1. Prevention of nausea and vomiting associated with initial and repeat courses of emetogenic cancer chemotherapy, including high-dose cisplatin. Efficacy of the 32-mg single dose beyond 24 hours in these patients has not been established.
2. Prevention of postoperative nausea and/or vomiting. As with other antiemetics, routine prophylaxis is not recommended for patients in whom there is little expectation that nausea and/or vomiting will occur postoperatively. In patients where nausea and/or vomiting must be avoided postoperatively, ZOFRAN Injection is recommended even where the incidence of postoperative nausea and/or vomiting is low. For patients who do not receive prophylactic ZOFRAN Injection and experience nausea and/or vomiting postoperatively, ZOFRAN Injection may be given to prevent further episodes (see CLINICAL TRIALS).

Prevention of Chemotherapy-Induced Nausea and Vomiting

Adult Dosing: The recommended I.V. dosage of ZOFRAN for adults is a single 32-mg dose or three 0.15-mg/kg doses. A single 32-mg dose is infused over 15 minutes beginning 30 minutes before the start of emetogenic chemotherapy. The recommended infusion rate should not be exceeded (see OVERDOSE). With the three-dose (0.15-mg/kg) regimen, the first dose is infused over 15 minutes beginning 30 minutes before the start of emetogenic chemotherapy. Subsequent doses (0.15 mg/kg) are administered 4 and 8 hours after the first dose of ZOFRAN.

ZOFRAN Injection should not be mixed with solutions for which physical and chemical compatibility have not been established. In particular, this applies to alkaline solutions as a precipitate may form.

Vial: DILUTE BEFORE USE FOR PREVENTION OF CHEMOTHERAPY- INDUCED NAUSEA AND VOMITING. ZOFRAN Injection should be diluted in 50 mL of 5% Dextrose Injection or 0.9% Sodium Chloride Injection before administration.

Flexible Plastic Container: REQUIRES NO DILUTION. ZOFRAN Injection Premixed, 32 mg in 5% Dextrose, 50 mL.

Pediatric Dosing: On the basis of the available information (see CLINICAL TRIALS: Pediatric Studies and CLINICAL PHARMACOLOGY: Pharmacokinetics), the dosage in pediatric cancer patients 6 months to 18 years of age should be three 0.15-mg/kg doses. The first dose is to be administered 30 minutes before the start of moderately to highly emetogenic chemotherapy, subsequent doses (0.15 mg/kg) are administered 4 and 8 hours after the first dose of ZOFRAN. The drug should be infused intravenously over 15 minutes. Little information is available about dosage in pediatric cancer patients younger than 6 months of age.

Vial: DILUTE BEFORE USE. ZOFRAN Injection should be diluted in 50 mL of 5% Dextrose Injection or 0.9% Sodium Chloride Injection before administration.

Flexible Plastic Container: REQUIRES NO DILUTION. ZOFRAN Injection Premixed, 32 mg in 5% Dextrose, 50 mL.

Geriatric Dosing: The dosage recommendation is the same as for the general population.

Prevention of Postoperative Nausea and Vomiting

Adult Dosing: The recommended I.V. dosage of ZOFRAN for adults is 4 mg undiluted administered intravenously in not less than 30 seconds, preferably over 2 to 5 minutes, immediately before induction of anesthesia, or postoperatively if the patient experiences nausea and/or vomiting occurring shortly after surgery. Alternatively, 4 mg undiluted may be administered intramuscularly as a single injection for adults. While recommended as a fixed dose for patients weighing more than 40 kg, few patients above 80 kg have been studied. In patients who do not achieve adequate control of postoperative nausea and vomiting following a single, prophylactic, preinduction, I.V. dose of ondansetron 4 mg, administration of a second I.V. dose of 4 mg ondansetron postoperatively does not provide additional control of nausea and vomiting.

Vial: REQUIRES NO DILUTION FOR ADMINISTRATION FOR POSTOPERATIVE NAUSEA AND VOMITING.

Pediatric Dosing: The recommended I.V. dosage of ZOFRAN for pediatric surgical patients (1 month to 12 years of age) is a single 0.1-mg/kg dose for patients weighing 40 kg or less, or a single 4-mg dose for patients weighing more than 40 kg. The rate of administration should not be less than 30 seconds, preferably over 2 to 5 minutes immediately prior to or following anesthesia induction, or postoperatively if the patient experiences nausea and/or vomiting occurring shortly after surgery. Prevention of further nausea and vomiting was only studied in patients who had not received prophylactic ZOFRAN.

Vial: REQUIRES NO DILUTION FOR ADMINISTRATION FOR POSTOPERATIVE NAUSEA AND VOMITING.

Geriatric Dosing: The dosage recommendation is the same as for the general population. Dosage Adjustment for Patients With Impaired Renal Function: The dosage recommendation is the same as for the general population. There is no experience beyond first-day administration of ondansetron.

Dosage Adjustment for Patients With Impaired Hepatic Function: In patients with severe hepatic impairment (Child-Pugh2 score of 10 or greater), a single maximal daily dose of 8 mg to be infused over 15 minutes beginning 30 minutes before the start of the emetogenic chemotherapy is recommended. There is no experience beyond first-day administration of ondansetron.

ZOFRAN Injection Premixed in Flexible Plastic Containers: Instructions for Use: To Open: Tear outer wrap at notch and remove solution container. Check for minute leaks by squeezing container firmly. If leaks are found, discard unit as sterility may be impaired.

Preparation for Administration: Use aseptic technique.

1. Close flow control clamp of administration set.
2. Remove cover from outlet port at bottom of container.
3. Insert piercing pin of administration set into port with a twisting motion until the pin is firmly seated. NOTE: See full directions on administration set carton.
4. Suspend container from hanger.
5. Squeeze and release drip chamber to establish proper fluid level in chamber during infusion of ZOFRAN Injection Premixed.
6. Open flow control clamp to expel air from set. Close clamp.
7. Attach set to venipuncture device. If device is not indwelling, prime and make venipuncture.
8. Perform venipuncture.
9. Regulate rate of administration with flow control clamp.

Caution: ZOFRAN Injection Premixed in flexible plastic containers is to be administered by I.V. drip infusion only. ZOFRAN Injection Premixed should not be mixed with solutions for which physical and chemical compatibility have not been established. In particular, this applies to alkaline solutions as a precipitate may form. If used with a primary I.V. fluid system, the primary solution should be discontinued during ZOFRAN Injection Premixed infusion. Do not administer unless solution is clear and container is undamaged.

Warning: Do not use flexible plastic container in series connections.

Stability: ZOFRAN Injection is stable at room temperature under normal lighting conditions for 48 hours after dilution with the following I.V. fluids: 0.9% Sodium Chloride Injection, 5% Dextrose Injection, 5% Dextrose and 0.9% Sodium Chloride Injection, 5% Dextrose and 0.45% Sodium Chloride Injection, and 3% Sodium Chloride Injection.

Although ZOFRAN Injection is chemically and physically stable when diluted as recommended, sterile precautions should be observed because diluents generally do not contain preservative. After dilution, do not use beyond 24 hours.

Note: Parenteral drug products should be inspected visually for particulate matter and discoloration before administration whenever solution and container permit.

Precaution: Occasionally, ondansetron precipitates at the stopper/vial interface in vials stored upright. Potency and safety are not affected. If a precipitate is observed, resolubilize by shaking the vial vigorously.

ZOFRAN Injection, 2 mg/mL, is supplied as follows:

NDC 0173-0442-02 2-mL single-dose vials (Carton of 5)
NDC 0173-0442-00 20-mL multidose vials (Singles)

Store between 2° and 30°C (36° and 86°F). Protect from light.

ZOFRAN Injection Premixed, 32 mg/50 mL, in 5% Dextrose, contains no preservatives and is supplied as a sterile, premixed solution for I.V. administration in single-dose, flexible plastic containers (NDC 0173-0461-00) (case of 6).

Store between 2° and 30°C (36° and 86°F). Protect from light. Avoid excessive heat. Protect from freezing.

GlaxoSmithKline, Research Triangle Park, NC 27709. ZOFRAN® Injection Premixed: Manufactured for GlaxoSmithKline, Research Triangle Park, NC 27709 by Hospira, Inc., Lake Forest, IL 60045. February 2006. FDA Rev date: NA

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