Pharmacologic class: Biosynthetic fragment of human parathyroid hormone
Therapeutic class: Parathyroid hormone
Pregnancy risk category C
FDA Box Warning
In male and female rats, drug increased incidence of osteosarcoma (malignant bone tumor). Because of uncertain relevance of this finding to humans, use drug only in patients for whom potential benefits outweigh potential risk. Don't administer to patient at increased baseline risk for osteosarcoma.
Stimulates new bone growth by binding to specific high-affinity cell-surface receptors
Injection: Multidose prefilled delivery device (pen) with 28 daily doses of 20 mcg/dose (600 mcg/2.4 ml)
Indications and dosages
➣ Osteoporosis in patients at high risk for bone fracture
Adults: 20 mcg/day subcutaneously for up to 2 years
• Hypersensitivity to drug
• Conditions that increase osteosarcoma risk (such as Paget's disease, unexplained alkaline phosphatase elevation, open epiphyses, skeletal radiation therapy)
• Bone cancer metastases or history of bone cancer
• Metabolic bone disease other than osteoporosis
Use cautiously in:
• urolithiasis, hypotension
• concurrent use of cardiac glycosides
• pregnant or breastfeeding patients.
• Inject subcutaneously into thigh or abdominal wall, with patient lying down.
• Know that prefilled injection pen delivers 20 mcg of drug per actuation and may be reused for up to 28 days after first injection. Discard pen in protected container after 28 days, even if it's not empty.
CNS: dizziness, headache, insomnia, depression, vertigo, asthenia
CV: hypertension, angina, syncope
EENT: rhinitis, pharyngitis
GI: nausea, vomiting, diarrhea, dyspepsia, anorexia
Musculoskeletal: joint pain, cramps
Respiratory: cough, dyspnea, pneumonia
Skin: rash, sweating
Drug-drug. Digoxin: increased digoxin toxicity
Drug-diagnostic tests. Calcium: increased level
• Monitor respiratory and neurologic status and assess patient's mood.
• Monitor bone mineral density tests and calcium level.
• Instruct patient to promptly report such adverse reactions as cough and difficulty breathing.
• Tell patient that prefilled injection pen delivers 20 mcg of drug per actuation. Inform him that he may reuse it for up to 28 days after first injection, and should then discard it in appropriate receptacle, even if it's not empty.
• Advise patient to establish effective bedtime routine to minimize insomnia.
• Caution patient to avoid driving and other hazardous activities until he knows how drug affects strength and balance.
• As appropriate, review all other significant adverse reactions and interactions, especially those related to the drugs and tests mentioned above.