Atezolizumab / Hyaluronidase Side Effects

Applies to atezolizumab / hyaluronidase: subcutaneous solution.

Important warnings This medicine can cause some serious health issues

Atezolizumab and hyaluronidase affects your immune system and may cause it to attack normal healthy tissues or organs, leading to serious or life-threatening medical problems.

Call your doctor at once if you have new or worsening symptoms such as: chest pain, cough, breathing problems, stomach pain, vomiting, changes in appetite or weight, increased thirst or urination, painful urination, headaches, neck stiffness, vision problems, tiredness, mood changes, muscle weakness, hair loss, feeling cold, bleeding or bruising, diarrhea, bloody or tarry stools, dark urine, or yellowing of the skin or eyes.

Get emergency medical help if you have signs of an allergic reaction (hives, difficult breathing, swelling in your face or throat) or a severe skin reaction (fever, sore throat, burning eyes, skin pain, red or purple skin rash with blistering and peeling).

Some side effects may occur during the injection. Tell your medical caregivers if you feel dizzy, nauseated, light-headed, itchy, sweaty, or have a headache, chest tightness, back pain, trouble breathing, or swelling in your face.

Call your doctor at once if you have:

• new or worsening cough, shortness of breath;

• chest pain, irregular heartbeats;

• severe stomach pain, nausea, vomiting, diarrhea, bloody or tarry stools;

• kidney problems--urinating less, blood in your urine, loss of appetite, swelling in your ankles;

• liver problems--right-sided upper stomach pain, drowsiness, easy bruising or bleeding, dark urine, jaundice (yellowing of the skin or eyes);

• skin problems--itching, fever, flu-like symptoms, swollen lymph nodes, painful sores or ulcers in mouth, nose, throat, or genital area;

• nervous system problems--neck stiffness, increased sensitivity to light, confusion, memory problems, problems with balance, severe muscle weakness, muscle cramps, numbness or tingling in your hands or feet, vision problems, eye pain or redness;

• low red blood cells (anemia)--pale skin, unusual tiredness, feeling light-headed or short of breath, cold hands and feet;

• signs of infection--fever, flu symptoms, cough, back pain, painful or frequent urination; or

• signs of a hormonal disorder--frequent or unusual headaches, extreme tiredness, dizziness or fainting, mood or behavior changes, hoarse or deepened voice, increased hunger or thirst, increased urination, constipation, hair loss, feeling cold, weight gain, or weight loss.

Your cancer treatments may be delayed or permanently discontinued if you have certain side effects.

Common side effects may include:

• anxiety;

• diarrhea, constipation, nausea, vomiting, loss of appetite;

• bleeding;

• fever, infections;

• cough, feeling short of breath;

• liver problems;

• mouth sores or swelling;

• irregular heartbeats, high blood pressure, abnormal blood or urine tests;

• headache, tiredness, weakness

• joint, muscle, or bone pain;

• numbness, pain or tingling in your hands or feet;

• swelling in your legs or arms;

• rash, itching, sunburn or being more sensitive to sunlight; or

• hair loss.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects.

For healthcare professionals

Applies to atezolizumab / hyaluronidase: subcutaneous solution.

General adverse events

Adverse reactions described here are compiled from clinical studies across all indications in which atezolizumab was administered IV or subcutaneously as monotherapy or in combination with other therapies.

The most common adverse effects occurring in 60% of patients or greater across all studies and formulations were rash, anemia, decreased lymphocytes, decreased hemoglobin, neutropenia, thrombocytopenia, lymphopenia, decreased platelets, decreased albumin, increased AST/ALT, neutralizing antibodies, hyperglycemia, decreased phosphorus, musculoskeletal pain/myalgia, increased creatine kinase, increased triacylglycerol lipase, increased alkaline phosphatase, and fatigue/asthenia.^[Ref]

Cardiovascular

• Very common (10% or more): Hypertension/hypertensive crisis (up to 30%), arrhythmia (up to 22%)
• Frequency not reported: Decreased ejection fraction, prolonged electrocardiogram QT, pericarditis, pericardial effusion, cardiac tamponade

Arrhythmia includes atrial fibrillation, sinus bradycardia, ventricular tachycardia, and sinus tachycardia.

Dermatologic

• Very common (10% or more): Rash (up to 75%), alopecia (up to 48%), pruritus (up to 26%), photosensitivity reaction (up to 21%)

Rash includes dermatitis, genital rash, skin exfoliation, maculo-papular rash, erythematous rash, papular rash, lichen planus, eczema asteatotic, exfoliative dermatitis, palmar-plantar erythrodysesthesia syndrome, dyshidrotic eczema, eczema, drug eruption, pruritic rash, toxic skin eruption, dermatitis acneiform, and pemphigoid.

Endocrine

• Very common (10% or more): Decreased thyroid stimulating hormone ([TSH]; up to 38%), increased TSH (up to 37%), increased triiodothyronine (up to 33%), increased free thyroxine (up to 32%), decreased total triiodothyronine (up to 32%), decreased triiodothyronine (up to 27%), hypothyroidism (up to 25%), hyperthyroidism (up to 18%)
• Frequency not reported: Vitiligo

Gastrointestinal

• Very common (10% or more): Increased amylase (up to 51%), nausea (up to 50%),diarrhea/colitis/enteritis (up to 43%), decreased amylase (up to 40%), vomiting (up to 37%), constipation (up to 36%), abdominal pain (up to 25%), stomatitis (up to 23%)

Stomatitis includes mucosal inflammation, aphthous ulcer, mouth ulceration, cheilitis and glossitis.

Hematologic

• Very common (10% or more): Anemia (up to 94%), decreased lymphocytes (up to 80%), decreased hemoglobin (up to 77%), neutropenia (up to 75%), thrombocytopenia (up to 73%), lymphopenia (up to 71%), decreased platelets (up to 68%), decreased albumin (up to 60%), hypoalbuminemia (up to 48%), decreased leukocytes (up to 32%), hemorrhage (up to 29%), increased platelets (up to 29%), decreased neutrophil (up to 26%), increased INR (up to 20%)
• Frequency not reported: Allogeneic hematopoietic stem cell transplant complications (HSCT)

Hemorrhage includes pulmonary hemorrhage, hemoptysis, conjunctival hemorrhage, epistaxis, hematuria, rectal hemorrhage, and laryngeal hemorrhage.

Fatal and other serious complications can occur in patients who receive allogeneic HSCT before or after being treated with a PD-1/PD-L1 blocking antibody.

Hepatic

• Very common (10% or more): Increased AST (up to 86%), increased ALT (up to 79%), increased bilirubin (up to 57%), hepatotoxicity (up to 50%)

Hepatoxicity includes increased ALT/AST, increased bilirubin, hepatitis, increased hepatic enzyme, hepatocellular injury, hyperbilirubinemia, increased/abnormal liver function test increased, hepatic failure, and fulminant hepatitis.

Immunologic

• Very common (10% or more): Neutralizing antibodies (up to 83%), anti-atezolizumab antibodies (up to 36%)
• Common (1% to 10%): Anti-rHuPH20 antibodies

Local

• Very common (10% or more): Infusion-related reaction (up to 11%)
• Common (1% to 10%): Injection site reactions

Metabolic

• Very common (10% or more): Hyperglycemia (up to 75%), decreased phosphorus (up to 67%), sodium (up to 54%), hypomagnesemia (up to 50%), increased glucose (up to 48%), decreased calcium (up to 47%), hyponatremia (up to 44%), decreased potassium (up to 36%), decreased glucose (up to 33%), decreased appetite (up to 30%), increased potassium (up to 29%), hyperkalemia (up to 29%), increased magnesium (up to 26%), decreased fasting glucose (up to 25%), increased calcium (up to 25%), hypophosphatemia (up to 25%), hyperphosphatemia (up to 25%), decreased hypocalcemia (up to 24%), decreased magnesium (up to 21%)

Musculoskeletal

• Very common (10% or more): Musculoskeletal pain/myalgia (up to 67%), arthralgia/arthritis (up to 26%)

Musculoskeletal pain/myalgia includes bone pain, back pain, spinal pain, musculoskeletal chest pain, pain in extremity, neck pain, non-cardiac chest pain, musculoskeletal discomfort, and musculoskeletal stiffness.

Nervous system

• Very common (10% or more): Peripheral neuropathy (up to 56%), headache (up to 43%), dizziness (up to 29%)
• Frequency not reported: Dysgeusia, syncope

Peripheral neuropathy includes paraesthesia, peripheral sensory neuropathy, hypoesthesia, polyneuropathy, dysesthesia, neuralgia, and axonal neuropathy.

Ocular

• Frequency not reported: Uveitis

Other

• Very common (10% or more): Increased creatine kinase (up to 88%), increased triacylglycerol lipase (up to 75%), increased alkaline phosphatase (up to 73%), fatigue/asthenia (up to 61%), pyrexia/increased body temperature (up to 57%), edema (up to 26%), decreased weight (up to 18%), influenza-like illness (up to 18%), increased weight (up to 16%)

Edema includes peripheral edema, lymphoedema, face edema, eyelid edema, periorbital edema, lip edema and generalized edema.

Psychiatric

• Very common (10% or more): Insomnia (up to 27%), anxiety (up to 25%)

Renal

• Very common (10% or more): Increased blood urea nitrogen (up to 52%), increased serum creatinine (up to 31%), proteinuria (up to 20%)
• Frequency not reported: Urinary tract infection

Respiratory

• Very common (10% or more): Cough (up to 45%), dyspnea/wheezing (up to 33%), epistaxis (up to 17%), allergic rhinitis (up to 16%), pneumonitis/interstitial lung disease (up to 12%)
• Frequency not reported: Pneumonia, oropharyngeal pain

Further information

Atezolizumab/hyaluronidase side effects can vary depending on the individual. Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Note: Medication side effects may be underreported. If you are experiencing side effects that are not listed, submit a report to the FDA by following this guide.

Medical Disclaimer