The Pharmaceutical Journal
Vol 279 No 7469 p286-287
15 September 2007

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Products

Accessing SPCs
The summaries of product characteristics and patient information leaflets for medicines licensed in the UK are available online

New medicines
• Atriance
• Increlex
Discontinued products
• Sustac
Supply issues
• Atarax
• Colofac
• Nitrocine
• Trasidrex

Medical device alert BD Luer slip syringes

New medicines

Atriance

Composition: Nelarabine.

Presentation: Solution for infusion.

Class: Antineoplastic agent.

Indications: Treatment of patients with T-cell acute lymphoblastic leukaemia and T-cell lymphoblastic lymphoma whose disease has not responded to or has relapsed following treatment with at least two chemotherapy regimens.

Dosage: For adults the recommended dose is 1,500mg/m² administered intravenously over two hours on days 1, 3 and 5 and repeated every 21 days. The recommended dose for children is 650mg/m² administered intravenously over one hour daily for five consecutive days, repeated every 21 days. In clinical studies doses of 650mg/m2 and 1,500mg/m² have both been used for patients aged 16 to 21 years, with similar efficacy and safety for both regimens.

Precautions: Atriance should be administered undiluted by intravenous infusion. Neurotoxicity is the dose-limiting toxicity of nelarabine. Patients should be closely observed for signs and symptoms of neurological toxicity, such as somnolence, confusion, convulsions, ataxia, paraesthesias, and hypoesthesia.

Severe neurological toxicity can manifest as coma, status epilepticus, demyelination, or ascending neuropathy similar in appearance to Guillain-Barré syndrome.

Patients treated previously or concurrently with intrathecal chemotherapy or previously with craniospinal irradiation are potentially at increased risk of neurological adverse events and therefore concomitant intrathecal therapy or craniospinal irradiation is not recommended.

Immunisation with live organism vaccines is not recommended. Leukopenia, thrombocytopenia, anaemia and neutropenia (including febrile neutropenia) have been associated with nelarabine therapy.

Complete blood counts including platelets must be monitored regularly.

Patients should receive intravenous hydration according to standard medical practice for the management of hyperuricaemia in patients at risk of tumour lysis syndrome.

For patients at risk of hyperuricaemia, the use of allopurinol should be considered.

Patients with renal impairment must be closely monitored for toxicities when treated with nelarabine and patients with hepatic impairment should be treated with caution.

Side effects: Very common (>=1/10; adults) infection, febrile neutropenia, neutropenia, thrombocytopenia, anaemia, somnolence, peripheral neurological disorders, hypoaesthesia, paraesthesia, dizziness, headache, dyspnoea, cough, diarrhoea, constipation, vomiting, nausea, myalgia, oedema, peripheral oedema, pyrexia, pain, fatigue, asthenia.

Legal category: POM.

Net price: 6 x 250mg/50ml vials, £1,332

Contact details: GlaxoSmithKline, Stockley Park West, Uxbridge, Middlesex UB11 1BT (tel 0800 221441).

Increlex

Composition: Mecasermin.

Presentation: Solution for injection.

Class: Recombinant human insulin-like growth factor-1.

Indications: Long-term treatment of growth failure in children and adolescents with severe primary insulin-like growth factor 1 (IGF-1) deficiency, defined by a height standard deviation score of –3.0 or less, basal IGF-1 levels below the 2.5th percentile for age and gender, and growth hormone sufficiency, with the exclusion of secondary forms of IGF-1 deficiency, such as malnutrition, hypothyroidism or chronic treatment with anti-inflammatory steroids.

Dosage: The dose should be individualised for each patient. The recommended starting dose is 0.04mg/kg twice daily by subcutaneous injection. If no significant treatment-related adverse events occur for at least one week, the dose may be raised in increments of 0.04mg/kg to the maximum dose of 0.12mg/kg given twice daily.

Contraindications: Intravenous administration. Active or suspected neoplasia; therapy should be discontinued if evidence of neoplasia develops. Premature babies or neonates (product contains benzyl alcohol).

Precautions: Increlex should be administered shortly before or after a meal or snack. If hypoglycaemia occurs with recommended doses, despite adequate food intake, the dose should be reduced. If the patient is unable to eat, for any reason, Increlex should be withheld.

Injection sites should be rotated to a different site with each injection. Increlex is not recommended for use in children below two years of age.

Thyroid and nutritional deficiencies should be corrected before beginning treatment.

Increlex is not a substitute for growth hormone treatment and it should not be used for growth promotion in patients with closed epiphyses.

Patients should avoid engaging in any high-risk activities within two to three hours after dosing, particularly when first starting treatment, until a well tolerated dose has been established.

Echocardiogram (ECG) is recommended before initiation and upon termination of Increlex treatment in all patients.

Those with abnormal findings or cardiovascular symptoms should be followed regularly with ECG procedures.

Lymphoid tissue (eg, tonsillar) hypertrophy associated with complications, such as snoring, sleep apnoea, and chronic middle-ear effusions, have been reported.

Intracranial hypertension with papilloedema, visual changes, headache, nausea and vomiting has been reported, and funduscopic examination is recommended before and during treatment and if clinical symptoms occur.

Slipped capital femoral epiphysis and progression of scoliosis can occur in patients who experience rapid growth.

Patients should be monitored and any patient with the onset of a limp or complaint of hip or knee pain should be evaluated.

Side effects: Very common (>=1/10) thymus hypertrophy, headache, hypoacusis, tonsillar hypertrophy, snoring, hypoglycaemia, injection site hypertrophy.

Legal category: POM.

Net price: 40mg/4ml vial, £384.

Contact details: Ipsen Ltd, 190 Bath Road, Slough, Berkshire SL1 3XE (tel 01753 627777).

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Discontinued products

Sustac
Sustac (glyceryl trinitrate) prolonged-release tablets 2.6mg and 6.4mg have been discontinued by Forest Laboratories and all stocks are exhausted.

Medical information on 01322 550550.

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Supply issues

Atarax
Atarax (hydroxyzine hydrochloride; Alliance) tablets 10mg are available again following recent supply difficulties. Atarax tablets 25mg remain available on a restricted basis, with normal supplies expected early in 2008. Customer services on 01249 705112.

Colofac
Colofac (mebeverine; Solvay) tablets 135mg are temporarily unavailable. Supplies are expected to resume in October. Medical information on 023 8046 7000.

Nitrocine
Nitrocine (glyceryl trinitrate) 50ml bottles are available again from Schwarz Pharma after being out of stock.

Trasidrex
Trasidrex (co-prenozide; Goldshield) tablets are currently unavailable. Medical information on 020 8588 9131.

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