Larotrectinib Capsules

What is this medication?

LAROTRECTINIB (LAR oh TREK ti nib) treats some types of cancer. It works by blocking a protein that causes cancer cells to grow and multiply. This helps to slow or stop the spread of cancer cells.

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

COMMON BRAND NAME(S): VITRAKVI

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 medications, foods, dyes, or preservatives
• If you or your partner are pregnant or trying to get pregnant
• Breastfeeding

How should I use this medication?

Take this medication by mouth with water. Take it as directed on the prescription label at the same time every day. Do not cut, crush, or chew this medication. Swallow the capsules whole. You can take it with or without food. If it upsets your stomach, take it with food. Keep taking it unless your care team tells you to stop.

Do not take this medication with grapefruit juice.

Talk to your care team about the use of this medication in children. While it may be prescribed for children 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 unless it is less than 6 hours before the next dose. If it is less than 6 hours before the next dose, skip the missed dose. Take the next dose at the normal time.

If you vomit a dose, skip it. Take your next dose at the normal time. Do not take extra or 2 doses at the same time to make up for the missed dose.

What may interact with this medication?

• Apalutamide
• Benzodiazepines, such as midazolam, triazolam
• Calcium channel blockers, such as isradipine, nisoldipine, nicardipine
• Certain antibiotics, such as clarithromycin, chloramphenicol, telithromycin, dalfopristin, quinupristin
• Certain antivirals for HIV or AIDS
• Certain medications for cancer, such as doxorubicin, idelalisib, ixabepilone, mitotane, ribociclib, vinorelbine
• Certain medications for fungal infections, such as itraconazole, ketoconazole, posaconazole, voriconazole
• Certain medications for irregular heartbeat, such as disopyramide, dofetilide
• Certain medications for seizures, such as carbamazepine, fosphenytoin, phenytoin, phenobarbital, primidone
• Conivaptan
• Eliglustat
• Ergot alkaloids, such as dihydroergotamine, ergotamine
• Flibanserin
• Grapefruit juice
• Lomitapide
• Lumacaftor and ivacaftor
• Medications that lower your chance of fighting infection, such as cyclosporine, sirolimus, tacrolimus
• Mifepristone
• Opioids
• 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?

Your condition will be monitored carefully while you are receiving this medication. You may need blood work while taking this medication.

This medication may affect your coordination, reaction time, or judgment. Do not drive or operate machinery until you know how this medication affects you. Sit up or stand slowly to reduce the risk of dizzy or fainting spells. Drinking alcohol with this medication can increase the risk of these side effects.

Talk to your care team if you may be pregnant. Serious birth defects can occur if you take this medication during pregnancy and for 1 week after the last dose. You will need a negative pregnancy test before starting this medication. Contraception is recommended while taking this medication and for 1 week after the last dose. Your care team can help you find the option that works for you.

If your partner can get pregnant, use a condom during sex while taking this medication and for 1 week after the last dose.

Do not breastfeed while taking this medication and for 1 week after the last dose.

This medication may cause infertility. Talk to your care team 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 care team as soon as possible:

• Allergic reactions—skin rash, itching, hives, swelling of the face, lips, tongue, or throat
• Liver injury—right upper belly pain, loss of appetite, nausea, light-colored stool, dark yellow or brown urine, yellowing skin or eyes, unusual weakness or fatigue
• Mood and behavior changes—anxiety, nervousness, confusion, hallucinations, irritability, hostility, thoughts of suicide or self-harm, worsening mood, feelings of depression
• Pain, tingling, or numbness in the hands or feet, muscle weakness, change in vision, confusion or trouble speaking, loss of balance or coordination, trouble walking, seizures

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

• Bone, joint, or muscle pain
• Constipation
• Diarrhea
• Dizziness
• Nausea
• Unusual weakness or fatigue
• Trouble sleeping

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 and pets.

Store at room temperature between 20 and 25 degrees C (68 and 77 degrees F). Get rid of any unused medication after the expiration date.

To get rid of medications that are no longer needed or have expired:

• Take the medication to a medication take-back program. Check with your pharmacy or law enforcement to find a location.
• If you cannot return the medication, check the label or package insert to see if the medication should be thrown out in the garbage or flushed down the toilet. If you are not sure, ask your care team. If it is safe to put it in the trash, take the medication out of the container. Mix the medication with cat litter, dirt, coffee grounds, or other unwanted substance. Seal the mixture in a bag or container. Put it in the trash.

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.