CASTLEFORD, England, March 31, 2010 /PRNewswire/ -- We are pleased to announce the launch of temozolomide available in 5mg, 20mg, 100mg, 140mg, 180mg and 250mg strength capsules. Temozolomide is indicated for the oncological treatment of brain tumours, specifically(1):

- adult patients with newly-diagnosed glioblastoma multiforme concomitantly with radiotherapy (RT) and subsequently as monotherapy treatment. - children from the age of three years, adolescents and adult patients with malignant glioma, such as glioblastoma multiforme or anaplastic astrocytoma, showing recurrence or progression after standard therapy.

It is a generic version of Temodal(R) from Schering-Plough and is available immediately in the award-winning Teva 360 livery, which is designed to aid patient safety.

Robyn Hughes, Director of Primary and Secondary Care at Teva UK Limited said We are proud to be the first to bring temozolomide to the generic market, and we view this product as an important addition to our oncology portfolio.


1. Temozolomide - Summary of Product Characteristics

About Teva UK Limited: Teva UK Limited is one of the UK's top ten pharmaceutical manufacturers, with a presence in the generics, branded respiratory and hospitals markets. It has the widest range of any UK generic pharmaceutical company and markets solid and liquid dose, injectable and respiratory medicines to healthcare professionals. The company is part of Teva Pharmaceutical Industries Ltd which has 38,000 employees based in 70 countries around the world.

Adverse events should be reported. Reporting forms and information can be found at Adverse events should also be reported to Teva UK Limited

Temozolomide Teva 5mg / 20mg / 100mg / 140mg / 180mg / 250mg hard capsules Prescribing Information:

Presentation: Each hard capsule contains 5 mg / 20 mg / 100mg / 140 mg / 180 mg / 250 mg temozolomide (TMZ). Indications: Treatment of adult patients newly-diagnosed glioblastoma multiforme concomitantly with radiotherapy (RT) and subsequently as monotherapy. Treatment of malignant glioma, such as glioblastoma multiforme or anaplastic astrocytoma, showing recurrence or progression after standard therapy in patients 3 years and above. Dosage and administration: Should only be prescribed by physicians experienced in the oncological treatment of brain tumours. Anti-emetic therapy may be administered. Administer in fasting state, swallow whole with glass of water and must not be opened or chewed. If vomiting occurs after dose is administered, a second dose should not be administered same day. Prior to dosing absolute neutrophil count (ANC) should be greater than or equal to 1.5 x 109/L and platelet count greater than or equal to 100 x 109/L. Children: under 3 years not recommended. Hepatic or renal impairment: caution, dose reduction unlikely. Elderly: 70 years increased risk of neutropenia and thrombocytopenia take special care. Consult product literature. Contraindications: Hypersensitivity to any component, patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption, pregnancy and lactation. Hypersensitivity to dacarbazine and severe myelosuppression. Precautions and warnings: Concomitant TMZ and RT increased risk of Pneumocystis carinii pneumonia (PCP). Prophylaxis against PCP is required during concomitant TMZ and RT treatment. To avoid nausea and vomiting anti-emetic therapy may be administered prior to or following administration of TMZ. Adult patients with newly-diagnosed glioblastoma multiforme; anti-emetic prophylaxis is recommended prior to treatment. Patients with recurrent or progressive malignant glioma: may require anti-emetic. Prior to dosing, the following laboratory parameters must be met: ANC greater than or equal to 1.5 x 109/L and platelet count greater than or equal to 100 x 109/L. Complete blood count on day 22 (21 days after the first dose) or within 48 hours of that day, and weekly until ANC 1.5 x 109/L and platelet count 100 x109/L. If ANC is 1.0 x 109/L or platelet count is 50 x 109/L during any cycle, next cycle should be reduced one dose level. Men: should be advised not to father a child up to 6 months after receiving last dose and to seek advice on cryoconservation of sperm prior to treatment. Contains lactose. Interactions: Temozolomide Teva hard capsules should be administered without food. Co-administration with valproic acid was associated with a small but statistically significant decrease in clearance of TMZ. Use of TMZ in combination with other myelosuppressive agents may increase the likelihood of myelosuppression. Pregnancy and lactation: Not recommended in pregnancy. If used during pregnancy, patient should be appraised of the potential risk to the foetus. Women of childbearing potential should be advised to use effective contraception. Not recommended in breast-feeding.

Side-effects: Very common: nausea, vomiting, constipation, anorexia, headache, fatigue, convulsions, rash, haematologic adverse reactions, alopecia. Common: haematologic adverse reactions, infection, herpes simplex, wound infection, decreased consciousness, somnolence, aphasia, impaired balance, dizziness, confusion, memory impairment, impaired concentration, neuropathy, paresthesia, speech disorder, tremor, hemiparesis, dysphasia, dysphagia, neurological disorder, peripheral neuropathy, visual field defect, vision blurred, diplopia, hearing impairment, tinnitus, pharyngitis, candidiasis oral, neutropenia, thrombocytopenia, lymphopenia, leukopenia , hyperglycaemia, anxiety, emotional lability, insomnia, depression, anaemia, febrile neutropenia, haemorrhage, deep venous thrombosis, oedema leg, oedema, dyspnoea, coughing, stomatitis, diarrhoea, abdominal pain, dyspepsia, dry mouth, dermatitis, dry skin, erythema, pruritus, muscle weakness, arthralgia, musculoskeletal pain, myalgia, micturition frequency, urinary incontinence, allergic reaction, fever, radiation injury, face oedema, pain, taste perversion, alanine transaminase increased, weight decrease. Serious: myelosuppression (neutropenia and thrombocytopenia), toxic epidermal necrolysis and Stevens-Johnson syndrome, hallucination, amnesia, status epilepticus, cerebral haemorrhage, embolism pulmonary, pancytopenia, anaemia (grade 3-4), leukopenia. Consult the Summary of Product Characteristics in relation to other side effects. Effects on ability to drive and to use machines: Ability to drive and use machines may be impaired due to fatigue and somnolence. Overdosage: Pancytopenia, pyrexia, multiorgan failure and death. Reports of patients taking recommended dose for more than 5 days of treatment (up to 64 days) reported bone marrow suppression, with or without infection, in some cases severe and prolonged and resulting in death. In overdose, haematological evaluation is needed. Supportive measures should be provided as necessary. NHS Price: Packs of 5: 5mg capsules GBP16.97; 20mg capsules GBP67.88; 100mg capsules GBP339.40; 140mg capsules GBP475.16; 180mg capsules GBP610.92; 250mg capsules GBP848.50.

Legal category: POM Marketing Authorisation Number: Temozolomide Teva 5 mg hard capsules EU/1/09/606/001-002; Temozolomide Teva 20 mg hard capsules EU/1/09/606/003-004; Temozolomide Teva 100 mg hard capsules EU/1/09/606/005-006; Temozolomide Teva 140 mg hard capsules EU/1/09/606/007-008; Temozolomide Teva 180 mg hard capsules EU/1/09/606/009-010; Temozolomide Teva 250 mg hard capsules EU/1/09/606/011-012. Marketing Authorisation Holder: Teva Pharma B.V., Computerweg 10, 3542 DR Utrecht, The Netherlands. Date of preparation: March 2010



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