Patient information: uses, side effects, how to take - Vitrakvi

What is VITRAKVI?

VITRAKVI is a prescription medicine that is used to treat adults and children with solid tumors (cancer) that:

are caused by certain abnormal neurotrophic receptor tyrosine kinase (NTRK) genes and
have spread or if surgery to remove their cancer is likely to cause severe complications, and
there is no acceptable treatment option or the cancer grew or spread on other treatment.

Your healthcare provider will perform a test to make sure that VITRAKVI is right for you.

Before taking VITRAKVI, tell your healthcare provider about all of your medical conditions, including if you:

have liver problems
have nervous system (neurological) problems

are pregnant or plan to become pregnant. VITRAKVI can harm your unborn baby. Tell your healthcare provider right away if you become pregnant during treatment with VITRAKVI or think you may be pregnant.
Females who are able to become pregnant:
- Your healthcare provider may do a pregnancy test before you start treatment with VITRAKVI.
- You should use effective birth control (contraception) during treatment and for 1 week after the last dose of VITRAKVI. Talk to your healthcare provider about birth control methods that may be right for you.
Males with female partners who are able to become pregnant:
- You should use effective birth control during treatment with VITRAKVI and for 1 week after the last dose of VITRAKVI.
are breastfeeding or plan to breastfeed. It is not known if VITRAKVI passes into your breast milk. Do not breastfeed during treatment and for 1 week after the last dose of VITRAKVI.

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

Taking VITRAKVI with certain other medicines may affect the amount of VITRAKVI or other medicines in your blood and may cause side effects or affect the way that VITRAKVI works.

Know the medicines you take. Keep a list of them to show your healthcare provider and pharmacist when you get a new medicine.

How should I take VITRAKVI?

Take VITRAKVI exactly as your healthcare provider tells you.
Do not change your dose or stop taking VITRAKVI unless your healthcare provider tells you.
VITRAKVI comes in capsules and as an oral solution.
If your healthcare provider prescribes VITRAKVI oral solution:
- Your healthcare provider will provide you with the VITRAKVI oral solution, oral syringes and bottle adaptors or send you to a pharmacy that can provide you with VITRAKVI oral solution, oral syringes and bottle adaptors.
- Your healthcare provider should show you how to correctly measure and give a dose of VITRAKVI oral solution.
- See the detailed Instructions for Use that comes with VITRAKVI oral solution for information about the correct way to measure and give a dose of VITRAKVI oral solution. If you have any questions, talk to your healthcare provider or pharmacist.
VITRAKVI is usually taken by mouth 2 times a day.
Swallow VITRAKVI capsules whole with water. Do not chew or crush the capsules.
Take VITRAKVI with or without food.
If you vomit after taking a dose of VITRAKVI, wait and take the next dose at your scheduled time.
If you miss a dose of VITRAKVI, take it as soon as you remember. If your next scheduled dose is due within 6 hours, skip the missed dose and take your next dose at your regularly scheduled time.
If you take too much VITRAKVI, call your healthcare provider or go to the nearest hospital emergency room right away.

What should I avoid while taking VITRAKVI?

VITRAKVI can make you feel dizzy. Do not drive or operate machinery until you know how VITRAKVI affects you.
Avoid taking St. John's wort, eating grapefruit, or drinking grapefruit juice during treatment with VITRAKVI.

What are the possible side effects of VITRAKVI?

VITRAKVI may cause serious side effects, including:

Central nervous system (CNS) problems. VITRAKVI may cause dizziness, confusion, problems with concentration, attention, and memory, changes in your mood, and sleep problems. Tell your healthcare provider if you develop any of these symptoms or they get worse.
Bone fractures. Bone fractures can happen with VITRAKVI. Tell your healthcare provider if you develop pain, changes in your ability to move around, or bone abnormalities.
Liver problems. Abnormal liver blood tests may occur with VITRAKVI and can sometimes become serious. Your healthcare provider will do blood tests to check your liver function before starting and during treatment with VITRAKVI as needed. Tell your healthcare provider right away if you develop new or worsening symptoms of liver problems including:

yellowing of your skin or the white part of your eyes (jaundice)
dark or brown urine
pain in the upper right side of your stomach area (abdomen)

bruising or bleeding more easily than normal
tiredness
nausea or vomiting
loss of appetite

Your healthcare provider may decrease your dose, temporarily stop or permanently stop your treatment with VITRAKVI if you develop serious side effects.

The most common side effects of VITRAKVI include:

increase in certain liver blood tests
low red blood cell and white blood cell counts
low levels of protein called albumin in the blood
muscle and bone pain
increased levels of enzyme called alkaline phosphatase in the blood (test for liver or bone problems)
low levels of calcium in the blood
tiredness
vomiting

cough
constipation
fever
diarrhea
nausea
stomach (abdomen) pain
dizziness
rash

VITRAKVI may affect fertility in females and may affect your ability to become pregnant. Talk to your healthcare provider if this is a concern for you.

These are not all the possible side effects with VITRAKVI. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

How should I store VITRAKVI?

Store VITRAKVI capsules at room temperature between 68˚F to 77˚F (20˚C to 25˚C).
Store VITRAKVI oral solution in the refrigerator between 36° F to 46° F (2° C to 8° C). Do not freeze.
Throw away (dispose of) any unused VITRAKVI oral solution:
- Bottle of 100 mL: remaining 90 days after first opening the bottle
- Bottle of 50 mL: remaining 31 days after first opening the bottle

Keep VITRAKVI and all medicines out of the reach of children.

General information about the safe and effective use of VITRAKVI.

Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. Do not use VITRAKVI for a condition for which it was not prescribed. Do not give VITRAKVI to other people, even if they have the same symptoms that you have. It may harm them. You can ask your healthcare provider or pharmacist for more information about VITRAKVI that is written for health professionals.

What are the ingredients in VITRAKVI?

Active ingredient: larotrectinib

Inactive ingredients:

Capsule: gelatin, titanium dioxide and edible ink

Oral Solution Packaged in One Bottle Containing 100 mL: purified water, hydroxypropyl betadex, sucrose, glycerin, sorbitol, citric acid, sodium phosphate, sodium citrate dihydrate, propylene glycol and flavoring. Preserved with methylparaben and potassium sorbate.

Oral Solution Packaged in Two Bottles Each Containing 50 mL: purified water, hydroxypropyl betadex, sucralose, sodium citrate, strawberry flavor, and citric acid. Preserved with sodium benzoate.

Manufactured for Bayer HealthCare Pharmaceuticals Inc., Whippany, NJ 07981

For more information, go to www.VITRAKVI.com or call 1-888-842-2937

INSTRUCTIONS FOR USE

VITRAKVI (vi trak vee)

(larotrectinib)

oral solution

Read this Instructions for Use before you take or give a dose of VITRAKVI oral solution for the first time and each time you get a refill. There may be new information. This information does not take the place of talking with your healthcare provider about your medical condition or your treatment.

Your healthcare provider should show you how to correctly measure the prescribed dose of VITRAKVI oral solution before you take or give a dose for the first time.

Important information about measuring VITRAKVI oral solution:

Always use the oral syringes provided with VITRAKVI to make sure that you correctly measure the prescribed dose.
When you receive VITRAKVI oral solution from your healthcare provider or pharmacist, you will get a box that contains VITRAKVI oral solution. You may receive more than 1 box of VITRAKVI oral solution.
Your healthcare provider or pharmacist will also provide you bottle adaptors and syringes. You will receive one bottle adaptor per bottle of VITRAKVI oral solution. After inserting the bottle adaptor into the bottle, do not remove the bottle adaptor.
You will receive five 1 mL or 5 mL oral syringes that are marked to help you correctly measure the prescribed dose of VITRAKVI oral solution. Each oral syringe may be used over a 7-day period. Do not use a household teaspoon to measure the dose.

Supplies needed to take or give a dose of VITRAKVI oral solution

Figure A

How to prepare a dose of VITRAKVI oral solution:

Step 1: Remove the VITRAKVI oral solution bottle from the box. Place the bottle on a flat work surface. Open the bottle by pushing down firmly on the child-resistant cap and turning it in the direction of the arrow (counter-clockwise) See Figure B . Do not throw away the child-resistant cap.

Figure B

Step 2: Insert the bottle adaptor by pressing it into the bottle neck and make sure it is secure. See Figure C . Do not remove the bottle adaptor. If the bottle adaptor is missing, talk to your healthcare provider.

Figure C

Step 3: Remove the oral syringe from the wrapper. Throw the wrapper away in your household trash. Look at the markings on the barrel of the oral syringe and find the marking that matches the VITRAKVI oral solution dose in mL prescribed by your healthcare provider. See Figure D .

Figure D

Step 4: With the bottle on your flat work surface, use 1 hand to hold the bottle upright. Using your other hand, push the air out of the oral syringe by pushing the plunger down. Then, insert the tip of the oral syringe into the bottle adaptor at the top of the bottle. See Figure E . The tip of the oral syringe should fit snugly into the hole of the bottle adaptor.

Figure E

Step 5: Use 1 hand to hold the oral syringe in place. With the other hand, turn the bottle upside down. Pull back on the plunger until the top of the plunger lines up with the marking on the barrel of the oral syringe that matches the dose of VITRAKVI oral solution prescribed by your healthcare provider. See Figure F. Your dose may be different than the dose shown in Figure F.

Figure F

Step 6: Check for air bubbles in the oral syringe. If you see air bubbles, push up gently on the plunger to push any large air bubbles back into the bottle. Then, pull back on the plunger to the prescribed dose. See Figure G.

Figure G

Step 7: Turn the bottle upright again and place it on your work surface. Remove the oral syringe from the bottle adaptor by gently pulling up on the syringe barrel. See Figure H . Do not push on the plunger during this step. The bottle adaptor should stay attached to the bottle.

Figure H

Giving a dose of VITRAKVI oral solution by mouth:

Step 8: Place the tip of the oral syringe into the child's mouth against the inside of the cheek. Slowly squirt VITRAKVI oral solution into the mouth by pressing down on the plunger and allow the child to swallow. See Figure I.

The child should be kept in an upright position for a few minutes right after giving a dose of VITRAKVI.
If the child spits up a dose or you are not sure the entire dose was given, do not give another dose. Wait until the next scheduled dose.

Figure I

Step 9: Replace the child-resistant cap on the bottle of VITRAKVI oral solution. Do not remove the bottle adaptor. Close the bottle by turning the bottle cap in the direction of the arrow (clockwise). See Figure J .

Figure J

Cleaning instructions for oral syringes

Follow the instructions below for cleaning the oral syringe (Step 10 through Step 16). After 7 days of use, throw away the oral syringe in your household trash. Use a new oral syringe for the next 7 days.

Step 10: Remove plunger from the barrel of the oral syringe. See Figure K .

Figure K

Step 11: Rinse the barrel and plunger in warm running water to help make sure that all of the medicine has been removed from the oral syringe. See Figure L. Do not boil the oral syringe.

Figure L

Step 12: Re-insert the plunger into the barrel of the oral syringe. See Figure M.

Figure M

Step 13: Draw warm water several times into the oral syringe and squirt out again until all of the medicine has been removed from the oral syringe. See Figure N.

Figure N

Step 14: Repeat steps 10 and 11 to rinse the barrel and plunger again with warm water. See Figure O .

Figure O

Step 15: Shake off excess water or wipe off the outside. See Figure P . Place the barrel and plunger on a clean, dry paper towel to dry.

Figure P

Step 16: Repeat step 12 to assemble the oral syringe and store in a clean place until the next use.

Replace the oral syringe after 7 days of use, or if:

there is any damage to the barrel, plunger, or tip
the dosage marking is no longer clearly recognizable or
it becomes difficult to move the plunger

How should I store VITRAKVI oral solution?

Store VITRAKVI oral solution in a refrigerator between 36° F to 46° F (2° C to 8° C). Do not freeze.
Write the date that you opened the bottle of VITRAKVI oral solution on the bottle. See Figure Q.
Throw away (dispose of) any unused VITRAKVI oral solution:
- Bottle of 100 mL: remaining 90 days after first opening the bottle
- Bottle of 50 mL: remaining 31 days after first opening the bottle

Keep VITRAKVI oral solution and all medicines out of the reach of children.

Figure Q

Talk to your healthcare provider if you have questions about how to use VITRAKVI oral solution.

For more information, go to www.VITRAKVI.com or call 1-888-842-2937.

This Instructions for Use has been approved by the U.S. Food and Drug Administration.