Applies to hyaluronidase / pertuzumab / trastuzumab: subcutaneous solution.

Serious side effects

Along with its needed effects, hyaluronidase / pertuzumab / trastuzumab may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor or nurse immediately if any of the following side effects occur while taking hyaluronidase / pertuzumab / trastuzumab:

More common

• Black, tarry stools
• bladder pain
• bleeding, blistering, burning, coldness, discoloration of the skin, 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

Other side effects

Some side effects of hyaluronidase / pertuzumab / trastuzumab may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may 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 or 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

For Healthcare Professionals

Applies to hyaluronidase / pertuzumab / trastuzumab: subcutaneous solution.

Hematologic

Very common (10% or more): Hemoglobin low (90%), absolute lymphocytes low (89%), leukocyte count low (82%), neutrophils low (68%), anemia (36%), platelets low (27%), neutropenia (22%)

Common (1% to 10%): Leukopenia, febrile neutropenia^[Ref]

Hypersensitivity

Common (1% to 10%): Hypersensitivity^[Ref]

Immunologic

Common (1% to 10%): Influenza-like illness^[Ref]

Local

Very common (10% or more): Radiation skin injury (19%), injection site reaction (15%), procedural pain (13%)

Common (1% to 10%): Injection site pain^[Ref]

Musculoskeletal

Very common (10% or more): Myalgia (25%), arthralgia (24%), pack pain (10%)

Common (1% to 10%): Bone pain, pain in extremity, muscle spasms, musculoskeletal pain^[Ref]

Ocular

Common (1% to 10%): Lacrimation increased, dry eye^[Ref]

Metabolic

Very common (10% or more): Decreased appetite (17%), potassium low (17%), albumin low (16%), potassium high (13%), sodium low (13%), weight loss (11%)

Common (1% to 10%): Hypokalemia, glucose low, sodium high^[Ref]

Psychiatric

Very common (10% or more): Insomnia (17%)^[Ref]

Genitourinary

Common (1% to 10%): Urinary tract infection^[Ref]

Hepatic

Very common (10% or more): Alanine aminotransferase high (58%), aspartate aminotransferase high (50%)

Common (1% to 10%): Bilirubin high

Respiratory

Very common (10% or more): Cough (15%), epistaxis (12%), upper respiratory infection (11%), dyspnea (10%)

Common (1% to 10%): Rhinorrhea, nasopharyngitis, paronychia

Frequency not reported: Dyspnea, interstitial pneumonitis, pulmonary infiltrates, pleural effusions, non-cardiogenic pulmonary edema, pulmonary insufficiency/hypoxia, acute respiratory distress syndrome, pulmonary fibrosis, exacerbation of chemotherapy-induced neutropenia^[Ref]

Other

Very common (10% or more): Asthenia (31%), fatigue (29%), pyrexia (13%)

Common (1% to 10%): Edema peripheral, malaise

Frequency not reported: Embryofetal toxicity^[Ref]

Nervous system

Very common (10% or more): Dysgeusia (17%), headache (17%), peripheral sensory neuropathy (16%), peripheral neuropathy (12%), dizziness (13%), paresthesia (10%)^[Ref]

Renal

Very common (10% or more): Creatinine high (84%)^[Ref]

Cardiovascular

Very common (10% or more): Hot flush (12%), left ventricular cardiac dysfunction (LVEF)

Common (1% to 10%): Ejection fraction decreased

Frequency not reported: Hypertension, arrhythmias, left ventricular cardiac dysfunction, disabling cardiac failure, cardiomyopathy, cardiac death^[Ref]

Dermatologic

Very common (10% or more): Alopecia (77%), rash (16%), dry skin (15%)

Common (1% to 10%): Nail discoloration, erythema, dermatitis, nail disorder, palmar-plantar erythrodysesthesia syndrome

Uncommon (0.1% to 1%): Pruritus^[Ref]

Gastrointestinal

Very common (10% or more): Nausea (60%), diarrhea (60%), stomatitis (25%), constipation (22%), vomiting (20%), mucosal inflammation (15%), dyspepsia (14%)

Common (1% to 10%): Hemorrhoids, abdominal pain, abdominal pain upper^[Ref]