OPDIVO QVANTIG
Clinical safety rating
cautionComprehensive clinical and safety monograph for OPDIVO QVANTIG (OPDIVO QVANTIG).
Comprehensive clinical and safety monograph for OPDIVO QVANTIG (OPDIVO QVANTIG).
Unresectable or metastatic melanomaMetastatic non-small cell lung cancerAdvanced renal cell carcinomaClassical Hodgkin lymphomaRecurrent or metastatic squamous cell carcinoma of the head and neckLocally advanced or metastatic urothelial carcinomaMicrosatellite instability-high or mismatch repair deficient metastatic colorectal cancerHepatocellular carcinomaEsophageal squamous cell carcinomaMalignant pleural mesotheliomaGastric cancer, gastroesophageal junction cancer, or esophageal adenocarcinomaCutaneous squamous cell carcinomaBasal cell carcinoma
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. |
| Molecular Weight | 146000 |
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 | Nivolumab is an IgG4 monoclonal antibody. Endogenous IgG crosses the placenta in significant amounts starting in the second trimester; however, minimal transfer occurs in the first trimester. However, based on its mechanism of PD-1 inhibition, there is potential risk to fetal immune development and pregnancy maintenance. Use only if maternal benefit outweighs potential fetal risk. |
| 2nd trimester | IgG antibody transfer increases across the placenta during the second trimester. Nivolumab can cross and may affect fetal immune system development. Given the risk of fetal harm (including immune-mediated disorders and potential for pregnancy loss), it is generally not recommended unless absolutely necessary. |
| 3rd trimester | Significant placental transfer of IgG antibodies occurs in the third trimester. Nivolumab exposure may lead to immune perturbations in the neonate. Use is generally avoided unless maternal condition warrants treatment and no alternatives exist. |
Clinical note
Comprehensive clinical and safety monograph for OPDIVO QVANTIG (OPDIVO QVANTIG).
| Placental transfer | Nivolumab, as an IgG4 monoclonal antibody, is expected to cross the placenta, particularly in the second and third trimesters when active FcRn-mediated transport increases. Placental transfer has been confirmed for other IgG antibodies; minimal transfer occurs in first trimester. The extent of transfer may increase with gestational age and higher maternal doses. |
| Breastfeeding | It is unknown whether nivolumab is excreted in human milk. IgG monoclonal antibodies are likely present in breast milk in small amounts during the early postpartum period, but absorption by the infant is limited due to gastrointestinal degradation. However, due to the potential for immunosuppression and adverse effects in the nursing infant, breastfeeding is not recommended during treatment and for at least 5 months after the last dose (approximately 5 half-lives). Consider pumping and discarding to maintain milk supply if desired. |
| Lactation Rating | L4 (Probably Hazardous) |
| 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. |
| 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. |
■ 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 |
Severe hypersensitivity reaction to nivolumab or any excipients
| 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. |
| Food/Dietary | No known food interactions. No dietary restrictions required. |
| Clinical Pearls | Opdivo Qvantig is a fixed-dose combination of nivolumab and relatlimab, approved for unresectable or metastatic melanoma. Monitor for immune-related adverse events (irAEs) including pneumonitis, colitis, hepatitis, endocrinopathies, and dermatitis. Discontinue for grade 3-4 irAEs. Infusion reactions may occur; premedicate as needed. Check baseline LFTs, TSH, cortisol, and cardiac function. Use with caution in patients with autoimmune disease or organ transplant. |
| Patient Advice | Report any new or worsening symptoms such as cough, chest pain, shortness of breath, diarrhea, abdominal pain, jaundice, severe fatigue, skin reactions, or changes in vision. · Do not receive live vaccines during treatment. · Females of childbearing potential should use effective contraception during and for 5 months after treatment. · This drug is given intravenously; appointments must be kept regularly. · Contact your healthcare provider immediately if you experience signs of infusion reaction (fever, chills, rash, difficulty breathing). |
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