Pemazyre

Pemazyre is a kinase inhibitor that blocks the action of protein kinases.

Pemazyre a prescription medicine used in adults to treat bile duct cancer (cholangiocarcinoma) that has spread to other parts of the body (metastatic) or cannot be removed with surgery. This medicine is usually given after your cancer has been treated with another medicine, and when the cancer has a certain type of abnormal FGFR2 gene. Your doctor will test you for this gene.

Pemazyre was approved by the US Food and Drug Administration (FDA) for bile duct cancer on an "accelerated" basis. In clinical studies, some people responded to Pemazyre, but further studies are needed.

Pemazyre is also used in adults to treat a type of blood cancer called myeloid/lymphoid neoplasms (MLNs) when the cancer has come back or did not respond to treatment, and when the cancer has a certain type of abnormal FGFR1 gene. Your doctor will test you for this gene.

It is not known if this medicine is safe and effective in children.

Take Pemazyre exactly as prescribed by your doctor. Follow all directions on your prescription label and read all medication guides or instruction sheets.

For bile duct cancer, Pemazyre is given in a 21-day treatment cycle. Take Pemazyre one time each day for 14 days, followed by 7 days off treatment, to complete a 21-day treatment cycle. Your doctor will determine how long to treat you with this medicine.

For myeloid/lymphoid neoplasms (MLNs), take Pemazyre one time each day.

Take the medicine at the same time each day, with or without food.

Swallow the tablet whole and do not crush, chew, break, or dissolve it.

If you vomit shortly after taking Pemazyre, do not take another dose. Wait until your next scheduled dose time to take the medicine again.

Pemazyre can cause you to have eye problems. An eye doctor will need to examine your eyes before you start taking this medicine, every 2 months for the first 6 months, and then every 3 months while you are taking it. Follow any instructions about using artificial tears or lubricating eye gel to treat or prevent dry eyes.

Pemazyre can cause you to have high levels of phosphate in your blood, which may lead to a buildup of minerals such as calcium in different tissues in your body. Your blood will need to be tested often. Your cancer treatments may be delayed based on the results.

You may be given other medication to help lower your phosphate. Keep using this medicine for as long as your doctor has prescribed.

You may also need to follow a special diet. Follow all instructions of your doctor or dietitian. Learn about the foods to eat or avoid to help control your phosphate levels.

Store at room temperature away from moisture and heat.

Follow all directions on your medicine label and package. Tell each of your healthcare providers about all your medical conditions, allergies, and all medicines you use.

To make sure Pemazyre is safe for you, tell your doctor if you have ever had:

• problems with your eyes;
• vision problems; or
• kidney or liver problems; or trouble swallowing pills.

You may need to have a negative pregnancy test before starting this treatment.

Both men and women using Pemazyre should use effective birth control to prevent pregnancy. Pemazyre can harm an unborn baby or cause a miscarriage if the mother or father is using this medicine.

Keep using birth control for at least 1 week after your last dose. Tell your doctor right away if a pregnancy occurs while either the mother or the father is using Pemazyre.

Do not breastfeed while using this medicine, and for at least 1 week after your last dose.

Get emergency medical help if you have signs of an allergic reaction to Pemazyre: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have:

• eye problems--eye pain or redness, dry or puffy eyes, watery eyes, your eyes may be more sensitive to light;
• vision changes--blurred vision, seeing black spots or "floaters," or seeing flashes of light; or
• high phosphate levels in your blood--muscle cramps, numbness, tingly feeling around your mouth.

Your cancer treatments may be delayed or permanently discontinued if you have certain side effects.

Common Pemazyre side effects in cholangiocarcinoma may include:

• hair loss;
• diarrhea;
• problems with your fingernails or toenails;
• feeling tired;
• changes in your sense of taste;
• nausea, vomiting, loss of appetite;
• constipation;
• mouth sores, dry mouth;
• dry eyes;
• joint pain, back pain;
• stomach-area (abdominal) pain;
• high or low phosphate levels in your blood;
• dry skin.

Common Pemazyre side effects in myeloid/lymphoid neoplasms may include:

• problems with your fingernails or toenails;
• hair loss;
• mouth sores, dry mouth;
• diarrhea;
• dry eyes;
• feeling tired;
• anemia;
• stomach-area (abdominal) pain;
• rash;
• constipation;
• nose bleeds;
• blurry vision, disorder of the retina;
• pain in feet or hands;
• loss of appetite;
• dry skin;
• indigestion;
• back pain;
• nausea;
• swelling in feet, legs, hands, or arms
• dizziness.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Usual Adult Dose for Cholangiocarcinoma of biliary tract:

13.5 mg orally once daily for 14 consecutive days followed by 7 days off therapy, in 21-day cycles until disease progression or unacceptable toxicity Use: for the treatment of adults with previously treated, unresectable locally advanced or metastatic cholangiocarcinoma with a fibroblast growth factor receptor 2 (FGFR2) fusion or other rearrangement.

Usual Adult Dose for Myeloid/Lymphoid Neoplasms:

13.5 mg orally once daily Duration of therapy: Until disease progression or unacceptable toxicity occurs. Comments: -FGFR 1 rearrangement positivity status must be known prior to the initiation of therapy. -Assessment for FGFR 1 rearrangement positivity in tumor specimen should be performed with an appropriate diagnostic test. Use: For the treatment of adults with relapsed or refractory myeloid/lymphoid neoplasms (MLNs) with fibroblast growth factor receptor 1 (FGFR1) rearrangement

Take the medicine as soon as you can, but skip the missed dose if you are more than 4 hours late for the dose. Do not take two doses at one time.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

Grapefruit may interact with Pemazyre and lead to unwanted side effects. Avoid the use of grapefruit products.

Sometimes it is not safe to use certain medications at the same time. Some drugs can affect your blood levels of other drugs you take, which may increase side effects or make the medications less effective.

Other drugs may affect Pemazyre, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell your doctor about all your current medicines and any medicine you start or stop using.