Teriparatide

Registered South African indications: 

• Osteoporosis 
  - With or without vertebral fractures in postmenopausal women and primary osteoporosis in men
  - Associated with sustained systemic glucocorticoid therapy in women and men at increased risk for fracture

Contraindications

• Hypersensitivity to the active ingredient or any of its excipients
• Pregnancy
• Breastfeeding  
• Severe renal impairment  
• Pre-existing hypercalcaemia
• Metabolic bone diseases (other than primary osteoporosis or glucocorticoid-induced osteoporosis)
  - Hyperparathyroidism
  - Paget's disease of the bone
• Unexplained elevations of alkaline phosphatase
• Prior external beam or implant radiation therapy to skeleton
• Skeletal malignancies or bone metastases

Cautions

• Moderate renal impairment
• Hepatic impairment
• Young adults, including premenopausal women
• Prolonged use (beyond 24 months)
• Active or recent urolithiasis
• May impair ability to drive and operate machinery

Forms avail. in SA and covered in this monograph: inj 

Dosages below include:

• International manufacturer recommendations
• South African manufacturer recommendations

International manufacturer recommendations

Osteoporosis
- In postmenopausal women and in men at increased risk of fracture
- Associated with sustained systemic glucocorticoid therapy in women and men at increased risk for fracture

• SC: 20μg, dly; Max treatment duration: 24 months

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Patients should receive supplemental calcium and vitamin D during treatment if dietary intake is inadequate

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The maximum total duration of treatment with teriparatide should be 24 months. The 24 month course of teriparatide should not be repeated over a patient's lifetime

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Following cessation of teriparatide therapy, patients may be continued on other osteoporosis therapies

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See additional prescribing points for administration instructions 

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South African manufacturer recommendations

Osteoporosis 
- With or without vertebral fractures in postmenopausal women and primary osteoporosis in men
- Associated with sustained systemic glucocorticoid therapy in women and men at increased risk for fracture

• SC: 20μg, dly

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Calcium (1000mg per day) and Vitamin D (400-1200 IU per day) must be administered concomitantly with teriparatide

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To be administered by subcutaneous (SC) injection in the thigh or abdomen. Patients must be educated to use the proper injection techniques

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See additional prescribing points for administration instructions

Not established for use in children

Pregnancy

• Contraindicated
• Teriparatide is contraindicated for use during pregnancy
• Women of childbearing potential should use effective methods of contraception during the use of teriparatide. If pregnancy occurs, teriparatide should be discontinued

Breastfeeding

• Contraindicated
• Teriparatide is contraindicated for use during breastfeeding. It is not known whether teriparatide is excreted in human milk

Fertility

• 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

Renal Impairment 

• Mild: No dose adjustment recommended
• Moderate: Caution; no dose adjustment recommended 
• Severe: Contraindicated

Hepatic Impairment 

• Caution; no information available

Elderly  

• No dose adjustment recommended 

Porphyria Information

• Not yet classified (NC)

Drugs in Sport

• Permitted - No warnings

Central Nervous System Disorders

• Dizziness
• Headache
• Sciatica
• Syncope
• Depression
• Fatigue

Cardiovascular Disorders

• Palpitations
• Tachycardia
• Hypotension
• Chest pain
• Cardiac murmur

Respiratory Disorders

• Dyspnoea
• Emphysema

Gastrointestinal Disorders

• Nausea and vomiting
• Hiatus hernia
• Gastro-oesophageal reflux disease
• Haemorrhoids

Hepatobiliary Disorders

• Increased alkaline phosphatase

Genitourinary Disorders

• Urinary incontinence
• Polyuria
• Micturition urgency
• Nephrolithiasis
• Renal failure
• Renal impairment

Endocrine and Metabolic Disorders

• Hypercholesterolaemia
• Hypercalcaemia
• Hyperuricaemia
• Increased weight  

Musculoskeletal Disorders 

• Limb pain
• Muscle cramps
• Myalgia
• Arthralgia
• Back pain
• Back cramp

Skin and Subcutaneous Tissue Disorders

• Increased sweating
• Mild and transient injection site events/ reactions:
  - Pain
  - Swelling
  - Erythema
  - Localised bruising
  - Pruritus
  - Minor bleeding  

Immune, Blood and Lymphatic System Disorders

• Anaemia
• Anaphylaxis
• Allergic events (soon after injection):
  - Acute dyspnoea
  - Oro/facial oedema
  - Generalised urticaria
  - Chest pain
  - Oedema (mainly peripheral)

Sensory Disorders

• Vertigo

• Digoxin

• Blood pressure
• Bone mineral density

Specific cases may require

• Urinary calcium
• Serum calcium
• Biochemical markers of bone turnover

Administration and storage instructions

• Teriparatide should be administered once daily by subcutaneous (SC) injection in the thigh or abdomen
• Patients must be trained to use the proper injection techniques. An instruction for use which is included in the carton of the delivery system is also available to instruct patients on the correct use of the pen
• Each cartridge and pen should be used by only one patient. The pen can be used with compatible pen needles. These are listed in the instruction for use for the pen. A new, sterile pen needle must be used for every injection
• The date of first injection should also be written on the outer carton of the product
• After each injection, the pen should be returned to the refrigerator. After the first use, the cartridge should not be removed from the pen during the 28 days of usage
• Store in a refrigerator (2°C–8°C). After insertion of the cartridge into the pen, the combined pen and cartridge should be returned to the refrigerator immediately after use
• Do not freeze. Keep the cartridge in the outer carton in order to protect from light

Traceability

• In order to improve the traceability of biological medicinal products, the name and the batch number of the administered product should be clearly recorded

Endogenous 84-amino-acid parathyroid hormone (PTH) is the primary regulator of calcium and phosphate metabolism in bone and kidney. Teriparatide (rhPTH(1-34)) is the active fragment (1-34) of endogenous human parathyroid hormone. Physiological actions of PTH include stimulation of bone formation by direct effects on bone forming cells (osteoblasts) indirectly increasing the intestinal absorption of calcium and increasing the tubular re-absorption of calcium and excretion of phosphate by the kidney.

Injection (per ml) 250μg

• Forteo (Eli Lilly) originator