Abaloparatide

Name: Abaloparatide

What is abaloparatide?

Abaloparatide is a man-made form of a hormone called parathyroid that exists naturally in the body. Abaloparatide increases bone density and increases bone strength to help prevent fractures.

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

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

How should I use abaloparatide?

Follow all directions on your prescription label. Do not use this medicine in larger or smaller amounts or for longer than recommended.

Abaloparatide is injected under the skin. You may be shown how to use injections at home. Do not give yourself this medicine if you do not understand how to use the injection and properly dispose of used needles and syringes.

Abaloparatide comes in a prefilled injection pen. Ask your pharmacist which type of needles are best to use with your pen.

Abaloparatide is usually given once per day. Use the medicine at the same time each day.

Your care provider will show you the best places 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.

The injection may cause dizziness. Until you know how this medicine will affect you, use each injection in a place where you can sit or lie down.

Use only the injection pen that comes with abaloparatide. Do not transfer the medicine from the pen into a syringe.

Do not use the medicine if it looks cloudy or has particles in it. Call your pharmacist for new medicine.

Use a disposable needle only once. Follow any state or local laws about throwing away used needles. Use a puncture-proof "sharps" disposal container (ask your pharmacist where to get one and how to throw it away). Keep this container out of the reach of children and pets.

Your doctor may have you take extra calcium and vitamin D supplements while you are using abaloparatide. Take only the type and amount of supplements your doctor has prescribed.

While using abaloparatide, you may need frequent blood and urine tests, and bone mineral density tests.

Store unopened injection pens in the refrigerator, do not freeze.

Once you start using an abaloparatide injection pen, store it at room temperature away from moisture and heat. Cover the pen with the outer needle cap. Do not store the pen with a needle attached.

After 30 days, throw away the injection pen even if it still contains medicine.

You should not use abaloparatide for longer than 2 years total.

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, muscle weakness, lack of energy, or rapid heartbeats.

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.

Call your doctor at once if you have:

  • bone pain;

  • unusual body aches;

  • a new or worsening lump or swelling under your skin;

  • pounding heartbeats or fluttering in your chest;

  • high levels of calcium in your blood--nausea, vomiting, constipation, weakness, tired feeling; or

  • symptoms of a kidney stone--severe pain in your side or lower back, blood in your urine, painful urination.

Common side effects may include:

  • dizziness, spinning sensation;

  • headache;

  • fast heart rate;

  • nausea, upper stomach pain; 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.

Drug Interactions

Specific Drugs

It is essential that the manufacturer's labeling be consulted for more detailed information on interactions with this drug, including possible dosage adjustments. Interaction highlights:

No specific drug-drug interaction studies have been performed.1

What do I need to tell my doctor BEFORE I take Abaloparatide?

  • If you have an allergy to abaloparatide or any part of this medicine.
  • If you are allergic to any drugs like this one, any other drugs, foods, or other substances. Tell your doctor about the allergy and what signs you had, like rash; hives; itching; shortness of breath; wheezing; cough; swelling of face, lips, tongue, or throat; or any other signs.
  • If you have any of these health problems: High calcium levels or overactive parathyroid gland.

This is not a list of all drugs or health problems that interact with abaloparatide.

Tell your doctor and pharmacist about all of your drugs (prescription or OTC, natural products, vitamins) and health problems. You must check to make sure that it is safe for you to take this medicine with all of your drugs and health problems. Do not start, stop, or change the dose of any drug without checking with your doctor.

How do I store and/or throw out Abaloparatide?

  • Store in a refrigerator. Do not freeze.
  • After first use, store at room temperature. Throw away any part not used after 30 days.
  • Protect from heat.
  • Keep all drugs in a safe place. Keep all drugs out of the reach of children and pets.
  • Check with your pharmacist about how to throw out unused drugs.

Consumer Information Use and Disclaimer

  • If your symptoms or health problems do not get better or if they become worse, call your doctor.
  • Do not share your drugs with others and do not take anyone else's drugs.
  • Keep a list of all your drugs (prescription, natural products, vitamins, OTC) with you. Give this list to your doctor.
  • Talk with the doctor before starting any new drug, including prescription or OTC, natural products, or vitamins.
  • This medicine comes with an extra patient fact sheet called a Medication Guide. Read it with care. Read it again each time this medicine is refilled. If you have any questions about abaloparatide, please talk with the doctor, pharmacist, or other health care provider.
  • If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.

This information should not be used to decide whether or not to take this medicine or any other medicine. Only the healthcare provider has the knowledge and training to decide which medicines are right for a specific patient. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about abaloparatide. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to this medicine. This information is not specific medical advice and does not replace information you receive from the healthcare provider. You must talk with the healthcare provider for complete information about the risks and benefits of using abaloparatide.

Review Date: October 4, 2017

Pronunciation

(a bal oh PAR a tide)

Dosing Adult

Osteoporosis: SubQ: 80 mcg once daily

Monitoring Parameters

Orthostatic hypotension; urinary calcium (patients with suspected active urolithiasis or preexisting hypercalciuria); bone mineral density (BMD) should be evaluated 1 to 2 years after initiating therapy and every 2 years thereafter (NOF [Cosman 2014]); serum calcium; consider measuring biochemical markers of bone turnover

Dialysis

Data not available

Other Comments

Administration advice:
-Administer as a subcutaneous injection into the periumbilical region of the abdomen; rotate the site of the injection every day.
-Administer at approximately the same time every day.
-Do not administer IV or IM.
-Administer the first several doses where the patient can sit or lie down if necessary, in case symptoms of orthostatic hypotension occur.

General:
-This drug is supplied as a clear and colorless solution. Visually inspect for particulate matter and discoloration prior to administration. Do not use if solid particles appear or if the solution is cloudy or colored.
-Provide appropriate training to patients and caregivers on the proper use of the delivery pen.

Abaloparatide Breastfeeding Warnings

Safety has not been established. Comments: -This drug is not indicated for use in female patients of reproductive potential. -There is no information on the presence of this drug in human milk, the effects on the breastfed infant, or the effects on milk production. Excreted into human milk: Unknown

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