Pemazyre

What is Pemazyre?

Pemazyre acts as an inhibitor of kinases, which hinders the actions of protein kinases.Pemazyre is a prescription medication that is used by adults to treat bile duct cancer (cholangiocarcinoma) that has regressed to other areas in your organs (metastatic) or is unable to be treated with surgery. The medication is typically prescribed after the cancer has been treated by another medication and when the cancer has an irregular FGFR2 gene. Your doctor will test you to determine if you have this particular gene.

Pemazyre was approved by the US Food and Drug Administration (FDA) to treat bile cancer of the duct on an "accelerated" basis. In clinical studies, a few patients showed improvement after taking Pemazyre; however, more research is needed.

Pemazyre can also be used in people over the age of 18 to combat a kind of blood cancer known as myeloid lymphoid neoplasms (MLNs) in cases where the cancer has returned or failed to respond to treatment. It is also used when the cancer is an unspecified type of unusual FGFR1 gene. Your doctor will determine if you have this gene.It isn't known whether this medication can be used safely and effectively for children.

Warnings

Follow the directions on the label of your medication and the packaging. Inform your health care providers about your medical issues, allergies, and any medications you take.

Before you take this drug

To ensure that Pemazyre is suitable for you, inform your physician if you've previously had:

• Issues with your eyes;
• Vision issues and vision problems
• Difficulty taking pills.

It is possible that you will need to take a pregnancy test that is negative prior to beginning this treatment.

Men and women who are taking Pemazyre should utilize effective birth control methods to avoid utilisima zyre can harm the unborn baby or trigger an unplanned pregnancy when the father or mother is taking this medication.Use birth control for a minimum of 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 Pemazyre.Avoid breastfeeding during the course of this medication and for at least one week following your last dose.

What is the best way to do Pemazyre?

You should take Pemazyre exactly as directed by your physician. Follow the directions on the prescription label and go through all medication guides or instruction sheets.

To treat bile duct cancer Pemazyre is prescribed as the course of a 21-day treatment. It is recommended to take Pemazyre once a day for 14 consecutive days, followed by 7 days of non-treatment to finish a 21-day cycle of treatment. Your physician will decide the duration of treatment with this medication.For myeloid and lymphoid cancers (MLNs), take Pemazyre for a single dose every day.Use the medicine every day, either with or without eating.Take the tablet in its entirety and don't break, crush, chew, or dissolve it.

If you have a stomach ache within a few minutes of taking Pemazyre, do not take a second dose. Make sure you wait until your next dose is scheduled to take the medication again.Pemazyre could cause problems with your eyes. A doctor for eye problems will have to check your eyes prior to when you begin taking this medication, at least at intervals of 2 to 3 months during the time you're taking it. Follow the directions for using artificial tears or lubricating gel for your eyes to prevent dry eyes.Pemazyre could cause the highest levels of phosphate present in your blood. Your blood needs to be checked frequently. The treatments for cancer could be delayed based on the results.

There may be other drugs to lower the phosphate level. Continue to take this medication for the time your doctor prescribes.It is also possible to adhere to a particular diet. Follow the guidelines from your physician or dietitian. Know what foods to consume or avoid to manage the levels of phosphate in your body.Keep at room temperature, free of heat and moisture.

Details on dosage

Normal Adult Dose for Cholangiocarcinoma in the Biliary Tract:

13.5 mg once a day every 14 hours for 14 consecutive days, followed by a period of 7 days without treatment in 21-day cycles, until the disease progresses or toxicity is unacceptable.
Use: to treat patients who have been treated previously for localized, non-resectable, or metastatic cholangiocarcinoma with the fibroblast growth factor receptor 2 (FGFR2) fusion or another rearrangement.

Usual Adult Dose for Lymphoma:

13.5 mg taken orally, once a day

Therapy duration: up to the progression of disease or unacceptably toxic events.
Comments:
FGFR-1 positive status should be determined prior to the initiation of treatment.
Evaluation for FGFR 1 positivity in tumor samples should be conducted using an appropriate diagnostic test.
Use: To treat adult patients with myeloid or lymphoid tumors that have relapsed or are MLNs that have the fibroblast growth factor receptor (FGFR1) rearrangement.

Usual Adult Dose for Multiple Myeloma:

13.5 mg taken orally, once a day
Therapy duration: up until the disease progresses or toxicity is unacceptable.
Comments:
FGFR-1 positive status should be determined prior to the initiation of treatment.
Evaluation for FGFR-1-positive rearrangements in tumor samples should be conducted using an appropriate diagnostic test.
Use: To treat adult patients with myeloid or lymphoid tumors that have relapsed or are MLNs that have fibroblast growth factor receptor 1 (FGFR1) rearrangement.

What happens If I miss a dose?

You should take the medication as fast as you can. However, 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?

Get medical attention in an emergency or contact the poison help line at 1-800-222-1222.

What should be avoided?

Grapefruit could interact with Pemazyre and cause undesirable negative side effects. Do not use grapefruit-related products.

Side effects of Pemazyre

See a doctor immediately. If you are experiencing symptoms for an allergic reaction to Pemazyre, such as hives, breathing problems, or swelling of your lips, tongue, throat, or face,

See your doctor right away. If you suffer from:

• Eye issues: redness or pain in the eyes, eye problems, dry eyes or puffy, dry eyes, or your eyes could have a greater sensitivity to light.
• Vision changes: blurred vision, seeing floaters or "floaters," or seeing flashes of light
• High levels of phosphate in your blood cause muscle cramps, numbness, and a tingly sensation in your mouth.

The treatment for cancer may be delayed or completely stopped when you experience certain negative side effects.

Common Pemazyre adverse effects of cholangiocarcinoma can be:

• Hair loss;
• Diarrhea;
• Issues with your fingernails or toenails
• Being tired;
• Changes in your sense of taste
• Vomiting, nausea, nausea, vomiting,
• Constipation;
• Dry mouth, mouth sores;
• Dry eyes;
• Joint pain, back pain;
• Stomach-area (abdominal) pain;
• Low or high levels of phosphate in your blood.
• Dry skin.

Common Pemazyre adverse effects of myeloid or lymphoid tumors could be:

• Issues with your fingernails or toenails
• Hair loss;
• Dry mouth, mouth sores;
• Diarrhea;
• Dry eyes;
• Fatigue;
• Anemia;
• Stomach-area (abdominal) pain;
• Rash;
• Constipation;
• Nose bleeds;
• Blurred vision, disturbance in the retina
• Hands or feet hurt;
• Loss of appetite
• Dry skin;
• Indigestion;
• Back discomfort;
• Nausea;
• Swelling of legs, feet, or hands

This is not a comprehensive list of possible side effects, and other effects may also be present. Consult your physician to seek medical advice on adverse effects. You can report any adverse reactions to the FDA at 1-800-FDA-1088.

Interaction with other drugs

There are times when it's not recommended to take certain medications together. Certain drugs may affect your blood levels and the other medications that you are taking. This could cause more side effects or make the medication less effective.

Other medications could interfere with Pemazyre, such as prescription and over-the-counter medicines, vitamins, and herbal products. Inform your physician about your current medications and any medications you begin or stop taking.