Sotorasib oral
- Drugs List
- Therapeutic Indications
- Dosage
- Contraindications
- Precautions and Warnings
- Pregnancy and Lactation
- Side Effects
- Monograph
Presentation
Oral formulations of sotorasib.
Drugs List
Therapeutic Indications
Uses
Locally advanced/metastatic Non-Small Cell Lung Cancer (NSCLC)
Treatment of adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with KRAS G12C mutations, who have progressed on, or are intolerant to platinum-based chemotherapy and/or anti PD-1/PD-L1 immunotherapy.
Dosage
Adults
960mg once daily.
Additional Dosage Information
Recommended dose reduction levels
First dose reduction: 480mg once daily.
Second dose reduction: 240mg once daily.
Recommended dose modifications for sotorasib
Hepatotoxicity
Grade 2 AST or ALT with symptoms or Grade 3 or greater AST or ALT: Stop treatment until recovered to less than or equal to grade 1 or to baseline. After recovery, resume sotorasib treatment at the next dose reduction level.
AST or ALT greater than 3 times ULN with total bilirubin greater than 2 times ULN, in the absence of alternative causes: Permanently discontinue sotorasib treatment.
Interstitial lung disease/pneumonitis
Interstitial lung disease (ILD) or pneumonitis of any grade: Stop treatment if ILD/pneumonitis is suspected. Permanently discontinue sotorasib treatment if ILD/pneumonitis is confirmed.
Nausea or vomiting despite appropriate supportive measures (including anti-emetic therapy)
Grade 3 to 4 nausea or vomiting despite appropriate supportive measures (including anti-emetic therapy): Stop treatment until recovered to less than or equal to grade 1 or to baseline. After recovery, resume sotorasib treatment at the next dose reduction level.
Diarrhoea despite appropriate supportive measures (including anti-diarrhoeal therapy)
Grade 3 to 4 diarrhoea despite appropriate supportive measures (including anti-diarrhoeal therapy): Stop treatment until recovered to less than or equal to grade 1 or to baseline. After recovery, resume sotorasib treatment at the next dose reduction level.
Other adverse reactions
Other grade 3 to 4 adverse reactions: Stop treatment until recovered to less than or equal to grade 1 or to baseline. After recovery, resume sotorasib treatment at the next dose reduction level.
Co-administration with acid-reducing agents
Co-administration of sotorasib with proton pump inhibitors (PPIs) or H2 receptor antagonists is not recommended. If treatment with an acid-reducing agent is required, a local antacid may be used. Sotorasib should be taken either 4 hours before or 10 hours after administration of a local antacid.
Missed doses
If a dose is more than 6 hours late, the missed dose should not be taken and the next dose should be taken at the next scheduled time.
Contraindications
Children under 18 years
Breastfeeding
Galactosaemia
Moderate hepatic impairment
Moderate renal impairment
Pregnancy
Precautions and Warnings
Glucose-galactose malabsorption syndrome
Lactose intolerance
Advise patient to avoid H2 antagonists
Confirm KRAS G12C mutation status prior to treatment
Treatment to be initiated and supervised by a specialist
Contains lactose
Consult local policy on the safe use of oral anti-cancer drugs
Staff: Not to be handled by pregnant staff
Monitor liver function before, every 3 weeks for 3 months & periodically
Advise patient to report any new or worsening respiratory symptoms
Suspend treatment if pneumonitis is suspected
Suspend/reduce dose if grade 3 diarrhoea despite anti-diahorreal treatment
Suspend/reduce dose if grade 3 nausea despite anti-emetic treatment
Consider suspending/reducing dose if AST/ALT is 3-5 times ULN
Discontinue if AST/ALT > 3 x ULN and bilirubin > 2 x ULN
Discontinue if evidence of interstitial lung disease
Discontinue if treatment related pneumonitis is diagnosed
Suspend treatment if grade 3 vomiting unresponsive to antiemetic occurs
Suspend treatment if interstitial lung disease is suspected
Suspend treatment/reduce dose if grade 3 adverse reactions occur
Avoid concurrent use of proton pump inhibitors
Pregnancy and Lactation
Pregnancy
Sotorasib is contraindicated during pregnancy.
The manufacturer recommends that patients must be informed of the potential hazards to the foetus if sotorasib is used during pregnancy, or if the patient becomes pregnant while taking sotorasib. There are no data in the use of sotorasib in pregnant women, however animal studies have shown reproductive toxicity.
Lactation
Sotorasib is contraindicated during breastfeeding.
The manufacturer recommends that either a decision should be made to discontinue breastfeeding during sotorasib therapy, or to discontinue sotorasib during breastfeeding. It is unknown whether sotorasib or its metabolites are excreted in human milk, therefore a risk to the infant cannot be excluded.
Counselling
If the patient has difficulty swallowing the tablet whole, the tablet can be dispersed in 120ml of non-carbonated room temperature water without crushing. Other liquids must not be used. Patients should stir until the tablet has been dispersed into small pieces and drink immediately. The container must be rinsed with an additional 120ml of water which should be drunk immediately. If it is not drunk immediately, patients must stir again to ensure that the tablet is dispersed. The dispersion should be discarded if it has not been drunk within 2 hours.
Co-administration of sotorasib with proton pump inhibitors (PPIs) or H2 receptor antagonists is not recommended. If treatment with a local antacid is required, sotorasib should be taken either 4 hours before or 10 hours after administration of the PPI or H2 receptor antagonist.
Advise patient to report any new or worsening respiratory symptoms.
Side Effects
Abdominal pain
Alanine aminotransferase increased
Anaemia
Arthralgia
Aspartate aminotransferase increased
Back pain
Constipation
Cough
Decrease in haemoglobin
Decrease in plasma calcium
Decreased appetite
Decreased serum sodium
Diarrhoea
Drug-induced liver injury
Dyspnoea
Fatigue
Headache
Hepatotoxicity
Hypertension
Hypocalcaemia
Hypokalaemia
Hyponatraemia
Increase in alkaline phosphatase
Musculoskeletal pain
Myalgia
Nausea
Peripheral oedema
Pneumonia
Proteinuria
Pyrexia
Rash
Reduced lymphocyte count
Urinary tract infections
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: January 2021
Reference Sources
Summary of Product Characteristics: Lumykras 120mg film-coated tablets. Amgen Ltd. Revised September 2021.
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