Page 27 - PHESGO (PERTUZUMAB-TRASTUZUMAB) - Product Monograph

anaphylaxis or severe injection-related reactions. Medications to treat such reactions, as well as emergency equipment, should be available for
immediate use. Drug Interactions: Patients who receive anthracycline after stopping Phesgo may be at increased risk of cardiac dysfunction because
of Phesgo’s long washout period. If possible, avoid anthracycline-based therapy for up to 7 months after stopping Phesgo. If anthracyclines are used,
carefully monitor the patient’s cardiac function.
Use in Special Populations:
Females and Males of Reproductive Potential. Phesgo can cause embryo-fetal harm when administered during pregnancy. Verify the pregnancy
status of females of reproductive potential prior to the initiation of Phesgo. Advise females of reproductive potential to use effective contraception
during treatment and for 7 months following the last dose of Phesgo. If Phesgo is administered during pregnancy, or if a patient becomes pregnant
while receiving Phesgo or within 7 months following the last dose of Phesgo, report exposure details by e-mail: dubai.drug_safety@roche.com or
mobile: 00971544409415. Lactation: There is no information regarding the presence of pertuzumab, trastuzumab or hyaluronidase in human milk, the
effects on the breastfed infant, or the effects on milk production. Consider the developmental and health benefits of breastfeeding along with the
mother’s clinical need for Phesgo treatment and any potential adverse effects on the breastfed child from Phesgo or from the underlying maternal
condition. This consideration should also take into account the elimination half-life of pertuzumab and the trastuzumab wash out period of 7 months.
Pediatric Use: The safety and effectiveness of Phesgo in pediatric patients have not been established. Geriatric Use: Clinical studies of Phesgo did not
include sufficient numbers of patients age 65 years and older to determine whether they respond differently from younger patients.In the intravenous
trastuzumab trials, the risk of cardiac dysfunction was increased in geriatric patients as compared to younger patients, in both those receiving
treatment for adjuvant therapy or metastatic disease. In the intravenous pertuzumab in combination with trastuzumab trials, the risk of decreased
appetite, anemia, weight decreased, asthenia, dysgeusia, neuropathy peripheral and hypomagnesemia was increased in patients 65 years of age and
older compared to patients less than 65 years of age.
Adverse Reactions:
The most common adverse reactions with Phesgo were alopecia, nausea, diarrhea, anemia, and asthenia. The most common adverse reactions with
pertuzumab in combination with trastuzumab and docetaxel were diarrhea, alopecia, neutropenia, nausea, fatigue, rash, and peripheral neuropathy
Mode of Prescription: POM

Presentation:
•1200mg pertuzumab/600 mg trastuzumab/30000U hyaluronidase 15 mL solution in a vial
• 600 mg pertuzumab/600 mg trastuzumab/20000U hyaluronidase 10 mL solution in a vial
Excipients: L-histidine, L-histidine hydrochloride monohydrate, α,α-trehalose dihydrate, sucrose, polysorbate 20, L-methionine, water for injection
Marketing Authorization Holder: F. Hoffmann-La Roche Ltd, Basel, Switzerland.
PI version date: Jun 2020

Date of preparation: 10 Feb 2021
Full prescribing information is available upon request. In case of any adverse event occurring with Phesgo please forward details to e-mail:
dubai.drug_safety@roche.com Mobile: 00971544409415
Roche Pharmaceuticals Middle East FZCO- Dubai Branch P.O. Box 27309 Dubai, UAE, Tel: +97148164800, Fax: +97148800212, www.roche.com
If a patient becomes pregnant while receiving PHESGO, or within 7 months following the last dose of PHESGO, please immediately report pregnancy
to the local Roche Adverse Event Line dubai.drug_safety@roche.com Mobile: 00971544409415. Additional information will be requested during a
PHESGO-exposed pregnancy and the first year of the infant’s life. This will enable Roche to better understand the safety of PHESGO and to provide
appropriate information to health authorities, healthcare providers, and patients. For additional information, please refer to the PHESGO local PI

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