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.
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)].
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
- NDC 0169-1401-01 List: 140101
(macimorelin) for oral solution
CONTAINS ONE POUCH.
Use the Macrilen™ solution within
30 minutes after preparation.
Discard any unused Macrilen™ solution.
For oral use only.
| MACRILEN |
macimorelin acetate granule, for solution
|Labeler — Novo Nordisk (622920320)|
Revised: 11/2019 Novo Nordisk
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