WARNING

Fedratinib is a medication used to treat certain types of myelofibrosis, a rare type of bone marrow disorder. While it can be effective in managing the condition, there are potential risks associated with its use. Some of the common risks include:

• Cardiac Issues: Fedratinib can cause heart-related side effects such as irregular heartbeat, palpitations, and chest pain.
• Liver Toxicity: It may lead to liver problems, including elevated liver enzymes and liver failure.
• Hematologic Effects: There’s a risk of decreased blood cell counts, including low red blood cells (anemia), white blood cells (leukopenia), and platelets (thrombocytopenia), which can increase the risk of infections, bleeding, and bruising.
• Gastrointestinal Issues: Fedratinib can cause gastrointestinal side effects such as nausea, vomiting, diarrhea, and abdominal pain.
• Central Nervous System Toxicity: Some individuals may experience dizziness, headache, or other neurological symptoms.
• Fluid Retention: It may lead to swelling, especially in the legs and feet, due to fluid retention.
• Hypertension: Fedratinib can increase blood pressure, so regular monitoring of blood pressure is necessary.
• Serious Bleeding: There’s a risk of severe bleeding, including gastrointestinal bleeding or intracranial hemorrhage.
• Embryo-Fetal Toxicity: Fedratinib can harm the developing fetus, so it’s not recommended for use during pregnancy.
• Drug Interactions: It may interact with other medications, leading to adverse effects or reducing the effectiveness of either medication.

It’s essential for individuals taking Fedratinib to be closely monitored by their healthcare providers for any signs of these potential risks and to report any concerning symptoms promptly. Additionally, patients should discuss their medical history and any other medications they are taking with their healthcare provider before starting Fedratinib to mitigate the risks of adverse effects.

Why is this medication prescribed?

Fedratinib is a medication used in the treatment of a specific type of blood disorder called myelofibrosis. Myelofibrosis is a rare type of chronic leukemia that affects the bone marrow, leading to scarring and fibrosis within the marrow. Fedratinib belongs to a class of drugs known as JAK inhibitors, which work by blocking the activity of enzymes called Janus kinases, thereby helping to reduce the abnormal cell growth and scarring associated with myelofibrosis.

When prescribed, fedratinib is typically used to alleviate symptoms such as enlarged spleen and related discomfort, as well as to improve overall quality of life for patients with myelofibrosis.

How should this medicine be used?

As for how Fedratinib should be used:

• Dosage: The dosage of Fedratinib can vary depending on factors such as the patient’s weight, overall health, and response to treatment. It is typically taken orally in the form of capsules.
• Administration: Fedratinib is usually taken once daily, with or without food, as directed by a healthcare provider.
• Follow Healthcare Provider’s Instructions: It’s essential to follow the dosage and administration instructions provided by the healthcare provider carefully. Do not adjust the dosage or stop taking Fedratinib without consulting the healthcare provider first.
• Regular Monitoring: Patients taking Fedratinib should undergo regular monitoring, including blood tests, to assess their response to treatment and monitor for any potential side effects.
• Adherence to Treatment Plan: It’s important to take Fedratinib consistently as prescribed to achieve the maximum benefit from the medication.
• Handling of Medication: Handle Fedratinib capsules with care and store them according to the instructions provided by the pharmacist or healthcare provider.
• Missed Dose: If a dose is missed, it should be taken as soon as remembered, unless it’s almost time for the next dose. In that case, the missed dose should be skipped, and the regular dosing schedule resumed.
• Precautions: Patients should inform their healthcare provider about any other medications, supplements, or medical conditions they have before starting Fedratinib to prevent potential interactions or complications.
• Pregnancy and Breastfeeding: Fedratinib may harm an unborn baby, so it’s not recommended during pregnancy. It’s essential to discuss pregnancy planning and contraceptive methods with the healthcare provider. Additionally, breastfeeding while taking Fedratinib is not recommended.
• Adverse Effects: Patients should be aware of the potential side effects of Fedratinib and report any unusual symptoms or concerns to their healthcare provider promptly.

Overall, adherence to the prescribed dosage and administration instructions, along with regular monitoring and communication with the healthcare provider, is crucial for the safe and effective use of Fedratinib in the treatment of myelofibrosis.

Other uses for this medicine

Fedratinib is primarily prescribed for the treatment of certain types of myelofibrosis, as mentioned earlier. However, there may be instances where healthcare providers prescribe medications off-label, meaning for uses not specifically approved by regulatory agencies such as the FDA. Off-label uses of Fedratinib may include investigational or experimental treatments for other conditions, but these uses should be carefully considered and monitored by healthcare providers.

What special precautions should I follow?

As for special precautions to follow when taking Fedratinib:

• Medical History: Inform your healthcare provider about your complete medical history, including any past or present medical conditions, allergies, surgeries, and medications (prescription, over-the-counter, herbal supplements, or vitamins).
• Pregnancy and Breastfeeding: Fedratinib may cause harm to an unborn baby, so it’s essential to use effective contraception during treatment and avoid becoming pregnant. Additionally, breastfeeding while taking Fedratinib is not recommended.
• Liver Function: Fedratinib can affect liver function, so regular monitoring of liver enzymes is necessary. Inform your healthcare provider if you have a history of liver disease or if you experience symptoms such as abdominal pain, jaundice (yellowing of the skin or eyes), or dark urine while taking Fedratinib.
• Cardiac Health: Fedratinib may cause cardiovascular side effects, so patients with a history of heart problems or those at risk for heart disease should be closely monitored during treatment.
• Blood Cell Counts: Fedratinib can lower blood cell counts, increasing the risk of infections, bleeding, and bruising. Regular blood tests are needed to monitor these counts, and patients should report any signs of infection, bleeding, or unusual bruising to their healthcare provider.
• Fluid Retention and Hypertension: Fedratinib may cause fluid retention and increase blood pressure. Patients should monitor their weight regularly and report any significant weight gain or symptoms of hypertension, such as headaches or vision changes, to their healthcare provider.
• Drug Interactions: Fedratinib can interact with other medications, including over-the-counter drugs, supplements, and herbal products. Inform your healthcare provider about all the medications you are taking to avoid potential interactions.
• Driving and Operating Machinery: Fedratinib may cause dizziness or drowsiness, which can impair your ability to drive or operate machinery. Use caution when performing activities that require mental alertness until you know how Fedratinib affects you.
• Follow Healthcare Provider’s Instructions: It’s essential to follow the dosage and administration instructions provided by your healthcare provider carefully. Do not adjust the dosage or stop taking Fedratinib without consulting your healthcare provider first.
• Adverse Effects: Be aware of the potential side effects of Fedratinib and report any unusual symptoms or concerns to your healthcare provider promptly.

By following these precautions and closely monitoring your health during treatment, you can help ensure the safe and effective use of Fedratinib.

What special dietary instructions should I follow?

There are no specific dietary restrictions associated with Fedratinib. However, it’s essential to maintain a balanced diet and stay hydrated while taking the medication. If you experience gastrointestinal side effects such as nausea, vomiting, or diarrhea, eating small, frequent meals and avoiding spicy or greasy foods may help alleviate symptoms.

What should I do if I forget a dose?

If you forget to take a dose of Fedratinib:

• Take It as Soon as Possible: If you remember within a few hours of the missed dose, take it as soon as you remember.
• Skip the Missed Dose If It’s Almost Time for the Next Dose: If it’s almost time for your next scheduled dose, skip the missed dose and continue with your regular dosing schedule.
• Do Not Double Dose: Do not take a double dose to make up for a missed dose. Taking too much medication at once can increase the risk of side effects or complications.
• Consult Your Healthcare Provider: If you’re unsure about what to do or if you have missed multiple doses, consult your healthcare provider or pharmacist for guidance.

What side effects can this medication cause?

Fedratinib, like any medication, can cause side effects. Not everyone will experience these side effects, and their severity can vary from person to person. Common side effects of Fedratinib may include:

• Nausea and vomiting: Some individuals may experience nausea or vomiting while taking Fedratinib. These symptoms can often be managed with anti-nausea medications or by taking Fedratinib with food.
• Diarrhea: Diarrhea is a common side effect of Fedratinib. Staying hydrated and avoiding foods that may worsen diarrhea can help manage this side effect.
• Abdominal pain: Some people may experience abdominal discomfort or pain while taking Fedratinib. It’s essential to inform your healthcare provider if you experience persistent or severe abdominal pain.
• Fatigue: Feeling tired or fatigued is a common side effect of Fedratinib. Getting enough rest and practicing good sleep hygiene can help manage fatigue.
• Dizziness: Fedratinib may cause dizziness or lightheadedness in some individuals. Avoiding sudden changes in position and taking precautions when performing activities that require mental alertness can help prevent falls or accidents.
• Headache: Headaches are another possible side effect of Fedratinib. Over-the-counter pain relievers may help alleviate mild headaches, but it’s essential to consult your healthcare provider if headaches persist or worsen.
• Decreased appetite: Some individuals may experience a decreased appetite while taking Fedratinib. Eating smaller, more frequent meals and choosing nutrient-rich foods can help maintain adequate nutrition.
• Hair loss: Hair thinning or hair loss may occur as a side effect of Fedratinib treatment. This side effect is usually temporary, and hair growth typically resumes after discontinuing the medication.
• High blood pressure: Fedratinib can raise blood pressure in some individuals. Regular monitoring of blood pressure and following lifestyle modifications recommended by your healthcare provider can help manage this side effect.
• Liver abnormalities: Fedratinib may cause liver function abnormalities, such as elevated liver enzymes. Regular monitoring of liver function tests is essential during treatment with Fedratinib.
• Hematologic abnormalities: Fedratinib can affect blood cell counts, leading to conditions such as anemia, leukopenia (low white blood cell count), and thrombocytopenia (low platelet count). Regular blood tests are necessary to monitor these parameters.
• Cardiac issues: Some individuals may experience heart-related side effects such as irregular heartbeat, palpitations, or chest pain while taking Fedratinib.

It’s important to report any side effects or concerns to your healthcare provider promptly. They can provide guidance on managing side effects and may adjust your treatment regimen if necessary. Additionally, some side effects may require immediate medical attention, so it’s crucial to seek medical help if you experience severe or concerning symptoms while taking Fedratinib.

What should I know about storage and disposal of this medication?

Storage and disposal of Fedratinib:

Storage:

• Room Temperature: Store Fedratinib capsules at room temperature away from moisture and heat.
• Original Container: Keep Fedratinib in its original container, tightly closed, and out of reach of children and pets.
• Avoid Pill Splitting: Do not split or crush Fedratinib capsules unless instructed by your healthcare provider.
• Proper Labeling: Ensure proper labeling of the medication container to prevent confusion with other medications.

Disposal:

• Consult Pharmacist: Check with your pharmacist or healthcare provider regarding the proper disposal method for unused or expired Fedratinib capsules.
• Take-Back Programs: Some pharmacies or community organizations may offer drug take-back programs for safe disposal of medications.
• Do Not Flush: Do not flush Fedratinib capsules down the toilet unless specifically instructed to do so by the medication guide or pharmacist.

In case of emergency/overdose

• Seek Medical Help: If you suspect an overdose of Fedratinib or experience severe symptoms such as severe dizziness, fainting, or difficulty breathing, seek immediate medical attention or call your local emergency services.
• Poison Control: Contact a poison control center or emergency room for guidance on managing Fedratinib overdose. Have the medication container or label available for reference.

What other information should I know?

• Follow-up Appointments: Attend all scheduled follow-up appointments with your healthcare provider for monitoring of your condition and response to Fedratinib treatment.
• Lab Tests: Undergo regular blood tests as recommended by your healthcare provider to monitor your blood cell counts, liver function, and overall health during treatment.
• Avoid Alcohol: Limit or avoid alcohol consumption while taking Fedratinib, as it may exacerbate certain side effects or interact with the medication.
• Inform Healthcare Providers: Inform all healthcare providers involved in your care, including dentists and specialists, about your use of Fedratinib to prevent potential drug interactions or complications.
• Keep Updated: Stay informed about any updates or changes to the medication’s safety information provided by your healthcare provider, pharmacist, or regulatory agencies.
• Patient Education: Educate yourself about Fedratinib, including its purpose, dosage, potential side effects, and precautions, to ensure safe and effective use of the medication.

By following these guidelines, you can help ensure the safe storage, disposal, and handling of Fedratinib, as well as be prepared to take appropriate action in case of emergencies or overdoses. Always consult your healthcare provider or pharmacist if you have any questions or concerns about your medication regimen.