Perjeta

GENERIC AVAILABLE: No

Pertuzumab is a cancer medication that interferes with the growth and spread of cancer cells in the body.

Pertuzumab is used together with other cancer medicines (trastuzumab and docetaxel) to treat HER2-positive breast cancer.

Pertuzumab may also be used for purposes not listed in this medication guide.

Pertuzumab can cause birth defects or death to the unborn baby. Do not use if you are pregnant. Use effective birth control while you are using this medication.

Pertuzumab can cause life-threatening heart problems. Your heart function may need to be checked before you start using pertuzumab and during your treatment.

Call your doctor at once if you have shortness of breath (even with mild exertion), swelling, or rapid weight gain.

You should not use pertuzumab if you are allergic to it, or if you are pregnant or breast-feeding.

To make sure pertuzumab is safe for you, tell your doctor if you have:

• heart disease, congestive heart failure, heart rhythm disorder;
• untreated or uncontrolled high blood pressure (hypertension);
• if you have recently had a heart attack; or
• if you have ever had a radiation treatment in your chest area.

Do not use pertuzumab if you are pregnant. It can cause birth defects or death to the unborn baby. You may need to have a negative pregnancy test before starting this treatment.

Use effective birth control to prevent pregnancy while you are using pertuzumab and for at least 7 months after your last dose. This is especially important if you also use trastuzumab. Tell your doctor if you become pregnant during treatment or within 7 months after your treatment ends.

If you are pregnant, your name may be listed on a pregnancy registry. This is to track the outcome of the pregnancy and to evaluate any effects of pertuzumab on the baby.

It is not known whether pertuzumab passes into breast milk or if it could harm a nursing baby. You should not breast-feed while you are using pertuzumab.

Dosage Forms And Strengths

PERJETA (pertuzumab) 420 mg/14 mL (30 mg/mL) in a single-use vial

Storage And Handling

PERJETA is supplied as a 420 mg/14 mL (30 mg/mL) single-use vial containing preservativefree solution. NDC 50242-145-01.

Store vials in a refrigerator at 2°C to 8°C (36°F to 46°F) until time of use.

Keep vial in the outer carton in order to protect from light.

DO NOT FREEZE. DO NOT SHAKE.

Manufactured by: Genentech, Inc., A Member of the Roche Group, 1 DNA Way,  South San Francisco, CA 94080-4990. Revised: Mar 2016

You should not use pertuzumab if you are allergic to it, or if you are pregnant or breast-feeding.

To make sure you can safely receive pertuzumab, tell your doctor if you have any of these other conditions:

• heart disease;
• a heart rhythm disorder;
• congestive heart failure;
• untreated or uncontrolled high blood pressure (hypertension);
• if you have recently had a heart attack;
• if you have received a cancer medication such as doxorubicin (Adriamycin, Doxil), daunorubicin (Cerubidine, Daunoxome), epirubicin (Ellence), idarubicin (Idamycin), or valrubicin (Valstar); or
• if you have ever had a radiation treatment in your chest area.

FDA pregnancy category D. Do not use pertuzumab if you are pregnant. It can cause birth defects or death to the unborn baby. Use effective birth control, and tell your doctor if you become pregnant during treatment. Use effective birth control while you are using this medication and for at least 6 months after your treatment ends.

If you are pregnant, your name may be listed on a pregnancy registry. This is to track the outcome of the pregnancy and to evaluate any effects of pertuzumab on the baby.

It is not known whether pertuzumab passes into breast milk or if it could harm a nursing baby. You should not breast-feed while you are using pertuzumab.

Serious side effects can occur. See "Perjeta Precautions" section.

The most common side effects of Perjeta  when given with trastuzumab and docetaxel (chemotherapy) are:

• Diarrhea
• Hair loss
• Low levels of white blood cells with or without a fever
• Upset stomach
• Fatigue
• Rash
• Damage to the nerves (numbness, tingling, pain in hands/feet)

This is not a complete list of Perjeta side effects. Ask your doctor or pharmacist for more information.

Tell your doctor if you have any side effect that bothers you or that does not go away.

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

Before receiving Perjeta, tell your doctor if you:

• are allergic to Perjeta or any other medicines
• are pregnant or plan to become pregnant
• are breastfeeding or plan to breastfeed
• have heart disease

Tell your doctor what prescription medicines you take as well as non-prescription medicines, vitamin, and herbal supplements.

Perjeta comes as a solution to administer slowly into a vein (intravenous infusion).

The initial dose of Perjeta is 840 mg administered as a 60-minute intravenous infusion, followed every 3 weeks thereafter by 420 mg administered as a 30 to 60 minute intravenous infusion.

For metastatic breast cancer, Perjeta is injected every 3 weeks. 

For treatment for early stage breast cancer before surgery, Perjeta is injected every 3 weeks for 3 to 6 cycles. 

Pertuzumab is a cancer medication that interferes with the growth and spread of cancer cells in the body.

Pertuzumab is used together with other cancer medicines (trastuzumab and docetaxel) to treat HER2-positive breast cancer.

Pertuzumab may also be used for purposes not listed in this medication guide.

Since this medication is given by a healthcare professional in a medical setting, an overdose is unlikely to occur.

Specific Drugs

Absorption

Bioavailability

Steady-state concentrations achieved after first maintenance dose.1

Special Populations

Age, gender, or ethnicity (Japanese versus non-Japanese): No effects on pertuzumab pharmacokinetics.1 12

Baseline serum albumin concentration or lean body weight: Minor influence on pertuzumab pharmacokinetics.1 (See Special Populations under Dosage and Administration.)

Mild (Clcr of 60–90 mL/minute) or moderate (Clcr of 30–60 mL/minute) renal impairment: Systemic exposure is similar to that in patients with normal renal function.1 (See Renal Impairment under Dosage and Administration.)

Severe renal impairment (Clcr <30 mL/minute): Limited data.1

No relationship between Clcr and pertuzumab exposure observed over Clcr range of 27–244 mL/minute.1

Elimination

Half-life

Median half-life: 18 days.1

WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:

• Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
• Signs of infection like fever, chills, very bad sore throat, ear or sinus pain, cough, more sputum or change in color of sputum, pain with passing urine, mouth sores, or wound that will not heal.
• Chest pain or pressure or a fast heartbeat.
• Very bad headache.
• Very upset stomach or throwing up.
• Very loose stools (diarrhea).
• Any unexplained bruising or bleeding.
• Feeling very tired or weak.
• A burning, numbness, or tingling feeling that is not normal.

• If you need to store Perjeta at home, talk with your doctor, nurse, or pharmacist about how to store it.

Perjeta (pertuzumab) is a cancer medication that interferes with the growth and spread of cancer cells in the body.

Perjeta is used together with other cancer medicines (trastuzumab and docetaxel) to treat HER2-positive breast cancer.

Perjeta may also be used for purposes not listed in this medication guide.

Usual Adult Dose for Breast Cancer:

Metastatic Breast Cancer:
The initial dose of pertuzumab is 840 mg intravenously administered as a 60 minute infusion, followed every 3 weeks with 420 mg intravenously over 30 to 60 minutes.

When administered with Perjeta, the recommended initial dose of trastuzumab is 8 mg/kg intravenously over 90 minutes, followed every 3 weeks with 6 mg/kg intravenously over 30 to 90 minutes.

When administered with Perjeta, the recommended initial dose of docetaxel is 75 mg/m2 intravenously. The dose may be escalated to 100 mg/m2 administered every 3 weeks if the initial dose is well tolerated.

Neoadjuvant Therapy:
840 mg intravenously, followed by 420 mg intravenously every 3 weeks with trastuzumab and docetaxel for 3 to 6 cycles. Refer to manufacturer's product information for complete dosing information on all concomitant treatment medications.

Pertuzumab can pass into body fluids (urine, feces, vomit). For at least 48 hours after you receive a dose, avoid allowing your body fluids to come into contact with your hands or other surfaces. Caregivers should wear rubber gloves while cleaning up a patient's body fluids, handling contaminated trash or laundry or changing diapers. Wash hands before and after removing gloves. Wash soiled clothing and linens separately from other laundry.

Applies to pertuzumab: intravenous solution

Cardiovascular

Common (1% to 10%): Left ventricular dysfunction (including congestive heart failure)[Ref]

Dermatologic

Very Common (10% or more): Alopecia (up to 61%), rash (up to 34%), nail disorder (up to 23%), pruritus (up to 14%)
Common (1% to 10%): Dry skin, palmar-plantar erythrodysesthesia syndrome[Ref]

Gastrointestinal

Very common (10% or more): Diarrhea (up to 67%), nausea (up to 42%), mucositis/mucosal inflammation (up to 28%), constipation (up to 25%), vomiting (up to 24%), stomatitis (up to 19%), dyspepsia (up to 12%)[Ref]

Hematologic

Very common (10% or more): Neutropenia (up to 53%), anemia (up to 23%), leucopenia (up to 20%), febrile neutropenia (up to 13%)[Ref]

Hypersensitivity

Very common (10% or more): Hypersensitivity/anaphylactic reaction, infusion reaction/cytokine release syndrome[Ref]

Metabolic

Very common (10% or more): Decreased appetite (up to 29%)[Ref]

Musculoskeletal

Very common (10% or more): Myalgia (up to 24%), arthralgia (up to 15%), pain in extremity (up to 15%)[Ref]

Nervous system

Very common (10% or more): Peripheral neuropathy (up to 21%), headache (up to 21%), dysgeusia (up to 18%), peripheral sensory neuropathy (up to 14%), dizziness (up to 13%)[Ref]

Ocular

Very common (10% or more): Increased lacrimation (up to 14%)[Ref]

Psychiatric

Very common (10% or more): Insomnia (up to 13%)[Ref]

Respiratory

Very common (10% or more): Cough (up to 21%), upper respiratory tract infection (up to 17%), dyspnea (up to 16%), nasopharyngitis (up to 13%)
Common (1% to 10%): Paronychia, pleural effusion, epistaxis
Uncommon (0.1% to 1%): Interstitial lung disease[Ref]

Other

Very common (10% or more): Fatigue (up to 38%), peripheral edema (up to 30%), asthenia (up to 30%), pyrexia (up to 19%), pain
Common (1% to 10%): Chills[Ref]

Some side effects of Perjeta may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.