Padcev Injection: Uses, Dosage, Side Effects, Precautions and Alternates

Quick overview

Padcev Injection (enfortumab vedotin) is a prescription antibody-drug conjugate used to treat adults with bladder cancer and cancers of the urinary tract that have spread or cannot be removed by surgery. It is given as an intravenous infusion by a healthcare professional, either alone or together with pembrolizumab. Padcev works by delivering a cell-killing medicine directly into cancer cells, which can also cause side effects affecting normal cells.

What is Padcev Injection

Padcev is a prescription medicine used to treat adults with bladder cancer and cancers of the urinary tract that have spread or cannot be removed by surgery. It is an antibody-drug conjugate, a type of targeted therapy that delivers cell-killing medicine directly to cancer cells.

Padcev Injection uses

• Treatment of adults with bladder cancer and cancers of the urinary tract (renal pelvis, ureter, or urethra) that has spread or cannot be removed by surgery
• Used with pembrolizumab when bladder or urinary tract cancer has spread or cannot be removed by surgery
• Used alone if you have received PD-1 or PD-L1 immunotherapy medicine and chemotherapy that contains platinum, or if you are not able to receive cisplatin-containing chemotherapy and have received one or more prior therapies

Benefits of Padcev Injection

• Treats certain advanced urothelial cancers
• Targets Nectin-4 on cancer cells
• Delivers a cytotoxic medicine directly to targeted cells
• Can be used alone or with pembrolizumab
• May help shrink tumors or delay cancer progression in eligible adults

How Padcev Injection works

Padcev is made of an antibody that attaches to a protein on cancer cells, a linker, and a cell-killing medicine. Once the antibody attaches to the cancer cell, the drug enters the cell and releases the cell-killing medicine, which disrupts the cell's internal skeleton and causes the cancer cell to die. This can also affect normal cells and cause side effects.

Padcev Injection dosage

Padcev is given by a healthcare professional in a healthcare setting as an intravenous (IV) infusion into your vein over 30 minutes.

When given alone, each treatment cycle is 28 days: you receive this medicine once a week for 3 weeks in every cycle, then take a week off before starting the next cycle.

When given with pembrolizumab, each treatment cycle is 21 days: you receive a dose on day 1 and day 8, then have a dose-free week before the next cycle.

Your healthcare professional will tell you how many treatment cycles you need. You may have blood tests during treatment with this medicine.

If you miss your appointment to receive Padcev, you should make every effort to receive the missed dose as soon as possible; doses should be given at least 1 week apart.

Available forms and strengths

• Single-use vials containing 20 mg of enfortumab vedotin for injection
• Single-use vials containing 30 mg of enfortumab vedotin for injection
• Lyophilized powder for solution for intravenous infusion

Side effects of Padcev Injection

Common

• Low red blood cells (anemia)
• Low numbers of neutrophils (neutropenia)
• Nausea
• Diarrhea
• Vomiting
• Feeling tired
• Decreased appetite
• Bad taste in your mouth
• Rash
• Hair loss
• Weight loss
• Increased liver enzymes (AST or ALT)
• Itching
• Low platelet counts
• Changes in liver and kidney function tests
• Increased uric acid in blood
• Increased lipase
• Dry skin
• Difficulty sleeping
• Constipation
• Stomach pain
• Fever
• Urinary tract infection
• Pain in the muscles and bones
• Bleeding
• Infection in the blood

Serious

• Severe skin reactions including Stevens-Johnson syndrome and toxic epidermal necrolysis
• High blood sugar (hyperglycemia) and diabetic ketoacidosis
• Peripheral neuropathy (nerve damage) causing weakness, numbness and pain in hands and feet
• Lung inflammation (pneumonitis/interstitial lung disease)
• Eye problems such as dry eye and blurred vision
• Infusion site extravasation (drug leaking outside the blood vessels) causing redness, pain, swelling, bruising, infection, or blisters
• Fast heart rate

Warnings and precautions

• Severe and fatal skin reactions, including Stevens-Johnson syndrome and toxic epidermal necrolysis, have occurred in patients treated with Padcev.
• High blood sugar, including a serious condition called diabetic ketoacidosis (DKA), and death have occurred in patients with and without diabetes treated with Padcev.
• Padcev may cause severe or life-threatening lung inflammation that can lead to death.
• Do not use Padcev if you are allergic to enfortumab vedotin or any of its ingredients.
• Padcev may cause fertility problems in females and males, which may affect the ability to have children.
• Padcev can harm an unborn baby and should not be used during pregnancy. A pregnancy test is recommended before starting treatment, and effective contraception should be used during treatment and for a period after the last dose.
• It is not known if Padcev passes into breast milk. Breastfeeding is not recommended during treatment and for a period after the last dose.
• No dose adjustment is required for patients with mild, moderate, or severe kidney impairment, but tell your healthcare provider if you have or have had kidney problems.
• Padcev should be avoided in patients with moderate or severe liver impairment. Tell your healthcare provider if you have or have had liver problems.

Storage

• PADCEV will be stored by the healthcare professional at the hospital or clinic
• Do not use this medicine after the expiry date
• Store this medicine at 2°C to 8°C
• Do not freeze
• Do not shake
• Do not expose to sunlight
• 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
• Keep out of reach and sight of children

When to see a doctor

• Get medical help right away if you have signs of a new or worsening skin reaction, such as ring-like skin reactions, worsening rash or itching, blistering or peeling skin, painful sores or ulcers in the mouth, nose, throat, or genital area, fever or flu-like symptoms, or swollen lymph nodes.
• Tell your healthcare provider right away if you get symptoms of high blood sugar, such as frequent urination, increased thirst, blurred vision, confusion, drowsiness, loss of appetite, a fruity smell on your breath, nausea, vomiting, or stomach pain.
• Tell your healthcare provider right away if you get new or worsening trouble breathing, shortness of breath, or cough.
• Tell your healthcare provider right away if you get new or worsening numbness or tingling in your hands or feet or muscle weakness.
• Tell your healthcare provider right away if you notice redness, swelling, itching, blistering, peeling skin, or discomfort at the infusion site.
• If you think you have taken too much Padcev, contact a healthcare professional, hospital emergency department, or your local poison control center immediately, even if there are no symptoms.

Alternatives

• Trodelvy (sacituzumab govitecan)
• Keytruda (pembrolizumab)
• Opdivo (nivolumab)