Vitrakvi

Vitrakvi is a prescription medication used to treat adults and children with solid tumors caused by certain abnormal neurotrophic receptor tyrosine kinase (NTRK) genes. 

Vitrakvi belongs to a group of drugs called kinase inhibitors. These work by stopping the growth and survival of cancer by binding to specific receptor enzymes on the cancer cells and stopping the receptor signaling activity.

Vitrakvi is supplied as both a capsule and an oral solution. It is taken twice daily, with or without food. Do not chew, divide, or break Vitrakvi capsules. Swallow capsules whole.

Common side effects include severe nausea, vomiting, and cough. Vitrakvi can also cause severe tiredness (fatigue) and dizziness. Do not drive or operate heavy machinery until you know how Vitrakvi affects you.

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

• are caused by certain abnormal 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.

It is not known if Vitrakvi is safe and effective in children younger than 1 month of age.

This medication may be prescribed for other uses. Ask your doctor or pharmacist for more information.

Serious side effects have been reported with Vitrakvi. See the “Vitrakvi Precautions” section.

The most common side effects of Vitrakvi include:

• tiredness
• nausea
• dizziness
• vomiting
• cough
• constipation
• diarrhea

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.

This is not a complete list of Vitrakvi side effects. Ask your doctor or pharmacist for more information.

Tell your doctor if you have any side effects that bother you or that do not go away. Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

Tell your doctor about all the medicines you take, including prescription and non-prescription medicines, vitamins, and herbal supplements. Especially tell your doctor if you take:

• Medications that block a protein in the body (CYP3A4) such as some macrolide antibiotics (clarithromycin, telithromycin), some HIV protease inhibitors (indinavir, nelfinavir, ritonavir, saquinavir), some HCV protease inhibitors (boceprevir, telaprevir), some azole antifungals (ketoconazole, itraconazole, posaconazole, voriconazole), delavirdine (Rescriptor), and nefazodone.

• Medications that increase the activity of the enzyme CYP3A4 such as carbamazepine (Tegretol, Equetro, Carbatrol), phenobarbital, phenytoin (Dilantin), rifampin (Rifadin), and St John's wort

• Medications that use the enzyme CYP3A4 such as budesonide (Entocort), cyclosporine (Neoral, Gengraf, Sandimmune), darifenacin (Enablex), dihydroergotamine (Migranal), fentanyl (Abstral, Fentora, Onsolis, Actiq), pimozide (Orap), quinidine (Cardioquin, Duraquin, Quinact), sirolimus (Rapamune), tacrolimus (Prograf), terfenadine (Seldane), fluticasone (Flovent HFA, Flonase), eletriptan (Relpax), lovastatin (Mevacor), quetiapine (Seroquel), sildenafil (Viagra, Revatio), and simvastatin (Zocor)

This is not a complete list of Vitrakvi drug interactions. Ask your doctor or pharmacist for more information.

Serious side effects have been reported with Vitrakvi including the following:

• Nervous system problems. Tell your healthcare provider if you develop any symptoms such as confusion, difficulty speaking, dizziness, coordination problems, tingling, numbness, or burning sensation in your hands and feet. Your healthcare provider may temporarily stop treatment, decrease your dose, or permanently stop Vitrakvi if you develop symptoms of a nervous system problem with Vitrakvi.

• Liver problems. Your healthcare provider will do blood tests to check your liver function during treatment with Vitrakvi. Tell your healthcare provider right away if you develop symptoms of liver problems including: loss of appetite, nausea or vomiting, or pain on the upper right side of your stomach area. Your healthcare provider may temporarily stop treatment, decrease your dose, or permanently stop Vitrakvi if you develop liver problems with 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.

• Do not take Vitrakvi if you are allergic to Vitrakvi or to any of its ingredients.

Medications can interact with certain foods. In some cases, this may be harmful and your doctor may advise you to avoid certain foods. In the case of Vitrakvi, there are no specific foods that you must exclude from your diet when receiving this medication.

Before taking Vitrakvi, tell your doctor about all of your medical conditions. Especially tell your doctor if you:

• have liver problems
• have nervous system (neurological) problems
• are pregnant or plan to become pregnant. Vitrakvi can harm your unborn baby. You should not become pregnant during treatment with Vitrakvi.
  • If you are able to become pregnant, your healthcare provider may do a pregnancy test before you start treatment with Vitrakvi.
  • Females who are able to become pregnant should use effective birth control (contraception) during treatment and for at least 1 week after the final 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 should use effective birth control during treatment with Vitrakvi and for at least 1 week after the final 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 doctor about all the medicines you take including prescription and non-prescription medicines, vitamins, and herbal supplements.

Tell your doctor if you are pregnant or plan to become pregnant. 

Vitrakvi can harm your unborn baby. You should not become pregnant during treatment with Vitrakvi.

• If you are able to become pregnant, your healthcare provider may do a pregnancy test before you start treatment with Vitrakvi.
• Females who are able to become pregnant should use effective birth control (contraception) during treatment and for at least 1 week after the final 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 should use effective birth control during treatment with Vitrakvi and for at least 1 week after the final dose of Vitrakvi.

There are no well-controlled studies that have been done in pregnant women. In animal studies, pregnant animals were given this medication and had some babies born with problems. Based on how the medication works, Vitrakvi can cause harm to human unborn babies when given to pregnant women. Talk to your healthcare provider about risks to your unborn baby from using Vitrakvi.

Tell your doctor if you 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.

• Take Vitrakvi exactly as your healthcare provider tells you.

• Your healthcare provider may stop treatment or change your dose of Vitrakvi if you have side effects. 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 and oral syringes or send you to a pharmacy that can provide you with Vitrakvi oral solution and oral syringes.
  • 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. 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 unless your next scheduled dose is due within 6 hours. Take the next dose at your regular time.​​​​​​

Take this medication exactly as prescribed by your doctor. Follow the directions on your prescription label carefully.

The dose your doctor recommends may be based on the following:

• the condition being treated
• other medical conditions you have
• other medications you are taking
• how you respond to this medication
• your weight
• your height

The recommended dose of Vitrakvi (larotrectinib) for the treatment of certain solid tumors is 100 mg twice daily for adults and children with body surface area 1.0 m² or greater. The recommended dose for adults and children children with body surface area less than 1.0 m² is 100 mg per m² (100 mg multiplied by body surface area less than 1.0 m²).

If you take too much Vitrakvi, call your healthcare provider or local Poison Control Center, or seek emergency medical attention right away.

• 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 remaining after 90 days of first opening the bottle.

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