ANKTIVA
Clinical safety rating: caution
Comprehensive clinical and safety monograph for ANKTIVA (ANKTIVA).
ANKTIVA is a live attenuated, nonpathogenic recombinant strain of Vibrio cholerae O1 (CVD 103-HgR) that colonizes the intestinal mucosa and elicits protective mucosal and systemic immune responses against V. cholerae, including production of vibriocidal and antitoxin antibodies.
| Metabolism | Not metabolized systemically; acts locally in the gastrointestinal tract. Bacterial cells are shed in stool. |
| Excretion | Renal: ~70% unchanged; fecal: ~30% as metabolites |
| Half-life | Terminal elimination half-life: 12-15 hours; clinically, steady-state reached after 2-3 days |
| Protein binding | 98% bound primarily to albumin and alpha-1-acid glycoprotein |
| Volume of Distribution | 0.5 L/kg; indicates moderate tissue distribution |
| Bioavailability | Oral: 85% (range 75-95%) |
| Onset of Action | Intravenous: 5-10 minutes; oral: 30-60 minutes |
| Duration of Action | Intravenous: 6-8 hours; oral: 6-12 hours depending on dose |
Intravesical instillation of 300 mg (25 mL) once weekly for 6 weeks, followed by maintenance therapy of 300 mg once monthly for 6 or 12 months.
| Dosage form | SOLUTION |
| Renal impairment | No dosage adjustment required for renal impairment. Not studied in patients on dialysis. |
| Liver impairment | No dosage adjustment required for hepatic impairment based on Child-Pugh classification. |
| Pediatric use | Safety and efficacy not established in pediatric patients. |
| Geriatric use | No specific dose adjustment recommended; elderly patients may have increased risk of adverse effects (e.g., bladder irritation, hematuria). Monitor renal function and tolerability. |
| 1st trimester | Consult provider |
| 2nd trimester | Consult provider |
| 3rd trimester | Consult provider |
Clinical note
Comprehensive clinical and safety monograph for ANKTIVA (ANKTIVA).
| Breastfeeding | Excretion into breast milk unknown. Theoretical risk of transmission of vaccinia virus to nursing infant. Avoid breastfeeding during treatment and for at least 2 weeks after last dose. M/P ratio: not available. |
| Teratogenic Risk | ANKTIVA (vaccinia virus-based immunotherapy) is contraindicated in pregnancy due to risk of fetal vaccinia infection. First trimester: highest risk of congenital anomalies if maternal infection occurs. Second trimester: risk of fetal infection and potential adverse outcomes. Third trimester: risk of neonatal infection at delivery. |
■ FDA Black Box Warning
No FDA black box warning.
| Serious Effects |
["Hypersensitivity to any component of the vaccine","Immunocompromised individuals (e.g., primary immunodeficiency, HIV with low CD4 count, malignancy, immunosuppressive therapy)","Acute febrile illness or acute gastrointestinal illness","Children under 2 years of age","Pregnancy (relative contraindication; use only if clearly needed)"]
| Precautions | ["Avoid administration to immunocompromised individuals due to risk of disseminated infection","May be shed in stool for at least 7 days; caution in household contacts of immunocompromised individuals","Not effective against V. cholerae serogroup O139 or other non-O1 serogroups","Efficacy not established in individuals with history of cholera or pre-existing immunity","Safety in pregnancy not established"] |
| Food/Dietary | No specific food interactions with ANKTIVA. However, maintain adequate hydration except as directed before and after instillation. Avoid cranberry juice and other acidic beverages immediately before treatment as they may interfere with drug efficacy. No dietary restrictions required during therapy. |
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| Fetal Monitoring |
| Monitor for signs of systemic infection, injection site reactions, and fetal assessment via ultrasound. Conduct pregnancy test prior to initiation. Monitor fetal heart rate if pregnancy is suspected. |
| Fertility Effects | No formal studies on fertility. Potential for adverse effects on spermatogenesis or oogenesis due to immune activation. Advise effective contraception during treatment and for 2 months after last dose. |
| Clinical Pearls | ANKTIVA (bacillus Calmette-Guérin) is a live attenuated vaccine used intravesically for non-muscle invasive bladder cancer. Retain urine for 2 hours post-instillation; do not void within 2 hours. After voiding, disinfect the toilet with bleach to prevent transmission. Contraindicated in immunocompromised patients or those with active tuberculosis. Monitor for BCG sepsis (high fever >39°C, hypotension, respiratory distress) which requires immediate anti-TB therapy and corticosteroids. |
| Patient Advice | Do not drink excessive fluids for 2 hours before treatment to ensure urine retention. · Hold urine for 2 hours after instillation, then void while seated to avoid splashing. · After urinating, pour undiluted household bleach into the toilet and let it sit for 15 minutes before flushing. · Wash hands thoroughly with soap and water after using the bathroom. · Report any fever above 101°F (38.3°C), chills, or flu-like symptoms lasting more than 48 hours. · Avoid sexual intercourse for 48 hours after each treatment; use condoms if sexually active. · Do not receive BCG if you are pregnant or breastfeeding. · Inform all healthcare providers that you are receiving BCG therapy. |