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Reference ID: 4090621 - Home - Radius

HIGHLIGHTS OF PRESCRIBING INFORMATION Administer initially where the patient can sit or lie down in case These highlights do not include all the information needed to use symptoms of orthostatic hypotension occur. ( , ). TYMLOS safely and effectively. See full prescribing information for TYMLOS. ---------------------DOSAGE FORMS AND STRENGTHS-------------------- Injection: 3120 mL (2000 mcg/mL) in a single-patient-use prefilled TYMLOS (abaloparatide) injection, for subcutaneous use pen. The prefilled pen delivers 30 daily doses of 80 mcg abaloparatide in 40. Initial Approval: 2017 mcL of sterile, clear, colorless solution.

2.2 Administration Instructions • Administer TYMLOS as a subcutaneous injection into the periumbilical region of the abdomen. Rotate the site of the injection every day and administer at approximately the same

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PROGRAM APPLICATION - radiuspharm.com

radiuspharm.com

PROGRAM APPLICATION Prescribers and Patients must review and include the required documentation, as well as complete and sign this form. Fax or mail all pages of the application as well as all required documentation to:

  Form

HIGHLIGHTS OF PRESCRIBING INFORMATION …

radiuspharm.com

In this study, the incidence of all-cause mortality was 0.4% in the TYMLOS group and 0.6% in the placebo group. The incidence of serious adverse events was 10% in the TYMLOS group and 11% in the placebo group. The percentage of patients who discontinued study drug due to adverse events was 10% in the TYMLOS group and 6% in the placebo group.

  Study, Tymlos

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