Anktiva (nogapendekin alfa inbakicept-pmln)
Intravesical Vial (Ml)
Last reviewed · Source: First Databank (FDB) drug data
Overview
Nogapendekin alfa inbakicept-pmln, an interleukin-15 (IL-15) receptor agonist, is an antineoplastic agent.
Nogapendekin alfa inbakicept-pmln is an IL-15 receptor agonist. IL-15 activates immune cells by binding to a receptor consisting of 3 parts: the common gamma chain (gammac), the beta chain (betac), and the IL-15-specific alpha subunit (IL-15Ralpha). The IL-15Ralpha presents IL-15 to the shared IL-2/IL-15 receptor (betac and gammac) on CD4+ and CD8+ T cells, as well as natural killer (NK) cells.
Binding of nogapendekin alfa inbakicept activates and expands NK cells, CD8+ T cells, and memory T cells without promoting regulatory T cell proliferation. In vivo, intravesical nogapendekin alfa inbakicept-pmln alone or with BCG demonstrated greater anti-tumor activity than BCG alone in an immunocompetent rat model of bladder cancer. Nogapendekin alfa inbakicept-pmln is produced using engineered Chinese Hamster Ovary-K1 cells and consists of the soluble nogapendekin alfa protein complex (a human IL-15N72D variant) bound to inbakicept (a dimeric human IL-15Ralpha sushi domain/human IgG1 Fc fusion protein).
Patients who receive the approved dosage of nogapendekin alfa inbakicept-pmln by intravesical installation do not appear to exhibit quantifiable systemic exposure to the drug.
USES: This medication is used in combination with another medication (BCG) to treat certain types of bladder cancer. It works by causing the body's defense system (immune system) to become more active against bladder cancer cells. This medication may not cure your cancer.
Delaying other treatment (such as surgery) could lead to a more serious condition (metastatic cancer). Discuss the risks and benefits of this medication with your doctor.
Generic name: nogapendekin alfa inbakicept-pmln
Pronunciation: (noe-GAP-en-DE-kin AL-fa in-BAK-i-sept)
Therapeutic class: Antineoplastics
Reference product & biosimilars
No reference, biosimilar or interchangeable associated with this drug.
Today’s intelligence on Anktiva
Indications
The following indications are listed for Anktiva:
- Non-Muscle Invasive Bladder Cancer With Carcinoma In Situ
Dosing
No dosing information is available for this tab.
Administer nogapendekin alfa inbakicept-pmln by intravesical instillation into the bladder. Do not administer by the subcutaneous, IV, or IM routes.
Must be administered with BCG and diluted before administration.
Nogapendekin alfa inbakicept-pmln is available as a 400 mcg/0.4 mL solution in single-dose vials.
Store vials under refrigeration at 2-8degreesC in the original carton to protect from light. Do not freeze. Do not shake.
No dosing information is available for this tab.
No dosing information is available for this tab.
Drug interactions
There is no enhanced messaging for this drug.
There are no contraindication interactions for this drug.
There are no severe interactions for this drug.
There are no moderate interactions for this drug.
Contraindications
*None.
There are no contraindication contraindications for this drug.
There are no severe contraindications for this drug.
- No disease contraindications
Adverse reactions
The most common (>=15%) adverse reactions, including laboratory test abnormalities, reported with nogapendekin alfa inbakicept-pmln are increased creatinine, dysuria, hematuria, urinary frequency, micturition urgency, urinary tract infection, increased potassium, musculoskeletal pain, chills, and pyrexia.
More Frequent
- Hematuria
More Frequent
- Chills
- Dysuria
- Fever
- Hyperkalemia
- Increased urinary frequency
- Musculoskeletal pain
- Urinary tract infection
Less Frequent
- Bladder irritability
- Diarrhea
- Fatigue
- Nausea
- Nocturia
Precautions
No enhanced messaging available.
Safety and effectiveness of nogapendekin alfa inbakicept-pmln in pediatric patients have not been established.
Systemic exposure of nogapendekin alfa inbakicept-pmln following intravesical administration at the approved dosage was below the limit of quantitation. Based on its mechanism of action, nogapendekin alfa inbakicept-pmln may cause fetal harm when administered to a pregnant woman if systemic exposure occurs. There are no available data on use of the drug in pregnant women to inform a drug-associated risk.
Advise pregnant women and females of reproductive potential of the potential risk to a fetus.
There are no data on the presence of nogapendekin alfa inbakicept-pmln in human milk, its effects on the breastfed child, or on milk production. Systemic exposure following intravesical administration at the approved dose was below the limit of quantitation, suggesting any drug in milk would be low.
Weigh the benefits of breastfeeding against the mother's clinical need for treatment and the potential risks to the child.
The manufacturer makes no specific dosage recommendations for geriatric patients.
In clinical studies of nogapendekin alfa inbakicept-pmln for BCG-unresponsive NMIBC, 84% of patients were >=65 years of age and 40% were >=75 years of age. There were insufficient younger adults to assess differences in response by age.
ICD codes
| Code | Type | Description |
|---|---|---|
| Non-muscle invasive bladder cancer with carcinoma in situ | ||
| C67 | ICD10CM | Malignant neoplasm of bladder |
| C67.0 | ICD10CM | Malignant neoplasm of trigone of bladder |
| C67.1 | ICD10CM | Malignant neoplasm of dome of bladder |
| C67.5 | ICD10CM | Malignant neoplasm of bladder neck |
| C67.8 | ICD10CM | Malignant neoplasm of overlapping sites of bladder |
| C67.9 | ICD10CM | Malignant neoplasm of bladder, unspecified |
| D09.0 | ICD10CM | Carcinoma in situ of bladder |
ICD code information from First Databank (FDB).
Formulary status
Search health-plan coverage for this drug by ZIP code.
Choose the first character of a health plan name.
Last reviewed · Source: First Databank (FDB) drug data
On this page
Actions
Sign in to save favorites
Saving this drug requires a free Physicians Office Resource account.