New medicines
Prialt
Composition: Ziconotide.
Presentation: Solution for infusion 100µg/ml.
Action: N-type calcium channel blocker.
Indications: The treatment of severe, chronic pain in patients who require
intrathecal analgesia.
Dosage: Initiate at 2.4µg/day and titrate according to response
and adverse reactions. Titrate in increments of 2.4µg per day up
to a maximum of 21.6µg/day. The minimal interval between dose increases
is 24 hours but 48 hours or more is recommended. Prialt should be administered
by continuous infusion via an intrathecal catheter using an external
or internally implanted mechanical infusion pump.
Precautions: Not recommended for use in patients under 18 years. Caution
during long-term treatment and when administered to patients with impaired
hepatic or renal function or in patients receiving systemic chemotherapy.
Patients and doctors should be vigilant for signs and symptoms of meningitis.
Monitoring of creatinine kinase is recommended.Cognitive and neuropsychiatric
adverse reactions are common and the Prialt dose should be reduced or
discontinued if these occur.
Contraindications: Prialt should not be given in combination with intrathecal
chemotherapy.
Side effects: Very common (>1/10) confusional state,
dizziness, nystagmus, memory impairment, headache, blurred vision, nausea,
vomiting, abnormal
gait, asthenia. Common (>1/100, <1/10): decreased appetite, anorexia,
anxiety, auditory hallucination, insomnia, agitation, disorientation,
visual hallucination, depression, paranoia, irritability, aggravation
of depression, nervousness, affect liability, mental status changes,
thought blocking, abnormal dreams, aggravation of anxiety and confusion,
diplopia, visual disturbance, photophobia, vertigo, tinnitus, orthostatic
hypotension, hypotension, dyspnoea, diarrhoea, dry mouth, constipation,
aggravated nausea, dyspepsia, upper abdominal pain, pruritis, increased
sweating, rash, limb pain, myalgia, muscle spasms, muscle cramp, muscle
weakness, arthralgia, peripheral swelling, back pain, muscle twitching,
neck pain, urinary retention, urinary hesitation, dysuria, urinary incontinence,
fatigue, pyrexia, lethargy, peripheral oedema, rigors, falls, chest pain,
feeling cold, pain, difficulty walking, feeling jittery, exacerbation
of pain, increased blood creatinine phosphokinase, increased aspartate
aminotransferase, increased blood creatinine phosphokinase MM, increased
body temperature.
Legal category: POM.
Net price: 1ml vial £271.83, 5ml vial £1,359.14.
Contact details: Eisai Ltd, 3 Shortlands, London W6 8EE. Telephone 020
8600 1400.
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