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OSNUVO is a brand name for Teriparatide, supplied as a solution. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: Indications have been granted on the basis of similarity between Osnuvo and the reference biologic drug Forteo. Osnuvo [teriparatide (rDNA origin) injection] is indicated: For the treatment of postmenopausal women with severe osteoporosis who are at high risk of fracture or who have failed or are intolerant to…
Verbatim from this product's HC label. Tap a section to expand.
1 Dosing Considerations Osnuvo should be administered initially under circumstances in which the patient can sit or lie down if symptoms of orthostatic hypotension occur. In general, the maximum lifetime exposure to teriparatide for an individual patient should be 24 months (see 7 WARNINGS AND PRECAUTIONS, General).
Use of Osnuvo for more than 24 months during a patient’s lifetime should only be considered if a patient remains at or has returned to having a high risk for fracture. Patients should receive supplemental calcium and vitamin D if dietary intake is inadequate.
Osnuvo should not be used in patients with severe renal impairment (see 2 CONTRAINDICATIONS). No data are available on the safety or efficacy of intravenous or intramuscular injection of Osnuvo. Following cessation of therapy with teriparatide, patients may be continued on other osteoporosis therapies.
2 Recommended Dose and Dosage Adjustment The recommended dosage of Osnuvo is 20 mcg once a day. Osnuvo should be administered as a subcutaneous injection into the thigh or abdominal wall. 3 Pediatrics). 4 Geriatrics). 3 Administration Osnuvo is a clear and colourless solution for injection.
Osnuvo should not be used if the solution is cloudy, coloured or contains visible particles. Osnuvo is supplied in a cartridge. 4mL of solution with 600 mcg of teriparatide (rDNA origin) (corresponding to 250 mcg/mL). OSNUVO (teriparatide) Page 6 of 47 Osnuvo should be administered with the dedicated, reusable, multidose medicine delivery system (“pen”) and the injection needles which are listed as compatible in the instructions which are provided with the pen.
The pen and injection needles are not included with Osnuvo. Osnuvo must not be used with any other pen. Patients must be trained to use the proper injection techniques (see 12 SPECIAL HANDLING INSTRUCTIONS). 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.
Before using the pen device for the first time, the patient should read and understand the instructions. 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. Batch (Lot) number of the cartridge and the date of first injection should be recorded by the patient on a calendar. After each injection, Osnuvo must be returned to the refrigerator.
The adverse drug reaction profiles reported in clinical studies that compared Osnuvo to Forteo (the reference biologic drug) were comparable. The description of adverse reactions in this section is based on clinical experience with the reference biologic drug.
1 Adverse Reaction Overview The safety of teriparatide (rDNA origin) injection has been evaluated in 24 clinical trials that enrolled over 2800 women and men. Four long-term, Phase 3 clinical trials included one large placebo- controlled, double-blind multicentre trial with 1637 postmenopausal women, one placebo-controlled, double-blind multicentre trial with 437 men, and two active-controlled trials including 393 postmenopausal women.
Teriparatide doses ranged from 5 to 100 mcg/day in short-term trials and 20 to 40 mcg/day in the long-term trials. A total of 1943 of the patients studied received teriparatide (rDNA origin), including 815 patients at 20 mcg/day and 1107 patients at 40 mcg/day.
In the long-term clinical trials, 1137 patients were exposed to teriparatide (rDNA origin) for greater than 1 year (500 at 20 mcg/day and 637 at 40 mcg/day). The maximum exposure duration to teriparatide (rDNA origin) was 2 years. Adverse events associated with teriparatide (rDNA origin) injection usually were mild and generally did not require discontinuation of therapy.
The safety of teriparatide (rDNA origin) has also been evaluated in a Phase 3 randomised, double blind, double-dummy, active controlled clinical trial that enrolled 428 men and women with glucocorticoid- induced osteoporosis. Patients received either teriparatide (rDNA origin) 20 mcg/day plus oral placebo (n=214) or alendronate 10 mg/day plus injectable placebo (n=214) for up to 3 years.
An additional Phase 3, randomised, multinational, multicentre, open-label study that enrolled 868 patients evaluated safety and efficacy of up to 24 months continuous treatment with 20 mcg/day of teriparatide (rDNA origin). 2 Clinical Trial Adverse Reactions Clinical trials are conducted under very specific conditions.
3Pediatrics). 4 Geriatrics). 2 CONTRAINDICATIONS Osnuvo is contraindicated for: Hypersensitivity to teriparatideor to any ingredient in the formulation, including any non-medicinal ingredient, or component of the container. For a complete listing, see 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING.
Pre-existing hypercalcemia. Severe renal impairment. 1 Forteo is a registered trademark for teriparatide (rDNA origin) injection of Eli Lilly and Company. OSNUVO (teriparatide) Page 5 of 47 Metabolic bone diseases other than primary or glucocorticoid-induced osteoporosis (including hyperparathyroidism and Paget's disease of the bone).
Unexplained elevations of alkaline phosphatase. Prior external beam or implant radiation therapy involving the skeleton. Bone metastases or a history of skeletal malignancies. 1 Special Populations). 1 Special Populations). 1 Dosing Considerations Osnuvo should be administered initially under circumstances in which the patient can sit or lie down if symptoms of orthostatic hypotension occur.
In general, the maximum lifetime exposure to teriparatide for an individual patient should be 24 months (see 7 WARNINGS AND PRECAUTIONS, General). Use of Osnuvo for more than 24 months during a patient’s lifetime should only be considered if a patient remains at or has returned to having a high risk for fracture.
Patients should receive supplemental calcium and vitamin D if dietary intake is inadequate. Osnuvo should not be used in patients with severe renal impairment (see 2 CONTRAINDICATIONS). No data are available on the safety or efficacy of intravenous or intramuscular injection of Osnuvo.
Following cessation of therapy with teriparatide, patients may be continued on other osteoporosis therapies. 2 Recommended Dose and Dosage Adjustment The recommended dosage of Osnuvo is 20 mcg once a day. Osnuvo should be administered as a subcutaneous injection into the thigh or abdominal wall.
3Pediatrics). 4 Geriatrics). 2 CONTRAINDICATIONS Osnuvo is contraindicated for: Hypersensitivity to teriparatideor to any ingredient in the formulation, including any non-medicinal ingredient, or component of the container. For a complete listing, see 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING.
Pre-existing hypercalcemia. Severe renal impairment. 1 Forteo is a registered trademark for teriparatide (rDNA origin) injection of Eli Lilly and Company. OSNUVO (teriparatide) Page 5 of 47 Metabolic bone diseases other than primary or glucocorticoid-induced osteoporosis (including hyperparathyroidism and Paget's disease of the bone).
Unexplained elevations of alkaline phosphatase. Prior external beam or implant radiation therapy involving the skeleton. Bone metastases or a history of skeletal malignancies. 1 Special Populations). 1 Special Populations).
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
Other brands of Teriparatide in Canada.
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Brand names are compiled from public regulatory records for active-ingredient mapping only. Drugvu is not affiliated with any manufacturer. This is not medical advice.
Once used, the cartridge should not be removed from the pen during the 28 days of usage. Expiry date on cartridge label must always be checked before inserting the cartridge into the pen. To avoid medication errors, make sure that there is at least one month between the date when starting to use a new cartridge and the expiry date.
Osnuvo must not be transferred to a syringe. Empty cartridges must not be refilled. 4 Missed Dose If a dose of Osnuvo was missed or it could not be taken at the usual time, it should be administered as soon as possible. Do not use a double dose to make up for a forgotten dose.
Do not use more than one injection in the same day.
The adverse reaction rates observed in the clinical trials; therefore, may not reflect the rates observed in practice and should not be compared to the rates in the clinical trials of another drug. Adverse reaction information from clinical trials may be useful in identifying and approximating rates of adverse drug reactions in real-world use.
1% of patients assigned to teriparatide (rDNA origin) injection. 0% in the teriparatide (rDNA origin) groups and in more teriparatide-treated patients than in placebo-treated patients. Adverse events are shown without attribution of causality.
7% a Treatment emergent adverse events that occurred at a frequency ≥ 2% in patients treated with teriparatide (rDNA origin) at 20 mcg/day irrespective of causality assessment by Clinical Study Investigators. COSTART terminology. Treatment emergent adverse events considered by clinical study investigators to be causally related to teriparatide (rDNA origin) injection, reported by at least 1% of teriparatide-treated patients and reported in more teriparatide-treated patients than placebo-treated patients are: dizziness, nausea, arthralgia, asthenia and headache.
Leg cramps is an adverse event that may also be causally related to teriparatide (rDNA origin) injection.
NOTE:
The incidence of hypertension, syncope, dyspepsia, rhinitis, and pharyngitis in patients treated with teriparatide (rDNA origin) 40 mcg/day (twice the recommended dose) was lower than the incidence in placebo-treated patients. During the 18-month primary phase of a double-blind, double-dummy, active comparator-controlled study in men and women with glucocorticoid-induced osteoporosis, early discontinuation due to treatment-emergent adverse events (TEAEs) occurred in 31 (15%) patients assigned to teriparatide (rDNA origin) (n = 214) and in 25 (12%) patients assigned to alendronate (n = 214).
6%) patients assigned to alendronate (n = 214). Table 3 lists drug-related adverse events reported in ≥ 1% of patients treated with teriparatide (rDNA origin) injection or alendronate 10 mg/day in a clinical trial of men and women with glucocorticoid- induced osteoporosis up to 24 months.
OSNUVO (teriparatide) Page 13 of 47 Table 3 Drug-Relateda Adverse Events Reported in ≥ 1% of Patients Treated with teriparatide (rDNA origin) injection 20 mcg/day or alendronate 10 mg/day in a Principle Clinical Trial in Men and Women with […]
3 Pediatrics). 4 Geriatrics). 3 Administration Osnuvo is a clear and colourless solution for injection. Osnuvo should not be used if the solution is cloudy, coloured or contains visible particles. Osnuvo is supplied in a cartridge.
4mL of solution with 600 mcg of teriparatide (rDNA origin) (corresponding to 250 mcg/mL). OSNUVO (teriparatide) Page 6 of 47 Osnuvo should be administered with the dedicated, reusable, multidose medicine delivery system (“pen”) and the injection needles which are listed as compatible in the instructions which are provided with the pen.
The pen and injection needles are not included with Osnuvo. Osnuvo must not be used with any other pen. Patients must be trained to use the proper injection techniques (see 12 SPECIAL HANDLING INSTRUCTIONS). 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.
Before using the pen device for the first time, the patient should read and understand the instructions. 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. Batch (Lot) number of the cartridge and the date of first injection should be recorded by the patient on a calendar. After each injection, Osnuvo must be returned to the refrigerator.
Once used, the cartridge should not be removed from the pen during the 28 days of usage. Expiry date on cartridge label must always be checked before inserting the cartridge into the pen. To avoid medication errors, make sure that there is at least one month between the date when starting to use a new cartridge and the expiry date.
Osnuvo must not be transferred to a syringe. Empty cartridges must not be refilled. 4 Missed Dose If a dose of Osnuvo was missed or it could not be taken at the usual time, it should be administered as soon as possible. Do not use a double dose to make up for a forgotten dose.
Do not use more than one injection in the same day. 5 OVERDOSAGE No cases of overdose were reported during clinical trials with teriparatide (rDNA origin) injection. Teriparatide (rDNA origin) injection has been administered in single doses of up to 100 mcg and in repeated doses of up to 60 mcg/day for 6 weeks.
The effects of overdose that might be expected include a delayed hypercalcemic effect and risk of orthostatic hypotension. Nausea, vomiting, dizziness, and headache might also occur. In post-marketing spontaneous reports, there have been cases of medication error in which the entire contents (up to 800 mcg) of the teriparatide (rDNA origin) injection pen have been administered as a single dose.
Transient events reported have included nausea, weakness/lethargy and hypotension. In some cases, no adverse events occurred as a result of the overdose. No fatalities associated with overdose have been reported. Overdose management - There is no specific antidote for teriparatide (rDNA origin).
Treatment of suspected […]