OPDIVO QVANTIG
Clinical safety rating: caution
Comprehensive clinical and safety monograph for OPDIVO QVANTIG (OPDIVO QVANTIG).
Nivolumab is a human IgG4 monoclonal antibody that binds to the programmed death-1 (PD-1) receptor and blocks its interaction with PD-L1 and PD-L2, thereby enhancing T-cell anti-tumor immune responses.
| Metabolism | Nivolumab is a monoclonal antibody; it is degraded into small peptides and amino acids via general protein metabolism, not metabolized by cytochrome P450 enzymes. |
| Excretion | Nivolumab is eliminated primarily via proteolytic catabolism. Renal excretion of intact drug is negligible (<1%). No biliary or fecal elimination data are available for intact nivolumab. |
| Half-life | 12 days (range: 6–26 days) with linear pharmacokinetics. The long half-life supports a 2- or 4-week dosing interval. |
| Protein binding | Not extensively bound; estimated at 0–10% (mainly albumin and IgG-like interactions). |
| Volume of Distribution | 5.6 L (approximately 0.08 L/kg for a 70 kg patient), indicating limited extravascular distribution and mainly plasma and interstitial fluid. |
| Bioavailability | Only administered intravenously; bioavailability is 100% IV. |
| Onset of Action | IV: Anti-tumor effects are observed after several weeks (typically 8–12 weeks) of therapy; time to response varies by tumor type. |
| Duration of Action | Duration of PD-1 blockade persists for weeks to months after discontinuation due to the long terminal half-life. Clinical responses may continue after treatment cessation. |
OPDIVO QVANTIG (nivolumab) is administered as an intravenous infusion. The recommended adult dose is 240 mg every 2 weeks or 480 mg every 4 weeks. For melanoma adjuvant therapy, 240 mg every 2 weeks for up to 1 year. For monotherapy or combination, refer to specific regimen.
| Dosage form | INJECTABLE |
| Renal impairment | No dose adjustment required for mild to moderate renal impairment (CrCl ≥30 mL/min). For severe renal impairment (CrCl <30 mL/min), use with caution due to limited data. |
| Liver impairment | No dose adjustment recommended for mild hepatic impairment (Child-Pugh A). For moderate (Child-Pugh B) or severe (Child-Pugh C), use with caution as safety and efficacy have not been established. |
| Pediatric use | Safety and efficacy in pediatric patients have not been established; no approved pediatric dosing available. |
| Geriatric use | No specific dose adjustment required for elderly patients (≥65 years). Clinical studies included similar numbers of elderly patients; overall no differences in safety or efficacy observed compared to younger adults. |
| 1st trimester | Consult provider |
| 2nd trimester | Consult provider |
| 3rd trimester | Consult provider |
Clinical note
Comprehensive clinical and safety monograph for OPDIVO QVANTIG (OPDIVO QVANTIG).
| Breastfeeding | Nivolumab is excreted in human milk in low amounts; however, the M/P ratio is not well characterized. Due to the potential for adverse reactions in nursing infants, including immune-mediated effects, breastfeeding is not recommended during treatment and for at least 5 months after the last dose. |
| Teratogenic Risk | Nivolumab is an IgG4 monoclonal antibody and is expected to cross the placenta. Based on its mechanism of action (PD-1 inhibition), there is a potential risk of immune-mediated fetal harm, including increased rates of abortion, stillbirth, and neonatal death. Animal studies have shown adverse developmental effects at maternal exposures similar to clinical doses. During the first trimester, placental transfer is minimal, but in the second and third trimesters, IgG transfer increases significantly, potentially affecting fetal immune tolerance and development. The drug should be avoided during pregnancy unless the potential benefit justifies the potential risk. |
■ FDA Black Box Warning
Immune-mediated adverse reactions: severe and fatal immune-mediated adverse reactions including pneumonitis, colitis, hepatitis, endocrinopathies, nephritis, skin adverse reactions, and encephalitis.
| Serious Effects |
None known.
| Precautions | Immune-mediated adverse reactions (pneumonitis, colitis, hepatitis, endocrinopathies, nephritis, skin reactions, encephalitis, other), infusion-related reactions, complications of allogeneic hematopoietic stem cell transplantation, embryo-fetal toxicity, increased mortality in patients with multiple myeloma when added to a thalidomide analogue and dexamethasone. |
Loading safety data…
| Fetal Monitoring | Monitor for immune-mediated adverse reactions in the mother (e.g., pneumonitis, colitis, hepatitis, endocrinopathies, nephritis, dermatologic reactions). In the fetus, ultrasound monitoring for growth parameters and fetal well-being is recommended. Consider monitoring for neonatal immune-related complications if exposure occurred in the second or third trimester. |
| Fertility Effects | Based on animal studies, nivolumab may impair fertility in females of childbearing potential. Effects on male fertility are unknown. Women of childbearing potential should use effective contraception during treatment and for at least 5 months after the last dose. |