Product Dossier
SPRYCEL
Product Dossier for SPRYCEL (dasatinib, Bristol-Myers Squibb). ARTG record, PBS listing, PBAC outcomes, AusPAR — compiled by arcimedes.
- Sponsor: Bristol-Myers Squibb
- Active ingredient: dasatinib
- Therapeutic area: Oncology
- Related brand: DASATINIB-TEVA
- Related brand: TE-DASATINIB
- Same area: TALZENNA
- Same area: ZARZIO
What it is
SPRYCEL contains dasatinib and is available as film-coated tablets in strengths of 20 mg, 50 mg, 70 mg and 100 mg.
Approved indications
SPRYCEL is indicated for the treatment of adults aged 18 years or over with newly diagnosed Philadelphia chromosome positive chronic myeloid leukaemia in the chronic phase. — Chronic, accelerated or myeloid or lymphoid blast phase chronic myeloid leukaemia with resistance or intolerance to prior therapy including imatinib. — Newly diagnosed Philadelphia chromosome positive acute lymphoblastic leukaemia integrated with chemotherapy. — Philadelphia chromosome positive acute lymphoblastic leukaemia with resistance or intolerance to prior therapy. — Paediatric patients with Philadelphia chromosome positive chronic myeloid leukaemia in the chronic phase. — Paediatric patients with newly diagnosed Philadelphia chromosome positive acute lymphoblastic leukaemia in combination with chemotherapy.
Dosing overview
Paediatric dosing is based on body weight, with recommended starting doses ranging from 40 mg daily for patients weighing 10 to less than 20 kg, up to 100 mg daily for patients weighing at least 45 kg. The dose should be recalculated every 3 months based on changes in body weight, or more often if necessary. Tablets must not be crushed, cut or chewed and should be swallowed whole. SPRYCEL can be taken with or without a meal.
Key safety warnings
SPRYCEL tablets are not recommended for patients weighing less than 10 kg. There is no experience with SPRYCEL treatment in children under 1 year of age. SPRYCEL should not be taken with grapefruit or grapefruit juice.
Regulatory history
SPRYCEL was first registered on the ARTG on 15 January 2007 with dasatinib 20 mg, 50 mg and 70 mg tablets, followed by registration of 100 mg tablets on 16 February 2010. The TGA approved SPRYCEL for the treatment of adults aged 18 years or over with newly diagnosed Philadelphia chromosome positive acute lymphoblastic leukaemia integrated with chemotherapy on 7 March 2018 following a major variation submission. In July 2016, the PBAC recommended a change to the PBS listing for chronic myeloid leukaemia, amending the benefit type from Authority Required (Written) to Authority Required (Telephone) for second continuing and subsequent treatment applications. In March 2019, the PBAC recommended a new listing for newly diagnosed Philadelphia chromosome positive acute lymphoblastic leukaemia on a cost-minimisation basis against imatinib.