nadofaragene firadenovec

ROUTE	ONSET	PEAK	DURATION
Intravesicular	unknown	unknown	unknown

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.

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.

Availability ⬆ ⬇

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

Assessment ⬆ ⬇

Monitor for bladder spasm, instillation site discharge, and benign neoplasm of the bladder. May require permanent discontinuation of treatment.

Lab Test Considerations:

Verify negative pregnancy status before starting therapy.
May ↑ glucose, triglycerides, and creatinine.
May ↓ phosphate.

Implementation ⬆ ⬇

Follow universal biosafety precautions for handling nonreplicating adenoviral vector-based gene therapy. Individuals who are immunosuppressed or immune deficient should not prepare, administer, or come into contact with nadofaragene firadenovec.
Thawing of vials: All 4 vials must be thawed (at room temperature or in refrigerator) and brought to room temperature before use. Frozen vials will thaw in ~3–5 hr outside or 8–10 hr inside the cardboard nest when placed at room temperature. Frozen vials thaw in the refrigerator in 4–5 hr outside or 11–13 hr inside the cardboard nest; once thawed, they require 2.5 hr outside the nest or 6 hr inside to reach room temperature. Do not expose to higher temperatures, protect from light, and do not refreeze. Vials may move between refrigerator and room temperature as long as total limits are not exceeded: 24 hr at room temperature and 7 days refrigerated, including thawing time.
Intravesicular instillation: Nadofaragene firadenovec is not for IV, topical use, or PO administration. Items required for instillation: 4 thawed vials, 4 vented vial adapters (for 20-mL vials), two 50–60 mL polypropylene Luer-Lok syringes or 1 Luer-Lok syringe ≥75 mL (max = 100 mL), 2 Luer-Lok adapters, and 1 straight or intermittent urethral catheter with a proximal funnel opening compatible with the Luer-Lok adapter. Only use catheters made of vinyl/PVC (uncoated or hydrogel coated), red rubber latex, or silicone. Do not use catheters coated or embedded with silver or antibiotics.
Preparing: Visually inspect all 4 vials before use. The suspension should be clear to slightly opalescent and may contain opalescent flecks. Do not use if discoloration or visible particles are present. Mix gently. Do not shake. Using aseptic technique, attach a vented vial adapter to each vial, connect a syringe, and withdraw the contents. Repeat for all 4 vials until a total of 75 mL is collected into 1 or 2 Luer-Lok syringes (volumes do not need to be equal). Discard any unused volume per universal precautions. If not administered immediately, the filled syringes may be stored for up to 6 hr at room temperature and must be protected from light.
Bladder instillation: Premedicate with an anticholinergic before each instillation. Insert a straight or intermittent urinary catheter with a proximal funnel opening, fully drain the bladder, and leave the catheter in place. Attach the Luer-Lok adapter from the syringe to the catheter and slowly instill 75 mL of nadofaragene firadenovec into the bladder, ensuring the full dose is delivered.
Postinstillation and elimination: Retain nadofaragene firadenovec in the bladder for 1 hr. During the dwell time, reposition the patient approximately every 15 min (left, right, back, abdomen) to maximize bladder exposure; repositioning may be adjusted or stopped if bladder cramping or premature voiding occurs. After 1 hr, evacuate the bladder via catheter or allow the patient to void completely. Disinfect voided urine for 15 min with an equal volume of a virucidal agent before flushing.

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.

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Pronunciation ⬇

Classifications ⬆ ⬇

Indications ⬆ ⬇

Action ⬆ ⬇

Pharmacokinetics ⬆ ⬇

Time/Action Profile ⬆ ⬇

Contraind./Precautions ⬆ ⬇