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Brand Name :
Opdivo Qvantig
Synonyms :
nivolumab and hyaluronidase-nvhy
Class :
PD-L1 Inhibitors
Brand Name :
Opdivo Qvantig
Synonyms :
nivolumab and hyaluronidase-nvhy
Class :
PD-L1 Inhibitors
Dosage Forms & StrengthsÂ
Renal Cell Carcinoma (RCC)
Monotherapy after Previous Treatment
This therapy is recommended for patients with intermediate- or poor-risk advanced RCC following prior treatment with a combination of IV nivolumab and IV nivolumab
Not approved for use in combination with ipilimumab for Renal cell carcinoma
Also approved for advanced RCC in adults who have previously undergone antiangiogenic therapy
The suggested dose is 600 mg of nivolumab with 10,000 units of hyaluronidase subcutaneously each two weeks, OR
The suggested dose is 1200 mg of nivolumab with 20,000 units of hyaluronidase subcutaneously each four weeks
Treatment should continue until disease progression or unacceptable side effects occur
Cabozantinib first line treatment
Nivolumab, when combined with cabozantinib, is indicated as a first-line treatment for advanced RCC
The suggested dose is 600 mg of nivolumab with 10,000 units of hyaluronidase subcutaneously each two weeks, OR
The suggested dose is 1200 mg of nivolumab with 20,000 units of hyaluronidase subcutaneously each four weeks.
Continue therapy until disease progression, intolerable toxicity, or up to 2 years, PLUS
Cabometyx (cabozantinib) 40 mg orally once daily until disease progression or unacceptable toxicity
Metastatic NSCLC
Indicated for the treatment of metastatic NSCLC in adults who have experienced disease progression following platinum-based chemotherapy, or after progression on therapies targeting EGFR or ALK genomic tumor mutations
Not recommended for use in combination with ipilimumab for metastatic NSCLC
600 mg nivolumab of and 10,000 units of hyaluronidase via subcutaneous injection each two weeks, or
1200 mg of nivolumab and 20,000 units of hyaluronidase via subcutaneous injection each four weeks
Continue treatment until disease progression or unacceptable toxicity occurs
Squamous Cell Carcinoma of the Head and Neck (SCCHN)
Indicated for the treatment of recurrent or metastatic SCCHN in adults with disease progression following platinum-based therapy
600 mg of nivolumab and 10,000 units of hyaluronidase via subcutaneous injection each two weeks, or
1200 mg of nivolumab and 20,000 units of hyaluronidase via subcutaneous injection each four weeks
Continue treatment until disease progression or unacceptable toxicity occurs
Colorectal Cancer (CRC)
Indicated for the treatment of metastatic colorectal cancer (CRC) with microsatellite instability-high (MSI-H) or mismatch repair deficiency (dMMR) that has progressed after treatment with a fluoropyrimidine, oxaliplatin, and irinotecan. It is also indicated following treatment with intravenous nivolumab and ipilimumab combination therapy
Not recommended for use in combination with ipilimumab for MSI-H or dMMR metastatic CRC
600 mg of nivolumab and 10,000 units hyaluronidase administered subcutaneously each two weeks, or
1200 mg of nivolumab and 20,000 units hyaluronidase administered Subcutaneously each four weeks
Treatment should continue until disease progression or unacceptable toxicity occurs
Hepatocellular Carcinoma (HCC)
Indicated for the treatment of hepatocellular carcinoma (HCC) in adults who have been previously treated with sorafenib. It is also indicated following treatment with intravenous nivolumab and ipilimumab combination therapy
Not recommended for use in combination with ipilimumab for HCC
600 mg of nivolumab and 10,000 units hyaluronidase administered subcutaneously each two weeks, or
1200 mg of nivolumab and 20,000 units hyaluronidase administered subcutaneously each four weeks
Treatment should continue until disease progression or unacceptable toxicity occurs
Esophageal Cancer
Adjuvant Therapy
Indicated for the adjuvant treatment of completely resected esophageal or gastroesophageal junction (GEJ) cancer with residual pathologic disease in adults who have received neoadjuvant chemoradiotherapy (CRT)
600 mg of nivolumab and 10,000 units hyaluronidase administered subcutaneously each two weeks, or
1200 mg of nivolumab and 20,000 units hyaluronidase administered subcutaneously each four weeks
Continue until disease recurrence or unacceptable toxicity, for up to 1 year
Unresectable Advanced, Recurrent, or Metastatic Esophageal Squamous Cell Carcinoma (ESCC)
Single-Agent Therapy After Prior Treatment
Indicated for the treatment of unresectable advanced, recurrent, or metastatic ESCC after prior fluoropyrimidine- and platinum-based chemotherapy.
600 mg of nivolumab and 10,000 units hyaluronidase Subcutaneously each two weeks, or
1200 mg of nivolumab and 20,000 units hyaluronidase Subcutaneously each four weeks
Continue until disease progression or unacceptable toxicity
First-Line Therapy with Fluoropyrimidine- and Platinum-Containing Chemotherapy
Indicated in combination with fluoropyrimidine- and platinum-containing chemotherapy as first-line treatment for unresectable advanced or metastatic ESCC
Not indicated in combination with ipilimumab for unresectable advanced or metastatic ESCC
600 mg of nivolumab and 10,000 units hyaluronidase Subcutaneously each two weeks, or
1200 mg of nivolumab and 20,000 units hyaluronidase Subcutaneously each four weeks
Continue until disease progression, unacceptable toxicity, or up to 2 years
Fluoropyrimidine- and platinum-containing chemotherapy should continue until disease progression or unacceptable toxicity
Gastric Cancer, GEJ Cancer, and Esophageal Adenocarcinoma
Indicated in combination with fluoropyrimidine- and platinum-containing chemotherapy for the treatment of advanced or metastatic gastric cancer, gastroesophageal junction (GEJ) cancer, and esophageal adenocarcinoma
600 mg of nivolumab and 10,000 units hyaluronidase administered subcutaneously each two weeks, PLUS fluoropyrimidine- and platinum-containing chemotherapy, or
900 mg of nivolumab and 15,000 units hyaluronidase administered SC every 3 weeks, PLUS fluoropyrimidine- and platinum-containing chemotherapy
Continue nivolumab/hyaluronidase until disease progression, unacceptable toxicity, or up to 2 years
Continue chemotherapy until disease progression or unacceptable toxicity
Single-agent treatment after earlier treatment
This therapy is recommended for patients with intermediate- or poor-risk advanced RCC following prior treatment with a combination of IV nivolumab and IV nivolumab
Not approved for use in combination with ipilimumab for Renal cell carcinoma
Also approved for advanced RCC in adults who have previously undergone antiangiogenic therapy
The suggested dose is 600 mg of nivolumab with 10,000 units of hyaluronidase subcutaneously each two weeks, OR
The suggested dose is 1200 mg of nivolumab with 20,000 units of hyaluronidase subcutaneously each four weeks
Treatment should continue until disease progression or unacceptable side effects occur
Cabozantinib first line treatment
Nivolumab, when combined with cabozantinib, is indicated as a first-line treatment for advanced RCC
The suggested dose is 600 mg of nivolumab with 10,000 units of hyaluronidase subcutaneously each two weeks, OR
The suggested dose is 1200 mg of nivolumab with 20,000 units of hyaluronidase subcutaneously each four weeks.
Continue therapy until disease progression, intolerable toxicity, or up to 2 years, PLUS
Cabometyx (cabozantinib) 40 mg orally once daily until disease progression or unacceptable toxicity
Dosage Forms & StrengthsÂ
Safety and efficacy are not established
Actions and Spectrum:Â
Action:
Nivolumab is a monoclonal antibody that targets and blocks the programmed cell death protein 1 (PD-1) receptor. PD-1 is found on T cells and acts as an “off switch” to prevent these immune cells from attacking normal cells. In some cancers, PD-1 is upregulated, helping tumors evade immune detection. By inhibiting PD-1, nivolumab helps enhance the body’s immune response to recognize and attack cancer cells.
Hyaluronidase-nvhy is an enzyme that catalyzes the breakdown of hyaluronic acid, a component of the extracellular matrix. By hydrolyzing hyaluronic acid, it increases the permeability of tissues and facilitates the absorption and dispersion of injected drugs or fluids. It is commonly used as an adjuvant in subcutaneous fluid administration or in combination with other drugs to enhance their absorption.
Spectrum:
Non-small cell lung cancer (NSCLC)
Melanoma
Renal cell carcinoma (RCC)
Hodgkin lymphoma
Squamous cell carcinoma of the head and neck
Urothelial carcinoma
Frequency defined
Cough
Rash
Pruritus
Musculoskeletal pain
Fatigue
Black Box Warning
None
Contraindications/caution:Â
Hypersensitivity
Severe Immune-Related Adverse Events
Pregnancy and Lactation
Pregnancy Warnings:Â
Pregnancy category: N/A
Lactation: Excretion of the drug into the human breast milk is unknown
Pregnancy categories:Â
Category A: Satisfactory and well-controlled studies show no evidence of risk to the fetus in the first trimester or in the later trimester.
Category B: No evidence of risk to fetus found in animal reproduction studies and there are not enough studies on pregnant women.
Category C: Adverse effects on the fetus found with evidence in animal reproduction studies and no adequate evidence for an effect in humans, care must be taken for potential risks in pregnant women.
Category D: There is adequate data available with sufficient evidence of human fetal risk from various platforms, but despite potential risks may be used only in emergency cases for potential benefits.
Category X: Drugs listed in this category clearly outweigh risks over benefits. These category drugs should be prohibited for pregnant women.
Category N: There is no data available for the drug under this category.
Pharmacology Â
Nivolumab works by inhibiting the programmed cell death protein 1 (PD-1) receptor on T cells. PD-1 is a checkpoint that normally downregulates immune responses, preventing the immune system from attacking normal cells. By blocking PD-1, nivolumab enhances the immune system’s ability to recognize and destroy cancer cells.
Pharmacodynamics
Nivolumab is a monoclonal antibody that targets and blocks the programmed cell death protein 1 (PD-1) receptor. PD-1 is found on T cells and acts as an “off switch” to prevent these immune cells from attacking normal cells. In some cancers, PD-1 is upregulated, helping tumors evade immune detection. By inhibiting PD-1, nivolumab helps enhance the body’s immune response to recognize and attack cancer cells.
Hyaluronidase-nvhy is an enzyme that catalyzes the breakdown of hyaluronic acid, a component of the extracellular matrix. By hydrolyzing hyaluronic acid, it increases the permeability of tissues and facilitates the absorption and dispersion of injected drugs or fluids. It is commonly used as an adjuvant in subcutaneous fluid administration or in combination with other drugs to enhance their absorption.
Pharmacokinetics:Â
Absorption
Pharmacokinetic studies of nivolumab demonstrate linear pharmacokinetics, with a dose-proportional increase in peak concentration and area under the curve (AUC). The time to reach peak plasma concentration ranges from 1 to 4 hours.
When administered subcutaneously or intramuscularly, hyaluronidase is absorbed into the bloodstream, but its primary action is local, breaking down hyaluronic acid at the injection site to help spread injected substances.
Distribution
The mean volume of distribution of nivolumab at steady state is 6.8 L, with a coefficient of variation (CV%) of 27.3%.
Once absorbed, hyaluronidase quickly distributes to tissues, especially those rich in hyaluronic acid, like connective tissues, skin, and joints, where it acts in the extracellular space.
Metabolism
While formal studies on the specific metabolism of nivolumab are lacking, it is hypothesized that, as a human monoclonal antibody, it is broken down into small peptides and individual amino acids.
Hyaluronidase is metabolized mainly in the liver and kidneys, where it breaks down into smaller peptides and amino acids for use or excretion by the body.
Excretion and Elimination
There are no specific studies on the elimination route of nivolumab. However, the drug has a half-life of 25 days.
The metabolic breakdown products of hyaluronidase are excreted through the kidneys in urine, and the enzyme itself is eliminated after completing its biological function.
Administration
Nivolumab is typically administered via intravenous (IV) infusion. The dosage and frequency depend on the specific type of cancer and the treatment plan.
The infusion usually takes 30 minutes but may vary based on the clinical protocol.
It is given in a clinical setting by a healthcare provider.
Hyaluronidase is typically administered as a subcutaneous injection.
Hyaluronidase is usually given before or alongside other drugs to increase the absorption of the drug.
Patient information leafletÂ
Generic Name: nivolumab and hyaluronidase-nvhy
Why do we use nivolumab and hyaluronidase-nvhy?Â
The combination of nivolumab and hyaluronidase-nvhy is used primarily for administration convenience. By using hyaluronidase-nvhy, the volume required for administering nivolumab can be reduced, making the infusion process potentially more manageable for patients. This combination is typically used in cancer immunotherapy settings, though it may not be part of the standard treatment protocol in every case.
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