Generic Name: abaloparatide
Dosage Form: Injection, for Subcutaneous Use
Date of Approval: April 28, 2017
Company: Radius Health, Inc.
Treatment for: Osteoporosis
FDA Approves Tymlos
The U.S. Food and Drug Administration (FDA) has approved Tymlos (abaloparatide), a synthetic peptide analog of hPTHrP (human parathyroid hormone-related protein) for the treatment of postmenopausal women with osteoporosis at high risk for fracture defined as history of osteoporotic fracture, multiple risk factors for fracture, or patients who have failed or are intolerant to other available osteoporosis therapy.
Read this Medication Guide before you start treatment, and each time you get a refill. There may be new information. This information does not take the place of talking with your healthcare provider about your medical condition or treatment.
Tymlos may cause serious side effects including:
- Possible bone cancer (osteosarcoma). During animal drug testing, Tymlos caused some rats to develop a bone cancer called osteosarcoma. It is not known if people will have a higher chance of getting osteosarcoma.
- Tell your healthcare provider right away if you have pain in your bones, pain in any areas of your body that does not go away, or any new or unusual lumps or swelling under your skin that is tender to touch.
What is Tymlos?
Tymlos is a prescription medicine used to:
- decrease the chance of having a fracture of the spine and other bones in postmenopausal women with thinning and weakening bones (osteoporosis).
- treat osteoporosis in postmenopausal women who are at high risk for bone fracture.
It is not known if this medicine is safe and effective for children 18 years and younger.
- It is not recommended that people use Tymlos for more than two years during their lifetime.
Tymlos should not be used in children and young adults whose bones are still growing.
Before taking Tymlos
Before you start treatment, tell your healthcare provider about all of your medical conditions, including if you:
- have Paget’s disease of the bone or other bone disease.
- have or have had cancer in your bones.
- have or have had radiation therapy involving your bones.
- have or have had too much calcium in your blood.
- have or have had too much of an enzyme called alkaline phosphatase in your blood.
- have or have had an increase in your parathyroid hormone (hyperparathyroidism).
- will have trouble injecting yourself with the Tymlos pen and do not have someone who can help you.
- are pregnant or plan to become pregnant. Tymlos is not for pregnant women.
- are breastfeeding or plan to breastfeed. It is not known if Tymlos passes into your breast milk. You and your healthcare provider should decide if you will take Tymlos or breastfeed. You should not do both.
Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.
Know the medicines you take. Keep a list of them to show your healthcare provider or pharmacist each time you get a new medicine.
How should I use Tymlos?
- Read the detailed Instructions for Use provided with your medicine.
- Use this medicine exactly as your healthcare provider tells you to use it.
- Do not try to inject yourself until you or your caregiver receive training from a healthcare provider on the right way to use the injection pen.
- You should receive your first several injections where you can sit or lie down if necessary, until you know how it affects you.
- Inject Tymlos one time each day into your lower stomach area (abdomen) just under your skin (subcutaneous). Avoid giving your injection within the 2-inch area around your belly button (navel).
- Talk to your healthcare provider about how to change (rotate) your injection site for each injection. Do not give the injection in your veins (intravenously) or deep into your muscles (intramuscularly).
- You can take this medicine with or without food or drink.
- You should receive the injection at about the same time each day.
- If you forget or cannot receive the injection at your usual time, take it as soon as you can on that day.
- The pen has enough medicine for 30 days. It is set to give one dose of medicine with each injection. Do not take more than one injection in the same day.
- Do not transfer the medicine from the pen to a syringe. This can cause you to use the wrong dose. If you do not have pen needles to use with your pen, talk with your healthcare provider.
- Do not share your pen or pen needles with other people, even if the needle has been changed. You may give other people a serious infection, or get a serious infection from them.
- Tymlos should look clear and colorless. Do not use the injection if it has particles in it, or if it is cloudy or colored.
- Your healthcare provider may do blood and urine tests during your treatment.
- Your healthcare provider may ask you to have a bone mineral density test after your treatment.
- If you take more Tymlos than prescribed you may experience symptoms such as muscle weakness, low energy, headache, nausea, dizziness (especially when getting up after sitting for a while) and a faster heartbeat. Stop treatment and call your healthcare provider right away.
- If your healthcare provider recommends calcium and vitamin D supplements, you can take them while using Tymlos.
Tymlos side effects
Tymlos can cause serious side effects including:
- See Important information
- Decrease in blood pressure when you change positions. Some people may feel dizzy, have a faster heartbeat, or feel lightheaded soon after the injection is given. These symptoms generally go away within a few hours. Take your injections in a place where you can sit or lie down right away if you get these symptoms. If your symptoms get worse or do not go away, stop treatment and call your healthcare provider.
- Increased blood calcium (hypercalcemia). Tymlos can cause some people to have a higher blood calcium level than normal. Your healthcare provider may check your blood calcium before you start and during your treatment. Tell your healthcare provider if you have nausea, vomiting, constipation, low energy, or muscle weakness. These may be signs there is too much calcium in your blood.
- Increased urine calcium (hypercalciuria). Tymlos can cause some people to have higher levels of calcium in their urine than normal. Increased calcium may also cause you to develop kidney stones (urolithiasis) in your kidneys, bladder or urinary tract. Tell your healthcare provider right away if you get any symptoms of kidney stones which may include pain in your lower back or lower stomach area, pain when you urinate, or blood in your urine.
The most common side effects include:
- fast heartbeat
- feeling very tired (fatigue)
- upper stomach pain
These are not all the possible side effects. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
How should I store Tymlos?
- Before first use, store the injection 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 Tymlos after the expiration date printed on the pen and packaging.
- Throw away the pen after 30 days even if some medicine is left in the pen.
Keep all medicines out of the reach of children and pets.
General information about the safe and effective use of Tymlos.
Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use this medicine for a condition for which it was not prescribed. Do not give it to other people, even if they have the same condition you have. It may harm them.
You can ask your pharmacist or healthcare provider for information that is written for health professionals.
What are the ingredients?
Active ingredient: abaloparatide
Inactive ingredients: phenol, sodium acetate trihydrate, acetic acid, and water for injection.