TYMLOS Solution for injection Ref.[9933] Active ingredients: Abaloparatide

2.1 Recommended Dosage

• The recommended dosage of TYMLOS is 80 mcg subcutaneously once daily.
• Cumulative use of TYMLOS and parathyroid hormone analogs (e.g., teriparatide) for more than 2 years during a patient’s lifetime is not recommended [see Warnings and Precautions (5.1)].
• Patients should receive supplemental calcium and vitamin D if dietary intake is inadequate.

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 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)].
• TYMLOS is a clear and colorless solution. Visually inspect TYMLOS for particulate matter and discoloration prior to administration. 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.

In a clinical study, accidental overdose was reported in a patient who received 400 mcg in one day (5 times the recommended clinical dose); dosing was temporarily interrupted. The patient experienced asthenia, headache, nausea, and vertigo. Serum calcium was not assessed on the day of the overdose, but on the following day the patient’s serum calcium was within the normal range. The effects of overdose may include hypercalcemia, nausea, vomiting, dizziness, tachycardia, orthostatic hypotension, and headache.

Overdosage Management

There is no specific antidote for TYMLOS. Treatment of suspected overdose should include discontinuation of TYMLOS, monitoring of serum calcium and phosphorus, and implementation of appropriate supportive measures, such as hydration. Based on the molecular weight, plasma protein binding and volume of distribution, abaloparatide is not expected to be dialyzable.

• Before first use, store TYMLOS in a refrigerator between 2°C to 8°C (36°F to 46°F).
• After first use, store for up to 30 days at 20°C to 25°C (68°F to 77°F).
• Do not freeze or subject to heat.