Teriparatide injection
- Drugs List
- Therapeutic Indications
- Dosage
- Administration
- Contraindications
- Precautions and Warnings
- Pregnancy and Lactation
- Side Effects
- Monograph
Presentation
Solution for injection containing teriparatide.
These products have been produced by recombinant DNA technology using E.coli.
Drugs List
Therapeutic Indications
Uses
Treatment of osteoporosis
Treatment of established osteoporosis in post-menopausal women and in men at increased risk of fracture.
Teriparatide has been shown to reduce significantly the incidence of vertebral and non-vertebral fractures, but not hip fractures, in post-menopausal women.
Treatment of osteoporosis associated with sustained systemic glucocorticoid therapy in men and women at increased risk of fracture.
Dosage
Adults
20 micrograms once daily, administered by subcutaneous injection.
Additional Dosage Information
Following cessation of teriparatide therapy, patients may be continued on other osteoporosis therapies.
Administration
For subcutaneous injection into the thigh or abdomen.
Patients should receive training in the correct injection technique.
Contraindications
Children under 18 years
Unexplained elevations of alkaline phosphatase
Breastfeeding
History of radiotherapy to the skeleton
Hypercalcaemia
Hyperparathyroidism
Malignant bone disease
Paget's disease of bone
Pregnancy
Severe renal impairment
Skeletal metastasis
Precautions and Warnings
Hepatic impairment
Moderate renal impairment
Urolithiasis
Not for use in metabolic bone diseases other than primary osteoporosis
Advise ability to drive/operate machinery may be affected by side effects
Exclude patients with open epiphyses before initiation
Record name and batch number of administered product
Use designated delivery device only
Ensure patient's dietary intake of calcium and vitamin D is adequate
Take blood samples at least 16 hours after last injection
Advise patient to sit or lie down at first signs of orthostatic hypotension
May cause postural hypotension
May exacerbate urolithiasis
Treatment time should not exceed 24 months
Course not to be repeated during the patients' lifetime
Female: Ensure adequate contraception during treatment
Transient elevations of serum calcium have been observed in normocalcaemic patients following teriparatide injection. Effects reach a maximum after 4 to 6 hours then usually return to baseline by 16 to 24 hours after administration of teriparatide.
If blood samples are required from a patient, they should be taken at least 16 hours after the most recent teriparatide injection.
Transient orthostatic hypotension may occur; symptoms may be relieved by placing patient in a reclining position. This symptom typically occurs within 4 hours of administration of teriparatide and spontaneously resolves with a few minutes or hours. Where orthostatic hypotension does occur, it is usually during the first few doses and does not preclude continued treatment.
Treatment in young adults and pre-menopausal women should proceed with caution as experience on the use of teriparatide in this patient population is limited.
Pregnancy and Lactation
Pregnancy
Teriparatide is contraindicated during pregnancy.
The manufacturer states that teriparatide should not be used during pregnancy. Animal studies have shown reproductive toxicity and the potential risk for humans is unknown. There is insufficient data on the use of teriparatide during human pregnancy, therefore its use is not recommended.
Lactation
Teriparatide is contraindicated during breastfeeding.
The manufacturer states that teriparatide should not be used during breastfeeding. The presence of teriparatide in human breast milk is unknown but due to its large molecular weight and poor oral bioavailability, it is unlikely to cross into the milk. There is insufficient evidence on the use of teriparatide during breastfeeding.
Counselling
Patients should receive training in the correct injection technique.
Advise patients that if affected by transient orthostatic hypotension or dizziness they should not drive or use machinery until symptoms have subsided.
Advise women of child-bearing potential to use adequate contraception during treatment with teriparatide.
Advise patient to sit or lie down at first signs of orthostatic hypotension.
Side Effects
Acute renal failure
Anaemia
Anaphylaxis
Antibody formation
Arthralgia
Asthenia
Back pain
Chest pain
Depression
Dizziness
Dyspnoea
Emphysema
Erythema at injection site
Facial oedema
Fatigue
Gastroesophageal reflux
Haemorrhoids
Headache
Heart murmur
Hiatus hernia
Hypercalcaemia
Hypercholesterolaemia
Hypersensitivity reactions
Hyperuricaemia
Hypotension
Increase in alkaline phosphatase
Increased sweating
Injection site reactions
Limb pain
Local pain (injection site)
Minor bleeding (injection site)
Muscle cramps
Myalgia
Nausea
Nephrolithiasis
Oedema
Orthostatic hypotension
Palpitations
Polyuria
Pruritus
Renal impairment
Sciatica
Syncope
Tachycardia
Urinary incontinence
Urinary urgency
Urticaria
Vertigo
Vomiting
Weight gain
Overdosage
It is strongly recommended that the UK National Poisons Information Service be consulted on cases of suspected or actual overdose where there is doubt over the degree of risk or about appropriate management.
The following number will direct the caller to the relevant local centre (0844) 892 0111
Information may be obtained if you have access to ToxBase the primary clinical toxicology database of the National Poisons Information Service. This is available via password on the internet ( www.toxbase.org ) or if this is unavailable at the backup site ( www.toxbasebackup.org ).
Further Information
Last Full Review Date: November 2022
Reference Sources
Summary of Product Characteristics: Forsteo 20 micrograms/80 microlitres solution for injection in pre-filled pen. Eli Lilly and Company Limited. Revised october 2020.
Summary of Product Characteristics: Movymia 20 micrograms/80 microlitres solution for injection. Thornton & Ross Ltd. Revised January 2021.
Summary of Product Characteristics: Sondelbay 20 micrograms/80 microlitres solution for injection in pre-filled pen. Accord Healthcare Limited. Revised March 2022.
Summary of Product Characteristics: Terrosa 20 micrograms/80 microlitres solution for injection. Geodeon Richter (UK) Ltd. Revised January 2021.
NICE Evidence Services Available at: www.nice.org.uk Last accessed: 10 November 2022
Medscape UK | Univadis prescription drug monographs & interactions are based on FDB Multilex Content
FDB Disclaimer : FDB Multilex is intended for the use of healthcare professionals and is provided on the basis that the healthcare professionals will retain FULL and SOLE responsibility for deciding what treatment to prescribe or dispense for any particular patient or circumstance.