Vitrakvi

Many medications can cause side effects. A side effect is an unwanted response to a medication when it is taken in normal doses. Side effects can be mild or severe, temporary or permanent.

The side effects listed below are not experienced by everyone who takes Vitrakvi (Larotrectinib). If you are concerned about side effects, discuss the risks and benefits of Vitrakvi (Larotrectinib) with your doctor.

The following side effects have been reported by at least 1% of people taking Vitrakvi (Larotrectinib). Many of these side effects can be managed, and some may go away on their own over time.

Contact your doctor if you experience these side effects and they are severe or bothersome. Your pharmacist may be able to advise you on managing side effects.

• abdominal pain
• Constipation
• cough
• Diarrhea
• dizziness
• fatigue
• Fever
• headache
• loss of appetite
• muscle and joint aches or pain
• nausea
• shortness of breath
• stuffy nose
• swelling or pain in the arms, legs, hands, or feet
• vomiting
• weakness
• weight gain

Although most of the side effects listed below don't happen very often, they could lead to serious problems if you do not seek medical attention.

Check with your doctor as soon as possible if any of the following side effects occur:

• anxiety
• balance problems
• blood in the urine
• change in mental status, ability to concentrate
• difficulty speaking
• difficulty walking normally
• falls
• high blood pressure
• memory problems
• numbness or tingling in hands and feet
• signs of Anemia (low red blood cells; e.g., dizziness, pale skin, unusual tiredness or weakness, shortness of breath)
• signs of dehydration (e.g., decreased urine, dry skin, dry and sticky mouth, sleepiness, dizziness, headache, thirst, confusion)
• signs of infection (symptoms may include fever or chills, severe diarrhea, shortness of breath, prolonged dizziness, headache, stiff neck, weight loss, or listlessness)
• signs of liver problems (e.g., nausea, vomiting, diarrhea, loss of appetite, weight loss, yellowing of the skin or whites of the eyes, dark urine, pale stools)
• signs of clotting problems (e.g., unusual nosebleeds, bruising, blood in urine, coughing blood, bleeding gums, cuts that don't stop bleeding)
• signs of low potassium levels in the blood (e.g., weakness, fatigue, muscle cramps, irregular heartbeat)
• signs of low sodium levels in the blood (e.g., achy, stiff, or uncoordinated muscles; confusion; tiredness; weakness)
• signs of a skin infection (heat, redness, pain or tenderness on an area of skin)
• symptoms of low blood sugar (e.g., cold sweat, cool pale skin, headache, fast heartbeat, weakness)
• tremor

Stop taking the medication and seek immediate medical attention if any of the following occur:

• delirium
• signs of Stroke (e.g., sudden or severe headache; sudden loss of coordination; vision changes; sudden slurring of speech; or unexplained weakness, numbness, or pain in arm or leg)
• symptoms of blood infection (e.g., high fever, shaking, chills, weakness, fast heartbeat, fast breathing)

Some people may experience side effects other than those listed. Check with your doctor if you notice any symptom that worries you while you are taking Vitrakvi (Larotrectinib).

Capsule

25 mg
Each white opaque, hard gelatin capsule (size 2) with blue printing of "BAYER" cross and "25 mg" on the body of capsule, contains 25 mg of Vitrakvi (Larotrectinib). Nonmedicinal ingredients: gelatin printing ink (shellac, FD&C Blue No. 2 Aluminum Lake, titanium dioxide, propylene glycol, ammonia solution, dimethicone), and titanium dioxide.

100 mg
Each white opaque, hard gelatin capsule (size 0) with blue printing of "BAYER" cross and "100 mg" on the body of capsule, contains 100 mg of Vitrakvi (Larotrectinib). Nonmedicinal ingredients: gelatin printing ink (shellac, FD&C Blue No. 2 Aluminum Lake, titanium dioxide, propylene glycol, ammonia solution, dimethicone), and titanium dioxide.

Oral Solution

20 mg/mL
Each mL of clear yellow to orange liquid solution contains 20 mg of Vitrakvi (Larotrectinib). Nonmedicinal ingredients: bitterness masking flavour (propylene glycol, natural flavour), taste modifier flavour (propylene glycol, glycerol, natural flavour), hydroxypropyl betadex, natural bitterness masking type flavour (glycerol, natural flavor ingredients), natural masking type flavour (glycerol, natural flavour ingredients), Ora-SweetÒ (purified water, sucrose, glycerol, sorbitol, citric acid, sodium dihydrogen phosphate, flavouring and preservative agents methylparahydroxybenzoate and potassium sorbate), purified water, and sodium citrate.

Do not take Vitrakvi (Larotrectinib) if you are allergic to Vitrakvi (Larotrectinib) or any ingredients of the medication.

There may be an interaction between Vitrakvi (Larotrectinib) and any of the following:

• Abiraterone acetate
• alpha-blockers (e.g., Alfuzosin, Doxazosin, Silodosin, Tamsulosin)
• antiaarrythmics (e.g., Amiodarone, Dipyridamole, Disopyramide, dofetilide, Dronedarone, quinidine)
• anti-cancer medications (e.g., Cabazitaxel, Docetaxel, Doxorubicin, Etoposide, Ifosfamide, Irinotecan, Vincristine)
• antipsychotics (e.g., Aripiprazole, Brexpiprazole, Haloperidol, Lurasidone, Quetiapine)
• Apalutamide
• Aprepitant
• "azole" antifungals (e.g., fluconazole, ketoconazole, Voriconazole)
• benzodiazepines (e.g., Chlordiazepoxide, Clonazepam, Diazepam, Triazolam)
• Bicalutamide
• Bisoprolol
• Bosentan
• Buprenorphine
• Buspirone
• Calcitriol
• calcium channel blockers (e.g., Amlodipine, Diltiazem, Nifedipine, Verapamil)
• Carbamazepine
• Carvedilol
• chloroquine
• Cobicistat
• Colchicine
• conivaptan
• Cyclosporine
• Darifenacin
• Deferasirox
• Desipramine
• Dexamethasone
• Dihydroergotamine
• Elagolix
• Enzalutamide
• estrogens (e.g., conjugated estrogen, Estradiol, ethinyl estradiol)
• Fentanyl
• Flibanserin
• "gliptin" Diabetes medications (e.g., Linagliptin, Saxagliptin, Sitagliptin)
• grapefruit juice
• haloperidol
• Hepatitis C antivirals (dasabuvir, ombitasvir, paritaprevir)
• HIV non-nucleoside reverse transcriptase inhibitors (NNRTIs; e.g., efavirenz, etravirine, nevirapine)
• Idelalisib
• lidocaine
• Lomitapide
• Losartan
• lumacaftor
• macrolide antibiotics (e.g., clarithromycin, erythromycin)
• maraviroc
• Mefloquine
• Methadone
• mifepristone
• Mirtazapine
• Mitotane
• Modafinil
• nitrates (e.g., isosorbide dinitrate, isosorbide mononitrate)
• Oxycodone
• Phenobarbital
• Phenytoin
• phosphodiesterase 5 inhibitors (e.g., Sildenafil, Tadalafil, Vardenafil)
• Pimozide
• praziquantel
• primidone
• protein kinase inhibitors (e.g., Bosutinib, Crizotinib, Lapatinib)
• proton pump inhibitors (e.g., Lansoprazole, Omeprazole)
• quinine
• rifabutin
• rifampin
• St. John's wort
• salmeterol
• Sarilumab
• selective serotonin reuptake inhibitors (SSRIs; e.g., Citalopram, Fluoxetine, Paroxetine, Sertraline)
• Sirolimus
• Solifenacin
• "statin" anti-cholesterol medications (e.g., Atorvastatin, Lovastatin, Simvastatin)
• Stiripentol
• suvorexant
• Tacrolimus
• Tamoxifen
• tenofovir
• Trazodone
• Theophylline
• Tocilizumab
• Tolterodine
• Tolvaptan
• trazodone
• Zopiclone

If you are taking any of these medications, speak with your doctor or pharmacist. Depending on your specific circumstances, your doctor may want you to:

• stop taking one of the medications,
• change one of the medications to another,
• change how you are taking one or both of the medications, or
• leave everything as is.

An interaction between two medications does not always mean that you must stop taking one of them. Speak to your doctor about how any drug interactions are being managed or should be managed.

Medications other than those listed above may interact with Vitrakvi (Larotrectinib). Tell your doctor or prescriber about all prescription, over-the-counter (non-prescription), and herbal medications you are taking. Also tell them about any supplements you take. Since caffeine, alcohol, the Nicotine from cigarettes, or street drugs can affect the action of many medications, you should let your prescriber know if you use them.

Before you begin using a medication, be sure to inform your doctor of any medical conditions or Allergies you may have, any medications you are taking, whether you are pregnant or breast-feeding, and any other significant facts about your health. These factors may affect how you should use Vitrakvi (Larotrectinib).

Drowsiness/reduced alertness: Vitrakvi (Larotrectinib) may cause drowsiness or dizziness, affecting your ability to drive or operate machinery. Avoid driving, operating machinery, or performing other potentially hazardous tasks until you have determined how you are affected by Vitrakvi (Larotrectinib).

Kidney function: Kidney Disease or reduced kidney function may cause Vitrakvi (Larotrectinib) to build up in the body, causing side effects. If you have kidney problems, discuss with your doctor how Vitrakvi (Larotrectinib) may affect your medical condition, how your medical condition may affect the dosing and effectiveness of Vitrakvi (Larotrectinib), and whether any special monitoring is needed. Your doctor may want to test your liver function regularly with blood tests while you are taking Vitrakvi (Larotrectinib).

Liver function: Liver disease or reduced liver function may cause Vitrakvi (Larotrectinib) to build up in the body, causing side effects. If you have liver problems, discuss with your doctor how Vitrakvi (Larotrectinib) may affect your medical condition, how your medical condition may affect the dosing and effectiveness of Vitrakvi (Larotrectinib), and whether any special monitoring is needed. Your doctor may want to test your liver function regularly with blood tests while you are taking Vitrakvi (Larotrectinib).

Pregnancy: Vitrakvi (Larotrectinib) should not be used during pregnancy unless the benefits outweigh the risks. Women of childbearing age who are taking Vitrakvi (Larotrectinib) and women whose partners are taking Vitrakvi (Larotrectinib), should use an effective method of birth control, such as condoms, during treatment and for at least 1 month after stopping the medication. If you become pregnant while taking Vitrakvi (Larotrectinib), contact your doctor immediately.

Breast-feeding: It is not known if Vitrakvi (Larotrectinib) passes into breast milk. If you are a breast-feeding mother and are taking Vitrakvi (Larotrectinib), it may affect your baby. Talk to your doctor about whether you should continue breast-feeding.

Children: The safety and effectiveness of using Vitrakvi (Larotrectinib) have not been established for infants less than one month of age.