Enfortumab vedotin

What is Enfortumab vedotin?

• Enfortumab vedotin (Padcev) is an antibody-drug conjugate (ADC)
• Enfortumab refers to the monoclonal antibody part, and vedotin refers to the payload drug

Antibody-drug-conjugates

What are the uses of this medicine?

• Enfortumab vedotin (Padcev) is indicated for the treatment of adult patients with locally advanced or metastatic urothelial cancer (mUC)

How does this medicine work?

• An antibody drug conjugate (ADC) containing a human monoclonal antibody AGS-22 targeting the cell adhesion molecule nectin-4 and conjugated to the cytotoxic agent monomethyl auristatin E (MMAE), via a proprietary enzyme-cleavable linker (AGS-22CE), with potential antineoplastic activity.
• The monoclonal antibody moiety of AGS-22CE selectively binds to nectin-4.
• After internalization and proteolytic cleavage, MMAE binds to tubulin and inhibits its polymerization, which results in G2/M phase arrest and induces apoptosis in nectin-4 overexpressing tumor cells.
• Nectin-4, a tumor associated antigen belonging to the nectin family, is overexpressed in a variety of cancers, including breast, bladder, lung and pancreatic cancer.

Who Should Not Use this medicine?

• This medicine have no usage limitations.

Is this medicine FDA approved?

• The U.S. Food and Drug Administration (FDA) considers it to be a first-in-class medication

How should this medicine be used?

• It will be given to you by intravenous (IV) infusion into your vein over 30 minutes.
• You will receive your Padcev over periods of time called cycles.
• Each Padcev cycle is 28 days.
• You will receive Padcev on days 1, 8 and 15 of every cycle.

What are the dosage forms and brand names of this medicine?

• Padcev is the brand name
• For Injection: 20 mg and 30 mg of enfortumab vedotin-ejfv as a white to off-white lyophilized powder in a single-dose vial for reconstitution.

What side effects can this medication cause?

• skin reactions
• hyperglycemia[excessive urination,excessive thrist,drowsiness, etc]
• peripheral neuropathy
• tiredness (fatigue)
• numbness or tingling in your hands or feet, or muscle weakness
• decreased appetite
• rash
• hair loss
• nausea
• diarrhea
• change in sense of taste
• dry eyes
• dry skin

What special precautions should I follow?

• skin reactions : occur anytime after taking the injection but mostly occurs in first 28 days .

Tell your healthcare provider right away if you develop any of these signs of a new or worsening skin reaction: target lesions (skin reactions that look like rings) rash or itching that continues to get worse blistering or peeling of the skin painful sores or ulcers in mouth or nose, throat, or genital area fever or flu-like symptoms swollen lymph nodes

• Closely monitor blood glucose levels in patients with, or at risk for, diabetes mellitus or hyperglycemia.
• Monitor patients for eye problems
• Ensure adequate venous access prior to starting Padcev and monitor for possible extravasation during administration. If extravasation occurs, stop the infusion and monitor for adverse reactions.
• Advise patients of the potential risk to the baby.

What to do in case of emergency/overdose?

• In case of overdose, call the poison control helpline of your country. In the United States, call 1-800-222-1222.

• Overdose related information is also available online at poisonhelp.org/help.
• In the event that the victim has collapsed, had a seizure, has trouble breathing, or can't be awakened, immediately call emergency services. In the United States, call 911.

Can this medicine be used in pregnancy?

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

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.

Can this medicine be used in children?

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

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

• Store Padcev vials refrigerated at 2ºC to 8ºC (36ºF to 46ºF) in the original carton.
• Do not freeze.
• Do not shake.
• Padcev is a cytotoxic drug. Follow applicable special handling and disposal procedures

• Dailymed label info on Enfortumab vedotin
• FDA Enfortumab vedotin

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