Tevagrastim

Country: European Union

Language: English

Source: EMA (European Medicines Agency)

Active ingredient:

filgrastim

Available from:

Teva GmbH

ATC code:

L03AA02

INN (International Name):

filgrastim

Therapeutic group:

Immunostimulants,

Therapeutic area:

Neutropenia; Hematopoietic Stem Cell Transplantation; Cancer

Therapeutic indications:

Tevagrastim is indicated for the reduction in the duration of neutropenia and the incidence of febrile neutropenia in patients treated with established cytotoxic chemotherapy for malignancy (with the exception of chronic myeloid leukaemia and myelodysplastic syndromes) and for the reduction in the duration of neutropenia in patients undergoing myeloablative therapy followed by bone-marrow transplantation considered to be at increased risk of prolonged severe neutropenia. The safety and efficacy of filgrastim are similar in adults and children receiving cytotoxic chemotherapy.Tevagrastim is indicated for the mobilisation of peripheral blood progenitor cells (PBPC).In patients, children or adults, with severe congenital, cyclic, or idiopathic neutropenia with an absolute neutrophil count (ANC) of 0.5 x 109/l, and a history of severe or recurrent infections, long term administration of Tevagrastim is indicated to increase neutrophil counts and to reduce the incidence and duration of infection-related events.Tevagrastim is indicated for the treatment of persistent neutropenia (ANC less than or equal to 1.0 x 109/l) in patients with advanced HIV infection, in order to reduce the risk of bacterial infections when other options to manage neutropenia are inappropriate.

Product summary:

Revision: 18

Authorization status:

Authorised

Authorization date:

2008-09-15

Patient Information leaflet

49
B. PACKAGE LEAFLET
50
PACKAGE LEAFLET: INFORMATION FOR THE USER
TEVAGRASTIM 30 MIU/0.5 ML SOLUTION FOR INJECTION/INFUSION
TEVAGRASTIM 48 MIU/0.8 ML SOLUTION FOR INJECTION/ INFUSION
filgrastim
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS
MEDICINE
BECAUSE IT CONTAINS
IMPORTANT INFORMATION FOR YOU.
-
Keep this leaflet. You may need to read it again.
-
If you have any further questions, ask your doctor, pharmacist or
nurse.
-
This medicine has been prescribed for you only. Do not pass it on to
others. It may harm them,
even if their signs of illness are the same as yours.
-
If you get any side effects, talk to your doctor, pharmacist or nurse.
This includes any possible
side effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
What Tevagrastim is and what it is used for
2.
What you need to know before you use Tevagrastim
3.
How to use Tevagrastim
4.
Possible side effects
5.
How to store Tevagrastim
6.
Contents of the pack and other information
7.
Information for injecting yourself
8.
The following information is intended for healthcare professionals
only
1.
WHAT TEVAGRASTIM
IS AND WHAT IT IS USED FOR
WHAT TEVAGRASTIM IS
Tevagrastim is a white blood cell growth factor (granulocyte
colony-stimulating factor) and belong to
a group of medicines called cytokines. Growth factors are proteins
that are produced naturally in the
body but they can also be made using biotechnology for use as a
medicine. Tevagrastim works by
encouraging the bone marrow to produce more white blood cells.
WHAT TEVAGRASTIM IS USED FOR
A reduction in the number of white blood cells (neutropenia) can occur
for several reasons and makes
your body less able to fight infection. Tevagrastim stimulates the
bone marrow to produce new white
cells quickly.
Tevagrastim can be used
-
to increase the number of white blood cells after treatment with
chemotherapy to help prevent
infections.
-
to increase the number of white blood cells after a bone marrow
transplant to help prevent
infections.
-
before high-dose chemo

Summary of Product characteristics

1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE MEDICINAL PRODUCT
Tevagrastim 30 MIU/0.5 mL solution for injection/infusion
Tevagrastim 48 MIU/0.8 mL solution for injection/infusion
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each mL of solution for injection/infusion contains 60 million
international units [MIU] (600 µg) of
filgrastim.
Tevagrastim 30 MIU/0.5 mL solution for injection/infusion
Each pre-filled syringe contains 30 MIU (300 µg) of filgrastim in 0.5
mL solution for injection/
infusion.
Tevagrastim 48 MIU/0.8 mL solution for injection/infusion
Each pre-filled syringe contains 48 MIU (480 µg) of filgrastim in 0.8
mL solution for
injection/infusion.
Filgrastim (recombinant methionyl human granulocyte colony-stimulating
factor) is produced in
_Escherichia coli_
K802 by recombinant DNA technology.
_Excipient with known effect _
Each mL of solution contains 50 mg of sorbitol.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Solution for injection/infusion
Clear, colourless solution.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Tevagrastim is indicated for the reduction in the duration of
neutropenia and the incidence of febrile
neutropenia in patients treated with established cytotoxic
chemotherapy for malignancy (with the
exception of chronic myeloid leukaemia and myelodysplastic syndromes)
and for the reduction in the
duration of neutropenia in patients undergoing myeloablative therapy
followed by bone marrow
transplantation considered to be at increased risk of prolonged severe
neutropenia.
The safety and efficacy of filgrastim are similar in adults and
children receiving cytotoxic
chemotherapy.
Tevagrastim is indicated for the mobilisation of peripheral blood
progenitor cells (PBPC).
In patients, children or adults, with severe congenital, cyclic, or
idiopathic neutropenia with an
absolute neutrophil count (ANC) of ≤ 0.5 x 10
9
/L, and a history of severe or recurrent infections, long
term administration of Tevagrastim is indicated to increase neutrophi