Abaloparatide

Name: Abaloparatide

What should I discuss with my healthcare provider before using abaloparatide?

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.

Preparations

Excipients in commercially available drug preparations may have clinically important effects in some individuals; consult specific product labeling for details.

Please refer to the ASHP Drug Shortages Resource Center for information on shortages of one or more of these preparations.

Abaloparatide

Routes

Dosage Forms

Strengths

Brand Names

Manufacturer

Parenteral

Injection, Solution

2000 mcg/1 mL

Tymlos

Radius Health Inc.

Uses of Abaloparatide

  • It is used to treat soft, brittle bones (osteoporosis).

Pharmacology

Abaloparatide is an analog of human parathyroid hormone related peptide (PTHrP[1-34]), which acts as an agonist at the PTH1 receptor (PTH1R). This results in stimulation of osteoblast function and increased bone mass (Harslof 2016; Leder 2017).

Distribution

Vd: ~50 L

Metabolism

Hepatic (nonspecific proteolysis)

Excretion

Urine (as peptide fragments)

Time to Peak

0.51 hours (range: 0.25 to 0.52 hours)

Half-Life Elimination

1.7 hours

Protein Binding

~70%

Dosing Geriatric

Refer to adult dosing.

Dosing Hepatic Impairment

There is no dosage adjustment provided in the manufacturer's labeling

Adverse Reactions

>10%:

Endocrine & metabolic: Increased uric acid (25%)

Genitourinary: Hypercalciuria (11% to 20%)

Immunologic: Antibody development (49%; neutralizing antibodies: 68%; antibody formation was not found to have any clinical significance)

Local: Erythema at injection site (58%)

1% to 10%:

Cardiovascular: Palpitations (5%), orthostatic hypotension (1% to 4%), sinus tachycardia (≤2%), tachycardia (≤2%)

Central nervous system: Dizziness (10%), headache (8%), fatigue (3%)

Endocrine & metabolic: Hypercalcemia (3%)

Gastrointestinal: Nausea (8%), upper abdominal pain (3%)

Local: Swelling at injection site (10%), pain at injection site (9%)

Abaloparatide Interactions

This is not a complete list of Abaloparatidedrug interactions. Ask your doctor or pharmacist for more information.

Administration

SC Preparation

Clear and colorless solution

Visually inspect for particulate matter and discoloration prior to administration

Do not use if solid particles appear or if the solution is cloudy or colored

Provide appropriate training and instruction to patients and caregivers on the proper use of the pen

SC Administration

Administer as a SC injection 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 IV or IM

Administer the first several doses where the patient can sit or lie down if necessary, in case symptoms of orthostatic hypotension occur

Storage

Before first use: Refrigerate between 2-8°C (36-46°F)

After first use: Store for up to 30 days at 20-25°C (68-77°F)

Do not freeze or subject to heat

For Healthcare Professionals

Applies to abaloparatide: subcutaneous solution

Cardiovascular

Very common (10% or more): Common (1% to 10%): Orthostatic hypotension, tachycardia (e.g., sinus tachycardia), palpitations[Ref]

Immunologic

Very common (10% or more): Immunogenicity[Ref]

Local

Very common (10% or more): Injection site redness (58%), injection site edema (10%)
Common (1% to 10%): Injection site pain[Ref]

Gastrointestinal

Common (1% to 10%): Nausea, upper abdominal pain[Ref]

Metabolic

Very common (10% or more): Increased serum uric acid (25%)
Common (1% to 10%): Hypercalcemia[Ref]

Renal

Very common (10% or more): Hypercalciuria (20%)
Common (1% to 10%): Urolithiasis[Ref]

Nervous system

Very common (10% or more): Dizziness (10%)
Common (1% to 10%): Headache, vertigo[Ref]

Some side effects of abaloparatide may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

Abaloparatide Pregnancy Warnings

Animal reproduction studies have not been conducted. There are no controlled data in human pregnancy. It is not known whether this drug can cause fetal harm or adversely affect reproductive capacity in humans. US FDA pregnancy category Not Assigned: The US FDA has amended the pregnancy labeling rule for prescription drug products to require labeling that includes a summary of risk, a discussion of the data supporting that summary, and relevant information to help health care providers make prescribing decisions and counsel women about the use of drugs during pregnancy. Pregnancy categories A, B, C, D and X are being phased out.

This drug is not indicated for use in female patients of reproductive potential. US FDA pregnancy category: Not assigned. Risk Summary: No data available on use of this drug in pregnant women to inform a drug-related risk.

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