Inaqovi 35 mg/100 mg film coated tablets

• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor, pharmacist or nurse.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4.

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

Inaqovi is a cancer medicine. It contains the active substances decitabine and cedazuridine.

Inaqovi is used alone to treat acute myeloid leukaemia (AML) in adults, when chemotherapy is not considered suitable. You will be given Inaqovi when you are first diagnosed with AML.

AML is a type of cancer affecting white blood cells called myeloid cells. In AML, myeloid cells multiply and grow very quickly in bone marrow and blood.

Inaqovi contains two active substances that work in different ways. Decitabine works by stopping cancer cells from growing. It also kills cancer cells. Cedazuridine does not affect the cancer cells directly, but it inhibits the break down of decitabine. This increases the amount of decitabine that is available in the body, and so helps to increase the effects of decitabine.

• if you are allergic to decitabine or cedazuridine, or any of the other ingredients of this medicine (listed in section 6).
• If you are breast-feeding (see section 2, Breast-feeding).

Talk to your doctor, pharmacist or nurse before taking Inaqovi if you:

• have lung problems
• have liver problems
• have kidney problems
• have heart problems

Myelosuppression and ‘differentiation syndrome’

Inaqovi can cause serious myelosuppression (a condition in which the bone marrow cannot make enough blood cells), or a serious immune reaction called ‘differentiation syndrome’. Both may be fatal.

Seek urgent medical attention if you notice any signs and symptoms (for symptoms see section 4)

Cardiovascular disease

Talk to your doctor if you have a history of heart problems so that you can be monitored for signs and symptoms of heart failure.

Blood tests

You will have blood tests while on treatment. These will occur before you start treatment with Inaqovi, at the start of each treatment cycle or if you notice any signs and symptoms of myelosuppression. These tests are to check that:

• you have enough blood cells, and
• your liver and kidneys are working properly

Your doctor may change or delay your dose of Inaqovi. Your doctor may also give you medicines to help prevent infections.

Children and adolescents under 18 years of age must not be given Inaqovi. This medicine has not been studied in this age group.

Tell your doctor, pharmacist or nurse if you are taking, have recently taken, or might take any other medicines before you begin treatment with Inaqovi. Inaqovi may affect the way some medicines work, especially if you are also taking the following medicines to treat:

• cancer, such as cytarabine, gemcitabine or azacitidine

Pregnancy

If you are pregnant, think you may be pregnant or are planning to have a baby, ask your doctor for advice before taking this medicine.

You should not take Inaqovi during pregnancy as it may harm your unborn baby. If you are able to become pregnant, a pregnancy test is recommended before starting treatment with Inaqovi.

Contraception

Women who are able to become pregnant must use effective contraception both during treatment with Inaqovi, and for 6 months after taking the last dose of Inaqovi.

Men with female partners who are able to become pregnant must use effective contraception both during treatment with Inaqovi, and for 3 months after the last dose.

Talk to your doctor about the most effective methods of contraception.

Breast-feeding

Do not breast-feed during treatment with Inaqovi. This is because it is not known if Inaqovi passes into breast milk and whether this could harm your baby.

Male and female fertility

Inaqovi may affect fertility. It is not known if the effect on fertility is permanent. Talk with your doctor before taking this medicine if you have any concerns, or if you wish to conserve your sperm or freeze your eggs before starting treatment.

Inaqovi may affect your ability to drive or use tools or machines. If you feel tired or dizzy after taking Inaqovi, do not drive or use tools or machinery until you feel better.

If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.

This medicine contains less than 1 mmol sodium (23 mg) per tablet, that is to say essentially “sodium-free”.

Overdose can result in myelosuppression, sepsis or pneumonia (see section 4, Possible side effects). If you take more Inaqovi than you should, seek urgent medical attention.

If you miss a dose within 12 hours of the time you usually need to take it, you should take the missed dose as soon as possible and resume the normal daily dosing schedule.

If you miss a dose by 12 or more hours: Do no take a dose and take the next dose the following day at the usual time. Extend the dosing period by one day for every missed dose. Please ensure that you complete a total of 5 daily doses for each cycle.

If you stop taking this medicine your cancer may no longer be controlled, and your symptoms from the cancer may reoccur. Therefore, you should only stop taking this medicine if your doctor tells you to.

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

• urinary tract infection
• infection caused by bacteria, viruses or fungi
• high blood glucose levels
• mouth or tongue ulcers because of painful inflammation of the lining of the mouth
• diarrhoea
• feeling sick and vomiting
• altered liver function tests (increased ALT, AST, alkaline phosphatase, bilirubin)

Common (may affect up to 1 in 10 people)

• inflammation of the sinuses
• headache
• inflamed gut (neutropaenic colitis)

Uncommon (may affect up to 1 in 100 people)

• a drop in the number of red blood cells, white blood cells and platelets
• sudden fever with, multiple red or bluish-red raised painful patches on the skin, usually on the arms, legs, trunk, face or neck. (‘Acute Febrile Neutrophilic Dermatosis’ or ‘Sweet’s Syndrome’)
• heart muscle disease

If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store. By reporting side effects you can help provide more information on the safety of this medicine.

• The active substances are decitabine and cedazuridine. Each film-coated tablet contains 35 mg decitabine and 100 mg cedazuridine.
• The other ingredients are:
  Inaqovi contains lactose and sodium, see section 2.
  Tablet core
  lactose monohydrate, hypromellose (E464), croscarmellose sodium (E466), silica, colloidal anhydrous, magnesium stearate (E572).
  Film-coating
  polyvinyl alcohol (E1203), titanium dioxide (E171), polyethylene glycol (E1521), talc (E553b), iron oxide red (E172).

Inaqovi are red, oval biconvex shaped film-coated tablets, 14 mm diameter, plain on one side and debossed with ‘H35’ on the other side.

They are supplied in foil blister packs containing 5 tablets.

For any information about this medicine, please contact: