Abaloparatide

Generic name: abaloparatide [ a-BAL-oh-PAR-a-tide ]
Brand name: Tymlos
Dosage form: subcutaneous solution (3120 mcg/1.56 mL)
Drug class: Parathyroid hormone and analogs

Medically reviewed by Drugs.com on Jan 20, 2023. Written by Cerner Multum.

What is abaloparatide?

Abaloparatide is used to treat osteoporosis in postmenopausal women who have a high risk of bone fracture.

Abaloparatide is also used to increase bone density in men with osteoporosis who are at high risk for bone fracture.

Abaloparatide is used to treat people who cannot use another treatment for osteoporosis or other treatments did not work well.

Abaloparatide may also be used for purposes not listed in this medication guide.

Warnings

Abaloparatide has caused bone cancer (osteosarcoma) in animals but it is not known whether this would occur in people using abaloparatide. 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.

Before taking this medicine

You should not use abaloparatide if you are allergic to it.

Abaloparatide is not for use in children or young adults whose bones are still growing.

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

• f you have trouble injecting yourself with abaloparatide and do not have someone to help you.

Abaloparatide 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.

Abaloparatide is for use only in women who can no longer get pregnant. It is not known whether abaloparatide 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 abaloparatide?

Follow all directions on your prescription label and read all medication guides or instruction sheets. Use the medicine exactly as directed.

Abaloparatide is injected under the skin, usually once per day. A healthcare provider may teach you how to properly use the medication by yourself.

Read and carefully follow any Instructions for Use provided with your medicine. Ask your doctor or pharmacist if you don''t understand all instructions.

Never share an injection pen, cartridge, or syringe even if you changed the needle. Sharing these devices can pass infections from person to person.

Use abaloparatide 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 abaloparatide. Do not transfer the medicine to a syringe or other injection device or you could get an overdose.

Your healthcare provider will show you where on your body to inject abaloparatide. Use a different place each time you give an injection. Do not inject into the same place two times in a row.

Abaloparatide can cause dizziness. Always give your injection at a time and place where you can sit or lie down for a short time.

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.

Abaloparatide 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.

Abaloparatide is often given for only 2 years. Your doctor will determine how long to treat you with abaloparatide.

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 abaloparatide?

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.

Abaloparatide side effects

Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Abaloparatide may cause 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--pain in your side or lower back, blood in your urine, painful or difficult urination.

Common side effects of abaloparatide may include:

• dizziness, spinning sensation;

• redness, swelling and pain at the injection site;

• joint and bone pain;

• bruising;

• headache;

• fast heart rate;

• nausea, upper stomach pain, bloating, diarrhea; or

• feeling very tired.

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.

Abaloparatide dosing information

Usual Adult Dose for Osteoporosis:

80 mcg subcutaneously once a day

Comments:
-Cumulative use of this drug and parathyroid hormone analogs (e.g., teriparatide) for more than 2 years during a patient''s lifetime is not recommended.
-Patients should receive supplemental calcium and vitamin D if dietary intake is inadequate.

Use: For the treatment of postmenopausal women with osteoporosis at high risk for fracture defined as a history of osteoporotic fracture, multiple risk factors for fracture, or patients who have failed or are intolerant to other available osteoporosis therapy; in postmenopausal women with osteoporosis, this drug reduces the risk of vertebral fractures and nonvertebral fractures

What other drugs will affect abaloparatide?

Other drugs may affect abaloparatide, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell your doctor about all other medicines you use.

Where can I get more information?

Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Medical Disclaimer

Copyright 1996-2023 Cerner Multum, Inc. Version: 4.01.

Abaloparatide (Subcutaneous)

Medically reviewed by Drugs.com. Last updated on Jul 19, 2022.

Commonly used brand name(s)

In the U.S.

• Tymlos

Available Dosage Forms:

• Solution

Therapeutic Class: Endocrine-Metabolic Agent

Uses for abaloparatide

Abaloparatide is used to treat osteoporosis, and reduces the risk of having bone and spine fractures, in postmenopausal women with osteoporosis. It also increases bone density in men with osteoporosis who are at high risk for bone fracture, or who cannot use another osteoporosis treatment or other osteoporosis treatments did not work well.

Abaloparatide is available only with your doctor''s prescription.

Before using abaloparatide

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For abaloparatide, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to abaloparatide or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Appropriate studies have not been performed on the relationship of age to the effects of abaloparatide injection in the pediatric population. Safety and efficacy have not been established. Use is not recommended in children with open epiphyses (bones are still growing) or genetic disorders.

Geriatric

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of abaloparatide injection in the elderly. However, elderly patients are more sensitive to the effects of abaloparatide than younger adults.

Breastfeeding

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Interactions with medicines

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. Tell your healthcare professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine.

Interactions with food/tobacco/alcohol

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other medical problems

The presence of other medical problems may affect the use of abaloparatide. Make sure you tell your doctor if you have any other medical problems, especially:

• Bone cancer, or history of or
• High levels of alkaline phosphatase (enzyme found in the bones) or
• Paget''s disease of the bone—Use with caution. May increase the risk of developing bone cancer (osteosarcoma).

• Hypercalcemia (high calcium levels in the blood) or
• Hypercalciuria (high calcium levels in the urine) or
• Hyperparathyroidism (overactive parathyroid) or
• Kidney stones, history of—Use with caution. May cause side effects to become worse.

• Kidney disease, severe—Use with caution. The effects may be increased because of slower removal of the medicine from the body.

Proper use of abaloparatide

A nurse or other trained health professional will give you abaloparatide. It is given as a shot under your skin, usually in the stomach area.

Abaloparatide comes with a Medication Guide and patient instructions. Read and follow the instructions carefully. Ask your doctor if you have any questions.

Abaloparatide may sometimes be given at home to patients who do not need to be in a hospital or clinic. If you are using abaloparatide at home, your doctor or nurse will teach you how to prepare and inject the medicine. Be sure that you understand how to use the medicine.

You should receive the first several injections of abaloparatide while sitting or lying down if needed, until you know how abaloparatide affects you.

If you use abaloparatide at home, you will be shown the body areas where this shot can be given. Use a different body area each time you give yourself a shot. Keep track of where you give each shot to make sure you rotate body areas. This will help prevent skin problems. Do not inject into skin areas that are tender, bruised, red, scaly, or hard.

Use a new needle each time you inject your medicine. Do not store the prefilled pen with the needle attached.

If the medicine in the prefilled syringe has changed color, or if you see particles in it, do not use it.

You may take calcium and vitamin D supplements while you are using abaloparatide if needed. Follow your doctor''s instructions about how to take these supplements.

Use of abaloparatide for more than 2 years during your lifetime is not recommended.

Dosing

The dose of abaloparatide will be different for different patients. Follow your doctor''s orders or the directions on the label. The following information includes only the average doses of abaloparatide. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

• For injection dosage form (prefilled pen):
  • For osteoporosis in postmenopausal women:
    • Adults—80 micrograms (mcg) injected under the skin once a day.
    • Children—Use and dose must be determined by your doctor.

Missed dose

If you miss a dose of abaloparatide, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Storage

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

Before first use: Store the medicine in the refrigerator. Do not freeze.

After first use: Store the medicine at room temperature, away from heat and direct light for up to 30 days. Do not freeze.

You might not use all of the medicine in each prefilled pen. Throw away any unused medicine that has been stored at room temperature after 30 days.

Throw away used needles in a hard, closed container that the needles cannot poke through. Keep this container away from children and pets.

Precautions while using abaloparatide

It is very important that your doctor check your progress at regular visits to make sure abaloparatide is working properly. Blood and urine tests may be needed to check for unwanted effects.

Abaloparatide may increase your risk of having osteosarcoma (bone cancer). This is more likely to occur if you have a history of radiation treatment involving your bones. Check with your doctor right away if you have bone pain that does not go away or a new soft tissue mass that is tender to palpation.

Abaloparatide may cause some people to become dizzy or drowsy. Make sure you know how you react to abaloparatide before you drive, use machines, or do anything else that could be dangerous if you are not alert.

Dizziness, lightheadedness, or fainting may occur, especially when you get up from a lying or sitting position. Getting up slowly may help. If this problem continues or gets worse, check with your doctor.

Abaloparatide may increase levels of calcium in the blood and urine. High calcium in the urine may cause kidney stones. Call your doctor right away if you have blood in the urine, confusion, constipation, dry mouth, metallic taste, muscle weakness, nausea or vomiting, pain in the side, back, or stomach, or weight loss.

Abaloparatide side effects

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

More common

• Blood in the urine
• constipation
• depression
• loss of appetite
• loss of weight
• muscle weakness
• nausea or vomiting
• pain in the bone, joint, back, arms, or legs
• pain in the side, back, or stomach
• thirst
• unusual tiredness or weakness

Less common

• Fast, irregular, pounding, or racing heartbeat or pulse

Incidence not known

• Chest tightness
• cough
• difficulty swallowing
• dizziness
• fast heartbeat
• puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
• trouble breathing

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common

• Bleeding, blistering, burning, coldness, discoloration of skin, feeling of pressure, hives, infection, inflammation, itching, lumps, numbness, pain, rash, redness, scarring, soreness, stinging, swelling, tenderness, tingling, ulceration, or warmth at the injection site
• difficulty in moving
• headache
• muscle pain or stiffness

Less common

• Dizziness, faintness, or lightheadedness when getting up from a lying or sitting position
• feeling of constant movement of self or surroundings
• sensation of spinning
• unusual bruising

Incidence not known

• Diarrhea
• full or bloated feeling
• general feeling of discomfort or illness
• itching, rash
• lack or loss of strength
• muscle spasms of the leg and back
• pressure in the stomach
• swelling of the stomach area
• trouble sleeping
• unusual drowsiness, dullness, or feeling of sluggishness

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Medical Disclaimer