotuzumab Ozogamicin
  • Itraconazole
  • Ivabradine
  • Ivosidenib
  • Lansoprazole
  • Lapatinib
  • Lenvatinib
  • Letermovir
  • Leuprolide
  • Levofloxacin
  • Lofexidine
  • Lopinavir
  • Lorlatinib
  • Lumacaftor
  • Lumefantrine
  • Macimorelin
  • Magaldrate
  • Magnesium Carbonate
  • Magnesium Hydroxide
  • Magnesium Oxide
  • Magnesium Trisilicate
  • Mefloquine
  • Methadone
  • Methotrimeprazine
  • Metronidazole
  • Mifepristone
  • Mirtazapine
  • Mitotane
  • Mizolastine
  • Modafinil
  • Moricizine
  • Moxifloxacin
  • Nafarelin
  • Nafcillin
  • Nefazodone
  • Nelfinavir
  • Netupitant
  • Nilotinib
  • Nizatidine
  • Norfloxacin
  • Octreotide
  • Ofloxacin
  • Olanzapine
  • Omeprazole
  • Ondansetron
  • Osilodrostat
  • Osimertinib
  • Oxaliplatin
  • Oxycodone
  • Paclitaxel
  • Paliperidone
  • Panobinostat
  • Pantoprazole
  • Papaverine
  • Paroxetine
  • Pasireotide
  • Pazopanib
  • Pentamidine
  • Perphenazine
  • Phenobarbital
  • Phenytoin
  • Pimavanserin
  • Pipamperone
  • Pitolisant
  • Primidone
  • Probucol
  • Procainamide
  • Prochlorperazine
  • Promethazine
  • Propafenone
  • Protriptyline
  • Quetiapine
  • Quinidine
  • Quinine
  • Rabeprazole
  • Ranitidine
  • Ranolazine
  • Ribociclib
  • Rifabutin
  • Rifampin
  • Risperidone
  • Ritonavir
  • Sertindole
  • Sertraline
  • Sevoflurane
  • Siponimod
  • Sirolimus
  • Sodium Bicarbonate
  • Sodium Phosphate
  • Sodium Phosphate, Dibasic
  • Sodium Phosphate, Monobasic
  • Solifenacin
  • Sorafenib
  • Sotalol
  • St John's Wort
  • Sulpiride
  • Sultopride
  • Sunitinib
  • Tacrolimus
  • Tamoxifen
  • Telaprevir
  • Telavancin
  • Telithromycin
  • Temsirolimus
  • Tetrabenazine
  • Tolterodine
  • Toremifene
  • Trazodone
  • Triclabendazole
  • Trimipramine
  • Triptorelin
  • Vandetanib
  • Vardenafil
  • Vemurafenib
  • Venlafaxine
  • Verapamil
  • Vilanterol
  • Vinflunine
  • Voriconazole
  • Vorinostat
  • Zotepine
  • Zuclopenthixol

Interactions with food/tobacco/alcohol

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following is usually not recommended, but may be unavoidable in some cases. If used together, your doctor may change the dose or how often you use this medicine, or give you special instructions about the use of food, alcohol, or tobacco.

  • Grapefruit Juice

Other medical problems

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

  • Bleeding problems or
  • Heart disease or
  • Heart rhythm problems (eg, long QT syndrome, slow heartbeat, uncontrolled heart failure) or
  • Hypertension (high blood pressure), controlled or
  • Liver disease—Use with caution. May make these conditions worse.
  • Hypertension (high blood pressure), uncontrolled or
  • Hypocalcemia (low calcium in the blood) or
  • Hypokalemia (low potassium in the blood) or
  • Hypomagnesemia (low magnesium in the blood)—These conditions must be corrected first before using and during treatment with this medicine.
  • Surgery, recent—Use with caution. May cause side effects to become worse.

Proper use of Retevmo

Medicines used to treat cancer are very strong and can have many side effects. Before receiving this medicine, make sure you understand all the risks and benefits. It is important for you to work closely with your doctor during your treatment.

Take this medicine exactly as directed by your doctor. Do not take more of it, do not take it more often, and do not take it for a longer time than your doctor ordered. To do so may increase the chance of side effects.

This medicine comes with a patient information leaflet. It is very important that you read and understand this information. Be sure to ask your doctor about anything you do not understand.

You may take this medicine with or without food.

Swallow the capsule whole. Do not crush, open, or chew it. Take it at least 12 hours apart.

Take this medicine at least 2 hours before or 2 hours after taking antacids that contain aluminum, calcium, magnesium, simethicone, or buffered medicines.

Take this medicine at least 2 hours before or 10 hours after taking an H2 blocker (eg, cimetidine, famotidine, nizatidine).

Take this medicine with food if you are also taking a proton pump inhibitor (eg, dexlansoprazole, esomeprazole, lansoprazole, omeprazole, pantoprazole sodium, rabeprazole).

Dosing

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

  • For oral dosage form (capsules):
    • For non-small cell lung cancer (NSCLC):
      • Adults weighing 50 kilograms (kg) or more—160 milligrams (mg) 2 times a day. Your doctor may adjust your dose as needed and tolerated.
      • Adults weighing less than 50 kg—120 mg 2 times a day. Your doctor may adjust your dose as needed and tolerated.
      • Children—Use and dose must be determined by your doctor.
    • For medullary thyroid cancer (MTC) and thyroid cancer:
      • Adults and children 12 years of age and older weighing 50 kilograms (kg) or more—160 milligrams (mg) 2 times a day. Your doctor may adjust your dose as needed and tolerated.
      • Adults and children 12 years of age and older weighing less than 50 kg—120 mg 2 times a day. Your doctor may adjust your dose as needed and tolerated.
      • Children younger than 12 years of age—Use and dose must be determined by your doctor.

Missed dose

If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

If your next dose is less than 6 hours away, skip the missed dose and take the medicine at your regular dosing time. If your missed dose is more than 6 hours until the time you normally take a dose, take it as soon as you remember and go back to your regular dosing schedule. If you vomit after taking your medicine, do not take an extra dose.

Storage

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

Precautions while using Retevmo

It is very important that your doctor check your progress at regular visits to make sure that this medicine is working properly. Blood tests may be needed to check for unwanted effects.

Using this medicine while you are pregnant can harm your unborn baby. If you are a woman who can bear children, your doctor may give you a pregnancy test before you start using this medicine to make sure you are not pregnant. Use an effective form of birth control during treatment and for at least 1 week after the last dose. Males with female partners who are able to become pregnant should use an effective form of birth control during treatment and for at least 1 week after the last dose. If you think you have become pregnant, tell your doctor right away.

Check with your doctor right away if you have pain or tenderness in the upper stomach, pale stools, dark urine, loss of appetite, nausea, vomiting, unusual tiredness or weakness, or yellow eyes or skin. These could be symptoms of a serious liver problem.

Check with your doctor right away if blurred vision, dizziness, nervousness, headache, pounding in the ears, or slow or fast heartbeat occurs during or after treatment with this medicine. These can be symptoms of hypertension (high blood pressure).

This medicine can cause changes in your heart rhythm, including a condition called QT prolongation. Call your doctor right away if you have dizziness, fainting, or slow, fast, pounding, or uneven heartbeats.

This medicine can cause serious bleeding problems that may be life-threatening. Check with your doctor right away if you have coughing up blood, increased menstrual flow or vaginal bleeding, nosebleeds, red or black, tarry stools, red or dark brown urine, vomiting of blood or material that looks like coffee grounds, or any unusual bleeding or bruising.

Selpercatinib may cause serious allergic reactions. Check with your doctor right away if you have a fever, rash, itching, joint or muscle pain, swelling of the face, tongue, and throat, trouble breathing, or chest pain after you take the medicine.

This medicine may affect the way your body heals from cuts and wounds. Make sure any doctor who treats you knows that you are using this medicine. You may need to stop using this medicine several days before and after having surgery.

Talk with your doctor before using this medicine if you plan to have children. Some men and women using this medicine have become infertile (unable to have children).

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal (eg, St. John's wort) or vitamin supplements.

Retevmo side effects

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

More common

  • Bleeding gums
  • blurred vision
  • constipation
  • coughing up blood
  • depressed mood
  • diarrhea
  • difficulty in breathing or swallowing
  • dizziness or fainting
  • dry skin and hair
  • hair loss
  • headache
  • increased menstrual flow or vaginal bleeding
  • muscle cramps and stiffness
  • nervousness
  • nosebleeds
  • paralysis
  • pounding in the ears
  • prolonged bleeding from cuts
  • red or black, tarry stools
  • red or dark brown urine
  • slow, fast, irregular, or pounding heartbeat
  • stomach pain
  • swelling of the hands, ankles, feet, or lower legs
  • tightness in the chest
  • unusual tiredness or weakness
  • vomiting of blood or material that looks like coffee grounds
  • weight gain

Less common

  • Chest pain
  • cough
  • fever or chills
  • hives, itching, skin rash
  • hoarseness
  • irritation
  • joint pain, stiffness, or swelling
  • loss of appetite
  • nausea and vomiting
  • redness of the skin
  • sore throat
  • stomach tenderness
  • swelling of the eyelids, face, or lips
  • yellow eyes or skin

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common

  • Dry mouth

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.