Pronunciation:

lar-oh-TREK-ti-nib

Brand Names:

• Vitrakvi

Dosage Forms:

• Capsule
• Solution

Classifications:

Therapeutic—

Antineoplastic Agent

Pharmacologic—

Tyrosine Kinase Inhibitor

Uses of This Medicine:

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

Larotrectinib 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 performed to date have not demonstrated pediatric-specific problems that would limit the usefulness of larotrectinib in children. Safety and efficacy have been established.

Older adults—

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

• Abametapir
• Acalabrutinib
• Alfentanil
• Alprazolam
• Amiodarone
• Apalutamide
• Aprepitant
• Atazanavir
• Avanafil
• Avapritinib
• Boceprevir
• Bosentan
• Bosutinib
• Budesonide
• Buprenorphine
• Buspirone
• Carbamazepine
• Cenobamate
• Ciprofloxacin
• Clarithromycin
• Clozapine
• Cobicistat
• Cobimetinib
• Codeine
• Conivaptan
• Crizotinib
• Cyclosporine
• Darifenacin
• Darunavir
• Dasatinib
• Diltiazem
• Dronedarone
• Efavirenz
• Eletriptan
• Entrectinib
• Enzalutamide
• Eplerenone
• Erythromycin
• Etravirine
• Everolimus
• Fedratinib
• Felodipine
• Fexinidazole
• Finerenone
• Fluconazole
• Fluticasone
• Fosaprepitant
• Fosnetupitant
• Fosphenytoin
• Ibrexafungerp
• Ibrutinib
• Idelalisib
• Imatinib
• Indinavir
• Itraconazole
• Ivabradine
• Ivacaftor
• Ketoconazole
• Lemborexant
• Letermovir
• Lomitapide
• Lopinavir
• Lorlatinib
• Lovastatin
• Lumacaftor
• Lurasidone
• Maraviroc
• Mavacamten
• Midazolam
• Mitotane
• Modafinil
• Nafcillin
• Naloxegol
• Nefazodone
• Nelfinavir
• Netupitant
• Nilotinib
• Omaveloxolone
• Oxycodone
• Phenobarbital
• Phenytoin
• Posaconazole
• Primidone
• Quetiapine
• Rifabutin
• Rifampin
• Ritonavir
• Saquinavir
• Sildenafil
• Simvastatin
• Sirolimus
• Sirolimus Protein-Bound
• St John's Wort
• Tacrolimus
• Telaprevir
• Telithromycin
• Temsirolimus
• Ticagrelor
• Tipranavir
• Tolvaptan
• Triazolam
• Ubrogepant
• Vardenafil
• Venetoclax
• Verapamil
• Voclosporin
• Voriconazole
• Zolpidem

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:

• Brain or nerve problems—Use with caution. May make this condition worse.

• Liver disease, moderate to severe—Use with caution. The effects may be increased because of the slower removal of the medicine from the body.

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 a patient information leaflet. Read and follow these instructions carefully. Ask your doctor if you have any questions.

Swallow the capsule whole with water. Do not chew, crush, or open it. You may take this medicine with or without food.

Measure the oral liquid with a marked measuring spoon, oral syringe, or medicine cup. The average household teaspoon may not hold the right amount of liquid.

Do not eat grapefruit or drink grapefruit juice while you are using this medicine.

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 forms (capsule, solution):
  • For solid tumors:
    • Adults and children with a body surface area of 1 meter squared (m2) or more—Dose is based on body surface area and must be determined by your doctor. The dose is usually 100 milligrams (mg) 2 times a day. Your doctor may adjust your dose as needed and tolerated.
    • Children with a body surface area of less than 1 m2—Dose is based on body surface area and must be determined by your doctor. The dose is usually 100 milligrams per meter squared (mg/m2) 2 times a day. Your doctor may adjust your dose as needed and tolerated.

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 regular dose is in 6 hours or less, skip the missed dose and return to your regular dosing schedule.

If you vomit after taking a dose, take the next dose at the regular time.

Storage—

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.

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

Store the oral liquid in the refrigerator. Do not freeze. Throw away any unused oral liquid after 90 days of first opening the bottle.

Precautions While Using This Medicine:

It is very important that your doctor check your or your child's 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. It may also cause birth defects if the father is using it when his sexual partner becomes pregnant. If you are a woman who can get pregnant, your doctor may do tests to make sure you are not pregnant before starting treatment. Female patients should use effective birth control during treatment with this medicine and for at least 1 week after the last dose. Male patients who have female partners should use effective birth control during treatment with this medicine and for 1 week after the last dose. If you think you have become pregnant while using this medicine, tell your doctor right away.

Check with your doctor right away if you have confusion, dizziness, memory loss, mood or mental changes, or sleep problems. These may be symptoms of a nervous system problem.

This medicine may make you dizzy, confused, or less alert than you are normally. Do not drive or do anything else that could be dangerous until you know how this medicine affects you.

This medicine may increase your risk of bone fractures. Check with your doctor right away if you have bone pain, changes in movement, or any bone problems. Ask your doctor about ways to keep your bones strong to help prevent fractures.

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, or yellow eyes or skin. These could be symptoms of a serious liver problem.

If you plan to have children, talk with your doctor before using this medicine. Some women using this medicine have become infertile (unable to have children).

Cancer medicines can cause diarrhea, nausea, vomiting, or stomach pain in most people, sometimes even after receiving medicines to prevent it. Ask your doctor or nurse about other ways to control these unwanted effects.

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.

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

black, tarry, stools

bladder pain

bloating or swelling of the face, arms, hands, lower legs, or feet

bloody or cloudy urine

blurred vision

chest tightness

chills

confusion as to time, place, or person

cough

difficult, burning, or painful urination

discouragement

dizziness

falls

fear, nervousness

feeling sad or empty

fever

frequent urge to urinate

headache

holding false beliefs that cannot be changed by fact

irritability

lack of appetite

loss of interest or pleasure

loss of memory

lower back or side pain

nervousness

painful or difficult urination

pale skin

pounding in the ears

problems with memory

problems with speech or speaking

rapid weight gain

seeing, hearing, or feeling things that are not there

sleepiness or unusual drowsiness

slow or fast heartbeat

sore throat

tingling of the hands or feet

trouble breathing

trouble concentrating

trouble sleeping

ulcers, sores, or white spots in the mouth

unusual bleeding or bruising

unusual excitement, nervousness, or restlessness

unusual tiredness or weakness

unusual weight gain or loss

Less common

Chest pain or discomfort

confusion

decreased urination

diarrhea

dry mouth

fainting

heartburn

increase in heart rate

increased thirst

indigestion

irregular heartbeat

itching, pain, redness, swelling, tenderness, or warmth on the skin

lightheadedness

loss of consciousness

muscle pain, cramps, or weakness

nausea

problems with movement or walking

rapid, shallow breathing

seizures

severe stomach pain, cramping, or burning

sunken eyes

swelling of the face, ankles, or hands

vomiting

vomiting of material that looks like coffee grounds, severe and continuing

wrinkled skin

yellow skin or eyes

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

Back pain

constipation

decreased appetite

difficulty in moving

increased weight

joint pain or swelling

muscle stiffness

pain in the arms or legs

stuffy nose

Less common

Lack or loss of strength

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.