pharmacopeia
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Boxed warning

SERIOUS SKIN REACTIONS • PADCEV can cause severe and fatal cutaneous adverse reactions including Stevens-Johnson syndrome (SJS) and Toxic Epidermal Necrolysis (TEN), which occurred predominantly during the first cycle of treatment, but may occur later. • Closely monitor patients for skin reactions. • Immediately withhold PADCEV and consider referral for specialized care for suspected SJS or TEN or severe skin reactions. • Permanently discontinue PADCEV in patients with confirmed SJS or TEN; or Grade 4 or recurrent Grade 3 skin reactions [see Dosage and Administration ( 2.2 ), Warnings and Precautions ( 5.1 ), and Adverse Reactions ( 6.1 )]. WARNING: SERIOUS SKIN REACTIONS See full prescribing information for complete boxed warning. • PADCEV can cause severe and fatal cutaneous adverse reactions, including Stevens-Johnson syndrome (SJS) and Toxic Epidermal Necrolysis (TEN). • Immediately withhold PADCEV and consider referral for specialized care for suspected SJS or TEN or severe skin reactions. • Permanently discontinue PADCEV in patients with confirmed SJS or TEN; or Grade 4 or recurrent Grade 3 skin reactions. ( 2.2 ), ( 5.1 ), ( 6.1 )

Mechanism of action

Sourced from openFDA

Enfortumab vedotin-ejfv is an ADC. The antibody is a human IgG1 kappa directed against Nectin-4, an adhesion protein located on the surface of cells.

Indications

Sourced from openFDA
  • PADCEV ® , in combination with pembrolizumab or pembrolizumab and berahyaluronidase alfa-pmph, as neoadjuvant treatment and then continued after cystectomy as adjuvant treatment, is indicated for the treatment of adult patients with muscle invasive bladder cancer (MIBC) who are ineligible for cisplatin-containing chemotherapy. PADCEV ® , in combination with pembrolizumab or pembrolizumab and berahyaluronidase alfa-pmph, is indicated for the treatment of adult patients with locally advanced or metastatic urothelial cancer (mUC).

Contraindications

Sourced from openFDA
  • None. None.contraindicated

Dosage & administration

Sourced from openFDA

• For intravenous infusion only. Do not administer PADCEV as an intravenous push or bolus. Do not mix with, or administer as an infusion with, other medicinal products. ( 2.3 ) • MIBC: The recommended dose of PADCEV in combination with pembrolizumab or pembrolizumab and berahyaluronidase alfa-pmph is 1.25 mg/kg (up to a maximum dose of 125 mg) given as an intravenous infusion over 30 minutes. PADCEV is administered as neoadjuvant treatment on Days 1 and 8 of each 21-day cycle for 3 cycles or until disease progression that precludes curative intent cystectomy or unacceptable toxicity, followed by adjuvant treatment on Days 1 and 8 of each 21-day cycle for 6 cycles or until disease recurrence or unacceptable toxicity. ( 2.1 ) • Locally Advanced or mUC: The recommended dose of PADCEV in combination with pembrolizumab or pembrolizumab and berahyaluronidase alfa-pmph is 1.25 mg/kg (up to a maximum dose of 125 mg) given as an intravenous infusion over 30 minutes on Days 1 and 8 of a 21-day cycle until disease progression or unacceptable toxicity. ( 2.1 ) • The recommended dose of PADCEV as a single agent is 1.25 mg/kg (up to a maximum dose of 125 mg) given as an intravenous infusion over 30 minutes on Days 1, 8, and 15 of a 28-day cycle until disease progression or unacceptable toxicity. ( 2.1 ) • Avoid use in patients with moderate or severe hepatic impairment. ( 8.6 ) 2.1 Recommended Dosage The recommended dosages for PADCEV in combination with pembrolizumab or pembrolizumab and berahyaluronidase alfa-pmph, and PADCEV as a single agent are presented in Table 1 and Table 2 .

Warnings & precautions

Sourced from openFDA

• Hyperglycemia: Diabetic ketoacidosis may occur in patients with and without preexisting diabetes mellitus, which may be fatal. Closely monitor blood glucose levels in patients with, or at risk for, diabetes mellitus or hyperglycemia. Withhold PADCEV if blood glucose is >250 mg/dL. ( 2.2 , 5.2 ) • Pneumonitis/Interstitial Lung Disease (ILD): Severe, life-threatening or fatal pneumonitis/ILD may occur. Withhold PADCEV for Grade 2 pneumonitis/ILD and consider dose reduction. Permanently discontinue PADCEV for Grade 3 or 4 pneumonitis/ILD. ( 2.2 , 5.3 ) • Peripheral Neuropathy: Monitor patients for new or worsening peripheral neuropathy and consider dose interruption, dose reduction, or discontinuation of PADCEV. ( 2.2 , 5.4 ) • Ocular Disorders: Ocular disorders, including vision changes, may occur. Monitor patients for signs or symptoms of ocular disorders. Consider prophylactic artificial tears for dry eyes and treatment with ophthalmic topical steroids after an ophthalmic exam. Consider dose interruption or dose reduction of PADCEV when symptomatic ocular disorders occur. ( 5.5 ) • Infusion Site Extravasation: Ensure adequate venous access prior to administration. Monitor the infusion site during PADCEV administration and stop the infusion immediately for suspected extravasation. ( 5.6 ) • Embryo-Fetal Toxicity: PADCEV can cause fetal harm. Advise of the potential risk to a fetus and to use effective contraception. ( 5.7 , 8.1 , 8.3 ) 5.1 Skin Reactions Severe cutaneous adverse reactions, including fatal cases of SJS or TEN occurred in patients treated with PADCEV.

Adverse reactions

Sourced from openFDA

The following serious adverse reactions are described elsewhere in the labeling: • Skin Reactions [see Boxed Warning , Warnings and Precautions ( 5.1 )] • Hyperglycemia [see Warnings and Precautions ( 5.2 )] • Pneumonitis/Interstitial Lung Disease (ILD) [see Warnings and Precautions ( 5.3 )] • Peripheral Neuropathy [see Warnings and Precautions ( 5.4 )] • Ocular Disorders [see Warnings and Precautions ( 5.5 )] • Infusion Site Extravasation [see Warnings and Precautions ( 5.6 )] The most common adverse reactions, including laboratory abnormalities, (≥20%) were: • PADCEV in combination with intravenous pembrolizumab for the treatment of MIBC: increased glucose, decreased hemoglobin, increased aspartate aminotransferase, rash, increased alanine aminotransferase, fatigue, pruritus, increased creatinine, decreased sodium, decreased lymphocytes, peripheral neuropathy, increased potassium, alopecia, dysgeusia, diarrhea, decreased appetite, constipation, nausea, decreased phosphate, urinary tract infection, dry eye, and decreased weight.

Use in specific populations

Sourced from openFDA

• Lactation: Advise women not to breastfeed. ( 8.2 ) 8.1 Pregnancy Risk Summary Based on the mechanism of action and findings in animals, PADCEV can cause fetal harm when administered to a pregnant woman [see Clinical Pharmacology ( 12.1 )] . There are no available human data on PADCEV use in pregnant women to inform a drug-associated risk. In an animal reproduction study, administration of enfortumab vedotin-ejfv to pregnant rats during organogenesis caused maternal toxicity, embryo-fetal lethality, structural malformations, and skeletal anomalies at maternal exposures similar to the exposures at the recommended human dose of 1.25 mg/kg (see Data ) . Advise patients of the potential risk to the fetus. The background risk of major birth defects and miscarriage for the indicated population is unknown. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2%-4% and 15%-20%, respectively. Data Animal Data In a rat pilot embryo-fetal development study, administration of enfortumab vedotin-ejfv on gestation day 6 and 13 during the period of organogenesis resulted in a complete litter loss in all pregnant rats at the maternally toxic dose of 5 mg/kg (approximately 3 times the exposure at the recommended human dose).

Pharmacokinetics

Sourced from openFDA
Metabolism
Enfortumab vedotin-ejfv (ADC) pharmacokinetics were characterized after single and multiple doses in patients with solid tumors. The pharmacokinetics of the ADC and unconjugated MMAE were consistent when assessed following PADCEV administration as a single agent and in combination with intravenous pembrolizumab after 1 treatment cycle.

Approval history

Sourced from openFDA
  • Dec 18, 2019BLABLA761137Astellas

FAERS reports

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Reference statistics only. FAERS reports are voluntarily submitted and are not incidence rates, safety signals, or causal evidence. Counts reflect reporting volume — how often a reaction was reported, not how often it occurs. For decision-grade use, consult openFDA and the FAERS Public Dashboard directly.
6,506 total reports matchedLatest report Share = reports listing the reaction ÷ total matched reports. Rows can sum to >100% because a single report often lists multiple reactions.
  1. 1Rash87013%
  2. 2Malignant Neoplasm Progression77312%
  3. 3Neuropathy Peripheral75812%
  4. 4Diarrhoea3916.0%
  5. 5Pruritus3835.9%
  6. 6Decreased Appetite3735.7%
  7. 7Fatigue3725.7%
  8. 8Death3555.5%
  9. 9Off Label Use3385.2%
  10. 10Alopecia2844.4%
  11. 11Pyrexia2634.0%
  12. 12Nausea2523.9%
  13. 13Skin Disorder2473.8%
  14. 14Taste Disorder2303.5%
  15. 15Hyperglycaemia2253.5%

Clinical trials

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The 10 most recently updated of 95 ClinicalTrials.gov registrations naming Enfortumab as an intervention. Registration is not evidence of efficacy or safety — reference crosswalk only.

Frequently asked questions

How does Enfortumab work?
Enfortumab vedotin-ejfv is an ADC. The antibody is a human IgG1 kappa directed against Nectin-4, an adhesion protein located on the surface of cells.
What is Enfortumab used for?
According to FDA labeling, Enfortumab carries indications including: PADCEV ® , in combination with pembrolizumab or pembrolizumab and berahyaluronidase alfa-pmph, as neoadjuvant treatment and then continued after cystectomy as adjuvant treatment, is indicated for the treatment of adult patients with muscle invasive bladder cancer (MIBC) who are ineligible for cisplatin-containing chemotherapy. PADCEV ® , in combination with pembrolizumab or pembrolizumab and berahyaluronidase alfa-pmph, is indicated for the treatment of adult patients with locally advanced or metastatic urothelial cancer (mUC).. This is a reference summary of labeled uses, not medical advice or a treatment recommendation.
What class of drug is Enfortumab?
Enfortumab is classified as Antibody-Soluble Protein Interactions, Increased Cellular Death, Microtubule Inhibition.
What are the brand names for Enfortumab?
Enfortumab is marketed under brand names including Padcev.
What are the contraindications for Enfortumab?
Enfortumab labeling lists contraindications including: None. None.. Always consult the full prescribing information and a clinician.
Note. Data for enfortumab is illustrative MVP content compiled from public sources. pharmacopeia is for educational and informational use only and is not a substitute for professional medical advice.

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