Stivarga 40 mg film-coated tablets
Indication:
Stivarga is indicated for the treatment of adult patients with:
- metastatic colorectal cancer (CRC) who have been previously treated with, or are not considered candidates for, available therapies. These include fluoropyrimidine-based chemotherapy, an anti-VEGF therapy and an anti-EGFR therapy (see section 5.1 of the SmPC).
- unresectable or metastatic gastrointestinal stromal tumours (GIST) who progressed on or are intolerant to prior treatment with imatinib and sunitinib.
Contraindications:
Hypersensitivity to the active substance or any of the excipients.
Warnings and Precautions:
It is recommended to perform liver function tests before
initiation of treatment and monitor closely (at least every 2 weeks)
during the first 2 months of treatment. Thereafter, periodic monitoring
should be continued at least monthly and as clinically indicated. Mild,
indirect (unconjugated) hyperbilirubinaemia may occur in patients with
Gilbert’s syndrome. Close monitoring of the overall safety is
recommended in patients with mild or moderate hepatic impairment.
Stivarga is not recommended for use in patients with severe hepatic impairment (Child-Pugh C).
When prescribing in patients with KRAS mutant tumours, physicians
are recommended to carefully evaluate benefits and risks.
Blood counts and coagulation parameters should be monitored in
patients with conditions predisposing to bleeding, and in those treated
with anticoagulants or other concomitant medicinal products that
increase the risk of bleeding. Permanent discontinuation should be
considered in the event of severe bleeding. Patients with a history of
ischemic heart disease should be monitored for clinical signs and
symptoms of myocardial ischemia. In patients who develop cardiac
ischaemia and/or infarction, interruption of Stivarga is recommended
until resolution. The decision to restart Stivarga therapy should be
based on careful consideration of the potential benefits/risks of the
individual patient. Stivarga should be permanently discontinued if there
is no resolution.
In patients developing posterior reversible encephalopathy
syndrome (PRES), discontinuation of Stivarga, along with control of
hypertension and supportive medical management of other symptoms is
recommended.
Discontinuation of Stivarga is recommended in patients developing gastrointestinal perforation or fistula.
Blood pressure should be controlled prior to initiation and during
treatment and it is recommended to treat hypertension. In cases of
severe or persistent hypertension despite adequate medical management,
treatment should be temporarily interrupted and/or the dose reduced. In
case of hypertensive crisis, treatment should be discontinued.
For patients undergoing major surgical procedures it is
recommended to interrupt treatment temporary for precautionary reasons,
and to resume treatment based on clinical judgment of adequate wound
healing.
Management of hand-foot skin reaction (HFSR) may include the use
of keratolytic creams and moisturizing creams for symptomatic relief.
Dose reduction and/or temporary interruption, or, in severe or
persistent cases, permanent discontinuation of Stivarga should be
considered.
It is recommended to monitor biochemical and metabolic parameters
during treatment and to institute replacement therapy if required. Dose
interruptions or reduction, or permanent discontinuation should be
considered in case of persistent or recurrent significant abnormalities.
Each daily dose of 160 mg contains 2.427 mmol (or 55.8 mg) of sodium and 1.68 mg of lecithin (derived from soya).
Undesirable effects:
Very Common: infection, thrombocytopenia, anaemia,
decreased appetite and food intake, headache, haemorrhage*,
hypertension, dysphonia, diarrhea, stomatitis, vomiting, nausea,
hyperbilirubinaemia, HFSR, rash, alopecia, asthenia/fatigue, pain,
fever, mucosal inflammation, weight loss.
Common: leucopenia, hypothyroidism, hypokalaemia,
hypophosphataemia, hypocalcaemia, hyponatraemia, hypomagnesaemia,
hyperuricaemia, tremor, taste disorders, dry mouth, gastro-oesophageal
reflux, gastroenteritis, increase in transaminases, dry skin,
exfoliative rash, musculoskeletal stiffness, proteinuria, increase in
amylase, increase in lipase, abnormal International normalized ratio.
Uncommon: myocardial infarction, myocardial ischaemia,
hypertensive crisis, gastrointestinal perforation*, gastrointestinal
fistula, severe liver injury*, nail disorder, erythema multiforme.
Rare: keratoacanthoma/squamous cell carcinoma of the skin, PRES, Stevens-Johnson syndrome, toxic epidermal necrolysis.
* fatal cases have been reported
Classification for Supply:
Medicinal product subject to restricted medical prescription.
Marketing Authorisation Holder:
Bayer Pharma AG, D-13342 Berlin, Germany
▼ This medicinal product is subject to additional monitoring.
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