Padcev 30 mg powder for concentrate for solution for infusion – patient leaflet, side effects, dosage

1. What Padcev is and what it is used for

Padcev contains the active substance enfortumab vedotin which is made up of a monoclonal antibody linked to a substance intended to kill cancer cells. The monoclonal antibody recognises certain cancer cells and delivers the substance to the cancer cells.

This medicine is used alone or in combination with pembrolizumab in adults to treat a kind of cancer called bladder cancer (urothelial carcinoma).

People get Padcev when their cancer has spread into the muscle layer of the bladder and possibly a nearby lymph node but not to other parts of the body. It is used before surgical removal of the bladder (neoadjuvant therapy) and then continued after surgery (adjuvant therapy) to help prevent cancer from coming back.

People get Padcev when their cancer has spread or cannot be taken out by surgery.

Padcev when used alone is given to people that have received an immunotherapy medicine and also received a chemotherapy-containing platinum medicine.

This medicine may be given in combination with pembrolizumab. It is important that you also read the package leaflet for this other medicine. If you have any questions, ask your doctor.

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

You must not be given Padcev

• if you are allergic to enfortumab vedotin or any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions

Talk to your doctor immediately if you:

• have any of the following skin reaction symptoms:

  • rash or itching that continues to get worse or comes back after treatment,
  • skin blistering or peeling,
  • painful sores or ulcers in mouth or nose, throat, or genital area,
  • fever or flu-like symptoms,
  • or swollen lymph nodes.
• these may be signs of a severe skin reaction that can happen while receiving this medicine, particularly during the first few weeks of your treatment. Skin reactions may occur in more patients when this medicine is given with pembrolizumab. If it occurs, your doctor will monitor you and may give you a medicine to treat your skin condition. She or he may pause treatment until symptoms are reduced. If your skin reaction worsens, your doctor may stop your treatment. You will also find this information in the Patient Card that is included in the packaging. It is important that you keep this Patient Card with you and show it to any healthcare professional you see.
• have any symptoms of high blood sugar, including frequent urination, increased thirst, blurred vision, confusion, drowsiness, loss of appetite, fruity smell on your breath, nausea, vomiting, or stomach pain. You can develop high blood sugar during treatment.
• have lung problems (pneumonitis/interstitial lung disease) or if you get new or worsening symptoms, including trouble breathing, shortness of breath, or cough. These lung problems may occur more often when this medicine is given with pembrolizumab. If it occurs, your doctor may pause treatment until symptoms are improved or reduce your dose. If your symptoms worsen, your doctor may stop your treatment.
• have, or think you have, an infection. Some infections may be serious and can be life-threatening.
• have any symptoms of nerve problems (neuropathy) such as numbness, tingling or a tingling sensation in your hands or feet or muscle weakness. If it occurs, your doctor may pause treatment until symptoms are improved or reduce your dose. If your symptoms worsen, your doctor may stop your treatment.
• have eye problems such as dry eyes during your treatment. You can develop dry eye problems while receiving Padcev.

Children and adolescents

This medicine should not be used in children and adolescents below 18 years of age.

Other medicines and Padcev

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

Tell your doctor if you take medicines for fungal infections (e.g., ketoconazole) as they can increase the amount of Padcev in your blood. If you normally take these medicines, your doctor might change it and prescribe a different medicine for you during your treatment.

Other possible side effects

If you get any side effects, talk to your doctor. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme at: Pregnancy and breast-feeding and fertility

The following side effects have been reported with Padcev in combination with pembrolizumab for bladder cancer that has spread into the muscle layer of the bladder and possibly a nearby lymph node but not to other parts of the body and for bladder cancer that has spread or cannot be taken out by surgery:

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

You should not use this medicine if you are pregnant. Padcev may harm your unborn baby.

If you are a woman starting this medicine who is able to become pregnant, you should use effective contraception during treatment and for at least 6 months after stopping Padcev.

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

• low red blood cells (anaemia)
• nausea, diarrhoea and vomiting

It is not known if this medicine passes into your breast milk and could harm your baby. Do not breast-feed during treatment and for at least 6 months after stopping Padcev.

• tiredness
• decreased appetite
• change in sense of taste

Men being treated with this medicine are advised to have sperm samples frozen and stored before treatment. Men are advised not to father a child during treatment with this medicine and for at least 4 months following the last dose of this medicine.

• rash
• dry eye
• hair loss
• weight loss

Driving and using machines

• dry or itchy skin
• flat or red raised bumps on the skin

Do not drive or operate machines if you feel unwell during treatment.

• increased liver enzymes (aspartate aminotransferase [AST] or alanine aminotransferase [ALT])

Padcev contains polysorbate 20

• reduced thyroid gland activity (hypothyroidism)

This medicine contains 0.40 mg and 0.60 mg of polysorbate 20 in each 20 mg and 30 mg dose of Padcev, respectively. Polysorbates may cause allergic reactions. Tell your doctor if you have any known allergies.

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

• abnormal walking (gait disturbance)
• eye redness
• hives on the skin

3. How you are given Padcev

• redness in the skin
• inflamed, itchy, cracked and rough patches of skin

You will receive Padcev in a hospital or clinic, under the supervision of a doctor experienced in giving such treatments.

• redness and tingling on the palms or soles of feet
• skin peeling
• skin peeling all over the body

How much Padcev you will receive

• mouth ulcer
• rash with accompanying symptoms: itchiness, redness, red bumps or red patches on the skin, fluid-filled blisters, large blisters, skin lesions

When used alone, the recommended dose of this medicine is 1.25 mg/kg on days 1, 8 and 15 every 28 days. When used with pembrolizumab, the recommended dose of this medicine is 1.25 mg/kg on days 1 and 8 every 21 days. Your doctor will decide how many treatments you need.

• increased lipase (a blood test done to check your pancreas)
• inflammation of the muscles (myositis)
• low levels of blood platelets which can lead to bleeding and bruising (thrombocytopenia)

How you will receive Padcev

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

You will receive Padcev by intravenous infusion into your vein over 30 minutes. Padcev will be added to an infusion bag containing either glucose, sodium chloride or Lactated Ringer’s solution before use.

• skin irritation
• skin burning sensation
• problems affecting nerve function causing odd sensation or problems with movement
• allergic reaction to skin

If you miss a dose of Padcev

• rash with accompanying symptoms: spots that look like bullseyes, skin peeling, flat fluid-filled blister

It is very important for you to keep all of your appointments to receive Padcev. If you miss an appointment, ask your doctor when to schedule your next dose.

• inflammation in skin folds including the groin
• blister or blister-like lesions on the skin
• inflammation or itchiness appearing on the legs and feet only

If you stop receiving Padcev

Do not stop treatment with Padcev unless you have discussed this with your doctor. Stopping your treatment may stop the effect of the medicine.

Not known (frequency cannot be estimated from the available data):

• low white blood cell count with or without fever
• discoloration or abnormal darkening of the skin (skin hyperpigmentation, skin discoloration, pigmentation disorder)

4. Possible side effects

The following side effects have been reported with Padcev alone:

Like all medicines, this medicine can cause side effects, although not everybody gets them.

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

Some possible side effects may be serious:

• low red blood cells (anaemia)
• Skin reactions (Stevens-Johnson syndrome, toxic epidermal necrolysis and other severe rashes such as symmetrical drug-related intertriginous and flexural exanthaema). Tell your doctor right away if you have any of these signs of a severe skin reaction: rash or itching that continues to get worse or comes back after treatment, skin blistering or peeling, painful sores or ulcers in mouth or nose, throat, or genital area, fever or flu-like symptoms or swollen lymph nodes (frequency not known).
• nausea, diarrhoea and vomiting
• tiredness
• decreased appetite
• change in sense of taste
• dry eye
• hair loss
• weight loss
• High blood sugar (hyperglycaemia). Tell your doctor right away if you have any symptoms of high blood sugar, including: frequent urination, increased thirst, blurred vision, confusion, drowsiness, loss of appetite, fruity smell on your breath, nausea, vomiting or stomach pain (may affect more than 1 in 10 people).
• dry or itchy skin
• rash
• flat or red raised bumps on the skin
• increased liver enzymes (aspartate aminotransferase [AST] or alanine aminotransferase [ALT])

• A serious complication of diabetes with high levels of ketones in the blood that can make blood more acidic (diabetic ketoacidosis) (frequency not known).

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

• Lung problems (pneumonitis/interstitial lung disease). Tell your doctor right away if you get new or worsening symptoms, including trouble breathing, shortness of breath, or cough (may affect up to 1 in 10 people).
• abnormal walking (gait disturbance)
• eye redness
• hives on the skin
• redness in the skin
• Nerve problems (peripheral neuropathy such as motor neuropathy, sensimotor neuropathy, paraesthesia, hypoaesthesia and muscular weakness). Tell your doctor right away if you get numbness, tingling or a tingling sensation in your hands or feet or muscle weakness (may affect more than 1 in 10 people).
• inflamed, itchy, cracked and rough patches of skin
• redness and tingling on the palms or soles of feet
• skin peeling
• mouth ulcer
• rash with accompanying symptoms: itchiness, redness, red bumps or red patches on the skin, fluid-filled blisters, large blisters, skin lesions
• Leakage of Padcev out of your vein into the tissues around your infusion site (extravasation). Tell your doctor or get medical help right away if you notice any redness, swelling, itching or discomfort at the infusion site. If Padcev leaks from the injection site or the vein into the nearby skin and tissues, it could cause an infusion site reaction. These reactions can happen right after you receive an infusion, but sometimes may happen days after your infusion (may affect up to 1 in 10 people).
• low levels of blood platelets which can lead to bleeding and bruising (thrombocytopenia)

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

• skin irritation
• skin burning sensation
• Serious infection (sepsis) when bacteria and their toxins circulate in the blood leading to organ damage (may affect up to 1 in 10 people).
• problems affecting nerve function causing odd sensation or problems with movement
• muscle decreasing in size
• blood blister
• Infection of the lungs (pneumonia) (may affect up to 1 in 10 people).
• allergic reaction to skin
• rash with accompanying symptoms: spots that look like bullseyes, skin peeling, flat fluid-filled blister

• Infusion related reaction

  Medicines of this type (monoclonal antibodies) can cause infusion related reactions such as:

• skin peeling all over the body
• low blood pressure
• inflammation in skin folds including the groin
• tongue swelling
• blister or blister-like lesions on the skin
• difficulty breathing (dyspnoea)
• inflammation or itchiness appearing on the legs and feet only
• fever
• chills

• redding of the skin (flushing)

  Not known (frequency cannot be estimated from the available data):

• itching
• low white blood cell count with or without fever
• rash
• discoloration or abnormal darkening of the skin (skin hyperpigmentation, skin discoloration, pigmentation disorder)
• being sick (vomiting)
• feeling generally unwell (malaise)

• In general, these types of reactions occur within minutes to several hours following completion of the infusion. However, they may develop more than several hours after completion of the infusion but this is uncommon. Infusion-related reactions may affect up to 1 in 10 people.

  Reporting of side effects

  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.

5. How to store Padcev

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 label after EXP. The expiry date refers to the last day of that month.

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

Do not store any unused portion of the infusion solution for reuse. Any unused medicine or waste material should be disposed of in accordance with local requirements.

6. Contents of the pack and other information

What Padcev contains

• The active substance is enfortumab vedotin.
• One vial of 20 mg powder for concentrate for solution for infusion contains 20 mg of enfortumab vedotin.
• One vial of 30 mg powder for concentrate for solution for infusion contains 30 mg of enfortumab vedotin.
• After reconstitution, each mL of solution contains 10 mg of enfortumab vedotin.

The other ingredients are histidine, histidine hydrochloride monohydrate, trehalose dihydrate and polysorbate 20 (see section 2 “Padcev contains polysorbate 20”).

What Padcev looks like and contents of the pack

Padcev powder for concentrate for solution for infusion is a white to off-white lyophilized powder. Padcev is supplied in a box containing 1 glass vial.

Marketing Authorisation Holder

Astellas Pharma Ltd.

300 Dashwood Lang Road

Bourne Business Park

Addlestone

United Kingdom

KT15 2NX

Manufacturer

Astellas Ireland Co. Ltd.

Killorglin, Co. Kerry

V93 FC86

Ireland

This leaflet was last revised in 09/2026.

--------------------------------------------------------------------------------------------------------------------------

The following information is intended for healthcare professionals only:

Traceability

In order to improve the traceability of biological medicinal products, the name and the batch number of the administered product should be clearly recorded.

Instructions for preparation and administration

Reconstitution in single-dose vial

1. 1. Follow procedures for proper handling and disposal of anticancer medicinal products.
2. 2. Use appropriate aseptic technique for reconstitution and preparation of dosing solutions.
3. 3. Calculate the recommended dose based on the patient’s weight to determine the number and strength (20 mg or 30 mg) of vials needed.
4. 4.

   Reconstitute each vial as follows and, if possible, direct the stream of sterile water for injection along the walls of the vial and not directly onto the lyophilized powder: a. 20 mg vial: Add 2.3 mL of sterile water for injection, resulting in 10 mg/mL enfortumab vedotin.

   b. 30 mg vial: Add 3.3 mL of sterile water for injection, resulting in 10 mg/mL enfortumab vedotin.

5. 5. Slowly swirl each vial until the contents are completely dissolved. Allow the reconstituted vial(s) to settle for at least 1 minute until the bubbles are gone. Do not shake the vial. Do not expose to direct sunlight.
6. 6. Visually inspect the solution for particulate matter and discolouration. The reconstituted solution should be clear to slightly opalescent, colourless to light yellow and free of visible particles. Discard any vial with visible particles or discolouration.

Dilution in infusion bag

1. 7. Withdraw the calculated dose amount of reconstituted solution from the vial(s) and transfer into an infusion bag.
2. 8.

   Dilute enfortumab vedotin with either dextrose 50 mg/mL (5%), sodium chloride 9 mg/mL

   (0.9%) or Lactated Ringer’s solution for injection. The infusion bag size should allow enough solvent to achieve a final concentration of 0.3 mg/mL to 4 mg/mL enfortumab vedotin.

Diluted dosing solution of enfortumab vedotin is compatible with intravenous infusion bags composed of polyvinyl chloride (PVC), ethylvinyl acetate, polyolefin such as polypropylene (PP), or IV bottles comprised of polyethylene (PE), polyethylene terephthalate glycol-modified, and infusion sets composed of PVC with either plasticizer (bis(2-ethylhexyl) phthalate (DEHP) or tris(2-ethylhexyl) trimellitate (TOTM)), PE and with filter membranes (pore size: 0.2-1.2 μm) composed of polyethersulfone, polyvinylidene difluoride, or mixed cellulose esters.

1. 9. Mix diluted solution by gentle inversion. Do not shake the bag. Do not expose to direct sunlight.
2. 10. Visually inspect the infusion bag for any particulate matter or discolouration prior to use. The reconstituted solution should be clear to slightly opalescent, colourless to light yellow and free of visible particles. Do not use the infusion bag if particulate matter or discolouration is observed.
3. 11. Discard any unused portion left in the single-dose vials.

Administration

1. 12. Administer the infusion over 30 minutes through an intravenous line. Do not administer as an intravenous push or bolus.

No incompatibilities have been observed with closed system transfer device composed of acrylonitrile butadiene styrene (ABS), acrylic, activated charcoal, ethylene propylene diene monomer, methacrylate ABS, polycarbonate, polyisoprene, polyoxymethylene, PP, silicone, stainless steel, thermoplastic elastomer for reconstituted solution.

1. 13. Do not co-administer other medicinal products through the same infusion line.
2. 14.

   In-line filters or syringe filters (the pore size: 0.2-1.2 μm, recommended materials:

   polyethersulfone, polyvinylidene difluoride, mixed cellulose esters) are recommended to be used during administration.

Disposal

Padcev is for single use only.

Any unused medicinal product or waste material should be disposed of in accordance with local requirements.

4009032A 172144A

4009032A/172144A

PADCEV

INF VIAL

United Kingdom GB

435 X 697 mm FD

LFT_331

Project 62025

Eq. to: N/A

Proof_02

04 Sep 2026 17:16

4009032B/ 172144B

Front panel Back panel

PADCEV

INF VIAL

United Kingdom GB

270 x 71 mm FD

CRD_006

Project 62025

Eq. to: N/A

Proof_02

04 Sep 2026 17:16