• Tymlos is a brand (trade) name for abaloparatide which may be used to increase bone density.
• Tymlos (abaloparatide) is a man-made version of a protein related to the human parathyroid hormone (also called parathyrin). Parathyrin is important in bone remodeling where bone tissue is resorbed and rebuilt over time. Tymlos (abaloparatide) acts on specific receptors that stimulate osteoblasts (cells that lay down new bone), increasing bone mass (bone mineral density).
• Tymlos belongs to the class of drugs known as parathyroid hormone-related protein (PTHrP) analogs.

• May be considered for the treatment of osteoporosis in postmenopausal women who have tried and not responded to, or been intolerant of, other medications for osteoporosis.
• May also be used to increase bone density in men with osteoporosis at high risk of fracture (for example, those with a history of osteoporotic fracture or multiple risk factors for fracture), or in those intolerant to, or who have not responded to other osteoporosis treatment options.
• Significantly reduces the risk of vertebral and nonvertebral fractures.
• No dosage adjustment is required in kidney disease. The manufacturer does not state if a dosage adjustment is needed for liver disease.
• There are no significant drug interactions reported with Tymlos.
• Administered by self-injection under the skin, once a day.
• Available as single-use prefilled pens.

If you are between the ages of 18 and 60, take no other medication or have no other medical conditions, side effects you are more likely to experience include:

• High calcium levels in urine (may exacerbate active or recent urolithiasis), increased uric acid levels, and redness or pain around the injection site are the most common side effects reported. Dizziness, headache, nausea, tiredness, palpitations, a fast heartbeat, and a drop in blood pressure on standing have also been reported.
• Is associated with an increased risk of osteosarcoma (a type of cancerous bone tumor) in some animal studies. It is not known if this increased risk occurs in humans; however, Tymlos should not be given to people with unexplained elevations of alkaline phosphatase, women with Paget's disease of the bone, pre-existing bone cancer, prior radiation therapy, hereditary disorders that increase their risk of osteosarcoma, and certain other conditions.
• Not recommended for use for longer than two years (use of teriparatide should be taken into account as part of this cumulative duration).
• Tymlos is the only brand available. There is no generic equivalent of abaloparatide.

Note: In general, seniors or children, people with certain medical conditions (such as liver or kidney problems, heart disease, diabetes, seizures) or people who take other medications are more at risk of developing a wider range of side effects. View complete list of side effects

• Inject Tymlos under the skin as instructed into the area around your belly button (periumbilical region). Rotate the injection site every day and administer it at the same time every day. Do not administer into a vein or a muscle. You may like to sit or lie down the first few times you administer Tymlos, just in case you feel dizzy and faint.
• Keep unopened Tymlos in the refrigerator at 2°C to 8°C (36°F to 46°F). May be stored for up to 30 days at room temperature. Each pre-filled pen contains enough Tymlos for 30 separate injections. Only use the injection pen provided with Tymlos; do not transfer to another container. Only use if the injection solution is clear and colorless. Throw used needles away in an approved sharps container. Do not store the pen with the needle attached.
• Your doctor may require you to take supplements or change aspects of your diet while you are taking Tymlos. Follow his/her advice and talk to him/her before taking any other supplements or medication.
• If you forget your daily dose of Tymlos, just continue with your normal dosing schedule. Do not administer more than two doses in one day.
• You may require regular blood tests and bone mineral density tests to monitor your response to Tymlos. Always keep your appointments with your doctor.
• Tell your doctor if you experience any nausea, headache, weakness, abdominal pain or signs of high calcium (such as bone pain, confusion, constipation, fatigue, headache, nausea and vomiting, weakness), signs of a kidney stone such as (back pain, abdominal pain, or blood in the urine), bone pain, swelling, a lump, a fast heartbeat, a bad cough or any other concerning symptoms.
• Tymlos may make you feel dizzy when you get up from a lying down position to standing. Take your time when getting up to reduce your risk of having a fall.
• Seek urgent medical attention if you develop shortness of breath or wheezing, chest pain or tightness, facial swelling, or blue skin color.
• To help maintain your bone mineral density and reduce your risk of fracturing a bone, stop smoking if you smoke and limit your alcohol intake.

• Tymlos reaches peak blood levels in approximately 30 minutes.
• The cumulative lifetime duration of use of Tymlos and other parathyroid hormone analogs should not exceed two years.
• FDA approval for the use of Tymlos in men was based on the Phase 3 ATOM study (Abaloparatide Treatment of Men), a randomized, double-blind, placebo-controlled, 12-month multicenter study designed to evaluate the efficacy and safety of abaloparatide 80 micrograms in men with osteoporosis. After 12 months there was an 8.5% change in bone mineral density (BMD) at the lumbar spine in those men treated with abaloparatide compared with only a 1.2% change in those assigned a placebo (treatment difference: 7.3% [99% CI: 5.1%, 9.6%]).

Few interaction studies have been done with Tymlos. Medicines that interact with Tymlos may either decrease its effect, affect how long it works, increase side effects, or have less of an effect when taken with Tymlos. An interaction between two medications does not always mean that you must stop taking one of the medications; however, sometimes it does. Speak to your doctor about how drug interactions should be managed.

Common medications that may interact with Tymlos include:

• calcipotriene topical
• calcitriol topical
• digitoxin
• digoxin.

Tymlos, at recommended dosages, does not inhibit or induce cytochrome P450 enzymes.

Note that this list is not all-inclusive and includes only common medications that may interact with Tymlos. You should refer to the prescribing information for Tymlos for a complete list of interactions.