Padcev

Padcev is a prescription medicine used to treat adults with bladder cancer and cancers of the urinary tract that has spread or cannot be removed by surgery.

This medication belongs to a group of drugs called monoclonal antibodies. It is thought to work by attaching to the surface of cancer cells and entering and releasing cell-killing medicine. 

Padcev comes as an injectable medication to be given by intravenous (IV) infusion into your vein over 30 minutes. It is given on days 1, 8 and 15 of every 28-day cycle.

Common side effects include numbness or tingling in your hands or feet, or muscle weakness, fatigue and decreased appetite.

Padcev is a prescription medicine used to treat adults with bladder cancer and cancers of the urinary tract (renal pelvis, ureter or urethra) that has spread or cannot be removed by surgery. Padcev may be used if you have:

• received an immunotherapy medicine and
• also received a chemotherapy-containing platinum medicine.

It is not known if Padcev is safe and effective in children.

This medication may be prescribed for other uses. Ask your doctor or pharmacist for more information.

The recommended dose of Padcev is 1.25 mg/kg (up to a maximum dose of 125 mg) given as an intravenous infusion over 30 minutes on Days 1, 8 and 15 of a 28-day cycle until disease progression or unacceptable toxicity.

Padcev may cause serious side effects, including:

• High blood sugar (hyperglycemia). You can develop high blood sugar during treatment with Padcev. Tell your healthcare provider right away if you have any symptoms of high blood sugar, including:
  • frequent urination 
  • increased thirst
  • blurred vision
  • confusion
  • it becomes harder to control your blood sugar
  • drowsiness
  • loss of appetite
  • fruity smell on your breath
  • nausea, vomiting, or stomach pain

• Peripheral neuropathy. While receiving Padcev you may experience nerve problems called peripheral neuropathy. Tell your healthcare provider right away if you get numbness or tingling in your hands or feet or muscle weakness.

• Eye problems. You can develop certain eye problems while receiving Padcev. Tell your healthcare provider right away if you have dry eyes, or blurred vision.

• Skin Reactions. Rashes and severe skin reactions can happen while receiving Padcev. Tell your healthcare provider right away if you get a rash or a skin reaction that continues to get worse.

• Leakage of Padcev out of your vein into the tissues around your infusion site (extravasation). 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. Tell your healthcare provider or get medical help right away if you notice any redness, swelling, itching, or discomfort at the infusion site.

Padcev may cause serious side effects. See “Padcev Precautions” section.

The most common side effects of Padcev include:

• numbness or tingling in your hands or feet, or muscle weakness
• fatigue
• decreased appetite
• rash
• hair loss 
• nausea 
• diarrhea
• change in sense of taste  
• dry eyes
• dry skin

If you have certain side effects, your healthcare provider may decrease your dose or stop your treatment with Padcev for a period of time (temporarily) or completely.

Padcev may cause fertility problems in males, which may affect the ability to father children. Talk to your healthcare provider if you have concerns about fertility.

These are not all of the possible side effects of Padcev.
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Tell your doctor about all the medicines you take, including prescription and non-prescription medicines, vitamins, and herbal supplements. Especially tell your doctor if you take:

Drugs categorized as strong CYP3A4 inhibitors such as: clarithromycin, telithromycin, nefazodone, itraconazole, ketoconazole, atazanavir, darunavir, indinavir, lopinavir, nelfinavir, ritonavir, saquinavir, and tipranavir.

Drugs categorized as strong CYP3A4 inducers such as: carbamazepine, phenobarbital, phenytoin, primidone, and rifampin.

This is not a complete list of Padcev drug interactions. Ask your doctor or pharmacist for more information.

Tell your healthcare provider right away if you become pregnant or think you may be pregnant during treatment with Padcev. Padcev can harm your unborn baby. 

Females who are able to become pregnant:

• Your healthcare provider should do a pregnancy test before you start treatment with Padcev.
• You should use an effective method of birth control during your treatment and for at least 2 months after the last dose of Padcev.

Males with a female sexual partner who is able to become pregnant:

• If your female partner is pregnant, Padcev can harm the unborn baby.
• You should use an effective method of birth control during your treatment and for at least 4 months after the last dose of Padcev.

Tell your healthcare provider right away if you are breastfeeding or plan to breastfeed. It is not known if Padcev passes into your breast milk. Do not breastfeed during treatment and for at least 3 weeks after the last dose of Padcev.