Document Details

Generated Narrative: Bundle TEST PURPOSES ONLY - zynlonta

Document Subject

Generated Narrative: MedicinalProductDefinition mp4aba175a0cd44d120f1be90c1da17ad7

identifier: http://ema.europa.eu/identifier/EU/1/22/1695/001

type: Medicinal Product

domain: Human use

status: active

legalStatusOfSupply: Medicinal product subject to medical prescription

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productName: Zynlonta 10 mg powder for concentrate for solution for infusion

type: Full name

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part: nan

type: Invented name part

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part: nan

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Usages

-	Country	Jurisdiction	Language
*	EU	EU	en

Document Content

Generated Narrative: Composition composition-en-4aba175a0cd44d120f1be90c1da17ad7

identifier: http://ema.europa.eu/identifier/EU/1/22/1695/001

status: Final

type: Package Leaflet

category: Raw

date: 2022-02-16 13:28:17+0000

author: Organization ACME industry

title: TEST PURPOSES ONLY - zynlonta

Attesters

What is in this leaflet

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

Zynlonta is a cancer medicine that contains the active substance loncastuximab tesirine.

Zynlonta is used to treat adults with a certain type of cancer called diffuse large B-cell lymphoma (DLBCL) that:

• has come back (relapsed) after two or more treatments, or that
• did not respond to previous treatment (refractory).

Diffuse large B-cell lymphoma is a cancer that develops from a type of white blood cell called B-lymphocyte (also called B-cell).

Talk to your doctor or nurse if you have any questions about how Zynlonta works or why this medicine has been prescribed for you.

How does Zynlonta work?

Loncastuximab tesirine consist of 2 parts; an antibody (a type of protein designed to recognize and attach to a specific target) and a cytotoxic agent (a medicine able to kill cells, including cancer cells). The antibody in this medicine is designed to attach to CD19, a protein that is found on the surface of B cells. When the antibody binds to these cells, including the cancer cells, the medicine enters the cells and kills them.

You must not be given Zynlonta if you are allergic to loncastuximab tesirine or any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions

Talk to your doctor or nurse before you are given Zynlonta if you:

• have an active infection or have had one recently
• have liver problems; symptoms may include skin and eyes appearing yellowish (jaundice). Your doctor will monitor you for side effects during treatment.
• are pregnant or plan to become pregnant. Zynlonta can harm your unborn baby (see section Pregnancy and breast-feeding and fertility for further information).

Tell your doctor or nurse straight away if you have any of the following serious side effects.

Infections Serious infections, including infections that can cause death, have occurred in people treated with Zynlonta. Tell your doctor or nurse straight away if you have new or worsening signs or symptoms of infection, which are listed in section 4, under Serious side effects .

Fluid retention Your body may hold too much fluid during treatment with Zynlonta. This can be serious. Tell your doctor or nurse straight away if you have any signs or symptoms of fluid retention, which are listed in section 4, under Serious side effects . Your doctor will give appropriate treatment for the fluid retention. If you have serious swelling your doctor may stop treatment until the swelling goes down.

Low blood cell counts (platelets, red blood cells, and white blood cells) Low levels of certain blood cells (low blood cell counts) can be serious or severe. Your doctor or nurse will monitor your blood cell counts during treatment with Zynlonta. Tell your doctor or nurse straight away if you have any signs and symptoms of infection, which are listed in section 4, under Serious side effects . Low blood cell counts could be responsible for your infection.

Skin reactions Serious skin reactions have occurred in people treated with Zynlonta. Exposure to sunlight (including through glass or car windows) may cause severe sunburn. It is important to wear sunscreen and appropriate clothing to ensure you do not burn. Tell your doctor or nurse straight away if you get new or worsening severe skin reactions. Signs and symptoms are listed in section 4, under Possible side effects .

Children and adolescents This medicine should not be given to children or young people under the age of 18. This is because there is no information about its use in this age group.

Other medicines and Zynlonta Tell your doctor if you are taking, have recently taken or might take any other medicines.

Contraception (men and women) Women of child-bearing potential must use effective contraception during treatment with Zynlonta, and for 10 months after the last dose.

Men with partners of child-bearing potential must use effective contraception during treatment with Zynlonta, and for 7 months after the last dose.
Talk to your doctor about effective contraception.

Pregnancy You should avoid getting pregnant if you are taking this medicine. Tell your doctor immediately if you become pregnant or think that you are pregnant during treatment with Zynlonta. Your doctor may do a pregnancy test before starting treatment with Zynlonta.

Breast-feeding Do not breast-feed during treatment, and for 3 months after the last dose. It is not known if Zynlonta passes into breast milk.

Fertility Zynlonta may cause fertility problems in men, which may affect their ability to father children. You can seek advice on how to preserve sperm before starting treatment. Talk to your doctor for more information.

Driving and using machines Zynlonta has no or negligible influence on your ability to drive and use machines. If you get infusion-related reactions or if you feel tired, weak or dizzy (see section 4) do not drive, cycle or use tools or machines until you feel better.

See section 4 for more information about side effects.

Zynlonta is given under supervision of a doctor experienced in giving such treatments. It is given into a vein as a drip (infusion) over a period of 30 minutes.

The dose of this medicine depends on your body weight. The usual starting dose is 0.15 mg for each kg of body weight.

The table below shows the recommended dose in each treatment cycle.

Recommended dose Cycle 0.15 mg per kg every 21 days 1st cycle 0.15 mg per kg every 21 days
2nd cycle 0.075 mg per kg every 21 days 3rd cycle onwards

Your doctor may lower your dose if you experience any serious side effects.

Taking dexamethasone with Zynlonta During your treatment with Zynlonta you will also be given another medicine called dexamethasone to help reduce side effects as a result of treatment.
You will be given 4 mg of dexamethasone either by mouth or into your vein twice a day for three days, beginning the day before you receive Zynlonta treatment.
If you do not receive dexamethasone the day before your treatment, then it must be given at least 2 hours before you are given Zynlonta.

How often will you be given Zynlonta Zynlonta is usually given every 3 weeks (on day 1 of a 21-day cycle).

• Your doctor will give you medicines before each infusion to lower your chance of side effects.
• Your doctor may stop your treatment, delay your treatment, or change your dose of Zynlonta if you have severe side effects (see section 4 possible side effects).
• Your doctor will do regular blood tests to check for side effects of Zynlonta.
• Your doctor will decide how many treatment cycles you need.

If you are given more Zynlonta than you should Since the infusion is given to you by your doctor or other appropriately trained staff, an overdose is unlikely. If you inadvertently receive too much medicine, your doctor will monitor you and give you additional treatment as required.

If you miss a dose of Zynlonta If you miss a dose of Zynlonta, it should be given as soon as possible. You might need to reschedule receiving the next planned dose to ensure that it is given 21 days after the missed dose. The 21-day interval between doses should be maintained.

If you stop receiving Zynlonta You should not stop the therapy early without talking with your doctor first.

The therapy for lymphoma with Zynlonta usually requires a number of infusions. The number of infusions that you receive will depend on how you are responding to treatment. Therefore, even if you see your symptoms improve, you should continue to take Zynlonta until your doctor decides that your medicine should be stopped. If the treatment is stopped too early, your symptoms may return.

If you have any further questions on the use of this medicine, ask your doctor or nurse.

Like all medicines, this medicine can cause side effects, although not everybody gets them. The following side effects have been reported with this medicine:

Serious side effects

Infections Serious infections, including infections that can cause death, have occurred in people treated with Zynlonta. Tell your doctor or nurse straight away if you notice any of the following signs and symptoms:

• fever
• chills
• flu-like symptoms (cough, tiredness or weakness, and body aches)
• severe headache
• cuts or scrapes that are red, warm, swollen, or painful

Fluid retention Your body may hold too much fluid during treatment with Zynlonta. This can be serious. You can get swelling in various parts of your body including your hands, feet (very common) and abdomen (common), or around internal organs such as your heart (common) and lungs (very common). Tell your doctor or nurse straight away if you notice any of the following signs and symptoms:

• have chest pain (common)
• difficulty breathing (very common)
• swelling in any part of your body (very common)

Low blood cell counts
Low blood cell counts (very common) can be serious or severe. Your doctor or nurse will monitor your blood counts during treatment with Zynlonta. Tell your doctor or nurse straight away if you notice any bruising or bleeding, or any of the signs and symptoms of infections above.

Skin reactions Skin reactions (common) have occurred in people treated with Zynlonta. Some of these can be serious. Tell your doctor or nurse straight away if you get new or worsening severe skin reactions, including:

• sensitivity to sunlight including sunburn-like reactions such as skin peeling and irritation following exposure to light
• itchy rash
• blistering of skin
• darker skin patches
• irritation, swelling, pain, and/or skin damage at the injection site. Other side effects Tell your doctor or nurse if you notice any of the following side effects:

Very common: may affect more than 1 in 10 people

• tiredness and pale skin
• abnormal blood tests showing: * low levels of neutrophils, a type of white blood cell that fight infection, sometimes with fever * low blood platelet count which can lead to bleeding and bruising * liver problems
• loss of appetite
• feeling sick or vomiting
• diarrhoea
• stomach pain
• constipation
• reddening of the skin
• rash
• itching.

Common: may affect up to 1 in 10 people

• infection of the lungs including bronchitis or pneumonia
• nose and throat infection
• rash characterised by a flat, red area on the skin that is covered with small, raised bumps
• muscle pain
• joint pain
• back and neck pain
• pain in the arms and legs
• lack of energy.

Uncommon: may affect less than 1 in 10 people

• pus filled raised bumps on the skin
• limb discomfort
• muscle and bone discomfort
• inflammation of the membrane around the heart.

Not known: frequency cannot be estimated from the available data

• spider veins (broken blood vessels located near surface of skin)
• blisters
• rash consisting of tiny-to-small fluid-filled blisters

Reporting of side effects 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 national reporting system listed in Appendix V. By reporting side effects you can help provide more information on the safety of this medicine.

Zynlonta will be stored by the doctor and pharmacist at the hospital or clinic where you are treated. Your doctor, pharmacist or nurse is responsible for storing this medicine and disposing of any unused product correctly. The following information is intended for healthcare professionals.

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date which is stated on the carton and the vial after EXP. The expiry date refers to the last day of that month.

Store in a refrigerator (2 C 8 C). Do not freeze.

Keep the vial in the outer carton in order to protect from light. Both the reconstituted solution and the diluted solution for infusion should not be frozen or exposed to direct sunlight.

Zynlonta is a cytotoxic medicine. Applicable special handling and disposal procedures must be followed.

Your doctor or pharmacist is responsible for disposing of any unused Zynlonta correctly. These measures will help protect the environment.

What Zynlonta contains

• The active substance is loncastuximab tesirine. Each vial contains 10 mg of loncastuximab tesirine. After reconstitution, each mL contains 5 mg of loncastuximab tesirine.
• The other ingredients are: L-histidine, L-histidine monohydrochloride, polysorbate 20, sucrose.

What Zynlonta looks like and contents of the pack This medicine is a white to off-white powder, which has a cake-like appearance. It comes in a glass vial and is for single use only. The powder needs to be reconstituted and diluted before infusion.

Each pack contains 1 vial.

Marketing Authorisation Holder Swedish Orphan Biovitrum AB (publ) SE-112 76 Stockholm Sweden

Manufacturer Swedish Orphan Biovitrum AB (publ)
Strandbergsgatan SE-112 51 Stockholm
Sweden

This leaflet was last revised in

This medicine has been given conditional approval . This means that there is more evidence to come about this medicine. The European Medicines Agency will review new information on this medicine at least every year and this leaflet will be updated as necessary.

Other sources of information

Detailed information on this medicine is available on the European Medicines Agency web site: