TRIKAFTA film-coated tablets blister pack

Product Defect Correction - Misorientation of tablets in the medicine wallet.

TRIKAFTA tablets may be incorrectly located in their pack (wallets). In some cases, morning doses (orange tablet) are in the evening dosing section of the wallet and evening dose (blue tablet) are in the morning section.

The affected batch number is 1846070 (expiry 03/2023).

Day 1-3 (Incorrect orientation) Day 4-7 (Incorrect orientation)

TRIKAFTA is a prescription medicine used in the treatment of cystic fibrosis (CF).

What should I do?

If you or someone you care for is taking TRIKAFTA tablets:

• Check the batch number on the packaging. The batch number (BN) can be found on
  • the bottom of the carton and
  • the side of each of the four wallets

• Check if the tablets are in the right place - see the picture below. The colour of the tablet should match the background colour.

• If there are any tablets in the wrong place, immediately contact the pharmacy that normally dispenses your TRIKAFTA who will advise you on how to arrange for replacement and return of medication.
• If you have any questions or concerns, contact Vertex Pharmaceuticals on 1800 179 987 or your health professional.

What should pharmacists do?

Pharmacists should inspect all packs of batch number 1846070 prior to supply and confirm the correct orientation of all tablets.

To inspect, open the carton via the instructions on the front panel of the box and then open each wallet. Any product affected by this problem should be quarantined until returned.

What are the risks?

Patients would receive the same daily dose of the product but would take the tablets in a different dosing schedule.

Continuity of treatment to prevent recurrence of the patients' underlying disease is essential.

Reporting problems

Consumers and health professionals are encouraged to report problems with medicines or vaccines. Your report will contribute to the TGA's monitoring of these products.

The TGA cannot give advice about an individual's medical condition. You are strongly encouraged to talk with a health professional if you are concerned about a possible adverse event associated with a medicine or vaccine.