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Safety in Lactation: Other antineoplastic drugs

23 September 2020Antineoplastic agents, whether used as monotherapy or in combination with other antineoplastics, are contra-indicated in breastfeeding (unless indicated below) because of their effects on dividing…

In use product safety assessment report for trastuzumab

3 May 2019A UKMi Product Safety assessment on  trastuzumab products (including the biosimilars) which describes the in-use medication safety considerations resultant from the product’s presentation or other…

Trastuzumab deruxtecan

23 December 2018Anti-HER2 monoclonal antibody
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Refrigerated Storage

HerceptinRoche Products Ltd

Roche Products Ltd
Herceptin
600mg solution for Injection in Vial

In the event of an inadvertent temperature excursion the following data may be used:
Once removed from the refrigerator Herceptin subcutaneous formulation must be administered within 6 hours and should not be kept above 30°C.
Please also refer to the manufacturer’s product literature for recommended storage information at https://www.medicines.org.uk

Storage at ambient temperature: not provided by manufacturer.

Do not freeze. Keep the vial in the outer carton in order to protect from light.

28 September 2020
London MI Service

Herceptin (trastuzumab) Roche Products Limited

Roche Products Limited
Herceptin (trastuzumab)
150mg powder for concentrate for solution for infusion

Contact Roche Products Limited in all cases where a deviation from the recommended storage conditions has occurred. Refer to the current BNF for company contact details.

Storage at ambient temperature: not provided by manufacturer.

Do not freeze the reconstituted solution.

28 September 2020
London Medicines Information service

HerzumaNapp Pharmaceuticals

Napp Pharmaceuticals
Herzuma
Powder for concentrate for solution, 150mg

In the event of an inadvertent temperature excursion the following data may be used:
In-house stability data from the manufacturers have shown that the unopened vials may be kept up to 25°C for 6 months, or up to 40°C for 3 months.

In-house stability data from the manufacturers for 150mg strength have shown that the unopened vials can be kept for 6 months at 2-8°C after exposure to stress/cycling stability conditions (a total of 12 days at temperatures cycling between -20 ± 5°C and 40 ± 2°C).

Please also refer to the manufacturer’s product literature for recommended storage information at https://www.medicines.org.uk

Reduce to 6 months from the date of exposure if stored up to 25°C or 3 months from the date of exposure if stored up to 40°C. Reduce to 6 months from the date of exposure if stored less than 2°C.
Yes
14 May 2020
London MI Service

Herzuma Napp Pharmaceuticals

Napp Pharmaceuticals
Herzuma
Powder for concentrate for solution, 420mg

In the event of an inadvertent temperature excursion the following data may be used:
In-house stability data from the manufacturers for the 420mg strength have shown that the unopened vials may be kept at up to 25°C for 6 months, or up to 40°C for 3 months.

In-house stability data from the manufacturers for 420mg strength have also shown that the unopened vials can be kept up to -20 ± 5° C for 4 weeks.

Please also refer to the manufacturer’s product literature for recommended storage information at https://www.medicines.org.uk

Reduce to 6 months from the date of exposure if stored up to 25°C or 3 months from the date of exposure if stored up to 40°C. For the 420mg strength reduce to 4 weeks from the date of exposure if stored less than 2°C.
Information not provided by the company
23 June 2020
London Medicines Information Service

Lactation Safety Information

No
No published evidence of safety
Serious adverse effects reported in adults
Low levels anticipated in milk due to the drug’s properties and likely to be degraded in infant’s GI tract. However, the effects on the infant of even small amounts in breast milk are unknown
16 September 2020

New Medicines

ZercepacHER2-positive breast cancer and metastatic HER2 positive gastroesophageal cancer

Information

Zercepac
Biosimilar
Accord Healthcare
Henlius

Development and Regulatory status

Launched
Launched
Phase III Clinical Trials
September 2020
Sep 20Launched in the UK [7].
Aug 20Zercepac licensed (EPAR on EMEA website) [6].
May 20Recommended for EU approval by CHMP - the full indications include metastatic and early breast cancer and metastatic gastric cancer as for the originator product [5].
Jun 19Henlius announces that the EMA has accepted for review the MAA for trastuzumab biosimilar HLX02 [1].

Category

Anti-HER2 monoclonal antibody
In 2012, the estimated age-adjusted annual incidence of breast cancer in 40 European countries was 94.2/100,000 and the mortality 23.1/100,000 [2]
HER2-positive breast cancer and metastatic HER2 positive gastroesophageal cancer
Intravenous infusion

Trial or other data

Nov 19HLX02 achieved similar overall response rate to reference trastuzumab in women with HER2+ recurrent or previously untreated metastatic breast cancer, according to a large, randomised phase III study to be reported at the ESMO Asia Congress 2019 [4].
Jun 19PIII trial NCT03084237 comparing HLX02 with Herceptin ongoing, recruiting completed [3].

Evidence based evaluations

trastuzumab biosimilar (EG12014)HER2-positive breast cancer

Information

trastuzumab biosimilar (EG12014)
Biosimilar
Sandoz
Sandoz

Development and Regulatory status

Phase III Clinical Trials
Phase III Clinical Trials
Phase III Clinical Trials

Category

Anti-HER2 monoclonal antibody
In 2012, the estimated age-adjusted annual incidence of breast cancer in 40 European countries was 94.2/100,000 and the mortality 23.1/100,000 [2]
HER2-positive breast cancer
Intravenous infusion

Trial or other data

Mar 21PIII trial NCT03433313 of EG12014 has met its primary endpoint, EG12014 has shown equivalent efficacy to Herceptin® in regards to its clinical response (pathologic complete response, pCR), in addition to demonstrating a comparable safety profile [4].
Jun 19PIII trial comparing EG12014 with Herceptin (NCT03433313), primary completion date Aug 2020 [3].