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PROLIA is a brand name for Denosumab, supplied as a solution. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: , 1.1 Pediatrics XX/XXXX 4 DOSAGE AND ADMINISTRATION, 4.4 Administration 12/2022 7 WARNINGS AND PRECAUTIONS, Endocrine and Metabolism, Hypercalcemia in Pediatric Patients with Osteogenesis Imperfecta 03/2022 7 WARNINGS AND PRECAUTIONS, Endocrine and Metabolism, Hypocalcemia XX/XXXX 7 WARNINGS AND PRECAUTIONS,…
Verbatim from this product's HC label. Tap a section to expand.
3 Pediatrics 03/2022 XX/XXXX TABLE OF CONTENTS Sections or subsections that are not applicable at the time of authorization are not listed. RECENT MAJOR LABEL CHANGES .........................................................................................
2 TABLE OF CONTENTS ............................................................................................................... 2 PART I: HEALTH PROFESSIONAL INFORMATION .................................................................
4 1 INDICATIONS ..................................................................................................................... 1 Pediatrics ....................................................................................................................
2 Geriatrics .................................................................................................................... 5 2 CONTRAINDICATIONS ......................................................................................................
5 4 DOSAGE AND ADMINISTRATION .................................................................................... 1 Dosing Considerations ...............................................................................................
2 Recommended Dose and Dosage Adjustment .......................................................... 3 Reconstitution ............................................................................................................. 4 Administration .............................................................................................................
5 Missed Dose ............................................................................................................... 6 5 OVERDOSAGE ...................................................................................................................
6
, Postmarket Adverse Drug Reactions). • Hypocalcemia (see 7 WARNINGS AND PRECAUTIONS, Endocrine and Metabolism, Hypocalcemia) • Female patients who are pregnant or who are trying to become pregnant. PROLIA may cause fetal harm when administered to a pregnant woman.
In women of reproductive potential, pregnancy testing should be performed prior to initiating treatment with PROLIA. In utero denosumab exposure in cynomolgus monkeys resulted in increased fetal loss, stillbirths, and postnatal mortality, along with evidence of absent lymph nodes, abnormal bone growth and decreased neonatal growth.
If this drug is used during pregnancy, or if the patient becomes pregnant while taking this drug, the patient should be apprised of the potential hazard to a fetus (see 7 WARNINGS AND PRECAUTIONS, Special Populations, Pregnant Women).
1 Dosing Considerations PROLIA is intended for use under the guidance and supervision of physicians who have fully familiarized themselves with the efficacy/safety profile of PROLIA. After an initial training in proper subcutaneous injection technique, patients may self-inject PROLIA if a physician determines that is appropriate and with medical follow-up as necessary.
Patients should be informed that serious hypersensitivity reactions including anaphylaxis have been reported with PROLIA injections. Pregnancy must be ruled out prior to administration of PROLIA. Perform pregnancy testing in all women of reproductive potential prior to administration of PROLIA.
Based on findings in animals, PROLIA may cause fetal harm when administered to pregnant women (see 2 CONTRAINDICATIONS, 7 WARNINGS AND PRECAUTIONS and 16 NON-CLINICAL TOXICOLOGY, Animal Toxicology). PROLIA (denosumab injection) Page 6 of 81 Patients must be adequately supplemented with calcium and vitamin D at the recommended dosesa.
3 Pediatrics 03/2022 XX/XXXX TABLE OF CONTENTS Sections or subsections that are not applicable at the time of authorization are not listed. RECENT MAJOR LABEL CHANGES .........................................................................................
2 TABLE OF CONTENTS ............................................................................................................... 2 PART I: HEALTH PROFESSIONAL INFORMATION .................................................................
4 1 INDICATIONS ..................................................................................................................... 1 Pediatrics ....................................................................................................................
2 Geriatrics .................................................................................................................... 5 2 CONTRAINDICATIONS ......................................................................................................
5 4 DOSAGE AND ADMINISTRATION .................................................................................... 1 Dosing Considerations ...............................................................................................
2 Recommended Dose and Dosage Adjustment .......................................................... 3 Reconstitution ............................................................................................................. 4 Administration .............................................................................................................
5 Missed Dose ............................................................................................................... 6 5 OVERDOSAGE ...................................................................................................................
• PROLIA is contraindicated in patients who are hypersensitive to this drug or 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.
Anaphylactic reactions have been reported (see 7 WARNINGS AND PRECAUTIONS, Hypersensitivity and 8 ADVERSE REACTIONS, Postmarket Adverse Drug Reactions). • Hypocalcemia (see 7 WARNINGS AND PRECAUTIONS, Endocrine and Metabolism, Hypocalcemia) • Female patients who are pregnant or who are trying to become pregnant.
PROLIA may cause fetal harm when administered to a pregnant woman. In women of reproductive potential, pregnancy testing should be performed prior to initiating treatment with PROLIA. In utero denosumab exposure in cynomolgus monkeys resulted in increased fetal loss, stillbirths, and postnatal mortality, along with evidence of absent lymph nodes, abnormal bone growth and decreased neonatal growth.
If this drug is used during pregnancy, or if the patient becomes pregnant while taking this drug, the patient should be apprised of the potential hazard to a fetus (see 7 WARNINGS AND PRECAUTIONS, Special Populations, Pregnant Women).
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
Other brands of Denosumab 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.
2 Recommended Dose and Dosage Adjustment Health Canada has not authorized an indication for pediatric use (see 7 WARNINGS AND PRECAUTIONS, Special Populations, Pediatrics). The recommended dose of PROLIA (denosumab) is a single SC injection of 60 mg, once every 6 months.
4 Administration Administration of PROLIA should be performed by an individual who has been adequately trained in injection techniques. The prefilled syringe is not made with natural rubber latex. Parenteral drug products should be inspected visually for particulate matter and discolouration prior to administration, whenever solution and container permit.
PROLIA is a clear, colourless to slightly yellow solution that may contain trace amounts of translucent to white proteinaceous particles. Do not use if the solution is cloudy. Prior to administration, PROLIA may be allowed to reach room temperature (up to 25C) in the original container.
Administer PROLIA via SC injection in the upper arm, the upper thigh, or the abdomen. 5 Missed Dose If a dose is missed, it should be given as soon as convenient. The next dose should be scheduled 6 months from the date of the previous injection.
5 OVERDOSAGE There is no experience with overdosage with PROLIA. For management of a suspected drug overdose, contact your regional poison control centre. 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING To help ensure the traceability of biologic products, including biosimilars, health professionals should recognize the importance of recording both the brand name and the non-proprietary (active ingredient) name as well as other product-specific identifiers such as the Drug Identification Number (DIN) and the batch/lot number of the product supplied.
a2010 clinical practice guidelines for the diagnosis and management of osteoporosis in Canada: summary PROLIA (denosumab injection) Page 7 of 81 Route of Administration Dosage Form / Strength/Composition Non-medicinal Ingredients Subcutaneous Solution for injection / 60 mg denosumab in 1 mL solution in a single use prefilled syringe (PFS) Acetate, polysorbate 20, sodium hydroxide, sorbitol, and water for injection (USP).
2. PROLIA is supplied in a single use prefilled syringe with a safety guard. The prefilled syringe is not made with natural rubber latex. 2. PROLIA is supplied in a dispensing pack containing one prefilled syringe. 7 WARNINGS AND PRECAUTIONS General Adequate intake of calcium and vitamin D is important in all patients.
PROLIA contains the same active ingredient as found in XGEVA® (denosumab). Patients being treated with PROLIA should not be treated concomitantly with XGEVA. Endocrine and Metabolism Hypercalcemia in Pediatric Patients with Osteogenesis Imperfecta PROLIA is not indicated for use in pediatric patients.
In clinical trials, hypercalcemia has been reported in pediatric patients with osteogenesis imperfecta treated with denosumab. Some cases required hospitalization [see Special Populations, Pediatrics]. Hypocalcemia Hypocalcemia must be corrected by adequate intake of calcium and vitamin D prior to initiating therapy with PROLIA.
Other disorders affecting mineral metabolism (such as vitamin D deficiency) should be treated. Clinical monitoring of calcium levels is recommended before each dose and, in patients predisposed to hypocalcemia within two weeks after the initial dose (see Monitoring and Laboratory Tests).
Patients are advised to report to their physicians any symptoms of hypocalcemia, such as paresthesias or muscle spasms, twitching and muscle cramps (8 ADVERSE REACTIONS, Hypocalcemia). Calcium levels should be measured if any patient presents with suspected symptoms of hypocalcemia during treatment.
PROLIA (denosumab injection) Page 8 of 81 In the postmarket setting, severe symptomatic […]
6 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING ............................ 6 7 WARNINGS AND PRECAUTIONS ..................................................................................... 1 Special Populations ..................................................................................................
1 Pregnant Women ..................................................................................................... 2 Breast-feeding ..........................................................................................................
3 Pediatrics .................................................................................................................. 4 Geriatrics ..................................................................................................................
12 PROLIA (denosumab injection) Page 3 of 81 8 ADVERSE REACTIONS ................................................................................................... 1 Adverse Reaction Overview .....................................................................................
2 Clinical Trial Adverse Reactions ............................................................................... 3 Less Common Clinical Trial Adverse Reactions (< 1%) ........................................... 4 Abnormal Laboratory Findings: Hematologic, Clinical Chemistry and Other Quantitative Data ......................................................................................................
5 Postmarket Adverse Reactions ................................................................................ 45 9 DRUG INTERACTIONS ....................................................................................................
1 Serious Drug Interactions ......................................................................................... 2 Drug interactions Overview ......................................................................................
3 Drug-Behavioural Interactions .................................................................................. 4 Drug-Drug Interactions .............................................................................................
5 Drug-Food Interactions ............................................................................................. 6 Drug-Herb Interactions .............................................................................................
7 Drug-Laboratory Test Interactions ............................................................................ 46 10 CLINICAL PHARMACOLOGY .......................................................................................... 1 Mechanism of Action ................................................................................................
2 Pharmacodynamics .................................................................................................. 3 Pharmacokinetics .....................................................................................................
48 11 STORAGE, STABILITY AND DISPOSAL ........................................................................ 50 12 SPECIAL HANDLING INSTRUCTIONS ........................................................................... 50 PART II: SCIENTIFIC INFORMATION ......................................................................................
51 13 PHARMACEUTICAL INFORMATION .............................................................................. 51 14 CLINICAL TRIALS ............................................................................................................
1 Clinical Trials by Indication […]