Methotrexate
[pic]
|Shared Care Guideline |
|Denosumab |
|Treatment of osteoporosis in post menopausal women |
| | |
|Introduction |This shared care agreement outlines the responsibilities between the specialist and the |
| |generalist for managing the prescribing of denosumab for indications listed below. |
|Indication |NICE guidance recommends denosumab as a treatment option for the primary prevention of |
| |osteoporotic fragility fractures only in postmenopausal women at increased risk of fractures: |
| |• who are unable to comply with the special instructions for administering alendronate and |
| |either risedronate or etidronate, or have an intolerance of, or a contraindication to, those |
| |treatments and |
| |• who have a combination of T-score, age and |
| |number of independent clinical risk factors for |
| |fracture as indicated in the following table. |
| | |
| |Age (Years) |
| |Numbers of independent clinical risk factors for fracture |
| | |
| | |
| |0 |
| |1 |
| |2 |
| | |
| |65-69 |
| |Not recommended |
| |-4.5 |
| |-4.0 |
| | |
| |70-74 |
| |-4.5 |
| |-4.0 |
| |-3.5 |
| | |
| |75 or older |
| |-4.0 |
| |-4.0 |
| |-3.0 |
| | |
| | |
| |Denosumab is recommended as a treatment option for the secondary prevention of osteoporotic |
| |fragility fractures only in |
| |postmenopausal women at increased risk of fractures who are unable to comply with the special |
| |instructions for administering alendronate and either risedronate or etidronate, or have |
| |an intolerance of, or a contraindication to, those treatments. |
|Licensing information |Denosumab is licensed for the treatment of osteoporosis in postmenopausal women at increased |
| |risk of fractures. |
| | |
| |Denosumab is contraindicated in the following: |
| |Hypocalcaemia - Hypocalcaemia must be corrected by adequate intake of calcium and vitamin D |
| |before initiating therapy. Patients with severe renal impairment (creatinine clearance < 30 |
| |ml/min) or receiving dialysis are at greater risk of developing hypocalcaemia. Clinical |
| |monitoring of calcium levels is recommended for patients predisposed to hypocalcaemia. |
| | |
| |Hypersensitivity to the active substance or to any of the excipients |
| | |
| |The needle cover for the prefilled syringe contains natural dry rubber (derivative of latex) |
| |which may cause allergic reactions |
| | |
| | |
| | |
|Dosage and administration |The recommended dose of denosumab is 60 mg administered as a single subcutaneous injection |
| |once every 6 months into the thigh, abdomen or upper arm. Patients must be adequately |
| |supplemented with calcium and vitamin D. |
| | |
| |No dosage reduction is required in renal or hepatic impairment or in the elderly population. |
| | |
| |HDFT policy is to prescribe denosumab according to the NICE guidance and Harrogate and |
| |District NHS Foundation Trust Osteoporosis Guidelines |
| | |
|Adverse drug reactions |For a comprehensive list of adverse drug reactions consult Summary of Product Characteristics |
| |or BNF |
| | |
| |Constipation, UTI, upper respiratory tract infection, pain in the extremity, sciatica, |
| |cataracts, rash; less commonly-diverticulitis, cellulitis, ear infection, eczema; rarely- |
| |osteonecrosis of the jaw, atypical femoral fractures; very rarely-hypocalcaemia |
| | |
|Drug Interactions |There are no known interactions with denosumab |
| | |
| |Note: This information is not exhaustive and the current BNF/SPC should be referred to for |
| |more information. |
|Duration of Treatment |4 years then review |
|Responsibilities of the |Assess the suitability of the patient for treatment. |
|specialist initiating treatment|Confirm absence of any contra indication to denosumab |
| |Inform patient of side effects of denosumab and obtain informed consent for treatment |
| |Provide advice to patient as set out below |
| |Baseline tests prior to initiation and communication of results to the GP. |
| |Ask the GP whether they are willing to participate in shared care. |
| |Ensure patient is co-prescribed calcium and vitamin D if appropriate |
| |As with bisphosphonates assess oral hygiene and use clinical judgment as to if a dental |
| |examination is required prior to starting therapy. |
| |Initiate treatment by prescribing and administering first dose in secondary care. |
| |Make decision whether to continue denosumab |
| |Provide continuing clinical support to the patient and GP |
| |Review therapy in 4 years and communicate decision to stop or continue with GP |
| |Baseline Tests |
| | |
| |Secondary care specialist will monitor the patient's renal and calcium levels prior to |
| |initiation of denosumab. Secondary care specialist will correct any hypocalcaemia prior to |
| |starting therapy. |
| |Monitoring of calcium levels is recommended for those patients predisposed to hypocalcaemia. |
| |Highest risk of hypocalcaemia is if GFR ................
................
In order to avoid copyright disputes, this page is only a partial summary.
To fulfill the demand for quickly locating and searching documents.
It is intelligent file search solution for home and business.
Related download
- ggc medicines
- optimal dosage and route of administration of
- methotrexate
- shared care policy and prescribing information for general
- auspar attachment 1 product information for methotrexate
- metoject 50 mg ml solution for injection pre filled syringe
- framework shared care
- auspar attachment 2 extract from the clinical evaluation
Related searches
- methotrexate calculation formula
- methotrexate injection dose calculator
- methotrexate dosage ectopic pregnancy
- methotrexate for arthritis
- methotrexate dosage calculator
- methotrexate dosing calculator for ectopic
- methotrexate injection dosage
- methotrexate dosage chart
- methotrexate 2 5 mg side effects
- methotrexate for arthritis treatment
- methotrexate injection dose chart
- methotrexate for arthritis side effects