lHEPATIC IMPAIRMENTUse with caution—no information
available.
lRENAL IMPAIRMENTUse with caution—no information
available.
lMONITORING REQUIREMENTS
▶Monitor renal function, hepatic function and clotting
parameters.
▶Monitor patients with history of venous thrombosis,
vasculitis, or unstable cardiovascular disorders for
persistent or worsening symptoms during
administration—consult product literature.
lNATIONAL FUNDING/ACCESS DECISIONS
NICE decisions
▶Mifamurtide for the treatment of osteosarcoma (October
2011 )NICE TA235
Mifamurtide in combination with postoperative multi-
agent chemotherapy is recommended (within its licensed
indication), as an option for the treatment of high-grade
resectable non-metastatic osteosarcoma after
macroscopically complete surgical resection in children,
adolescents and young adults and when mifamurtide is
made available at a reduced cost to the NHS under the
patient access scheme.
http://www.nice.org.uk/TA235
lMEDICINAL FORMS
There can be variation in the licensing of different medicines
containing the same drug.
Powder for suspension for infusion
▶Mepact(Takeda UK Ltd)
Mifamurtide 4 mgMepact 4 mg powder for suspension for infusion
vials| 1 vialP£ 2 , 375. 00
4 Targeted therapy
responsive malignancy
ANTINEOPLASTIC DRUGS›PROTEIN KINASE
INHIBITORS
Everolimus 24-Jul-2017
lDRUG ACTIONEverolimus is a protein kinase inhibitor.
lINDICATIONS AND DOSE
VOTUBIA®DISPERSIBLE TABLETS
Subependymal giant cell astrocytoma associated with
tuberous sclerosis complex
▶BY MOUTH USING DISPERSIBLE TABLETS
▶Child 1–17 years:(consult product literature)
Adjunctive treatment of refractory partial-onset seizures,
with or without secondary generalisation, associated
with tuberous sclerosis complex
▶BY MOUTH USING DISPERSIBLE TABLETS
▶Child 2–17 years:(consult product literature)
VOTUBIA®TABLETS
Subependymal giant cell astrocytoma associated with
tuberous sclerosis complex
▶BY MOUTH USING TABLETS
▶Child 1–17 years:(consult product literature)IMPORTANT SAFETY INFORMATION
RISKS OF INCORRECT DOSING OF ORAL ANTI-CANCER MEDICINES
See Cytotoxic drugs p. 531.lCAUTIONSHistory of bleeding disorders
lINTERACTIONS→Appendix 1 : everolimus
lSIDE-EFFECTS
▶Common or very commonAlopecia.anaemia.appetite
decreased.arthralgia.asthenia.cough.decreased
leucocytes.dehydration.diabetes mellitus.diarrhoea.dry
mouth.dyslipidaemia.dysphagia.dyspnoea.electrolyte
imbalance.eye inflammation.fever.gastrointestinal
discomfort.haemorrhage.headache.hyperglycaemia.
hypertension.increased risk of infection.insomnia.
menstrual cycle irregularities.mucositis.nail disorders.
nausea.neutropenia.oral disorders.peripheral oedema.
proteinuria.renal impairment.respiratory disorders.skin
reactions.taste altered.thrombocytopenia.vomiting.
weight decreased
▶UncommonCongestive heart failure.embolism and
thrombosis.flushing.healing impaired.hepatitis B.
musculoskeletal chest pain.pancytopenia.sepsis.urinary
frequency increased
▶Rare or very rarePure red cell aplasia
▶Frequency not knownHepatitis B reactivation
SIDE-EFFECTS, FURTHER INFORMATIONReduce dose or
discontinue if severe side-effects occur—consult product
literature.
lCONCEPTION AND CONTRACEPTIONEffective
contraception must be used during and for up to 8 weeks
after treatment.
lPREGNANCYManufacturer advises avoid (toxicity in
animalstudies). See alsoPregnancy and reproductive
functionin Cytotoxic drugs p. 531.
lBREAST FEEDINGManufacturer advises avoid.
lHEPATIC IMPAIRMENTConsult product literature.
lMONITORING REQUIREMENTS
▶ForVotubia®preparations: manufacturer advises
everolimus blood concentration monitoring is required—
consult product literature.
▶Monitor blood-glucose concentration, serum-triglycerides
and serum-cholesterol before treatment and periodically
thereafter.
▶Monitor renal function before treatment and periodically
thereafter.
lDIRECTIONS FOR ADMINISTRATION
VOTUBIA®DISPERSIBLE TABLETSManufacturer advises
tablets must be dispersed in water before administration—
consult product literature for details.
VOTUBIA®TABLETSTablets may be dispersed in
approximately 30 mL of water by gently stirring,
immediately before drinking. After solution has been
swallowed, any residue must be re-dispersed in the same
volume of water and swallowed.
lPRESCRIBING AND DISPENSING INFORMATIONVotubia®is
available as bothtabletsanddispersible tablets. These
formulations vary in their licensed indications and are not
interchangeable—consult product literature for
information on switching between formulations.
lPATIENT AND CARER ADVICE
PneumonitisNon-infectious pneumonitis reported.
Patients should be advised to seek urgent medical advice if
new or worsening respiratory symptoms occur.lMEDICINAL FORMS
There can be variation in the licensing of different medicines
containing the same drug.
Dispersible tablet
CAUTIONARY AND ADVISORY LABELS 13
▶Votubia(Novartis Pharmaceuticals UK Ltd)
Everolimus 2 mgVotubia 2 mg dispersible tablets sugar-free|
30 tabletP£ 960. 00
Everolimus 3 mgVotubia 3 mg dispersible tablets sugar-free|
30 tabletP£ 1 , 440. 00
Everolimus 5 mgVotubia 5 mg dispersible tablets sugar-free|
30 tabletP£ 2 , 250. 00BNFC 2018 – 2019 Targeted therapy responsive malignancy 559
Immune system and malignant disease8