ZYNLONTA 10 mg POWDER FOR CONCENTRATE FOR SOLUTION FOR INFUSION

Introduction

Package Leaflet: Information for the Patient

Zynlonta 10 mg powder for concentrate for solution for infusion

loncastuximab tesirine

This medicine is subject to additional monitoring, which will allow for quick identification of new safety information. You can help by reporting any side effects you may get. The last section of the leaflet includes information on how to report side effects.

Read all of this leaflet carefully before you are given this medicine because it contains important information for you.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or nurse.
• If you get any side effects, talk to your doctor or nurse, even if you think they might be unrelated to the medicine. See section 4.

Contents of the pack

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

1. What is Zynlonta and what is it used for

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

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

• have had a relapse after two or more treatments, or
• have not responded to previous treatments (refractory).

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

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

How Zynlonta works

Loncastuximab tesirine consists of two parts: an antibody (a type of protein designed to recognize and bind to a specific target) and a cytotoxic agent (a drug that can kill cells, including cancer cells). The antibody in this medicine is designed to bind to CD19, a protein found on the surface of B cells. When the antibody binds to these cells, including cancer cells, the medicine enters the cells and kills them.

2. What you need to know before you are given Zynlonta

You must not be given Zynlontaif you are allergicto loncastuximab tesirineor 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 Zynlontaif:

• you have an active infectionor have had one recently
• you have liver problems; symptoms may include yellowing of the skin and eyes (jaundice). Your doctor will monitor you during treatment for side effects.
• you are pregnant or planning to become pregnant.Zynlonta may harm the fetus (see the section "Pregnancy, breastfeeding, and fertility" for more information).

Tell your doctor or nurse immediatelyif you have any of the following serious side effects:

Infections

Severe infections, including life-threatening infections, have occurred in people treated with Zynlonta. Tell your doctor or nurse immediatelyif you have signs or symptoms of a new or worsening infection. These signs and symptoms are listed in section 4 "Serious side effects".

Fluid retention

During treatment with Zynlonta, your body may retain too much fluid. This can be serious. Tell your doctor or nurse immediatelyif you have signs or symptoms of fluid retention. These signs and symptoms are listed in section 4 "Serious side effects". Your doctor will give you treatment for fluid retention. If you have severe swelling, your doctor may temporarily stop your treatment until the swelling has resolved.

Low blood cell count(platelets, red blood cells, and white blood cells)

Low levels of certain blood cells (low blood cell count) can be serious or severe. Your doctor or nurse will monitor your blood counts during treatment with Zynlonta. Tell your doctor or nurse immediatelyif you have signs or symptoms of infection. These signs and symptoms are listed in section 4 "Serious side effects". Infection can be due to a low blood cell count.

Skin reactions

Severe skin reactions have occurred in patients treated with Zynlonta. Exposure to sunlight (even through glass or car windows) can cause severe sunburn. It is essential to use sunscreen and protective clothing to avoid sunburn. Tell your doctor or nurse immediatelyif you experience the onset or worsening of severe skin reactions. The signs and symptoms are listed in section 4 "Possible side effects".

Children and adolescents

This medicine must not be given to children or adolescents under 18 years of age. There is no information on 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 childbearing age must use an effective method of contraceptionduring treatment with Zynlonta and for 10 months after the last dose.

Menwith a partner who could become pregnant must use an effective method of contraceptionduring treatment with Zynlonta and for 7 months after the last dose. Talk to your doctor about effective contraception.

Pregnancy

You must avoid becoming pregnantif you are taking this medicine. Tell your doctor immediately during treatment with Zynlonta if you become pregnant or think you may be pregnant. Your doctor will perform a pregnancy test before starting treatment with Zynlonta.

Breastfeeding

Do not breastfeedduring treatment and for 3 months after the last dose. It is not known if Zynlonta is excreted in breast milk.

Fertility

Zynlonta may cause fertility problems in men, affecting their ability to father children. You should discuss sperm preservation before starting treatment. Talk to your doctor for more information.

Driving and using machines

Zynlonta has no or negligible influence on the ability to drive and use machines. If you develop infusion-related reactions or feel tired, weak, or dizzy (see section 4), do not drive or ride a bicycle or use tools or machines until you feel better.

See section 4 for more information on side effects.

3. How Zynlonta is given

Zynlonta is given under the supervision of a doctor with experience in the administration of these treatments. It is given into a veinas a drip (infusion) over a period of 30 minutes.

The dose of this medicine depends on your body weight. The usual initial dose is 0.15 mg per kilogram of body weight.

The following table shows the recommended dose for each cycle of treatment.

Your doctor will reduce the dose if you experience a serious side effect.

Taking dexamethasone with Zynlonta

During treatment with Zynlonta, you will also be given another medicine called dexamethasone to help reduce the side effects of treatment.

You will be given 4 mg of dexamethasone by mouth or intravenously twice a day for three days, starting the day before the start of treatment with Zynlonta.

If you are not given dexamethasone the day before treatment, you must be given it at least 2 hours before you are given Zynlonta.

Frequency of Zynlonta administration

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 reduce the likelihood of you experiencing side effects.
• Your doctor may interrupt or delay your treatment or change the dose of Zynlonta if you experience serious side effects (see section 4 "Possible side effects").
• Your doctor will perform regular blood tests to check for side effects of Zynlonta.
• Your doctor will decide on the number of treatment cycles you need.

If you are given too much Zynlonta

An overdose is unlikely because the infusion is given by your doctor or other trained personnel. If you are given too much of the medicine by mistake, your doctor will monitor you and give you any additional treatment if needed.

If you miss a dose of Zynlonta

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

If you stop taking Zynlonta

You should never stop treatment early without talking to your doctor first.

Lymphoma therapy with Zynlonta usually requires a number of infusions. The number of infusions you receive will depend on your response to treatment. Therefore, even if you experience an improvement in your symptoms, you should continue taking Zynlonta until your doctor decides that the medicine should be stopped. If treatment is stopped too early, your symptoms may come back.

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

4. Possible side effects

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

Severe infections, including life-threatening infections, have occurred in people treated with Zynlonta. Tell your doctor or nurse immediatelyif you experience any of the following signs and symptoms:

• fever
• chills
• flu-like symptoms (cough, tiredness or weakness, and generalized aches and pains)
• severe headache
• cuts or scratches that are red, hot, swollen, or painful

Fluid retention

During treatment with Zynlonta, your body may retain too much fluid. This can be serious. You may experience swelling in different parts of your body, such as your hands, feet (very common), and abdomen (common), or around your internal organs such as your heart (common) and lungs (very common).

Tell your doctor or nurse immediatelyif you experience any of the following signs and symptoms:

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

Low blood cell count

A low blood cell count (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 immediatelyif you experience bruising or bleeding, or any of the signs and symptoms of infection mentioned earlier.

Skin reactions

Severe skin reactions have occurred in patients treated with Zynlonta. Some can be serious. Tell your doctor or nurse immediatelyif you experience the onset or worsening of severe skin reactions such as:

• sensitivity to sunlight, sunburn-like reactions such as peeling or skin irritation after exposure to sunlight
• itchy rash
• blisters on the skin
• dark skin patches
• irritation, swelling, pain, and/or skin injury at the injection site.

Other side effects

Tell your doctor or nurse if you experience any of the following side effects:

Very common: may affect more than 1 in 10 people

• fatigue and pale skin
• abnormal blood tests with:

• low levels of neutrophils, a type of white blood cell that fights infection, sometimes with fever
• low platelet count, which can cause bleeding and bruising
• liver problems

• loss of appetite
• feeling dizzy or vomiting
• diarrhea
• stomach pain
• constipation
• redness of the skin
• skin rash
• itching.

Common: may affect up to 1 in 10 people

• lung infection, including bronchitis or pneumonia
• nose and throat infection
• rash characterized by a flat red area on the skin covered with small bumps
• muscle pain
• joint pain
• back and neck pain
• arm and leg pain
• lack of energy.

Uncommon: may affect up to 1 in 100 people

• pus-filled bumps on the skin
• discomfort in the limbs
• discomfort in the muscles and bones
• inflammation of the membrane around the heart.

Frequency not known: cannot be estimated from the available data

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

Reporting of side effects

If you experience any side effects, talk to your doctor or pharmacist, even if you think they might be unrelated to the medicine. 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.

5. Storage of Zynlonta

Zynlonta is stored by your doctor and pharmacist in the hospital or clinic where you are being 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 vial after EXP. The expiry date is the last day of the month shown.

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

Store the vial in the outer packaging to protect it from light.

Both the reconstituted solution and the diluted solution for infusion must not be frozen or exposed to direct sunlight.

Zynlonta is a cytotoxic medicine. Special procedures for handling and disposal must be followed.

Your doctor or pharmacist is responsible for the correct disposal of Zynlonta that has not been used. This will help protect the environment.

6. Container Contents and Additional Information

Zynlonta Composition

• The active substanceis loncastuximab tesirina. Each vial contains 10 mg of loncastuximab tesirina. After reconstitution, each ml contains 5 mg of loncastuximab tesirina.
• The other componentsare: L-histidine, L-histidine monohydrochloride, polysorbate 20, sucrose.

Product Appearance and Container Contents

This medicinal product is a white to off-white powder with a cake-like appearance. It is packaged in a glass vial and is for single use. The powder must be reconstituted and diluted before infusion.

Each container contains 1 vial.

Marketing Authorization Holder

Swedish Orphan Biovitrum AB (publ)

SE-112 76 Stockholm

Sweden

Manufacturer

Swedish Orphan Biovitrum AB (publ)

Strandbergsgatan 49

SE-112 51 Stockholm

Sweden

Date of Last Revision of this Leaflet:

This medicinal product has been authorized under a “conditional approval”. This type of approval means that more information on this medicinal product is expected.

The European Medicines Agency will review the new information on this medicinal product at least once a year and this leaflet will be updated as necessary.

Other Sources of Information

Detailed information on this medicinal product is available on the European Medicines Agency website: http://www.ema.europa.eu.

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This information is intended solely for healthcare professionals:

Procedures for the handling and proper disposal of antineoplastic medicinal products.

Reconstitution of Powder for Concentrate

• Reconstitute each vial of powder for concentrate with 2.2 ml of sterile water for injectable preparations with the jet directed towards the inner wall of the vial, to obtain a final concentration of 5 mg/ml.
• Gently rotate the vial with circular movements until the powder is completely dissolved. Do not shake.
• Check if the reconstituted solution contains particles or has changed color. The solution should have a clear to slightly opalescent appearance, colorless to slightly yellow. Do not use if the reconstituted solution has changed color, is turbid, or contains visible particles.
• Discard the vial that has not been used after reconstitution if the recommended storage time has been exceeded.

Dilution in an Intravenous Infusion Bag

• Withdraw the necessary volume of the reconstituted solution from the vial using a sterile syringe. Discard the unused solution that remains in the vial.
• Add the calculated dose volume of the reconstituted Zynlonta solution to a 50 ml intravenous infusion bag containing 5% glucose.
• Gently mix the infusion bag by turning it upside down. Do not shake.
• No incompatibilities have been observed between Zynlonta and intravenous infusion bags made of polyvinyl chloride (PVC), polyolefin (PO), and PAB (ethylene-propylene copolymer) that come into contact with the medicinal product.
• Zynlonta should be administered through a dedicated infusion line equipped with an in-line or added sterile, apyrogenic filter with low protein binding (pore size of 0.2 or 0.22 micrometers) and catheter.

Reconstituted Solution

From a microbiological point of view, the reconstituted solution should be used immediately. If not used immediately, it is the user's responsibility to ensure the storage times and conditions before use. The maximum storage time is 4 hours in the refrigerator (between 2°C and 8°C) or 4 hours at room temperature (between 20°C and 25°C), unless the reconstitution was done under controlled and validated aseptic conditions. The chemical and physical stability of the reconstituted solution has been demonstrated for a maximum of 4 hours refrigerated (between 2°C and 8°C) or 4 hours at room temperature (between 20°C and 25°C).

Diluted Solution

From a microbiological point of view, the solution prepared for infusion should be used immediately. If not used immediately, it is the user's responsibility to ensure the storage times and conditions before use. The maximum storage time is 24 hours in the refrigerator (between 2°C and 8°C) or 8 hours at room temperature (between 20°C and 25°C), unless the dilution was done under controlled and validated aseptic conditions. The chemical and physical stability of the prepared solution has been demonstrated for a maximum of 24 hours at room temperature (between 20°C and 25°C).