New medicines
Evoltra
Composition: Clofarabine.
Presentation: Concentrate for solution for infusion 1mg/ml.
Action: Purine nucleoside
antimetabolite.
Indication: Treatment of acute lymphoblastic leukaemia in paediatric
patients who have relapsed or are refractory after receiving at least
two other regimens and for whom no other treatment option is anticipated
to result in a durable response.
Dosage: The recommended dose for paediatric patients
is 52mg/m2 of body
surface area administered by intravenous infusion over two hours daily
for five consecutive days. Treatment cycles should be repeated every
two to six weeks (from the starting day of the previous cycle) following
recovery of normal haematopoiesis (ie, absolute neutrophil count >=0.75
x 109/L) and return to baseline organ function. A 25 per cent dose reduction
may be warranted in patients experiencing significant toxicities (see
SPC). There is limited experience of patients receiving more than three
treatment cycles. A safe and effective dosage recommendation for patients
under one year of age has yet to be established. For children weighing
less than 20kg an infusion time of longer than two hours should be considered
to help reduce symptoms of anxiety and irritability and to avoid unduly
high maximum drug concentrations. There are currently insufficient data
to support the safety and efficacy of using Evoltra to treat adults.
Contraindications: Evoltra is contraindicated for use in patients with
severe renal insufficiency or severe hepatic impairment.
Precautions: The following parameters should be closely monitored: regular
complete blood and platelet counts; renal and hepatic function before,
during and after treatment; and respiratory status, blood pressure, fluid
balance and weight throughout and immediately after the five-day dosing
period. Patients should be monitored for signs of tumour lysis syndrome
and cytokine release; Evoltra should be discontinued immediately and
appropriate supportive measures should be initiated if this occurs. Patients
with cardiac disease and those taking medicinal products known to affect
blood pressure or cardiac function should be closely monitored.
Side effects: Very common (>=1/10) febrile neutropenia,
anxiety, headache, flushing, vomiting, diarrhoea, nausea, dermatitis,
pruritus,
pyrexia, mucosal inflammation, fatigue. Common (>=1/100 to <1/10)
septic shock, sepsis, bacteraemia, pneumonia, herpes zoster, herpes simplex,
implant infection, oral candidiasis, tumour lysis syndrome, neutropenia,
hypersensitivity, dehydration, anorexia, decreased appetite, decreased
weight, agitation, irritability, restlessness, peripheral neuropathy,
paraesthesia, somnolence, dizziness, tremor, hearing impairment, pericardial
effusion, tachycardia, hypotension, haematoma, capillary leak syndrome,
tachypnoea, epistaxis, dyspnoea, cough, haematemesis, mouth haemorrhage,
abdominal pain, gingival bleeding, mouth ulceration, proctalgia, stomatitis,
jaundice, hyperbilirubinaemia, elevated alanine and aspartate aminotransferases,
exfoliative dermatitis, petechiae, contusion, palmar-plantar erythrodysaesthesia
syndrome, rash, erythema, alopecia, skin disorder, localised exfoliation,
skin hyperpigmentation, increased sweating, dry skin, chest wall pain,
bone pain, neck and back pain, limb pain, myalgia, arthralgia, haematuria,
multi-organ failure, pain, rigors, oedema, peripheral oedema, mental
state changes, feeling hot, feeling abnormal.
Legal category: POM.
Net price: 4 x 20mg, £4,800.
Contact details: Bioenvision Ltd, 10 Lochside Place, Edinburgh Park,
Edinburgh EH12 9RG. Telephone 0131 2483600.
Nexavar
Composition: Sorafenib.
Presentation: Film-coated tablet.
Class: Protein kinase inhibitor.
Indications: Treatment of patients with advanced renal cell carcinoma
who have failed to respond to interferon alpha or interleukin-2 based
therapy or are considered unsuitable for such therapy.
Dosage: The recommended dose of Nexavar for adults is 400mg twice a day,
taken without food or with a low or moderate fat meal.
Precautions: Management of suspected adverse drug reactions may require
temporary interruption or dose reduction of Nexavar; when necessary the
dose should be reduced to 400mg once a day. Infrequent bleeding events
or elevations in international normalised ratio (INR) have been reported
in some patients taking warfarin and Nexavar concomitantly; such patients
should be monitored regularly for changes in prothrombin time, INR or
bleeding episodes. Monitoring of renal function should be considered
when using Nexavar for elderly patients. Caution is recommended when
administering Nexavar with drugs that are metabolised predominantly by
the UGT1A1 or UGT1A9 pathways. Enzyme-inducing drugs and anti-acidic
medicines may decrease plasma concentrations of Nexavar.
Side effects: Very common (>1/10) lymphopenia, hypophosphataemia,
haemorrhage, hypertension, diarrhoea, nausea, vomiting, rash, alopecia,
palmar plantar erythrodysaesthesia syndrome, erythema, pruritus, fatigue,
pain (including mouth, abdominal, bone, headache). Common (>1/100)
leucopenia, neutropenia, anaemia, thrombocytopenia, anorexia, depression,
peripheral neuropathy, neuropathy, tinnitus, hoarseness, constipation,
stomatitis, dyspepsia, dysphagia, dry skin, exfoliative dermatitis, acne,
skin desquamation, arthralgia, myalgia, erectile dysfunction, asthenia,
fever, influenza-like illness.
Legal category: POM.
Net price: 112 x 200mg, £2,504.60.
Contact details: Bayer Plc, Pharmaceutical Division, Bayer House, Strawberry
Hill, Newbury, Berkshire RG14 1JA. Telephone 01635 563000.
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