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Care During Chemotherapy and Beyond

Fedratinib

(fed RA ti nib)

Trade Name: INREBIC®

Fedratinib is the generic name for the trade name drug INREBIC®. In some cases, health care professionals may use the trade name INREBIC® when referring to the generic drug name Fedratinib.

Drug Type: Fedratinib is an anti-cancer ("antineoplastic") targeted agent. This medication is classified as a "JAK2 inhibitor". For more detail, see "How Fedratinib Works" below.

What Fedratinib Is Used For

  • For the treatment of intermediate and high risk myelofibrosis.
  • Treatment of intermediate-2 or high-risk primary or secondary (post-polycythemia vera or post-essential thrombocythemia) myelofibrosis (MF)

Note: If a drug has been approved for one use, physicians may elect to use this same drug for other problems if they believe it may be helpful.

How Fedratinib Is Given

  • Fedratinib is a pill, taken by mouth, with or without food.
  • Taking this drug with a high-fat meal may help if you have an upset stomach.
  • Take fedratinib exactly as prescribed, even if you are feeling better.
  • Swallow fedratinib tablets whole. Do not chew, crush of break.
  • Those who have feeding tubes may also use the tablet. Mix each tablet with 40 mL of water. Stir for 10 minutes. Give within 6 hours of mixing. Flush the feeding tube with water before and after this drug is given.
  • Do not change your dose or stop fedratinib unless your health care provider tells you to.
  • If a dose is missed, return to the usual dosing schedule. Do not take an additional dose.
  • Do not take extra doses of fedratinib. Call your health care provider right away if you take too much.
  • Avoid grapefruit, grapefruit juice, and supplements that contain grapefruit extract while taking fedratinib. Grapefruit products may increase the amount of fedratinib.
  • The amount of fedratinib that you will receive depends on many factors, including your height and weight, your general health or other health problems, and the type of cancer or condition you have. Your doctor will determine your exact dosage and schedule.

Side Effects

Important things to remember about the side effects of fedratinib:

  • Most people will not experience all of the fedratinib aide effects listed.
  • Side effects are often predictable in terms of their onset, duration, and severity.
  • Side effects will improve after therapy is complete.
  • Side effects may be quite manageable. There are many options to minimize or prevent the side effects of fedratinib.

The following side effects are common (occurring in greater than 30%) for patients taking fedratinib:

These are less common side effects (occurring in 10-29%) for patients receiving fedratinib:

Not all side effects are listed above. Side effects that are very rare -- occurring in less than about 10 percent of patients -- are not listed here. But you should always inform your health care provider if you experience any unusual symptoms.

A serious but rare occurrence with patients taking fedratinib is encephalopathy - including Wernicke encephalopathy. Wernicke's encephalopathy is a neurological emergency resulting from acute thiamine (Vitamin B1) deficiency. Your doctor will assess thiamine levels prior to starting fedratinib and routinely while you are taking this medication. Signs of Wernicke encephalopathy are changes in balance, vision changes, trouble thinking or walking, or trouble with memory.

When to Contact Your Doctor or Health Care Provider

Contact your health care provider immediately, day or night, if you should experience any of the following symptoms:

  • Any change in mental status such as confusion, drowsiness or trouble with memory, balance, vision changes, trouble thinking or walking. These may be signs/symptoms of Wernicke encephalopathy - a neurologic emergency resulting from thiamine (Vitamin B1) deficiency.
  • Fever of 100.4º F (38º C) or higher, chills (possible signs of infection)

The following symptoms require medical attention, but are not an emergency. Contact your health care provider within 24 hours of noticing any of the following:

  • Nausea (interferes with ability to eat and unrelieved with prescribed medication)
  • Vomiting (vomiting more than 4-5 times in a 24-hour period)
  • Diarrhea (4-6 episodes in a 24-hour period)
  • Unusual bleeding or bruising
  • Black or tarry stools, or blood in your stools
  • Blood in the urine
  • Pain or burning with urination
  • Extreme fatigue (unable to carry on self-care activities)
  • Abdominal pain

Always inform your health care provider if you experience any unusual symptoms.

Precautions

  • Before starting fedratinib treatment, make sure you tell your doctor about any other medications you are taking (including prescription, over-the-counter, vitamins, herbal remedies, etc.). Do not take aspirin, products containing aspirin unless your doctor specifically permits this.
  • Do not receive any kind of immunization or vaccination without your doctor's approval while taking fedratinib.
  • For pregnancy usage the side effects were observed in animal reproduction studies.
  • Inform your health care professional if you are pregnant or may be pregnant prior to starting this treatment. If a woman becomes pregnant while taking fedratinib. The medication must be stopped immediately and the woman given appropriate counseling.
  • For both men and women: use contraceptives, and do not conceive a child (get pregnant) while taking fedratinib. Barrier methods of contraception, such as condoms, are recommended.
  • Do not breast feed while taking fedratinib due to the potential for serious adverse reactions to the infant.

Self-Care Tips

  • Drink at least two to three quarts of fluid every 24 hours, unless you are instructed otherwise.
  • You may be at risk of infection so try to avoid crowds or people with colds and those not feeling well, and report fever or any other signs of infection immediately to your health care provider.
  • Wash your hands often.
  • You may be at risk of infection so report any fever or any other signs of infection immediately to your health care provider.
  • Use an electric razor and a soft toothbrush to minimize bleeding.
  • Avoid contact sports or activities that could cause injury.
  • This medication causes little nausea, but if you should experience nausea, take anti-nausea medications as prescribed by your doctor, and eat small frequent meals. Suck on lozenges and chewing gum may also help.
  • Avoid sun exposure. Wear SPF 30 (or higher) sunblock and protective clothing.
  • In general, drinking alcoholic beverages should be kept to a minimum or avoided completely. You should discuss this with your doctor.
  • Get plenty of rest.
  • Maintain good nutrition.
  • If you experience symptoms or side effects, be sure to discuss them with your health care team. They can prescribe medications and/or offer suggestions that are effective in managing such problems.
  • Keep your bowels moving. Your health care provider may prescribe a stool softener to help prevent constipation that may be caused by this medicine.
  • You may experience drowsiness or dizziness; avoid driving or engaging in tasks that require alertness until your response to the drug is known.
  • For flu-like symptoms, keep warm with blankets and drink plenty of liquids. There are medications that can help reduce the discomfort caused by chills.
  • Acetaminophen or ibuprofen may help relieve discomfort from fever, headache and/or generalized aches and pains. However, be sure to talk with your doctor before taking it.

Monitoring and Testing While Taking Fedratinib

You will be checked regularly by your doctor while you are taking fedratinib, to monitor side effects and check your response to therapy. Periodic blood work will be obtained to monitor your complete blood count (CBC) and thiamine (Vitamin B1) level as well as the function of other organs (such as your kidneys and liver) will also be ordered by your doctor.

How Fedratinib Works

Targeted therapy is the result of about 100 years of research dedicated to understanding the differences between cancer cells and normal cells. To date, cancer treatment has focused primarily on killing rapidly dividing cells because one feature of cancer cells is that they divide rapidly. Unfortunately, some of our normal cells divide rapidly too, causing multiple side effects.

Targeted therapy is about identifying other features of cancer cells. Scientists look for specific differences in the cancer cells and the normal cells. This information is used to create a targeted therapy to attack the cancer cells without damaging the normal cells, thus leading to fewer side effects. Each type of targeted therapy works a little bit differently but all interfere with the ability of the cancer cell to grow, divide, repair and/or communicate with other cells.

There are different types of targeted therapies, defined in three broad categories. Some targeted therapies focus on the internal components and function of the cancer cell. The targeted therapies use small molecules that can get into the cell and disrupt the function of the cells, causing them to die. There are several types of targeted therapy that focus on the inner parts of the cells. Other targeted therapies target receptors that are on the outside of the cell. Therapies that target receptors are also known as monoclonal antibodies. Antiangiogenesis inhibitors target the blood vessels that supply oxygen to the cells, ultimately causing the cells to starve.

Researchers agree that targeted therapies are not a replacement for traditional therapies. They may best be used in combination with traditional therapies. More research is needed to identify which cancers may be best treated with targeted therapies and to identify additional targets for more types of cancer.

Fedratinib is a targeted therapy that targets and binds to the tyrosine kinase receptors and inhibits Janus Associated Kinases (JAK1 and JAK2) which mediate the signaling of a number of cytokines and growth factors that are important for hematopoiesis and immune function. By binding to these receptors, Fedratinib blocks important pathways that promote cell division. Myelofibrosis (MF) is a myeloproliferative neoplasm (MPN) known to be associated with dysregulated JAK signaling. Fedratinib is active in both wild type (unmutated) and mutated JAK2 and also has activity against other receptors, including FMS-like tyrosine kinase 3 (FLT3).

Note: We strongly encourage you to talk with your health care professional about your specific medical condition and treatments. The information contained in this website is meant to be helpful and educational, but is not a substitute for medical advice.

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