Generic drug: pemigatinib
Brand name: Pemazyre
What is Pemazyre (pemigatinib), and how does it work?
- who have already received a previous treatment, and
- whose tumor has a certain type of abnormal "FGFR2" gene.
Your healthcare provider will test your cancer for a certain type of abnormal FGFR2 gene and make sure that Pemazyre is right for you.
It is not known if Pemazyre is safe and effective in children.
What are the side effects of Pemazyre?
- Eye problems. Certain eye problems are common with Pemazyre but can also be serious. Eye problems include dry eye or inflamed eyes, inflamed cornea (front part of the eye), increased tears, and a disorder of the retina (an internal part of the eye). You will need to see an eye specialist for a complete eye exam before you begin treatment with Pemazyre, every 2 months for the first 6 months, and then every 3 months during treatment with Pemazyre.
- You should use artificial tears or substitutes, hydrating or lubricating eye gels as needed, to help prevent or treat dry eyes.
- Tell your healthcare provider right away if you develop any changes in your vision during treatment with Pemazyre, including: blurred vision, flashes of light, or see black spots. You may need to see an eye specialist right away.
- High phosphate levels in your blood (hyperphosphatemia). Hyperphosphatemia is common with Pemazyre but can also be serious. Your healthcare provider will check your blood phosphate levels during treatment with Pemazyre.
The most common side effects of Pemazyre include:
- hair loss
- nails separate from the bed or poor formation of the nail
- feeling tired
- change in sense of taste
- mouth sores
- dry eyes
- dry mouth
- decrease in appetite
- joint pain
- stomach-area (abdominal) pain
- low phosphate in blood
- back pain
- dry skin
These are not all the possible side effects of Pemazyre. For more information, ask your healthcare provider or pharmacist.
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
What is the dosage for Pemazyre?
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.
Information on FDA-approved test(s) for the detection of an FGFR2 fusion or rearrangement in cholangiocarcinoma is available at http://www.fda.gov/CompanionDiagnostics.
- 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.
- Take Pemazyre with or without food at approximately the same time every day.
- Swallow tablets whole. Do not crush, chew, split, or dissolve tablets.
- If the patient misses a dose of Pemazyre by 4 or more hours or if vomiting occurs, resume dosing with the next scheduled dose.
Dosage Modification For Adverse Reactions
- The recommended dose reductions for adverse reactions are provided in Table 1.
Table 1: Recommended Dose Reductions for Pemazyre for Adverse Reactions
|Dose Reduction||Recommended Dosage|
|First||9 mg once daily for first 14 days of each 21-day cycle|
|Second*||4.5 mg once daily for first 14 days of each 21-day cycle|
|* Permanently discontinue Pemazyre if unable to tolerate 4.5 mg once daily.|
- The recommended dosage modifications for adverse reactions are provided in Table 2.
Table 2: Recommended Dosage Modifications for Pemazyre Adverse Reactions
|Adverse Reaction||Severity*||Pemazyre Dosage Modification|
|Retinal Pigment Epithelial Detachment (RPED)||RPED|
|Hyperphosphatemia||Serum phosphate > 7 mg/dL- ≤10 mg/dL|
|Serum phosphate >10 mg/dL|
|Other Adverse Reactions||Grade 3|
|*Severity as defined by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 4.03.|
Dosage Modification For Concomitant Use With Strong Or Moderate CYP3A Inhibitors
Avoid concomitant use of strong and moderate CYP3A inhibitors with Pemazyre . If concomitant use with a strong or moderate CYP3A inhibitor cannot be avoided:
- Reduce Pemazyre dosage from 13.5 mg to 9 mg.
- Reduce Pemazyre dosage from 9 mg to 4.5 mg.
If concomitant use of a strong or moderate CYP3A inhibitor is discontinued, increase the Pemazyre dosage (after 3 plasma half-lives of the CYP3A inhibitor) to the dosage that was used before starting the strong or moderate inhibitor.
Recommended Dosage For Severe Renal Impairment
- The recommended dosage of Pemazyre for patients with severe renal impairment (eGFR estimated by MDRD 15 to 29 mL/min/1.73 m2) is 9 mg orally once daily for 14 consecutive days followed by 7 days off therapy, in 21-day cycles.
Recommended Dosage For Severe Hepatic Impairment
- The recommended dosage of Pemazyre for patients with severe hepatic impairment (total bilirubin > 3 × ULN with any AST) is 9 mg orally once daily for 14 consecutive days followed by 7 days off therapy, in 21-day cycles.
What drugs interact with Pemazyre?
Effect Of Other Drugs On Pemazyre
Strong And Moderate CYP3A Inducers
- Concomitant use of Pemazyre with a strong or moderate CYP3A inducer decreases pemigatinib plasma concentrations, which may reduce the efficacy of Pemazyre. Avoid concomitant use of strong and moderate CYP3A inducers with Pemazyre.
Strong And Moderate CYP3A Inhibitors
- Concomitant use of a strong or moderate CYP3A inhibitor with Pemazyre increases pemigatinib plasma concentrations, which may increase the incidence and severity of adverse reactions.
- Avoid concomitant use of strong and moderate CYP3A inhibitors with Pemazyre.
- Reduce Pemazyre dosage if concomitant use of strong and moderate CYP3A inhibitors cannot be avoided.
Is Pemazyre safe to use while pregnant or breastfeeding?
- Based on findings in an animal study and its mechanism of action, 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.
- There are no data on the presence of pemigatinib or its metabolites in human milk or their effects on either the breastfed child or on milk production.
- Because of the potential for serious adverse reactions in breastfed children from Pemazyre, women should not breastfeed during treatment and for 1 week after the final dose.
Latest Cancer News
Daily Health News
Multimedia: Slideshows, Images & Quizzes
Understanding Cancer: Metastasis, Stages of Cancer, and More
Learn the basics about cancer including types, causes, how it spreads, symptoms and signs, stages and treatment options. Read...
Colorectal Cancer: Symptoms, Signs, Screening, Stages
Colorectal cancer (colon cancer) is the cause of many cancer deaths. Learn about the warning signs, symptoms, screening process,...
Bladder Cancer Symptoms, Stages, Treatments
Bladder cancer occurs when cancerous cells, often from the lining of the bladder, begin to multiply. Find more information about...
Signs of Cancer in Women: Symptoms You Can't Ignore
Colon and stomach cancer symptoms can surprise women but can be treated if detected early. Learn about breast cancer signs and...
Colon Cancer: How Your Diet Can Affect Colorectal Cancer
Diet, including nutrient, antioxidant, and vitamin intake, affects colon cancer risk. Certain dietary factors either decrease or...
What Is Gastric (Stomach) Cancer? Signs, Symptoms, Causes
What are the common signs and symptoms of stomach cancer? Learn about gastric cancer diagnosis, treatment, and their risks, how...
Cancer: Symptoms of Common Cancers in Men
Can men get breast cancer? Cancer symptoms men need to watch out for include skin changes, difficulty swallowing, rapid weight...
Colorectal (Colon) Cancer Quiz: Test Your Medical IQ
What is colorectal (colon) cancer and who gets it? Take this quiz to find out how this disease may be prevented.
Top 10 Cancers Quiz
Take this quiz to learn the causes of cancer. Get the facts about the causes, symptoms, and treatments for the world's most...
Gastric Cancer Quiz
What are the main risk factors for gastric cancer? Where does gastric cancer occur? Take this quiz to learn about this different...
Related Disease Conditions
Colon Polyps: Symptoms, Causes, Cancer Risk, Treatment, and Prevention
Colon polyps are common growths on the inner lining of the colon. Colon polyps may become cancerous. There are several different types of colon polyps, and the chance of the polyp becoming cancerous depends on the type, size, and histology. Blood in the stool or rectal bleeding are the most common symptoms of colon polyps. Treatment for colon polyps depend on the type, size, and histology.
Early Warning Signs and Stages of Colon Cancer
Colon cancer or colorectal cancer, is a type of cancer that begins in the cells lining the large intestine (colon). In the early stages of colon cancer, warning signs and symptoms usually don’t occur. Colon cancer usually does not have any signs or symptoms. As the cancer grows and expands it may begin to produce signs and symptoms, for example, diarrhea, constipation, blood in the stool, and narrow or pencil-thin stools.There are four stages of colon cancer; however, The term Stage 0 is sometimes used for a very early cancer that only affects the lining of the intestine. The other stages of colon cancer are stage 1, 2, 3, and 4.
Colon cancer (bowel cancer) is a malignancy that arises from the inner lining of the colon. Most, if not all, of these cancers develop from colonic polyps. Removal of these precancerous polyps can prevent colon cancer.
Bile Duct Cancer (Cholangiocarcinoma)
Bile duct cancer (cholangiocarcinoma) is a rare type of cancer that arises from cells that line the drainage system from the liver and gallbladder to the intestine. Symptoms of bile duct cancer include jaundice, itching, weight loss, and abdominal pain. Physical examination, specialized blood tests, and imaging tests may be used to diagnose bile duct cancer. Treatment for bile duct cancer may include chemotherapy, radiation therapy, and photodynamic therapy. Bile duct cancer typically has a poor prognosis. Preventing liver damage may decrease the risk of developing bile duct cancer.
Second Source article from Government
Treatment for bladder cancer depends on the stage of the disease, the grade of the tumor, and the type of bladder cancer. Options for treatment include surgery, radiation therapy, chemotherapy, and biological therapy.
Anal cancer, cancer located at the end of the large intestine, has symptoms that include anal or rectal bleeding, anal pain or pressure, anal discharge or itching, a change in bowel movements, and/or a lump in the anal region. Treatment for anal cancer may involve radiation, chemotherapy, or surgery and depends upon the stage of the cancer, its location, whether cancer is eradicated after the first treatment, and whether the patient has HIV.Anal cancer is usually curable when found localized. Early detection remains the key to long-term survival as it is in many forms of cancer.
At What Stage of Cancer is Chemotherapy Used?
The decision to use chemotherapy may vary depending on the aggressiveness, stage and type of cancer. Usually, chemotherapy may be used for all stages in most cancer types. Chemotherapy is a type of medicine or combination of medications that is used to treat or kill cancer cells.
There are several types of kidney cancer, including renal cell cancer (renal adenocarcinoma or hypernephroma), transitional cell carcinoma, and Wilms tumor. Symptoms of kidney cancer include blood in the urine, an abdominal lump or mass, chronic pain in the side, and tiredness. Treatment of kidney cancer -- which may include surgery, arterial embolization, radiation therapy, biological therapy or chemotherapy -- depends upon the stage of the disease and the patient's overall health.
Early Signs of Colon Cancer
Colon or colorectal cancer may not cause any symptoms during the early stages of the disease. A person may have polyps or colon cancer but may not have any symptoms till the late stages of the disease.
Gallbladder cancer is a rare form of cancer with symptoms that include jaundice, abdominal pain, fever, nausea and vomiting, abdominal lumps, and bloating. Risk factors include being female and Native American. Treatment of gallbladder cancer depends upon the stage of the cancer, the type of gallbladder cancer, and whether the cancer can be removed by surgery.
Is Gallbladder Cancer Aggressive?
Gallbladder cancer (GBC) is one of the aggressive cancers of the biliary tract. The gallbladder generates and concentrates bile that aids in the digestion of fats. GBC is a rare, yet deadly cancer of the gastrointestinal tract.
Is Cancer Contagious?
Cancer is an abnormal growth of cells. A variety of parasites and viruses have been linked to various cancers. Cancer may metastasize, spreading from its original location to other organs. If you have cancer, you should seek medical care immediately if you experience high fever, shortness of breath, intense headaches, vomiting blood or passing blood rectally, chest pain or moderate to severe weakness, passing out (fainting), mental status changes, or seizures.
Colon Cancer Prevention
Colorectal cancer is both curable and preventable if it is detected early and completely removed before the cancerous cells metastasize to other parts of the body. Colonoscopy and flexible sigmoidoscopy (along with digital rectal examination and stool occult blood testing) are both effective at preventing colo-rectal cancers and detecting early colo-rectal cancers.
Guide for COVID-19 Vaccine for Cancer Patients
The authorities have jointly agreed that patients on active cancer treatment are at a higher risk of COVID-19 infection and complications. Hence, there is a necessity to prioritize patients with cancer for the COVID-19 vaccine.
How Can We Prevent Cancer?
Cancer is a medical condition in which cells grow out of control and crowd out the normal cells. This makes it difficult for the body to work the way it should. Cancer can start at any place in the body. There are many types of cancer. It’s not just one disease. Cancer can start in the lungs, breast, colon, or blood.
Treatment & Diagnosis
- Colon Cancer
- Anal Cancer
- Stomach Cancer
- Stomach Cancer
- Bladder Cancer
- Kidney Cancer
- Small Intestine Cancer
- Gallbladder Cancer
- Bile Duct Cancer (Cholangiocarcinoma)
- Colorectal Cancer Issues: An Update with Doctors
- Colon Cancer Update: James Church, MD
- Colon Cancer Update
- Colon Cancer Update with The Cleveland Clinic
- Cancer FAQs
- Gastric Cancer FAQs
- Colorectal (Colon) Cancer FAQs
- Colon Cancer Prevention And Fiber?
- Payton, Bile Duct Cancer & Sclerosing Cholangitis
- Colon Cancer and Polyp Screening Guidelines
- Colon Cancer Silences Howard Keel
- Colon Cancer, The Genetic Factor
- Treatment of Anal Cancer
- Ray Manzarek Dies of Bile Duct Cancer
- What Are the Early Signs of Colon Cancer?
- What Is the Best Way to Prevent Colon Cancer?
- Does HIV Cause Colorectal Cancer?
- Can Gallbladder Problems Cause Blood Clots?
- What Is the Number One Cause of Cancer?
- How Do You Test for Stomach Cancer?
- How Does Colon Cancer Affect a Person's Body?
- Does BBQ Meat Cause Cancer?
- Red Meats and Processed Meats Raise Cancer Risk
- Bladder Cancer Causes, Symptoms, and Signs
Health Solutions From Our Sponsors
Report Problems to the Food and Drug Administration
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.