Abaloparatide

Abaloparatide is used to treat 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.

Abaloparatide is available under the following different brand names: Tymlos.

Dosages of Abaloparatide:

Solution for Subcutaneous (SC) Injection

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

Dosage Considerations – Should be Given as Follows:

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 subcutaneously (SC) once daily
• Cumulative use of abaloparatide and parathyroid hormone (PTH) analogs for more than 2 years 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 (e.g., teriparatide) for more than 2 years during a patient’s lifetime is not recommended
• Safety and efficacy not established in pediatric patients

Common side effects of abaloparatide include:

• Injection site redness
• Elevated calcium in the urine (hypercalciuria)
• Dizziness
• Injection site swelling
• Nausea
• Headache
• Palpitations
• Dizziness on standing
• Fatigue
• Upper abdominal pain
• High calcium in the blood (hypercalcemia)
• Spinning sensation (vertigo)
• Fast heart rate

This document does not contain all possible side effects and others may occur. Check with your physician for additional information about side effects.

If your doctor has directed you to use this medication, your doctor or pharmacist may already be aware of any possible drug interactions and may be monitoring you for them. Do not start, stop, or change the dosage of any medicine before checking with your doctor, health care provider, or pharmacist first.

• Abaloparatide has no listed severe interactions with other drugs.
• Abaloparatide has no listed serious interactions with other drugs.
• Abaloparatide has no listed moderate interactions with other drugs.
• Abaloparatide has no listed mild interactions with other drugs.

Warnings

• This medication contains abaloparatide. Do not take Tymlos if you are allergic to abaloparatide or any ingredients contained in this drug.

Black Box Warnings

• Abaloparatide caused a dose-dependent increase in the incidence of osteosarcoma (a malignant bone tumor) in male and female rats; this effect was observed at systemic exposures to abaloparatide ranging from 4-28 times the exposure in humans receiving the 80-mcg dose
• It is unknown if abaloparatide causes osteosarcoma in humans
• Use is not recommended in patients at increased risk of osteosarcoma, including those with Paget 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 abaloparatide and PTH analogs (e.g., teriparatide) for more than 2 years during a patient’s lifetime is not recommended

Contraindications

• None

Effects of Drug Abuse

• No information is available.

Short-Term Effects

• See "What Are Side Effects Associated with Using Abaloparatide?"

Long-Term Effects

• See "What Are Side Effects Associated with Using Abaloparatide?"

Cautions

• A dose-dependent increase in the incidence of osteosarcoma in rats observed
• May cause orthostatic hypotension, typically within 4 hours after injection; instruct patient to sit or lie down for the first several doses if necessary
• May cause hypercalcemia; not recommended with preexisting hypercalcemia or in patients who have an underlying hypercalcemic disorder (e.g., primary hyperparathyroidism) because of the possibility of exacerbating hypercalcemia
• May cause hypercalciuria; unknown whether the drug may exacerbate urolithiasis in patients with active or a history of urolithiasis; if active urolithiasis or preexisting hypercalciuria is suspected, measurement of urinary calcium excretion should be considered

Pregnancy and Lactation

• Abaloparatide is not indicated for females of reproductive potential so is unlikely to be used during pregnancy or while breastfeeding.