Teriparatide
Indications
Teriparatide is used for:
Osteoporosis
Adult Dose
Subcutaneous
Corticosteroid-induced osteoporosis, Hypogonadal osteoporosis in men, Osteoporosis in postmenopausal women, Primary osteoporosis in men
Adult:
In patients at high risk of fracture, or who have failed or are intolerant to other available osteoporosis therapies:
20 mcg once daily to be injected into the thigh or abdominal wall.
Max duration of treatment: 24 months (a treatment course must not to be repeated over a patient's lifetime).
Hepatic impairment
No studies have been performed in patients with hepatic impairment
Child Dose
Renal Dose
Renal impairment
CrCl <30 mL/min: Dose adjustment not necessary; in clinical trial, AUC and half-life increased but maximum plasma concentration did not increase
Administration
SC administration only
Contra Indications
Hypersensitivity. Pre-existing hypercalcaemia, skeletal malignancies or bone metastases, other metabolic bone diseases (e.g. Paget's disease, hyperparathyroidism), unexplained elevations of alkaline phosphatase, previous implant or external beam radiation therapy to the skeleton, hereditary disorders predisposing to osteosarcoma.
Young adults with open epiphyses. Severe renal impairment. Pregnancy.
Precautions
Transient orthostatic hypotension may occur with initial doses
May exacerbate urolithiasis; consider risk/benefit in patients with active or recent urolithiasis
Osteosarcoma risk: Avoid use in patients with with increased risk of osteosarcoma
Patient must be supplemented with Ca and vitamin D if dietary intake is inadequate
Pregnancy-Lactation
Pregnancy
There are no available data on use in pregnant women to evaluate for drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes; consider discontinuing drug when pregnancy is recognized
Animal data
In animal reproduction studies, drug increased skeletal deviations and variations in mouse offspring at subcutaneous doses equivalent to more than 60 times recommended 20 mcg human daily dose (based on body surface area, mcg/m2), and produced mild growth retardation and reduced motor activity in rat offspring at subcutaneous doses equivalent to more than 120 times the human dose
Lactation
Not known whether teriparatide is excreted in human milk, affects human milk production, or has effects on breastfed infant; because of potential for osteosarcoma shown in animal studies, advise patients that breastfeeding is not recommended during therapy
Interactions
Concomitant use with digoxin may increase the risk of digitalis toxicity due to the effect of teriparatide on serum Ca levels.
Side Effects
Side effects of Teriparatide :
>10%
Pain (21.3%)
Arthralgia (10.1%)
1-10%
Rhinitis (9.6%)
Asthenia (8.7%)
Nausea (8.5%)
Dizziness (8%)
Headache (7.5%)
Hypertension (7.1%)
Increased cough (6.4%)
Pharyngitis (5.5%)
Constipation (5.4%)
Dyspepsia (5.2%)
Diarrhea (5.1%)
Rash (4.9%)
Insomnia (4.3%)
Depression (4.1%)
Pneumonia (3.9%)
Vertigo (3.8%)
Dyspnea (3.6%)
Neck pain (3%)
Vomiting (3%)
Syncope (2.6%)
Leg cramps (2.6%)
Angina pectoris (2.5%)
Gastrointestinal disorder (2.3%)
Tooth disorder (2%)
Mode of Action
Teriparatide is a recombinant peptide identical to the N-terminal 34-amino acid sequence of endogenous PTH.
It binds to the PTH receptor with the same affinity as the intact endogenous hormone and exerts similar physiologic effects as PTH, including stimulation of bone formation by direct effects on bone forming cells (osteoblasts) and increasing gastrointestinal Ca absorption, renal tubular Ca reabsorption and phosphate excretion in the kidney.
Anabolic effects of teriparatide demonstrate as increase in bone strength, skeletal mass, and bone formation and resorption markers.