Nivolumab

نیولوماب

⚠ Unverified

🎗️ Antineoplastic And Immunomodulating AgentsPD-1 blocking antibody

Market / country: 🇺🇸 USA

Opdivo (US)

🧮 Dose calculator

Lung cancer (small-cell and non-small-cell) · Regimen source: FDA Opdivo · 2.2, Table 1

  • • 30-min infusion. Combinations with ipilimumab or chemotherapy use different doses (label tables). No dose reductions. FDA Opdivo · 2.2FDA Opdivo · 2.3
  • • Only under an oncologist; protocol, cycle interval and adjustment rest with the treating team. FDA Opdivo · 2

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🛡️ Safety & information

Warnings

  • • Severe and fatal immune-mediated reactions (pneumonitis, colitis, hepatitis, endocrinopathies, nephritis, skin); infusion reactions; allogeneic HSCT complications; embryo-fetal toxicity. FDA Opdivo · 5

Formulations

👥 Special populations

  • 🤰 PregnancyDangerous / avoid

    Label: can cause fetal harm. Dangerous in pregnancy. FDA Opdivo · 8.1

    “Risk Summary Based on data from animal studies and its mechanism of action [see Clinical Pharmacology (12.1) ] , OPDIVO can cause fetal harm when administered to a pregnant woman.”
  • 🤱 BreastfeedingDangerous / avoid

    Label: breastfeeding not recommended, or choose between the drug and breastfeeding. FDA Opdivo · 8.2

    “Because of the potential for serious adverse reactions in the breastfed child, advise women not to breastfeed during treatment and for 5 months after the last dose of OPDIVO.”
  • 👶 ChildrenUse with caution

    The label has conditions, age limits or notes for children; the label sentence is quoted below. FDA Opdivo · 8.4

    “The safety and effectiveness of OPDIVO have been established in pediatric patients aged 12 years and older for the following indications: as a single agent and in combination with ipilimumab for the treatment of unresectable or metastatic melanoma, as a single agent for the adjuvant treatment of completely resected …”
  • 👴 Older adultsNo specific problem stated

    Label: no specific difference or dose adjustment stated for older adults. FDA Opdivo · 8.5

    “No overall differences in safety or effectiveness were observed between elderly patients and younger patients [see Clinical Studies (14.1 , 14.2 , 14.5 , 14.7 , 14.10 , 14.13 , 14.14) ].”
  • ⚥ Females & males of reproductive potentialUse with caution

    Label has advice on pregnancy testing, contraception or fertility for females and males. FDA Opdivo · 8.3

    “Contraception OPDIVO can cause fetal harm when administered to a pregnant woman [see Use in Specific Populations (8.1) ] .”

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