Orkambi 100 mg/125 mg granules and 150 mg/188 mg granules

  • Name:

    Orkambi 100 mg/125 mg granules and 150 mg/188 mg granules

  • Company:
    info
  • Active Ingredients:

    Ivacaftor, Lumacaftor

  • Legal Category:

    Product subject to medical prescription which may be renewed (B)

Patient Information Leaflet Patient Information Leaflet last updated on medicines.ie: 01/10/20

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Summary of Product Characteristics last updated on medicines.ie: 21/9/2020
This medicinal product is subject to additional monitoring. This will allow quick identification of new safety information. Healthcare professionals are asked to report any suspected adverse reactions. See section 4.8 for how to report adverse reactions.

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Vertex Pharmaceuticals (Ireland) Limited

Vertex Pharmaceuticals (Europe) Limited

Company Products

Medicine NameActive Ingredients
Medicine Name Kaftrio 75 mg, 50 mg, 100 mg film coated tablets Active Ingredients Ivacaftor, Tezacaftor, Elexacaftor
Medicine Name Kalydeco 150 mg film-coated tablets Active Ingredients Ivacaftor
Medicine Name Kalydeco 25mg, 50mg and 75mg granules sachets Active Ingredients Ivacaftor
Medicine Name Orkambi 100 mg/125 mg granules and 150 mg/188 mg granules Active Ingredients Ivacaftor, Lumacaftor
Medicine Name Orkambi 200 mg/125 mg tablets and 100mg/125mg tablets Active Ingredients Ivacaftor, Lumacaftor
Medicine Name Symkevi 100 mg/150 mg film coated tablets Active Ingredients Tezacaftor 100mg, Ivacaftor 150mg
1 - 0 of 6 items.Total: Infinity pages

When a pharmaceutical company changes any document, a new version is published on medicines.ie. For each version, we show the dates it was published on medicines.ie and the reasons for change.

Updated on 1 October 2020 PIL

Reasons for updating

  • Change to MA holder contact details

Free text change information supplied by the pharmaceutical company

Addition of local representative details for marketing authorisation holder.

Updated on 21 September 2020 SmPC

Reasons for 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 - how to report a side effect
  • Change to section 5.1 - Pharmacodynamic properties

Legal category: Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company

Orkambi SmPC

Administrative edits throughout to change “Trials” to “trials”, “Week” to “week” and “Day” to “day” where applicable.

 

Section 4.4

Update to include information on conducting through investigation regarding the causes of a significant elevation of ALT or AST.

Previous text:

Hepatobiliary events

……….

In the event of significant elevation of ALT or AST, with or without elevated bilirubin (either ALT or AST > 5 x the upper limit of normal [ULN], or ALT or AST > 3 x ULN with bilirubin > 2 x ULN), dosing with lumacaftor/ivacaftor should be discontinued and laboratory tests closely followed until the abnormalities resolve.Following resolution of transaminase elevations, the benefits and risks of resuming dosing should be considered (see sections 4.2, 4.8, and 5.2).

 

Updated text:

Hepatobiliary events

……….

In the event of significant elevation of ALT or AST, with or without elevated bilirubin (either ALT or AST > 5 x the upper limit of normal [ULN], or ALT or AST > 3 x ULN with bilirubin > 2 x ULN and/or clinical jaundice), dosing with lumacaftor/ivacaftor should be discontinued and laboratory tests closely followed until the abnormalities resolve. A thorough investigation of potential causes should be conducted and patients should be followed closely for clinical progression. Following resolution of transaminase elevations, the benefits and risks of resuming dosing should be considered (see sections 4.2, 4.8, and 5.2).

 

Section 4.5

Table 3

Update to advice on dose recommendation for patients taking clarithromycin or telithromycin to reduce  to one sachet every other day instead of once daily.

Update to advice on dose recommendation for patients taking itraconazole, ketoconazole, posaconazole, voriconazole to one sachet every other day instead of once daily.

 

Section 4.8

Under paediatric population addition of long-term safety data from the 96-week rollover extension study in patients 2 yrs and older. Statement that data was generally consistent with the parent study has been added. Also the addition of long-term safety data from 96-week rollover study in patients 6 yrs and older. Statement that data was generally consistent with 24-week parent studies.

Addition of text:

Paediatric population

……….

Long-term safety data from a 96-week rollover extension study in 57 patients aged 2 years and older who were homozygous for the F508del mutation in the CFTR gene were generally consistent with the24-week parent study in patients aged 2 to 5 years (trial 8) and safety data in patients aged 6 to 11 years.

Long-term safety data from a 96-week rollover extension study in 239 patients aged 6 years and older who were homozygous for the F508del mutation in the CFTR gene (trial 9) were generally consistent with the 24-week parent studies in patients aged 6 to 11 years (trial 6 and trial 7).

Section 5.1

Addition of data related to Trial 9 (rollover extension study) including the addition of Table 8 Long-term effect of lumacaftor/ivacaftor in trial 9

Addition of text:

Patients with CF aged 6 years and older from trial 6 and trial 7 were included in a phase 3, multicentre, rollover extension study (trial 9). This extension trial was designed to evaluate the safety and efficacy of long-term treatment of lumacaftor/ivacaftor. Of the 262 patients who received any treatment in trial 6 or trial 7, 239 (91%) were dosed and received active treatment (patients 6 to <12 years of age received lumacaftor 200 mg q12h/ivacaftor 250 mg q12h; patients ≥12 years of age received lumacaftor 400 mg q12h/ivacaftor 250 mg q12h) in the extension study for up to an additional 96 weeks (i.e., up to a total of 120 weeks) (see section 4.8). Secondary efficacy results and pulmonary exacerbation event rate per patient year are presented in Table 8.

Updated on 21 September 2020 PIL

Reasons for updating

  • Change to section 2 - what you need to know - contraindications
  • Change to section 4 - possible side effects
  • Change to section 5 - how to store or dispose

Free text change information supplied by the pharmaceutical company

Update to section 2. header from “Do not take Orkambi” to “Do not use Orkambi”.

Administrative edit to “Common” side effect to change “Increase of an enzyme in your blood (blood creatine phosphokinase)” to “Increase of an enzyme in the blood (blood creatine phosphokinase)”

Update to possible side effects section “uncommon” side effects to clarify enlargement of the breast can be observed in males when ivacaftor is used alone.

Update to section 5, to add the word “child” in the statement regarding disposal of medicines.

Updated on 11 June 2020 SmPC

Reasons for updating

  • Change to section 6.3 - Shelf life

Legal category: Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company

Update to Orkambi 100/125 mg granules in sachet and Orkambi 150/ 188 mg granules in sachet SmPC:

Change from 2 year to 3 years shelf life in section 6.3 of SmPC.

Correction made to file to include granules information only.

Updated on 11 June 2020 SmPC

Reasons for updating

  • Change to section 6.3 - Shelf life

Legal category: Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company

Update to Orkambi 100/125 mg granules in sachet and Orkambi 150/ 188 mg granules in sachet SmPC:

Change from 2 year to 3 years shelf life in section 6.3 of SmPC.

Updated on 8 February 2019 PIL

Reasons for updating

  • New PIL for new product

Updated on 8 February 2019 SmPC

Reasons for updating

  • New SmPC for new product

Legal category: Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company

  • A new SmPC has been created for the granule formulation which follows on from the tablet formulation SmPC
  • Sections 1 to 4.2 (name, composition, pharmaceutical form,  indication, posology and administration, dose adjustments for special populations):l new information regarding the granule formulation
  • Inclusion of Trial 8 (809-115; 2-5 year olds) in section 4.8
  • Undesirable effects to highlight the consistency of the safety profile in ages 2-5
  • Inclusion of Trial 8 in section 5.1 Pharmacological properties, pharmacodynamics effects
  • Addition of pharmacokinetic properties in children aged 2-5 (consistent exposures to the adult population)
  • Update to section 6. Pharmaceutical Particulars to incorporate information for the granule formulation

6.4 Special precautions for storage, this has now been updated to state that no special storage conditions are required, as per EMA requirements