Ruxolitinib IPI is used to treat adult patients with an enlarged spleen or with symptoms related to myelofibrosis, a rare form of blood cancer. Additionally, Ruxolitinib IPI is used to treat patients with polycythaemia vera who are resistant to or intolerant of hydroxyurea.
1. Dosage:
- 5 mg
- 15 mg
2. What Ruxolitinib IPI is and what is it used for:
Ruxolitinib IPI contains the active substance ruxolitinib. Ruxolitinib IPI is used to treat adult patients with an enlarged spleen or with symptoms related to myelofibrosis, a rare form of blood cancer. Additionally, Ruxolitinib IPI is used to treat patients with polycythaemia vera who are resistant to or intolerant of hydroxyurea.
3. What you need to know before you take Ruxolitinib IPI:
Follow all the doctor’s instructions carefully. They may differ from the general information contained in this leaflet.
Do Not Take Ruxolitinib IPI:
- If you are allergic to ruxolitinib or any of the other ingredients of this medicine.
- If you are pregnant or breastfeeding.
If either of the above applies to you, tell your doctor who will then decide whether you should start treatment with Ruxolitinib IPI.
Blood Tests: Before you start treatment with Ruxolitinib IPI, your doctor will perform blood tests to determine the best starting dose for you.
When you stop taking Ruxolitinib IPI, the myelofibrosis symptoms may come back. Your doctor may want to gradually reduce the amount of Ruxolitinib IPI taken each day before stopping it completely.
Children and Adolescents: This medicine is not intended for use by children or adolescents aged below 18 years because it has not been studied in this age group.
Other Medicines and Ruxolitinib IPI: Tell your doctor if you are taking, have recently taken, or might take any other medicines.
While You Are Taking Ruxolitinib IPI: You should never start a new medicine without checking first with the doctor who prescribed Ruxolitinib IPI.
Pregnancy and Breastfeeding: Do not take Ruxolitinib IPI during pregnancy. Talk to your doctor about how to take appropriate measures to avoid becoming pregnant during your treatment with Ruxolitinib IPI.
Do not breastfeed while taking Ruxolitinib IPI.
If you are pregnant or breastfeeding, think you may be pregnant, or planning to have a baby, ask your doctor for advice before taking this medicine.
Driving and Using Machines: If you experience dizziness after taking Ruxolitinib IPI, do not drive or use machines.
Ruxolitinib IPI Contains Lactose and Sodium.
4. Warnings and Precautions:
Talk to your doctor before taking Ruxolitinib IPI:
- If you have any infections. It may be necessary to treat your infection before starting Ruxolitinib IPI. You must tell your doctor if you have ever had tuberculosis or if you have been in close contact with someone who has or has had tuberculosis. You must tell your doctor if you have ever had hepatitis B.
- If you have any kidney problems.
- If you have or have ever had any liver problems.
- If you are taking other medicines.
- If you have ever had tuberculosis.
- If you have ever had skin cancer.
Talk to your doctor during your treatment with Ruxolitinib IPI:
- If you experience unexpected bruising or bleeding, unusual tiredness, shortness of breath during exercise or at rest, unusually pale skin, or frequent infections.
- If you experience fever, chills, or other symptoms of infections.
- If you experience chronic coughing with blood-tinged sputum, fever, night sweats, and weight loss.
- If you have any of the following symptoms or if anyone close to you notices that you have any of these symptoms: confusion or difficulty thinking, loss of balance or difficulty walking, clumsiness, difficulty speaking, decreased strength or weakness on one side of your body, blurred and/or loss of vision.
- If you develop a painful skin rash with blisters.
- If you notice skin changes. This may require further observation, as certain types of skin cancer have been reported.
5. How and When to Take Ruxolitinib IPI:
Always take this medicine exactly as your doctor has told you.
The dose of Ruxolitinib IPI depends on the patient’s blood cell count.
- The recommended starting dose in myelofibrosis is 15mg twice daily or 20mg twice daily, depending on your blood cell count.
- The recommended starting dose for polycythaemia vera is 10mg twice daily.
- The maximum dose is 25mg twice daily.
During the treatment, your doctor may recommend a lower or higher dose to you if the results of blood tests show that this is necessary, if you have problems with your liver or kidneys, or if you also need treatment with certain other medicines.
If you receive dialysis, take either one single dose or two separate doses of Ruxolitinib IPI only on dialysis days, after the dialysis has been completed. Your doctor will tell you if you should take one or two doses and how many tablets to take for each dose.
You should take Ruxolitinib IPI every day at the same time, either with or without food.
You should continue taking Ruxolitinib IPI for as long as your doctor tells you to. This is a long-term treatment.
If you experience certain side effects, your doctor might need to change the amount of Ruxolitinib IPI you have to take or tell you to stop taking Ruxolitinib IPI for a while.
If you accidentally take more Ruxolitinib IPI than your doctor prescribed, contact your doctor immediately.
If you forget to take Ruxolitinib IPI, simply take your next dose at the scheduled time. Do not take a double dose to make up for a forgotten dose.
If you interrupt your treatment with Ruxolitinib IPI your myelofibrosis-related symptoms may come back. Therefore, you should not stop taking Ruxolitinib IPI without discussing it with your doctor.
If you have any further questions about the use of this medicine, ask your doctor.
6. Possible Side Effects:
Most of the side effects of Ruxolitinib IPI are mild to moderate and will generally disappear after a few days to a few weeks of treatment.
Tell your doctor immediately if you experience any of the following side effects.
Some are very common (may affect more than 1 in 10 people), and some are common (may affect up to 1 in 10 people):
- Any sign of bleeding in the brain, such as sudden altered level of consciousness, persistent headache, numbness, tingling, weakness, or paralysis.
- Any sign of bleeding in the stomach or intestine, such as passing black or bloodstained stools, or vomiting blood.
- Unexpected bruising or bleeding, unusual tiredness, shortness of breath during exercise or at rest, unusually pale skin, or frequent infections.
- Painful skin rash with blisters.
- Fever, chills, or other symptoms of infections.
- Low level of red blood cells, low level of white blood cells, or low level of platelets.
Other Side Effects of Ruxolitinib IPI:
Very common (may affect more than 1 in 10 people):
- High level of cholesterol or fat in the blood.
- Abnormal liver function test results.
- Dizziness.
- Headache.
- Urinary tract infections.
- Weight gain.
- Fever, cough, difficult or painful breathing, wheezing, pain in the chest when breathing.
- High blood pressure, which may also be the cause of dizziness and headaches.
- Constipation.
- High level of lipase in the blood.
Common (may affect up to 1 in 10 people):
- Reduced number of all three types of blood cells - red blood cells, white blood cells, and platelets.
- Frequently passing wind.
Uncommon (may affect up to 1 in 100 people):
- Tuberculosis.
- Recurrence of hepatitis B infection (which can cause yellowing of the skin and eyes, dark brown-coloured urine, right-sided stomach pain, fever, feeling nauseous, or being sick).
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