Tymlos
Tymlos (abaloparatide) is a medication used for osteoporosis in men and postmenopausal women at high risk for breaking bones (fractures). It's given once per day as an injection under the skin. This medication can't be used for longer than 2 years because of a theoretical risk of causing bone cancer.
What is Tymlos (abaloparatide)?
What is Tymlos (abaloparatide) used for?
- Osteoporosis in women who have gone through menopause (postmenopause)
- Osteoporosis in men
How Tymlos (abaloparatide) works
Tymlos (abaloparatide) is a parathyroid hormone (PTH) analog. This means it acts just like the PTH your body normally makes. PTH is a hormone that's important in balancing bone breakdown and formation to keep your bones healthy. When Tymlos (abaloparatide) attaches to the PTH receptors in your body, it promotes bone formation and causes your bones to become stronger. This lowers your risk for bone fractures or breaks.
Drug facts
Side effects of Tymlos (abaloparatide)
The following side effects may get better over time as your body gets used to the medication. Let your healthcare provider know immediately if you continue to experience these symptoms or if they worsen over time.
Common Side Effects
- Redness at injection site (up to 58%)
- Swelling at injection site (up to 10%)
- Dizziness (up to 10%)
- Pain at injection site (up to 9%)
- Nausea (up to 8%)
*Percentages of people who reported these side effects might differ between men and postmenopausal women taking this medication.
Less Common Side Effects
- High urine calcium levels
- Headache
- Tiredness
- Bloating
- Diarrhea
- Stomach pain
- Joint or bone pain
- Feeling like chest is pounding
- Feeling like the room is spinning (vertigo)
Tymlos (abaloparatide) serious side effects
Contact your healthcare provider immediately if you experience any of the following.
- High blood calcium levels: constipation, nausea, vomiting, loss of appetite, muscle weakness, low energy, confusion
- Kidney stones: low back or stomach pain, dark-colored urine, nausea, vomiting
The following Tymlos (abaloparatide) side effects have also been reported
Side effects that you should report to your care team as soon as possible:
- Allergic reactions—skin rash, itching, hives, swelling of the face, lips, tongue, or throat
- High calcium level—increased thirst or amount of urine, nausea, vomiting, confusion, unusual weakness or fatigue, bone pain
- Kidney stones—blood in the urine, pain or trouble passing urine, pain in the lower back or sides
- Low blood pressure—dizziness, feeling faint or lightheaded, blurry vision
Side effects that usually do not require medical attention (report these to your care team if they continue or are bothersome):
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Pros and cons of Tymlos (abaloparatide)
Pros
- Available as a pre-filled pen with 30 doses
- Good choice for men and postmenopausal women with osteoporosis at high risk for fracture or who've previously tried other osteoporosis medications
- Can keep at room temperature after its first use for up to 30 days, making it convenient to take it on the go
Cons
- Needs to be injected under the skin once per day
- Not approved for osteoporosis from long-term corticosteroid use
- Can't use for longer than 2 years
Pharmacist tips for Tymlos (abaloparatide)
- Make sure your provider or pharmacist teaches you how to give yourself Tymlos (abaloparatide) so that you avoid accidentally hurting yourself or wasting the medication. Read the directions or watch the instructional video on how to give yourself Tymlos (abaloparatide) injections under the skin. Contact your provider or pharmacist if you have any questions on how to use this medication.
- Store unused Tymlos (abaloparatide) pens in the refrigerator. After using the pen for the first time, you can keep it at room temperature for up to 30 days.
- When you first start using Tymlos (abaloparatide), make sure to sit down when you're giving yourself the injection and get up slowly afterwards. The medication can make you feel dizzy when you stand up too fast after sitting or lying down. This usually happens within 4 hours of injecting Tymlos (abaloparatide) during the first few times, but it should get better as you continue treatment.
- When you start a new pen, you'll need to prime it to remove air bubbles before using it for the first time. You only need to prime each pen once. Contact your provider or pharmacist if you have any questions on how to prime this medication.
- Each Tymlos (abaloparatide) pen will last you about a month because it contains 30 doses. But you'll need to use a new pen needle for each injection. This helps prevent infection.
- If you drop your Tymlos (abaloparatide) pen and it isn't damaged, wipe it with a clean, damp cloth and continue using it. If the pen looks like it's damaged, don't use it. Call your provider, pharmacist, or the manufacturer at 1-855-672-3487 to get a replacement.
- Throw away your needles (after each use) and pens (30 days after you first use it) in a sharps container or something made of heavy-duty plastic, such as an empty milk carton or laundry detergent bottle. Don't throw away them away in your trash can. These steps help lower your risk of needle-stick injuries. For more information on how to throw away your sharps container safely and guidance for your specific state, visit the FDA's website.
- Ask your provider or pharmacist to see if you qualify for a savings program that can lower your out-of-pocket costs for Tymlos (abaloparatide).
Common questions about Tymlos
In studies, postmenopausal women with a high risk of fracture who took Tymlos for 1.5 years had an 86% lower risk of breaking their spinal bone when compared to those who didn't get treatment (placebo). They also had a 43% lower risk of breaking other bones in the body. In addition, studies showed that the bone density in the spine and hip went up significantly in men with high fracture risk after 1 year of treatment and in postmenopausal women with high fracture risk after 1.5 years of treatment when compared to placebo. Having higher bone density means that your bones are getting stronger and might be less likely to break.
Tymlos will work better to build strong bones if you eat foods rich in calcium and vitamin D. Calcium and vitamin D are both essential nutrients for building strong and healthy bones. If you aren't getting enough of these nutrients from your diet, your provider might recommend taking calcium and vitamin D supplements to raise your levels. Since Tymlos can raise your calcium levels, make sure to only take calcium and vitamin D supplements if your provider said it's safe for you to do so. You can also do regular weight-bearing exercises, like walking, jogging, and dancing, to help prevent bone loss. Speak with your provider about other ways to strengthen your bones.
There isn't a specific amount of time for how long you'll need to take Tymlos. You'll likely continue taking the medication as long as it's helping your osteoporosis and you're not having side effects. But the longest you can take Tymlos is up to 2 years. It's not known if the medication is safe or works well in people who take it longer than 2 years since it hasn't been studied. There's also a theoretical risk for the medication to cause bone cancer. After 2 years, the American Association of Clinical Endocrinology (AACE) guideline for osteoporosis recommends using a bisphosphonate or Prolia (denosumab) to maintain your bone strength and keep fracture risk low. If you're still at high risk for fracture after 2 years of taking Tymlos, talk to your provider about what osteoporosis medication to take next.
Tymlos and Forteo (teriparatide) are PTH analogs that are available as brand-only medications. They come as pre-filled pens that are injected under the skin once per day. The two medications also work well to treat osteoporosis and have similar side effects. But they both can't be used for longer than 2 years because of a theoretical risk of bone cancer. While Tymlos and Forteo (teriparatide) are both approved for men and postmenopausal women with osteoporosis and a high risk of fracture, Forteo (teriparatide) can also be used for people with osteoporosis due to long-term use of corticosteroids. Another difference is that Tymlos can be stored at room temperature for up to 30 days, while Forteo (teriparatide) must be refrigerated at all times when you're not using it. Discuss with your provider which medication is right for you.
Tymlos is given as an injection under the skin in your lower stomach. Don't inject within 2 inches from your belly button. Never inject the medication into your muscle or vein. To lower the risk of bruising and irritation, rotate between different injection sites within your stomach area so that the same site isn't used repeatedly. Avoid injecting into skin that's tender, bruised, red, scaly, or hard or skin with scars or stretch marks to avoid further damage to your skin.
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Risks and warnings for Tymlos (abaloparatide)
Tymlos (abaloparatide) can cause some serious health issues. This risk may be even higher for certain groups. If this worries you, talk to your doctor or pharmacist about other options.
Bone cancer
- Risk factors: Certain bone diseases (e.g., rickets, Paget's disease) | History of bone cancer or cancer that has spread to the bones | History of radiation therapy to the bones | Inherited conditions with higher risk of bone cancer | Using Tymlos (abaloparatide) for longer than 2 years
Although rare, there have been reports of people taking a medication similar to Tymlos (abaloparatide) who developed bone cancer (osteosarcoma). Additionally, Tymlos (abaloparatide) caused bone cancer in some animals that received much higher doses of the medication than what's typically used in humans. But it's not known if Tymlos (abaloparatide) can cause or raise the risk of bone cancer. The risk of bone cancer when the medication is used any longer than 2 years also hasn't been studied. Because of this risk, Tymlos (abaloparatide) can't be used for longer than 2 years and shouldn't be used in people who are at higher risk of bone cancer.
Sudden low blood pressure (orthostatic hypotension)
Tymlos (abaloparatide) can suddenly drop your blood pressure if you get up too fast after sitting or lying down (orthostatic hypotension). This usually happens within 4 hours of injecting the medication and is more common with the first few doses. It should get better as you continue using the medication. For the first few doses, sit down when you're giving yourself Tymlos (abaloparatide) to prevent accidental injuries in case this happens. Get up slowly and hold onto something for support. If you suddenly become dizzy, feel like your heart is pounding or racing, or become nauseous, sit or lie down so you don't fall.
High blood calcium levels
- Risk factors: Too much calcium or vitamin D intake | History of high blood calcium levels | Medical conditions that raise calcium levels (e.g., high blood PTH levels, certain cancers)
Tymlos (abaloparatide) can cause your blood calcium levels to become too high. You're at risk for high calcium levels if you take Tymlos (abaloparatide) and your intake of calcium and vitamin D is too high or if you have medical conditions that raise your calcium levels. Your provider might regularly check your calcium levels through blood tests during treatment with Tymlos (abaloparatide).
Only take calcium and vitamin D supplements with Tymlos (abaloparatide) if your prescriber told you to do so. Also, make sure your provider knows about all your medical conditions and the medications you take. If you experience symptoms of high calcium levels, such as muscle weakness, nausea, vomiting, loss of appetite, low energy, or confusion, while taking Tymlos (abaloparatide), contact your provider right away.
Kidney stones
- Risk factors: Current or history of kidney stones | History of high calcium levels in your urine
Along with high blood calcium levels, Tymlos (abaloparatide) can also raise the calcium levels in your urine. In general, having too much calcium in the urine can lead to kidney stones to form. It isn't clear if Tymlos (abaloparatide) raises your risk of getting kidney stones if you've had any before. If you experience symptoms of kidney stones (e.g., low back pain, nausea, vomiting, dark-colored urine), contact your provider. They might measure the amount of calcium in your urine.
Tymlos (abaloparatide) dosage
Pen| Dosage | Quantity | Price as low as | Price per unit |
|---|---|---|---|
| 1.56ml of 80mcg/dose | 1 pen | $2,577.07 | $2,577.07 |
Typical dosage for Tymlos (abaloparatide)
The typical dose is 80 mcg injected under the skin once a day.
How much does Tymlos (abaloparatide) cost?
$2,577.07
What are alternatives to Tymlos (abaloparatide)?
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