Alvimopan: Package Insert and Label Information (Page 3 of 3)

16 HOW SUPPLIED/STORAGE AND HANDLING

Alvimopan capsules, 12 mg, are white to off-white, hard gelatin capsules printed with “2312 ” on body of the capsule. Alvimopan capsules are available as follows for hospital use only:

Carton containing 30 (6 x 5) unit-dose capsules NDC 0591-2312-15

Store at 25°C (77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature].

17 PATIENT COUNSELING INFORMATION

Recent Use of Opioids

Inform patients that they must disclose long-term or intermittent opioid pain therapy to their healthcare provider, including any use of opioids in the week prior to receiving alvimopan. Inform patients that recent use of opioids may make them more susceptible to adverse reactions to alvimopan, primarily those limited to the gastrointestinal tract (e.g., abdominal pain, nausea and vomiting, diarrhea).

Hospital Use Only

Inform patients that alvimopan capsules are available only through a program called the Alvimopan REMS Program under a REMS that restricts use to enrolled hospitals because of the potential risk of myocardial infarction with long-term use of alvimopan. Alvimopan capsules are for hospital use only for no more than 7 days after their bowel resection surgery.

Most Common Adverse Reaction

Inform patients that the most common adverse reaction with alvimopan in patients undergoing surgeries that include bowel resection is dyspepsia.

Brands listed are the trademarks of their respective owners.

Manufactured In India By:
Watson Pharma Private Ltd.
Verna, Salcette Goa 403 722 INDIA

Manufactured For:
Teva Pharmaceuticals USA, Inc.
Parsippany, NJ 07054

Rev. A 1/2021

PACKAGE LABEL PRINCIPAL DISPLAY PANEL

NDC 0591-2312-15

Alvimopan Capsules

12 mg

HOSPITAL USE ONLY

Rx only

30 (6 x 5) unit-dose capsules

1
(click image for full-size original)
ALVIMOPAN
alvimopan capsule
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0591-2312
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ALVIMOPAN (ALVIMOPAN ANHYDROUS) ALVIMOPAN ANHYDROUS 12 mg
Inactive Ingredients
Ingredient Name Strength
POLYETHYLENE GLYCOL 3350
GELATIN
SODIUM LAURYL SULFATE
TITANIUM DIOXIDE
FERROSOFERRIC OXIDE
POTASSIUM HYDROXIDE
PROPYLENE GLYCOL
SHELLAC
AMMONIA
Product Characteristics
Color white (white to off white) Score no score
Shape CAPSULE Size 19mm
Flavor Imprint Code 2312
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0591-2312-15 30 BLISTER PACK in 1 CARTON contains a BLISTER PACK (0591-2312-45)
1 NDC:0591-2312-45 1 CAPSULE in 1 BLISTER PACK This package is contained within the CARTON (0591-2312-15)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA208295 12/01/2020
Labeler — Actavis Pharma, Inc. (119723554)

Revised: 01/2021 Actavis Pharma, Inc.

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