Abaloparatide

Name: Abaloparatide

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.

What other drugs will affect abaloparatide?

Other drugs may interact with abaloparatide, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell each of your health care providers about all medicines you use now and any medicine you start or stop using.

What are some other side effects of Abaloparatide?

All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:

  • Dizziness.
  • Upset stomach.
  • Headache.
  • Feeling tired or weak.
  • Belly pain.
  • Irritation where the shot is given.

These are not all of the side effects that may occur. If you have questions about side effects, call your doctor. Call your doctor for medical advice about side effects.

You may report side effects to the FDA at 1-800-FDA-1088. You may also report side effects at http://www.fda.gov/medwatch.

Pharmacologic Category

  • Parathyroid Hormone Analog

Use Labeled Indications

Osteoporosis: 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.

Limitations of use: Use of abaloparatide and parathyroid hormone analogs for >2 years is not recommended.

Storage

Store refrigerated at 2°C to 8°C (36°F to 46°F). Do not freeze or heat. After first use, store for up to 30 days at 20°C to 25°C (68°F to 77°F).

Patient Education

• Discuss specific use of drug and side effects with patient as it relates to treatment. (HCAHPS: During this hospital stay, were you given any medicine that you had not taken before? Before giving you any new medicine, how often did hospital staff tell you what the medicine was for? How often did hospital staff describe possible side effects in a way you could understand?)

• Patient may experience headache, loss of strength and energy, abdominal pain, or injection site irritation. Have patient report immediately to prescriber signs of high calcium (weakness, confusion, fatigue, headache, nausea and vomiting, constipation, or bone pain), signs of a kidney stone (back pain, abdominal pain, or hematuria), bone pain, skin edema, lump, persistent pain, severe dizziness, passing out, tachycardia, abnormal heartbeat, severe nausea, vomiting, or painful urination (HCAHPS).

• Educate patient about signs of a significant reaction (eg, wheezing; chest tightness; fever; itching; bad cough; blue skin color; seizures; or swelling of face, lips, tongue, or throat). Note: This is not a comprehensive list of all side effects. Patient should consult prescriber for additional questions.

Intended Use and Disclaimer: Should not be printed and given to patients. This information is intended to serve as a concise initial reference for health care professionals to use when discussing medications with a patient. You must ultimately rely on your own discretion, experience, and judgment in diagnosing, treating, and advising patients.

In Summary

Commonly reported side effects of abaloparatide include: dizziness and hypercalciuria. Other side effects include: nausea and palpitations. See below for a comprehensive list of adverse effects.

What are some side effects that I need to call my doctor about right away?

WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:

  • Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
  • Signs of high calcium levels like weakness, confusion, feeling tired, headache, upset stomach and throwing up, hard stools (constipation), or bone pain.
  • Very bad dizziness or passing out.
  • A fast heartbeat.
  • A heartbeat that does not feel normal.
  • Very upset stomach or throwing up.
  • Back pain, belly pain, or blood in the urine. May be signs of a kidney stone.
  • Pain when passing urine.

What are some other side effects of this drug?

All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:

  • Dizziness.
  • Upset stomach.
  • Headache.
  • Feeling tired or weak.
  • Belly pain.
  • Irritation where the shot is given.

These are not all of the side effects that may occur. If you have questions about side effects, call your doctor. Call your doctor for medical advice about side effects.

You may report side effects to the FDA at 1-800-FDA-1088. You may also report side effects at http://www.fda.gov/medwatch.

Liver Dose Adjustments

Data not available

Precautions

US BOXED WARNINGS:
RISK OF OSTEOSARCOMA:
-This drug caused a dose-dependent increase in the incidence of osteosarcoma, a malignant bone tumor, in animal studies. The effect was observed at systemic exposures ranging from 4 to 28 times the exposure in humans receiving the 80 mcg dose. It is unknown whether it can cause osteosarcoma in humans. Use is not recommended in patients at increased risk for osteosarcoma including those with Paget's disease of bone or unexplained elevations of alkaline phosphatase, open epiphyses, bone metastases or skeletal malignancies, hereditary disorders predisposing to osteosarcoma, or prior external beam or implant radiation therapy involving the skeleton. 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.

Safety and efficacy have not been established in patients younger than 18 years.

Consult WARNINGS section for additional precautions.

Abaloparatide Dosage

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.

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.

Use the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not use extra medicine to make up the missed dose.

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