New medicines
Kepivance
Composition: Palifermin 6.25mg.
Presentation: Lyophilised powder for solution for injection.
Class: Human keratinocyte growth factor.
Indication: To decrease the incidence, duration and severity of oral
mucositis in patients with haematological malignancies on myeloablative
therapy associated with a high incidence of severe mucositis and requiring
autologous haemopoietic stem cell support.
Dosage: 60µg/kg/day by bolus intravenous injection for six doses.
The first three doses are given before chemotherapy on consecutive days
with the third dose given 24 to 48 hours before myeloablative therapy.
Three doses are given on consecutive days post-myeloablative therapy
starting after, but on the same day as, haematopoietic stem cell infusion,
and at least four days after the most recent Kepivance administration.
Precautions: Kepivance should not be administered during the infusion
of or within 24 hours either side of cytotoxic therapy, because of a
risk of increased severity and duration of oral mucositis. Because palifermin
can bind to heparin in vitro, heparin-maintained intravenous lines should
be rinsed with sodium chloride before and after Kepivance administration.
The safety and efficacy have not been established in patients with keratinocyte
growth factor receptor expressing non-haematological malignancies.
Side effects: Very common (>1/10) mouth/tongue thickness or discolouration,
altered taste, rash, pruritus, erythema, administration site reactions,
arthralgia, and fever.
Legal category: POM.
Net price: 6 vials £3,265.44.
Contact details: Amgen, 240 Cambridge Science Park, Milton Road, Cambridge
CB4 0WD. Telephone 01223 420305.
Noxafil
Composition: Posaconazole.
Presentation: Oral suspension 40mg/ml.
Class: Triazole derivative antimycotic for systemic use.
Indication: Invasive aspergillosis in patients refractory to or intolerant
of amphotericin B or itraconazole; chromoblastomycosis and mycetoma in
patients refractory to or intolerant of itraconazole; coccidioidomycosis
in patients refractory to or intolerant of amphotericin B, itraconazole
or fluconazole; fusariosis in patients refractory to or intolerant of
amphotericin B.
Dosage: 400mg twice a day with a meal or with 240ml of nutritional supplement.
Patients not tolerating food or supplements should take 200mg four times
a day.
Precautions: Caution in patients with severe hepatic impairment, where
prolonged elimination half-life may increase exposure. Patients who develop
abnormal liver function tests must be routinely monitored for the development
of more severe hepatic injury where treatment should be ceased. Avoid
using with drugs that are CYP3A4 substrates known to prolong QTc interval.
Caution in patients with pro-arrhythmic conditions.
Side effects: Common side effects (>1/100, <1/10) include anorexia,
neutropenia, insomnia, headache, dizziness, paraesthesia, somnolence,
hot flushes, diarrhoea, flatulence, abdominal pain, dry mouth, dyspepsia,
nausea, vomiting, dry skin, pruritus, rash and back pain.
Legal category: POM.
Net price: 105ml bottle £500.69.
Contact details: Schering-Plough, Shire Park, Welwyn Garden City, AL7
1TW. Telephone 01707 363636.
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