What is Padcev?
Padcev is a prescription medication that is used to treat patients with urothelial cancer, which is the most prevalent kind of bladder cancer. Padcev (enfortumab vedotin) is a form of medicine referred to by the name of an antibody-drug conjugate (ADC). It targets Nectin-4, which is a protein that is located on the cell's surface and extensively expressed in bladder cancer. Enfortumab is used to treat bladder cancer by inhibiting the proliferation and division of cancerous cells. By securing itself on the outer surface of Nectin-4-expressing cancer cells, Padcev can then enter cells and release an anti-tumor drug known as monomethyl Auristatin E (MMAE) that results in cell cycle stoppage (cells cannot reproduce) and the process of apoptosis (programmed cells dying).
Padcev is a treatment for people suffering from bladder cancer and tumors in the urinary tract (renal pelvis or ureter) that have spread or are not able to be treated with surgery. Padcev can be used on its own when you've taken an immunotherapy drug as well as chemotherapy that is based on platinum, if you are unable to undergo a treatment that contains the cisplatin medicine, and if you've had one or more prior treatments. It can be used in conjunction with pembrolizumab (Keytruda) when you are unable to receive a treatment that includes the medication Cisplatin. It is not clear whether this medicine can be used safely and effectively for children.
Padcev could cause a life-threatening or severe skin itching rash. Get emergency medical help if you experience a swollen rash that is worsening with itching or peeling skin lesions that resemble rings, flu-like or fever-like symptoms, or swollen glands. painful sores that appear in your nose, mouth, throat, or genital area. Before starting treatment, inform your doctor about all your medical issues, including the possibility of sensations of tingling or numbness in your feet or hands, a history of having high glucose or blood sugar, or that you're pregnant or planning to be pregnant. Enfortumab vedotin may be harmful to your unborn child.
Follow the instructions on the medicine label and in the package. Inform your health care providers about your medical issues, allergies, and all medications you take.
Before you take this drug.
To ensure that this medication is appropriate for you, tell your physician if you have any of the following:
- Numbness or tingling in your feet or hands.
- An antecedent or a history of diabetes, high blood sugar levels, or diabetes.
- Liver disease.
Enfortumab vedotin may harm an unborn child when either the father or mother uses this medicine.
- If you're female, you may need an ultrasound test to be sure that you're not pregnant. Utilize birth control throughout treatment and at least for 2 months after the last dose.
- If you're male, use birth control when your sex partner is likely to become pregnant. Use birth control for at least four months after the last dose.
- It might be difficult to induce pregnancy when you're taking this drug. It is still recommended to take birth control in order to prevent pregnancies because this medicine could cause harm to a baby who is not born.
- Inform your doctor immediately in the event of a pregnancy.
Don't breastfeed while taking Padcev or for at least three weeks after the last dose.
How to take Padcev?
Padcev is instilled into a vein by a healthcare professional. This medication must be administered slowly over the course of 30 minutes. Contact your physician. If you experience any burning or pain after Padcev is administered, Padcev is performed over long periods of time, referred to as "cycles''. If you choose to receive Padcev as a single treatment, each cycle will last 28 days. The patient will be given Padcev on days 1, 8, and 15 of each treatment cycle. Your physician will determine the number of cycles you will require. If you have received Padcev along with pembrolizumab, each treatment cycle lasts 21 days. The patient will be given Padcev on days 1 through 8 of each cycle. Your doctor will advise you on how many cycles you'll need.
This medication can trigger extremely serious or dangerous itching, particularly when the first treatment cycle is completed. Contact your doctor immediately when you notice new skin rashes that cause itching that becomes more severe. Padcev may create high blood glucose (hyperglycemia) even in the absence of it or if you aren't diabetic. A severe case of hyperglycemia can be life-threatening. Your blood sugar level may require frequent testing. Padcev can cause dry eyes. Your physician may advise you to apply artificial tear drops to treat dry eyes.
Details on dosage
Usual Adult Dose of Padcev for Urothelial Carcinoma:
As an agent in a single
1.25 mg/kg (up to an maximum of 135 mg for patients who weigh who weigh more than 100 kg) administered by intravenous injection over 30 minutes on Days 1 8, 8 and 15 of a 28-day period until the progression of disease or unacceptably toxic.
When combined with pembrolizumab
1.25 mg/kg (up to a maximum of 135 mg for patients who weigh more than 100 kg) administered by intravenous injection over thirty minutes between Days 1 through 8 of a 21-day course until progression of the disease or unacceptably toxic
Uses: As a single agent for treating adult patients suffering from metastatic or locally advanced urothelial cancer that have previously received a programmed death receptor 1 (PD-1) or programmed death ligand 1 (PD-L1) inhibitor and chemotherapy containing platinum, or who are not eligible for chemotherapy containing cisplatin and have had one or more treatments.
In combination with pembrolizumab to treat adults with metastatic or locally advanced tumors of the urothelial system who aren't suitable for chemotherapy with cisplatin. The indication has been approved with accelerated approval based on tumor-response speed and duration of the response. The approval of this indication for the foreseeable future could be contingent on the evidence of clinical benefits in the confirmation studies.
What happens if I miss a dose?
Contact your doctor for advice in the event that you don't make an appointment for an injection.
What happens if I overdose?
In a medical facility, the overdose is immediately treated.
What should be avoided?
Follow the instructions of your physician regarding restrictions on drinks, food, or any activity.
Side effects of Padcev
Get immediate medical attention. If you show symptoms that you are experiencing an allergic reaction, Padcev: hives, breathing difficulties, or swelling of your lips, face, and tongue,
This medication can trigger an extremely life-threatening itchy rash. Get emergency medical assistance if you experience an increase in itching or peeling skin lesions that resemble rings, flu-like or fever-like symptoms, or swollen, painful sores on your nose, mouth, throat, or genital region.
Contact your doctor immediately. If you experience symptoms of elevated glucose levels:
- Dry mouth, thirsty lips, fruity smell.
- More frequent urination.
- Vision blurred, confused, or drowsy.
- Nausea, vomiting, stomach discomfort, and loss of appetite.
Contact your doctor at the earliest opportunity if you are suffering from:
- Tingling, numbness, or muscle weakness in your feet or hands.
- New or worsening cough, difficulty breathing, or a shortness of breath.
- Irritation, redness, or peeling, scaly skin that appears on your feet and hands.
- Very dry, irritated eyes, and vision issues.
- Itching, swelling, redness, or discomfort in the area where the medicine was injected.
- Low blood cell count low blood cell counts: chills, fever, fatigue, mouth sores, skin sores, easy bruising, unusual bleeding, pale skin, cold feet, and hands, and being lightheaded or breathless.
The treatment for cancer may be delayed or discontinued permanently when you experience certain negative side effects.
Common Padcev side effects can include:
- High blood sugar levels.
- Numbness or tingling.
- Muscles weak.
- low blood cell count.
- Being tired.
- Nausea, diarrhea.
- Loss of appetite; reduction in weight.
- Itching, dry skin itching.
- Changes in your sense of taste.
- Hair loss.
- Blood tests that are abnormal.
Other side effects that can be experienced when using pembrolizumab in conjunction with it include:
- Infections of the urinary tract.
- Edema of the peripheral region (swelling of the hands, arms, feet, legs, and arms).
- Dry eyes.
- Arthralgia (joint pains).
This is not an exhaustive list of probable adverse effects; more may occur. Contact your doctor for advice regarding medical effects. You may report any adverse reactions to the FDA at 1-800-FDA-1088.
Interaction with other drugs
A variety of drugs can affect the levels in your blood of enfortumab vedotin. This can increase the risk of adverse effects. Inform your doctor about any other medications you are taking, such as prescription and over-the-counter medications, vitamins, and herbal supplements. The interactions of all drugs are not mentioned here.