Larotrectinib oral solution

What is this medication?

LAROTRECTINIB (lar oh trek ti nib) is a medicine that targets proteins in cancer cells and stops the cancer cells from growing. It is used to treat neurotrophic receptor tyrosine kinase gene fusion-positive solid tumors.

This medicine may be used for other purposes; ask your health care provider or pharmacist if you have questions.

COMMON BRAND NAME(S): VITRAKVI Solution

What should I tell my care team before I take this medication?

They need to know if you have any of these conditions:

• liver disease
• tingling of the fingers or toes, or other nerve disorder
• an unusual or allergic reaction to larotrectinib, other medicines, foods, dyes, or preservatives
• pregnant or trying to get pregnant
• breast-feeding

How should I use this medication?

Take this medicine by mouth. Follow the directions on the prescription label. Use a specially marked oral syringe to measure each dose. Ask your pharmacist if you do not have one. Household spoons are not accurate. Refer to the patient Instructions for Use for detailed instructions. You can take this medicine with or without food. Do not take with grapefruit juice. Take your medicine at regular intervals. Do not take it more often than directed. Do not stop taking except on your doctor's advice.

Talk to your pediatrician regarding the use of this medicine in children. While this drug may be prescribed for children as young as 28 days for selected conditions, precautions do apply.

Overdosage: If you think you have taken too much of this medicine contact a poison control center or emergency room at once.

NOTE: This medicine is only for you. Do not share this medicine with others.

What if I miss a dose?

If you miss a dose, take it as soon as you can. If your next dose is to be taken in less than 6 hours, then do not take the missed dose. Take the next dose at your regular time. Do not take double or extra doses.

What may interact with this medication?

This medicine may interact with the following medications:

• antiviral medicines for HIV or AIDS
• apalutamide
• certain antibiotics like clarithromycin, chloramphenicol, telithromycin, and dalfopristin; quinupristin
• certain antiarrhythmic agents like disopyramide and dofetilide
• certain chemotherapy like doxorubicin, idelalisib, ixabepilone, mitotane, ribociclib, and vinorelbine
• certain calcium channel blockers like isradipine, nisoldipine, and nicardipine
• certain ergot alkaloids like dihydroergotamine and ergotamine
• certain immunosuppressive agents like cyclosporine, sirolimus, and tacrolimus
• certain medicines for fungal infections like itraconazole, ketoconazole, posaconazole, and voriconazole
• certain medicines for seizures like carbamazepine, fosphenytoin/phenytoin, phenobarbital, and primidone
• certain sedatives like midazolam and triazolam
• conivaptan
• eliglustat
• flibanserin
• grapefruit juice
• lomitapide
• lumacaftor; ivacaftor
• mifepristone
• narcotic medicines for pain
• nefazodone
• rifampin
• St.John's Wort

This list may not describe all possible interactions. Give your health care provider a list of all the medicines, herbs, non-prescription drugs, or dietary supplements you use. Also tell them if you smoke, drink alcohol, or use illegal drugs. Some items may interact with your medicine.

What should I watch for while using this medication?

You may need blood work done while you are taking this medicine.

Do not drive, use machinery, or do anything that needs mental alertness until you know how this medicine affects you.

Do not become pregnant while taking this medicine or for a least 1 week after stopping it. Women should inform their healthcare professional if they wish to become pregnant or think they might be pregnant. Men should not father a child while taking this medicine or for at least 1 week after stopping it. There is a potential for serious effects to an unborn child. Talk to your healthcare professional for more information.

Do not breast-feed an infant while taking this medicine or for 1 week after stopping it.

This medicine may make it more difficult to get pregnant. Talk to your healthcare professional if you are concerned about your fertility.

What side effects may I notice from receiving this medication?

Side effects that you should report to your doctor or health care professional as soon as possible:

• allergic reactions like skin rash, itching or hives, swelling of the face, lips, or tongue
• confusion
• dizziness
• loss of balance or coordination
• pain, tingling, numbness in the hands or feet
• signs and symptoms of liver injury like dark yellow or brown urine; general ill feeling or flu-like symptoms; light-colored stools; loss of appetite; nausea; right upper belly pain; unusually weak or tired; yellowing of the eyes or skin
• trouble speaking

Side effects that usually do not require medical attention (report these to your doctor or health care professional if they continue or are bothersome):

• constipation
• cough
• diarrhea
• tiredness
• vomiting

This list may not describe all possible side effects. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Where should I keep my medication?

Keep out of the reach of children.

Store in the refrigerator between 2 and 8 degrees C (36 and 46 degrees F). Do not freeze. Throw away any unused medicine after 90 days.

NOTE: This sheet is a summary. It may not cover all possible information. If you have questions about this medicine, talk to your doctor, pharmacist, or health care provider.