Last Updated on eMC 22-07-2016 View medicine  | Astellas Pharma Ltd 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 5.2 - Pharmacokinetic properties
  • Change to section 10 - Date of revision of the text

Date of revision of text on the SPC:29-06-2016

Legal Category:POM

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:



Section 4.2 Posology and method of administration

Amendment of dosing section to introduce a separate dosing table for children (including neonates) <4 months:

 

Use in children (including neonates) < 4 months

 

Indication

 

Treatment of invasive candidiasis

4 -10 mg/kg/day*

Prophylaxis of Candida infection

2 mg/kg/day

*Micafungin dosed at 4 mg/kg in children less than 4 months approximates drug exposures achieved in adults receiving 100 mg/day for the treatment of invasive candidiasis. If central nervous system (CNS) infection is suspected, a higher dosage (e.g. 10 mg/kg) should be used due to the dose-dependent penetration of micafungin into the CNS (see section 5.2).The safety and efficacy in children (including neonates)  less than 4 months of age of doses of 4 and 10 mg/kg for the treatment of invasive candidiasis with CNS involvement has not been adequately established in controlled clinical studies.

 

Section 4.9 Overdose

Amendment of wording as follows:

 

In Oone spontaneous case, of mis-dosage of 7.8 mg/kg/day for 7 days it was reported a dosage of 16 mg/kg/day was administered in a newborn patient. No adverse reactions associated with this high dose were noted.

 

Section 5.2 Pharmacokinetic properties; Special populations

Amended as follows:

 

Special populations

Paediatric patients: In paediatric patients AUC values were dose proportional over the dose range of 0.5‑4 mg/kg. Clearance was influenced by weight, with mean values of weight-adjusted clearance 1.35 times higher in the younger children (4 months to 5 years) and 1.14 times higher in paediatric patients aged 6 to 11 years. Older children (12-16 years) had mean clearance values similar to those determined in adult patients.  Mean clearance in premature infants (gestational age approximately 26 weeks) is approximately 5‑fold greater than in adults. Mean weight-adjusted clearance in children less than 4 months of age is approximately 2.6-fold greater than older children (12-16 years) and 2.3-fold greater than in adults.

 

PK/PD bridging study demonstrated dose-dependent penetration of micafungin into CNS with the minimum AUC of 170 µg*hr/L required to achieve maximum eradication of fungal burden in the CNS tissues. Population PK modeling demonstrated that a dose of 10 mg/kg in children less than 4 month of age would be sufficient to achieve the target exposure for the treatment of CNS Candida infections.

Reasons for adding or updating:

  • 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:17-12-2015

Legal Category:POM

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:

$0Section 5.2 Pharmacokineticproperties – special populations section$0$0The information regarding mean drug clearance values in paediatricpatients has been re-worded.  $0$0 Section 10 is updated.$0

Reasons for adding or updating:

  • Change to section 4.8 - Undesirable effects - how to report a side effect
  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 10 - Date of revision of the text

Date of revision of text on the SPC:18-12-2013

Legal Category:POM

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:



Section 4.8 (Undesirable effects):

– addition of mandatory AE wording highlighting the importance of reporting adverse reactions, and provision of details for the Yellow Card Scheme.

 

Section 5.1 (Pharmacological Properties):

– complete revision of the ‘PK/PD relationship’ section

– addition of ‘Fks2’ gene under ‘Mechanism(s) of resistance’

– complete revision of the ‘Breakpoints’ section

 

Section 10 Date of Revision has also been updated.

 

Reasons for adding or updating:

  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 7 - Marketing authorisation holder
  • Change to section 9 - Date of first authorisation/renewal of the authorisation
  • Change to section 10 - Date of revision of the text

Date of revision of text on the SPC:20-12-2012

Legal Category:POM

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:



Section 4.4 = Removal of lactose warning

 

Section 7 = Change to MAH Address

Section 9 = Change to ‘date of latest renewal’

Section 10 = Change to ‘date of revision of text’

Reasons for adding or updating:

  • Removal of Black Triangle

Date of revision of text on the SPC:24-08-2011

Legal Category:POM

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:

Removal of Black Triangle

Reasons for adding or updating:

  • Change to section 4.3 - Contraindications
  • Change to section 4.4 - Special warnings and precautions for Use
  • Change to section 4.8 - Undesirable Effects
  • Change to section 10 date of revision of the text

Date of revision of text on the SPC:24-08-2011

Legal Category:POM

Black Triangle (CHM): YES

Free-text change information supplied by the pharmaceutical company:



Section 3
In the first sentence, the wording “ to other echinocandins” has been added.

 

Section 4.4

 

The paragraph: “Exfoliative cutaneous reactions, such as Stevens-Johnson syndrome and toxic epidermal necrolysis have been reported. If patients develop a rash they should be monitored closely and micafungin discontinued if lesions progress.”  has been removed

 

Section 4.8

 

Additions to the adverse event table in Section 4.8. Additions include adverse events listed under ‘Not Known’ for the following type’s of effects:

 

- Blood and lymphatic system disorders

Side effect: disseminated intravascular coagulation was added

 

- Skin and subcutaneous tissue disorders

Side effect: erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis was added

Section 10
Change to date of revision of text

Reasons for adding or updating:

  • Change to section 4.4 - Special warnings and precautions for Use
  • Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
  • Change to section 10 date of revision of the text

Date of revision of text on the SPC:20-12-2010

Legal Category:POM

Black Triangle (CHM): YES

Free-text change information supplied by the pharmaceutical company:



Section 4.4

In the second paragraph (under the boxed paragraph) the word "anaphylactic" has been added.

The following paragraph has been copied from Section 4.5 into Section 4.4:

"Patients receiving sirolimus, nifedipine or itraconazole in combination with Mycamine should be monitored for sirolimus, nifedipine or itraconazole toxicity and the sirolimus, nifedipine or itraconazole dosage should be reduced if necessary (see Section 4.5)."

 

 

Section 4.5

 

In paragraph three the word "Mycamine" has been changed to "micafungin".

 

At the end of the last paragraph the words "See Section 4.4" has been added.

 

 

Section 10

Date of revision

Reasons for adding or updating:

  • Change to section 4.4 - Special warnings and precautions for Use
  • Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
  • Change to section 4.8 - Undesirable Effects
  • Change to section 10 date of revision of the text

Date of revision of text on the SPC:06-08-2010

Legal Category:POM

Black Triangle (CHM): YES

Free-text change information supplied by the pharmaceutical company:



In Section 4.4 the following paragraph has been added (third paragraph from the end of the section):-

 

Co-administration of micafungin and amphotericin B desoxycholate should only be used when the benefits clearly outweigh the risks, with close monitoring of amphotericin B desoxycholate toxicities (see Section 4.5).

In Section 4.5 the following paragraph has been added (second paragraph from the end of the section):-

 

Co-administration of Mycamine and amphotericin B desoxycholate was associated with a 30% increase in amphotericin B desoxycholate exposure.  Since this may be of clinical significance this co-administration should only be used when the benefits clearly outweigh the risks, with close monitoring of amphotericin B desoxycholate toxicities (see Section 4.4).

 

 

In Section 4.8 "Toxic skin eruption" has been added to the table under the System Organ Class heading Skin and subcutaneous tissue disorders,  under the Frequency column heading Not known (frequency cannot be estimated from available data).

 

 

In Section 10 the Date of revision has been changed to 6th August 2010.

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 5.2 - Pharmacokinetic Properties
  • Change to section 10 date of revision of the text

Date of revision of text on the SPC:20-11-2009

Legal Category:POM

Black Triangle (CHM): YES

Free-text change information supplied by the pharmaceutical company:



Section 4.2

Use in patients with hepatic impairment

The sentence has been changed from:

“There are currently no data available for the use of Mycamine in patients with severe hepatic impairment…….”

to:

“There are currently insufficient data available for the use of Mycamine in patients with severe hepatic impairment……”

Section 4.4

The following sentence has been deleted:

“There are insufficient data on the pharmacokinetics of micafungin in patients with severe hepatic impairment (see section 5.2).”

Section 5.2

The following sentence has been deleted:

“The pharmacokinetics of micafungin has not been studied in patients with severe hepatic insufficiency.”

The following sentences have been added:

“In a study performed in patients with severe hepatic impairment (Child-Pugh score 10-12)(n=8), lower plasma concentrations of micafuncin and higher plasma concentrations of the hydroxide metabolite (M-5) were seen compared to healthy subjects (n=8). These data are insufficient to support a dosing recommendation in patients with severe hepatic impairment.” 
 

Reasons for adding or updating:

  • Change to section 7 - Marketing Authorisation Holder
  • Change to section 10 date of revision of the text

Date of revision of text on the SPC:29-09-2008

Legal Category:POM

Black Triangle (CHM): YES

Free-text change information supplied by the pharmaceutical company:

The update is a change of Marketing Authorisation Holder address and Section 10. Date of Revision of the Text.

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