nadofaragene firadenovec

Contraindicated in:

Hypersensitivity to interferon alfa or any component of product;
OB: Pregnancy.

Use Cautiously in:

Patients without a complete response after 3 mo or in whom carcinoma in situ recurs (should consider cystectomy);
Immunocompromised (↑ risk for disseminated adenovirus infection);
Rep: Women of reproductive potential and men with female partners of reproductive potential;
Lactation: Use while breastfeeding only if potential maternal benefit justifies potential risk to infant;
Pedi: Safety and effectiveness not established in children.

Adv. Reactions/Side Effects ⬆ ⬇

CV: ACUTE CORONARY SYNDROME, atrial fibrillation

Endo: hyperglycemia, hypoglycemia

F and E: hypophosphatemia, dehydration

GU: ↑serum creatinine, bladder spasm, dysuria, hematuria, urinary urgency

Hemat: anemia

Local: instillation site discharge

Metab: hypertriglyceridemia

Neuro: fatigue, syncope

Misc: chills, fever

Interactions ⬆ ⬇

Drug-drug:

None reported.

Availability ⬆ ⬇

Solution for intravesicular instillation: 3 × 10¹¹viral particles/mL

Route/Dosage ⬆ ⬇

Intravesicular instillation(Adults ): 75 mL (at a concentration of 3 × 10¹¹ viral particles/mL) instilled every 3 mo into the bladder via a urinary catheter for up to 12 mo (total of 4 doses) or until disease progression or unacceptable toxicity; may continue beyond 12 mo in patients without evidence of high-grade recurrence. If patient does not have a complete response to treatment after 3 mo or if carcinoma in situ recurs, consider cystectomy.

US Brand Names ⬆ ⬇

Action ⬆ ⬇

It is a nonreplicating adenoviral vector-based gene therapy that delivers a copy of a gene encoding human interferon-alfa 2b to the bladder urothelium. This results in local expression of interferon-alfa 2b, which has antitumor effects.

Therapeutic effects:

Decreased recurrence of bladder cancer.

Classifications ⬆ ⬇

Therapeutic Classification: antineoplastics

Pharmacologic Classification: temporary class

Pharmacokinetics ⬆ ⬇

Absorption: Unknown.

Distribution: Unknown.

Metabolism/Excretion: Unknown.

Half-Life: Unknown.

Time/Action Profile ⬆ ⬇

ROUTE	ONSET	PEAK	DURATION
Intravesicular	unknown	unknown	unknown

Patient/Family Teaching ⬆ ⬇

Explain purpose and side effects of medication to patient. Advise patient to read Patient Information before starting therapy.
Advise patient to notify health care provider of all Rx or OTC medications, vitamins, or herbal products being taken and to consult health care provider before taking other medications.
Advise patient and caregivers to notify health care provider if chest pain, shortness of breath, or fatigue occur and to seek immediate medical attention if applicable.
Advise patient that delaying cystectomy in patients with BCG-unresponsive carcinoma in situ could lead to development of muscle-invasive or metastatic bladder cancer.
Advise patient and caregivers that transient and low-level shedding of nadofaragene firadenovec may occur in urine. Advise that for 2 days following treatment, voided urine should be disinfected for 15 min with an equal volume of bleach before flushing.
Rep: Advise women of reproductive potential to avoid pregnancy during therapy. Advise women of reproductive potential to notify health care provider if breastfeeding.

section name header

Indications ⬇

Contraind./Precautions ⬆ ⬇