Zofran Ondansetron Prior Authorization Form

Prior Authorization Approval Criteria

Zofran (ondansetron)

Generic Name: ondansetron

Brand Name: Zofran

Medication Class: 5HT3 antiemetic

FDA Approved Uses: -Prevention of nausea and vomiting associated with emetogentic cancer chemotherapy. -Prevention of nausea and vomiting associated with radiotherapy in patients receiving either total body irradiation, single high-dose fraction to the abdomen, or daily fractions to the abdomen. -Postoperative nausea and vomiting; Prophylaxis.

Other Uses: -Hyperemesis gravidarum

Usual Doses: -Prevention of nausea and vomiting associated with chemotherapy or radiation therapy:8 mg every 8 hours for 1-2 doses beginning 30 minutes prior to chemotherapy or 1-2 hours prior to radiation therapy followed by 8 mg every 12-24 hours for 1-2 days after chemotherapy or radiation therapy. - Postoperative nausea and vomiting: 8-16mg 1 hour prior to surgery -Hyperemesis gravidarum: Determined by prescriber.

Duration of Therapy: -Prevention of nausea and vomiting associated with chemotherapy or radiation therapy: 3days total - Postoperative nausea and vomiting: 1 day -Hyperemesis gravidarum: Up to the duration of pregnancy

Criteria for Use: (bullet points below are all inclusive unless otherwise noted)  Prevention of postoperative nausea and/or vomiting. Allowed for 1 dose 1 hour before induction of anesthesia Or

 Patient has tried approved dosing (30 tablets (4mg or 8mg) or 45ml per month) and it is insufficient to control nausea and vomiting.

 Patient has one of the following conditions:  Nausea and vomiting due to chemotherapeutic agents.

 Nausea and vomiting due to total body irradiation, single high-dose fraction to the abdomen, or daily fractions to the abdomen.

 Use in pregnant woman who have failed conventional antiemetic therapy (ie. promethazine, prochlorperazine and metoclopramide) and are at risk of dehydration and require IV fluids. Allowed for only 1 month at a time.

Page 1 of 2 11/19/04 Revised 1/13/13 Revised 11/15/13

Criteria for continuation of therapy in pregnancy: (bullet points below are all inclusive unless otherwise noted)  Patient is tolerating and responding to medication and there continues to be a medical need for the medication.

 Only approved for 1 month at a time

Not approved if:  Nausea and vomiting is due to a GI viral illness.  Chronic use of an antiemetic is needed, without a clinically defined etiology.

Notes:  No PA required for up to 30 tablets (4mg or 8mg) or 45ml per month  Doses could be tablets or oral solution

P&T Approval: ______Date: ______

Page 2 of 2 11/19/04 Revised 1/13/13 Revised 11/15/13