Xgeva Dosage & Drug Information

Concise Prescribing Info Full Prescribing Info Contents Description Action Indications/Uses Dosage/Direction for Use Overdosage Contraindications Special Precautions Use In Pregnancy & Lactation Adverse Reactions Drug Interactions Caution For Usage Storage MIMS Class ATC Classification Regulatory Classification Presentation/Packing

Concise Prescribing Info

Contents

Denosumab

Indications/Uses

Prevention of skeletal-related events (pathological fracture, bone radiation, spinal cord compression or bone surgery) in patients w/ multiple myeloma & bone metastases from solid tumours. Adults & skeletally mature adolescents w/ giant cell bone tumour that is unresectable or where surgical resection likely results in severe morbidity.

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Dosage/Direction for Use

Prevention of skeletal-related events in adult w/ multiple myeloma & bone metastasis from solid tumours 120 mg single SC inj once every 4 wk. Giant cell bone tumour 120 mg single SC inj once every 4 wk w/ additional 120 mg doses on days 8 & 15 for 1st mth of therapy.

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Overdosage

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Contraindications

Hypersensitivity. Severe untreated hypocalcaemia; unhealed lesions from dental or oral surgery.

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Special Precautions

Not recommended in patients w/ growing skeletons. Ensure adequate intake of Ca & Vit D to correct hypocalcemia prior to therapy. Osteonecrosis of the jaw (ONJ) & external auditory canal. Atypical femoral fractures. Multiple vertebral fractures following discontinuation of treatment. Perform oral & dental exam w/ preventive dentistry prior to treatment. Avoid invasive dental procedures & maintain good oral hygiene during treatment. Monitor Ca level in patients w/ risk factors for hypocalcaemia. Not to be used concomitantly w/ other denosumab-containing products & bisphosphonates. Fructose intolerance. Severe renal impairment (CrCl <30 mL/min) or dialysis patients. Hepatic impairment. Women of childbearing potential should use effective contraception during & for at least 5 mth after last dose. Not recommended during pregnancy. Lactation. Not recommended in paed <18 yr.

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Use In Pregnancy & Lactation

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Adverse Reactions

Hypocalcaemia; dyspnoea; diarrhoea; musculoskeletal pain. New primary malignancy; hypophosphataemia; tooth extraction; hyperhidrosis, alopecia; ONJ.

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Caution For Usage

For caution against possible variation of physical aspect of medicine... Click to view Xgeva detailed prescribing information

Storage

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Description

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Action

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MIMS Class

Agents Affecting Bone Metabolism

ATC Classification

M05BX04 - denosumab ; Belongs to the class of other drugs affecting bone structure and mineralization. Used in the treatment of bone diseases.

Regulatory Classification

Presentation/Packing

Form

Xgeva soln for inj 120 mg/1.7 mL

Packing/Price

1's

Xgeva

denosumab

Manufacturer:

Amgen

Distributor:

Zuellig Pharma