Medication info

Femazair Tablets 13.5 mg (Femicatinib)

Prescription medicationTablet경구
Ingredient · strength
Pemigatinib›13.5mg / 1 tablet
Manufacturer / importer
(주)한독
Appearance
White to light yellow round tablets engraved on one side with "I" and on the other side with "13.5".
Packaging
14 tablets/box [14 PTX x 1]
Approval status
Active

MFDS item code 202301337 · Approved 2023.04.25 · Insurance code 652105860

Summary

Main use
Treatment of locally advanced or metastatic cholangiocarcinoma with FGFR2 fusion or rearrangement.
Who takes it
Adults
Adult dose
Administer 13.5 mg of this drug orally once daily for 14 days followed by a 7-day break. It should be taken preferably at the same time each day and swallowed whole. It can be taken regardless of meals. In patients taking strong CYP3A4 inhibitors, those on 13.5 mg once daily should reduce to 9 mg once daily, and those on 9 mg once daily should reduce to 4.5 mg once daily.

Ingredients

Importer
(주)한독

Efficacy & effects

Treatment of locally advanced or metastatic cholangiocarcinoma with FGFR2 fusion or rearrangement.

  • Locally advanced cholangiocarcinoma
  • metastatic cholangiocarcinoma
View approved original text

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

How to take

Adult dose

Administer 13.5 mg of this drug orally once daily for 14 days followed by a 7-day break. It should be taken preferably at the same time each day and swallowed whole. It can be taken regardless of meals. In patients taking strong CYP3A4 inhibitors, those on 13.5 mg once daily should reduce to 9 mg once daily, and those on 9 mg once daily should reduce to 4.5 mg once daily.

Precautions

This drug may be harmful to the fetus during pregnancy, so women who are pregnant or may become pregnant should not use it. Female patients of childbearing age must use effective contraception during and for one week after taking this drug, and male patients must also practice contraception during the same period to prevent their partner from becoming pregnant. It is contraindicated to take this drug if there is a hypersensitivity reaction to it or in conjunction with the herbal remedy St. John's Wort. This drug can affect phosphate levels in the blood, which could lead to hyperphosphatemia or hypophosphatemia, so phosphate levels should be regularly monitored through blood tests. It can also affect eye health, causing a condition called serous retinal detachment; therefore, regular eye examinations should be conducted before and during treatment, and if symptoms such as blurred vision or light scattering arise, a doctor should be consulted immediately. This medication can cause various side effects, with common symptoms including diarrhea, nausea, vomiting, hair loss, fatigue, dry skin, and inflammation in the mouth. In severe cases, abnormalities in liver function, reduction in kidney function, infections, and blood disorders may occur, so any abnormities should be reported to healthcare professionals immediately. This drug may interact with certain medications, so it is crucial to inform healthcare providers of any other medications being taken, especially when combined with strong CYP3A4 inhibitors or inducers or proton pump inhibitors. While taking this drug, it is advisable to avoid grapefruit or grapefruit juice, and dosage adjustments may be made as necessary to control drug concentration and effects. This medication may impair driving or operating machinery, so caution is advised while taking it. The safety and efficacy in children or patients under 18 years of age have not been established, and elderly patients take the same dosage as adults. Store this drug in its original packaging away from direct sunlight and keep it out of reach of children, and do not use expired medication.

Side effects and when to seek care immediately

Serious side effects

  • Abdominal pain
  • fever
  • cholangitis
  • pleural effusion
  • acute kidney failure
  • infectious cholangitis
  • growth retardation
  • hypercalcemia
  • hyponatremia
  • small bowel obstruction
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  • pneumonia
  • sepsis
  • urinary tract infection
  • growth retardation
  • bile duct obstruction
  • cholangitis
  • sepsis
  • pleural effusion
  • intestinal obstruction
  • acute kidney failure
  • stomatitis
  • palmoplantar erythrodysesthesia syndrome
  • joint pain
  • fatigue
  • increased aspartate aminotransferase
  • weakness
  • fever
  • alanine aminotransferase.

Mild side effects

  • Hyperphosphatemia
  • hypophosphatemia
  • hypercalcemia
  • dehydration
  • hair loss
  • nail toxicity
  • dry skin
  • palmoplantar erythrodysesthesia syndrome
  • diarrhea
  • nausea
Show 20 more
  • constipation
  • stomatitis
  • dry mouth
  • vomiting
  • abdominal pain
  • fatigue
  • peripheral edema
  • fever
  • taste abnormalities
  • headache
  • dry eyes
  • joint pain
  • back pain
  • limb pain
  • urinary tract infection
  • weight loss
  • decrease in hemoglobin
  • decrease in lymphocytes
  • decrease in platelets
  • increase in leukocytes.

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

Storage

This medication should be stored in a tightly sealed container to protect it from air and moisture, at room temperature between 1 to 30 degrees Celsius. Storing it this way will help maintain the effectiveness of the drug for a long time.

Appearance and packaging

Appearance

White to light yellow round tablets engraved on one side with "I" and on the other side with "13.5".

Package unit

14 tablets/box [14 PTX 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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For anything that needs medical judgment, consult a doctor or pharmacist.

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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.