TM Owner Roche / Genentech
Phesgo SC 1200mg/600mg Subcutaneous Injection
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Indications & Clinical Uses
- 'Phesgo SC' is not a separate registered brand name - no product under this exact name appears on DailyMed, FDA, or EMA records; only 'Phesgo' exists.
- Phesgo IS the subcutaneous (SC) fixed-dose combination of pertuzumab, trastuzumab and hyaluronidase-zzxf - subcutaneous delivery is the entire basis of the brand, not a variant of it, so this row appears to duplicate row 'Phesgo' in this batch under a modified label.
- This information describes the actual product, Phesgo.
- It is used in adults with HER2-positive breast cancer for neoadjuvant treatment (before surgery), adjuvant treatment (after surgery) of high-risk early disease, and first-line metastatic treatment with docetaxel.
- It is given only by a healthcare professional in a hospital or clinic setting - never self-injected. (The corresponding intravenous originator products are Perjeta [pertuzumab] and Herceptin [trastuzumab], each a separate medicine.)
Side Effects
- The most common Phesgo (marketed under this row as 'Phesgo SC') side effects (affecting 30% or more of patients) are hair loss, diarrhoea, nausea, fatigue, anaemia and administration-site reactions such as pain or redness (up to 15%).
- Phesgo (marketed under this row as 'Phesgo SC') carries THREE BOXED WARNINGS.
- Cardiomyopathy: it can cause subclinical and clinical heart failure, with the highest risk when combined with anthracycline chemotherapy - heart function is checked before treatment and monitored regularly throughout.
- Embryo-fetal toxicity: Phesgo (marketed under this row as 'Phesgo SC') can cause fetal harm or death, including oligohydramnios with lung and skeletal problems in the baby, if used during pregnancy.
- Infusion-related and pulmonary toxicity: severe, sometimes fatal reactions - including anaphylaxis and lung problems such as interstitial pneumonitis - can occur, and treatment is stopped immediately if they do.
- You are observed for 30 minutes after the first dose and 15 minutes after later doses; report breathlessness, chest pain or leg swelling to your care team at once.
Precautions & Warnings
- Before starting Phesgo and periodically during treatment, your heart function (left ventricular ejection fraction) is checked, especially if you have previously had anthracycline chemotherapy, because of the boxed warning on cardiomyopathy.
- Phesgo must be avoided in pregnancy: women of childbearing potential need a pregnancy test before starting and must use effective contraception during treatment and for 7 months after the last dose, reflecting the boxed embryo-fetal toxicity warning.
- Breastfeeding is not recommended during treatment and for 7 months afterward.
- Phesgo is given only as a subcutaneous injection into the thigh by a healthcare professional - it must never be given intravenously or by the patient at home.
- Treatment is stopped immediately for signs of anaphylaxis, angioedema, or severe pulmonary toxicity.
- Use with caution if you have pre-existing lung disease, and keep all scheduled cardiac-monitoring appointments.
Avoid Interactions
- No formal pharmacokinetic drug-interaction studies have been conducted with the pertuzumab and trastuzumab components of Phesgo.
- Combining Phesgo with anthracycline chemotherapy drugs such as doxorubicin substantially increases the cardiotoxicity risk described in the boxed warning, and this combination is generally avoided outside of clinical trials.
- Because Phesgo is usually given alongside other chemotherapy, and chemotherapy causes immunosuppression, discuss any live vaccines with your care team before receiving them during treatment.
- Tell your healthcare provider about every other medicine, chemotherapy agent, and supplement you are taking before each dose.
- Phesgo must not be mixed or diluted with other medicines, and is administered only by trained staff using the specific subcutaneous delivery device.
References
Frequently Asked Questions
'Phesgo SC' and 'Phesgo' are the same medicine - Phesgo is only available as a subcutaneous (SC) injection. It combines pertuzumab and trastuzumab to treat HER2-positive breast cancer before surgery, after surgery, or with metastatic disease.
Phesgo SC is injected under the skin of the thigh by a healthcare professional: an 8-minute first dose, then a 5-minute maintenance dose every 3 weeks, always given in a clinic or hospital, never at home.
Phesgo SC carries boxed warnings for heart failure, harm to an unborn baby in pregnancy, and severe infusion or lung reactions. Heart function is monitored before and throughout treatment because of the cardiac risk.
Avoid pregnancy during Phesgo SC treatment and for 7 months after the last dose. Combining it with anthracycline chemotherapy increases the risk of heart failure and is generally avoided.
You receive the subcutaneous injection in your thigh, then are observed for 30 minutes after the first dose (15 minutes after later doses) for signs of a severe reaction, with regular heart-function checks.
No - they are the same product. Phesgo is approved only in a subcutaneous form, so there is no separate intravenous 'Phesgo' to distinguish it from; treat any 'Phesgo SC' listing as referring to standard Phesgo.
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