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Pemigatinib

Generic Name: Pemigatinib [PEM-iGA-tib]
The Brand Name is Pemazyre.
Dosage Format: Oral tablet (13.5 mg; 4.5 mg; 9 mg)
Drug Class: Multikinase inhibitors

What is Pemigatinib?

Pemigatinib is a treatment for adult patients to manage cancer of the bile duct that has spread into other regions of the body (metastatic) or is not eliminated by surgical intervention. Pemigatinib is typically prescribed after cancer is treated with other medications.Pemigatinib is indicated only when the cancer you are suffering from has a particular gene indicator (an irregular "FGFR2" gene). The doctor will test on this genetic trait.

Pemigatinib has been approved by the US Food and Drug Administration (FDA) on an "accelerated" basis. In clinical studies, a few patients responded to pemigatinib; however, further studies are required.Pemigatinib can also be employed for other purposes that are not covered in this guideline.

Side effects of Pemigatinib

See a doctor immediately. If you are experiencing symptoms that indicate an allergic reaction, such as symptoms of hives, difficulty breathing, or swelling of your lips, face, or tongue,Pemigatinib can cause severe adverse effects. Contact your physician immediately in the event that you experience:

  • Eye problems, such as redness or pain. Dry eyelids that are puffy or watery. Your eyes might become more sensitive.
  • Vision changes: blurred vision, seeing floaters or "floaters," or seeing flashes of light or
  • The levels of phosphate are high in your blood, causing muscle cramps, numbness, and a tingly sensation within your mouth.

The treatment you receive for cancer could be delayed or completely stopped when you experience certain adverse consequences.

Common adverse effects of pemigatinib could include:

  • Low or high levels of phosphate in your blood.
  • Dry eyes;
  • Stomach discomfort, nausea and vomiting, and stomach pain;
  • Diarrhea, constipation;
  • Mouth ulcers; dry or irritable mouth;
  • Joint discomfort, back pain;
  • Fatigue;
  • Issues with your fingernails or toenails
  • Dry skin; losing hair
  • Changes in your perception of your taste.

It's not a comprehensive list of the possible consequences, but other effects may occur. Consult your physician for advice on the effects of medicine. If you have any concerns, report the reaction to FDA by calling 1-800-FDA-1088.

Warnings

Follow the directions on your prescription label and on the label of your package. Inform your healthcare professionals about your medical issues, allergies, and any medications you take.

Before you take this drug

Inform your doctor if you were ever diagnosed with:

  • Eye problems;
  • Vision issues
  • Trouble swallowing pills.

You might need to undergo an unfavorable pregnancy test prior to commencing this treatment.

Men and women who are taking pemigatinib must use effective birth control to stop pregnancies. Pemigatinib can harm the unborn baby or trigger an abortion if the father or mother is taking this medication.

Continue using contraceptives for at least one week following the last dose. Inform your doctor immediately in the event of a pregnancy occurring when both the mother and father are taking pemigatinib.

Don't breastfeed during the course of this medicine or for a minimum of one week following your last dose.

How to take Pemigatinib?

Follow the directions on the prescription label and read the medication guide or instructions sheets. Follow the medication precisely as directed.

Pemigatinib is given as an entire 21-day cycle of treatment. The medicine is taken for the first two weeks of each cycle. Your doctor will decide how long you will be treated with this medication.Use the medicine daily at the same time every day, either with or without meals.Suck the tablet completely and don't break, crush, chew, or dissolve it.If you have a stomach ache within a few minutes of taking pemigatinib, don't take a dose again. Be patient until the next dose is scheduled to start taking the medicine once more.

Pemigatinib could cause eye issues. Eye doctors will have to inspect your eyes before you begin taking this medication every 2 to 3 months during the time you're taking it. Follow any directions regarding the use of artificial tears or lubricating gel for your eyes to treat dry eyes.Pemigatinib could cause an elevated level of phosphate in the blood. Your blood should be checked frequently. The treatment for cancer may be delayed based on the results.

You could be prescribed different drugs to help reduce the phosphate level. Use this medicine as long as your physician prescribes it.There is a possibility that you will need to follow a particular diet. Follow the advice of your physician or dietitian. Know what foods to consume or avoid to manage those phosphate levels.Keep at room temperature, free of heat and moisture.

Details on dosage

The Usual Adult Dose of Cholangiocarcinoma from the Biliary Tract:

13.5 mg once a day orally for 14 consecutive days, followed by seven days of no therapy for 21 days in 21-day cycles
Time of therapy: up to the progression of disease or unacceptably toxic events.
Comments:
FGFR-2 fusion positivity status has to be determined prior to the beginning of treatment.
Evaluation of FGFR-2 fusion in the tumor specimen must be done using a suitable diagnostic test.
This indication is approved under an accelerated approval based on the overall response time and the time to respond.
Use: To treat adults who have previously treated localized, non-resectable, or metastatic tumors of cholangiocarcinoma that have a fibroblast growth factor receptor 2 (FGFR2) combination or another rearrangement that is detected using an FDA-approved test.

Usual Adult Dose for Lymphoma:

13.5 mg once a day, orally

Therapy duration: up until the disease progresses or toxicity is unacceptable.
Comments:
FGFR-1 positive status should be determined prior to the beginning of treatment.
Evaluation for FGFR-1-positive rearrangements in tumor samples should be conducted using an appropriate diagnostic test.
Use: To treat patients suffering from relapsed or resistant myeloid lymphoid neoplasms (MLNs) that have the fibroblast growth factor receptor (FGFR1) rearrangement.

Usual Adult Dose for Multiple Myeloma:

13.5 mg once a day, orally
Therapy duration: up until the disease progresses or a toxic level occurs.
Comments:
FGFR1 rearrangement positivity status should be determined prior to the beginning of treatment.
Evaluation for FGFR 1 positivity in the tumor specimen must be done using a suitable diagnostic test.
Use: To treat adult patients with myeloid or lymphoid cancers that have relapsed or who (MLNs) have fibroblast-growth factor receptor 1 (FGFR1) rearrangement.

What happens If I miss a dose?

You should take the medicine as fast as you are able, but avoid your missed dose if you are more than four hours behind on the dose. Don't take two doses at once.

What happens if I overdose?

For medical emergencies, seek emergency medical attention or contact the Poison Help line toll-free at 1-800-222-1222.

What should be avoided?

Grapefruit can interact with pemigatinib and cause undesirable side effects. Beware of grapefruit-related products.

Interaction with other drugs

It is sometimes not safe to take certain medicines together. Certain drugs may affect your blood levels and the other medications that you are taking. This could create side effects or render the drugs less effective.

Other medications may interact with pemigatinib's effects, such as medications that are prescribed and available over the counter, vitamins, and herbal products. Inform your physician about the medicines you are currently taking as well as any medications you are about to start or stop taking.