This notice provides information to 340B covered entities regarding
the distribution of Rivfloza® (Nedosarin):
| Product Name | NDC | Strength | Package Size |
| RIVFLOZA | 00169530801 | 80mg | 1 X 0.5ML SINGLE DOSE VIAL |
| RIVFLOZA | 00169530708 | 128mg | 1 X 0.8ML SINGLE DOSE PREFILLED SYRINGE |
| RIVFLOZA | 00169530610 | 160mg | 1 X 1ML SINGLE DOSE PREFILLED SYRINGE |
Rivfloza® is a ribonucleic acid interference (RNAi) therapy approved for the treatment of primary hyperoxaluria type 1 (PH1), which is an orphan indication. Rivfloza® works to lower urinary oxalate levels in children 9 years of age and older and adults with primary hyperoxaluria type 1 (PH1) and relatively preserved kidney function. Primary hyperoxaluria (PH) is a rare genetic disease that causes overproduction of oxalate by the liver that is estimated to affect 1 in 38,600 individuals worldwide.
To help ensure that patients treated with Rivfloza® receive high quality support, Novo Nordisk Inc. has established a defined distribution network. Rivfloza® will be made available exclusively through the following defined specialty distributor and specialty pharmacy:
Defined Specialty Distributor:
| NAME | ADDRESS | PHONE # | FAX # |
| ProCare Pharmacy Direct, L.L.C. | 105 Mall Boulevard, Suite B (wholesale), Monroeville, PA 15146-2230 | 888-217-4240 | 412-717-9508 |
Defined Specialty Pharmacy:
| NAME | ADDRESS | PHONE # | FAX # |
| ProCare Pharmacy Direct, L.L.C. | 105 Mall Boulevard, Monroeville PA 15146-2230 | 800-238-7828 | 800-567-8000 |
This distribution network will apply equally to all customers
(340B covered entities and all other customers). The
Rivfloza® defined specialty distributor is authorized to
sell directly to 340B covered entities and certain other customers.
Rivfloza® will not be distributed to any retail or
specialty pharmacies other than the defined specialty pharmacy listed above.
340B covered entities can purchase Rivfloza® at the 340B ceiling price from the defined specialty distributor for delivery to an in-house pharmacy or through a contract pharmacy arrangement with the defined specialty pharmacy. Novo Nordisk Inc. is committed to ensuring that Rivfloza® is available to eligible 340B covered entities at the statutory ceiling price, and via the same distribution avenues made available to all other customers.
If you have any questions regarding access to Rivfloza® via the distribution network described above, please contact 340bInfo@novonordisk.com.