Idelalisib oral
- Drugs List
- Therapeutic Indications
- Dosage
- Contraindications
- Precautions and Warnings
- Pregnancy and Lactation
- Side Effects
- Monograph
Presentation
Oral formulations of idelalisib.
Drugs List
Therapeutic Indications
Uses
Chronic lymphocytic leukaemia with anti-CD20 monoclonal antibody
Maintenance for patients with relapsed / refractory follicular lymphoma
Monotherapy for follicular lymphoma (FL), refractory to two previous treatments.
Treatment of adult chronic lymphocytic leukaemia (CLL), in combination with anti-CD20 monoclonal antibody (rituximab or ofatumumab):
In patients who have received one prior treatment.
As first line treatment in patients with 17p deletion or TP53 mutation who were unsuitable for other therapies.
Dosage
Whilst the doses stated below are those recommended by the manufacturer, local cancer network protocols for the relevant indication should be consulted.
Adults
150mg twice daily.
Treatment should continue until disease progression or unacceptable toxicity.
Additional Dosage Information
Grade 3 or 4 aminotransferase elevation (ALT or AST greater than 5 x upper limit of normal (ULN))
Suspend treatment until grade 1 values (ALT or AST less than or equal to 3 ULN) have been reached, resume treatment at 100mg twice daily.
Monitor for symptoms and increase to 150mg twice daily, depending on patient tolerance.
If symptoms reoccur suspend treatment until values return to grade 1 and resume treatment at 100mg twice daily if suitable.
Grade 3 or 4: Diarrhoea/colitis or rash
Suspend treatment until symptoms have returned to grade 1, resume treatment at 100mg twice daily.
Monitor for symptoms and increase to 150mg twice daily, depending on patient tolerance.
Pneumonitis
Suspend treatment until symptoms resolve, if appropriate resume treatment at 100mg twice daily.
Discontinue permanently in cases of moderate or severe symptomatic pneumonitis or organising pneumonia.
Absolute neutrophil count (ANC) less than 500per cubic mm
Suspend treatment until ANC is above 500per cubic mm, monitor ANC at least weekly until ANC is greater than or equal to 500per cubic mm
Then resume treatment at 100mg twice daily.
Absolute neutrophil count (ANC) greater than 500per cubic mm
Maintain regular treatment.
Monitor ANC at least weekly until ANC is greater than or equal to 1000per cubic mm.
Missed dose
If the patient misses a dose within 6 hours of the time it is usually taken, the patient should take the missed dose as soon as possible and resume normal dosing schedule.
If the patient misses a dose by more than 6 hours, the missed dose should not be taken. The patient should then resume the usual dosing schedule.
Contraindications
Children under 18 years
Infection
Breastfeeding
Pregnancy
Precautions and Warnings
Females of childbearing potential
Hepatic impairment
Hepatitis
Prophylaxis for pneumocystis jiroveci pneumonia recommended
Treatment to be initiated and supervised by a specialist
Some formulations contain sunset yellow (E110); may cause allergic reaction
Consult local policy on the safe use of oral anti-cancer drugs
Staff: Not to be handled by pregnant staff
Consider immunosuppressant adjustment in the event of PML
Monitor AST, ALT and total bilirubin every 2 weeks for first 3 months
Monitor neutrophil count every 2 weeks for first 6 months of treatment
Monitor neutrophil count weekly if ANC is less than 1000 per cubic mm
Monitor patients with hepatic impairment for adverse effects
Monitor regularly for cytomegalovirus (CMV) infection
Monitor respiratory function
Advise patient to report any new or worsening respiratory symptoms
Advise patient to report headaches, seizures, confusion, visual disturbance
Advise patient to report symptoms of infection immediately
Discontinue if active infection develops
Discontinue if cryptogenic organising pneumonia occurs
Discontinue if moderate or severe pneumonitis occurs
Discontinue treatment if DRESS is confirmed
Discontinue treatment if Stevens-Johnson syndrome is confirmed
Discontinue treatment if toxic epidermal necrolysis is confirmed
Reduce dose if grade 3 or 4 toxicities occur
Suspend treatment if DRESS is suspected
Suspend treatment if grade 3 or worse diarrhoea or colitis occurs
Suspend treatment if grade 3 or worse skin reaction occurs
Suspend treatment if pneumonitis is suspected
Suspend treatment if Stevens-Johnson syndrome is suspected
Suspend treatment if toxic epidermal necrolysis is suspected
Discontinue if Progressive multifocal leukoencephalopathy (PML) develops
Interrupt treatment if ALT or AST > 5 x ULN
Suspend treatment if neutrophil count < 500 cells per cubic mm
Advise patient not to take St John's wort concurrently
May cause impaired fertility
Female: Barrier or non-hormonal contraception required during treatment
Female: Contraception required during and for 1 month after treatment
Advise patients to report skin rash
If grade 2 or more elevations in ALT or AST are observed, monitor patients weekly until values have returned to grade 1 or less.
All patients should receive prophylaxis for Pneumocystis jirovecii pneumonia (PJP) during treatment and for 2 to 6 months following the end of treatment. Length of continued prophylaxis should be based on risk factors for opportunistic infections such as such as corticosteroid treatment and prolonged neutropenia.
Progressive multifocal leukoencephalopathy syndrome (PML) has been reported in some patients treated with this agent. If patients present with symptoms indicating PML such as worsening neurological, cognitive or behavioural signs or symptoms, an MRI should be performed. If PML is diagnosed, treatment should permanently discontinued.
Pregnancy and Lactation
Pregnancy
Idelalisib is contraindicated during pregnancy.
Use of idelalisib during pregnancy is contraindicated by the manufacturer. Animal studies have shown teratogenic effects. Human data is limited and as a potential risk cannot be ruled out.
Lactation
Idelalisib is contraindicated during breastfeeding.
Use if idelalisib when breastfeeding is contraindicated by the manufacturer. It is not known if idelalisib and its metabolites are excreted in human milk. Effects on exposed infants are unknown.
Side Effects
Bronchitis
Colitis
Cryptogenic organising pneumonia
Cytomegalovirus infection
Diarrhoea
Drug rash with eosinophilia and systemic symptoms (DRESS)
Elevated triglyceride levels
Erythematous rash
Exfoliative dermatitis
Hepatic failure
Hepatocellular damage
Increase of liver transaminases
Increases in hepatic enzymes
Infections
Lymphocytosis
Maculopapular rash
Neutropenia
Pneumocystis jiroveci pneumonia
Pneumonitis
Progressive multifocal leukoencephalopathy (PML)
Pruritic rash
Pyrexia
Rash
Sepsis
Skin disorder
Stevens-Johnson syndrome
Toxic epidermal necrolysis
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: May 2019
Reference Sources
NICE Evidence Services Available at: www.nice.org.uk Last accessed: 28 May 2019
Summary of Product Characteristics: Zydelig 100mg film-coated tablets. Gilead Sciences Ltd. Revised January 2021.
Summary of Product Characteristics: Zydelig 150mg film-coated tablets. Gilead Sciences Ltd. Revised January 2021.
Medscape UK | Univadis prescription drug monographs & interactions are based on FDB Multilex Content
FDB Disclaimer : FDB Multilex is intended for the use of healthcare professionals and is provided on the basis that the healthcare professionals will retain FULL and SOLE responsibility for deciding what treatment to prescribe or dispense for any particular patient or circumstance.