Chemical formula: C₁₈₁H₂₉₁N₅₅O₅₁S₂ Molecular mass: 4,116.134 g/mol
Teriparatide interacts in the following cases:
No data are available in patients with impaired hepatic function. Therefore, teriparatide should be used with caution.
In patients with moderate renal impairment, teriparatide should be used with caution.
Studies in rabbits have shown reproductive toxicity. The effect of teriparatide on human foetal development has not been studied. The potential risk for humans is unknown.
In a study of 15 healthy subjects administered digoxin daily to steady state, a single teriparatide dose did not alter the cardiac effect of digoxin. However, sporadic case reports have suggested that hypercalcaemia may predispose patients to digitalis toxicity. Because teriparatide transiently increases serum calcium, teriparatide should be used with caution in patients taking digitalis.
In short-term clinical studies with teriparatide, isolated episodes of transient orthostatic hypotension were observed. Typically, an event began within 4 hours of dosing and spontaneously resolved within a few minutes to a few hours. When transient orthostatic hypotension occurred, it happened within the first several doses, was relieved by placing subjects in a reclining position, and did not preclude continued treatment.
Teriparatide has not been studied in patients with active urolithiasis. Teriparatide should be used with caution in patients with active or recent urolithiasis because of the potential to exacerbate this condition.
Teriparatide is contraindicated for use during pregnancy.
Teriparatide is contraindicated for use during breast-feeding. It is not known whether teriparatide is excreted in human milk.
Women of childbearing potential should use effective methods of contraception during use of teriparatide. If pregnancy occurs, teriparatide should be discontinued.
Studies in rabbits have shown reproductive toxicity. The effect of teriparatide on human foetal development has not been studied. The potential risk for humans is unknown.
Teriparatide has no or negligible influence on the ability to drive and use machines. Transient, orthostatic hypotension or dizziness was observed in some patients. These patients should refrain from driving or the use of machines until symptoms have subsided.
The most commonly reported adverse reactions in patients treated with teriparatide are nausea, pain in limb, headache and dizziness.
Of patients in the teriparatide trials, 82.8% of the teriparatide patients and 84.5% of the placebo patients reported at least 1 adverse event.
The adverse reactions associated with the use of teriparatide in osteoporosis clinical trials and post-marketing exposure are summarised in the list below. The following convention has been used for the classification of the adverse reactions: very common (≥1/10), common (≥1/100 to <1/10), uncommon (≥1/1,000 to <1/100), rare (≥1/10,000 to <1/1,000) very rare (<1/10,000).
| Blood and lymphatic system disorders | |
| Common | Anaemia |
| Immune system disorder | |
| Rare | Anaphylaxis |
| Metabolism and nutrition disorders | |
| Common | Hypercholesterolaemia |
| Uncommon | Hypercalcaemia greater than 2.76 mmol/L, hyperuricemia |
| Rare | Hypercalcaemia greater than 3.25 mmol/L |
| Psychiatric disorders | |
| Common | Depression |
| Nervous system disorders | |
| Common | Dizziness, headache, sciatica, syncope |
| Ear and labyrinth disorders | |
| Common | Vertigo |
| Cardiac disorders | |
| Common | Palpitations |
| Uncommon | Tachycardia |
| Vascular disorders | |
| Common | Hypotension |
| Respiratory, thoracic and mediastinal disorders | |
| Common | Dyspnoea |
| Uncommon | Emphysema |
| Gastrointestinal disorders | |
| Common | Nausea, vomiting, hiatus hernia, gastroesophageal reflux disease |
| Uncommon | Haemorrhoids |
| Skin and subcutaneous tissue disorders | |
| Common | Sweating increased |
| Musculoskeletal and connective tissue disorders | |
| Very common | Pain in limb |
| Common | Muscle cramps |
| Uncommon | Myalgia, arthralgia, back cramp/pain* |
| Renal and urinary disorders | |
| Uncommon | Urinary incontinence, polyuria, micturition urgency, nephrolithiasis |
| Rare | Renal failure/impairment |
| General disorders and administration site conditions | |
| Common | Fatigue, chest pain, asthenia, mild and transient injection site events, including pain, swelling, erythema, localised bruising, pruritis and minor bleeding at injection site. |
| Uncommon | Injection site erythema, injection site reaction |
| Rare | Possible allergic events soon after injection: acute dyspnoea, oro/facial oedema, generalised urticaria, chest pain, oedema (mainly peripheral) |
| Investigations | |
| Uncommon | Weight increased, cardiac murmur, alkaline phosphatase increase |
* Serious cases of back cramp or pain have been reported within minutes of the injection.
In clinical trials the following reactions were reported at a ≥1% difference in frequency from placebo: vertigo, nausea, pain in limb, dizziness, depression, dyspnoea.
Teriparatide increases serum uric acid concentrations. In clinical trials, 2.8% of teriparatide patients had serum uric acid concentrations above the upper limit of normal compared with 0.7% of placebo patients. However, the hyperuricemia did not result in an increase in gout, arthralgia, or urolithiasis.
In a large clinical trial, antibodies that cross-reacted with teriparatide were detected in 2.8% of women receiving teriparatide. Generally, antibodies were first detected following 12 months of treatment and diminished after withdrawal of therapy. There was no evidence of hypersensitivity reactions, allergic reactions, effects on serum calcium, or effects on Bone Mineral Density (BMD) response.
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