Tymlos (abaloparatide)

What is Tymlos?

Tymlos is a brand-name prescription medication. It’s used to treat osteoporosis after menopause. Osteoporosis is a disease that causes your bones to become weak. With osteoporosis, your bones may fracture or break more easily than usual.

For this use, Tymlos is given to those with a high risk for bone fracture. (To learn more about risk factors for osteoporosis, see the “Tymlos for osteoporosis” section below.)

Drug details

Tymlos contains the active drug abaloparatide. This drug is not currently available in generic form.

Tymlos contains a synthetic (lab-made) form of the human parathyroid hormone that’s found naturally inside your body. Tymlos works in the same way that your natural parathyroid hormone does to increase bone density and strength.

Tymlos comes as a solution inside a prefilled pen with 30 doses. The drug is typically given once each day as a subcutaneous injection (an injection under your skin). Your doctor or healthcare professional will show you how to give yourself injections of the drug.

Tymlos is available in one strength: 2,000 micrograms/milliliter (mcg/mL). One pen is meant to last 1 month. Each dose delivers 80 micrograms of abaloparatide.

Effectiveness

For information about the effectiveness of Tymlos, see the “Tymlos for osteoporosis” section below.

Tymlos generic

Tymlos is available only as a brand-name medication. It’s not currently available in generic form.

A generic drug is an exact copy of the active drug in a brand-name medication. Generics usually cost less than brand-name drugs.

Tymlos side effects

Tymlos can cause mild or serious side effects. The following lists contain some of the key side effects that may occur while taking Tymlos. These lists don’t include all possible side effects.

For more information on the possible side effects of Tymlos, talk with your doctor or pharmacist. They can give you tips on how to deal with any side effects that may be bothersome.

Note: The Food and Drug Administration (FDA) tracks side effects of drugs it has approved. If you would like to notify the FDA about a side effect you’ve had with Tymlos, you can do so through MedWatch.

Mild side effects

Mild side effects of Tymlos can include:*

• dizziness
• nausea
• headache
• fatigue (lack of energy)
• pain in the upper belly
• vertigo (problems with balance)

Most of these side effects may go away within a few days or a couple of weeks. But if they become more severe or don’t go away, talk with your doctor or pharmacist.

* This is a partial list of mild side effects from Tymlos. To learn about other mild side effects, talk with your doctor or pharmacist, or visit the Tymlos Medication Guide.

Serious side effects

Serious side effects from Tymlos aren’t common, but they can occur. Call your doctor right away if you have serious side effects. Call 911 or your local emergency number if your symptoms feel life threatening or if you think you’re having a medical emergency.

Serious side effects, explained in more detail below in “Side effect details,” include:

• allergic reaction
• dizziness and orthostatic hypotension (low blood pressure when you stand up quickly)
• increased calcium levels in your blood or urine
• changes in heart rate, such as increased heart rate and heart palpitations

Side effect details

You may wonder how often certain side effects occur with this drug. Here’s some detail on certain side effects this drug may cause.

Allergic reaction

As with most drugs, it’s possible to have an allergic reaction after taking Tymlos. However, it isn’t known how many people in clinical trials may have had an allergic reaction to Tymlos.

Symptoms of a mild allergic reaction can include:

• skin rash
• itchiness
• flushing

A more severe allergic reaction is rare but possible. Symptoms of a severe allergic reaction can include:

• swelling under your skin, usually in your eyelids, lips, hands, or feet
• swelling of your tongue, mouth, or throat
• trouble breathing

Call your doctor right away if you have a severe allergic reaction to Tymlos. Call 911 or your local emergency number if your symptoms feel life threatening or if you think you’re having a medical emergency.

Injection side effects

Injection side effects may occur with Tymlos use. Injection site reactions can cause symptoms such as redness, swelling, or pain where a drug is injected.

One clinical trial showed the frequency of these symptoms to be as follows:

• redness at the injection site:
  • occurred in 58% of people taking Tymlos
  • occurred in 28% of people taking a placebo (a treatment with no active drug)
  • was considered severe in 2.9% of people taking Tymlos
• swelling at the injection site:
  • occurred in 10% of people taking Tymlos
  • occurred in 3% of people taking a placebo
  • was considered severe in 0.4% of people taking Tymlos
• pain at the injection site:
  • occurred in 9% of people taking Tymlos
  • occurred in 7% of people taking a placebo
  • was considered severe in 0.4% of people taking Tymlos

If you develop a reaction where you injected Tymlos, talk with your doctor. They may be able to suggest ways to help prevent the side effect.

Orthostatic hypotension and dizziness

Orthostatic hypotension, as well as dizziness, may occur with Tymlos use. Orthostatic hypotension is a drop in your blood pressure that can occur when you move from sitting to standing. It can also occur when you move from lying down to a sitting position.

Symptoms of orthostatic hypotension may include feeling faint, having blurry vision, or being confused.

In one clinical trial, dizziness was seen in:

• 10% of people taking Tymlos
• 6% of people taking a placebo (treatment with no active drug)

Also in the trial, orthostatic hypotension occurred in some people taking Tymlos. For example, 1 hour after a dose, blood pressure decreased by at least 20/10 mmHg* in:

• 4% of people taking Tymlos
• 3% of people taking a placebo

If you feel dizzy or you’re having symptoms of orthostatic hypotension, talk with your doctor. They may be able to recommend ways to lessen these side effects, such as switching positions more slowly.

* Millimeters of mercury (mmHg) is the unit of measurement that’s used to describe blood pressure.

Increased calcium levels

Increased calcium levels are a possible side effect of Tymlos. This includes having increased calcium levels in your blood or urine.

Increased calcium in your urine

Some people develop an increased calcium level in their urine while taking Tymlos.

In one clinical trial, increased calcium levels in urine occurred in:

• 20% of people who took Tymlos
• 15% of people who took a placebo

It’s possible that having increased calcium in your urine can increase your risk for kidney or bladder stones. If you have kidney or bladder stones or increased calcium in your urine, your doctor may monitor your urine more often than usual. This helps them make sure that your levels don’t become too high.

Symptoms of increased calcium in your urine may include:

• nausea
• vomiting
• bone pain
• headache

If you have concerns about having increased calcium in your urine, or developing kidney or bladder stones, talk with your doctor. They may suggest ways to lower your risk. Or they may recommend a medication other than Tymlos to treat your osteoporosis.

Increased calcium in your blood

It’s possible to develop an increased calcium level in your blood while you’re taking Tymlos.

In one clinical trial, increased levels of calcium in the blood occurred in:

• 3% of people taking Tymlos
• 0.1% of people taking a placebo (treatment with no active drug)

Too much calcium in your blood can cause pain and weakness. It may also make you feel confused and tired.

During Tymlos treatment, your doctor may monitor your blood levels of calcium. This allows them to be sure that the levels don’t get too high. If you have any questions or concerns, be sure to talk with your doctor.

If you have high calcium levels in your blood or a condition that may cause increased blood calcium levels, talk with your doctor. (Hyperparathyroidism is an example of a condition that may increase this risk.) Your doctor may recommend a medication other than Tymlos to treat your osteoporosis.

Changes in heart rate

Tymlos may cause changes in heart rate. These include an increased heart rate or palpitations (feeling like your heart is skipping beats).

In one clinical trial, increased heart rate occurred in:

• 2% of females* taking Tymlos
• 1% of females taking a placebo (treatment with no active drug)

About 38% of females taking Tymlos who experienced increased heart rate had symptoms within 1 hour of their dose.

Also in the study, palpitations occurred in:

• 5% of females taking Tymlos
• 0.4% of females taking a placebo

If you have an increased heart rate or palpitations while taking Tymlos, talk with your doctor. They may suggest a different medication to treat your osteoporosis. But if your symptoms feel life threatening or you think you’re having a medical emergency, call 911 or your local emergency number.

* Sex and gender exist on spectrums. Use of the term “female” in this article refers to sex assigned at birth.

Tymlos dosage

The Tymlos dosage your doctor will prescribe is typically 80 micrograms (mcg) per day. This is one injection. Your doctor will ultimately prescribe the smallest dosage that provides the desired effect.

The following information describes dosages that are commonly used or recommended. However, be sure to use the dosage your doctor prescribes for you. Your doctor will determine the best dosage to fit your needs.

Drug forms and strengths

Tymlos comes as a solution inside a prefilled pen. Each pen holds enough of the drug to supply doses for 30 days.

Tymlos is available in one strength: 2,000 mcg/milliliter (mL). Each dose delivers 80 mcg of abaloparatide, which is the active drug in Tymlos.

Tymlos is given as a subcutaneous injection (an injection under your skin). Your doctor or another healthcare professional will show you how to give yourself injections of the drug.

Note: Because of the lack of clinical studies and the possible risk of bone cancer, it’s not recommended that you use Tymlos for more than 2 years throughout your lifetime. You also shouldn’t use other parathyroid medications, such as teriparatide, while you are taking Tymlos. For more information about this risk, see “Does Tymlos cause bone cancer?” in “Common questions about Tymlos” below.

Dosage for osteoporosis

The recommended dosage of Tymlos for osteoporosis is 80 mcg per day. This is one injection.

Because of the lack of clinical studies and the possible risk of bone cancer, it’s not recommended that you use Tymlos for more than 2 years throughout your lifetime. You also shouldn’t use other parathyroid medications, such as teriparatide, while you are taking Tymlos.

In some cases, your doctor may recommend that you take calcium and vitamin D supplements with Tymlos.

Note: The first time you use Tymlos, your doctor may recommend that you inject the drug while you’re sitting or lying down. Doing this may help prevent symptoms of orthostatic hypotension (a sudden drop in blood pressure caused by changing position).

In most cases, orthostatic hypotension occurs within 4 hours of your dose. It’s best to be someplace where you’re able to sit or lie down within 4 hours of your dose. (For more information on orthostatic hypotension, see the “Tymlos side effects” section above.)

What if I miss a dose?

If you miss your dose of Tymlos, take it as soon as you can that day. For example, if you miss a dose on Wednesday, take your dose as soon as you remember on Wednesday. However, if it’s already the next day, just skip your missed dose and take only one dose as usual.

To help make sure that you don’t miss a dose, try using a medication reminder. This can include setting an alarm on your phone or downloading a reminder app. A kitchen timer can work, too.

Will I need to use this drug long term?

Because of the lack of clinical studies and the possible risk of bone cancer, Tymlos shouldn’t be used for more than 2 years. If Tymlos is safe and effective for you, you’ll likely use it for up to 2 years. After that, your doctor may recommend a different medication to treat your osteoporosis.

Tymlos overdose

Using more than the recommended dosage of Tymlos can lead to serious side effects.

Do not use more Tymlos than your doctor recommends.

Overdose symptoms

In clinical trials, one person accidentally took five times the recommended dose of Tymlos in one day. They experienced weakness, headache, nausea, and vertigo (problems with balance).

Other symptoms of an overdose can include:

• increased calcium in your blood
• dizziness
• increased heart rate
• orthostatic hypotension (a drop in blood pressure when moving from sitting to standing or from lying to sitting)

What to do in case of overdose

If you think you’ve taken too much of this drug, call your doctor. You can also call the American Association of Poison Control Centers at 800-222-1222 or use their online tool. But if your symptoms are severe, call 911 or your local emergency number, or go to the nearest emergency room right away.

Alternatives to Tymlos

Other drugs are available that can treat osteoporosis after menopause. Some may be a better fit for you than others. If you’re interested in finding an alternative to Tymlos, talk with your doctor. They can tell you about other medications that may work well for you.

Examples of other drugs that may be used to treat osteoporosis after menopause include:

• alendronate (Fosamax)
• calcitonin (Miacalcin)
• denosumab (Prolia)
• ibandronate (Boniva)
• raloxifene (Evista)
• risedronate (Actonel)
• romosozumab-aqqg (Evenity)
• teriparatide (Forteo)
• zoledronic acid (Reclast)

Tymlos vs. Forteo

You may wonder how Tymlos compares with other medications that are prescribed for similar uses. Here we look at how Tymlos and Forteo are alike and different.

Ingredients

Tymlos contains the active drug abaloparatide, while Forteo contains the active drug teriparatide. Tymlos is a synthetic (lab-made) form of the natural human parathyroid hormone that your body produces naturally. Forteo is also a synthetic form of parathyroid hormone.

Uses

Here is a list of conditions that the Food and Drug Administration (FDA) has approved Tymlos and Forteo to treat.

• Both Tymlos and Forteo are FDA-approved to treat:
  • osteoporosis after menopause for females* who have a high risk for fracture
• Forteo is also FDA-approved to treat:
  • osteoporosis in males* with a high risk for fracture
  • osteoporosis in people who have a high risk for fracture due to long-term use of steroid medications, such as prednisone

* Sex and gender exist on spectrums. Use of the terms “female” and “male” in this article refers to sex assigned at birth.

Drug forms and administration

Both Tymlos and Forteo come as a solution that’s taken once daily as a subcutaneous injection (an injection under the skin). Tymlos should be injected into the belly, at least 2 inches away from the belly button. Forteo should be injected into the thigh or belly.

Side effects and risks

Tymlos and Forteo both contain forms of parathyroid hormone. So these medications can cause very similar side effects, but some different ones as well. Below are examples of these side effects.

Mild side effects

These lists contain up to 10 of the most common mild side effects that can occur with Tymlos and Forteo, as well as mild side effects that both drugs may share.

• Can occur with Tymlos:
  • pain in the upper belly
• Can occur with Forteo:
  • joint pain
• Can occur with both Tymlos and Forteo:
  • nausea
  • dizziness
  • vertigo (problems with balance)
  • headache
  • fatigue (lack of energy)
  • pain

Serious side effects

These lists contain examples of serious side effects that can occur with Tymlos or Forteo, as well as serious side effects that both drugs may share.

• Can occur with Tymlos:
  • changes in heart rate, such as increased heart rate and heart palpitations
• Can occur with Forteo:
  • no unique, serious side effects
• Can occur with both Tymlos and Forteo:
  • allergic reaction
  • increased calcium in your blood or urine
  • dizziness and orthostatic hypotension (decrease in blood pressure caused by changing positions)
  • increased uric acid in your blood

Effectiveness

Tymlos and Forteo have different FDA-approved uses. However, they’re both used to treat osteoporosis after menopause for those who have a high risk for fractures.

The use of Tymlos and Forteo in treating osteoporosis after menopause has been compared in a clinical study. People took Tymlos, Forteo, or a placebo (a treatment with no active drug).

In the study, Forteo was used as an “open-label” treatment. This means the people who were taking Forteo knew they were taking this drug.

The results showed that Tymlos was more effective than the placebo at treating osteoporosis. Also, people who took Tymlos had a lower risk for increased calcium blood levels than people who took Forteo.

Costs

Tymlos costs significantly less than Forteo. The actual price you’ll pay for either drug depends on your insurance plan, your location, and the pharmacy you use.

Tymlos and Forteo are both brand-name drugs. There are currently no generic forms of either drug.

Tymlos vs. Prolia

Like Forteo (above), the drug Prolia has uses similar to those of Tymlos. Here’s a comparison of how Tymlos and Prolia are alike and different.

Ingredients

Tymlos contains the active drug abaloparatide, while Prolia contains the active drug denosumab. These drugs belong to different classes of medications. (A medication class describes a group of drugs that work in the same way.)

Uses

Here is a list of conditions that the Food and Drug Administration (FDA) has approved Tymlos and Prolia to treat.

• Both Tymlos and Prolia are FDA-approved to treat:
  • osteoporosis after menopause in females* who have a high risk for fracture
• Prolia is also FDA-approved to treat:
  • osteoporosis in males* who have a high risk for fracture
  • osteoporosis in people with a high risk for fracture due to long-term use of steroid medications, such as prednisone
  • bone loss in males with a high risk for fracture after taking certain medications to treat prostate cancer that hasn’t spread to other areas of their body
  • bone loss in people with a high risk for fracture after taking certain medication for breast cancer

* Sex and gender exist on spectrums. Use of the terms “female” and “male” in this article refers to sex assigned at birth.

Drug forms and administration

Tymlos comes as a solution that’s taken once daily as a subcutaneous injection (an injection under the skin). Tymlos should be injected into the belly, at least 2 inches away from the belly button. Your doctor or another healthcare professional will show you how to give yourself injections of the drug.

Prolia also comes as a solution that’s taken as an injection under the skin. However, this medication needs to be taken only once every 6 months. Unlike Tymlos, you can’t inject Prolia yourself. Instead, Prolia must be given by a healthcare professional. The drug is injected into your upper arm, upper thigh, or belly.

Side effects and risks

Tymlos and Prolia both contain medications used to treat osteoporosis in certain people with a high risk for fracture. These medications can cause very similar side effects, but some different ones as well. Below are examples of these side effects.

Mild side effects

These lists contain up to 10 of the most common mild side effects that can occur with Tymlos or Prolia, as well as mild side effects that both drugs may share.

• Can occur with Tymlos:
  • dizziness
  • nausea
  • headache
  • fatigue (lack of energy)
• Can occur with Prolia:
  • back pain
  • pain in your arms or legs
  • increased cholesterol level
  • muscle pain
  • swelling of your bladder
• Can occur with both Tymlos and Prolia:
  • pain in the upper belly
  • vertigo (problems with balance)

Serious side effects

These lists contain examples of serious side effects that can occur with Tymlos or Prolia, as well as serious side effects that both drugs may share.

• Can occur with Tymlos:
  • changes in heart rate, such as increased heart rate and heart palpitations
  • orthostatic hypotension (decrease in blood pressure caused by changing positions) and dizziness
• Can occur with Prolia:
  • pancreatitis
  • osteonecrosis of the jaw (decreased blood flow to the jaw bone that can cause death of the bone)
  • unusual fractures of the femur (bone in the upper leg)
  • serious infections, such as skin infections
  • serious rashes
  • severe pain in bones, joints, or muscles
  • decreased bone regrowth
• Can occur with both Tymlos and Prolia:
  • allergic reaction
  • increased calcium levels in your blood or urine

Effectiveness

Tymlos and Prolia have different FDA-approved uses. However, they’re both used to treat osteoporosis in certain people with a high risk for fractures.

These drugs haven’t been directly compared in clinical studies. But studies have found both Tymlos and Prolia to be effective for treating postmenopausal people with osteoporosis at high risk for fractures.

Costs

Tymlos costs significantly more than Prolia. The actual price you’ll pay for either drug depends on your insurance plan, your location, and the pharmacy you use.

Tymlos and Prolia are both brand-name drugs. There are currently no generic or biosimilar forms of either drug.

Common questions about Tymlos

Here are answers to some frequently asked questions about Tymlos.

Can Tymlos cause weight gain or weight loss?

You shouldn’t have changes in your weight from taking Tymlos. Weight gain and weight loss side effects weren’t reported in clinical trials of people taking this drug.

In some cases, weight loss can be a sign of an increased calcium level in your blood or kidney stones. These conditions are also possible side effects of Tymlos. For more information, see the “Tymlos side effects” section above.)

If you have any unexpected changes in your weight while you’re taking Tymlos, talk with your doctor. They may give you blood tests to see what’s causing your weight loss or weight gain.

How long can I use Tymlos?

You shouldn’t use Tymlos for more than 2 years. This is because Tymlos and other parathyroid medications may increase your risk for developing osteosarcoma (a form of bone cancer).* Parathyroid medications work to increase bone density and strength.

In fact, it’s recommended that you don’t use Tymlos or other parathyroid medications for more than 2 years in your lifetime. Limiting use like this may help prevent bone cancer from developing.

After 2 years of treatment with Tymlos, talk with your doctor about other options for treating osteoporosis.

* For more information, see “Does Tymlos cause bone cancer?” just below.

Will I be able to have dental work while using Tymlos?

You’ll likely be able to have dental work while you’re taking Tymlos. This drug shouldn’t cause any problems with healing after you’ve had dental work.

However, other medications used to treat osteoporosis may cause problems with healing after dental work. Specifically, some drugs may increase your risk for osteonecrosis of the jaw. Other osteoporosis medications can cause your jaw bone to become exposed after a dental procedure, which can delay healing. (With an exposed jaw bone, the bone is visible through holes in your gums.)

Some medications that may cause these jaw problems include:

• alendronate (Fosamax)
• denosumab (Prolia)
• ibandronate (Boniva)
• risedronate (Actonel)
• zoledronic acid (Reclast)

If you’re taking any of the drugs listed above, talk with your doctor before having any dental work. In some cases, they may suggest that you stop using the medication before your procedure. Once your mouth has healed, your doctor may have you restart your treatment.

However, if you’re taking Tymlos, you don’t need to stop using it before a dental procedure.

Could taking Tymlos lead to depression?

No, depression isn’t a known side effect of Tymlos. Clinical trials looked at people taking Tymlos for up to 25 months, and depression wasn’t reported as a side effect.

However, osteoporosis may be related to depression. (Tymlos is used to treat osteoporosis.) With osteoporosis, your bones are weakened, and they may fracture more easily than usual. According to one study, having bone fractures may affect your quality of life. This may cause you to feel depressed. For instance, you may feel anxious about falling and developing another fracture.

There’s also some evidence that depression may increase your risk for developing osteoporosis. Some antidepressants may lower your body’s ability to form new bone tissue and cause you to lose bone. Examples of these antidepressants include fluoxetine (Prozac) and escitalopram (Lexapro).

If you have concerns about depression while you’re taking Tymlos, talk with your doctor. They’ll be able to help you determine what’s causing your depression and recommend the best way to treat it.

Can Tymlos be used by men as well as women?

It’s not known if Tymlos is safe for males* to use. The drug has been studied only in females* who have gone through menopause.

However, there’s an ongoing clinical trial that’s studying the use of Tymlos in males with osteoporosis. It’s possible that this medication may be approved for use in males. But at this time, Tymlos is approved to treat only osteoporosis in certain females.

If you have questions about osteoporosis treatments given your gender, talk with your doctor.

* Sex and gender exist on spectrums. Use of the terms “male” and “female” in this article refers to sex assigned at birth.

Should I be concerned about osteonecrosis when using Tymlos?

No. You shouldn’t be concerned about osteonecrosis while you’re taking Tymlos. Osteonecrosis isn’t a side effect of the drug.

With osteonecrosis, bones don’t have enough blood flow, and as a result, some bones can die. The condition can cause painful bones.

However, other medications used to treat osteoporosis may cause osteonecrosis. Examples of these medications include:

• alendronate (Fosamax)
• denosumab (Prolia)
• ibandronate (Boniva)
• risedronate (Actonel)
• zoledronic acid (Reclast)

Keep in mind that using Tymlos shouldn’t lead to osteonecrosis.

Does Tymlos build bone?

Yes, Tymlos can help your body build new bone tissue. This isn’t the case with several other drugs used for osteoporosis.

Most medications used to treat osteoporosis work by stopping the breakdown of bone tissue. Although these drugs may slow down how quickly osteoporosis gets worse, they don’t build bone tissue.

Tymlos, on the other hand, does build bone tissue. The drug causes osteoblasts (a type of cell in bones) to work harder than usual. Osteoblasts build new bone. Tymlos activates your osteoblasts and helps your body replace bone that osteoporosis has destroyed.

For more information on how Tymlos works, see the “How Tymlos works” section below.

Can I still take calcium and vitamin D supplements while using Tymlos?

Yes, if you’re already taking calcium or vitamin D supplements, you can most likely keep taking them while you’re using Tymlos. Calcium helps to strengthen your bones, and vitamin D helps your body absorb calcium. So these nutrients are important in people with osteoporosis, which Tymlos is used to treat.

Before you start taking Tymlos, your doctor will probably check your blood levels of calcium and vitamin D. Your doctor may also ask you about your diet. This will help them learn how much calcium and vitamin D you’re getting from the foods and drinks you’re consuming.

In some cases, your doctor may recommend that you take a calcium and vitamin D supplement along with Tymlos. Talk with your doctor about whether this is something you’ll need to do.

Does Tymlos cause bone cancer?

Tymlos use may increase the risk of bone cancer.

It’s not known if Tymlos causes bone cancer in humans. This wasn’t reported in human studies of Tymlos. However, animals given abaloparatide (the active drug in Tymlos) in studies had an increased risk for developing the disease. With higher doses, the animals had an even greater risk for bone cancer.

Tymlos used to have a boxed warning about risk of bone cancer. A boxed warning is the most serious warning from the Food and Drug Administration (FDA). Tymlos no longer has this boxed warning, however.

Symptoms of bone cancer can include:

• bone pain
• swelling in the area
• increased risk of fractures
• feeling more tired than usual

Your doctor won’t prescribe Tymlos if you have certain conditions or health factors that may increase your risk for developing bone cancer. These conditions include:

• Paget’s disease of the bone (a disease in which bones become larger and more fragile than normal)
• increased level of alkaline phosphatase (ALP)
• bones that are still growing
• cancer that has spread to your bones or any cancer that affects your bones
• having radiation therapy in the past that involved your bones
• genetic conditions that make it more likely for you to develop bone cancer

If any of the above applies to you, tell your doctor before taking Tymlos. They may prescribe a medication other than Tymlos to treat your osteoporosis.

Because of the lack of clinical studies and the possible risk of bone cancer, it’s not recommended that you use Tymlos for more than 2 years throughout your lifetime. You also shouldn’t use other parathyroid medications, such as teriparatide, while you are taking Tymlos.

How to use Tymlos

You should use Tymlos according to your doctor’s or healthcare professional’s instructions. Tymlos comes as a solution inside prefilled pens. The drug is given as a subcutaneous injection (an injection under your skin).

Below, we describe how to use Tymlos pens to administer your doses of the drug. But your doctor or healthcare professional will also show you how to give yourself injections of the drug.

How to inject Tymlos

Before you use Tymlos, your doctor or healthcare professional will teach you how to inject the drug. You shouldn’t try to inject Tymlos before you’ve been shown how to do so properly.

Tymlos should be injected once per day. The injection site that you should use for this drug is your lower belly area. But don’t inject the drug within 2 inches of your belly button. The skin near your belly button is thicker than the skin on the rest of your belly. Injecting Tymlos too close to your belly button may keep your body from fully absorbing the drug.

Tymlos injections should be administered under your skin. They shouldn’t ever be administered into a muscle or vein.

You should change injection sites with each dose of the drug. This means that you should inject the drug into different areas every day. Injecting in the same spot over and over may cause lumps to form under your skin. And when this happens, your body may not fully absorb the medication.

The first time you use Tymlos, your doctor may recommend that you inject the drug while you’re sitting or lying down. Doing this may help prevent symptoms of orthostatic hypotension. In most cases, orthostatic hypotension occurs within 4 hours of your dose. During this time, it’s best to be someplace where you can easily sit or lie down if needed. (For information on this possible side effect, see the “Tymlos side effects” section above.)

For more information on the proper way to inject Tymlos, see the dosing instructions. You’ll also find a video that shows how to use the Tymlos pen.

When to take

You should take your dose of Tymlos once per day, at about the same time each day. This will help ensure that the amount of drug is consistent in your body all the time.

To help make sure that you don’t miss a dose, try using a medication reminder. This can include setting an alarm on your phone or downloading a reminder app. A kitchen timer can work, too.

Taking Tymlos with food

You can take your dose of Tymlos with or without food.

Tymlos for osteoporosis

The Food and Drug Administration (FDA) approves prescription drugs such as Tymlos to treat certain conditions.

Tymlos is used to treat osteoporosis after menopause. Osteoporosis is a disease that causes your bones to become weak. With this condition, your bones may fracture or break more easily than usual.

Osteoporosis may be caused by many factors, including changes in your hormone levels. Having decreased levels of calcium or vitamin D may also lead to osteoporosis.

Specifically, Tymlos should be used by those who have a high risk for bone fracture. The risk of fracture is higher if:

• you have a history of fractures due to osteoporosis
• other medications to treat osteoporosis either didn’t work for you or you couldn’t take them

Your risk for this condition is increased if you have more than one risk factor for it.

Tymlos works to treat osteoporosis by increasing your bone density and strength.

Effectiveness for osteoporosis

Tymlos was shown to be effective in treating osteoporosis in females who have gone through menopause and have a high risk for fractures. (Sex and gender exist on spectrums. Use of the term “female” in this article refers to sex assigned at birth.)

In clinical trials, some females took Tymlos, while other females took a placebo. (A placebo is a treatment with no active drug.) After 18 months of treatment, fractures occurred in:

• 0.6% of females taking Tymlos
• 4.2% of females taking a placebo

After 25 months of treatment, fractures occurred in:

• 0.6% of females taking Tymlos
• 4.4% of females taking a placebo

Females taking Tymlos also had improvements in their bone mineral density (BMD). BMD is a measurement that shows how strong your bones are.

In the studies, after 18 months of treatment, the following changes in BMD were reported.

* The femoral neck is the part of your thigh bone that meets your hip bone.

After 25 months of treatment, the following increases in BMD were reported.

* The femoral neck is the part of your thigh bone that meets your hip bone.

Tymlos use with other treatments

Tymlos is approved to treat osteoporosis in certain people. With osteoporosis, you have weakened bones.

Calcium helps to strengthen your bones, and vitamin D helps your body absorb calcium. So these nutrients are important in people with osteoporosis.

If you don’t get enough calcium or vitamin D in your diet, your doctor may recommend that you take these nutrients as supplements with Tymlos.

Before you start using Tymlos, your doctor may test your calcium and vitamin D blood levels. If the levels are low, your doctor may recommend that you take calcium and vitamin D each day to help keep your bones strong.

Tymlos expiration, storage, and disposal

When you get Tymlos from the pharmacy, the pharmacist will add an expiration date to the label on your medication. This date is typically 1 year from the date they dispensed the drug.

The expiration date helps guarantee that the medication is effective during this time. The current stance of the Food and Drug Administration (FDA) is to avoid using expired medications. If you have unused medication that has gone past the expiration date, talk with your pharmacist about whether you should still use it.

Storage

How long a medication remains good can depend on many factors, including how and where you store the medication.

Before they’re being used, Tymlos prefilled pens should be stored in a refrigerator at a temperature between 36°F and 46°F (2°C and 8°C). After you’ve used a pen for the first time, it should be stored at room temperature (68°F to 77°F/20°C to 25°C). Tymlos pens can be kept at room temperature for up to 30 days.

Tymlos should not be frozen or placed in a hot area.

Disposal

Right after you’ve used a syringe, needle, or autoinjector, dispose of it in an FDA-approved sharps disposal container. This helps prevent others, including children and pets, from taking the drug by accident or harming themselves with the needle. You can buy a sharps container online, or ask your doctor, pharmacist, or health insurance company where to get one.

This article provides several useful tips on medication disposal. You can also ask your pharmacist for information on how to dispose of your medication.

Tymlos interactions

Tymlos isn’t known to interact with other medications, supplements, or foods. But that doesn’t mean that interactions aren’t possible.

Different interactions can cause different effects. For instance, some interactions can interfere with how well a drug works. Other interactions can increase side effects or make them more severe.

Before taking Tymlos, talk with your doctor or pharmacist. Tell them about all prescription, over-the-counter, and other drugs you take. Also tell them about any vitamins, herbs, and supplements you use. Sharing this information can help you avoid possible interactions.

Tymlos and alcohol

There aren’t any known interactions between Tymlos and alcohol. If you have questions about drinking alcohol while using this medication, talk with your doctor or pharmacist.

Tymlos cost

As with all medications, the cost of Tymlos can vary. The actual price you’ll pay depends on your insurance plan, your location, and the pharmacy you use.

Before approving coverage for Tymlos, your insurance company may require you to get prior authorization. This means that your doctor and insurance company will need to communicate about your prescription before the insurance company will cover the drug. The insurance company will review the prior authorization request and decide if the drug will be covered.

If you’re not sure if you’ll need to get prior authorization for Tymlos, contact your insurance company. There is also a tool on the Tymlos webpage that you can use to see if your insurance will cover the drug.

Financial and insurance assistance

If you need financial support to pay for Tymlos, or if you need help understanding your insurance coverage, help is available.

Radius Health, Inc., the manufacturer of Tymlos, offers a program called Together with Tymlos. For more information and to find out if you’re eligible for support, call 866-896-5674 or visit the program website. The Tymlos site also has a section on insurance coverage.

Generic version

Tymlos is not available in a generic form. A generic drug is an exact copy of the active drug in a brand-name medication. Generics tend to cost less than brand-name drugs.

How Tymlos works

Tymlos is approved to treat osteoporosis after menopause.

What happens in osteoporosis

Osteoporosis is a disease that causes your bones to become weak. With osteoporosis, your bones may fracture or break more easily than usual.

Usually, your body breaks down bone tissue and rebuilds it throughout your life. But sometimes, your body may break down bone faster than it can rebuild it. This may happen with certain hormonal changes, such as those that occur with menopause.

What Tymlos does

Tymlos helps your body build bone to replace the bone that’s been lost due to osteoporosis.

Tymlos contains a synthetic (lab-made) form of human parathyroid hormone. Tymlos works in the same way as your natural parathyroid hormone to increase bone density and strength.

This medication helps cells in your bone, called osteoblasts, work harder than usual. Osteoblasts are responsible for building bone. Tymlos activates your osteoblasts, helping your body build bone to replace bone that’s been destroyed by osteoporosis.

How long does it take to work?

Tymlos begins working to strengthen your bones after your first dose. But you may not notice that the drug is working. The effects of Tymlos may be seen on a bone mineral density test, which shows how strong your bones are.

Tymlos and pregnancy

Tymlos is approved for use only after menopause. After menopause, you’re no longer able to become pregnant.

It’s not known if Tymlos is safe to use during pregnancy. There haven’t been any animal or human studies to know what risks the drug may have if it’s used during pregnancy.

If you’re pregnant or planning to become pregnant, talk with your doctor. They can recommend a different medication to treat your osteoporosis.

Tymlos and birth control

It’s not known if Tymlos is safe to use during pregnancy. However, Tymlos is only approved to be used after menopause. After menopause, you’re no longer able to become pregnant.

If you’re sexually active and you or your partner can become pregnant, talk with your doctor. They can discuss other medications you can use to treat your osteoporosis.

For more information about taking Tymlos during pregnancy, see the “Tymlos and pregnancy” section above.

Tymlos and breastfeeding

Tymlos is approved for use after menopause. The drug hasn’t been studied in those who are breastfeeding. So you should avoid taking Tymlos while breastfeeding.

It isn’t known if Tymlos passes into breastmilk or if it can affect a breastfed child.

If you’re breastfeeding, talk with your doctor about what medications are safe for treating your osteoporosis.

Tymlos precautions

This drug comes with several precautions.

Before taking Tymlos, talk with your doctor about your health history. Tymlos may not be right for you if you have certain medical conditions or other factors affecting your health. These include:

• Increased risk of bone cancer. Tymlos may increase the risk of bone cancer. (See “Does Tymlos cause bone cancer?” in “Common questions about Tymlos” above for details.) Your doctor won’t prescribe Tymlos if you have certain conditions or health factors that may increase your risk of bone cancer. These include Paget’s disease of the bone and increased alkaline phosphatase (ALP) levels. Having bones that are still growing or some genetic conditions may also increase your risk. Also, having cancer that affects your bones or any history of radiation therapy involving your bones increases your risk of bone cancer. Be sure to talk with your doctor about your current and past health before starting Tymlos.
• High parathyroid hormone levels. If your blood level of parathyroid hormone is high, or if you’ve had an increased level in the past, talk with your doctor before you use Tymlos. The drug can increase your parathyroid hormone levels. If they are already high, the increase can be dangerous. Your doctor will be able to order a blood test to check your levels and make sure they aren’t too high.
• History of kidney or bladder stones. Tymlos can cause increased calcium in your urine. Sometimes, this increase may cause you to develop kidney stones, which are mineral deposits that form in the kidneys. This increase may also cause bladder stones, which are small stones that form in the bladder. If you have a history of kidney or bladder stones, your risk for developing them while taking Tymlos may increase. Talk with your doctor before starting Tymlos if you have had kidney or bladder stones.
• Allergic reaction. If you’ve had an allergic reaction to Tymlos or any of its ingredients, you shouldn’t use Tymlos. Ask your doctor what other medications are better options for you.
• Pregnancy. You shouldn’t use Tymlos while pregnant. This medication is approved only for use after menopause. After menopause, you’re no longer able to become pregnant. For more information, see the “Tymlos and pregnancy” section above.
• Breastfeeding. You shouldn’t use Tymlos while you’re breastfeeding. This medication is approved for use only after menopause. For more information, see the “Tymlos and breastfeeding” section above.

Note: For more information about the potential negative effects of Tymlos, see the “Tymlos side effects” section above.