Ruxolitinib Vivanta

Patient Information Leaflet

Ruxolitinib Vivanta 5 mg tablets, 10 mg tablets, 15 mg tablets, 20 mg tablets

ruxolitinib
Generic medicine
Please read all of this leaflet carefully before taking this medicine because it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not give it to others, even if their symptoms are the same as yours, because it could be harmful.
• If you experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.
• The information in this leaflet is intended for you or for the child, but the text will refer only to “you”.

Contents of this leaflet:

1. What Ruxolitinib Vivanta is and what it is used for
2. What you need to know before taking Ruxolitinib Vivanta
3. How to take Ruxolitinib Vivanta
4. Possible side effects
5. How to store Ruxolitinib Vivanta
6. Contents of the pack and other information

1. What Ruxolitinib Vivanta is and what it is used for

Ruxolitinib Vivanta contains the active substance ruxolitinib.
Ruxolitinib Vivanta is used to treat adult patients with an enlarged spleen or symptoms related to myelofibrosis, a rare form of blood cancer.
Ruxolitinib Vivanta is also used to treat adult patients with polycythaemia vera who are resistant to or intolerant of hydroxyurea.
Ruxolitinib Vivanta is also used to treat:

• children aged 28 days and older and adults with acute graft-versus-host disease (GvHD).
• children aged 6 months and older and adults with chronic GvHD. There are two forms of GvHD: an early form called acute GvHD, which normally develops soon after transplantation and may involve the skin, liver, and gastrointestinal tract, and a later form called chronic GvHD, which develops later, usually weeks or months after transplantation. Almost any organ can be affected by chronic GvHD.

How Ruxolitinib Vivanta works
One of the features of myelofibrosis is an enlarged spleen. Myelofibrosis is a disorder of the bone marrow in which the marrow is replaced by scar tissue. The abnormal marrow can no longer produce enough blood cells, causing the spleen to become significantly enlarged. By blocking the action of certain enzymes (called Janus Associated Kinases), Ruxolitinib Vivanta can reduce spleen size in patients with myelofibrosis and relieve symptoms such as fever, night sweats, bone pain, and weight loss in patients with myelofibrosis. Ruxolitinib Vivanta may help reduce the risk of serious blood or vascular complications.
Polycythaemia vera is a disorder of the bone marrow in which the marrow produces too many red blood cells. Blood becomes thicker as a result of the increased number of red blood cells. Ruxolitinib Vivanta can relieve symptoms, reduce spleen size, and decrease the volume of red blood cells produced in patients with polycythaemia vera by selectively blocking certain enzymes called Janus Associated Kinases (JAK1 and JAK2), thereby potentially reducing the risk of serious blood or vascular complications.
Graft-versus-host disease is a complication that occurs after transplantation when specific cells (T cells) present in the donor’s transplanted organ (e.g., bone marrow) fail to recognize the recipient’s cells/organs and attack them. By selectively blocking certain enzymes called Janus Associated Kinases (JAK1 and JAK2), Ruxolitinib Vivanta reduces the signs and symptoms of both acute and chronic forms of graft-versus-host disease, leading to improvement of the disease and survival of the transplanted cells.
If you have any questions about how Ruxolitinib Vivanta works or why this medicine has been prescribed for you, please consult your doctor.

2. What you should know before taking Ruxolitinib Vivanta

Follow carefully all instructions given by your doctor. These instructions may differ from the general
information contained in this leaflet.
Do not take Ruxolitinib Vivanta

• if you are allergic to ruxolitinib or to any of the other ingredients of this medicine (listed in section 6).
• if you are pregnant or breastfeeding (see section 2 “Pregnancy, breastfeeding and contraception”).

Warnings and precautions
Talk to your doctor or pharmacist before taking Ruxolitinib Vivanta if:

• you have infections. It may be necessary to treat the infection before starting treatment with Ruxolitinib Vivanta.
• you have ever had tuberculosis or have been in close contact with someone who has or has had tuberculosis. Your doctor may perform tests to check whether you have tuberculosis or other infections.
• you have ever had hepatitis B.
• you have kidney problems or have or have ever had liver problems, as your doctor may need to prescribe a different dose of Ruxolitinib Vivanta.
• you have ever had cancer, particularly skin cancer.
• you have or have had heart problems.
• you are aged 65 years or older. Patients aged 65 years or older may have an increased risk of heart problems, including heart attack, and certain types of cancer.
• you are a smoker or have smoked in the past.

Talk to your doctor or pharmacist during treatment with Ruxolitinib Vivanta if:

• you develop fever, chills, or other signs of infection.
• you develop a chronic cough with blood-streaked sputum, fever, night sweats, or weight loss (these may be signs of tuberculosis).
• you experience any of the following symptoms, or if someone close to you notices any of these symptoms: confusion or difficulty concentrating, loss of balance or difficulty walking, lack of coordination, difficulty speaking, loss of strength or weakness on one side of the body, blurred vision and/or loss of vision. These may be signs of a serious brain infection, and your doctor may recommend further tests and follow-up examinations.
• you develop painful skin rashes with blisters (these are signs of shingles).
• you notice changes in your skin. This may require further monitoring, as some types of non-melanoma skin cancer have been reported.
• you experience sudden shortness of breath or difficulty breathing, chest pain or upper back pain, swelling of an arm or leg, pain or tenderness in the leg, or redness or discoloration in the arm or leg, as these may be signs of blood clots in the veins.

Children and adolescents
This medicine is not recommended for use in children or adolescents under 18 years of age with myelofibrosis or polycythaemia vera, as it has not been studied in this age group.
For the treatment of graft-versus-host disease, Ruxolitinib Vivanta may be used in patients aged 28 days and older.
Other medicines and Ruxolitinib Vivanta
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines. While taking Ruxolitinib Vivanta, you must never start taking a new medicine without first consulting the doctor who prescribed Ruxolitinib Vivanta.
This applies to prescription medicines, over-the-counter medicines, and herbal or alternative remedies.
It is particularly important that you inform your doctor about medicines containing the following active substances, as your doctor may need to adjust the dose of Ruxolitinib Vivanta.

• Some medicines used to treat infections:
• medicines used to treat fungal infections (such as ketoconazole, itraconazole, posaconazole, fluconazole, and voriconazole)
• antibiotics used to treat bacterial infections (such as clarithromycin, telithromycin, ciprofloxacin, or erythromycin)
• medicines to treat viral infections, including HIV/AIDS infection (such as amprenavir, atazanavir, indinavir, lopinavir/ritonavir, nelfinavir, ritonavir, saquinavir)
• medicines to treat hepatitis C (boceprevir, telaprevir).
• A medicine used to treat depression (nefazodone).
• Medicines to treat high blood pressure (hypertension) and chest tightness, heaviness, or pain (chronic angina pectoris) (mibefradil or diltiazem).
• A medicine used to treat heartburn (cimetidine).
• A medicine used to treat heart disease (avasimibe).
• Medicines used to prevent seizures or convulsions (phenytoin, carbamazepine, or phenobarbital and other antiepileptics).
• Medicines used to treat tuberculosis (TB) (rifabutin or rifampicin).
• An herbal product used to treat depression (St. John’s wort (Hypericum perforatum)).

Talk to your doctor if you are unsure whether any of the above applies to you.
Pregnancy, breastfeeding and fertility
Pregnancy

• If you are pregnant, suspect you may be pregnant, or are planning to become pregnant, consult your doctor or pharmacist before taking this medicine.
• Do not take Ruxolitinib Vivanta during pregnancy (see section 2 “Do not take Ruxolitinib Vivanta”).

Breastfeeding

• Do not breastfeed while taking Ruxolitinib Vivanta (see section 2 “Do not take Ruxolitinib Vivanta”). Consult your doctor.

Contraception

• Ruxolitinib Vivanta is not recommended for women who could become pregnant and who are not using contraceptive measures. Talk to your doctor about using appropriate contraception to avoid becoming pregnant during treatment with Ruxolitinib Vivanta.
• Talk to your doctor if you become pregnant while taking Ruxolitinib Vivanta.

Driving and using machines
If you experience dizziness after taking Ruxolitinib Vivanta, do not drive or operate machinery.
Ruxolitinib Vivanta contains lactose and sodium
Ruxolitinib Vivanta contains a sugar called lactose. If your doctor has diagnosed you with an intolerance to certain sugars, contact him or her before taking this medicine.
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, i.e. essentially ‘sodium-free’.

3. How to take Ruxolitinib Vivanta

Take this medicine exactly as your doctor or pharmacist has told you. If
you have any doubts, consult your doctor or pharmacist.
Before starting treatment with Ruxolitinib Vivanta and during treatment, your doctor will perform
blood tests to determine the best dose, to assess how you are responding to
treatment, and whether Ruxolitinib Vivanta is causing any unwanted effects. Your doctor may need to
adjust the dose or stop treatment. Your doctor will carefully check for any
signs or symptoms of infection before starting and during treatment with Ruxolitinib
Vivanta.
Myelofibrosis

• Adults: The recommended starting dose in myelofibrosis is 5 to 20 mg twice daily. The maximum dose is 25 mg twice daily.

Polycythaemia vera

• Adults: The recommended starting dose in polycythaemia vera is 10 mg twice daily. The maximum dose is 25 mg twice daily.

Acute and chronic graft-versus-host disease

• Children aged 6 years and older but less than 12 years: the recommended starting dose is 5 mg twice daily.
• Children aged 12 years and older and adults: the recommended starting dose is 10 mg twice daily.

An oral solution from other brands is available if you have difficulty swallowing whole tablets
and for children under 6 years of age.
You must take Ruxolitinib Vivanta every day at the same time, with or without food.
Your doctor will always tell you exactly how many tablets of Ruxolitinib Vivanta to take.
You must continue taking Ruxolitinib Vivanta for as long as your doctor tells you to.
If you take more Ruxolitinib Vivanta than you should
If you accidentally take more Ruxolitinib Vivanta than prescribed by your doctor, contact
your doctor or pharmacist immediately.
If you forget to take Ruxolitinib Vivanta
If you forget to take Ruxolitinib Vivanta, simply take the next dose at the scheduled time. Do not take a double dose to make up for the forgotten dose.
If you have any questions about the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone gets them.
Most of the side effects of Ruxolitinib Vivanta are mild to moderate in severity and usually disappear after a period of treatment ranging from a few days to a few weeks.

Myelofibrosis and Polycythaemia Vera
Some side effects can be serious.
Contact your doctor immediately before taking your next scheduled dose if you experience any of the following serious side effects:

Very common (may affect more than 1 in 10 people):

• any signs of bleeding in the stomach or intestines, such as black or blood-stained stools, or vomiting blood
• unexpected bruising and/or bleeding, unusual tiredness, shortness of breath during exercise or at rest, unusually pale skin, or frequent infections – possible symptoms of blood disorders
• painful skin rashes with blisters – possible symptoms of shingles (herpes zoster)
• fever, chills, or other signs of infections
• low levels of red blood cells (anaemia), low levels of white blood cells (neutropenia), or low levels of platelets (thrombocytopenia)

Common (may affect up to 1 in 10 people):

• any signs of bleeding in the brain, such as sudden change in consciousness, persistent headache, numbness, tingling, weakness, or paralysis

Other side effects
Other possible side effects include those listed below. If you experience any of these side effects, contact your doctor or pharmacist.
Very common (may affect more than 1 in 10 people):

• high levels of cholesterol or fats in the blood (hypertriglyceridaemia)
• abnormal liver function test results
• dizziness
• headache
• urinary tract infections
• weight gain
• fever, cough, difficulty breathing or painful breathing, wheezing, chest pain when breathing – possible symptoms of pneumonia
• high blood pressure (hypertension), which may also cause dizziness and headache
• constipation
• elevated levels 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 (pancytopenia)
• frequent flatulence

Uncommon (may affect up to 1 in 100 people):

• tuberculosis
• reactivation of hepatitis B infection (which may cause yellowing of the skin and eyes, dark brown urine, stomach pain on the right side, fever, and feelings of nausea or malaise)

Graft-versus-host disease (GvHD)
Some side effects can be serious.
Contact your doctor immediately before taking your next scheduled dose if you experience any of the following serious side effects:

Very common (may affect more than 1 in 10 people):

• signs of infection with fever associated with:
• muscle pain, skin redness and/or difficulty breathing (cytomegalovirus infection)
• pain when urinating – (urinary tract infection)
• rapid heartbeat, confusion, and shortness of breath (sepsis, a condition associated with infection and widespread inflammation)
• frequent infections, fever, chills, sore throat, and mouth ulcers
• spontaneous bleeding or bruising – possible symptoms of thrombocytopenia, a condition caused by low platelet levels

Other side effects
Very common (may affect more than 1 in 10 people):

• headache
• high blood pressure (hypertension)
• abnormal blood test results, including:
• high levels of lipase and/or amylase
• high levels of cholesterol
• abnormal liver function
• increased levels of an enzyme found in muscles (increased blood creatine phosphokinase)
• increased levels of creatinine, an enzyme that may indicate your kidneys are not functioning properly
• low levels of all three types of blood cells: red blood cells, white blood cells, and platelets (pancytopenia)
• nausea
• tiredness, fatigue, pale skin – possible symptoms of anaemia, a condition caused by low levels of red blood cells

Common (may affect up to 1 in 10 people):

• fever, muscle pain, pain or difficulty urinating, blurred vision, cough, cold symptoms, or difficulty breathing – possible symptoms of BK virus infection
• weight gain
• constipation (constipation)

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, contact your doctor or pharmacist. You can also report side effects directly via the national reporting system at https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Ruxolitinib Vivanta

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton or blister after "Exp".
This medicine does not require any special storage conditions.
Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Ruxolitinib Vivanta contains

• The active substance in Ruxolitinib Vivanta is ruxolitinib.
• Each Ruxolitinib Vivanta 5 mg tablet contains 5 mg of ruxolitinib.
• Each Ruxolitinib Vivanta 10 mg tablet contains 10 mg of ruxolitinib.
• Each Ruxolitinib Vivanta 15 mg tablet contains 15 mg of ruxolitinib.
• Each Ruxolitinib Vivanta 20 mg tablet contains 20 mg of ruxolitinib.

The other components are: monohydrate lactose, microcrystalline cellulose (E460), sodium starch
glycolate, hydroxypropylcellulose (E463a), povidone K30 (E1201), anhydrous colloidal silica (E551),
magnesium stearate (E470b).

Description of the appearance of Ruxolitinib Vivanta and contents of the pack
Ruxolitinib Vivanta 5 mg tablets are white to almost white, round, biconvex tablets, printed with “MR” on one side and “14” on the other.
Ruxolitinib Vivanta 10 mg tablets are white to almost white, round, biconvex tablets, printed with “MR” on one side and “11” on the other.
Ruxolitinib Vivanta 15 mg tablets are white to almost white, oval, biconvex tablets, printed with “MR” on one side and “12” on the other.
Ruxolitinib Vivanta 20 mg tablets are white to almost white, elongated, biconvex tablets, printed with “MR” on one side and “13” on the other.
Ruxolitinib Vivanta tablets are supplied in calendar blister packs containing 56 tablets or in unit-dose divisible blister packs containing 56 x 1 tablet.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Vivanta Generics s.r.o.
Trtinova 260/1, Cakovice,
19600, Prague 9
Czech Republic

Manufacturer
Pharmadox Healthcare Limited
KW20A Kordin Industrial Park, Paola, PLA 3000
Malta
MSN Labs Europe Limited
KW20A Corradino Park, Paola, PLA 3000
Malta

This medicinal product is authorised in the Member States of the European Economic Area under the following names:
Netherlands Ruxolitinib Vivanta 5 mg tabletten
Ruxolitinib Vivanta 10 mg tabletten
Ruxolitinib Vivanta 15 mg tabletten
Ruxolitinib Vivanta 20 mg tabletten

Germany Ruxolitinib Vivanta 5 mg Tabletten (ENR: 7018818)
Ruxolitinib Vivanta 10 mg Tabletten (ENR: 7018819)
Ruxolitinib Vivanta 15 mg Tabletten (ENR: 7018820)
Ruxolitinib Vivanta 20 mg Tabletten (ENR: 7018821)

Spain Ruxolitinib Vivanta 5 mg comprimidos EFG
Ruxolitinib Vivanta 10 mg comprimidos EFG
Ruxolitinib Vivanta 15 mg comprimidos EFG
Ruxolitinib Vivanta 20 mg comprimidos EFG

Italy Ruxolitinib Vivanta 5 mg compresse
Ruxolitinib Vivanta 10 mg compresse
Ruxolitinib Vivanta 15 mg compresse
Ruxolitinib Vivanta 20 mg compresse

Denmark Ruxolitinib Vivanta

Sweden Ruxolitinib Vivanta 5 mg tabletter
Ruxolitinib Vivanta 10 mg tabletter
Ruxolitinib Vivanta 15 mg tabletter
Ruxolitinib Vivanta 20 mg tabletter

Finland Ruxolitinib Vivanta 5 mg tabletti
Ruxolitinib Vivanta 10 mg tabletti
Ruxolitinib Vivanta 15 mg tabletti
Ruxolitinib Vivanta 20 mg tabletti

Norway Ruxolitinib Vivanta