Nivolumab

Nivolumab - Medicine for tumors treatment

Nivolumab is a programmed death ligand 1 (PD-L1) blocking monoclonal antibody, indicated for the treatment of the following tumors:

  • Metastatic non-small cell lung cancer
  • Advanced renal cell carcinoma
  • Squamous cell carcinoma of the head and neck
  • Hodgkin lymphoma
  • Metastatic or unresectable melanoma. It can be used alone or in combination with Ipilimumab.

It was recently (on February 2, 2017) approved by FDA for the treatment of patients who have progression of locally advanced or metastatic urothelial carcinoma after platinum chemotherapy.

Precautions

Nivolumab is linked to the following severe immune-mediated adverse reactions:

  • Pneumonitis. If you are experiencing shortness of breath or wheezing, you should inform your doctor immediately. Fatal cases of Nivolumab-associated pneumonitis have been reported.
  • Colitis. If you're experiencing symptoms of a colitis, such as: diarrhea, abdominal pain, nausea, vomiting and blood in the stool, you should call your doctor immediately. No fatal cases of Nivolumab-associated colitis have been reported so far.
  • Nephritis.
  • Encephalitis
  • Skin adverse reactions, such as: Stevens-Johnson syndrome and toxic epidermal necrolysis (including fatal cases) have been reported.
  • Hepatitis. If you're experiencing symptoms of a hepatitis, such as: jaundice (yellowing of the eyes and the skin), pain in the right upper abdomen or loss of appetite, you should call your doctor right away. No fatal cases of Nivolumab-associated hepatitis have been reported so far.

Nivolumab, pregnancy and lactation

Nivolumab blocks the programmed death ligand 1 and therefore it is expected to cause harm to an unborn baby. AU TGA has assigned this drug to the pregnancy category D which means that it is proven that Nivolumab causes embryo-fetal toxicity.

Dosage

Nivolumab is applied as an intravenous infusion and only in healthcare facilities by professional medical staff.

Recommended dosage is given in table below:

Type of cancer Recommended dosage
Metastatic or unresectable melanoma

If applied alone, recommended dose is 240 mg as an intravenous infusion over one hour, every 14 days.

If applied in combination with Ipilimumab, recommended dose is 1 mg/kg as an intravenous infusion over one hour, every 21 days.

Renal cell carcinoma 240 mg as an intravenous infusion over one hour, every 14 days.
Non-small cell lung cancer 240 mg as an intravenous infusion over one hour, every 14 days.
Hodgkin lymphoma 3 mg/kg as an intravenous infusion over one hour, every 14 days.
Squamous cell carcinoma of the head and neck 3 mg/kg as an intravenous infusion over one hour, every 14 days.
Locally advanced or metastatic urothelial carcinoma 240 mg as an intravenous infusion over one hour, every 14 days.

Interactions

There are currently no available clinical studies about pharmacokinetic or pharmacodynamic interactions.

Adverse reactions

Nivolumab can cause following adverse reactions:

  • Skin rash
  • Pruritus
  • Toxic epidermal necrolysis
  • Steven-Johnson syndrome
  • Upper respiratory infections
  • Irregular heartbeat
  • Increased levels of liver function enzymes
  • Increased levels of potassium in the blood
  • Decreased levels of sodium in the blood
  • Fatigue
  • Neuropathy
  • Nausea
  • Vomiting
  • Diarrhea
  • Loss of appetite
  • Cough
  • Arthralgia
  • Migraine
  • Headache
  • Pneumonitis
  • Colitis
  • Pain in the muscles
  • Pain in the joints
  • Neutropenia
  • Thrombocytopenia