Tymlos (abaloparatide) dosing, indications, interactions, adverse effects, and more

Sections

Sections abaloparatide
Dosing & Uses
Adverse Effects
Warnings
Pregnancy
Pharmacology
Administration
Images
Patient Handout
Formulary

Dosing & Uses

AdultPediatric

Dosage Forms & Strengths

solution for SC injection

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

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 qDay

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 qDay

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 >2 yr not recommended

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

Safety and efficacy not established

>10%

Women

Injection site redness (58%)
Hypercalciuria (11%)
Injection site edema (11%)

Men

Injection site erythema (13%)

1-10%

Women

Dizziness (10%)
Nausea (8%)
Headache (8%)
Palpitations (5%)
Orthostatic hypotension (4%)
Fatigue (3%)
Upper abdominal pain (3%)
Hypercalcemia (3%)
Vertigo (2%)
Tachycardia (2%)

Men

Dizziness (9%)
Arthralgia (7%)
Injection site swelling (7%)
Increased serum uric acid (7%)
Injection site pain (6%)
Orthostatic hypotension (6%)
Contusion (3%)
Abdominal distention (3%)
Diarrhea (3%)
Nausea (3%)
Hypercalcemia (3%)
Abdominal pain (2%)
Bone pain (2%)
Urolithiases (2%)

Postmarketing Reports

Abdominal distension, abdominal pain

Constipation, diarrhea, vomiting

Asthenia, lethargy, malaise

Insomnia

Hypersensitivity and anaphylactic reactions, dyspnea (in the context of allergic reactions)

Pruritus, rash

Generalized pain and pain in bone, joint, back, and extremity

Muscle spasms of the leg and back

Injection site reactions including bruising, hemorrhage, pruritus, and rash

Contraindications

History of systemic hypersensitivity to drug or components of product formulation

Cautions

May cause orthostatic hypotension, typically within 4 hr after injection; associated symptoms may include dizziness, palpitations, tachycardia, or nausea; advise patients to sit or lie down for first several doses if necessary; administer where patient can sit or lie down 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, consider measuring urinary calcium excretion

Osteosarcoma

Dose-dependent increase in incidence of osteosarcoma in rats observed; unknown whether it will occur in humans
Osteosarcoma reported in post-marketing setting; however, an increased risk of osteosarcoma has not been observed in observational studies in humans
There are limited data assessing the risk of osteosarcoma beyond 2 years of this drug and/or use of a PTH-analog; therapy >2 years not recommended
Avoid use in the following patients
- Open epiphyses (pediatric and young adult patients) (not approved in pediatric patients)
- Metabolic bone diseases other than osteoporosis, including Paget’s disease of the bone
- Bone metastases or a history of skeletal malignancies
- Prior external beam or implant radiation therapy involving the skeleton
- Hereditary disorders predisposing to osteosarcoma

Pregnancy

Not indicated for females of reproductive potential

Lactation

Not indicated for females of reproductive potential

Pregnancy Categories

A: Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.

B: May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.

C: Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.

D: Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk.

X: Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist.

NA: Information not available.

Mechanism of Action

Synthetic peptide analog of human parathyroid hormone-related protein (hPTHrP); hPTHrP is a naturally occurring hormone that, among other functions, regulates bone formation

Elicits anabolic effect on bone, demonstrated by increases in bone mineral density and content that correlated with increases in bone strength at vertebral and/or nonvertebral sites

Absorption

Absolute bioavailability: 36%

Peak plasma time: 0.51 hr

Peak plasma concentration: 312 pg/mL

AUC: 1622 pg·hr/mL

Distribution

Protein bound: 70%

Vd: ~50 L

Metabolism

No specific metabolism or excretion studies have been performed

Metabolism is consistent with nonspecific proteolytic degradation into smaller peptide fragments, followed by elimination by renal clearance

Elimination

Half-life: 1.7 hr

Excretion: Primarily in urine

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

Images

No images available for this drug.

Patient Handout

A Patient Handout is not currently available for this monograph.

Formulary

FormularyPatient Discounts

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The above information is provided for general informational and educational purposes only. Individual plans may vary and formulary information changes. Contact the applicable plan provider for the most current information.

View explanations for tiers and restrictions

Tier	Description
1	This drug is available at the lowest co-pay. Most commonly, these are generic drugs.
2	This drug is available at a middle level co-pay. Most commonly, these are "preferred" (on formulary) brand drugs.
3	This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs.
4	This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
5	This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
6	This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
NC	NOT COVERED – Drugs that are not covered by the plan.

Code	Definition
PA	Prior Authorization Drugs that require prior authorization. This restriction requires that specific clinical criteria be met prior to the approval of the prescription.
QL	Quantity Limits Drugs that have quantity limits associated with each prescription. This restriction typically limits the quantity of the drug that will be covered.
ST	Step Therapy Drugs that have step therapy associated with each prescription. This restriction typically requires that certain criteria be met prior to approval for the prescription.
OR	Other Restrictions Drugs that have restrictions other than prior authorization, quantity limits, and step therapy associated with each prescription.

Medscape prescription drug monographs are based on FDA-approved labeling information, unless otherwise noted, combined with additional data derived from primary medical literature.

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