Pemigatinib

What is Pemigatinib?

• Pemigatinib (Pemazyre) is a kinase inhibitor used to treat adults with bile duct cancer (cholangiocarcinoma).

What are the uses of this medicine?

This medicine is a prescription medicine that is used to treat adults with bile duct cancer (cholangiocarcinoma) that has spread or cannot be removed by surgery:

• who have already received a previous treatment, and
• whose tumor has a certain type of abnormal "FGFR2” gene.

How does this medicine work?

• An orally bioavailable inhibitor of the fibroblast growth factor receptor (FGFR) types 1, 2, and 3 (FGFR1/2/3), with potential antineoplastic activity.
• Pemigatinib binds to and inhibits FGFR1/2/3, which may result in the inhibition of FGFR1/2/3-related signal transduction pathways.
• This inhibits proliferation in FGFR1/2/3-overexpressing tumor cells.
• FGFR, a family of receptor tyrosine kinases upregulated in many tumor cell types, plays a key role in cellular proliferation, migration, and survival.

Who Should Not Use this medicine ?

• This medicine have no usage limitations.

What drug interactions can this medicine cause?

• Avoid concomitant use of strong and moderate CYP3A inducers with Pemazyre.
• Avoid concomitant use with strong and moderate CYP3A Inhibitors.

Is this medicine FDA approved?

• It was approved for use in the United States in 2020.

How should this medicine be used?

• Select patients for the treatment of locally advanced or metastatic cholangiocarcinoma with Pemazyre based on the presence of an FGFR2 fusion or rearrangement as detected by an FDA-approved test.

Recommended Dosage

• The recommended dosage of Pemazyre is 13.5 mg orally once daily for 14 consecutive days followed by 7 days off therapy, in 21-day cycles.
• Continue treatment until disease progression or unacceptable toxicity occurs.

Administration

• Take Pemazyre exactly as your healthcare provider tells you.
• Pemazyre is taken in cycles of 21 days. Take Pemazyre 1 time each day for 14 days, followed by 7 days off treatment, to complete a 21-day treatment cycle.
• Take Pemazyre 1 time each day at about the same time each day.
• Take Pemazyre with or without food.
• Swallow tablets whole. Do not crush, chew, split, or dissolve Pemazyre tablets.
• You should not eat or drink grapefruit products during treatment with Pemazyre.
• Your healthcare provider may change your dose of Pemazyre, or may temporarily or completely stop treatment if you get certain side effects.
• If you miss a dose of Pemazyre, you can take the missed dose within 4 hours on the same day. If more than 4 hours have passed, do not make up the dose. Take your regular dose of Pemazyre the next day at the usual time. Do not take more Pemazyre than prescribed to make up for the missed dose.
• If you vomit after taking Pemazyre, do not take another Pemazyre tablet. Take your regular dose of Pemazyre the next day at the usual time.

What are the dosage forms and brand names of this medicine?

This medicine is available in fallowing doasage form:

• As Tablets: 4.5 mg, 9 mg, and 13.5 mg.

This medicine is available in fallowing brand namesː

• Pemazyre

What side effects can this medication cause?

Common possible side effects and laboratory abnormalities of this medicine include:

• hair loss
• diarrhea
• nails separate from the bed or poor formation of the nail
• feeling tired
• change in sense of taste
• nausea
• constipation
• mouth sores
• dry eyes
• dry mouth
• decrease in appetite
• vomiting
• joint pain
• stomach-area (abdominal) pain
• low phosphate in blood
• back pain
• dry skin

Pemazyre may cause serious side effects, including:

• Eye problems
• High phosphate levels in your blood (hyperphosphatemia) and buildup of minerals in different tissues in your body

What special precautions should I follow?

• Pemazyre can cause retinal pigment epithelial detachment. Perform ophthalmological examination including optical coherence tomography (OCT) prior to initiation of therapy, every 2 months for the first 6 months of treatment and every 3 months thereafter, and urgently at any time for visual symptoms.
• Pemazyre can cause hyperphosphatemia leading to soft tissue mineralization, cutaneous calcification, calcinosis, and non-uremic calciphylaxis. Monitor for hyperphosphatemia and withhold, reduce the dose, or permanently discontinue based on duration and severity of hyperphosphatemia.
• Advise patients of reproductive potential of the potential risk to the fetus and use effective contraception.

What to do in case of emergency/overdose?

• In case of overdose, call the poison control helpline of your country. In the United States, call 1-800-222-1222.

• Overdose related information is also available online at poisonhelp.org/help.
• In the event that the victim has collapsed, had a seizure, has trouble breathing, or can't be awakened, immediately call emergency services. In the United States, call 911.

Can this medicine be used in pregnancy?

• Pemazyre can cause fetal harm or loss of pregnancy when administered to a pregnant woman .
• There are no available data on the use of Pemazyre in pregnant women.

Can this medicine be used in children?

• The safety and effectiveness of Pemazyre have not been established in pediatric patients.

What should I know about storage and disposal of this medication?

• Store Pemazyre tablets at room temperature 20°C ‑ 25°C (68°F ‑ 77°F); excursions permitted to 15°C ‑ 30°C (59°F ‑ 86°F).

• Dailymed label info on Pemigatinib
• FDA Pemigatinib

Pemigatinib Resources
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