Generic Name and Formulations:
Ondansetron (as base) 4mg, 8mg; oral soluble film; peppermint flavor.

Company:
Strativa Pharmaceuticals

Indications for ZUPLENZ:
Prevention of nausea and vomiting associated with highly emetogenic chemotherapy, including cisplatin ≥50mg/m2. Prevention of nausea and vomiting associated with initial and repeat courses of moderately emetogenic chemotherapy. Prevention of nausea and vomiting associated with radiotherapy in patients receiving total body irradiation, single high-dose fraction to the abdomen, or daily fractions to the abdomen. Prevention of post-op nausea and/or vomiting.

Adult Dose for ZUPLENZ:
Allow each soluble film to dissolve completely before administering the next film. Dissolve on tongue for 4–20 secs before swallowing. Highly emetogenic chemotherapy: 24mg (given successively as three 8mg films) 30 minutes before start of single-day chemotherapy (multi-day, single-dose not studied). Moderately emetogenic chemotherapy: 8mg every 8 hours for 2 doses beginning 30 minutes before chemotherapy, then 8mg every 12 hours for 1–2 days after chemotherapy completed. Total body irradiation: 8mg 1 to 2 hours before each fraction of radiotherapy administered each day. Single high-dose fraction radiotherapy to abdomen: 8mg 1 to 2 hours before radiotherapy, then 8mg every 8 hours after 1st dose for 1–2 days after radiation completed. Daily fractionated radiotherapy to abdomen: 8mg 1 to 2 hours before radiotherapy, then 8mg every 8 hours after 1st dose for each day of radiotherapy. Post-op prophylaxis: 16mg (given successively as two 8mg films) 1 hour before induction of anesthesia. For all: severe hepatic dysfunction: max 8mg/day.

Children's Dose for ZUPLENZ:
Highly emetogenic chemotherapy, radiotherapy, post-op prophylaxis or <4yrs of age: not recommended. Allow each soluble film to dissolve completely before administering the next film. Dissolve on tongue for 4–20 secs before swallowing. 4–11yrs: moderately emetogenic chemotherapy: 4mg every 4 hours for 3 doses beginning 30 minutes before chemotherapy, then 4mg every 8 hours for 1–2 days after chemotherapy completed.

Pharmacological Class:
Selective 5-HT3 receptor antagonist.

Contraindications:
Concomitant apomorphine: risk of profound hypotension or loss of consciousness.

Warnings/Precautions:
May mask progressive ileus and/or gastric distention (esp. after abdominal surgery or patients with chemotherapy-induced nausea/vomiting). Do not use as alternative to nasogastric suction. Hepatic dysfunction. Pregnancy (Cat.B). Nursing mothers.

Interactions:
Potent CYP3A4 inducers (eg, phenytoin, carbamazepine, rifampicin) may increase clearance of ondansetron. May reduce analgesic activity of tramadol.

Adverse Reactions:
Headache, malaise/fatigue, constipation, diarrhea; rare: bronchospasm, anaphylaxis, transient ECG changes, QT prolongation (esp. IV form).

How Supplied:
Soluble film—10