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The following information outlines the critical safety warnings associated with the use of Tymlos (abaloparatide). Please review these carefully and discuss any concerns with your healthcare provider.

• Bone Cancer Risk: Although it is rare, there have been reports of bone cancer (osteosarcoma) in individuals using medications similar to Tymlos. Animal studies have shown bone cancer development at high doses, but it's unclear if Tymlos increases this risk in humans, particularly beyond two years of use. Therefore, do not use Tymlos for more than two years, especially if you have conditions like certain bone diseases (e.g., rickets, Paget's disease), a history of bone cancer, cancer spreading to bones, previous radiation therapy to bones, or inherited conditions that elevate bone cancer risk.

• Sudden Low Blood Pressure (Orthostatic Hypotension): Tymlos can cause a sudden drop in blood pressure when standing up quickly after sitting or lying down, particularly within four hours of injection and during initial doses. To minimize risk, administer Tymlos while seated and rise slowly, using support if necessary. If you experience dizziness, a racing heart, or nausea, sit or lie down immediately to prevent falls.

• High Blood Calcium Levels: Tymlos may elevate blood calcium levels, particularly if combined with high calcium or vitamin D intake, or if you have conditions that naturally increase calcium. Regular blood tests may be necessary to monitor calcium levels during treatment. Exercise caution if you have a history of high calcium levels or underlying conditions causing elevated calcium.

• Kidney Stones: Increased calcium levels in urine due to Tymlos can potentially lead to kidney stones. The risk remains uncertain for individuals with a history of kidney stones. Watch for symptoms such as lower back pain, nausea, vomiting, or dark-colored urine, and consult your healthcare provider for further evaluation, including possible urine calcium measurement.

When using this medication, some individuals may experience common side effects such as redness (up to 58%) and swelling (up to 10%) at the injection site, dizziness (up to 10%), pain at the injection site (up to 9%), and nausea (up to 8%). These effects are generally mild and should subside as your body adjusts. To help manage dizziness or lightheadedness, rise slowly from sitting or lying positions. If these symptoms persist or worsen, consult your healthcare provider.

Other side effects that might occur include headache, tiredness, bloating, diarrhea, stomach pain, joint or bone pain, and a sensation of the room spinning (vertigo). Some people may also experience high urine calcium levels or a feeling of their chest pounding. While these effects are less common, it's important to inform your healthcare provider if you experience them.

Serious side effects, though rare, require immediate medical attention. These include high blood calcium levels, which can manifest as constipation, nausea, vomiting, loss of appetite, muscle weakness, low energy, or confusion. Additionally, symptoms of kidney stones such as low back or stomach pain, dark-colored urine, nausea, and vomiting should be promptly addressed by a medical professional. In rare instances, an allergic reaction may occur, marked by rash, itching, swelling (particularly of the face, tongue, or throat), severe dizziness, or trouble breathing.

While abaloparatide has been linked to an increased risk of bone cancer in animal studies, its effect on humans remains unclear. If you notice bone pain or unusual growths, contact your healthcare provider promptly. Always report any other unexpected side effects to your doctor or pharmacist for guidance.