Forsteo ® (teriparatide)

This information is intended for UK registered healthcare professionals only as a scientific exchange in response to your search for information. Please refer to the link for full prescribing information: Forsteo Summary of Product Characteristics (SmPC)

Forsteo® (teriparatide): Common Adverse Reactions

The most commonly reported adverse reactions in patients treated with Forsteo are nausea, pain in limb, headache and dizziness.

Reactions reported at a ≥1% difference from Placebo

In clinical trials the following reactions were reported at a ≥ 1 % difference in frequency from placebo: vertigo, nausea, pain in limb, dizziness, depression, dyspnoea.1

Description of selected Adverse Reactions

Serum and urine calcium, urolithiasis

In normocalcaemic patients, slight and transient elevations of serum calcium concentrations have been observed following teriparatide injection. Serum calcium concentrations reach a maximum between 4 and 6 hours and return to baseline by 16 to 24 hours after each dose of teriparatide. Therefore, if blood samples for serum calcium measurements are taken, this should be done at least 16 hours after the most recent Forsteo injection. Routine calcium monitoring during therapy is not required.1

Forsteo may cause small increases in urinary calcium excretion, but the incidence of hypercalciuria did not differ from that in the placebo-treated patients in clinical trials.1

Forsteo has not been studied in patients with active urolithiasis. Forsteo should be used with caution in patients with active or recent urolithiasis because of the potential to exacerbate this condition.1

Orthostatic Hypotension

In short-term clinical studies with Forsteo, 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.1

Increases in serum uric acid concentration

Forsteo increases serum uric acid concentrations. In clinical trials, 2.8 % of Forsteo 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.1

Antibodies

In a large clinical trial, antibodies that cross-reacted with teriparatide were detected in 2.8 % of women receiving Forsteo. 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.1

Tabulated list of Adverse Reactions

The adverse reactions associated with the use of teriparatide in osteoporosis clinical trials and postmarketing exposure are summarised below inTable 1. 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).1

Table 1. List of adverse Reactions in osteoporosis clinical trials and postmarketing exposure 1

System Organ Class

Frequency

Adverse reaction

Blood and lymphatic system disorders

Common

Anaemia

Immune System Disorder

Rare

Anaphylaxis

Metabolism and nutrition disorders

Common

Hypercholesterolaemia

Uncommon

Hypercalcaemia > 2.76 mmol/L, hyperuricemia

Rare

Hypercalcaemia > 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 (Serious cases of back cramp or pain have been reported within minutes of the injection)

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

Of patients in the teriparatide trials, 82.8 % of the Forsteo patients and 84.5 % of the placebo patients reported at least 1 adverse event.1

Reporting of suspected adverse Reactions

Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions.1

References

1. Forsteo [summary of product characteristics]. Eli Lilly Nederland B.V., The Netherlands.

Date of Last Review: February 06, 2020

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