anktiva
Anktiva (Nogapendekin Alfa Inbakicept-Pmln) is an interleukin-15 receptor agonist used to treat Urinary Bladder Neoplasms.
Nogapendekin Alfa Inbakicept-Pmln · by Altor Bioscience, LLC, An Indirect Wholly-Owned Su
Key facts
- Active ingredient
- Nogapendekin Alfa Inbakicept-Pmln
- Drug class
- Interleukin-15 Receptor Agonist
- Form
- Solution
- Strength
- Nogapendekin Alfa inbakicept-pmln 400mcg/0.4 mL
- Type
- Prescription (Rx)
- Brand or generic
- Brand-name
- May treat
- urinary bladder neoplasms
- FDA application
- BLA761336
What is Anktiva?
From the FDA label:Nogapendekin alfa inbakicept-pmln is an interleukin-15 (IL-15) receptor agonist. It is a soluble complex consisting of (a) nogapendekin alfa (a human IL-15N72D variant, 114 amino acids) bound to (b) inbakicept [a dimeric human IL-15Rα sushi domain (65 amino acids)/human IgG1 Fc fusion protein (232 amino acids)]. Each fully assembled nogapendekin alfa inbakicept-pmln complex consists of a single inbakicept and two nogapendekin alfa components. Each IL-15N72D component is bound to one of the IL-15Rα sushi domains. The recombinant protein complex is produced by a recombinant cell line that was created by transfecting a Chinese hamster ovary (CHO-K1) cell line with plasmids carrying genes for the IL-15N72D and IL-15RαSu/IgG1 Fc proteins. Purification of the product is achieved by conventional chromatography. The molecular weight of the deglycosylated nogapendekin alfa inbakicept-pmln complex is 92,106.5 Da. The molecular weights of the individual deglycosylated sub-units are 66565.6 Da (dimer) and 12,770.45 Da for the IL-15RαSu/IgG1 Fc domain and the IL-15N72D domain, respectively. ANKTIVA (nogapendekin alfa inbakicept-pmln) solution is a clear to slightly opalescent, colorless to slightly yellow solution provided in a single-dose vial containing 400 mcg in 0.4 mL for intravesical administration upon dilution [see Dosage and Administration ( 2 )] . Each vial also contains dibasic…
How to use
For Intravesical Use Only For induction: 400 mcg administered intravesically with BCG once a week for 6 weeks. A second induction course may be administered if complete response is not achieved at month 3. ( 2.1 ) For maintenance: 400 mcg administered intravesically with BCG once a week for 3 weeks at months 4, 7, 10, 13 and 19. For patients with an ongoing complete response at month 25 and later, additional maintenance instillations with BCG may be administered once a week for 3 weeks at months 25, 31, and 37. ( 2.1 ) Instill intravesically only after dilution. Total time from vial puncture to the completion of the intravesical instillation should not exceed 2 hours. ( 2.2 ) See full Prescribing Information for dilution and administration instructions. 2.1 Recommended Dosage For Intravesical Use Only. Do NOT administer by subcutaneous or intravenous or intramuscular routes. For induction: ANKTIVA is recommended at a dose of 400 mcg administered intravesically with BCG once a week for 6 weeks. A second induction course may be administered if complete response is not achieved at month 3. For maintenance: After BCG and ANKTIVA induction therapy, ANKTIVA is recommended at a dose of 400 mcg administered intravesically with BCG once a week for 3 weeks at months 4, 7, 10, 13 and 19 (for a total of 15 doses). For patients with an ongoing complete response at month 25 and later,…
Side effects
The most common (≥15%) adverse reactions, including laboratory test abnormalities, are increased creatinine, dysuria, hematuria, urinary frequency, micturition urgency, urinary tract infection, increased potassium, musculoskeletal pain, chills and pyrexia. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Altor BioScience, LLC, an indirect wholly-owned subsidiary of ImmunityBio, Inc. at toll-free phone 877-265-8482 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch . 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. The safety of ANKTIVA with BCG was evaluated in Cohort A of QUILT-3.032, a single-arm, multicenter clinical study in 88 patients with BCG-unresponsive high-grade NMIBC with CIS with or without Ta/T1 papillary disease [see Clinical Studies ( 14 )]. Patients received 400 mcg ANKTIVA with BCG weekly for 6 consecutive weeks during induction and then once a week for every 3 weeks at 4, 7, 10, 13, and 19 months for patients with no or low grade disease. Patients with persistent CIS or high grade Ta at 3 months were eligible to receive a second induction. Patients with ongoing CR at 25 months were eligible to receive additional…
Warnings
Important safety information
Delaying cystectomy can lead to the development of metastatic bladder cancer, which can be lethal. ( 5.1 ) 5.1 Risk of 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, which can be lethal. The risk of developing muscle invasive or metastatic bladder cancer increases the longer cystectomy is delayed in the presence of persisting CIS. Of the 77 evaluable patients with BCG-unresponsive CIS treated with ANKTIVA with BCG in QUILT-3.032, 10% (n = 8) progressed to muscle invasive (T2 or greater) bladder cancer, including 7 during the treatment period. Three patients had progression determined at the time of cystectomy. The median time between determination of persistent or recurrent CIS and progression to muscle-invasive disease was 107 days (range: 0 – 210). If patients with CIS do not have a complete response to treatment after a second induction course of ANKTIVA with BCG, reconsider cystectomy.
Who should not take Anktiva
None None ( 4 )
Storing Anktiva, and how long it keeps
Quoted from this product’s own FDA label. Storage belongs to the product and its device, not to the drug in general — a pen and a tablet of the same medicine are kept completely differently.
- “If the admixture of ANKTIVA in combination with BCG is not used immediately, store refrigerated at 2°C to 8°C (36°F to 46°F) and use within 2 hours.”
- “If the admixture of ANKTIVA in combination with BCG is not used immediately, store refrigerated at 2°C to 8°C (36°F to 46°F) and use within 2 hours.”
Drug class
May treat (source: NIH RxClass)
Dosage forms
Solution
The forms currently marketed in the U.S., per the FDA National Drug Code Directory.
Ways to save
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Frequently asked questions
- What does Anktiva treat?
- Anktiva (Nogapendekin Alfa Inbakicept-Pmln) may be used to treat urinary bladder neoplasms, based on NIH RxClass drug-classification data (conditions a drug may treat — not a verbatim copy of the FDA-approved label). This is general reference, not medical advice.
- Is there a coupon or discount for Anktiva?
- pharmaranks is an independent ratings site, not a pharmacy — we don't issue coupons or sell Anktiva. To pay less, ask your prescriber or pharmacist whether a generic equivalent exists, check the manufacturer's copay/savings card and patient-assistance program, and compare a pharmacy discount card against your insurance copay. Prices vary by pharmacy, insurance, and location, so always confirm at the counter. This is general reference, not medical or financial advice.
- Who makes Anktiva?
- Anktiva is marketed by Altor Bioscience, LLC, An Indirect Wholly-Owned Su. You can see Altor Bioscience, LLC, An Indirect Wholly-Owned Su's full profile, rating, and other products on pharmaranks.
- Is Anktiva a brand-name or generic drug?
- Anktiva is a brand-name product with the active ingredient Nogapendekin Alfa Inbakicept-Pmln.
- Is Anktiva available over the counter?
- No. Anktiva is a prescription (Rx) medication in the US — you need a prescription from a licensed clinician (in person or via telehealth); it isn't sold over the counter. For some conditions there are OTC alternatives — ask your pharmacist.
- What forms does Anktiva come in?
- Anktiva is currently marketed as solution, per the FDA's National Drug Code Directory.
- What class of drug is Anktiva?
- Anktiva is classified as interleukin-15 receptor agonist, per the FDA's Established Pharmacologic Class.
- Is Anktiva FDA-registered?
- Anktiva is on record with the U.S. FDA under application number BLA761336. You can verify this on its official FDA label.
- Is Anktiva safe?
- There's no single safe-or-not verdict, and we don't yet have a composite recall-safety score for Anktiva. Review its FDA-label side effects and warnings below, and always consult a licensed professional.
- What are the side effects of Anktiva?
- Anktiva's side effects are taken directly from its FDA label. From the label: The most common (≥15%) adverse reactions, including laboratory test abnormalities, are increased creatinine, dysuria, hematuria, urinary frequency, micturition urgency, urinary tract infection, increased potassium, musculoskeletal pain, chills and pyrexia.… Both common and serious reactions are documented in full on this page. This is general reference from the FDA, not medical advice — always consult a professional.
Clinical content sourced from the FDA label via openFDA (U.S. FDA). View the FDA label on DailyMed → Provided for general reference only — not medical advice. Always consult a licensed professional and the current prescribing information.
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