How does the BRUKINSA tablet formulation compare with the capsule formulation?

Daily tablet burden reduced by half^1,2

With BRUKINSA 160 mg tablets, the daily tablet intake is reduced by 50%, from 4 capsules to 2 tablets.^1,2

One tablet is twice the strength of a capsule.^1,2

The recommended daily dose of BRUKINSA remains 320 mg.^1,2

Reduced size for easier swallowing^1–3

The film-coated tablet is almost one‑third smaller in length than the capsule (16 mm vs 22 mm), which may make it easier for patients to swallow.^1–3

BRUKINSA tablets continue to offer the same expected efficacy and safety as the capsules^1,4

This is based on the results of two single-dose, open-label, randomised Phase 1 cross-over studies of healthy adults to establish bioequivalence.⁴

There were no clinically meaningful differences between the tablet and capsule formulations in these studies.⁴

In the comparative bioavailability (BGB-3111-115) and bioequivalence (BGB-3111-114) studies, BRUKINSA exposure, C_max and AUC_last were comparable following a single 160 mg dose as either a tablet or capsules.⁴

What changes have been made to the tablet packaging compared with the capsule packaging?

Tablets are packaged in a child-resistant bottle containing 60 tablets;¹ capsules are packaged in a child-resistant bottle containing 120 capsules.²

There are different colours to differentiate pharmaceutical forms (white capsules vs blue tablets).^1,2

Is the shelf life of BRUKINSA tablets different from the shelf life of the capsules?

The capsules currently have a shelf life of 3 years, whereas the tablets have a shelf life of 2 years.^1,2

What changes have been made to the BRUKINSA dose or schedule?

The recommended total daily dose of BRUKINSA remains 320 mg, which can be taken as either two 160 mg tablets once daily or one 160 mg twice daily (one 160 mg tablet in the morning; one 160 mg tablet in the evening).¹

Patients should continue to take BRUKINSA tablets until disease progression or unacceptable toxicity.¹

How should patients take their BRUKINSA tablets?

Are BRUKINSA tablets suitable for all indications and regimens?

There is no difference in therapeutic indications between the capsules and tablets.^1,2

The BRUKINSA 160 mg tablet formulation will be available for all eligible adult patients.¹

BRUKINSA as monotherapy is indicated for the treatment of adult patients with:

• Chronic lymphocytic leukaemia (CLL)
• Waldenström’s macroglobulinaemia (WM) who have received at least one prior therapy, or in first line treatment for patients unsuitable for chemo-immunotherapy
• Marginal zone lymphoma (MZL) who have received at least one prior anti-CD20-based therapy
• Mantle cell lymphoma (MCL) who have received at least one prior therapy

BRUKINSA in combination with obinutuzumab is indicated for the treatment of adult patients with refractory or relapsed follicular lymphoma (FL) who have received at least two prior systemic therapies.

Have dose modifications changed with BRUKINSA tablets?

Dose modifications with BRUKINSA continue to be straightforward, with stepwise, specified dose reductions for adverse reactions.¹

The recommended daily dose of BRUKINSA is 320 mg; dose modifications should only be considered when clinically indicated per the label.¹

Dose modifications for co-administered medication
Acid-reducing agents	There are no dosage modifications required when taking BRUKINSA tablets with acid-reducing agents such as PPIs or H2-receptor antagonists1
CYP3A inhibitors or inducers	Dosage modifications for taking BRUKINSA tablets with CYP3A inhibitors or inducers remain generally the same as those with BRUKINSA capsules1,2 (The UK 160 mg tablet SmPC has updated guidance for when CYP3A inducers cannot be avoided)

Refer to the BRUKINSA Prescribing Information for full information on dose modifications.

If a dose reduction is required, how is this achieved with the tablet formulation?

Dose reductions can be achieved by splitting the tablet in half along the score line.¹ A whole tablet is 160 mg; half of a tablet is 80 mg.¹

When should new and existing patients be started on BRUKINSA tablets?

New and existing BRUKINSA patients should be prescribed tablets once capsule stock is depleted.

Ensure patients switching from capsules to tablets understand that one tablet is double the strength of one capsule.^1,2

Are new prescriptions required for BRUKINSA tablets?

Yes, patients will require a new prescription to be written and provided for BRUKINSA 160 mg tablets. Prescribers should specify the formulation and dosage of BRUKINSA on each prescription.

Are BRUKINSA capsules still available for prescription and usage?

BRUKINSA capsules will be phased out and replaced by BRUKINSA tablets on a permanent basis.

You should continue to prescribe BRUKINSA capsules until the stock is depleted. Using up existing capsule stock will reduce wastage and environmental impact, and a clear transition minimises risks to patient safety.

Will BRUKINSA tablets be available through the same distributors?

Yes. Contact your usual distributors and suppliers to request the new tablet formulations upon receiving prescriptions for tablets.

When is it not advisable for patients to take BRUKINSA tablets?

BRUKINSA must not be taken by patients with hypersensitivity to the active substance or to any of the excipients.¹

Please see the Prescribing Information for details on special warnings and precautions for use.

What blue colouring is used?

Film coat excipients include:¹

• Brilliant blue FCF aluminium lake (E133)
• Indigo carmine aluminium lake (E132)

Should patients return their BRUKINSA capsules?

No, there is no need for patients to return their remaining capsules when they are prescribed tablets. This transition is not related to a product recall or safety concern, and patients may continue taking capsules at their usual dose until they switch to the tablet formulation.

What happens if a patient accidentally takes too many tablets?

There is a risk of medication error if capsules and tablets are used interchangeably. To minimise the risk, it is important to make sure patients understand the difference between the formulations in terms of milligram doses, i.e. that one tablet is double the strength of one capsule.^1,2

Prescribers should specify the formulation and dosage of BRUKINSA on each prescription.

If a patient takes more BRUKINSA than they should, they should inform their doctor straight away. They should be advised to take their tablet packet and leaflet with them.⁸

There is no specific antidote for BRUKINSA. For patients who experience overdose, closely monitor and provide appropriate supportive treatment.¹