Chemotherapy induced nausea and vomiting (CINV)

Active Ingredient: Ondansetron

Indication for Ondansetron

Population group: only adults (18 years old or older)

For this indication, competent medicine agencies globally authorize below treatments:

8-32 mg in 2 doses

Route of admnistration

Oral

Defined daily dose

8 - 32 mg

Dosage regimen

From 4 To 16 mg 2 time(s) per day every day

Detailed description

The emetogenic potential of cancer treatment varies according to the doses and combinations of chemotherapy and radiotherapy regimens used. The selection of dose regimen should be determined by the severity of the emetogenic challenge.

Emetogenic chemotherapy and radiotherapy

Ondansetron can be given by oral (tablets or syrup) administration.

8mg taken 1 to 2 hours before chemotherapy or radiation treatment, followed by 8mg every 12 hours for a maximum of 5 days to protect against delayed or prolonged emesis.

For highly emetogenic chemotherapy: a single dose of up to 24mg ondansetron taken with 12mg oral dexamethasone sodium phosphate, 1 to 2 hours before chemotherapy, may be used.

To protect against delayed or prolonged emesis after the first 24 hours, oral treatment with ondansetron should be continued for up to 5 days after a course of treatment. The recommended dose for oral administration is 8mg twice daily.

8-32 mg in 2 doses

Route of admnistration

Intravenous

Defined daily dose

8 - 32 mg

Dosage regimen

From 4 To 16 mg 2 time(s) per day every day

Detailed description

The emetogenic potential of cancer treatment varies according to the doses and combinations of chemotherapy and radiotherapy regimens used. The route of administration and dose of ondansetron should be flexible in the range of 8-32 mg a day and selected as shown below.

Emetogenic chemotherapy and radiotherapy

Ondansetron can be given by intravenous administration.

For most patients receiving emetogenic chemotherapy or radiotherapy, ondansetron 8 mg should be administered as a slow intravenous injection (in not less than 30 seconds), immediately before treatment followed by 8 mg orally twelve hourly.

Highly emetogenic chemotherapy

For patients receiving highly emetogenic chemotherapy, e.g. high-dose cisplatin, ondansetron can be given either by oral, rectal, intravenous or intramuscular administration. Ondansetron has been shown to be equally effective in the following dose schedules over the first 24 hours of chemotherapy:

  • A single dose of 8 mg by slow intravenous injection (in not less than 30 seconds) or intramuscular injection immediately before chemotherapy.
  • A dose of 8 mg by slow intravenous injection (in not less than 30 seconds) or intramuscular doses of 8 mg two to four hours apart, or by a constant infusion of 1 mg/hour for up to 24 hours.
  • A maximum initial intravenous dose of 16 mg diluted in 50-100 ml of saline or other compatible infusion fluid (see section 6.6) and infused over not less than 15 minutes immediately before chemotherapy. The initial dose of ondansetron may be followed by two additional 8 mg intravenous doses (in not less than 30 seconds) or intramuscular doses four hours apart.
  • A single dose greater than 16 mg must not be given due to dose dependent increase of QT-prolongation risk.

The selection of dose regimen should be determined by the severity of the emetogenic challenge.

The efficacy of ondansetron in highly emetogenic chemotherapy may be enhanced by the addition of a single intravenous dose of dexamethasone sodium phosphate, 20 mg administered prior to chemotherapy.

16 mg once

Route of admnistration

Rectal

Defined daily dose

16 - 16 mg

Dosage regimen

From 16 To 16 mg once every day

Detailed description

The emetogenic potential of cancer treatment varies according to the doses and combinations of chemotherapy and radiotherapy regimens used. The selection of dose regimen should be determined by the severity of the emetogenic challenge.

Emetogenic chemotherapy and radiotherapy

Ondansetron can be given by rectal administration.

The recommended dose of ondansetron (ondansetron) suppositories is one 16 mg suppository given 1 to 2 hours before treatment.

To protect against delayed or prolonged emesis after the first 24 hours, rectal treatment with ondansetron should be continued for up to 5 days after a course of treatment. The recommended daily dose for rectal administration is one 16 mg suppository.

Highly emetogenic chemotherapy (e.g. high dose cisplatin)

Ondansetron can be given by rectal administration.

The recommended dose of ondansetron (ondansetron) suppositories is one 16 mg suppository given 1 to 2 hours before treatment.

To protect against delayed or prolonged emesis after the first 24 hours, rectal treatment with ondansetron should be continued for up to 5 days after a course of treatment. The recommended daily dose for rectal administration is one 16 mg suppository.

8-32 mg in 2 doses

Route of admnistration

Intramuscular

Defined daily dose

8 - 32 mg

Dosage regimen

From 4 To 16 mg 2 time(s) per day every day

Detailed description

The emetogenic potential of cancer treatment varies according to the doses and combinations of chemotherapy and radiotherapy regimens used. The route of administration and dose of ondansetron should be flexible in the range of 8-32 mg a day and selected as shown below.

Emetogenic chemotherapy and radiotherapy

Ondansetron can be given intramuscular administration.

For most patients receiving emetogenic chemotherapy or radiotherapy, ondansetron 8 mg should be administered as an intramuscular injection, immediately before treatment followed by 8 mg orally twelve hourly.

Highly emetogenic chemotherapy

For patients receiving highly emetogenic chemotherapy, e.g. high-dose cisplatin, ondansetron can be given by intramuscular administration. Ondansetron has been shown to be equally effective in the following dose schedules over the first 24 hours of chemotherapy:

  • A single dose of 8 mg by slow intravenous injection (in not less than 30 seconds) or intramuscular injection immediately before chemotherapy.
  • A dose of 8 mg by slow intravenous injection (in not less than 30 seconds) or intramuscular doses of 8 mg two to four hours apart, or by a constant infusion of 1 mg/hour for up to 24 hours.
  • A maximum initial intravenous dose of 16 mg diluted in 50-100 ml of saline or other compatible infusion fluid (see section 6.6) and infused over not less than 15 minutes immediately before chemotherapy. The initial dose of ondansetron may be followed by two additional 8 mg intravenous doses (in not less than 30 seconds) or intramuscular doses four hours apart.
  • A single dose greater than 16 mg must not be given due to dose dependent increase of QT-prolongation risk.

The selection of dose regimen should be determined by the severity of the emetogenic challenge.

The efficacy of ondansetron in highly emetogenic chemotherapy may be enhanced by the addition of a single intravenous dose of dexamethasone sodium phosphate, 20 mg administered prior to chemotherapy.

Active ingredient

Ondansetron

Ondansetron is a potent, highly selective 5HT3 receptor-antagonist. Its precise mode of action in the control of nausea and vomiting is not known.

Read more about Ondansetron

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