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Zuplenz

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Zuplenz

Indications
Dosage
How Supplied

INDICATIONS

Prevention Of Nausea And Vomiting Associated With Highly Emetogenic Cancer Chemotherapy

ZUPLENZ (ondansetron) oral soluble film is indicated for the prevention of nausea and vomiting associated with highly emetogenic cancer chemotherapy, including cisplatin ≥ 50 mg/m² [see Clinical Studies].

Prevention Of Nausea And Vomiting Associated With Moderately Emetogenic Cancer Chemotherapy

ZUPLENZ is indicated for the prevention of nausea and vomiting associated with initial and repeat courses of moderately emetogenic cancer chemotherapy [see Clinical Studies].

Prevention Of Nausea And Vomiting Associated With Radiotherapy

ZUPLENZ is indicated for the 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 [see Clinical Studies].

Prevention Of Postoperative Nausea And/Or Vomiting

ZUPLENZ is indicated for the 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, ZUPLENZ is recommended even where the incidence of postoperative nausea and/or vomiting is low [see Clinical Studies].

DOSAGE AND ADMINISTRATION

Prevention Of Nausea And Vomiting Associated With Highly Emetogenic Cancer Chemotherapy

Adults

The recommended adult oral dosage of ZUPLENZ (ondansetron) oral soluble film is 24 mg given successively as three 8 mg films administered 30 minutes before the start of single-day highly emetogenic chemotherapy, including cisplatin ≥ 50 mg/m² . Each ZUPLENZ oral soluble film should be allowed to dissolve completely before administering the next film [see Important Administration Instructions]. Multiday, single-dose administration of a 24 mg dosage has not been studied.

Pediatrics

Safety and effectiveness of ZUPLENZ in pediatric patients have not been established for this indication.

Prevention Of Nausea And Vomiting Associated With Moderately Emetogenic Cancer Chemotherapy

Adults

The recommended adult oral dosage is one 8 mg ZUPLENZ oral soluble film given twice a day. The first dose should be administered 30 minutes before the start of emetogenic chemotherapy, with a subsequent dose 8 hours after the first dose. One 8 mg ZUPLENZ oral soluble film should be administered twice a day (every 12 hours) for 1 to 2 days after completion of chemotherapy [see Important Administration Instructions].

Pediatrics

For pediatric patients 12 years of age and older, the dosage is the same as for adults. For pediatric patients 4 through 11 years of age, the dosage is one 4 mg ZUPLENZ oral soluble film given three times a day. The first dose should be administered 30 minutes before the start of emetogenic chemotherapy, with subsequent doses 4 and 8 hours after the first dose. One 4 mg ZUPLENZ oral soluble film should be administered three times a day (every 8 hours) for 1 to 2 days after completion of chemotherapy [see Important Administration Instructions].

Prevention Of Nausea And Vomiting Associated With Radiotherapy

Adults

The recommended adult oral dosage of ZUPLENZ oral soluble film is one 8 mg film given three times a day [see Important Administration Instructions].

For total body irradiation, one 8 mg ZUPLENZ oral soluble film should be administered 1 to 2 hours before each fraction of radiotherapy administered each day.

For single high-dose fraction radiotherapy to the abdomen, one 8 mg ZUPLENZ oral soluble film should be administered 1 to 2 hours before radiotherapy, with subsequent doses every 8 hours after the first dose for 1 to 2 days after completion of radiotherapy.

For daily fractionated radiotherapy to the abdomen, one 8 mg ZUPLENZ oral soluble film should be administered 1 to 2 hours before radiotherapy, with subsequent doses every 8 hours after the first dose for each day radiotherapy is given.

Pediatrics

Safety and effectiveness of ZUPLENZ in pediatric patients have not been established for this indication.

Prevention Of Postoperative Nausea And/Or Vomiting

Adults

The recommended adult oral dosage of ZUPLENZ oral soluble film is 16 mg given successively as two 8 mg films 1 hour before induction of anesthesia. Each ZUPLENZ oral soluble film should be allowed to dissolve completely before administering the next film [see Important Administration Instructions].

Pediatrics

Safety and effectiveness of ZUPLENZ in pediatric patients have not been established for this indication.

Dosage Adjustment For Patients With Impaired Hepatic Function

In patients with severe hepatic impairment (Child-Pugh score of 10 or greater)2, clearance is reduced and apparent volume of distribution is increased with a resultant increase in plasma half-life [see CLINICAL PHARMACOLOGY]. In such patients, a total daily dose of 8 mg should not be exceeded.

Important Administration Instructions

With dry hands, fold the pouch along the dotted line to expose the tear notch. While still folded, tear the pouch carefully along the edge and remove the ZUPLENZ oral soluble film from the pouch. Immediately place the film on top of the tongue where it dissolves in 4 to 20 seconds. Once the ZUPLENZ oral soluble film is dissolved, swallow with or without liquid [see CLINICAL PHARMACOLOGY]. Wash hands after taking ZUPLENZ.

HOW SUPPLIED

Dosage Forms And Strengths

ZUPLENZ (ondansetron) oral soluble film is available in 4 mg and 8 mg strengths. The thin white opaque films are rectangularly shaped strips with a printed identifier in black ink of “4 mg” for ZUPLENZ 4 mg or “8 mg” for ZUPLENZ 8 mg.

Storage And Handling

ZUPLENZ (ondansetron) oral soluble film 4 mg and ZUPLENZ (ondansetron) oral soluble film 8 mg, are supplied as thin rectangular white opaque films in individual foil-foil sealed child resistant pouches. Individual films are identified by “4 mg” or “8 mg”, according to the respective strengths, which is printed using pharmaceutical grade edible ink.

Individual pouches of ZUPLENZ 4 mg oral soluble film (NDC 57881-444-01) are packaged in boxes of 10 (NDC 57881-444-10).

Individual pouches of ZUPLENZ 8 mg oral soluble film (NDC 57881-448-01) are packaged in boxes of 10 (NDC 57881-448-10).

Store at controlled room temperature 20° to 25°C (68° to 77°F). Store pouches in cartons. Keep product in pouch until ready to use.

Manufactured by: Monosol Rx, LLC Warren, NJ 07059. Manufactured for: Galena Biopharma, Inc. Portland, OR 97239 Distributed by: Galena Biopharma, Inc. Portland, OR 97239. Revised: August 2014

Last reviewed on RxList: 10/1/2014
This monograph has been modified to include the generic and brand name in many instances.

Indications
Dosage
How Supplied
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