Medication info

Femajaire 9mg (Famitinib)

Prescription medicationTablet경구
Ingredient · strength
Pemigatinib›9mg / 1 tablet
Manufacturer / importer
(주)한독
Appearance
Oval white to light yellow tablets inscribed with "I" on one side and "9" on the other.
Packaging
PTP - 14 tablets per box [14 PTP x 1]
Approval status
Active

MFDS item code 202301338 · Approved 2023.04.25 · Insurance code 652105870

Summary

Main use
Treatment of locally advanced or metastatic bile duct cancer with FGFR2 fusion or rearrangement.
Who takes it
Adults
Adult dose
Administer 13.5 mg of this medication orally once daily for 14 days, followed by a 7-day break. Take it at the same time every day if possible, and swallow it whole. This medication can be taken with or without food. Dosage adjustment is necessary based on serum phosphate levels, and stepwise dose reduction or breaks should be implemented in case of side effects such as hyperphosphatemia or serous retinal detachment. When taken with potent CYP3A4 inhibitors, dosage reductions are required.

Ingredients

Importer
(주)한독

Efficacy & effects

Treatment of locally advanced or metastatic bile duct cancer with FGFR2 fusion or rearrangement.

  • Locally advanced bile duct cancer
  • metastatic bile duct cancer
View approved original text

This medication is used for the treatment of locally advanced or metastatic bile duct cancer confirmed to have FGFR2 fusion or rearrangement in adult patients who have received systemic therapy at least once.

How to take

Adult dose

Administer 13.5 mg of this medication orally once daily for 14 days, followed by a 7-day break. Take it at the same time every day if possible, and swallow it whole. This medication can be taken with or without food. Dosage adjustment is necessary based on serum phosphate levels, and stepwise dose reduction or breaks should be implemented in case of side effects such as hyperphosphatemia or serous retinal detachment. When taken with potent CYP3A4 inhibitors, dosage reductions are required.

Precautions

This medication can harm the fetus if administered to pregnant women, thus it should not be used during pregnancy. Women of childbearing potential must use effective contraception while taking this drug and for at least one week after completing treatment. Male patients should also take precautions to prevent their partners from becoming pregnant during and for one week after taking this drug. Patients with allergies to this drug or its components should not use it. It should also not be taken concurrently with a medication called St. John's Wort. Side effects may include hyperphosphatemia, which is an increase in phosphate levels in the blood; dietary adjustments and phosphate-lowering therapy may be required. If hypophosphatemia occurs, actions such as increasing phosphate intake or discontinuing phosphate-lowering therapy may be necessary. During this medication's use, periodic checks of bone mineral status are required. Attention to eye health is also necessary, as you may develop a retinal condition known as serous retinal detachment. If symptoms such as blurred vision, floaters, or light flashes occur, you should seek ophthalmic treatment immediately, and regular ophthalmic examinations are recommended. This medication can cause various side effects, the common symptoms include hair loss, diarrhea, stomatitis, fatigue, decreased appetite, joint pain, headache, and dry eyes. Severe adverse reactions include acute renal failure, pneumonia, and sepsis; in cases of serious adverse symptoms, it may be necessary to discontinue medication or adjust the dosage. This medication may interact with other drugs; caution is particularly needed when used with potent CYP3A4 inhibitors or inducers and proton pump inhibitors (PPIs). Grapefruit or grapefruit juice should also be avoided, and dosage adjustment may be necessary when taken with certain medications. Blood tests may show an increase in creatinine levels, but this does not necessarily indicate impaired kidney function; it should be considered during renal function assessments. This medication may moderately affect the ability to drive or operate machinery, so caution is needed during treatment. The safety and efficacy of this medication in children under 18 years old have not been established, and the same dosage applies to elderly patients as to adults. When storing, it should be kept in a place away from direct sunlight and out of reach of children, and expired medications should not be used. It is safest to store in its original packaging.

Side effects and when to seek care immediately

Serious side effects

  • Abdominal pain, fever, cholangitis, pleural effusion, acute renal failure, infectious cholangitis, growth retardation, hypercalcemia, hyponatremia, small bowel obstruction, pneumonia, sepsis, urinary tract infection
  • Serous retinal detachment (visual abnormalities such as blurred vision, floaters, light flashes)
  • Syncope, acute renal failure, hypotension
  • Severe hypophosphatemia (confusion, seizures, focal neurological findings, heart failure, respiratory failure, muscle weakness, rhabdomyolysis, hemolytic anemia, etc.)

Mild side effects

  • Decreased appetite, hair loss, nail toxicity, dry skin, hand-foot erythrodysesthesia syndrome, diarrhea, nausea, constipation, stomatitis, dry mouth, vomiting, fatigue, taste abnormalities, headaches, dry eyes, joint pain, back pain, limb pain, weight loss, fractures, etc.
  • Hematological and chemical test abnormalities (decreased hemoglobin, decreased lymphocytes, decreased platelets, increased and decreased white blood cells, increased alanine aminotransferase, etc.)

Not everyone experiences these, and they can vary from person to person.

Storage

This medication may be sensitive to air or moisture, so it must be stored in a tightly sealed container. Additionally, do not store the medication in excessively cold or hot places; it is best to keep it at a normal indoor temperature between 1 and 30 degrees Celsius.

Appearance and packaging

Appearance

Oval white to light yellow tablets inscribed with "I" on one side and "9" on the other.

Package unit

PTP - 14 tablets per box [14 PTP x 1]

Same-ingredient medicines

Even with the same ingredient, strength, dosage form and how it is taken can differ.

Even with the same ingredient, the dose and directions can differ by strength and dosage form. Talk to a doctor or pharmacist before switching from a medication you are already taking.

Questions about this medicine

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This drug information is based on data provided by the Korea Ministry of Food and Drug Safety.
Consult a doctor or pharmacist for accurate dosage, administration, and usage instructions.