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  • Prolia 60 mg
    / Amgen


    Active Ingredient
    Denosumab 60 mg/ml

    Status in Israel
    RX

    Presentation and Status in Health Basket

    Presentation Basket Yarpa Pharmasoft

    Pre-filled Syringe (solution for injection)

    1 X 60 mg

    partial basket chart 3486 16845

    Related information


    Dosage

    The recommended dose of Prolia 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.
    Patients with renal impairment: No dose adjustment is required in patients with renal impairment.
    No data is available in patients with long-term systemic glucocorticoid therapy and severe renal impairment (GFR < 30 mL/min).
    Patients with hepatic impairment: The safety and efficacy of denosumab have not been studied in patients with hepatic impairment.
    Elderly Patients (age  65): No dose adjustment is required in elderly patients.
    Paediatric Population: Prolia is not indicated for use in children and adolescents below 18 years.
    See prescribing information for full details.


    Indications

    Treatment of osteoporosis in postmenopausal women and in men at increased risk of fractures. In postmenopausal women Denosumab significantly reduces the risk of vertebral, non -vertebral and hip fractures.
    Treatment of bone loss associated with hormone ablation in men with prostate cancer at increased risk of fractures. In men with prostate cancer receiving hormone ablation, Denosumab significantly reduces the risk of vertebral fractures.
    Treatment of bone loss associated with long-term systemic glucocorticoid therapy of a daily dosage equivalent to 7.5 mg or greater of prednisone and expected to remain on glucocorticoids for at least 3 months, in adult patients at high risk of fracture.


    Contra-Indications

    Hypersensitivity to the active substance or to any of the excipients.
    Hypocalcaemia.


    Special Precautions

    Calcium and Vitamin D supplementation: Adequate intake of calcium and vitamin D is important in all patients.
    Precautions for use:
    Hypocalcaemia: It is important to identify patients at risk for hypocalcaemia. Hypocalcaemia must be corrected by adequate intake of calcium and vitamin D before initiating therapy. Clinical monitoring of calcium levels is recommended before each dose and, in patients predisposed to hypocalcaemia within two weeks after the initial dose. If any patient presents with suspected symptoms of hypocalcaemia during treatment calcium levels should be measured. Patients should be encouraged to report symptoms indicative of hypocalcaemia. In the post-marketing setting, severe symptomatic hypocalcaemia (including fatal cases) has been reported, with most cases occurring in the first weeks of initiating therapy, but it can occur later.
    Concomitant glucocorticoid treatment is an additional risk factor for hypocalcemia.
    Skin Infections: Patients receiving this drug may develop skin infections (predominantly cellulitis) leading to hospitalization.  Patients should be advised to seek prompt medical attention if they develop signs or symptoms of cellulitis.
    Osteonecrosis of the Jaw (ONJ): ONJ has been reported rarely in patients receiving this drug for osteoporosis.
    See prescribing information for full details.


    Side Effects

    The most common side effects with Prolia (seen in more than one patient in ten) are musculoskeletal pain and pain in the extremity. Uncommon cases of cellulitis, rare cases of hypocalcemia, hypersensitivity, osteonecrosis of the jaw and atypical femoral fractures have been observed in patients taking Prolia.
    See prescribing information for full details.


    Drug interactions

    In an interaction study, Prolia did not affect the pharmacokinetics of midazolam, which is metabolized by cytochrome P450 3A4 (CYP3A4). This indicates that Prolia should not alter the pharmacokinetics of drugs metabolized by CYP3A4. There are no clinical data on the co-administration of denosumab and hormone replacement therapy (oestrogen), however the potential for a pharmacodynamic interaction is considered to be low.
    In postmenopausal women with osteoporosis the pharmacokinetics and pharmacodynamics of denosumab were not altered by previous alendronate therapy, based on data from a transition study (alendronate to denosumab).


    Pregnancy and Lactation

    Pregnancy: There are no or limited amount of data from the use of denosumab in pregnant women. Studies in animals have shown reproductive toxicity.
    Prolia is not recommended for use in pregnant women and women of child-bearing potential not using contraception. Women should be advised not to become pregnant during and for at least 5 months after treatment with Prolia. Any effects of Prolia are likely to be greater during the second and third trimesters of pregnancy since monoclonal antibodies are transported across the placenta in a linear fashion as pregnancy progresses, with the largest amount transferred during the third trimester.
    Breast-feeding: It is unknown whether denosumab is excreted in human milk. In genetically engineered mice in which RANKL has been turned off by gene removal (a “knockout mouse”), studies suggest absence of RANKL during pregnancy may interfere with maturation of the mammary gland leading to impaired lactation post-partum. A decision on whether to abstain from breast-feeding or to abstain from therapy with Prolia should be made, taking into account the benefit of breast-feeding to the newborn/infant and the benefit of Prolia therapy to the woman.
    Fertility: No data are available on the effect of denosumab on human fertility. Animal studies do not indicate direct or indirect harmful effects with respect to fertility.


    Overdose

    There is no experience with overdose in clinical studies. Denosumab has been administered in clinical studies using doses up to 180 mg every 4 weeks (cumulative doses up to 1,080 mg over 6 months), and no additional adverse reactions were observed.


    Important notes

    Storage: Store in a refrigerator (2°C – 8°C). Do not freeze. Keep the pre-filled syringe in the originalouter carton in order to protect from light.
    Compatibility: In the absence of compatibility studies, this medicinal product must not be mixed with other medicinal products.


    Manufacturer
    Amgen Europe B.V., Breda, Netherlands.
    Licence holder
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