Abaloparatide

Name: Abaloparatide

Uses for Abaloparatide

Abaloparatide has the following uses:

Abaloparatide is a PTHrP(1-34) analog indicated for the treatment of postmenopausal women with osteoporosis at high risk for fracture.1

Abaloparatide Dosage and Administration

General

Abaloparatide is available in the following dosage form(s) and strength(s):

Injection: 3120 mcg/1.56 mL (2000 mcg/mL) in a single-patient-use prefilled pen. The prefilled pen delivers 30 daily doses of 80 mcg abaloparatide in 40 mcL of sterile, clear, colorless solution.1

Dosage

It is essential that the manufacturer's labeling be consulted for more detailed information on dosage and administration of this drug. Dosage summary:

  • Recommended dose is 80 mcg subcutaneously once daily; patients should receive supplemental calcium and vitamin D if dietary intake is inadequate.1

  • Administer as a subcutaneous injection into periumbilical region of abdomen.1

  • Administer initially where the patient can sit or lie down in case symptoms of orthostatic hypotension occur.1

Cautions for Abaloparatide

Contraindications

None.1

Warnings/Precautions

Risk of Osteosarcoma

Abaloparatide caused a dose-dependent increase in the incidence of osteosarcoma in male and female rats after subcutaneous administration at exposures 4–28 times the human exposure at the clinical dose of 80 mcg. It is unknown whether abaloparatide will cause osteosarcoma in humans.1

The use of abaloparatide is not recommended in patients at increased risk of 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.1

Cumulative use of abaloparatide and parathyroid hormone analogs (e.g., teriparatide) for more than 2 years during a patient’s lifetime is not recommended. 1

Orthostatic Hypotension

Orthostatic hypotension may occur with abaloparatide, typically within 4 hours of injection. Associated symptoms may include dizziness, palpitations, tachycardia, or nausea, and may resolve by having the patient lie down. For the first several doses, abaloparatide should be administered where the patient can sit or lie down if necessary.1

Hypercalcemia

Abaloparatide may cause hypercalcemia. Abaloparatide is not recommended in patients with pre-existing hypercalcemia or in patients who have an underlying hypercalcemic disorder, such as primary hyperparathyroidism, because of the possibility of exacerbating hypercalcemia.1

Hypercalciuria and Urolithiasis

Abaloparatide may cause hypercalciuria. It is unknown whether abaloparatide may exacerbate urolithiasis in patients with active or a history of urolithiasis. If active urolithiasis or pre-existing hypercalciuria is suspected, measurement of urinary calcium excretion should be considered.1

Specific Populations

Pregnancy

Abaloparatide is not indicated for use in females of reproductive potential. There are no human data with abaloparatide use in pregnant women to inform any drug-associated risks. Animal reproduction studies with abaloparatide have not been conducted.

Lactation

Abaloparatide is not indicated for use in females of reproductive potential. There is no information on the presence of abaloparatide in human milk, the effects on the breastfed infant, or the effects on milk production.

Pediatric Use

Safety and effectiveness of abaloparatide have not been established in pediatric patients. Abaloparatide is not recommended for use in pediatric patients with open epiphyses or hereditary disorders predisposing to osteosarcoma because of an increased baseline risk of osteosarcoma.1

Geriatric Use

Of the total number of patients in the postmenopausal osteoporosis clinical studies of abaloparatide, 82% were age 65 years and over, and 19% were age 75 years and over. No overall differences in safety or effectiveness were observed between these subjects and younger subjects, but greater sensitivity of some older individuals cannot be ruled out.1

Renal Impairment

No dosage adjustment is required for patients with mild, moderate, or severe renal impairment. A study of a single dose of abaloparatide 80 mcg given subcutaneously was conducted in subjects with normal renal function or mild, moderate, or severe renal impairment. The maximal concentration (Cmax) and area under the concentration-time curve (AUC) of abaloparatide increased 1.4- and 2.1-fold, respectively, in subjects with severe renal impairment, compared to subjects with normal renal function. Patients with severe renal impairment may have increased abaloparatide exposure that may increase the risk of adverse reactions; therefore, monitor for adverse reactions.1

Common Adverse Effects

The most common adverse reactions (incidence ≥2%) are hypercalciuria, dizziness, nausea, headache, palpitations, fatigue, upper abdominal pain, and vertigo.1

Actions

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

Additional Information

AHFS First Release. For additional information until a more detailed monograph is developed and published, the manufacturer's labeling should be consulted. It is essential that the manufacturer's labeling be consulted for more detailed information on usual uses, dosage and administration, cautions, precautions, contraindications, potential drug interactions, laboratory test interferences, and acute toxicity.

What are some things I need to know or do while I take Abaloparatide?

  • Tell all of your health care providers that you take abaloparatide. This includes your doctors, nurses, pharmacists, and dentists.
  • To lower the chance of feeling dizzy or passing out, rise slowly if you have been sitting or lying down. Be careful going up and down stairs.
  • Have a bone density test as you have been told by your doctor. Talk with your doctor.
  • Have blood work checked as you have been told by the doctor. Talk with the doctor.
  • Have your urine checked as you have been told by your doctor.
  • Take calcium and vitamin D as you were told by your doctor.
  • Do not share pen or cartridge devices with another person even if the needle has been changed. Sharing these devices may pass infections from one person to another. This includes infections you may not know you have.
  • This medicine is not approved for women who have not been through menopause. If you are pregnant, plan on getting pregnant, or are breast-feeding, talk with your doctor.

If OVERDOSE is suspected

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.

Brand Names U.S.

  • Tymlos

Pregnancy Considerations

Abaloparatide is not indicated for use in women of reproductive potential. Animal reproduction studies have not been conducted.

Abaloparatide Drug Class

Abaloparatide is part of the drug class:

  • PARATHYROID HORMONES AND ANALOGUES

Dosing & Uses

Dosage Forms & Strengths

solution for SC injection

  • 80mcg/40mcL (available as a prefilled pen that delivers 30 daily doses of 80mcg)

Osteoporosis

Indicated 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, clinical trials showed abaloparatide reduces the risk of vertebral fractures and nonvertebral fractures

80 mcg SC qDay

Cumulative use of abaloparatide and parathyroid hormone (PTH) analogs for >2 yr not recommended (see Dosing Considerations and Black Box Warnings)

Patients should receive supplemental calcium and vitamin D if dietary intake is inadequate

Dosing Considerations

Limitations of use: Because of the unknown relevance of the rodent osteosarcoma findings to humans, cumulative use of abaloparatide and PTH analogs (eg, teriparatide) for >2 yr during a patient’s lifetime is not recommended

Safety and efficacy not established

Usual Adult Dose for Osteoporosis

80 mg 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 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.

In animal studies, abaloparatide caused bone cancer. It is not known whether this medicine causes bone cancer in humans. Ask your doctor about your risk.

Call your doctor at once if you have bone pain, unusual body aches, or a lump or swelling under your skin.

Abaloparatide should not be used for longer than 2 years total.

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

To make sure abaloparatide is safe for you, tell your doctor if you have ever had:

  • a bone disease other than osteoporosis (such as Paget's disease);
  • high levels of calcium or alkaline phosphatase in your blood;
  • bone cancer or radiation treatment involving your bones;
  • a condition called hyperparathyroidism; or
  • kidney stones.

In animal studies, abaloparatide caused bone cancer. However, it is not known whether bone cancer would occur in humans using this medicine. Ask your doctor about your 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 is not known whether abaloparatide passes into breast milk or if it could harm a nursing baby. You should not breast-feed while using this medicine.

(web3)