Bicalutamide (Binarex) 50 mg tablets: Supply issue resolved

Last Updated: 10 February 2021

The supplier of bicalutamide (Binarex) 50 mg tablets, Rex Medical has advised that this medicine is now available and in stock.

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Bicalutamide (Binarex) 50 mg tablets are back in New Zealand

Rex Medical has advised that this medicine is now available and in stock.

If you have questions about supply, contact your wholesaler or email the supplier at admin@rexmed.co.nz.

Alternative brand listed 8 January 2021

Rex Medical has sourced an alternative product to ensure people can continue to access bicalutamide 50 mg tablets.

The alternative brand Calutide-50 is:

supplied by Rex Medical
the same formulation, active ingredient, and manufacturer as the currently listed product
listed from 8 January 2021
not approved by Medsafe (to be supplied under section 29 of the Medicines Act)
on monthly (non-stat) dispensing

Information about these bicalutamide tab 50 mg

Brand Name: Calutide-50
Pharmacode: 2603616
Active Ingredient: Bicalutamide
Presentation: 50mg
Pack size: 10 tablets per pack
Packaging type: Blister pack

For health professionals

Bicalutamide tab 50 mg (Calutide-50) is available in a 10 tablets per pack presentation. This differs from Binarex, which was packaged in a 28 or 30 pack.

Bicalutamide tab 50 mg (Calutide-50) is not approved by Medsafe. It needs to be supplied in line with section 29 of the Medicines Act 1981. Only medical practitioners registered with the Medical Council of New Zealand can prescribe section 29 medicines.

What section 29 means

Section 29 of the Medicines Act allows for medicines that are not Medsafe approved to be supplied to people. The medicine must be prescribed by someone registered with the Medical Council of New Zealand – e.g., doctors.

We know supplying a medicine under section 29 is not ideal. In this case, however, the alternative would be for patients to have no bicalutamide.

We apologise for any inconvenience this causes.

Information for your patients about what section 29 means – Health Navigator website(external link)

Information for pharmacists

Rule 5.5 has been removed. If you have any Binarex stock, it can be dispensed in monthly lots (non-stat).

Dispensing software

RxOne users: the new listing will be automatically updated by RxOne. If for some unforeseen circumstance it does not happen, please refer to the e-Noticeboard on the RxOne Home Screen for instructions.

TONIQ users: the new listing will automatically be updated in Toniq medicine databases from the effective date.

Claiming the subsidy

Ministry of Health Sector Operations Group will be unable to process claims for January 2021 dispensing of the above listing. Pharmacies can:

hold these claims until February 2021, or
reclaim them in February 2021 after they are rejected for payment in January 2021 claims.

23 December 2020: Initial notification of stock issue

Information for pharmacists

Due to an acute shortage of bicalutamide 50 mg tablets (Binarex) in New Zealand, PHARMAC has made the decision to apply the Pharmaceutical Supply Management Rule (5.5) of the Pharmaceutical Schedule.

We ask that pharmacists dispense a maximum of 10 days' supply of bicalutamide (Binarex) 50 mg tablets only. This change is in force from 23 December 2020 to 31 January 2021.

Pharmacists must clearly annotate the prescription for bicalutamide 50 mg tablets (Binarex) with the words “out of stock” or “OOS” and initial the annotation in their own handwriting.

Given the time of year, pharmacists may dispense more Binarex 50 mg tablets to ensure people have the medicine they need over the holiday period (Rule 4.4.2).

Read the Schedule Rules

We are working with the supplier to mitigate the impact of this supply issue. On 1 November 2020, we listed the 30 pack of Binarex 50 mg tablets. Stocks of this pack size are also low.

Information about the 30 tablet pack

Brand Name: Binarex
Active Ingredient: Bicalutamide
Presentation & Pack Size: 50mg, 30s Tabs
List Price: 4.07
Pharmacode: 2600315
Listing Date: 1 November 2020
Availability: Available now

Rex Medical’s alternative Binarex 30 tablet pack size is in New Zealand compliant packaging. The Binarex 30 tablet pack is the same formulation and same manufacturer as the currently supplied Binarex 28 tablet pack.

Information for people who take Binarex

Binarex 50mg Tabs 30’s is made by the same manufacturer, using the same
product formulation and testing specifications as your usual pack of Binarex 50mg Tabs 28’s.

There may be small differences in the packaging and the look of the tablets between the two pack sizes. Binarex 50mg Tabs 30’s has been packaged to meet New Zealand requirements.

Download an information sheet - Rex Medical's website(external link)

Who to contact

If you have any questions about this supply issue, email admin@rexmed.co.nz

Previous actions to manage the stock outage