Padcev 30 mg powder for concentrate for solution for infusion

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

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

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

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. 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 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.

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

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.

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 12 months after stopping Padcev.

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.

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 up to 9 months following the last dose of this medicine.

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

The recommended dose of this medicine is 1.25 mg/kg on days 1, 8 and 15 every 28 days. Your doctor will decide how many treatments you need.

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.

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.

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

• Skin reactions (Stevens-Johnson syndrome, toxic epidermal necrosis 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).
• 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 up to 1 in 10 people).
• 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 up to 1 in 100 people).
• 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 100 people).

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

• low red blood cells (anaemia)
• nausea, diarrhoea and vomiting
• tiredness
• decreased appetite
• change in sense of taste
• dry eye
• hair loss
• weight loss
• dry or itchy skin
• rash
• flat or red raised bumps on the skin
• increased liver enzymes (aspartate aminotransferase [AST] or alanine aminotransferase [ALT])

Common (may affect more than 1 in 100 people):

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

Uncommon (may affect more than 1 in 1000 people):

• skin irritation
• skin burning sensation
• problems affecting nerve function causing odd sensation or problems with movement
• muscle decreasing in size
• blood blister
• allergic reaction to skin
• rash with accompanying symptoms: spots that look like bullseyes, skin peeling, flat fluid-filled blister
• skin peeling all over the body
• 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 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: 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 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.

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.