PemiDX Pemigatinib 4.5mg 28 TABLET'S Approval No. 10 L 1023/23 Validity Date 09-10-2026

Introduction: Pemigatinib blocks tumor growth and spread by inhibiting FGFR kinases in tumor cells. It is the first and only targeted drug approved by the US FDA for the treatment of cholangiocarcinoma. It is a small molecule inhibitor of fibroblast growth factor receptor (FGFR) 1, FGFR2 and FGFR3. It was approved by the United States in April 2020 for the treatment of previously treated, unresectable, locally advanced or metastatic cholangiocarcinoma and adult patients with FGFR2 fusion or other rearrangements.

【Drug name】

Name: Pemetinib Tablets

Product Name: PEMIDX

  

【Specification】 4.5 mg

 

【Indications】

PEMIDX is a prescription medicine used in adults to treat:

• bile duct cancer (cholangiocarcinoma) that has spread or cannot be removed by surgery;

•People who have received treatment before;

•Their tumor has a certain type of abnormal FGFR2 gene;

• A type of blood cancer called myeloid/lymphoid neoplasm (MLN);

•When the condition relapses or does not respond to treatment;

•Their tumors have a certain type of abnormal FGFR1 gene.

Your healthcare provider will test your cancer for certain types of abnormal FGFR1 or FGFR2 genes and make sure PEMIDX is right for you.

It is not known if PEMIDX is safe and effective in children.

 

【Recommended dosage】

• Take PEMIDX exactly as your healthcare provider tells you to.

• For bile duct cancer, PEMIDX is taken in 21-day cycles. PEMIDX is taken once daily for 14 days, followed by a 7-day rest period to complete a 21-day treatment cycle.

• For myeloid/lymphoid tumors (MLN), take PEMIDX 1 time daily.

• Take PEMIDX at about the same time each day.

• You can take PEMIDX with or without food.

• Swallow the tablet whole. Do not crush, chew, split, or dissolve PEMIDX tablets.

• You should not eat or drink grapefruit products during PEMIDX treatment.

• Your healthcare provider may change your dose of PEMIDX or may temporarily or completely stop treatment if you have certain side effects.

• If you miss a dose of PEMIDX, you may take the missed dose within 4 hours that day. If it has been more than 4 hours, do not take the missed dose. Take your regular dose and take PEMIDX at your usual time the next day. Do not take a dose later than prescribed.

More PEMIDX to make up for the missed dose.

• If you vomit after taking PEMIDX, do not take another PEMIDX tablet. Take your regular dose of PEMIDX at your regular time the next day.

 

【side effect】

PEMIDX may cause serious side effects, including:

• Eye problems. Certain eye problems are common in PEMIDX but can also be serious. Eye problems include dry or irritated eyes, inflammation of the cornea (front part of the eye), increased tearing, and inflammation of the retina (inner part of the eye).

You will need to see an eye specialist for a complete eye exam before you start treatment with PEMIDX, every 2 months for the first 6 months, and then every 3 months during treatment with PEMIDX.

o You should use artificial tears or substitutes, moisturizing or lubricating eye gels as needed to help prevent or treat dry eyes.

Tell your healthcare provider right away if you have any changes in vision during treatment with PEMIDX, including blurred vision, flashing lights, or seeing black spots. You may need to see an eye specialist right away.

• High levels of phosphate in the blood (hyperphosphatemia), a condition in which the mineral accumulates in various tissues in the body. Hyperphosphatemia is common in PEMIDX, but it can be severe. High levels of phosphate in the blood may cause calcium

Minerals such as phosphorus accumulate in different tissues in the body. Your healthcare provider will check your blood phosphorus levels during treatment with PEMIDX.

o Your healthcare provider may recommend changes in your diet or phosphate-lowering therapy, or change, interrupt, or stop PEMIDX as needed.

o Tell your healthcare provider right away if you experience any muscle spasms, numbness, or tingling around your mouth.

The most common side effects of PEMIDX for bile duct cancer include:

• Hair loss • Diarrhea • Nails detaching from their nail beds or having a bad nail shape

• Feeling tired • Changes in taste • Low levels of phosphate in the blood

• Constipation • Mouth ulcers • Dry eyes • Dry mouth

• Loss of appetite • Vomiting • Joint pain • Dry skin

• Nausea • Back pain • Stomach (abdomen) pain

The most common side effects of PEMIDX for myeloid/lymphoid neoplasms (MLN) include:

• Nails pulling away from their bed or having a bad nail shape • Hair loss • Loss of appetite

• Diarrhea • Dry eyes • Fatigue • Anemia

• Skin rash • Constipation • Dry mouth • Nosebleeds

• Pain in the feet or hands • Mouth ulcers • Dry skin • Indigestion

• Nausea • Blurred vision • Dizziness • Swelling in your feet, legs, hands, or arms

• Back pain • Stomach (abdomen) pain • Retinal disease

These are not all the possible side effects of PEMIDX. For more information, talk with your healthcare provider or pharmacist.

 

【Storage】

• Store PEMIDX at room temperature between 68°F and 86°F (20°C and 30°C).

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