Abaloparatide

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.

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

Abaloparatide is a human parathyroid hormone related peptide [PTHrP(1-34)] analog.1

Maximum serum concentration increased 1-, 1.3- and 1.4-fold in patients with mild, moderate and severe renal impairment, respectively. AUC increased 1.2-, 1.7- and 2.1-fold in patients with mild, moderate and severe renal impairment, respectively.

No dosage adjustment necessary.

Inject subcutaneously into the periumbilical region of the abdomen. Rotate the site of the injection every day and administer at approximately the same time every day. Do not administer intravenously or intramuscularly. Initial doses should occur under circumstances in which the patient may sit or lie down, in the event of orthostasis.

Abaloparatide caused a dose-dependent increase in the incidence of osteosarcoma, a malignant bone tumor, in male and female rats. The effect was observed at systemic exposures to abaloparatide ranging from 4 to 28 times the exposure in humans receiving the 80 mcg dose. It is unknown whether abaloparatide will cause osteosarcoma in humans.

Use of abaloparatide 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 abaloparatide and parathyroid hormone analogs (eg, teriparatide) for more than 2 years during a patient's lifetime is not recommended.

Concerns related to adverse effects:

• Hypercalcemia: May cause or exacerbate hypercalcemia; use is not recommended in patients with preexisting hypercalcemia or with an underlying hypercalcemic disorder (eg, primary hyperparathyroidism).

• Orthostatic hypotension: May cause orthostatic hypotension. Transient orthostatic hypotension usually occurs within 4 hours of dosing.

• Osteosarcoma: [US Boxed Warning]: In animal studies, abaloparatide has been associated with an increase in osteosarcoma; risk was dependent on both dose and duration. Avoid use in patients with an increased risk of osteosarcoma (including Paget disease, bone metastases or skeletal malignancies, hereditary disorders predisposing to osteosarcoma, unexplained elevation of alkaline phosphatase, prior external beam or implant radiation therapy involving the skeleton, or in patients with open epiphyses).

Disease-related concerns:

• Urolithiasis: Use may cause hypercalciuria; use with caution in patients with active or recent urolithiasis because of risk of exacerbation.

Other warnings/precautions:

• Appropriate use: [US Boxed Warning]: Use for >2 years during a patient's lifetime is not recommended.

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 (eg, teriparatide) for >2 yr during a patient’s lifetime is not recommended

Contraindications

None

Cautions

Dose-dependent increase in incidence of osteosarcoma in rats observed (see Black Box Warnings)

May cause orthostatic hypotension, typically within 4 hr 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 (eg, 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

No adjustment recommended.

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.