Macrilen (Page 4 of 4)

16 HOW SUPPLIED/STORAGE AND HANDLING

MACRILEN 60 mg is supplied as white to off-white granules in an aluminum pouch. Each pouch contains 60 mg macimorelin (equivalent to 68 mg macimorelin acetate) that when reconstituted with 120 mL of water provides a 60 mg/120 mL (0.5 mg/mL) macimorelin solution.

MACRILEN is available in boxes containing 1 pouch per box (NDC 0169-1401-01).

Before administration, MACRILEN for oral solution must be reconstituted by a healthcare professional [see Dosage and Administration (2.3)].

Store pouches under refrigeration at 2-8°C (36-46°F).

The solution must be used within 30 minutes after preparation. Discard unused portion.

17 PATIENT COUNSELING INFORMATION

Instruct patients to discontinue treatment with GH at least one week before administering MACRILEN. Also, instruct patients to discontinue other medications that may interfere with the diagnostic test results prior to MACRILEN administration [see Drug Interactions (7.2, 7.3)].

Instruct patients to fast for at least 8 hours before MACRILEN administration [see Dosage and Administration (2.2)].

Manufactured by:
Allphamed Pharbil Arzneimittel GmbH, Goettingen, Germany

Distributed by: Novo Nordisk Inc. Plainsboro, NJ, USA

MACRILEN™ is a trademark of Aeterna Zentaris GmbH, licensed exclusively in the U.S. and Canada to Novo Nordisk Biopharm Limited.

Novo Nordisk® is a registered trademark of Novo Nordisk A/S.

MACRILEN is the subject of U.S. Patent Nos. 6,861,409 and 8,192,719.

For information contact:

Novo Nordisk Inc.

800 Scudders Mill Road

Plainsboro, NJ 08536

1-800-727-6500

www.novonordisk-us.com

Revised: 11/2019

NDC 0169-1401-01 List: 140101

Macrilen™

(macimorelin) for oral solution

60 mg

CONTAINS ONE POUCH.

Use the Macrilen™ solution within

30 minutes after preparation.

Discard any unused Macrilen™ solution.

For oral use only.

Rx only

Carton
(click image for full-size original)
MACRILEN
macimorelin acetate granule, for solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0169-1401
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
MACIMORELIN (MACIMORELIN) MACIMORELIN 60 mg in 1 mg
Inactive Ingredients
Ingredient Name Strength
Lactose Monohydrate
CROSPOVIDONE, UNSPECIFIED
Silicon Dioxide
Sodium Stearyl Fumarate
Saccharin Sodium
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0169-1401-01 1 POUCH in 1 CARTON contains a POUCH
1 60 mg in 1 POUCH This package is contained within the CARTON (0169-1401-01)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA205598 11/30/2020
Labeler — Novo Nordisk (622920320)

Revised: 11/2019 Novo Nordisk

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