Tymlos
Pronunciation: tim lows’
Generic name: abaloparatide [ a-BAL-oh-PAR-a-tide ]
Dosage form: injection pen
Drug class: Parathyroid hormone and analogs
What is Tymlos?
Tymlos injection is a prescription medicine used to treat osteoporosis in men and postmenopausal women who are at high risk for fracture or patients who have failed or are intolerant to other available osteoporosis therapies. Tymlos injection helps to stimulate the natural bone-rebuilding process to increase bone mineral density and bone strength, which may prevent fractures.
Tymlos is a man-made form of parathyroid hormone that is found naturally in the body and influences bone remodeling. Tymlos (abaloparatide) works by acting on specific receptors (PTH1 receptor) that stimulate osteoblasts (cells that lay down new bone), which increases bone mass (bone mineral density).
Tymlos is given as an injection under the skin (subcutaneous injection) daily using the Tymlos pen (autoinjector).
Tymlos is a human parathyroid hormone-related peptide (PTHrP) analog.
Who can use Tymlos?
Tymlos FDA approved to be used to treat:
- postmenopausal women with osteoporosis.
- men with osteoporosis to help increase bone density
Tymlos injection is used for patients who are at high risk for fracture or patients who have failed or are intolerant to other available osteoporosis therapies.
Patients should take calcium and vitamin D supplements if their dietary intake is inadequate.
This medicine should be used for a maximum of 24 months over a lifetime
Tymlos side effects
Common Tymlos side effects
Common Tymlos side effects in postmenopausal women are:
- Too much calcium in the urine, hypercalciuria 11%
- Dizziness 10%
- Nausea 8%
- Headache 8%
- Fast heart rate, palpitations 5%
- Feeling very tired, fatigue 3%
- Spinning sensation, vertigo 2%
- Injection site reactions.
The common side effects in postmenopausal women occurred in 2% or more of Tymlos patients in the Study 003 clinical trial (NCT 01343004).
Common Tymlos side effects in men are:
- Injection site redness 13%
- Dizziness 9%
- Joint pain 7%
- Injection site swelling 7%
- Injection site pain 6%
- Bruising 3%
- Stomach bloating or distension 3%
- Diarrhea 3%
- Nausea 3%
- Stomach pain 2%
- Bone pain 2%
The common side effects in men occurred in 2% or more of Tymlos patients in Study 019 (NCT 03512262).
Serious Tymlos side effects
Get emergency medical help if you have signs of an allergic reaction to Tymlos: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.
Tymlos may cause other serious side effects, call your doctor at once if you have:
- a light-headed feeling, like you might pass out (may occur within 4 hours after injection);
- bone pain;
- unusual body aches;
- a new or worsening lump or swelling under your skin;
- pounding heartbeats or fluttering in your chest;
- high calcium levels - confusion, tiredness, nausea, vomiting, loss of appetite, constipation, increased thirst or urination, weight loss; or
- signs of a kidney stone - severe pain in your side or lower back, blood in your urine, painful or difficult urination.
This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
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Warnings
The active ingredient in Tymlos has caused bone cancer (osteosarcoma) in animals but it is not known whether this would occur in people using this medicine. Talk with your doctor about your own risk.
Call your doctor at once if you have bone pain, unusual body aches, or a lump or swelling under your skin.
Avoid smoking cigarettes or drinking alcohol. Smoking or heavy drinking can reduce your bone mineral density, making fractures more likely.
What is the cost of Tymlos?
The cost of prescription drugs varies depending on your insurance plan and which pharmacy you use. Refer to our Tymlos Prices, Coupons, Copay Cards & Patient Assistance page for more information about the cost.
Tymlos copay card
You may pay as little as $0 out-of-pocket for a 30-day supply of Tymlos if you qualify for the Tymlos copay card (Tymlos coupon). The Copay card (Savings card) is available for patients with commercial or private insurance, who are over 18 years old with a valid prescription for this medicine.
It is not available for prescriptions covered by state or federal government-funded healthcare programs, such as Medicare (including Part D), Medicare Advantage, Medigap, Medicaid, TRICARE, Department of Defense, and Veterans Administration.
Before taking this medicine
You should not use Tymlos injections if you are allergic to the active ingredient abaloparatide, or any of the inactive ingredients.
Tymlos injection is not for use in children or young adults whose bones are still growing.
To make sure Tymlos injections are safe for you, tell your doctor if you have ever had:
- Paget's disease or a bone disease other than osteoporosis;
- high blood levels of calcium;
- overactive parathyroid glands;
- bone cancer or radiation treatment involving your bones;
- a kidney stone. or
- trouble injecting yourself with Tymlos and you do not have someone to help you.
Abaloparatide, the active ingredient, has caused bone cancer (osteosarcoma) in animals but it is not known whether this would occur in people using this medicine. Talk with your doctor about your own risk.
Tymlos is for use only in women who can no longer get pregnant. It is not known whether this medicine will harm an unborn baby. Tell your doctor if you think you may be pregnant.
It may not be safe to breastfeed while using this medicine. Ask your doctor about any risk.
How should I use Tymlos?
Tymlos is injected under the skin, usually once per day using the Tymlos pen. Each Tymlos pen contains 30 doses.
Injections should be given in the lower stomach area (abdomen). Avoid the 2- inch area around your belly button (navel). Use a different place each time you give an injection. Do not inject into the same place two times in a row
Use Tymlos injection at the same time each day with or without food or drink.
Prepare an injection only when you are ready to give it. Call your pharmacist if the medicine looks cloudy, has changed colors or has particles in it
Use only the injection pen provided with Tymlos. Do not transfer the medicine to a syringe or other injection device or you could get an overdose.
Never share a Tymlos injection pen, cartridge, or syringe even if you changed the needle. Sharing these devices can pass infections from person to person.
Tymlos injection can cause dizziness. Always give your injection at a time and place where you can sit or lie down for a short time.
General information
A healthcare provider may teach you how to properly use the medication by yourself.
Read and carefully follow these Instructions for Use which also contain diagrams. Ask your doctor or pharmacist if you don't understand all the instructions.
Use Tymlos exactly as prescribed by your doctor. Follow all directions on your prescription label and read all medication guides or instruction sheets.
Use a needle and syringe only once and then place them in a puncture-proof "sharps" container. Follow state or local laws about how to dispose of this container. Keep it out of the reach of children and pets.
Tymlos is only part of a complete treatment program that also includes diet changes, exercise, taking vitamin or mineral supplements, and changing certain behaviors. Follow your doctor's instructions very closely.
You may need medical tests during and after treatment.
Before first use, store the medication in the refrigerator.
After first use, store the medication for up to 30 days at room temperature.
Do not freeze or expose to heat.
Each prefilled injection pen contains enough abaloparatide for 30 separate injections. Throw the pen away after 30 days, even if there is still medicine left inside.
Tymlos dosing information
Usual Adult Tymlos Dose for Osteoporosis: 80 mcg subcutaneously once a day
General dosing information:
- This medicine should be used for a maximum of 24 months over a lifetime.
- Patients should also take calcium and vitamin D supplements if dietary intake is inadequate.
Dosage Forms and Strength
Tymlos pen:
- 3120 mcg/1.56 ml (2000 mcg/ml) of abaloparatide .
- The prefilled pen delivers 30 daily doses of 80 mcg abaloparatide in 40 mcl.
What happens if I miss a dose?
Use the missed dose on the same day you remember it. Use your next dose at the regular time and stay on your once-daily schedule. Do not use 2 doses in one day.
What happens if I overdose?
Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.
Overdose symptoms may include headache, dizziness, vomiting, rapid heartbeats, feeling light-headed, or fainting.
What should I avoid while using Tymlos?
Avoid getting up too fast from a sitting or lying position, or you may feel dizzy. Get up slowly and steady yourself to prevent a fall.
Avoid smoking, or try to quit. Smoking can reduce your bone mineral density, making fractures more likely.
Avoid drinking large amounts of alcohol. Heavy drinking can also cause bone loss.
What other drugs will affect Tymlos?
Other drugs may interact with abaloparatide, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell your doctor about all your current medicines and any medicine you start or stop using.
Not all possible drug interactions are listed here.
Tymlos Package Insert
HCPs and patients often use the Tymlos Package Insert (PI) for more detailed information about this medicine. The Package Insert (prescribing information) contains more comprehensive information on Indications and Usage, Dosage and Administration, Clinical Pharmacology, Clinical Studies, Drug Interaction, and more. Discuss any medical questions you have with your HCP (health care professional). This is not all the information you need to know about this medicine for safe and effective use, and it does not take the place of talking to your doctor about your treatment.
The Package Insert is sometimes called Tymlos Prescribing Information (PI) or FDA label.
Storage
- Before first use, store pens in the refrigerator between 36°F to 46°F (2°C to 8°C).
- After first use, store your pen for up to 30 days at room temperature between 68°F to 77°F (20°C to 25°C).
- Do not freeze the pen or expose it to heat.
- Do not use the pen after the expiration date printed on the pen and packaging.
- Throw away the pen after 30 days after you start using it even if some medicine is left in the pen.
Ingredients
Active ingredient: abaloparatide
Inactive ingredients: acetic acid, phenol, sodium acetate trihydrate, and water for injection.
Company
Tymlos manufacturer Radius Health, Inc., 22 Boston Wharf Road, 7th Floor, Boston, MA 02210
Popular FAQ
Can Tymlos cause bone cancer?
Some animal studies have found that Tymlos is associated with an increase in the risk of osteosarcoma (a type of cancerous bone tumor). It is not known if this increased risk translates to humans; however, authorities have warned that Tymlos should not be given to people already at increased risk of osteosarcoma, including those with Paget's disease of the bone, pre-existing bone malignancies, prior radiation therapy, or hereditary disorders that increase their risk of osteosarcoma. Continue reading
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Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.