Pronunciation:

re-poe-TREK-ti-nib

Brand Names:

• Augtyro

Dosage Forms:

• Capsule

Classifications:

Therapeutic—

Antineoplastic Agent

Pharmacologic—

Tyrosine Kinase Inhibitor

Uses of This Medicine:

Repotrectinib is used to treat ROS1-positive non-small cell lung cancer (NSCLC) that has spread within your chest or to other parts of the body. Your doctor will perform a test to see if you have the ROS1 gene before you take this medicine.

Repotrectinib is also used to treat solid tumors (cancer) that are caused by certain abnormal NTRK genes and have spread after treatment, or surgery to remove the cancer is likely to cause severe complications, and the cancer grew or spread on other treatments or there is no other treatment option. Your doctor will perform a test to make sure this medicine is right for you.

Repotrectinib 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 This Medicine:

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.

Children—

Appropriate studies have not been performed on the relationship of age to the effects of repotrectinib in children to treat non-small cell lung cancer (NSCLC) and in children younger than 12 years of age to treat solid tumors. Safety and efficacy have not been established.

Older adults—

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

Breast-feeding—

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.

Other 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.

• Bacillus of Calmette and Guerin Vaccine, Live
• Dengue Tetravalent Vaccine, Live
• Lefamulin
• Levoketoconazole
• Lonafarnib
• Mavacamten
• Measles Virus Vaccine, Live
• Mumps Virus Vaccine, Live
• Rubella Virus Vaccine, Live
• Smallpox Monkeypox Vaccine
• Typhoid Vaccine
• Varicella Virus Vaccine
• Yellow Fever Vaccine

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.

• Abemaciclib
• Abrocitinib
• Acalabrutinib
• Adagrasib
• Adenovirus Vaccine Type 4, Live
• Adenovirus Vaccine Type 7, Live
• Alfentanil
• Alogliptin
• Amiodarone
• Amprenavir
• Apalutamide
• Aprepitant
• Astemizole
• Asunaprevir
• Atazanavir
• Atorvastatin
• Avacopan
• Avapritinib
• Axitinib
• Azithromycin
• Bedaquiline
• Berotralstat
• Boceprevir
• Bosentan
• Bosutinib
• Brigatinib
• Canagliflozin
• Capmatinib
• Captopril
• Carbamazepine
• Cariprazine
• Carvedilol
• Cenobamate
• Ceritinib
• Cholera Vaccine
• Cimetidine
• Ciprofloxacin
• Cisapride
• Clarithromycin
• Clindamycin
• Clofazimine
• Cobicistat
• Cobimetinib
• Colchicine
• Conivaptan
• Crinecerfont
• Crizotinib
• Cyclosporine
• Dabrafenib
• Daclatasvir
• Darunavir
• Dasatinib
• Desogestrel
• Deutivacaftor
• Dienogest
• Dihydroergotamine
• Diltiazem
• Dipyrone
• Docetaxel
• Dofetilide
• Dronedarone
• Drospirenone
• Duvelisib
• Ebola Zaire Vaccine, Live
• Efavirenz
• Elacestrant
• Elagolix
• Eliglustat
• Enasidenib
• Encorafenib
• Ensartinib
• Entrectinib
• Enzalutamide
• Ergotamine
• Erythromycin
• Estetrol
• Estradiol
• Ethinyl Estradiol
• Ethynodiol
• Etonogestrel
• Etravirine
• Everolimus
• Felodipine
• Fentanyl
• Flibanserin
• Fluconazole
• Fluvoxamine
• Fosamprenavir
• Fosnetupitant
• Fosphenytoin
• Fostamatinib
• Gestodene
• Glecaprevir
• Ibrexafungerp
• Idelalisib
• Imatinib
• Indinavir
• Influenza Virus Vaccine, Live
• Isavuconazole
• Istradefylline
• Itraconazole
• Ivacaftor
• Ivosidenib
• Ketoconazole
• Lapatinib
• Lazertinib
• Lenacapavir
• Letermovir
• Levomethadyl
• Levonorgestrel
• Lomitapide
• Lorlatinib
• Lumacaftor
• Lurasidone
• Maribavir
• Medroxyprogesterone
• Meperidine
• Mestranol
• Mibefradil
• Midostaurin
• Mifepristone
• Mirabegron
• Mitotane
• Modafinil
• Nafcillin
• Nefazodone
• Nelfinavir
• Neratinib
• Netupitant
• Nifedipine
• Nilotinib
• Nomegestrol
• Norelgestromin
• Norethindrone
• Norgestimate
• Norgestrel
• Olaparib
• Osimertinib
• Oxycodone
• Paclitaxel
• Paritaprevir
• Paroxetine
• Pazopanib
• Pexidartinib
• Phenobarbital
• Phenytoin
• Pibrentasvir
• Pimavanserin
• Pimozide
• Pirtobrutinib
• Posaconazole
• Primidone
• Propafenone
• Quinidine
• Quinine
• Ranolazine
• Revumenib
• Ribociclib
• Rifabutin
• Rifampin
• Rifapentine
• Ritlecitinib
• Ritonavir
• Rolapitant
• Rotavirus Vaccine, Live
• Rucaparib
• Ruxolitinib
• Saquinavir
• Sarecycline
• Schisandra sphenanthera
• Segesterone
• Selpercatinib
• Simeprevir
• Sirolimus
• Sofosbuvir
• Sonidegib
• Sotorasib
• Spironolactone
• St John's Wort
• Sunitinib
• Suvorexant
• Suzetrigine
• Tacrolimus
• Tamoxifen
• Tazemetostat
• Telaprevir
• Telithromycin
• Telmisartan
• Telotristat Ethyl
• Temsirolimus
• Tepotinib
• Tezacaftor
• Thioridazine
• Ticagrelor
• Tolvaptan
• Troleandomycin
• Tucatinib
• Ulipristal
• Vandetanib
• Vanzacaftor
• Velpatasvir
• Vemurafenib
• Venetoclax
• Verapamil
• Vibegron
• Vilazodone
• Voclosporin
• Vorapaxar
• Voriconazole
• Voxelotor
• Warfarin
• Zanubrutinib

Other interactions—

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:

• Hyperuricemia (high uric acid in the blood) or
• Liver disease or
• Lung or breathing problem or
• Nervous system problem—Use with caution. May make these conditions worse.

Proper Use of This Medicine:

Medicines used to treat cancer are very strong and can have many side effects. Before using 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 only 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.

This medicine comes with patient information leaflet. Read and follow the instructions carefully and make sure you understand them before taking this medicine. Ask your doctor if you have any questions.

You may take this medicine with or without food.

Swallow the capsule whole with water at the same time each day. Do not open, chew, crush, or dissolve it. Do not take capsules that are broken, cracked, or damaged.

Do not eat grapefruit or drink grapefruit juice while you are using this medicine. Grapefruit and grapefruit juice may change the amount of medicine that is absorbed in the body.

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 ROS1-positive non-small cell lung cancer:
    • Adults—160 milligrams (mg) once a day for 14 days. Your doctor may adjust your dose as needed and tolerated.
    • Children—Use and dose must be determined by your doctor.
  • For solid tumors:
    • Adults and children 12 years of age and older—160 milligrams (mg) once a day for 14 days. 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, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

If a dose is missed or if you vomit, skip the missed dose. Take the next dose at the regular scheduled time.

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 This Medicine:

It is very important that your doctor check your progress at regular visits to make sure 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 woman who can get pregnant, 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 2 months after your final dose. Males with female partners who are able to become pregnant should use an effective form of birth control during treatment and for 4 months after the last dose. If you think you have become pregnant, tell your doctor right away.

This medicine may cause blurred vision, dizziness, memory loss, mental status changes, confusion, hallucinations, having trouble with balance or coordination, or trouble with concentration and attention. Make sure you know how you react to this medicine before you drive, use machines, or do other jobs that require you to be alert.

This medicine may cause swelling of the lungs (pneumonitis) or interstitial lung disease. These are life-threatening conditions and require immediate medical attention. The symptoms may be similar to the symptoms of lung cancer. Check with your doctor right away if you have new or worsening cough, fever, or trouble breathing.

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

This medicine may cause muscle problems, including myalgia. Check with your doctor right away if you have difficulty moving, joint pain, muscle aches, cramps, pains, or stiffness, or swollen joints.

Check with your doctor right away if you have joint pain, stiffness, or swelling, lower back or side pain, stomach pain, or swelling of the feet or lower legs. These may be symptoms of hyperuricemia (high uric acid in the blood).

This medicine may increase your risk of bone fractures. Ask your doctor about ways to keep your bones strong to help prevent fractures.

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 or vitamin supplements.

Side Effects of This Medicine:

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

Being forgetful

blindness

blurred vision

bone pain

burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings

chest tightness

confusion as to time, place, or person

decreased vision

difficulty in moving

eye pain

headache

holding false beliefs that cannot be changed by fact

joint pain

loss of memory

mental depression or anxiety

muscle aches, cramps, pains, stiffness ,or weakness

nausea or vomiting

nerve pain

nightmares or unusually vivid dreams

problems with memory

problems with speech or speaking

seeing, hearing, or feeling things that are not there

shakiness and unsteady walk

swelling

swollen joints

tearing

trouble breathing

unsteadiness, awkwardness, trembling, or other problems with muscle control or coordination

unusual excitement, nervousness, or restlessness

weakness in the arms, hands, legs, or feet

Incidence not known

Chest pain

chills

cough

dark urine

general feeling of discomfort or illness

joint stiffness or swelling

loss of appetite

lower back or side pain

pain or swelling in the arms or legs without any injury

stomach pain, severe

swelling of the feet or lower legs

thickening of bronchial secretions

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

Burning, dry or itching eyes

change in color vision

change in taste

constipation

diarrhea

difficulty seeing at night

discharge, excessive tearing

dizziness eye swelling

increased sensitivity of the eyes to sunlight

increased weight

loss of taste

redness, pain, swelling of the eye, eyelid, or inner lining of the eyelid

seeing floating dark spots or material before eyes

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.