Overview: Lyrfigtu is used to treat certain people with bile duct cancer. It works by blocking a protein that sends signals which lead to the growth and survival of cancer cells. Common side effects may include nail problems, mouth sores, hair loss, dry mouth and skin, tiredness, stomach problems, and numbness, redness, or pain in the palms of the hands and soles of the feet. Lyrfigtu may also cause severe eye problems, so tell your health care provider right away if you have any vision changes. Lyrfigtu is a capsule that is taken by mouth.
Uses
What is Lyrfigtu used for?
Lyrfigtu (lirafugratinib) is commonly used to treat certain types of bile duct cancer (cholangiocarcinoma).
How Lyrfigtu Treats Cholangiocarcinoma With an FGFR2 Gene Fusion
Lyrfigtu may also be used for other conditions as determined by your health care provider.
How does Lyrfigtu work (mechanism of action)?
Lyrfigtu is a type of medicine known as a kinase inhibitor. It attaches to a protein called fibroblast growth factor receptor 2 (FGFR2). FGFR2 sends signals that lead to the growth and survival of cancer cells. Some people with bile duct cancer have changes in FGFR2 that cause it to be too active. By attaching to and blocking FGFR2, Lyrfigtu can help prevent cancer cells from growing and surviving.
How is Lyrfigtu supplied (dosage forms)?
Brands and other names
- Lyrfigtu
Dosage forms and strengths
- 20 mg and 30 mg oral capsules
How should I store Lyrfigtu?
Lyrfigtu should be stored at room temperature, between 68 F and 77 F (20 C and 25 C). It can be exposed to temperatures between 59 F and 86 F (15 C and 30 C) for shorter periods of time, such as when transporting it. Store in a cool, dry place.
Side Effects
What are the most common side effects of Lyrfigtu?
The most common side effects of Lyrfigtu are listed below. Tell your health care provider if you have any of these side effects that bother you.
- Nail problems
- Numbness, tingling, redness, discoloration, swelling, or pain in the palms of your hands and soles of your feet (hand-foot syndrome, also called palmar-plantar erythrodysesthesia syndrome)
- Mouth sores (stomatitis)
- Hair loss
- Eye problems (see below)
- Dry mouth, skin, or nose
- Tiredness
- Change in how things taste
- Constipation or diarrhea
- Infection
- Rash
- Stomach pain, nausea, vomiting, or decreased appetite
- Bleeding
- Muscle or joint pain
- High phosphate levels (see below)
- Changes in certain lab tests
There may be other side effects of Lyrfigtu that are not listed here. Contact your health care provider if you think you are having a side effect of a medicine. In the U.S., you can report side effects to the FDA at www.fda.gov/medwatch or by calling 800-FDA-1088 (800-332-1088). In Canada, you can report side effects to Health Canada at www.health.gc.ca/medeffect or by calling 866-234-2345.
What are the serious side effects of Lyrfigtu?
While less common, the most serious side effects of Lyrfigtu are described below, along with what to do if they happen.
Severe Allergic Reactions. Lyrfigtu may cause allergic reactions, which can be serious. Stop taking Lyrfigtu and get help right away if you have any of the following symptoms of a serious allergic reaction.
- Breathing problems or wheezing
- Racing heart
- Fever or general ill feeling
- Swollen lymph nodes
- Swelling of the face, lips, mouth, tongue, or throat
- Trouble swallowing or throat tightness
- Itching or skin rash
- Bumps on the skin called hives that can be red, pink, white, or brown depending on your skin tone
- Nausea or vomiting
- Dizziness, feeling lightheaded, or fainting
- Stomach cramps
- Joint pain
Severe Eye Problems. Lyrfigtu may cause eye problems, such as having a part of the retina detach, inflammation of the cornea (keratitis), dry eye, and blurred vision. Keep all appointments to check the health of your eyes before starting and while taking Lyrfigtu. Follow any instructions from your health care provider about using any eye products, such as artificial tears or gels. Contact your health care provider right away if you have any of the following symptoms.
- Vision changes, such as blurry vision, trouble seeing, or vision loss
- Eye dryness, watering, or discharge
- Eye redness, itchiness, or pain
- Swollen or itchy eyelids
- Feeling like you have something in your eye
High Phosphate Levels. Lyrfigtu can cause high phosphate levels (hyperphosphatemia). This can lead to abnormal mineral or calcium deposits in your tissues or blood vessels, which may result in serious conditions such as calcinosis or calciphylaxis. Keep all appointments with your health care provider to check your blood work. Tell your health care provider right away if you have any of the following symptoms.
- Muscle cramps or spasms
- Numbness
- Tingling around the mouth
- Bone and joint pain
Warnings & Precautions
Who should not use Lyrfigtu?
Allergies to Ingredients. People who are allergic to any of the following should not take Lyrfigtu.
- Lirafugratinib
- Lyrfigtu
- Any of the ingredients in the specific product dispensed
Your pharmacist can tell you all of the ingredients in Lyrfigtu.
What should I know about Lyrfigtu before using it?
Do not take Lyrfigtu unless it has been prescribed to you by a health care provider. Take it as prescribed.
Do not share Lyrfigtu with other people, even if they have the same condition as you. It may harm them.
Keep Lyrfigtu out of the reach of children.
Do not open, chew, cut, or crush Lyrfigtu. Swallow the capsules whole.
If you throw up after taking Lyrfigtu, do not take another dose. Take your next dose at your usual time.
Lyrfigtu can make your skin more sensitive to light from the sun, sunlamps, and tanning beds. This is called photosensitivity. Exposure to this light can cause severe sunburns, blisters, and swelling. If you need to be in sunlight, wear sunscreen, a hat, and clothing that covers your skin.
It is important to keep all appointments with your health care team, including for lab tests and eye exams, while you are taking Lyrfigtu. This can help them make sure the medicine is safe and working well for you.
If you can get your partner pregnant, you should use effective birth control while taking Lyrfigtu and for 3 months after your last dose. See the Pregnancy section for details.
What should I tell my health care provider before using Lyrfigtu?
Tell your health care provider about all of your health conditions and any prescription or over-the-counter (OTC) medicines, vitamins/minerals, herbal products, and other supplements you are using. This will help them know if Lyrfigtu is right for you.
In particular, make sure that you discuss any of the following.
Other Medicines and Supplements. Lyrfigtu may interact with other medicines and supplements. Before taking Lyrfigtu, tell your health care provider about any prescription or over-the-counter (OTC) medicines, vitamins/minerals, herbal products, and other supplements you are using. See the Interactions section for more details.
Pregnancy. Lyrfigtu can cause harm to a fetus. You should not be pregnant before starting Lyrfigtu. If you can become pregnant, you should use effective birth control while taking Lyrfigtu and for 6 months after your last dose. Tell your health care provider right away if you are pregnant, think you might be pregnant, or plan to become pregnant.
Breastfeeding. Do not breastfeed while you are taking Lyrfigtu and for 1 week after your last dose. It is not known if Lyrfigtu passes into breast milk. Tell your health care provider if you are breastfeeding or plan to breastfeed.
How can I get more information about Lyrfigtu?
For more information about Lyrfigtu, you can visit the drugmaker’s website at www.lyrfigtu.com or call them at 866-435-3827.
Interactions
Does Lyrfigtu interact with foods or drinks?
You should avoid grapefruit and grapefruit juice while taking Lyrfigtu. Grapefruit may increase the amount of Lyrfigtu in your body and raise the risk of side effects.
It is unknown if drinking alcohol will affect Lyrfigtu, but heavy drinking can slow your immune response and make it harder for your body to fight cancer.
Does Lyrfigtu interact with other medicines (drug interactions)?
Always tell your health care provider about any prescription or over-the-counter (OTC) medicines, vitamins/minerals, herbal products, and other supplements you are using.
In particular, make sure that you discuss if you are using any of the following before taking Lyrfigtu.
- Fluconazole (Diflucan), ketoconazole, itraconazole (Sporanox, Tolsura), posaconazole (Noxafil), or voriconazole (Vfend), which is a medicine used for fungal infections
- Ciprofloxacin (Cipro), clarithromycin, or Erythromycin (Ery-Tab and others), which is a medicine used for bacterial infections
- Diltiazem (Cardizem CD and others) or verapamil (Verelan, Verelan PM), which is a medicine used for high blood pressure or other conditions
- Efavirenz, lopinavir/ritonavir (Kaletra), nelfinavir (Viracept), or ritonavir (Norvir), which is a medicine commonly used to treat HIV
- Carbamazepine (Carbatrol, Tegretol, and others), phenobarbital, or primidone, which is a medicine commonly used to treat seizures or nerve pain
- Phenytoin (Dilantin, Phenytek, and others), which is a medicine to control seizures
- Rifampin (Rifadin), which is a medicine commonly used to treat an infection called tuberculosis
- St. John’s wort, which is a supplement that may be used for depression
Many other medicines may alter the blood levels of Lyrfigtu, and vice versa. Tell your health care provider about all medicines that you take or have recently taken.
This may not be a complete list of medicines that can interact with Lyrfigtu. Always check with your health care provider.
Overdose/Missed Dose
What should I do if I accidentally use too much Lyrfigtu?
If you or someone else has used too much Lyrfigtu, get medical help right away, call 911, or contact a Poison Control center at 800-222-1222.
What should I do if I miss a dose of Lyrfigtu?
If you miss a dose by less than 4 hours, take the missed dose as soon as possible. If you miss a dose by 4 hours or more, skip the missed dose and take your next dose at the next scheduled time. Do not take double or extra doses.
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