Pemazyre (pemigatinib)

Pemazyre generic

Pemazyre is available only as a brand-name medication. It’s not currently available in generic form.

A generic drug is an exact copy of the active drug in a brand-name medication. Generics typically cost less than brand-name drugs.

Pemazyre dosage

The Pemazyre dosage your doctor prescribes will depend on several factors. These include:

• the condition you’re taking Pemazyre to treat
• other medications you may be taking
• how well your body responds to Pemazyre treatment
• other medical conditions you may have, including kidney or liver problems

The following information describes dosages that are commonly prescribed or recommended. However, be sure to follow the dosage your doctor prescribes for you. Your doctor will determine the best dosage to fit your needs.

Drug forms and strengths

Pemazyre comes as an oral tablet. It’s available in three strengths: 4.5 milligrams (mg), 9 mg, and 13.5 mg.

Dosage for bile duct cancer

Pemazyre is prescribed to treat bile duct cancer in certain adults. For this use, the recommended dose is 13.5 mg. You’ll take this dose once daily for 14 days, followed by 7 days without any doses. You’ll continue taking the drug in this pattern of 14 days on, 7 days off (21-day cycles) for as long as you and your doctor determine Pemazyre is working safely and effectively for you.

Dosage for myeloid/lymphoid neoplasms (MLNs)

Pemazyre is prescribed to treat MLNs in certain adults. For this use, the recommended dosage is 13.5 mg once daily. You’ll continue taking the drug once daily for as long as you and your doctor determine Pemazyre is working safely and effectively for you.

About taking Pemazyre

Below you’ll find information about key dosage issues.

• When to take. You should take Pemazyre at about the same time each day. Taking the medication around the same time of day helps keep a steady level of the drug in your body. This helps Pemazyre work effectively.
• If you miss a dose. You can take Pemazyre up to 4 hours late. But if you miss a dose by 4 or more hours, or if you vomit after taking dose, skip the dose you missed. Do not take another Pemazyre tablet to make up for a missed or vomited dose.
• Taking Pemazyre with food. You can take Pemazyre with or without food. If you’re taking Pemazyre for bile duct cancer, your doctor may recommend avoiding certain foods.
• Crushing, splitting, or chewing Pemazyre. Swallow Pemazyre tablets whole. You should not crush, split, chew, or dissolve these tablets.
• Length of use. Pemazyre is meant to be a long-term treatment. If you and your doctor determine that Pemazyre is safe and effective for you, you’ll likely take it long term. They may have you stop taking the drug if you experience certain side effects from it or if your cancer progresses (worsens).

Overdose

Do not take more Pemazyre than your doctor recommends. For some drugs, doing so may lead to unwanted side effects or overdose.

What to do in case you take too much Pemazyre

If you think you’ve taken too much of this drug, call your doctor. You can also call America’s Poison Centers at 800-222-1222 or use its online tool. However, if your symptoms are severe, call 911 or your local emergency number, or go to the nearest emergency room right away.

Pemazyre side effects

Pemazyre can cause mild or serious side effects. The following lists contain some of the key side effects that may occur while taking Pemazyre. These lists do not include all possible side effects.

The side effects of Pemazyre might differ slightly between people with bile duct cancer and people with myeloid/lymphoid neoplasms.

For more information about the possible side effects of Pemazyre, talk with your doctor or pharmacist. They can give you tips on how to manage any side effects that may be concerning or bothersome.

Note: The Food and Drug Administration (FDA) tracks side effects of drugs it has approved. If you would like to notify the FDA about a side effect you’ve had with Pemazyre, you can do so through MedWatch.

Mild side effects

Below is a partial list of mild side effects of Pemazyre. To learn about other mild side effects, talk with your doctor or pharmacist, or view Pemazyre’s prescribing information.

Mild side effects of Pemazyre can include:

• hair loss
• nail problems, such as infection, discoloration, changes in texture, or splitting
• diarrhea or constipation
• fatigue
• mouth ulcers
• dry mouth, eyes, and skin
• nausea and vomiting
• low appetite
• pain in your abdomen, joints, back, arms, or legs
• changes in your sense of taste
• nosebleeds
• dizziness
• weight loss
• mild allergic reaction*

Most of these side effects may go away within a few days to a couple of weeks. However, if they become more severe or don’t go away, talk with your doctor or pharmacist.

* For more information about allergic reaction and Pemazyre, see “Allergic reaction” below.

Serious side effects

Serious side effects from Pemazyre aren’t common, but they can occur. Call your doctor right away if you have serious side effects. Call 911 or your local emergency number if your symptoms feel life threatening or if you think you’re having a medical emergency.

Serious side effects and their symptoms can include:

• Hyperphosphatemia (too much phosphate in your blood). Symptoms may not occur but can lead to:
  • a buildup of mineral deposits in blood vessels, skin, other tissues, and organs, which may lead to damage
  • weakened bones or bone fractures
• A serious eye problem called retinal pigment epithelial detachment, in which a certain layer of cells separates within the retina (the layer of tissue at the back of the eyeball). Symptoms can include:
  • blurred vision
  • floaters in your vision
  • seeing abnormal flashes of light
• Acute kidney injury (sudden or short-term decline in kidney function). Symptoms can include changes in urination.
• Severe allergic reaction.*

* For details about allergic reaction and Pemazyre, see “Allergic reaction” below.

ALLERGIC REACTION

As with most drugs, some people can have an allergic reaction after taking Pemazyre. This side effect wasn’t reported in clinical trials of this drug but can still occur.

Symptoms of a mild allergic reaction can include:

• skin rash
• itchiness
• flushing

A more severe allergic reaction is rare but possible. Symptoms of a severe allergic reaction can include:

• swelling under your skin, typically in your eyelids, lips, hands, or feet
• swelling of your tongue, mouth, or throat
• trouble breathing

Call your doctor right away if you have an allergic reaction to Pemazyre, as the reaction could become severe. Call 911 or your local emergency number if your symptoms feel life threatening or if you think you’re having a medical emergency.

Pemazyre cost

As with all medications, the cost of Pemazyre can vary. The actual price you’ll pay depends on your insurance plan and your location.

Financial and insurance assistance. If you need financial support to pay for Pemazyre, or if you need help understanding your insurance coverage, help is available.

A program called IncyteCARES is available for Pemazyre. For more information and to find out whether you’re eligible for support, call 855-452-5234 or visit the program website.

To learn more about saving money on prescriptions, check out this article.

Generic version. Pemazyre is not available in a generic form. A generic drug is an exact copy of the active drug in a brand-name medication. Generics tend to cost less than brand-name drugs.

* Optum Perks is a sister site of Medical News Today.

Pemazyre uses

The Food and Drug Administration (FDA) approves prescription drugs such as Pemazyre to treat certain conditions.

Pemazyre for bile duct cancer

Pemazyre is approved to treat bile duct cancer,* also known as cholangiocarcinoma, in adults. The drug may be prescribed if the cancer:

• is locally advanced (has spread to nearby tissues) and cannot be removed by surgery, or metastatic (has spread to other areas of the body), and
• has specific abnormal changes in the fibroblast growth factor receptor 2 gene, which your doctor will test for before prescribing Pemazyre

For this use, doctors prescribe Pemazyre to adults who have received other treatments for this cancer in the past.

* For this use, Pemazyre has received accelerated approval from the FDA. This means the drug has been approved for this purpose based on limited data from early clinical trials. A decision regarding full approval will be made once additional clinical trials have been completed.

You can learn more about your condition by visiting our cancer hub.

Pemazyre for myeloid/lymphoid neoplasms (MLNs)

Pemazyre is approved to treat blood cancers called MLNs in adults. The drug may be prescribed if the cancer:

• has relapsed (returned after past treatment) or hasn’t responded to past treatment, and
• has a specific abnormal change in the fibroblast growth factor receptor 1 (FGFR1) gene (a change known as FGFR1 rearrangement)

MLNs are rare forms of blood cancer. The condition is also known as 8p11 myeloproliferative syndrome or stem cell leukemia-lymphoma syndrome. (“Myeloproliferative” means the bone marrow is making too many blood cells.)

In some cases, doctors may prescribe Pemazyre before or after someone has a stem cell transplant to treat this condition.

You can learn more about your condition by visiting our cancer hub.

Pemazyre and children

It isn’t known whether Pemazyre is safe or effective for any use in children. The drug has only received approval for use in adults.

Pemazyre interactions

Pemazyre can interact with several other medications. It can also interact with certain supplements as well as certain foods.

Before taking Pemazyre, talk with your doctor and pharmacist. Tell them about all prescription, over-the-counter, and other drugs you take. Also, tell them about any vitamins, herbs, and supplements you use. Sharing this information can help you avoid potential interactions.

Interactions with medications, foods, and supplements

Below is a list of medications, supplements, and foods that can interact with Pemazyre. This list does not contain all drugs that may interact with Pemazyre. If you have questions about drug interactions that may affect you, ask your doctor or pharmacist.

Alcohol interaction

Alcohol is not known to interact with Pemazyre. However, your doctor may recommend limiting or avoiding alcohol. Alcohol consumption might worsen certain cancers. Drinking alcohol may also worsen mouth ulcers, a common side effect of Pemazyre.

If you have questions about how much alcohol, if any, is safe to drink while taking Pemazyre, talk with your doctor or pharmacist.

Similar drugs

Other drugs are available that may be prescribed to treat your condition. Some may be a better fit for you than others. If you’re interested in finding an alternative to Pemazyre, talk with your doctor. They can tell you about other medications that may work well for you.

The following drugs are similar to Pemazyre:

• futibatinib (Lytgobi)
• erdafitinib (Balversa)
• certain chemotherapy drugs, such as gemcitabine and cisplatin
• ivosidenib (Tibsovo)
• durvalumab (Infinzi)
• pembrolizumab (Keytruda)

Things to consider when taking Pemazyre

If you can become pregnant, consider the following information about pregnancy, birth control, and breastfeeding.

Pemazyre and pregnancy

Pemazyre should not be taken during pregnancy. The drug cause harmful effects in a developing fetus, and in some cases, pregnancy loss.

If you can become pregnant, your doctor will likely suggest birth control options to use during treatment with Pemazyre.

Pemazyre and birth control

Pemazyre is not safe to take during pregnancy. If you’re sexually active and you or your partner can become pregnant, talk with your doctor about your birth control needs while you’re taking Pemazyre.

Note: Sex and gender exist on spectrums. Use of the terms “female” and “male” in this article refers to sex assigned at birth.

For females taking Pemazyre

Females who are able to become pregnant should use birth control, such as birth control pills, during Pemazyre treatment. They should continue using birth control for at least 1 week after their last dose of Pemazyre.

For males taking Pemazyre

Males with partners who are able to become pregnant should use birth control, such as condoms, during Pemazyre treatment. They should continue using birth control for at least 1 week after their last dose of Pemazyre.

Pemazyre and breastfeeding

Pemazyre should not be taken while breastfeeding. If you’re currently breastfeeding or planning to do so, talk with your doctor before taking this medication. Your doctor can recommend other ways to feed your child during this time.

Common questions about Pemazyre

Here are answers to some frequently asked questions about Pemazyre.

How does Pemazyre work?

Pemazyre is a targeted therapy. It’s designed to slow or stop the growth of cancer cells. It works by inhibiting (blocking) specific proteins in cancer cells from functioning.

Pemazyre targets fibroblast growth factor receptor proteins that are abnormal due to changes in the genes that encode these proteins. These abnormal proteins help cancer cells grow and survive. When Pemazyre blocks these proteins, the cancer cells may stop growing. This can stop the cancer from progressing (worsening) and may cause tumors to become smaller.

If you have questions about how Pemazyre works, talk with your doctor or pharmacist.

Does Pemazyre cause long-term side effects?

Pemazyre isn’t known to cause long-term side effects. If you develop certain bothersome or severe side effects, such as retinal pigment epithelial detachment, your doctor may have you pause or stop treatment. Side effects should go away soon after the drug is stopped.

Pemazyre was approved by the Food and Drug Administration (FDA) in 2020. As with any drug that’s relatively new, it’s possible that long-term side effects or risks could be identified in the future.

If you have questions about Pemazyre’s possible side effects or how long they might last, talk with your doctor or pharmacist.

Will Pemazyre cure bile duct cancer?

It’s possible, but the drug hasn’t been shown to cure cancer. In a clinical trial for bile duct cancer,* taking Pemazyre was shown to cause a partial response in some participants. This means the tumors of some participants shrunk, as seen on imaging scans. A few participants in these trials experienced a complete response with Pemazyre treatment. This means their tumor disappeared or became too small to detect on the scans.

Having a complete response doesn’t necessarily mean that the cancer is cured or won’t come back in the future. And your results may vary from what was seen in clinical trials.

Talk with your doctor if you have questions about what to expect with Pemazyre treatment.

* For this use, Pemazyre has received accelerated approval from the FDA. This means the drug has been approved for this purpose based on limited data from early clinical trials. A decision regarding full approval will be made once additional clinical trials have been completed.