Spalzact 100 100 mg POWDER FOR SUSPENSION FOR INJECTION

Spalzact 100 100 mg POWDER FOR SUSPENSION FOR INJECTION

S4
PDF Leaflet Revision Date: 13 December 2022


Clinical Summary

Quick overview from the medicine insert

Indication

Treatment of myelodysplastic syndromes.

Dosage (summary)

Starting dose: 75 mg/mu00b2 SC daily for 7 days every 4 weeks; may increase to 100 mg/mu00b2 if no response.

Special Populations

  • Renal impairment
  • Hepatic impairment
  • Elderly

Pregnancy & Breastfeeding

Not recommended in pregnancy; unknown if excreted in breast milk.

Contraindications

  • Hypersensitivity to azacitidine
  • Advanced malignant hepatic tumors

Common side effects

  • Nausea
  • Vomiting
  • Diarrhoea
  • Anaemia
  • Thrombocytopenia

Counselling Points

  • Monitor for signs of bleeding
  • Avoid pregnancy during treatment
  • Report febrile episodes immediately

Serious warnings

  • Haematological toxicity
  • Risk of necrotising fasciitis
  • Potential for renal failure
Important Disclaimer

The Spalzact 100 100 mg POWDER FOR SUSPENSION FOR INJECTION professional information leaflet below is the property of Ruby Pharmaceuticals and is provided on Medinsert exactly as issued, with no.. alterations or editorial changes. We make every effort to keep content current by updating documents as soon as new versions become available. Medinsert serves as a trusted access point for healthcare professionals, but does not replace official sources or clinical judgement. For more details, please read our full disclaimer. read more>>

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