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Padcev 20mg Injection
Prescription Required
Salt Composition : Enfortumab Vedotin
Manufacturer : ASTELLAS PHARMA INC
Origin of Medicine : India
1 Vial(s)
Introduction to Padcev 20mg Injection
Padcev 20mg Injection contains the active substance Enfortumab vedotin. It is an antineoplastic drug that belongs to the class of antibody-drug conjugates (ADCs). Padcev 20mg Injection is used to treat adults with locally advanced or metastatic urothelial cancer who have previously received a PD-1 or PD-L1 inhibitor and platinum-containing chemotherapy.
Padcev 20mg Injection works by targeting a protein called Nectin-4, which is highly expressed in urothelial cancer cells. The drug delivers a cytotoxic agent known as monomethyl auristatin E (MMAE) directly to the cancer cells. Once inside the cells, MMAE disrupts the microtubule network, leading to cell cycle arrest and cell death. This targeted mechanism helps to destroy cancer cells while minimising damage to healthy tissues.
Do not give Padcev 20mg Injection to children or adolescents under the age of 18.
Do not use Padcev 20mg Injection if you are allergic to Enfortumab vedotin or any other ingredients of this medicine. Before starting treatment, inform your doctor if you have a history of kidney problems, heart conditions, eye disorders or if you’ve experienced lung inflammation. Report any symptoms such as difficulty breathing with cough or fever, severe skin peeling, persistent fever, easy bruising or bleeding, unusual tiredness, pale skin, or signs of infection to your healthcare provider promptly.
Uses of Padcev 20mg Injection
Padcev 20mg Injection is used in the treatment of the following:
- Locally advanced or metastatic urothelial cancer in adult patients who have previously received a PD-1 or PD-L1 inhibitor and platinum-containing chemotherapy.
Therapeutic Effects of Padcev 20mg Injection
Padcev Injection works by targeting Nectin-4 on cancer cells and delivering monomethyl auristatin E (MMAE), a cytotoxic agent. Once inside the cancer cells, MMAE interferes with the microtubule network, causing cell cycle arrest and triggering cell death (apoptosis). This targeted mechanism enables the selective destruction of cancer cells while minimizing harm to healthy tissues.
Interaction of Padcev 20mg Injection with other drugs
It is important to inform your healthcare professional about all the medications you are taking, including prescription drugs, over-the-counter medications, nutritional supplements, and herbal products. Some medications may interact with Padcev 20mg Injection, potentially affecting their effectiveness or causing side effects.
More Information about Padcev 20mg Injection
- Keep out of reach of children and pets.
- Store in the original container.
- Store Padcev Injection in a refrigerator at a temperature 2ºC to 8ºC.
- Do not freeze
How to consume Padcev 20mg Injection
Treatment with Padcev Injection should be initiated and supervised by a physician experienced in anti-cancer therapies in a hospital setting, with administration in a healthcare facility equipped to manage potential infusion-related reactions. Padcev 20mg Injection is given as an intravenous (IV) infusion under the supervision of a qualified healthcare professional, requiring good venous access before starting treatment. This medication must not be self-administered.
Safety Advices for Padcev 20mg Injection
Pregnancy
It is unsafe to take Padcev 20mg Injection if you are pregnant, as it may cause fetal harm. Consult your doctor for advice and discuss effective contraception methods before starting treatment.
Breast Feeding
It is unknown if Padcev 20mg Injection are safe to take during breastfeeding. Please consult your healthcare provider if you have any concerns.
Lungs
If you have any pre-existing lung conditions, discuss them with your doctor before starting treatment with Padcev 20mg Injection.
Liver
If you have any pre-existing liver conditions, discuss them with your doctor before starting treatment with Padcev 20mg Injection.
Alcohol
It is unknown whether alcohol consumption is safe while you are undergoing Padcev 20mg Injection course. It is recommended to consult your doctor for better guidance.
Driving
It is safe to use Padcev 20mg Injection, as it has no or negligible influence on the ability to drive and use machines. However, if you experience any side effects such as dizziness or blurred vision, consult your doctor before engaging in these activities.
Side Effects of Padcev 20mg Injection
Side effects are unwanted symptoms caused by medicines. Although all drugs can cause side effects, not everyone experiences them.
Common side effects of Padcev 20mg Injection are
- Fatigue
- Nausea
- Decreased appetite
- Diarrhea
- Rash
- Hair loss (alopecia)
- Altered taste (dysgeusia)
- Dry eyes
Serious side effects of Padcev 20mg Injection are:
- Severe Peripheral Neuropathy: May require dose adjustment or discontinuation of treatment.
- Serious Skin Reactions: Including conditions like Stevens-Johnson syndrome and toxic epidermal necrolysis; treatment should be stopped immediately if these occur.
- Hyperglycemia: Can result in ketoacidosis or hyperosmolar hyperglycemic state; requires careful monitoring and management.
Word of Advice
Patients should immediately report any new or worsening symptoms, especially those related to nerve function, skin reactions, or blood sugar levels. Regular communication with healthcare providers is essential for the prompt management of side effects. Adhering to scheduled appointments and monitoring protocols is vital for the safe and effective use of treatment. Additionally, patients should follow their doctor’s advice regarding any necessary adjustments to their therapy.
FAQs
Q 1. What is the use of Padcev 20mg Injection?
Padcev 20mg Injection is primarily used to treat adults with locally advanced or metastatic urothelial carcinoma, which is the most common type of bladder cancer. It is typically prescribed for patients who have previously received a PD-1 or PD-L1 inhibitor and platinum-containing chemotherapy. Additionally, enfortumab vedotin may be used in combination with pembrolizumab for patients ineligible for cisplatin-containing chemotherapy.
Q 2. Is Padcev 20mg Injection chemotherapy or immunotherapy?
Padcev 20mg Injection is classified as an antibody-drug conjugate (ADC), which is a form of targeted cancer therapy. It combines a monoclonal antibody that specifically targets Nectin-4—a protein highly expressed in urothelial cancer cells—with a cytotoxic agent that disrupts cancer cell division. This mechanism allows it to deliver chemotherapy directly to cancer cells while sparing healthy tissues. Therefore, it is distinct from traditional chemotherapy and immunotherapy, representing a hybrid approach that leverages aspects of both treatment modalities.
Q 3. What is the success rate of Padcev 20mg Injection?
The effectiveness of Padcev 20mg Injection has been demonstrated in clinical trials. In a pivotal study, enfortumab vedotin achieved an overall response rate (ORR) of 44%, with 12% of patients experiencing a complete response and 32% showing a partial response. The median duration of response was 7.6 months. Furthermore, when combined with pembrolizumab, the ORR increased to approximately 67-68%, with notable improvements in progression-free and overall survival compared to traditional chemotherapy.
Q 4. How much does Padcev 20mg Injection cost?
The cost of Padcev 20mg Injection can vary based on dosage, treatment duration, and insurance coverage. In the United States, the price for a 20 mg vial of Padcev 20mg Injection is approximately Rs. 1,00,000, with a 30 mg vial costing around Rs. 1,55,000. Given that treatment involves multiple vials per dose, the total expense can be substantial. Patients are encouraged to consult with their healthcare providers and insurance companies to understand their financial responsibilities. Additionally, the manufacturer offers assistance programs to help eligible patients manage treatment costs.
Fact Box of Padcev 20mg Injection
| Molecule name: Enfortumab vedotin | Therapeutic class: Antineoplastic Agent |
| Pharmacological class: Antibody-Drug Conjugate (ADC) | Indications: reatment of adults with locally advanced or metastatic urothelial cancer who have previously received a PD-1 or PD-L1 inhibitor and platinum-containing chemotherapy.
|
References
- https://www.fda.gov/drugs/resources-information-approved-drugs/fda-grants-accelerated-approval-enfortumab-vedotin-ejfv-metastatic-urothelial-cancer
- https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/761137s019lbl.pdf
- https://fda.report/DailyMed/b5631d3e-4604-4363-8f20-11dfc5a4a8ed
- https://www.padcev.com/about-padcev
Disclaimer
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