New medicines / SPC changes / Prescription products / Discontinued products / Supply issues / Products miscellany

Composition: Trabectedin.

Presentation: Powder for concentrate for solution for infusion.

Class: Antineoplastic agent.

Indications: Treatment of patients with advanced soft tissue sarcoma, after failure of anthracyclines and ifosfamide, or who are unsuited to receive these agents.

Dosage: 1.5mg/m² body surface area, administered as a 24-hour intravenous infusion, every three weeks.

Contraindications: Concurrent serious or uncontrolled infection; breastfeeding; combination with yellow fever vaccine.

Precautions: Administration through a central venous line is strongly recommended.

All patients must receive 20mg dexamethasone intravenously 30 minutes before receiving Yondelis, both as anti-emetic prophylaxis and because it appears to offer hepatoprotection.

The patient needs to meet certain laboratory-marker criteria, as detailed in the summary of product characteristics, before treatment with Yondelis.

Additional monitoring of haematological parameters, bilirubin, alkaline phosphatase, aminotransferases and creatine phosphokinase should occur weekly during the first two cycles of therapy, and at least once between treatments in subsequent cycles.

Dose adjustment to 1.2mg/m² is required if test results indicate toxicity (under criteria described in the SPC) between cycles.

Patients who develop fever should seek medical attention promptly. Yondelis should not be used for children and adolescents.

Patients with clinically relevant liver diseases, such as active chronic hepatitis, must be closely monitored and the dose of Yondelis adjusted if needed.

Patients with elevated bilirubin must not be treated with Yondelis.

Caution should be taken with concomitant use of Yondelis with medicines associated with hepatotoxicity.

Yondelis should not be used for patients with severe renal insufficiency (creatinine clearance <30ml/min) and creatinine clearance must be monitored before and during treatment.

Co-administration of Yondelis with potent inhibitors of cytochrome P450 3A4 should be avoided.

Combination with phenytoin, live attenuated vaccines or alcohol is not recommended.

Contraception should be used throughout treatment and for three months afterwards for women of childbearing potential, and for five months afterwards for men of fertile age.

Side effects: Very common (>=1/10) increased serum creatinine phosphokinase and creatinine and decreased albumin, neutropenia, thrombocytopenia, anaemia, leukopenia, headache, vomiting, nausea, constipation, anorexia, fatigue, asthenia, hyperbilirubinaemia, increased alanine aminotransferase, increased aspartate aminotransferase, increased serium alkaline phosphatase, increased gamma-glutamyltransferase.

Common (>=1/100, <1/10) weight loss, febrile neutropenia, peripheral sensory neuropathy, dysgeusia, dizziness, paraesthesia, dyspnoea, cough, diarrhoea, stomatitis, abdominal pain, dyspepsia, alopecia, myalgia, arthralgia, back pain, dehydration, appetite loss, hypokalaemia, infection, hypotension, flushing, pyrexia, oedema, peripheral oedema, injection site reactions, insomnia.

Legal category: POM.

Net price: 0.25mg vial, £363; 1mg vial, £1,366.

Contact details: PharmaMar SA, Avda de los Reyes 1, Polígono Industrial La Mina, 28770 Colmenar Viejo, Spain (tel 01932 824026).

Prescription Products

Risperidone
Risperidone tablets are now available from Actavis in six strengths.
Net price:
20 x 0.5mg, £5.72
20 x 1mg, £9.41
60 x 1mg, £28.22
60 x 2mg, £55.62
60 x 3mg, £81.82
60 x 4mg, £108.01
28 x 6mg, £76.37
Legal category: POM

SPC changes

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

Neoral and Sandimmun
Concomitant use of rosuvastatin with Neoral (ciclosporin; Novartis) and Sandimmun (ciclosporin; Novartis) is specifically contraindicated, the summaries of product characteristics for both products now state. The interactions sections of the SPCs have been updated accordingly.

Protelos
A warning about severe hypersensitivity syndromes, including drug rash with eosinophilia and systemic syndromes, has been added to the summary of product characteristics for Protelos (strontium ranelate; Servier).

Somavert
The administration section of the summary of product characteristics for Somavert (pegvisomant; Pfizer) now states that the site of injection should be rotated daily to help prevent lipohypertrophy.

Discontinued products

BiCNU
BiCNU (carmustine) powder and solvent for solution for infusion will be discontinued by Bristol-Myers Squibb in June. Medical information on 0800 731 1736.

Duphaston
Duphaston (dydrogesterone) and Duphaston HRT (dydrogesterone) will be discontinued by Solvay from March. Medical information on 023 8046 7000.

Gyno-Pevaryl 1
Gyno-Pevaryl 1 CombiPak (econazole nitrate pessary + cream) will be discontinued by Janssen-Cilag at the end of March. Medical information on 01494 567444.

Minims Pilocarpine Nitrate
Bausch & Lomb is discontinuing Minims Pilocarpine Nitrate 4 per cent by the end of February. Minims Pilocarpine Nitrate 2 per cent remains available. Medical information on 01748 828864.

Minims Metripranolol
Bausch & Lomb is discontinuing Minims Metripranolol 0.3 per cent by the end of March. Minims Metripranolol 0.1 per cent presentation remains available. Medical information on 01748 828864.

Minims Gentamicin
Bausch & Lomb is discontinuing Minims Gentamicin Sulphate 0.3 per cent by the end of April. Medical information on 01748 828864.

Oramorph UDV
Oramorph Unit Dose Vials (morphine sulphate oral vials) will be discontinued by Boehringer Ingelheim at the end of March. Oramorph oral solution and concentrated oral solution will remain available. Medical information on 01344 424600.

Supply issues

Syntometrine
Alliance Pharmaceuticals is experiencing difficulties supplying Syntometrine (oxytocin 5iu; ergometrine maleate 0.5mg) ampoules. Further information on 01249 466966.

Migramax
Migramax (lysine acetylsalicylate and metoclopramide hydrochloride; Cephalon) packs of 20 sachets are currently unavailable. Packs of six sachets remain available. Further information on 0800 783 4869.

Products miscellany

Natecal D3
Natecal D3 (calcium and vitamin D₃) tablets 600mg/400iu are now available from Trinity Chiesi. Net price: 60, £3.85. Legal category: P.