nadofaragene firadenovec (Rx)

Brand and Other Names:Adstiladrin, nadofaragene firadenovec-vncg
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Dosing & Uses

AdultPediatric

Dosage Forms & Strengths

intravesical solution

  • 3 x 1011 viral particles (vp)/mL per vial
  • Each vial contains an extractable volume of 20 mL

Bladder Cancer

Indicated for high-risk Bacillus Calmette Guérin (BCG)-unresponsive non-muscle invasive bladder cancer (NMIBC) with carcinoma in situ (CIS) with or without papillary tumors

Premedicate with an anticholinergic is recommended before each instillation

Instill 75 mL into bladder at a concentration of 3 x 1011 viral particles (vp)/mL once q3months

Leave in bladder for 1 hr following instillation

Dosing Considerations

Verify pregnancy status in females of reproductive potential before initiating

Premedicate with an anticholinergic is recommended before each instillation

Safety and efficacy not established

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Interactions

Interaction Checker

and nadofaragene firadenovec

No Results

     activity indicator 
    No Interactions Found
    Interactions Found

    Contraindicated

      Serious - Use Alternative

        Significant - Monitor Closely

          Minor

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             activity indicator 

            Contraindicated (0)

              Serious - Use Alternative (0)

                Monitor Closely (1)

                • ublituximab

                  ublituximab and nadofaragene firadenovec both increase immunosuppressive effects; risk of infection. Modify Therapy/Monitor Closely. Owing to potential additive immunosuppressive effects, consider duration of effect and mechanism of action of these therapies if coadministered

                Minor (0)

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                  Adverse Effects

                  >10%

                  Glucose increased, all grades (38%)

                  Instillation site discharge (33%)

                  Triglycerides increased, all grades (30%)

                  Fatigue (24%)

                  Bladder spasm (20%)

                  Micturition urgency (19%)

                  Hematuria (17%)

                  Creatinine increased, all grades (17%)

                  Chills (16%)

                  Dysuria (16%)

                  Phosphate decreased, all grades (16%)

                  Hemoglobin decreased (16%)

                  Pyrexia (15%)

                  1-10%

                  Glucose increased, Grade 3 or 4 (6%)

                  Triglycerides increased, Grade 3 or 4 (1.9%)

                  Phosphate decreased, Grade 3 or 4 (1.4%)

                  Coronary artery disease (1.3%)

                  Acute coronary syndrome (1.3%)

                  Atrial fibrillation (1.3%)

                  Dehydration (1.3%)

                  Hypoglycemia (low blood sugar) (1.3%)

                  Syncope (fainting) (1.3%)

                  <1%

                  Heart failure (0.6%)

                  Pericarditis, (0.6%)

                  Brain edema (swelling) (0.6%)

                  Bile duct stone (0.6%)

                  Sepsis (0.6%)

                  Hemoglobin decreased (0.6%)

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                  Warnings

                  Contraindications

                  Hypersensitivity reactions to interferon alfa or to any component of the product

                  Cautions

                  Risk of muscle invasive or metastatic bladder cancer with delayed cystectomy

                  • Delaying cystectomy in patients with BCG-unresponsive CIS could lead to development of muscle invasive or metastatic bladder cancer
                  • Risk of developing muscle-invasive or metastatic bladder cancer increases the longer cystectomy is delayed in the presence of persisting CIS
                  • Median time from persistence or recurrence of CIS to cystectomy in these patients was 235 days
                  • If patients with CIS do not have a complete response to treatment after 3 months or if CIS recurs, consider cystectomy

                  Risk of disseminated adenovirus infection

                  • Owing to possible presence of low levels of replication-competent adenovirus in drug, immunocompromised persons, including those receiving immunosuppressant therapy, may be at risk for disseminated adenovirus infection
                  • Avoid exposing immunosuppressed or immune-deficient individuals to nadofaragene firadenovec
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                  Pregnancy & Lactation

                  Pregnancy

                  No adequate and well-controlled studies have been conducted in pregnant females

                  Advise pregnant females of potential risk to a fetus

                  Verify pregnancy status in females of reproductive potential before initiating

                  Contraception

                  • Females of reproductive potential: Use effective contraception during treatment and for 6 months following last dose
                  • Males with female partners of reproductive potential: Use effective contraception during treatment and for 3 months following last dose

                  Lactation

                  There is no information regarding drug presence in human milk, effects on breastfed infants, or effects on milk production

                  Pregnancy Categories

                  A: Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.

                  B: May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.

                  C: Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.

                  D: Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk.

                  X: Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist.

                  NA: Information not available.

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                  Pharmacology

                  Mechanism of Action

                  Non-replicating adenoviral vector-based gene therapy delivers a copy of a gene encoding a human interferon-alfa 2b (IFNα2b) to bladder urothelium

                  Intravesical instillation results in cell transduction and transient local expression of IFNα2b protein that is anticipated to have antitumor effects

                  Absorption

                  One patient receiving a second dose at dose level of 3 x 1011 vp/mL (2.25 x 1013 vp) had measurable vector DNA in blood; no other patients in either study had measurable vector DNA at 1 hr postdosing in blood

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                  Administration

                  Intravesicular Bladder Preparation

                  Drug is a nonreplicating adenoviral vector-based gene therapy

                  Follow universal biosafety precautions for handling

                  Immunosuppressed or immune-deficient individuals should not prepare, administer, and avoid exposure to nadofaragene firadenovec

                  Remove 4 vials from freezer; allow vials to thaw at room temperature (20-25ºC [68-77ºF]) until liquid; do NOT expose vials to higher temperatures; protect from light

                  Drug must be calibrated to room temperature (20-25ºC [68-77ºF]) before use

                  Time for thawing and calibrating drug to room temperature: ~8-10 hr (thawing vials in cardboard nest); ~3-5 hr (thawing vials outside cardboard nest); Do NOT refreeze

                  Visually inspect vials for visible particles and discoloration; suspension is clear to slightly opalescent and may contain opalescent flecks; discard if visible particles or discoloration observed

                  Mix gently; do not shake

                  Using aseptic technique, remove cap from vial and attach vented vial adapter according to manufacturer’s instructions

                  Connect syringe to vial adapter and withdraw contents of vial into syringe; repeat steps for remaining 3 vials until 75 mL has been withdrawn into 1-2 syringes

                  Note: Volumes in syringes do not have to be equal

                  Discard any unused product according to universal precautions

                  Use syringe(s) within 1 hr of drawing up

                  Intravesicular Bladder Administration

                  Intravesical instillation only

                  Not for IV use, topical use, or oral administration

                  Premedicate with an anticholinergic is recommended before each instillation

                  Before administering, insert 1 straight, or intermittent, urinary catheter with a proximal funnel opening that will accommodate the Luer-lock adapter

                  Use only catheters made of vinyl/PVC (uncoated or coated with hydrogel), red rubber latex or silicone to instill; do NOT use catheters coated or embedded with silver or antibiotics

                  Use catheter to completely empty patient’s bladder before instillation; do not remove catheter

                  Attach Luer lock end of same catheter adaptor to drug-containing syringe and insert tapered end of the catheter adaptor into funnel opening of catheter

                  Slowly instill 75 mL of nadofaragene firadenovec into bladder through catheter, ensuring that complete volume is administered

                  After instillation, retain drug in bladder for 1 hr

                  During 1-hour dwell time, reposition patient approximately every 15 minutes from left to right, back and abdomen to maximize bladder surface exposure

                  If, during dwell time, bladder cramping or premature voiding occurs, repositioning of patient may be adjusted or discontinued

                  Evacuate drug from bladder as part of routine emptying of bladder, or may void and completely empty bladder after 1 hr has elapsed

                  Disinfect voided urine for 30 minutes with an equal volume of virucidal agent before flushing of toilet

                  Storage

                  Unopened vials

                  Ship frozen at ≤ -60ºC (≤ -76ºF) in an insulated shipping box that will maintain required temperature for ≥72 hr after being sealed

                  Upon receipt, store cartons as indicated below
                  • In a freezer ≤ -60ºC (≤ -76ºF) until expiration date printed on carton
                  • In a freezer between -25º to -15ºC (-13°ºF to 5º) up to 3 months, without exceeding original expiration date on vial and outer carton
                  • When stored in freezer, note date of placement in freezer
                  • Additionally, write date on outer carton for when to discard carton if not used
                  • Instillation dates should be 3 months apart, but not past the original expiry date; discard date supersedes original expiration

                  Thawed vials

                  • May be stored at room temperature (20-25ºC [68-77ºF]) or refrigerated at 2-8ºC (36-46ºF) for up to 24 hr
                  • Do NOT refreeze

                  Drawn up syringes

                  • Use within 1 hr of drawing up

                  Decontamination and biohazard handling

                  • Treat any spills with a virucidal agent (eg, sodium hypochlorite with 0.5% active chlorine or 6% hydrogen peroxide solution) for 30 min
                  • Place disposable materials that have come into contact in biohazard containers for destruction
                  • Decontaminate non-disposable equipment according to facility’s standard operating procedures
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                  Patient Handout

                  A Patient Handout is not currently available for this monograph.
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                  Formulary

                  FormularyPatient Discounts

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                  • Compare formulary status to other drugs in the same class.
                  • Access your plan list on any device – mobile or desktop.

                  The above information is provided for general informational and educational purposes only. Individual plans may vary and formulary information changes. Contact the applicable plan provider for the most current information.

                  Tier Description
                  1 This drug is available at the lowest co-pay. Most commonly, these are generic drugs.
                  2 This drug is available at a middle level co-pay. Most commonly, these are "preferred" (on formulary) brand drugs.
                  3 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs.
                  4 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
                  5 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
                  6 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
                  NC NOT COVERED – Drugs that are not covered by the plan.
                  Code Definition
                  PA Prior Authorization
                  Drugs that require prior authorization. This restriction requires that specific clinical criteria be met prior to the approval of the prescription.
                  QL Quantity Limits
                  Drugs that have quantity limits associated with each prescription. This restriction typically limits the quantity of the drug that will be covered.
                  ST Step Therapy
                  Drugs that have step therapy associated with each prescription. This restriction typically requires that certain criteria be met prior to approval for the prescription.
                  OR Other Restrictions
                  Drugs that have restrictions other than prior authorization, quantity limits, and step therapy associated with each prescription.
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                  Medscape prescription drug monographs are based on FDA-approved labeling information, unless otherwise noted, combined with additional data derived from primary medical literature.