Medical Use
Padcev (enfortumab vedotin-ejfv) is a conjugate of a Nectin-4-directed antibody and a microtubule inhibitor. It is used:
- -As a monotherapy for adults with locally advanced or metastatic urothelial cancer who have previously received treatment with a PD-1 or PD-L1 inhibitor and platinum-based chemotherapy, or who are ineligible for cisplatin-based chemotherapy and have undergone one or more prior therapies.
- -In combination with pembrolizumab for adults with locally advanced or metastatic urothelial cancer who are not eligible for cisplatin-based chemotherapy.
The recommended dosage of Padcev as a single agent is 1.25 mg/kg (up to a maximum of 125 mg for patients weighing 100 kg or more), administered via intravenous (IV) infusion over 30 minutes on Days 1, 8, and 15 of a 28-day cycle, continuing until disease progression or unacceptable toxicity occurs.
When used with pembrolizumab, the recommended dose of Padcev is 1.25 mg/kg (up to a maximum of 125 mg for patients weighing 100 kg or more), administered via IV infusion over 30 minutes on Days 1 and 8 of a 21-day cycle, continuing until disease progression or unacceptable toxicity occurs.
Warning & Precautions
Patients treated with Padcev injection may experience severe cutaneous side effects, including fatal cases of Stevens-Johnson syndrome (SJS) or toxic epidermal necrolysis (TEN). These conditions can occur primarily during the first treatment cycle but may also develop later. It is crucial to monitor patients for skin reactions throughout the treatment. Consider using topical corticosteroids and antihistamines as needed.
Hyperglycemia and diabetic ketoacidosis (DKA), including fatal events, can occur in patients with or without preexisting diabetes mellitus who are treated with this drug. Blood glucose levels should be closely monitored in patients with, or at risk for, diabetes mellitus or hyperglycemia. If blood glucose levels exceed 250 mg/dL, therapy should be withheld.
Serious, life-threatening, or fatal pneumonitis/interstitial lung disease (ILD) may occur in patients treated with Enfortumab vedotin-ejfv. Patients should be monitored for symptoms such as cough, hypoxia, dyspnea, or interstitial infiltrates on radiologic exams. It is important to assess and rule out infectious, neoplastic, and other causes for these symptoms through appropriate investigations.
Peripheral neuropathy may develop in patients treated with Enfortumab vedotin-ejfv as a single agent. Patients should be monitored for new or worsening symptoms of peripheral neuropathy, and the dose should be interrupted or reduced if these symptoms occur. Treatment should be permanently discontinued in patients who develop Grade 3 or higher peripheral neuropathy.
Ocular disorders may also occur in patients treated with Padcev as a single agent. Ensure adequate venous access before starting treatment and monitor for possible extravasation during administration. If extravasation occurs, stop the infusion and monitor for side effects.
Documentation Availability
Documents required to import PADCEV to India?
PADCEV can be imported by patients or treating physicians on behalf of patients. The following documentation is required to import the product:
- (i)2 ID proofs along with PAN card details along with attested scanned copies
- (ii)Valid doctor prescription scanned copy
- (iii)Doctor’s MCI number
- (iv)Doctor’s mobile number
- (v)Patients diagnostic reports
How is the order confirmed?
The order will be confirmed only after the receipt of:
- (i)The above-mentioned documents and drug availability.
- (ii)Import permit if applicable.
Sourcing & Delivery
The Rx4U team has extensive experience in sourcing PADCEV (Cancer Treatment Medicines) from around the world, ensuring global access to the best available treatments for our customers. We are dedicated to promptly dispensing any valid prescription. All prescriptions are verified and dispatched directly to the patient’s address. Our patients are our top priority, and we strive to improve their lives through our services.
FAQ
What is the generic name for the trade name drug Padcev®?
The generic name for Padcev® is enfortumab vedotin-ejfv.
Who manufactures Padcev®?
Padcev® is manufactured by Astellas Pharma US, Inc.
Is Padcev® FDA approved?
Yes, Padcev® received FDA approval on December 18, 2019.
What is the dosage form of Padcev®?
Padcev® is available as injections, with each vial containing 20 mg or 30 mg of enfortumab vedotin-ejfv as a lyophilized powder for reconstitution for intravenous use.
How much does Padcev® cost in India?
The price of Padcev® in India can vary. For legal procurement, you can reach out to Rx4u team.
What are the storage conditions for Padcev®?
Padcev® vials should be stored in a refrigerator at 2°C to 8°C (36°F to 46°F) in their original carton. Avoid freezing and shaking the vials.
Is it safe to buy Padcev® online in India?
Yes, you can safely purchase Padcev® online in India through https://rx4u.in/.
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