SPRYCEL 50MG

Description

Sprycel 50mg is an oral dual BCR/ABL and Src family tyrosine kinase inhibitor approved for use in patients with chronic myelogenous leukaemia (CML). The main targets of Dasatinib, are BCRABL, SRC, Ephrin’s and GFR.Sprycel 50mg is a prescription drug which used under the supervision of doctor.

Indication

Sprycel 50mg is indicated for the treatment for

Chronic Myeloid Leukaemia

Newly diagnosed adults with Philadelphia chromosome-positive (Ph+) chronic myeloid leukaemia (CML) in chronic phase.

Chronic, accelerated, or myeloid or lymphoid blast phase Ph+ CML with resistance or intolerance to prior therapy including imatinib.

Acute Lymphoblastic Leukaemia

Philadelphia chromosome-positive (Ph+) acute lymphoblastic leukaemia (ALL) with resistance or intolerance to prior therapy

Mechanism of action

Dasatinib is a group of drugs called a protein tyrosine kinase inhibitor (TKI).

Multi-kinase inhibitor which prohibits BCR-ABL, SRC family (SRC, LCK, YES, FYN), c-Kit, EPHA2 and PDGFR-beta kinases; tyrosine kinase prevention of possibly stops angiogenesis and cellular proliferation

ADME Properties

Distribution: volume of distribution 2505 L and plasma protein binding is 96%

Metabolism: Extensively metabolized in humans, mainly by the cytochrome P450 enzyme 3A4.

Elimination: Dasatinib excreted through the feces.

Half-life is 3-5 hours

Dosage and administration

Sprycel indicated for Chronic Myeloid Leukaemia

Newly diagnosed

The recommended dose: starting 100 mg PO qDay (morning or evening).

May raised to 140 mg qDay if insufficient response.

Advanced CML

The recommended dose: starting 140 mg PO qDay

May increase to 180 mg qDay if insufficient reactions

Sprycel indicated for Acute Lymphoblastic Leukaemia

The recommended dose: starting 140 mg PO qDay

May increase to 180 mg PO qDay if insufficient reactions

 Side effects

• Anemia
• Skin rash
• Infection
• Nausea
• Dyspnea
• Anorexia
• Arthralgia
• Asthenia
• Constipation
• Dizziness
• Musculoskeletal pain
• Febrile neutropenia
• Thrombocytopenia
• Mucosal inflammation
• Diarrhea
• Headache
• Haemorrhage
• Fatigue
• Pyrexia

Drug interaction

1. Sprycel 50mg interaction with CYP3A4 inhibitors will increase Dasatinib plasma concentration.
2. Sprycel 50mg interaction with CYP3A4 inducers will reduces Dasatinib plasma concentration.
3. Sprycel 50mg interaction with antacids will reduces Dasatinib plasma concentration.
4. Sprycel 50mg interaction with H₂ antagonists/proton pump inhibitors will reduces Dasatinib plasma concentration.
5. Sprycel 50mg interaction with CYP3A4 substrates will have their plasma concentration altered by Dasatinib.

Precautions

• Myelosuppression contains severe thrombocytopenia, neutropenia and Anemia may develop; may manage by dose interruption, dose reduction, or stopping of treatment; hematopoietic growth factor has been used with resistant myelosuppression.
• Some patients with chronic phase CML and paediatric Ph+ ALL, show complete blood cell counts (CBCs) q2Weeks for 12 weeks, then q3Months thereafter, or as clinically indicated; show CBCs for the first 2 months weekly after that monthly, or as clinically indicated in patients with advanced phase CML or Ph+ ALL.
• Sprycel 50mg will occur Hypokalaemia, hypomagnesemia, congenital QT interval prolongation, hepatic impairment
• Sprycel 50mg should Use with caution in patients who have or may develop prolongation of QT interval

Pregnancy

Sprycel 50mg will cause fetal harm while using during pregnancy. Advise a pregnant woman of the possible risk to a foetus.

Lactation

Avoid breastfeeding during Sprycel treatment.

Storage

Stored at 20⁰C – 25⁰C

Missed Dose

In case of missed dose, patients must consult with medical oncologist and follow the regular dosing schedule.