Treatment of osteoporosis in postmenopausal women and men at increased risk of fractures. In postmenopausal women, a significant reduction in the incidence of vertebral fractures and non-vertebral fractures has been demonstrated, but this does not apply to the femoral neck. Treatment of osteoporosis caused by long-term use of systemic glucocorticosteroids in women and men, with an increased risk of fractures.
Composition:
1 dose (80 μl) contains 20 μg of teriparatide.
Action:
The preparation is an active fragment (1-34) of endogenous human parathyroid hormone. Endogenous parathyroid hormone (PTH), composed of 84 amino acids, is the main factor regulating the metabolism of Calcium and phosphate in bone tissue and kidneys. Parathormon stimulates the bone formation process directly affecting bone formation cells (osteoblasts), indirectly increases the absorption of calcium in the intestines and increases the reabsorption of calcium in kidney tubules and excretion of phosphates through the kidneys. The preparation supports the process of bone formation - it increases the deposition of new bone tissue on the surface of the trabecular and cortical layer due to a greater stimulation of osteoblast activity than osteoclasts. T0,5 drug is about 1 hour. The product is excreted by hepatic and extra-hepatic clearance (about 62 l / h in women, 94 l / h in men).
Contraindications:
Hypersensitivity to teriparatide or to any of the excipients. Pregnancy and breastfeeding. Previously disclosed hypercalcemia. Severe renal failure. Metabolic bone diseases (including hyperparathyroidism and Paget's disease of the bone), with the exception of primary osteoporosis and osteoporosis due to the use of glucocorticoids. Increased alkaline phosphatase activity with an unexplained cause. Condition after external or internal bone radiotherapy. Patients with skeletal malignancies or bone metastases should not be treated with teriparatide.
Precautions:
There are no studies on the use of the product in people with active urolithiasis. The preparation should be used with caution in people with active or recent history of urolithiasis, due to the risk of exacerbation of this disease. During the first few doses of the drug, isolated cases of transient orthostatic hypotension were observed (usually within 4 h after dosing, resolved spontaneously after a few minutes or hours, did not prevent continuation of treatment, the patient's position in the semi-recumbent position reduced the symptoms). Caution should be exercised in patients with moderate renal impairment. There are no data on the use of the drug in patients with impaired liver function - be careful. The product should not be used in children and adolescents under 18 years of age and in young adults before the development of the epiphysis bones. Data on the use of the preparation in young adults (after completion of the development of the long bone roots), including premenopausal women are limited - can be used only if the expected benefits clearly outweigh the risks. During long-term use of teriparatide, there is an increased risk of osteosarcoma - one should not exceed the recommended maximum duration of treatment, ie 24 months, until new clinical data are available.
Pregnancy and lactation:
The preparation is contraindicated in pregnancy and breast-feeding. Women of childbearing age must use effective methods of contraception.
Side effects:
Very often: pain in the limbs. Common: anemia, hypercholesterolemia, depression, pain and dizziness, sciatica, syncope, diarrheal headache, palpitations, hypotension, shortness of breath, nausea, vomiting, hiatus hernia, gastroesophageal reflux disease, increased sweating, muscle spasms, fatigue, chest pain, weakness, mild and transient symptoms at the injection site (pain, swelling, erythema, local bruising, pruritus, minor bleeding at the injection site).Uncommon: hypercalcemia above 2.76 mmol / L, increased serum uric acid, tachycardia, emphysema, haemorrhage, muscle pain, joint pain, cramps or back pain (reported a few minutes after injection), incontinence urinary incontinence, sudden urge to bladder, kidney stones, erythema at the injection site, injection site reaction, weight gain, cardiac murmur, increased alkaline phosphatase. Rare: hypercalcemia above 3.25 mmol / l, renal failure or renal impairment, allergic reactions shortly after injection (acute breathing disorders - shortness of breath, swelling of the mouth and face area, generalized urticaria, chest pain, mainly peripheral edema) . The preparation increases the concentration of uric acid in the blood serum (hyperuricemia) - there was no increase in the occurrence of gout, joint pain or urolithiasis. In a large clinical study, 2.8% of the women receiving the preparation had cross-reactivity with teriparatide. Antibodies were usually detected after 12 months of treatment, and their titer decreased after discontinuation of the drug. There were no hypersensitivity reactions, allergic reactions, changes in serum calcium or drug effects on bone mineral density (BMD).
Dosage:
Adults. The recommended dose is 20 μg once a day under the skin of the thigh or abdomen. The total maximum duration of treatment is 24 months. The patient should not be repeated for 24 months throughout the life of the product. After the therapy is finished, patients may use other methods of osteoporosis treatment.
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