Leqselvi 8 mg film-coated tablets

• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• 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 or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

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

• if you are allergic to deuruxolitinib or any of the other ingredients of this medicine listed in section 6.
• if you have a serious infection ongoing, including tuberculosis.
• if you have severe liver problems.
• if you are pregnant or breast-feeding (see the “pregnancy, contraception, breast-feeding and fertility” section).

Talk to your doctor or pharmacist before taking and during treatment with Leqselvi if you:

• Are older than 65. Patients aged 65 years and older may be at increased risk of infections, heart problems including heart attack and some types of cancer. Your doctor will discuss with you if Leqselvi is appropriate for you.
• have a chronic or recurrent infection or have a history of a serious or opportunistic infection
• have been exposed to tuberculosis or have resided or travelled in areas of endemic tuberculosis or endemic mycoses; or
• have underlying conditions that may predispose them to infection
• have viral reactivation, including cases of herpes virus reactivation (e.g., herpes zoster) or have ever had hepatitis B or hepatitis C
• have developed a cancer (other than successfully treated non-melanoma skin cancers)
• have cardiovascular risk factors
• are current or past smoker
• have had blood clots in an artery (thrombosis)
• have had lipid elevations (cholesterol), anaemia (not enough red blood cells), neutropenia (lower-than-normal levels of neutrophils, a type of white blood cell), and lymphopenia (few lymphocytes, white blood cells that protect you from infection)
• have recently had or plan to have a vaccination (immunization). Certain vaccines (live vaccines) are not recommended during or immediately prior to Leqselvi treatment

Prior to Leqselvi treatment, testing patients for CYP2C9 variants to determine if they are poor metabolizers is strongly recommended.

This medicine is not approved for use in paediatric population because the safety and benefits of Leqselvi have not been established in paediatric patients.

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines to treat:

• infections (herpes, hepatitis B or hepatitis C),
• cancer,
• heart rhythm problems,
• headache.

Leqselvi may increase the amount of these medicines in your blood.

If any of the above apply to you or if you are not sure, talk to your doctor or pharmacist before taking Leqselvi.

Leqselvi can be taken with food and drinks.

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

Women of childbearing potential

If you are a woman of childbearing potential, you should use an effective method of contraception during treatment with Leqselvi. Your doctor can advise you on suitable methods of contraception.

Pregnancy

Do not use Leqselvi if you are pregnant, think you may be pregnant or are planning to have a baby. This medicine can harm the developing baby. Tell your doctor right away if you become pregnant or think you might have become pregnant during treatment.

Breast-feeding

Do not use Leqselvi while breast-feeding as it is not known if this medicine passes into breast milk. A risk to newborns/infants cannot be excluded. You and your doctor should decide if you will breast-feed or use this medicine.

Fertility

Based on animal studies, deuruxolitinib may cause foetal harm when administered during pregnancy. Consider pregnancy planning and prevention for women of reproductive potential.

No data are available on the ability to drive and use machines during Leqselvi treatment.

If you have rare hereditary problems of lactose intolerance, or sugar malabsorption , contact your doctor before taking this medicine.

This medicine is not recommended for children and adolescents.

If you take more Leqselvi than you should, contact your doctor. You may get some of the side effects described in section 4.

Do not take a double dose to make up for a forgotten tablet, and resume dosing at the next scheduled dose.

You should not stop taking Leqselvi without discussing this with your doctor.

Tell your doctor or seek medical help immediately if you get the following symptoms, which may be signs of:

• shingles (herpes zoster): painful skin rash with blisters and fever (common)
• Pulmonary infections (e.g. COVID-19)
• Skin and soft tissue infections which include folliculitis, impetigo, skin infection, subcutaneous abscess, furuncle, paronychia, and pustule

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

• Headache
• Acne

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

• Runny nose and score throat (Nasopharyngitis)
• Skin infections
• Herpes
• Lipid elevations (cholesterol)
• Tiredness (asthenia, hypersomnia, somnolence, and lethargy)
• Blood creatine phosphokinase increased (enzyme shown by a blood test)
• Weight gain

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

• Anaemia (decrease or low red blood cell count)
• Neutropenia (lower-than-normal levels of neutrophils, a type of white blood cell)
• Lymphopenia (few lymphocytes, white blood cells that protect you from infection)
• Thrombocytosis (high number of platelets)

If you get any side effects, talk to your doctor or pharmacist. 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 substance is deuruxolitinib. Each tablet contains 8 mg of deuruxolitinib (as phosphate).
• The other ingredients are the following:
  • Tablet core content:
    • Microcrystalline cellulose
    • Lactose monohydrate
    • Povidone K30 (E1201)
    • Low-substituted hydroxypropyl cellulose
    • Colloidal silicon dioxide
    • Magnesium stearate
    • Purified water
  • Film coating content:
    • Polyvinyl alcohol
    • Talc
    • Titanium dioxide
    • Glyceryl mono and dicaprylocaprate
    • Sodium lauryl sulfate
    • Fd&c blue #2 aluminum lake
    • Carmine
    • Purified water

Leqselvi is a purple, round tablet of 6.5 mm diameter, debossed with “C” on one side and “8” on the other side.

Each high-density polyethylene (HDPE) bottle contains 60 film-coated tablets.

The bottle contains a silica gel desiccant used to keep the tablets dry. Do not swallow the silica gel desiccant.