ed. Patients experiencing infusion-related symptoms should be advised not to drive and use machines until symptoms abate.
4.8 Undesirable effects
Amongst the most serious and/or common adverse reactions reported in Herceptin usage to date are cardiotoxicity, infusion-related reactions, haematotoxicity (in particular neutropenia) and pulmonary adverse events.
In this section, the following categories of frequency have been used: very common (1/10), common (1/100 to <1/10), uncommon (1/1,000 to <1/100), rare (1/10,000 to <1/1,000), very rare (<1/10,000), not known (cannot be estimated from the available data). Within each frequency grouping, adverse reactions should be presented in order of decreasing seriousness.
List of adverse reactions
Presented in the following table are adverse reactions that have been reported in association with the use of Herceptin alone or in combination with chemotherapy in pivotal clinical trials and in the post-marketing setting. Pivotal trials included:
- H0648g and H0649g: Herceptin as a monotherapy or in combination with paclitaxel in metastatic -breast cancer.
- M77001: Docetaxel, with or without Herceptin in metastatic breast cancer.
- BO16216: Anastrozole with or without Herceptin in HER2 positive and hormone receptor positive metastatic breast cancer.
- BO16348: Herceptin as a monotherapy following adjuvant chemotherapy in HER2 positive breast cancer.
- BO18255: Herceptin in combination with a fluoropyrimidine and cisplatin versus chemotherapy alone as first-line therapy in HER2 positive advanced gastric cancer.
- B-31, N9831: Herceptin administered sequential to adjuvant chemotherapy with doxorubicin and cyclophosphamide, in combination with paclitaxel.
- BCIRG 006: Herceptin administered sequential to adjuvant chemotherapy with doxorubicin and cyclophosphamide, in combination with docetaxel or Herceptin administered in combination with adjuvant chemotherapy consisting of docetaxel and carboplatin.
All the terms included are based on the highest percentage seen in pivotal clinical trials.
|
System organ class
|
Adverse reaction
|
Frequency
|
|
Infections and infestations
|
+Pneumonia
|
Common (<1 %)
|
|
Neutropenic sepsis
|
Common
|
|
Cystitis
|
Common
|
|
Herpes zoster
|
Common
|
|
Infection
|
Common
|
|
Influenza
|
Common
|
|
Nasopharyngitis
|
Common
|
|
Sinusitis
|
Common
|
|
Skin infection
|
Common
|
|
Rhinitis
|
Common
|
|
Upper respiratory tract infection
|
Common
|
|
Urinary tract infection
|
Common
|
|
Erysipelas
|
Common
|
|
Cel |
|
