Lytgobi
Generic name: futibatinib
Dosage form: tablets
Drug class: Multikinase inhibitors
What is Lytgobi?
Lytgobi is a prescription medicine that is used to treat bile duct cancer (intrahepatic cholangiocarcinoma) in adults who have a certain type of abnormal FGFR2 gene.
Lytgobi is a fibroblast growth factor receptor (FGFR) inhibitor that works to stop cancer cells growing and multiplying.
What is Lytgobi used to treat?
Lytgobi is used to treat bile duct cancer that has spread or cannot be removed by surgery.
It is used in patients who have already received a previous treatment, and whose tumor has a certain type of abnormal FGFR2 gene.
Your healthcare provider will test your cancer for a certain type of abnormal FGFR2 gene and make sure that Lytgobi is right for you.
It is not known if this medicine is safe and effective in children.
Before taking Lytgobi
Before you start treatment, tell your healthcare provider about all of your medical conditions, including if you:
- have vision or eye problems.
- are pregnant or plan to become pregnant. Lytgobi can harm your unborn baby or cause loss of your pregnancy (miscarriage). You should not become pregnant during treatment.
Females who can become pregnant:- Your healthcare provider should do a pregnancy test before you start treatment.
- You should use an effective method of birth control during treatment, and for one week after your final dose. Talk to your healthcare provider about birth control methods that may be right for you.
- Tell your healthcare provider right away if you become pregnant or think that you may be pregnant.
Males with female partners who can become pregnant:
-
- You should use effective birth control when sexually active during treatment, and for one week after your last dose.
- are breastfeeding or plan to breastfeed. It is not known if Lytgobi passes into your breast milk. Do not breastfeed during treatment, and for one week after your last dose.
What other drugs will affect Lytgobi?
Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Lytgobi when taken together with other medicines may interact, affecting how well each one works, and may also cause side effects.
Especially tell your doctor if you take:
- ketoconazole, itraconazole, or posaconazole;
- clarithromycin;
- carbamazepine;
- phenytoin or fosphenytoin;
- cobicistat or cobicistat-containing coformulations;
- ritonavir or ritonavir-containing coformulations;
- rifampin or rifampin-containing coformulations;
- apalutamide;
- tucatinib; or
- levoketoconazole.
How should I take Lytgobi?
- Take Lytgobi tablets exactly as your healthcare provider tells you.
- Take the tablets one time each day with or without food at about the same time each day. You will continue for as long as your healthcare provider tells you to.
- Swallow the tablets whole. Do not crush, chew, split, or dissolve the tablets. Tell your healthcare provider if you have problems swallowing the tablets whole.
- You should not eat or drink grapefruit products during your treatment.
- Your healthcare provider may change your dose, or may temporarily or completely stop treatment if you get certain side effects.
- If you miss a dose, you can take the missed dose within 12 hours on the same day. If more than 12 hours have passed, do not make up the dose. Take your regular dose the next day at the usual time.
- Do not take more Lytgobi than prescribed to make up for the missed dose.
- If you vomit after taking your dose, do not take another dose. Take your regular dose the next day at the usual time.
Dosing information
Usual Adult Dose for Cholangiocarcinoma
- 20 mg orally (five 4 mg tablets) once daily.
Comments: continue treatment until disease progression or unacceptable toxicity occurs. Confirm the presence of an FGFR2 gene fusion or other rearrangement prior to initiation of treatment.
Use: treatment of adult patients with previously treated, unresectable, locally advanced or metastatic intrahepatic cholangiocarcinoma harboring fibroblast growth factor receptor 2 (FGFR2) gene fusions or other rearrangements. This indication is approved under accelerated approval based on overall response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s).
Lytgobi side effects
Lytgobi may cause serious side effects, including:
Eye problems. Certain eye problems are common with Lytgobi but can also be serious. Eye problems include dry eye or inflamed eyes, inflamed cornea (front part of the eye), increased tears, and a disorder of the retina (an internal part of the eye). You will need to see an eye specialist for a complete eye exam before you begin treatment, every 2 months for the first 6 months, and every 3 months thereafter during treatment.
- Tell your healthcare provider right away if you develop any changes in your vision during treatment, including blurred vision, flashes of light, or seeing black spots. You may need to see an eye specialist right away.
- You should use artificial tears or substitutes, or hydrating or lubricating eye gels during treatment to prevent or treat dry eyes.
High phosphate levels in your blood (hyperphosphatemia) and build up of minerals in different tissues in your body. Hyperphosphatemia is common with Lytgobi but can also be serious. High levels of phosphate in your blood may lead to buildup of minerals such as calcium, in different tissues in your body . Your healthcare provider will check your blood phosphate levels during treatment.
- Your healthcare provider may prescribe changes in your diet or phosphate lowering therapy, or change, interrupt or stop treatment if needed.
- Tell your healthcare provider right away if you develop any muscle cramps, or numbness or tingling around your mouth.
Lytgobi side effects
The most common side effects include:
- changes in kidney function blood tests
- increased blood glucose level
- decreased red blood cell, white blood cell, and platelet counts
- increased calcium level in the blood
- decreased sodium and phosphate levels in the blood
- changes in liver function blood tests
- nails separate from the bed or poor formation of the nail; change in the color of nails
- muscle pain
- constipation
- diarrhea
- feeling tired or weak
- changes in tests used to measure your blood clotting time
- dry mouth
- hair loss
- decreased protein level (albumin) in the blood
- mouth sores
- stomach area (abdominal) pain
- dry skin
- decreased glucose and potassium level in the blood
- joint pain
- changes in sense of taste
- dry eye
- nausea
- decrease in appetite
- urinary tract infection
- redness, swelling, peeling or tenderness, mainly on the hands or feet (hand-foot syndrome)
- vomiting
These are not all the possible side effects. For more information, ask your healthcare provider or pharmacist.
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 Lytgobi?
- Store the tablets at room temperature between 68°F to 77°F (20°C to 25°C).
Keep all medicines out of the reach of children and pets.
General information about the safe and effective use of Lytgobi.
Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. Do not use this medicine for a condition for which it is not prescribed. Do not give it to other people, even if they have the same symptoms you have. It may harm them. If you would like more information, talk with your healthcare provider.
You can ask your pharmacist or healthcare provider for information that is written for healthcare professionals.
What are the ingredients in Lytgobi?
Active ingredient: futibatinib
Inactive ingredients: corn starch, crospovidone, hydroxypropyl cellulose, lactose monohydrate, magnesium stearate, mannitol, microcrystalline cellulose, and sodium lauryl sulfate.
The film coating material contains: hypromellose, magnesium stearate, polyethylene glycol, and titanium dioxide.
References
More about Lytgobi (futibatinib)
- Check interactions
- Imprints, shape & color data
- Side effects
- Dosage information
- During pregnancy
- FDA approval history
- Drug class: multikinase inhibitors
Patient resources
Related treatment guides
Further information
Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.