Pertuzumab, trastuzumab, and hyaluronidase-zzxf (Subcutaneous)

Pertuzumab, trastuzumab, and hyaluronidase-zzxf combination injection is used first with other cancer medicines to treat HER2-positive, locally advanced, inflammatory, or early stage breast cancer (either greater than 2 centimeters in diameter or node positive) as part of a complete treatment plan for early breast cancer. It is also used after an initial treatment plan to treat HER2-positive early breast cancer that has a high risk of coming back.

Pertuzumab, trastuzumab, and hyaluronidase-zzxf combination injection is also used with docetaxel to treat HER2-positive metastatic (cancer that has spread) breast cancer in patients who have not received any cancer treatment before.

Pertuzumab, trastuzumab, and hyaluronidase-zzxf combination prevents the growth of some tumors that make extra amounts of a substance called the HER2 protein. It should only be used in patients whose tumors have been shown to make extra amounts of this protein (HER2 overexpression).

This medicine is to be given only by or under the direct supervision of your doctor.

It is very important that your doctor checks your progress closely and at regular visits to make sure this medicine is working properly. Blood and urine tests may be needed to check for unwanted effects.

Receiving this medicine while you are pregnant can harm your unborn baby. If you are a woman who can bear children, your doctor may give you a pregnancy test before you start receiving this medicine to make sure you are not pregnant. You should use an effective form of birth control during treatment and for at least 7 months after the last dose. If you think you have become pregnant while receiving this medicine, tell your doctor right away.

This medicine may cause heart problems, including heart failure, thickening of the heart, heart rhythm problems, or high blood pressure. Your doctor may test your heart before and during treatment with this medicine. Contact your doctor right away if you experience any chest pain, fast, slow, or uneven heartbeat, increased coughing, trouble with breathing, a sudden difficulty with breathing at night, rapid weight gain, swelling in your ankles or legs, blurred vision, dizziness, or headache.

You may also have an increased risk of having heart problems if you receive an anthracycline medicine after treatment with this medicine. You should not receive an anthracycline medicine for up to 7 months after stopping treatment with this medicine.

Serious lung or breathing problems may occur after you receive this medicine and could be life-threatening. Check with your doctor right away if you have changes in your breathing, chest tightness, or any type of breathing problem.

This medicine can temporarily lower the number of some types of blood cells in your body. Because of this, you may bleed or get infections more easily. To help with these problems, avoid being near people who are sick or have infections. Wash your hands often. Stay away from rough sports or other situations where you could be bruised, cut, or injured. Brush and floss your teeth gently. Be careful when using sharp objects, including razors and fingernail clippers.

This medicine may cause serious allergic reactions, including anaphylaxis, which can be life-threatening and requires immediate medical attention. Tell your doctor right away if you have a rash, itching, hoarseness, trouble breathing or swallowing, or any swelling of your hands, face, or mouth after receiving this medicine.

In deciding to use a medicine, you and your doctor will consider the risks of the medicine compared to its benefits. For this medicine, keep the following in mind:

Allergies

Inform your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also, let your healthcare professional know if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients closely.

Pediatric

There have not been appropriate studies on how age affects the use of pertuzumab, trastuzumab, and hyaluronidase-zzxf combination injection in children. Safety and effectiveness have not been established.

Geriatric

So far, studies have not shown any specific problems in elderly patients that would limit the use of pertuzumab, trastuzumab, and hyaluronidase-zzxf combination injection in older adults. However, older patients are more likely to have heart problems and other unwanted effects related to age (like decreased appetite and weight, burning, numbness, tingling, or pain in the skin, and loss of strength), which may require caution when using this medicine.

Breast Feeding

There are not enough studies in women to determine the risk to infants when using this medication while breastfeeding. Weigh the possible benefits against the potential risks before taking this medicine while breastfeeding.

Interactions with Medicines

Some medicines should not be taken together at all. In some cases, two different medicines can be used together, even if an interaction might happen. In these situations, your doctor may adjust the dose or take other precautions. It is particularly important for your healthcare professional to know if you are taking any of the medicines listed below while receiving this medicine. The following interactions are based on their potential significance and may not include all possibilities.

Using this medicine with any of the following is usually not recommended, but may be necessary in some cases. If both are prescribed, your doctor may adjust the dose or frequency of one or both medicines.

• Daunorubicin
• Daunorubicin Citrate Liposome
• Daunorubicin Liposome
• Doxorubicin
• Doxorubicin Hydrochloride Liposome
• Epirubicin
• Idarubicin
• Pirarubicin
• Pixantrone
• Valrubicin

Using this medicine with any of the following medicines may increase the risk of certain side effects, but it may be necessary to use both for your treatment. If both are prescribed, your doctor may adjust the dose or frequency of one or both medicines.

• Warfarin

Interactions with Food/Tobacco/Alcohol

Some medicines should not be used at the same time as eating food or certain types of food due to possible interactions. Using alcohol or tobacco with some medicines can also lead to interactions. Discuss with your healthcare professional about using your medicine with food, alcohol, or tobacco.

Other Medical Problems

Having other medical conditions may impact the use of this medicine. Be sure to inform your doctor if you have any other medical issues, especially:

• Heart disease or
• Lung disease (such as a lung tumor) or
• Neutropenia (low white blood cell count)—Use with caution. This may worsen these conditions.

Along with its needed effects, a medicine may cause some unwanted effects. Not all of these side effects may happen, but if they do, they might need medical attention.

Check with your doctor or nurse right away if any of the following side effects occur:

More common

• Black, tarry stools
• Bladder pain
• Bleeding, blistering, burning, coldness, skin discoloration, feeling of pressure, hives, infection, inflammation, itching, lumps, numbness, pain, rash, redness, scarring, soreness, stinging, swelling, tenderness, tingling, ulceration, or warmth at the injection site
• Bloody or cloudy urine
• Body aches or pain
• Burning, crawling, itching, numbness, prickling, "pins and needles," or tingling feelings
• Chest pain or tightness
• Chills
• Cough
• Cracked lips
• Decreased urine
• Diarrhea
• Difficult, burning, or painful urination
• Difficult or labored breathing
• Difficulty swallowing
• Dry mouth
• Ear congestion
• Fever
• Frequent urge to urinate
• General feeling of discomfort or illness
• Headache
• Increased thirst
• Irregular heartbeat
• Joint pain
• Lack or loss of strength
• Loss of appetite
• Loss of voice
• Lower back or side pain
• Mood changes
• Muscle pain or cramps
• Nausea
• Nosebleed
• Numbness or tingling in the hands, feet, or lips
• Pale skin
• Redness, swelling, pain of the skin
• Runny or stuffy nose
• Scaling of the skin on the hands and feet
• Seizures
• Shivering
• Sneezing
• Sore throat
• Sores, ulcers, or white spots on the lips, tongue, or inside the mouth
• Sweating
• Swelling of the hands, ankles, feet, or lower legs
• Trouble sleeping
• Unusual bleeding or bruising
• Unusual tiredness or weakness
• Vomiting

Less common

• Dizziness
• Itching, skin rash

Rare

• Chest discomfort
• Dilated neck veins
• Thickening of bronchial secretions
• Weight gain

Incidence not known

• Agitation
• Bleeding gums
• Confusion
• Decreased awareness or responsiveness
• Depression
• Hostility
• Irritability
• Joint stiffness or swelling
• Loss of consciousness
• Lower back, side, or stomach pain
• Mood or mental changes
• Muscle twitching
• Pinpoint red spots on the skin
• Severe sleepiness
• Stomach cramps
• Tremor
• Unusual drowsiness, dullness, or feeling of sluggishness

Some side effects may happen that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Your health care professional may also be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue, are bothersome, or if you have any questions about them:

More common

• Belching
• Bleeding after defecation
• Bone pain
• Change in or loss of taste
• Constipation
• Difficulty in moving
• Discoloration of the nails
• Dry eye or skin
• Feeling of warmth
• Heartburn
• Increased tearing of the eye
• Indigestion
• Pain and redness of the skin at the place of radiation treatment
• Redness of the face, neck, arms, and occasionally, upper chest
• Stomach discomfort or upset
• Thinning or loss of hair
• Uncomfortable swelling around the anus

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

In the U.S.

• Phesgo

Available Dosage Forms:

• Solution

Therapeutic Class: Antineoplastic Agent

Pharmacologic Class: Monoclonal Antibody

Find detailed information on biosimilars for this medication.

Medicines used to treat cancer are very strong and can have many side effects. Before receiving this medicine, make sure you understand all the risks and benefits. It is important for you to work closely with your doctor during your treatment.

A doctor or other trained health professional will give you this medicine in a medical facility. It is given as a shot under the skin of your thigh for at least 8 minutes for the initial dose then for at least 5 minutes once every 3 weeks.

Your doctor may want you stay for at least 15 to 30 minutes after each injection to check for unwanted effects.

You may also receive other medicines (including allergy medicine, fever medicine, pain medicine) before starting treatment with this medicine to help prevent unwanted effects.

Missed Dose

This medicine needs to be given on a fixed schedule. If you miss a dose, call your doctor, home health caregiver, or treatment clinic for instructions.