Recommended Dosage

• The recommended dosage of TYMLOS is 80 mcg administered subcutaneously once daily.
• Patients should receive supplemental calcium and vitamin D if dietary intake is inadequate.

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 time every day. Do not administer intravenously or intramuscularly.
• Administer the first several doses where the patient can sit or lie down if necessary, in case symptoms of orthostatic hypotension occur [see Warnings and Precautions (5.2) and Adverse Reactions (6.1)].
• Visually inspect TYMLOS for particulate matter and discoloration prior to administration. TYMLOS is a clear and colorless solution. Do not use if solid particles appear or if the solution is cloudy or colored.
• Provide appropriate training and instruction to patients and caregivers on the proper use of the TYMLOS pen.

Treatment Duration

The safety and efficacy of TYMLOS have not been evaluated beyond 2 years of treatment. Use of the drug for more than 2 years during a patient's lifetime is not recommended.