Usual Adult Dose for Nausea/Vomiting - Chemotherapy Induced

MODERATELY TO HIGHLY EMETOGENIC CANCER CHEMOTHERAPY (HEC/MEC):
Oral Capsules:

• Day 1: 125 mg orally once 1 hour before chemotherapy
• Days 2 and 3: 80 mg orally once a day, 1 hour before chemotherapy OR in the morning (if chemotherapy is not given on Days 2 and 3)
• Duration of therapy: 3 days/cycle

Oral Suspension:

• Day 1: 3 mg/kg orally once 1 hour before chemotherapy
• Maximum dose: 125 mg/dose
• Days 2 to 3: 2 mg/kg orally once a day, 1 hour before chemotherapy OR in the morning (if chemotherapy is not given on Days 2 and 3)
• Maximum dose: 80 mg/dose
• Duration of therapy: 3 days/cycle

Parenteral:
Single-Dose Regimen (HEC/MEC): 130 mg IV via 2-minute injection OR infused over 30 minutes ONCE, completing administration 30 minutes before chemotherapy
3-Day Regimen with Oral Formulations (MEC):

• Day 1: 100 mg IV via 2-minute injection OR infused over 30 minutes ONCE, completing administration 30 minutes before chemotherapy
• Days 2 to 3: 80 mg orally once a day

Comments:

• The recommended dosage of dexamethasone is 12 mg orally on Day 1 administered 30 minutes prior to chemotherapy and 8 mg orally in the mornings on Days 2 through 4 (HEC) or Days 2 through 3 (MEC).
• The 5-HT3 antagonist is administered on Day 1 only. Consult the package insert for the 5-HT3 antagonist dosing prior to initiation of treatment.
• This drug may be taken with or without food.

Uses:

• Oral and parenteral: In combination with other antiemetic agents for the prevention of acute and delayed nausea and vomiting associated with initial and repeat courses of HEC including high-dose cisplatin
• Oral and parenteral: In combination with other antiemetic agents for the prevention of nausea and vomiting associated with initial and repeat courses of MEC
• Parenteral: In combination with other antiemetic agents for the prevention of nausea and vomiting associated with initial and repeat courses of MEC (as a 3-day regimen)

Usual Pediatric Dose for Nausea/Vomiting - Chemotherapy Induced

MEC/HEC:
6 months to less than 12 years
GREATER THAN 6 kg:
Oral Suspension:

• Day 1: 3 mg/kg orally once 1 hour before chemotherapy
• Maximum dose: 125 mg/day
• Days 2 to 3: 2 mg/kg orally once a day, 1 hour before chemotherapy OR in the morning (if chemotherapy is not given on Days 2 and 3)
• Maximum dose: 80 mg/day
• Duration of therapy: 3 days/cycle

12 years and older:
Oral Capsules:

• Day 1: 125 mg orally once 1 hour before chemotherapy
• Days 2 and 3: 80 mg orally once a day, 1 hour before chemotherapy OR in the morning (if chemotherapy is not given on Days 2 and 3)
• Duration of therapy: 3 days/cycle

Oral Suspension:

• Day 1: 3 mg/kg orally once 1 hour before chemotherapy
• Maximum dose: 125 mg/dose
• Days 2 to 3: 2 mg/kg orally once a day, 1 hour before chemotherapy OR in the morning (if chemotherapy is not given on Days 2 and 3)
• Maximum dose: 80 mg/dose
• Duration of therapy: 3 days/cycle

Comments:

• If a corticosteroid (e.g., dexamethasone) is coadministered, patients should be given 50% of the recommended pediatric dose on Days 1 to 4. Consult the package insert for the corticosteroid dosing prior to initiation of treatment.
• The 5-HT3 antagonist is administered on Day 1 only. Consult the package insert for the 5-HT3 antagonist dosing prior to initiation of treatment.
• This drug may be taken with or without food.

Uses:

• In combination with other antiemetic agents for the prevention of acute and delayed nausea and vomiting associated with initial and repeat courses of HEC including high-dose cisplatin
• In combination with other antiemetic agents for the prevention of nausea and vomiting associated with initial and repeat courses of MEC

Renal Dose Adjustments

Renal dysfunction or patients with end-stage renal disease (ESRD): No adjustment recommended.

Liver Dose Adjustments

Mild to moderate liver dysfunction (Child-Pugh Score 5 to 9): No adjustment recommended.
Severe liver dysfunction (Child-Pugh Score greater than 9): Additional monitoring recommended.

Precautions

CONTRAINDICATIONS:

• Hypersensitivity to the active component or to any of the ingredients
• Patients taking pimozide

Safety and efficacy of oral formulations in the prevention of chemotherapy induced nausea and vomiting (CINV) with oral suspension formulations have not been established in patients younger than 6 months; safety and efficacy in the prevention of CINV with capsule formulations have not been established in patients younger than 12 years.

Safety and efficacy of parenteral formulations have not been established in pediatric patients.

Consult WARNINGS section for additional precautions.

Dialysis

Patients with ESRD undergoing hemodialysis: No adjustment recommended.
Peritoneal dialysis: Data not available

Other Comments

Administration advice:

• Take with or without food.
• Oral suspension: Oral syringes should be placed along the inner cheek, and should be dispensed slowly.
• Oral capsules: Swallow whole.
• For prevention of CINV, take first dose 1 hour prior to chemotherapy.
• Parenteral: IV lines should be flushed with normal saline prior to and after administration of this drug.

Storage requirements:

• Oral suspension: Refrigerate; use within 72 hours of preparation, and discard any remaining suspension after 72 hours.

Reconstitution/preparation techniques:

• The manufacturer product information should be consulted.

IV compatibility:

• Compatible: 0.9% sodium chloride (normal saline); 5% dextrose
• Incompatible: Lactated Ringer's solution; Hartmann's Solution; other solutions containing divalent cations (e.g., calcium, magnesium)

General:

• Limitations of use: Use has not been studied for the treatment of established nausea and vomiting.
• Patient profiles may change during chronic continuous administration; chronic use is not recommended.

Monitoring:

• Hematologic: INR in patients on chronic warfarin therapy
• Hypersensitivity: Hypersensitivity reactions at any time during treatment

Patient advice:

• Patients should be advised to report all concurrent prescription and nonprescription medications or herbal products they are taking.
• Instruct patients to immediately report any signs/symptoms of Stevens-Johnson syndrome, toxic epidermal necrolysis, or hypersensitivity reactions.
• Patients should be advised to speak to healthcare provider if pregnant, intend to become pregnant, or are breastfeeding; patients using hormonal contraception to prevent pregnancy will need to speak with their health care provider about using a non-hormonal back-up method of birth control for up to 2 months after completing therapy.

Frequently asked questions

• What is the difference between Cinvanti and Emend?