Drug Interaction:
Hydrochlorthiazide- co-admin of hydrochlorthiazide with teriparatide did not affect the
serum calcium response of teriparatide
Furosemide- patients with mild, moderate or severe renal insifficiency , co-admin of intervenous furosemide with teriparatide resulted in small increases in serum calcium and 24 hour urine calcium response to teripartide that did not appear too be clinically significant.
Teriparatide affects calcium and phosphorus metabolism in a pattern consistent with known actions of endogenous PTH
Laboratory Tests-
Serum calcium -Teriparatide transciently increases serum calcium with the maximal effect observed at approximately 4 to 6 hr post dose. By 16 hrs post dose, serum calcium generally has returned to or near baseline.If persistent hyper calcemia is observed treatment with Teriparatide should be discontuned.
Indication:
Osteoporosis in men and postmenopausal women with a high risk of fracture
Patent Expiry Date of drugs (Ref - IDMA Publication)
Chemical Category Manufacturer/ US Patent
Ingredient- Marketer Expiration Date
Teriparatide Hormone Eli Lily & Co 27-07-2013
New Drugs Approved by (DCI) Drug Controller GENERAL - India For Marketing
(Ref- IDMA Publication)
Name of Drug Indication Date of Approval
Teriparatide For Osteoporosis 04-09-2003
Adverse Reaction:
Adverse reaction associated with teriparatide is usually mild and did not require discontinuation of treatment.
Reported adveres events that appeared to be increased by teripartide treatment were dizziness and leg cramps.
Contra-Indications:
Not to be given to patients with hypersensitivity to teriparitide or any of the excepients
Warnings
Pagets disease of bone- should not be given to patients with Pagets disease of bone.
Unexpplained elevations of alkaline phosphatase may indicate Pagets disease of bone.
Pediatric populations- should not be used in pediatric patients or young adultswith open epiphyses.
Prior radiation therapy- patients with a prior history of radiation therapy invoving the skeleton should not be excluded from treatment
Patientswith bone metastases or skeletal malignancies should be excluded from treatment.
Patient with metabolic bone disease other than osteoporosis should be excluded from treatment.
Precautions-
Use of teriparatide beyond 18 months is not recommended.
When transcient hypotension occured , it happened with the first several doses, it was relieved by placing the person in a reclining position and it did not preclude continued treatment.
Concomittant treatment with digitalis- because teriparatide transiently increases serum calcium teriparatide should be used with caution in patients taking digitalis.
Hepatic,renal and cardiac - limited information available
Dosages/ Overdosage Etc:
Indication-
Osteoporosis in men and postmenopausal women with a high risk of fracture
Dosage
Recommeded dose is 20mcg once a day.
Overdosage-
Incidents of overdosage in humans have not been reported in clinical trials.
The effect of overdose that might be expected include dealyed hypercalemic effect and a risk of orthosatic hypotension. Nausea and vomiting, dizziness and headache,might also occur.
Overdose mangement-
There is no specific anidote for teripartide.Treatment of suspected overdose should include
discontiuation of drug, monitoring of serum calcium, phosphorus,and implementation of
supportive measures such as hydration.
Patient Information:
1. Patients should read the medication guide and pen user manual before starting therapy and re- read them each time the prescription is renewed
2. Patients should be made aware that teripartide caused ostesarcomas in rats and that the clinical relavance of these findings is unknown.
3. Teriparatide should be administered initially under circumstances where the patient can
immediately sit or lie down if symptoms occur.
4. Patients should be instructed that if they feel lightheaded or have palpitations after the injections they should sit or lie down until the symptoms resolve.
5. If symptoms persist or worsen patients should be instructed to consult a physician before
continuing treatment.
6. Although symptomatic hypercalcemia was not observed in clinical trials physician should
instruct patient to contact a health care provider if they develop persistent symptoms
of hypercalcemia ( i.e. nausea, vomiting, constipation, lethargy, muscle weakness)
7. Patients shouled be instructed on how to properly dispose of needles, and be adviced
not to share their pens with other patients.
8.Patients should be informed regarding te roles of supplemental calcium and or vitamin D,
weight bearing excercise, and modification of certain behavioural factors such as cigerette smoking and or alcohol consumption.
Pharmacology/ Pharmacokinetics:
Pharmacology-
Endogenous 84 amino acid parthyroid hormone (PTH) isthe primary regulator of calcium in bone and kidney. Physiological actions of PTH include regulation of bone metabolism, renal tubular reabsorption of calcium and phosphate and intestnal calcium absorption.
The biological actions of PTH and teripartide are mediated through binding to specific
high affinity cell receptors. Teripartide is not expected to accumulate in bone or other tissues.
Pharmacokinetics-
Teriparatide is extensively absorbed after subcutaneous injection.the absolute bioavialability is approximately 95% based on pooled data from 20 40 80mcg doses. Rate of absorption
and elimination are rapid. The peptide reaches peak serum conc about 30 minutes after subcutaneous inj of a 20mcg dose and declines to non-quantifiable conc within 3 hrs.
The half life of teripartide in serum is 5 minutes when administered by interevenous inj and
approx 1 hr when administered by sub cutaneous inj
Pregnancy and lactation:
Pregnancy-
Not indicatedfor use during pregnancy
Nursing mothers- No clinical studies to deterrmine if teripartide is secreted in breast milk.
Pediatric use-
Safety and efficacy has not establised in pediatric population Geriatric use- Elderly patients may have greater sensitivity to the adverse effects of teripartide.
