WARNING

Padcev, or enfortumab vedotin, is a medication used for the treatment of locally advanced or metastatic urothelial cancer. Like any medication, Padcev comes with potential risks and side effects. It’s important to note that the following information is a general overview, and individuals should consult with their healthcare providers for personalized advice.

• Common Side Effects:
  • Fatigue
  • Loss of appetite
  • Hair loss
  • Peripheral neuropathy (nerve damage leading to tingling or numbness in extremities)
• Serious Side Effects:
  • Skin reactions: Severe skin reactions, such as Stevens-Johnson syndrome or toxic epidermal necrolysis, can occur.
  • Eye problems: Vision changes or disorders, including corneal reactions, may happen.
  • Liver problems: Elevated liver enzyme levels have been reported.
  • Infusion-related reactions: Some individuals may experience reactions during the infusion process.
• Blood Disorders: Padcev may cause a decrease in blood cell counts, including white blood cells, red blood cells, and platelets.
• Infections: There is an increased risk of infections, and precautions may be necessary.
• Pregnancy and Breastfeeding: Padcev can cause fetal harm, and it is not recommended for use during pregnancy. Women are advised to use effective contraception during treatment and for a certain period afterward. It is not known if Padcev passes into breast milk.
• Pre-existing Conditions: Patients with pre-existing liver or kidney problems may be at a higher risk of adverse effects.
• Drug Interactions: Padcev may interact with other medications, and it’s important to inform your healthcare provider about all the drugs you are taking.

It’s crucial for individuals considering or undergoing Padcev treatment to have open and thorough discussions with their healthcare team. They can provide detailed information about the potential risks and benefits based on the individual’s health status and medical history. Regular monitoring and communication with healthcare providers are essential to manage any potential side effects and ensure the best possible outcome from the treatment.

Why is this medication prescribed?

Padcev (enfortumab vedotin) is a prescription medication used for the treatment of adult patients with locally advanced or metastatic urothelial cancer. Urothelial cancer is a type of cancer that starts in the cells lining the bladder and can also affect other parts of the urinary system. Padcev is specifically indicated for the following:

• Locally Advanced or Metastatic Urothelial Cancer: It is prescribed for the treatment of adult patients with locally advanced or metastatic urothelial cancer who have previously received a programmed death receptor-1 (PD-1) or programmed death-ligand 1 (PD-L1) inhibitor, and a platinum-containing chemotherapy.

How should this medicine be used?

Padcev is administered through intravenous (IV) infusion. Here are some key points regarding its use:

• Dosage: The recommended dose and schedule will be determined by the healthcare provider based on the individual patient’s condition.
• Infusion: Padcev is given as an intravenous infusion over a specified period of time.
• Treatment Cycles: Treatment is typically administered in cycles, with each cycle consisting of a specific number of weeks. The treatment plan and the number of cycles will depend on the patient’s response and tolerability.
• Monitoring: Patients receiving Padcev will be closely monitored for any signs of side effects or adverse reactions. Regular check-ups and laboratory tests may be conducted to assess the patient’s overall health and the response to treatment.
• Contraindications: Patients with a history of severe allergic reactions to Padcev or any of its components should not use this medication.
• Pregnancy and Contraception: Padcev can cause harm to a developing fetus, so effective contraception is advised for both men and women during treatment and for a certain period afterward.
• Interactions: Patients should inform their healthcare providers about all medications, including prescription and over-the-counter drugs, as well as herbal supplements, they are taking to avoid potential drug interactions.

It’s important for individuals to follow their healthcare provider’s instructions carefully, attend all scheduled appointments, and communicate any concerns or side effects experienced during the course of treatment. Every patient’s situation is unique, and decisions about treatment should be made in consultation with a qualified healthcare professional.

Other uses for this medicine

Padcev (enfortumab vedotin) is primarily indicated for the treatment of adult patients with locally advanced or metastatic urothelial cancer who have previously received a PD-1 or PD-L1 inhibitor and a platinum-containing chemotherapy. It’s important to note that new uses or indications for drugs may emerge, so it’s advisable to consult with a healthcare professional or refer to the most recent medical literature for updates.

What special precautions should I follow?

Regarding special precautions for Padcev, it’s crucial to follow the guidance provided by your healthcare provider. Here are general considerations:

• Allergies: Inform your healthcare team about any known allergies or hypersensitivity reactions to Padcev or its components.
• Medical History: Provide a comprehensive medical history, including information about pre-existing conditions, especially liver or kidney problems.
• Pregnancy and Contraception: Padcev may cause harm to a developing fetus, so it is generally not recommended during pregnancy. Effective contraception is advised for both men and women during treatment and for a certain period afterward.
• Breastfeeding: It’s not known whether Padcev passes into breast milk. Breastfeeding is not recommended during treatment and for a period after the last dose.
• Vision Changes: Patients may experience changes in vision or eye disorders. Report any vision-related issues promptly to your healthcare provider.
• Infusion Reactions: Infusion-related reactions can occur during the administration of Padcev. Healthcare providers will monitor patients closely during and after infusions.
• Blood Cell Counts: Padcev can affect blood cell counts. Regular blood tests will be conducted to monitor for any abnormalities, and dose adjustments may be made as needed.
• Liver Function: Liver enzyme levels may be affected by Padcev. Regular liver function tests will be performed, and healthcare providers will monitor for signs of liver problems.
• Peripheral Neuropathy: Peripheral neuropathy, which can cause tingling or numbness in extremities, is a potential side effect. Report any unusual sensations to your healthcare provider.
• Infections: Padcev may increase the risk of infections. Notify your healthcare provider if you develop signs of infection, such as fever or persistent cough.

Always follow your healthcare provider’s instructions for Padcev, attend scheduled appointments, and promptly report any side effects or concerns. Individual responses to medications can vary, and your healthcare team will tailor the treatment plan to your specific needs and circumstances.

Always follow the specific instructions provided by your healthcare provider or as indicated on the product label. If you have any concerns or experience unexpected side effects, consult with your healthcare professional for guidance. They can provide personalized advice based on your medical history and individual circumstances.

What special dietary instructions should I follow?

There are generally no specific dietary restrictions associated with Padcev. However, it’s important to maintain a well-balanced and nutritious diet to support overall health and well-being. If you have specific dietary concerns or restrictions, discuss them with your healthcare provider.

What should I do if I forget a dose?

If you miss a dose of Padcev, contact your healthcare provider as soon as possible for guidance. It’s important not to double up on doses to make up for a missed one, as this can increase the risk of side effects. Your healthcare provider will provide instructions on how to proceed based on your specific situation.

What side effects can this medication cause?

Padcev (enfortumab vedotin) can cause various side effects, and individuals may experience them to different extents. It’s important to note that not everyone will experience all of these side effects, and some may not experience any at all. Common and serious side effects of Padcev include:

Common Side Effects:

• Fatigue
• Peripheral neuropathy (tingling, numbness, or pain in the hands and feet)
• Loss of appetite
• Nausea
• Hair loss (alopecia)
• Rash
• Changes in taste

Serious Side Effects:

• Skin Reactions: Severe skin reactions, such as Stevens-Johnson syndrome or toxic epidermal necrolysis, can occur.
• Eye Problems: Vision changes or disorders, including corneal reactions, may happen.
• Liver Problems: Elevated liver enzyme levels have been reported.
• Infusion-Related Reactions: Some individuals may experience reactions during the infusion process.
• Blood Disorders: A decrease in blood cell counts, including white blood cells, red blood cells, and platelets, can occur.
• Infections: There is an increased risk of infections, and precautions may be necessary.

It’s crucial to promptly report any unusual or severe side effects to your healthcare provider. They will monitor your health and may adjust the dosage or provide supportive care to manage side effects effectively.

It’s important to remember that the benefits of Padcev in treating urothelial cancer are weighed against the potential risks and side effects. Healthcare providers will carefully assess each patient’s individual health status and make treatment decisions based on the specific circumstances. Regular communication with your healthcare team, attending follow-up appointments, and adhering to their guidance are essential components of managing the side effects of Padcev effectively.

What should I know about storage and disposal of this medication?

Storage and Disposal of Padcev:

• Storage:
  • Padcev is typically provided and administered by healthcare professionals in a clinical setting. If you are given a supply of Padcev to take at home, follow the storage instructions provided by your healthcare provider or pharmacist.
  • Generally, Padcev should be stored under specific conditions, such as refrigeration or room temperature. Always check the product labeling for storage recommendations.
• Disposal:
  • Unused or expired Padcev should be disposed of properly. Do not flush medications down the toilet or throw them in the trash unless specifically instructed to do so.
  • Contact your local pharmacy or healthcare facility for information on medication disposal programs or take-back initiatives in your area.

In case of emergency/overdose

In the event of an emergency or suspected overdose, it’s important to take the following steps:

• Seek Medical Attention: Contact emergency services (911 in the United States) or your local emergency number immediately.
• Contact Poison Control: If available in your country, contact the poison control center for guidance.
• Inform Healthcare Provider: If possible, inform your healthcare provider about the situation.

What other information should I know?

• Regular Monitoring: Your healthcare provider will monitor you regularly during Padcev treatment to assess your response to the medication and manage any potential side effects.
• Follow-Up Appointments: Attend all scheduled follow-up appointments with your healthcare provider. These appointments are important for monitoring your overall health and adjusting the treatment plan if necessary.
• Medication Interactions: Inform your healthcare provider about all medications you are taking, including prescription and over-the-counter drugs, as well as herbal supplements. Certain medications may interact with Padcev.
• Pregnancy and Contraception: If you are pregnant, planning to become pregnant, or breastfeeding, discuss this with your healthcare provider. Effective contraception is usually recommended during Padcev treatment.
• Vision Changes: Report any changes in vision or eye disorders to your healthcare provider promptly.
• Peripheral Neuropathy: Report any symptoms of peripheral neuropathy, such as tingling or numbness in extremities, to your healthcare provider.
• Infections: Be vigilant for signs of infection, such as fever or persistent cough, and inform your healthcare provider if they occur.

Always follow your healthcare provider’s instructions, attend scheduled appointments, and communicate openly about any concerns or side effects you may experience during Padcev treatment.