WARNING

Inrebic, also known by its generic name fedratinib, is a medication used to treat a rare type of bone marrow disorder called myelofibrosis. While Inrebic can be effective in managing this condition, it is important to be aware of its potential risks. Here are some of the notable risks associated with taking Inrebic:

• Worsening of Blood Counts: Inrebic can cause a decrease in blood cell counts, including red blood cells, white blood cells, and platelets. This can lead to anemia, increased susceptibility to infections, and an increased risk of bleeding. Regular blood tests are necessary to monitor these levels.
• Gastrointestinal Side Effects: Inrebic commonly causes side effects such as diarrhea, nausea, vomiting, and abdominal pain. These symptoms can be severe in some cases and may require medical intervention.
• Hepatotoxicity: There have been reports of liver damage associated with Inrebic use. Signs of liver problems include yellowing of the skin or eyes (jaundice), dark urine, abdominal pain, and persistent nausea. Regular liver function tests are required to monitor for any potential liver damage.
• Cardiovascular Effects: Inrebic may have an impact on the cardiovascular system. It can cause an irregular heart rhythm, which can be serious or life-threatening. Pre-existing heart conditions should be closely monitored, and patients should report any unusual symptoms such as chest pain or palpitations.
• Worsening of Existing Conditions: Inrebic may exacerbate certain medical conditions, such as pancreatitis, stomach ulcers, and kidney problems. It is important to inform your healthcare provider about any pre-existing conditions before starting this medication.
• Drug Interactions: Inrebic can interact with other medications, including those metabolized by the liver. It is crucial to inform your healthcare provider about all the medications, supplements, and herbal products you are taking to avoid potential interactions.

It is important to note that these risks may vary from person to person, and not everyone experiences these side effects. However, it is essential to have regular follow-up appointments with your healthcare provider while taking Inrebic to monitor for any potential complications and to discuss any concerns or symptoms you may have.

Why is this medication prescribed?

Inrebic (generic name: fedratinib) is a medication that is prescribed for the treatment of certain types of myelofibrosis, a rare bone marrow disorder. Myelofibrosis is characterized by the abnormal production of blood cells, leading to the formation of scar tissue in the bone marrow. This condition can cause symptoms such as enlarged spleen, anemia, fatigue, and other complications.

Inrebic is classified as a Janus kinase (JAK) inhibitor. It works by blocking certain enzymes called JAK kinases, which are involved in the signaling pathways of blood cell production. By inhibiting these enzymes, Inrebic helps reduce the abnormal cell growth and fibrosis in the bone marrow, thereby improving symptoms and overall quality of life for individuals with myelofibrosis.

How should this medicine be used?

Inrebic (fedratinib) is a prescription medication that should be used exactly as prescribed by your healthcare provider. It comes in the form of capsules and is taken orally. Here are some general guidelines for the use of Inrebic:

• Dosage: The recommended starting dose of Inrebic for myelofibrosis is 400 mg once daily. Your healthcare provider may adjust the dose based on your individual needs and response to the treatment.
• Timing: It is typically recommended to take Inrebic at the same time each day. You can take it with or without food, but try to be consistent with your choice to maintain a routine.
• Swallowing the Capsules: Take the Inrebic capsules whole with a glass of water. Do not crush, chew, or open the capsules, as they are designed to release the medication slowly.
• Duration of Treatment: Your healthcare provider will determine the duration of your treatment with Inrebic based on your condition and individual response. It is essential to continue taking the medication as prescribed, even if you start feeling better.
• Regular Monitoring: While taking Inrebic, you will need regular check-ups and blood tests to monitor your blood cell counts, liver function, and overall response to the treatment. Follow your healthcare provider’s instructions regarding follow-up appointments.
• Missed Dose: If you miss a dose, take it as soon as you remember. However, if it is close to the time for your next scheduled dose, skip the missed dose and continue with your regular dosing schedule. Do not double the dose to make up for a missed one.
• Precautions: It is important to follow your healthcare provider’s instructions and precautions while taking Inrebic. This may include avoiding certain medications or activities that can interfere with the treatment or increase the risk of side effects.

Always consult your healthcare provider or pharmacist if you have any specific questions or concerns regarding the use of Inrebic. They can provide you with detailed instructions and guidance based on your individual circumstances.

Other uses for this medicine

Inrebic (fedratinib) is primarily approved for the treatment of myelofibrosis, a rare bone marrow disorder. However, it is important to note that healthcare providers may sometimes prescribe medications for off-label uses, meaning uses not specifically approved by regulatory authorities. It is always recommended to consult your healthcare provider regarding the appropriate and approved uses of any medication.

What special precautions should I follow?

As for special precautions associated with Inrebic, here are a few important points to consider:

• Pregnancy and Breastfeeding: Inrebic may cause harm to an unborn baby, so it is important to inform your healthcare provider if you are pregnant or planning to become pregnant. Additionally, it is not known whether Inrebic passes into breast milk, so breastfeeding should be avoided while taking this medication.
• Liver Problems: Inrebic has the potential to cause liver damage. Your healthcare provider will monitor your liver function through regular blood tests. It is crucial to inform your healthcare provider about any existing liver problems or a history of liver disease before starting Inrebic.
• Drug Interactions: Inrebic can interact with other medications, including those metabolized by the liver. Inform your healthcare provider about all the medications, supplements, and herbal products you are taking, as well as any medication changes during your treatment with Inrebic.
• Heart Problems: Inrebic may cause an irregular heart rhythm, which can be serious. Inform your healthcare provider if you have a history of heart problems or any symptoms such as chest pain, rapid or irregular heartbeat, or lightheadedness.
• Pancreatitis: Inrebic has been associated with cases of pancreatitis (inflammation of the pancreas). Inform your healthcare provider if you have a history of pancreatitis or if you experience persistent abdominal pain.
• Bleeding and Bruising: Inrebic can increase the risk of bleeding and bruising due to its effects on blood cell counts. Inform your healthcare provider if you notice unusual bleeding, bruising, or signs of low blood cell counts.
• Surgery: If you are scheduled for any surgical procedure, including dental surgery, inform the healthcare professionals about your use of Inrebic. Your healthcare provider may recommend temporarily discontinuing Inrebic before the procedure.

These are just some of the special precautions associated with Inrebic. It is essential to discuss your medical history, current medications, and any specific concerns with your healthcare provider before starting this medication. They will be able to provide personalized guidance and advice based on your individual situation.

What special dietary instructions should I follow?

There are no specific dietary restrictions or instructions associated with Inrebic (fedratinib). However, it is generally recommended to follow a balanced and healthy diet while taking any medication to support overall well-being.

What should I do if I forget a dose?

Regarding a missed dose of Inrebic, here are some general guidelines:

• Timing: If you realize you have missed a dose close to the time for your next scheduled dose, it is generally recommended to skip the missed dose and continue with your regular dosing schedule. Do not double the dose to make up for the missed one.
• Consult Your Healthcare Provider: If you are unsure about what to do in case of a missed dose, it is best to consult your healthcare provider or pharmacist. They can provide specific instructions based on your treatment plan and individual circumstances.

What side effects can this medication cause?

Inrebic (fedratinib) can cause several side effects. It’s important to note that not everyone experiences these side effects, and their severity can vary from person to person. Common side effects of Inrebic include:

• Anemia: Inrebic may lower the red blood cell count, leading to anemia. This can cause symptoms such as fatigue, weakness, and shortness of breath.
• Nausea and Vomiting: These gastrointestinal symptoms are commonly reported with Inrebic use. Taking the medication with food may help alleviate these side effects.
• Diarrhea: Inrebic can cause diarrhea, which may be mild to severe. Staying hydrated and adjusting the diet to include easily digestible foods can be helpful.
• Fatigue: Many individuals taking Inrebic may experience fatigue or general weakness. It’s important to get adequate rest and communicate with your healthcare provider if these symptoms become severe or persistent.
• Headache: Headaches are a reported side effect of Inrebic. Over-the-counter pain relievers may help alleviate mild headaches, but consult your healthcare provider before taking any additional medications.
• Dizziness: Some individuals may experience dizziness or lightheadedness while taking Inrebic. It is advised to stand up slowly from a sitting or lying position to minimize the risk of falling.
• Increased Liver Enzymes: Inrebic can cause an increase in liver enzyme levels. Regular monitoring of liver function through blood tests is essential during treatment.
• Decreased Appetite: Some people may experience a decrease in appetite while taking Inrebic. It’s important to maintain proper nutrition, and if appetite loss becomes severe, consult your healthcare provider.
• Hair Loss: Inrebic can cause hair loss or thinning. This is typically reversible upon discontinuation of the medication.
• Upper Respiratory Tract Infections: Inrebic may increase the risk of upper respiratory tract infections, such as the common cold or flu. Practice good hygiene, such as regular handwashing, and avoid close contact with individuals who are sick.

It’s important to report any side effects you experience to your healthcare provider. They can provide guidance on managing these side effects and determine if any adjustments to the medication or additional treatments are necessary.

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

Storage:

• Keep Inrebic in its original container, tightly closed, and out of reach of children and pets.
• Store the medication at room temperature, away from excessive heat, moisture, and direct light.
• Do not transfer the capsules to other containers, as it may lead to confusion or misuse.

Disposal:

• Dispose of any unused or expired Inrebic capsules properly.
• Follow local guidelines and regulations for medication disposal. Do not flush the medication down the toilet or pour it into drains unless instructed to do so.
• Consult your healthcare provider or pharmacist for specific instructions on how to safely dispose of Inrebic.

In case of emergency/overdose

• Contact Emergency Services: If someone is experiencing severe symptoms, difficulty breathing, or loss of consciousness, immediately call emergency services or go to the nearest emergency room.
• Call Poison Control: If an overdose of Inrebic is suspected but the person is stable and conscious, contact your local poison control center or a helpline such as the National Poison Control Center at 1-800-222-1222 for guidance.
• Do not induce vomiting or take any other actions without medical advice unless directed to do so by healthcare professionals.

What other information should I know?

• Adherence to Treatment: It is essential to take Inrebic as prescribed by your healthcare provider. Do not stop taking the medication or change the dosage without consulting them first.
• Regular Monitoring: Regular follow-up appointments and blood tests are necessary to monitor your response to Inrebic, potential side effects, and the overall effectiveness of the treatment.
• Medication Interactions: Inform your healthcare provider about all the medications, supplements, and herbal products you are taking before starting Inrebic, as it can interact with other drugs. This includes prescription, over-the-counter, and alternative remedies.
• Compliance with Appointments: Keep all scheduled appointments with your healthcare provider. They will monitor your progress, adjust the dosage if necessary, and address any concerns or questions you may have.
• Patient Assistance Programs: In some cases, patient assistance programs or support services may be available to help with the cost of Inrebic or provide additional resources. Ask your healthcare provider or contact the manufacturer for more information.

Always consult your healthcare provider or pharmacist for specific instructions and guidance regarding storage, disposal, emergencies, and any additional information you may need about Inrebic.