LEEDS, England, November 18 /PRNewswire/ -- Teva UK Limited has signalled its commitment to developing biosimilar medicines by entering the G-CSF* therapy area. The launch of its proprietary version of filgrastim, TevaGrastim(R), marks the Company's first biosimilar*, and represents a major addition to Teva's Hospitals portfolio.
TevaGrastim(R) is licensed for a number of indications1, the most common being the reduction of chemotherapy-induced neutropenia. The product is available in two presentations, both are available from wholesalers:
- 30 MIU pre-filled syringe (5 pack)
- 48 MIU pre-filled syringe (5 pack)
TevaGrastim(R) is licensed for the same indications as the reference product, Neupogen(R) (filgrastim)(1,2). Teva's pre-filled syringe will also incorporate a needle guard to minimise the risk of needle stick injuries.
When comparing NHS list prices of filgrastim products, TevaGrastim(R) is a competitively priced(3) G-CSF treatment.
Notes to Editors:
A biosimilar is defined as a similar biological medicinal product, and is also sometimes called a biogeneric.
Teva UK Limited is one of the UK's leading pharmaceutical manufacturers, with a presence in the generics, branded respiratory and hospitals markets. Measured by the volume of boxes supplied, it is the biggest single medicines supplier to the NHS. With over 500 product lines, it has the widest range of any UK generic pharmaceutical company, and has a number of respiratory products including the Qvar(R) (beclometasone dipropionate) CFC-free inhaler.
For media enquiries, please refer to the contact details below. Adverse events should be reported. Information about adverse event reporting can be found at http://www.yellowcard.gov.uk
Adverse events should also be reported to Teva UK Limited.
TevaGrastim Abbreviated Prescribing Information:
Presentation: Pre-filled syringe containing filgrastim 30 MIU (300microg) in 0.5ml solution or 48 MIU (480microg) in 0.8ml solution. Indications: Reduction in the duration of neutropenia and the incidence of febrile neutropenia in patients treated with established cytotoxic chemotherapy for malignancy and for the reduction in the duration of neutropenia in patients undergoing myeloablative therapy followed by bone marrow transplantation considered to have increased risk of prolonged severe neutropenia. Mobilisation of peripheral blood progenitor cells (PBPC). Treatment of persistent neutropenia in patients with advanced HIV infection. Long term administration in children or adults with severe congenital, cyclic, or idiopathic neutropenia with an absolute neutrophil count of 0.5 x 109/L and a history of severe or recurrent infections. Dosage and administration: Only to be given in collaboration with an oncology centre experienced in granulocyte-colony stimulating factor treatment and haematology, and with the necessary diagnostic facilities. The use of filgrastim is not recommended in the period from 24 hours before to 24 hours after chemotherapy and within 24 hours of bone marrow infusion. For subcutaneous injection or infusion diluted with 5% glucose solution. Dilution to a concentration of 0.2 MIU (2microg) is not recommended. Established cytotoxic chemotherapy: 0.5 MIU (5microg)/kg/day. Daily dosing should continue until the expected neutrophil nadir is passed and the neutrophil count has recovered to the normal range. In patients treated with myeloablative therapy followed by bone marrow transplantation: Recommended starting dose is 1.0 MIU (10microg)/kg/day given as a 30 minute or 24 hour intravenous infusion or 1.0 MIU given by continuous 24 hour subcutaneous infusion. Mobilisation of PBPC: When used alone, 1.0 MIU (10microg)/kg/day as a 24 hour subcutaneous continuous infusion or a single daily subcutaneous injection for 5 to 7 consecutive days. After myelosuppressive chemotherapy, the recommended dose for PBPC is 0.5 MIU (5microg)/kg/day by subcutaneous injection from the first day after completion of chemotherapy until the expected neutrophil nadir is passed and the neutrophil count has recovered to the normal range. Should be administered at 1.0 MIU (10 microg)/kg/day subcutaneously for 4 to 5 consecutive days for PBPC mobilisation in normal donors prior to allogenic peripheral blood progenitor cell transplantation. Severe chronic neutropenia: Congenital neutropenia: 1.2 MIU (12microg )/kg/day. Idiopathic or cyclic neutropenia: 0.5 MIU (5microg)/kg/day. For reversal of neutropenia in patients with HIV infection: 0.1 MIU (1microg)/kg/day with titration up to a maximum of 0.4 MIU (4microg)/kg/day. Children: Safety and efficacy of filgrastim is similar in adults and children. The dosage recommendations are the same as those in adults receiving myelosuppressive cytotoxic chemotherapy. Elderly: Specific dosage recommendations cannot be made. Impaired renal or hepatic function: No dosage adjustments required. Contraindications: Hypersensitivity to filgrastim, or any excipients. Precautions and warnings: Not to be used to increase the dose of cytotoxic chemotherapy beyond established dosage regimens. Not to be administered to patients with severe congenital neutropenia with abnormal cytogenetics. Safety and efficacy has not been established in patients with myelodysplastic syndrome, or chronic myelogenous leukaemia.. Administer with caution in patients with secondary acute myeloid leukaemia. Monitoring of bone density may be indicated in patients with underlying osteoporotic bone diseases who undergo continuous therapy for more than 6 months. Patients with a recent history of pulmonary infiltrates or pneumonia may be at higher risk of rare pulmonary undesirable effects, in particular interstitial pneumonia. In cancer patients, a white blood cell count should be performed at regular intervals. During the period of administration for PBPC, filgrastim should be discontinued or the dosage reduced if the leukocyte counts rise to 70 x 109/L. Regular monitoring of platelet and haematocrit is also recommended. Special caution should be used when treating patients with high dose chemotherapy. Donors who receive G-CSFs for PBPC mobilisation should be monitored until haematological indices return to normal. Spleen size should be carefully monitored. Monitor platelet counts closely in patients with severe chronic neutropenia. Special care should be taken in the diagnosis of severe chronic neutropenias to distinguish them from other haematopoietic disorders. Filgrastim should be discontinued if myelodysplastic syndrome or leukaemia occur. It is recommended to perform morphologic and cytogenic bone marrow examinations approximately every 12 months in patients with severe chronic neutropenia. Causes of transient neutropenia, such as viral infections, should be excluded. Regular urinanalysis should be performed to monitor haematuria/proteinuria. In patients with HIV infection, absolute neutrophil count should be monitored closely. Caution when considering the use of filgrastim in patients with sickle cell disease. Filgrastim contains sorbitol. Patients with rare hereditary problems of fructose intolerance should not use this medicine. Interactions: Preliminary evidence from patients treated concomitantly with filgrastim and 5-Fluorouracil indicates that the severity of neutropenia may be exacerbated. Lithium is likely to potentiate the effect of filgrastim. Pregnancy and lactation: Not to be used in pregnancy unless clearly necessary. It is unknown whether filgrastim is excreted into breast milk. A decision should be made taking into account the benefit of breast-feeding to the child and the benefit of therapy to the woman. Effects on ability to drive and use machines: minor or moderate influence on the ability to drive and use machines. If experiencing fatigue, caution is advised when driving a car or operating machinery. Adverse reactions: Very Common: Elevated alkaline phosphatase, elevated LDH, elevated uric acid, nausea/vomiting, elevated GGT, chest pain, musculoskeletal pain, leukocytosis, thrombocytopenia, headache, anaemia, splenomegaly, decreased glucose, epistaxis. Common: Cough, sore throat, constipation, anorexia, diarrhoea, mucositis, alopecia, skin rash, fatigue, generalised weakness, thrombocytopenia, hepatomegaly, cutaneous vasculitis, injection site pain, rash, osteoporosis. Serious Very Rare: Sweet's syndrome, cutaneous vasculitis, allergic-type reactions, including anaphylaxis, angioedema, dyspnoea occurring on initial or subsequent treatment. Serious Rare: Pulmonary effects, including interstitial pneumonia, pulmonary oedema and pulmonary infiltrates have been reported with an outcome of respiratory failure or adult respiratory distress syndrome which may be fatal. Serious Uncommon: Splenic rupture. Consult the Summary of Product Characteristics in relation to other side effects. Overdosage: No cases of overdose reported. Discontinuation: usually results in a 50% decrease in circulating neutrophils within 1 to 2 days, with return to normal levels in 1 to 7 days. NHS List Price: 30 MIU 0.5 ml, 5 pre-filled syringes GBP311.25; 48 MIU 0.8 ml, 5 pre-filled syringes GBP496.45. Legal category: POM. Marketing Authorisation Number: PL EU/1/08/445/001-008. Marketing Authorisation Holder: Teva Generics GmbH, Kandelstr. 10, D-79199 Kirchzarten, Germany. Date of Preparation: October 2009 TVH09/AE/008
References: 1) TevaGrastim(R) Summary of Product Characteristics 2) Neupogen(R) Summary of Product Characteristics 3) MIMS November 2009 * G-CSF = Granulocyte-Colony Stimulating Factor
SOURCE: Teva UK Ltd
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