abaloparatide

Abaloparatide is a medication used to treat osteoporosis in postmenopausal women and osteoporotic men who are at high risk for fracture, and patients who do not respond or are intolerant to other osteoporosis treatments. Osteoporosis is a condition with lower than normal bone mineral density, which makes bones weak and brittle, increasing the risk for fractures with even minor falls. Osteoporosis is most common in postmenopausal women and elderly men. Abaloparatide is administered as a subcutaneous injection with pre-filled pens.

Bone tissue is constantly broken down and replaced in the body, and osteoporosis results when new bone tissue growth does not keep up with the loss of bone tissue. Abaloparatide is a synthetic protein fragment (peptide), structurally similar (analog) to human parathyroid hormone-related protein (hPTHrP), a peptide that promotes new bone tissue growth. Abaloparatide stimulates parathyroid hormone receptors in bones and cartilages which induces the growth of new bone cells, increasing bone mineral density, mass and strength.

• Do not use abaloparatide in patients with hypersensitivity to any component in the formulation.
• Provide appropriate training and instructions to the patients and caregivers for proper use of the pre-filled pens.
• Abaloparatide increased the incidence of dose-related osteosarcoma, a type of malignant bone cancer, in animal studies. It is not known if the drug can cause osteosarcoma in humans. Avoid use in patients at risk for osteosarcoma, including patients with:
  • Paget’s disease of bone
  • Unexplained elevation of alkaline phosphatase
  • Incomplete bone growth (open epiphysis - pediatric patients, use not approved)
  • Bone metastases or skeletal malignancies
  • Hereditary disorders predisposing to osteosarcoma
  • Prior external beam or implant radiation therapy involving the skeleton
• Cumulative use of abaloparatide and other parathyroid hormone analogs such as teriparatide for longer than 2 years during a patient’s lifetime is not recommended.
• Abaloparatide can cause positional (orthostatic) hypotension, typically within 4 hours after administration. The injection should be administered where the patient can sit or lie down, if necessary.
• Abaloparatide can increase blood calcium levels (hypercalcemia). Avoid use in patients with pre-existing hypercalcemia or hypercalcemic disorder.
• Abaloparatide can increase urinary excretion of calcium (hypercalciuria) and the risk of urinary stones. Use with caution in patients with active or prior history of urinary stones, and monitor urinary calcium levels.

Common side effects of abaloparatide include:

• Injection site reactions including:
  • Redness (erythema)
  • Swelling (edema)
  • Pain
• Dizziness
• Headache
• Nausea
• Excessive calcium in urine (hypercalciuria)
• Palpitations
• Rapid heart rate (tachycardia)
• Positional drop in blood pressure (orthostatic hypotension)
• Fatigue
• Joint pain (arthralgia)
• Bone pain
• Vertigo
• Increase in serum uric acid
• Increase in blood calcium levels (hypercalcemia)
• Urinary stones
• Contusion
• Abdominal distension
• Upper abdominal pain
• Diarrhea

Less common side effects of abaloparatide include:

• Vomiting
• Constipation
• Weakness (asthenia)
• Feeling ill (malaise)
• Lethargy
• Insomnia
• Injection site reactions such as:
  • Rash
  • Itching (pruritus)
  • Bruising
  • Bleeding (hemorrhage)
• Skin reactions such as:
  • Rash
  • Pruritus
• Hypersensitivity reactions including:
  • Shortness of breath (dyspnea)
  • Severe allergic reaction (anaphylaxis)
• Back pain
• Pain in extremity
• Generalized pain
• Muscle spasms of leg and back

Call your doctor immediately if you experience any of the following symptoms or serious side effects while using this drug:

• Serious heart symptoms include fast or pounding heartbeats, fluttering in your chest, shortness of breath, and sudden dizziness;
• Severe headache, confusion, slurred speech, severe weakness, vomiting, loss of coordination, feeling unsteady;
• Severe nervous system reaction with very stiff muscles, high fever, sweating, confusion, fast or uneven heartbeats, tremors, and feeling like you might pass out; or
• Serious eye symptoms include blurred vision, tunnel vision, eye pain or swelling, or seeing halos around lights.

This is not a complete list of all side effects or adverse reactions that may occur from the use of this drug. Call your doctor for medical advice about serious side effects or adverse reactions. You may also report side effects or health problems to the FDA at 1-800-FDA-1088.

Solution for subcutaneous (SC) injection

• 80 mcg/40 mcL (prefilled pen delivers 30 daily doses of 80 mcg)

Adult:

Osteoporosis

Women

• Indicated for treatment of osteoporosis in postmenopausal women at high risk for fracture (defined as history of osteoporotic fracture, multiple risk factors for fracture), or patients who have failed or are intolerant to other available osteoporosis therapy
• Shown to reduce risk of vertebral and nonvertebral fractures in postmenopausal women with osteoporosis
• 80 mcg SC once daily

Men

• Indicated to increase bone density in men with osteoporosis at high risk for fracture (defined as history of osteoporotic fracture or multiple risk factors for fracture), or patients who have failed or are intolerant to other available osteoporosis therapy
• 80 mcg SC once daily

Dosage Modifications

Renal impairment

• Mild or moderate: No dosage adjustment required
• Severe: No dosage adjustment required; severe renal impairment may have increased abaloparatide systemic exposure and increased risk of adverse reactions; therefore, monitor for adverse reactions

Dosing Considerations

• Cumulative use of abaloparatide and parathyroid hormone (PTH) analogs for longer than 2 years not recommended
• Patients should receive supplemental calcium and vitamin D if dietary intake is inadequate

Pediatric:

Safety and efficacy not established

Overdose

• Abaloparatide overdose can cause headache, nausea, vomiting, vertigo, weakness (asthenia), dizziness, rapid heart rate (tachycardia), positional drop in blood pressure (orthostatic hypotension), and high blood calcium levels (hypercalcemia).
• There is no specific antidote for abaloparatide. Overdose may be treated with discontinuation of the drug, symptomatic and supportive treatment including hydration and monitoring of calcium and phosphorous levels.

Inform your doctor of all medications you are currently taking, who can advise you on any possible drug interactions. Never begin taking, suddenly discontinue, or change the dosage of any medication without your doctor’s recommendation.

• Abaloparatide has no known severe, serious, moderate, or mild interactions with other drugs.

The drug interactions listed above are not all of the possible interactions or adverse effects. For more information on drug interactions, visit the RxList Drug Interaction Checker.

It is important to always tell your doctor, pharmacist, or health care provider of all prescription and over-the-counter medications you use, as well as the dosage for each, and keep a list of the information. Check with your doctor or health care provider if you have any questions about the medication.

Abaloparatide is intended for osteoporosis in postmenopausal women and not approved for women with pregnancy potential or nursing mothers.

• Follow instructions exactly for the administration of abaloparatide injections.
• Do not share your abaloparatide prefilled pens with others and do not transfer pen contents to syringes.
• Sit or lie down if you feel lightheaded or have palpitations after the injection. If symptoms persist or worsen, contact your physician.
• Notify your physician immediately if you develop symptoms of hypercalcemia, which can include vomiting, constipation, lethargy and muscle weakness.
• Report to your physician immediately if you feel persistent localized pain or growth of new soft tissue mass that feels tender.
• Store abaloparatide safely out of reach of children.
• In case of overdose, seek medical help or contact Poison Control.