Asciminib oral
- Drugs List
- Therapeutic Indications
- Dosage
- Contraindications
- Precautions and Warnings
- Pregnancy and Lactation
- Side Effects
- Monograph
Presentation
Oral formulations of asciminib.
Drugs List
Therapeutic Indications
Uses
Philadelphia chromosome positive (Ph+) chronic myeloid leukaemia (CML)
Philadelphia chromosome-positive chronic myeloid leukaemia (Ph+ CML) in chronic phase in adult patients, previously treated with two or more tyrosine kinase inhibitors, and without a known T315l mutation.
Dosage
Whilst the doses stated below are those recommended by the manufacturer, local cancer network protocols for the relevant indication should be consulted.
Adults
80mg once daily at the same time each day or 40mg twice daily at 12-hour intervals.
Additional Dosage Information
Dose modifications
Starting dose: 80mg once daily
Reduced dose: 40mg once daily
Resumed dose: 80mg once daily
Starting dose: 40mg twice daily
Reduced dose: 20mg twice daily
Resumed dose: 40mg twice daily
Asciminib should be permanently discontinued in patients unable to tolerate a total daily dose of 40mg.
Dose modifications for adverse reactions
Thrombocytopenia (absolute neutrophil count (ANC) less than 1.0 x 10 to power 10/L and/or platelet count (PLT) less than 50 x 10 to power 9/L): Withhold asciminib treatment until resolved to ANC greater than or equal to 1 x 10 to the power 10/L and/or PLT greater than or equal to 50 x 10 to the power 10/L. If resolved within 2 weeks then resume asciminib treatment at starting dose. If resolves after more than 2 weeks then resume asciminib at a reduced dose. For recurrent severe thrombocytopenia and/or neutropenia, withhold asciminib treatment until resolved to ANC greater than or equal to 1 x 10 to the power 9/L and PLT greater than or equal to 50 x 10 to the power 9/L, then resume asciminib at a reduced dose.
Asymptomatic amylase and/or lipase elevation greater than 2 x ULN: Withhold asciminib treatment until resolved to less than 1.5 x ULN. If resolved then resume at a reduced dose. If events reoccur at a reduced dose then permanently discontinue asciminib treatment. If not resolved then permanently discontinue asciminib treatment. Perform diagnostic tests to exclude pancreatitis.
Grade 3 or higher non-haematological adverse reactions: Withhold asciminib until resolved to grade 1 or lower. If resolved then resume asciminib at a reduced dose. If not resolved then permanently discontinue treatment with asciminib.
Contraindications
Children under 18 years
Breastfeeding
Galactosaemia
Long QT syndrome
Pregnancy
Torsade de pointes
Precautions and Warnings
Family history of long QT syndrome
Females of childbearing potential
History of treatment with anthracyclines
Electrolyte imbalance
Glucose-galactose malabsorption syndrome
History of cardiac disorder
History of hepatitis B
History of pancreatitis
History of torsade de pointes
History of uncontrolled cardiovascular disorder
Lactose intolerance
Moderate hepatic impairment
Correct electrolyte disorders before treatment
Advise ability to drive/operate machinery may be affected by side effects
Before initiating screen all patients for hepatitis B infection
Treatment to be initiated by specialist
Contains lactose
Advise patient to have no food for 2 hours before and 1 hour after dose
Avoid oral products containing hydroxypropyl-beta-cyclodextrin
Consult local policy on the safe use of oral anti-cancer drugs
Staff: Not to be handled by pregnant staff
Exclude pregnancy prior to initiation of treatment
Perform ECG before and during treatment
Monitor blood counts every 2 weeks for first 3 months then monthly
Monitor blood pressure regularly
Monitor for active hepatitis B during therapy and for several months after
Monitor pancreatic function
Monitor serum amylase and lipase monthly
Monitor serum electrolytes
Predisposition QT prolongation: Counsel patient on symptoms of arrhythmias
Reactivation of hepatitis B may occur in chronic carriers
Interrupt therapy if neutrophil count <1.0x10 to the power 9/L
Interrupt treatment if platelet count <50 x 10 to the power of 9/L
Suspend treatment and/or reduce dose in grade 3 non-haematological toxicity
Suspend treatment if elevated serum lipase/amylase with abdominal symptoms
Advise patient not to take St John's wort concurrently
Female: Contraception required during and for 3 days after treatment
Breastfeeding: Do not breastfeed during and for 3 days after treatment
Hydroxypropyl-beta-cyclodextrin
Caution should be exercised during concomitant administration of asciminib with hydroxypropyl-beta-cyclodextrin containing oral products, as bioavailability of asciminib may be reduced.
Pregnancy and Lactation
Pregnancy
Asciminib is contraindicated during pregnancy.
The manufacturer recommends that asciminib is not used during pregnancy or in women of childbearing potential not using contraception. There is no data available from the use of asciminib in pregnant women, however animal studies have shown reproductive toxicity.
Lactation
Asciminib is contraindicated during breastfeeding.
The manufacturer does not recommend breastfeeding during treatment with asciminib and for at least 3 days after stopping asciminib treatment. There are no data on the effects of asciminib on breastfed infants, and it is unknown whether asciminib is excreted in human milk.
Side Effects
Abdominal pain
Alterations in pancreatic enzymes
Anaemia
Arthralgia
Blurred vision
Cough
Creatine phosphokinase increased
Decreased appetite
Diarrhoea
Dizziness
Dry eyes
Dyslipidaemia
Dyspnoea
Fatigue
Febrile neutropenia
Headache
Hypertension
Increases in hepatic enzymes
Influenza
Lower respiratory tract infection
Musculoskeletal pain
Nausea
Neutropenia
Non-cardiac chest pain
Oedema
Palpitations
Pancreatitis
Pleural effusion
Prolongation of QT interval
Pruritus
Pyrexia
Rash
Serum bilirubin increased
Thrombocytopenia
Upper respiratory tract infection
Urticaria
Vomiting
Overdosage
It is strongly recommended that the UK National Poisons Information Service be consulted on cases of suspected or actual overdose where there is doubt over the degree of risk or about appropriate management.
The following number will direct the caller to the relevant local centre (0844) 892 0111
Information may be obtained if you have access to ToxBase the primary clinical toxicology database of the National Poisons Information Service. This is available via password on the internet ( www.toxbase.org ) or if this is unavailable at the backup site ( www.toxbasebackup.org ).
Further Information
Last Full Review Date: September 2022
Reference Sources
Summary of Product Characteristics: Scemblix 20mg film-coated tablets. Novartis Pharmaceuticals UK Ltd. Revised June 2022.
Summary of Product Characteristics: Scemblix 40mg film-coated tablets. Novartis Pharmaceuticals UK Ltd. Revised June 2022.
Medscape UK | Univadis prescription drug monographs & interactions are based on FDB Multilex Content
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