Larotrectinib (lar-oh-TREK-ti-nib)

Treats solid tumors.

Brand Name(s):

Vitrakvi

When This Medicine Should Not Be Used:

How to Use This Medicine:

Capsule, Liquid

• Take your medicine as directed. Your dose may need to be changed several times to find what works best for you.
• Swallow the capsule whole with water. Do not chew, crush, or open it.
• Oral liquid:
  • Measure the oral liquid medicine with a marked measuring spoon, oral syringe, or medicine cup.
  • Open the bottle by pushing down firmly on the child-resistant cap and turn it in the direction of the arrow.
  • Insert the bottle adaptor by pressing it into the bottle neck and make sure it is secure.
  • Use one hand to hold the bottle upright. Using your other hand, push the air out of the syringe by pushing the plunger down. Then, insert the tip of the syringe into the bottle adaptor at the top of the bottle.
  • Use one hand to hold the syringe in place. Turn the bottle upside down using your other hand. Pull back on the plunger until the top of the plunger lines up with the marking on the barrel of the syringe that matches the needed dose.
  • Check for air bubbles in the syringe. If you see air bubbles, push up gently on the plunger to push any large air bubbles back in to the bottle.
  • Place the tip of the syringe into your child's mouth against the inside of the cheek. Slowly squirt the oral liquid into the mouth by pressing down on the plunger and allow your child to swallow.
  • Make sure your child is in an upright position for a few minutes right after giving the dose. If your child spits up a dose or you are not sure the entire dose was given, do not give another dose. Wait for the next scheduled dose.
• Read and follow the patient instructions that come with this medicine. Talk to your doctor or pharmacist if you have any questions.
• Missed dose: Take a dose as soon as you remember. 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.
• Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Store the oral liquid in the refrigerator. Do not freeze. Throw away any unused oral liquid in bottle of 100 milliliters (mL) after 90 days and oral liquid in bottle of 50 mL after 31 days of first opening the bottle.

Drugs and Foods to Avoid:

Ask your doctor or pharmacist before using any other medicine, including over-the-counter medicines, vitamins, and herbal products.

• Some medicines can affect how larotrectinib works. Tell your doctor if you are using efavirenz, fluconazole, itraconazole, midazolam, rifampin, St John's wort.
• Do not eat grapefruit or drink grapefruit juice while you are using this medicine.

Warnings While Using This Medicine:

• This medicine may cause birth defects if either partner is using it during conception or pregnancy. Tell your doctor right away if you or your 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. Use an effective form of birth control during treatment with this medicine and for at least 1 week after the last dose. Male patients with female partners should use an effective form of birth control during treatment and for 1 week after the last dose.
• Do not breastfeed during treatment with this medicine and for 1 week after the last dose.
• Tell your doctor if you have liver disease or brain or nerve problems.
• This medicine may cause the following problems:
  • Nervous system problems
  • Increase risk of bone fractures
  • Liver problems
• 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.
• Talk with your doctor before using this medicine if you plan to have children. Some women who use this medicine have become infertile (unable to have children).
• 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.
• Cancer medicine can cause nausea or vomiting, sometimes even after you receive medicine to prevent these effects. Ask your doctor or nurse about other ways to control any nausea or vomiting that might happen.
• Your doctor will do lab tests at regular visits to check on the effects of this medicine. Keep all appointments.
• Keep all medicine out of the reach of children. Never share your medicine with anyone.

Possible Side Effects While Using This Medicine:

Call your doctor right away if you notice any of these side effects:

• Allergic reaction: Itching or hives, swelling in your face or hands, swelling or tingling in your mouth or throat, chest tightness, trouble breathing
• Bone pain, changes in movement
• Confusion, dizziness, memory loss, mood or mental changes, sleep problems
• Dark urine or pale stools, nausea, vomiting, loss of appetite, stomach pain, yellow skin or eyes
• Fever, chills, cough, sore throat, body aches
• Numbness, tingling, or burning pain in your hands, arms, legs, or feet
• Unusual bleeding, bruising, tiredness, or weakness

If you notice these less serious side effects, talk with your doctor:

• Constipation, diarrhea
• Headache
• Increased weight
• Joint or muscle pain or weakness

If you notice other side effects that you think are caused by this medicine, tell your doctor

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