Abaloparatide Subcutaneous

Name: Abaloparatide Subcutaneous

Commonly used brand name(s)

In the U.S.

  • Tymlos

Available Dosage Forms:

  • Solution

Therapeutic Class: Endocrine-Metabolic Agent

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 abdomen (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 and parathyroid hormone analogs 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.

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 urine
  • constipation
  • depression
  • loss of appetite
  • loss of weight
  • muscle weakness
  • nausea or vomiting
  • pain in the side, back, or stomach
  • thirst
  • unusual tiredness or weakness
Less common
  • Fast, irregular, pounding, or racing heartbeat or pulse

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
  • dizziness
  • headache
Less common
  • Feeling of constant movement of self or surroundings
  • sensation of spinning

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.

Side Effects

Dizziness or fast heartbeat may occur within 4 hours after using this medication. If these effects occur, sit or lie down right away. These symptoms usually go away within a few hours. These effects should go away after several doses as your body adjusts to the medication. Redness/pain/swelling at the injection site may also occur. If any of these effects last or get worse, tell your doctor or pharmacist promptly.

To reduce the risk of dizziness and lightheadedness, get up slowly when rising from a sitting or lying position.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell your doctor right away if you have any serious side effects, including: signs of a high level of calcium in the blood (such as nausea, vomiting, constipation, unusual tiredness, muscle weakness, mental/mood changes including confusion).

A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

List Abaloparatide Pen Injector side effects by likelihood and severity.

Interactions

Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval.

Overdose

If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center. Symptoms of overdose may include: nausea, vomiting, severe dizziness, unusual tiredness, headache.

Notes

Do not share this medication with others.

Lab and/or medical tests (such as blood calcium level, bone density) should be done while you are using this medication. Keep all medical and lab appointments.

Lifestyle changes that help promote healthy bones include increasing weight-bearing exercise, stopping smoking, limiting alcohol, and eating well-balanced meals that contain adequate calcium and vitamin D. You may also need to take calcium and vitamin D supplements. Consult your doctor for specific advice.

Missed Dose

If you miss a dose and remember on the same day, use it as soon as you remember. If you remember on the next day, skip the missed dose. Use your next dose at the regular time. Do not double the dose to catch up.

Storage

Refrigerate unopened pens. Do not freeze. After the first use of a pen, store it at room temperature for up to 30 days. Do not expose it to heat. Discard the pen after 30 days, even if there is still medication in the pen. Keep all medications away from children and pets.

Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company.Information last revised May 2017. Copyright(c) 2017 First Databank, Inc.

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