Description
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.
This product is available in the following dosage forms:
- Capsule
- Solution
Before Using
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.
Pediatric
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.
Geriatric
Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of larotrectinib in the elderly.
Breastfeeding
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.
Drug Interactions
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 not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.
- Bacillus of Calmette and Guerin Vaccine, Live
- Dengue Tetravalent Vaccine, Live
- Measles Virus Vaccine, Live
- Mumps Virus Vaccine, Live
- Rubella Virus Vaccine, Live
- Smallpox Monkeypox Vaccine
- Typhoid Vaccine
- Varicella Virus Vaccine
- Yellow Fever Vaccine
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
- Adenovirus Vaccine Type 4, Live
- Adenovirus Vaccine Type 7, Live
- Alfentanil
- Alprazolam
- Amiodarone
- Apalutamide
- Aprepitant
- Atazanavir
- Avacopan
- Avanafil
- Avapritinib
- Bedaquiline
- Benzhydrocodone
- Boceprevir
- Bosentan
- Bosutinib
- Budesonide
- Buprenorphine
- Buspirone
- Carbamazepine
- Cenobamate
- Cholera Vaccine
- Ciprofloxacin
- Clarithromycin
- Clozapine
- Cobicistat
- Cobimetinib
- Codeine
- Colchicine
- Conivaptan
- Crizotinib
- Cyclosporine
- Darifenacin
- Darunavir
- Dasatinib
- Dihydrocodeine
- Dihydroergotamine
- Diltiazem
Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.
- Mavacamten
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
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 and patient instructions. 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.
To use the oral liquid:
- 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.
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.
- For solid tumors:
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 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.
Precautions
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
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.
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