Bone disorders:

Indications for: TYMLOS

Postmenopausal women with osteoporosis at high risk for fracture or patients who have failed or are intolerant to other available osteoporosis therapy. To increase bone density in men with osteoporosis at high risk for fracture or patients who have failed or are intolerant to other available osteoporosis therapy.

Adult Dosage:

80mcg SC once daily into periumbilical region of abdomen; rotate inj sites. Give supplemental calcium and vitamin D if dietary intake inadequate. Cumulative use >2yrs not recommended.

Children Dosage:

Not established.

TYMLOS Warnings/Precautions:

Avoid in those with increased baseline risk for osteosarcoma (eg, open epiphyses, metabolic bone disease, Paget's disease of the bone, bone metastases, history of skeletal malignancies, prior external beam or skeletal implant radiation therapy, hereditary disorders predisposing to osteosarcoma), pre-existing hypercalcemia or underlying hypercalcemic disorder (eg, primary hyperparathyroidism). Urolithiasis. Hypercalciuria. Severe renal impairment: monitor. Pregnancy, nursing mothers: not indicated.

TYMLOS Classification:

Hormone (human parathyroid hormone related peptide analog).

Adverse Reactions:

Postmenopausal women: hypercalciuria, dizziness, nausea, headache, palpitations, fatigue, upper abdominal pain, vertigo; Men: inj site reactions (erythema, swelling, pain), dizziness, arthralgia, contusion, nausea, diarrhea, abdominal distention/pain, bone pain; orthostatic hypotension, hypercalcemia, urolithiasis.

Metabolism:

Proteolytic degradation.

Drug Elimination:

Renal. Half-life: 1.7 hours.

Generic Drug Availability:

NO

How Supplied:

Prefilled pen (1.56mL)—1