Usual Adult Dose for Nausea/Vomiting - Chemotherapy Induced

ORAL: 2 mg orally once a day (up to 1 hour before chemotherapy) OR 1 mg orally 2 times a day (1 mg given 1 hour before chemotherapy, and 1 mg given 12 hours later)

• Duration of therapy: Given on the day(s) chemotherapy is administered

PARENTERAL:
Immediate-release Formulations: 10 mcg/kg via IV infusion over 5 minutes OR IV injection over 30 seconds ONCE, starting 30 minutes before initiation of chemotherapy

Extended-release Formulations: 10 mg subcutaneously ONCE, at least 30 minutes before initiation of chemotherapy

Additional medications:
Moderately Emetogenic Chemotherapy (MEC):

• Day 1: Dexamethasone 8 mg IV 30 minutes prior to chemotherapy

Anthracyclines and Cyclophosphamide-Based (AC) Chemotherapy Regimens:

• Day 1: Dexamethasone 20 mg IV 30 minutes prior to chemotherapy
• Days 2 to 4: Dexamethasone 8 mg orally 2 times a day

TRANSDERMAL: 1 patch (34.3 mg) applied topically to the outer arm at least 24 hours before chemotherapy

• Duration of therapy: Up to 7 days

Comments:

• Parenteral formulation administration should be limited to days when chemotherapy is given.
• Extended-release parenteral formulations should not be given more frequently than every 7 days.
• Transdermal patches may be applied up to 48 hours before chemotherapy (as appropriate) and may be worn for up to 7 days, depending on the duration of the chemotherapy regimen.
• A 52 cm2 patch may release approximately 3.1 mg/day for up to 7 days.
• Continued oral treatment in patients not receiving chemotherapy has not been shown to be of use.

Uses:

• Prevention of nausea and/or vomiting associated with initial and repeat courses of emetogenic cancer therapy, including high-dose cisplatin
• In combination with other antiemetics for the prevention of acute and delayed nausea and vomiting associated with initial and repeat courses of MEC or AC combination chemotherapy regimens
• Prevention of nausea and vomiting in patients receiving moderately and/or highly emetogenic chemotherapy regimens of up to 5 consecutive days duration

Usual Adult Dose for Nausea/Vomiting - Radiation Induced

ORAL: 2 mg orally once a day within 1 hour of radiation

Use: Prevention of nausea and vomiting associated with radiation, including total body irradiation and fractionated abdominal radiation

Usual Pediatric Dose for Nausea/Vomiting - Chemotherapy Induced

PARENTERAL:
2 years and older:
Immediate-release Formulations: 10 mcg/kg via IV infusion over 5 minutes OR IV injection over 30 seconds ONCE, starting 30 minutes before initiation of chemotherapy

Comment: Parenteral formulation administration should be limited to days when chemotherapy is given.

Use: Prevention of nausea and/or vomiting associated with initial and repeat courses of emetogenic cancer therapy, including high-dose cisplatin

Renal Dose Adjustments

ORAL: Data not available

PARENTERAL:
Immediate-release Formulations: Data not available

Extended-release Formulations:

• Mild renal dysfunction (CrCl 60 mL/min and greater): Data not available
• Moderate to severe renal dysfunction (CrCl 30 to 59 mL/min): This drug should not be given more frequently than every 14 days.
• Severe renal dysfunction (CrCl less than 30 mL/min): Not recommended.

TRANSDERMAL: Data not available

Liver Dose Adjustments

ORAL: No adjustment recommended.

PARENTERAL:

• Immediate-release Formulations: No adjustment recommended.
• Extended-release Formulations: Data not available

TRANSDERMAL: No adjustment recommended.

Precautions

CONTRAINDICATIONS:

• Hypersensitivity to the active component, any of the other serotonin (5-HT3) receptor antagonists, or any of the ingredients

Safety and efficacy of parenteral formulations have not been established in patients younger than 2 years. Safety and efficacy of oral and transdermal patch formulations have not been established in patients younger than 18 years.

Consult WARNINGS section for additional precautions.

Dialysis

Data not available

Other Comments

Administration advice:
ORAL:

• Tablets should be swallowed whole with water.

PARENTERAL FORMULATIONS:

• Doses may be given as undiluted injections (injected over 30 seconds) OR as diluted infusions with 0.9% sodium chloride or 5% dextrose (infused over 5 minutes).
• Other IV substances, additives, or other medications should not be added to the injection or infused solution simultaneously.
• Extended-release parenteral formulations should be administered slowly (e.g., up to 20 to 30 seconds) and into the back of the upper arm or the skin of the abdomen at least 2.5 cm away from the umbilicus. Compromised or disrupted skin (e.g., burned, hardened, swollen, inflamed) skin should be avoided.

TRANSDERMAL PATCHES:

• Patients should apply patches to clean, dry, intact skin on the upper, outer arm immediately after opening the pouch containing the patch. Application of the patch to damaged, irritated, or red skin should be avoided.
• Patches should not be cut into pieces.
• Patches may be reapplied to the same position using medical tape. If reattachment is not possible or the patch becomes damaged, a new patch may be applied to the same position; if the area is irritated, the patch should be applied to the opposite arm. Once applied, the patch should be removed in line with the original timing.

Storage requirements:
ORAL: Protect from light; keep storage container tightly closed.

PARENTERAL:

• Reconstitution of infusion solutions should be prepared at the time of administration.
• Reconstituted injection solutions may be stored at room temperature and may be stable for at least 24 hours.
• Extended-release parenteral formulations should be kept refrigerated until approximately 60 minutes prior to use.

TRANSDERMAL PATCHES: Store patches in their original packaging until prior to use.

Reconstitution/preparation techniques:

• The manufacturer product information should be consulted.

IV compatibility:

• Compatible: 0.18% sodium chloride, 0.9% sodium chloride, 1.85% sodium lactate, 4% glucose, 5% dextrose, 5% glucose, dexamethasone, Hartmann's solution, mannitol
• Unknown: Other IV substances, additives, other medications (except dexamethasone)

General:

• Efficacy of oral and parenteral formulations may be enhanced with the concomitant use of IV corticosteroids (e.g., dexamethasone, methylprednisolone).
• LIMITATION OF USE: Transdermal formulations should be limited to patients whose chemotherapy treatment is unlikely to be delayed to reduce the possibility of unnecessary of drug exposure.
• A 52 cm2 transdermal patch releases approximately 3.1 mg of drug/day for up to 7 days.

Patient advice:

• Advise patients to speak to their healthcare provider if they become pregnant, intend to become pregnant, or are breastfeeding.