Last Updated on eMC 09-10-2017 View medicine  | Accord Healthcare Limited Contact details

When a pharmaceutical company changes an SPC or PIL, a new version is published on the eMC.  For each version, we show the dates it was published on the eMC and the reasons for change.

Reasons for adding or updating:

  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.8 - Undesirable effects

Date of revision of text on the SPC:12-09-2017

Legal Category:POM

Black Triangle (CHM): YES

Free-text change information supplied by the pharmaceutical company:



For Accofil 30 MU

In section 4.2 (Posology and method of administration), following is updated

Neutrophil Count

Filgrastim dose adjustment

> 1.0 x 109/L for 3 consecutive days

Reduce to 0.5 MU (5µg) /kg/day

Then, if ANC remains > 1.0 x 109/L for 3 more consecutive days

Discontinue filgrastim

If the ANC decreases to < 1.0 x 109/L during the treatment period, the dose of filgrastim should be re-escalated according to the above steps

ANC = absolute neutrophil count

 

The recommended dose of filgrastim for PBPC mobilisation when used alone is 1.0 MU (10 µg)/kg/day for 5-7 consecutive days. The timing of leukapheresis: 1 or 2 leukaphereses on days 5 and 6 are often sufficient. In other circumstances, additional leukaphereses may be necessary. Filgrastim dosing should be maintained until the last leukapheresis.

 

The recommended dose of filgrastim for PBPC mobilisation after myelosuppressive chemotherapy is 0.5 MU (5 µg)/kg/day given daily 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. Leukapheresis should be performed during the period when the ANC rises from
< 0.5 x 109/L to > 5.0 x 109/L. For patients who have not had extensive chemotherapy, one leukapheresis is often sufficient. In other circumstances, additional leukaphereses are recommended.

For the mobilisation of PBPCs in normal donors prior to allogeneic PBPC transplantation

 

For PBPC mobilisation in normal donors, filgrastim should be administered at 1.0 MU (10 µg)/kg/day for 4 - 5 consecutive days. Leukapheresis should be started at day 5 and continued until day 6 if needed in order to collect 4 x 106 CD34+ cells/kg recipient bodyweight.

In section 4.4 (Special warnings and precautions for use), following is updated

Glomerulonephritis has been reported in patients receiving filgrastim and pegfilgrastim. Generally, events of glomerulonephritis resolved after dose reduction or withdrawal of filgrastim and pegfilgrastim. Urinalysis monitoring is recommended.

 

Special precautions in sickle cell trait and sickle cell disease

 

Sickle cells crises, in some cases fatal, have been reported with the use of filgrastim in subjects with sickle cell trait or sickle cell disease. Physicians should exercise caution when considering the use of filgrastim in patients with sickle cell trait or sickle cell disease and only after careful evaluation of the potential risks and benefits.

In section 4.8 (Undesirable effects)

Cancer patients

 

MedDRA system organ class

Adverse reactions

Very common

 

Common

 

Uncommon

 

Rare

 

Very rare

 

Not known

Renal and urinary disorders

 

 

Urine abnormality

Glomerulonephritis

 

 

 

General disorders and administration site conditions

Pain

 

 

 

 

 

 

 

PBPC mobilisation in normal donors

MedDRA system organ class

Adverse reactions

Very common

 

Common

 

Uncommon

 

Rare

 

Very rare

 

Not known

Renal and urinary disorders

 

 

Glomerulonephritis

 

 

 

                                               

SCN patients

MedDRA system organ class

Adverse reactions

Very common

 

Common

 

Uncommon

 

Rare

 

Very rare

 

Not known

Renal and urinary disorders

 

Glomerulonephritis

 

 

 

 

 

Patients with HIV

MedDRA system organ class

Adverse reactions

 

Very common

 

Common

 

Uncommon

 

Rare

 

Very rare

 

Not known

Renal and urinary disorders

 

 

 

 

 

Glomerulonephritis

 

 

 

Reasons for adding or updating:

  • Change to section 8 - Marketing authorisation number(s)
  • Change to section 10 - Date of revision of the text

Date of revision of text on the SPC:13-01-2016

Legal Category:POM

Black Triangle (CHM): YES

Free-text change information supplied by the pharmaceutical company:

Following Changes has been made:$0$0$0$0In Section 8 Marketing Authorisation Number: $0$0$0$0$0Marketing Authorisation Number EU/1/14/946/018 has been added.$0$0$0

Reasons for adding or updating:

  • Change to section 4.7 - Effects on ability to drive and use machines
  • Change to section 6.5 - Nature and contents of container

Date of revision of text on the SPC:17-09-2015

Legal Category:POM

Black Triangle (CHM): YES

Free-text change information supplied by the pharmaceutical company:



 

Update in section 4.7 Effects on ability to drive and use machines

 

Update in section 6.5 Nature and contents of container

Reasons for adding or updating:

  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.6 - Fertility, pregnancy and lactation
  • Change to section 4.7 - Effects on ability to drive and use machines
  • Change to section 4.8 - Undesirable effects
  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 5.2 - Pharmacokinetic properties
  • Change to section 10 - Date of revision of the text

Date of revision of text on the SPC:22-05-2015

Legal Category:POM

Black Triangle (CHM): YES

Free-text change information supplied by the pharmaceutical company:



Update in section 4.2  Posology and method of administration

 

Update in section 4.4  Special warnings and precautions for use

 

Update in section 4.6  Fertility, pregnancy and lactation

 

Update in section 4.7  Effects on ability to drive and use machines

 

Update in section 4.8  Undesirable effects

 

Update in section 5.1  Pharmacodynamic properties

 

Update in section 5.2 Pharmacokinetic properties

 

Update in section 10 Date of revision of the text

Reasons for adding or updating:

  • Change to section 3 - Pharmaceutical form
  • Change to section 6.4 - Special precautions for storage
  • Change to section 6.5 - Nature and contents of container
  • Change to section 6.6 - Special precautions for disposal and other handling
  • Change to section 8 - Marketing authorisation number(s)
  • Change to section 9 - Date of first authorisation/renewal of the authorisation

Date of revision of text on the SPC:15-01-2015

Legal Category:POM

Black Triangle (CHM): YES

Free-text change information supplied by the pharmaceutical company:



Update in section Nature and content of container

Update in section 4 pharmaceutical form and contents

Update in section 6.4  :Special precautions for disposal and other handling

Update in section 6.6 : Using the pre-filled syringe with a needle safety guard
Update in section 12  marketing authorisation number
Update of Date of revision

Reasons for adding or updating:

  • New SPC for new product

Date of revision of text on the SPC:01-01-0001

Legal Category:POM

Black Triangle (CHM): YES