Complete adverse effect profile including incidence rates and management
Important Safety Information
This is not a complete list of all possible side effects. Contact your healthcare provider if you experience any unexpected symptoms. For serious or life-threatening side effects, seek emergency medical attention immediately.
6 ADVERSE REACTIONS The following clinically significant adverse reactions are described elsewhere in the labeling: Severe and Fatal Immune-Mediated Adverse Reactions [see Warnings and Precautions (5.1) ] Infusion-Related Reactions [see Warnings and Precautions (5.2) ] Complications of Allogeneic HSCT after PD-1/PD-L1 Inhibitors [see Warnings and Precautions (5.3) ] Most common adverse reactions (AR) (≥ 10%) with TECENTRIQ HYBREZA as monotherapy in patients with NSCLC were fatigue, musculoskeletal pain, cough, dyspnea, and decreased appetite.
( 6.1 ) Safety of TECENTRIQ HYBREZA for the approved NSCLC, EC-SCLC, HCC, melanoma and ASPS indications is based on safety of intravenous atezolizumab in these populations.
Most common AR with intravenous atezolizumab are presented below by indication and regimen ( 6.1 ): Most common AR (≥ 20%) as monotherapy were: First-line NSCLC : fatigue/asthenia.
Metastatic NSCLC : fatigue/asthenia, cough, decreased appetite, dyspnea, and myalgia/pain.
ASPS : musculoskeletal pain, fatigue, rash, cough, headache, nausea, hypertension, vomiting, constipation, dyspnea, dizziness, hemorrhage, diarrhea, insomnia, abdominal pain hypothyroidism, pyrexia, anxiety, arrhythmia and decreased appetite.
Most common AR (≥ 20%) in combination with other antineoplastic drugs were: NSCLC (with bevacizumab, paclitaxel, and carboplatin): neuropathy fatigue/asthenia, alopecia, myalgia, nausea, diarrhea, constipation, decreased appetite, arthralgia, hypertension, rash, cough.
Non-squamous NSCLC (with paclitaxel protein-bound and carboplatin): fatigue/asthenia, nausea, diarrhea, myalgia/pain, constipation, neuropathy, alopecia, dyspnea, decreased appetite, cough, vomiting and rash.
SCLC (with chemotherapy): fatigue/asthenia, nausea, alopecia, decreased appetite, constipation and vomiting.
HCC (with bevacizumab): hypertension, fatigue and proteinuria.
Melanoma (with cobimetinib and vemurafenib): rash, musculoskeletal pain, fatigue, hepatotoxicity, pyrexia, nausea, pruritus, edema, stomatitis, hypothyroidism, and photosensitivity reaction.
5 WARNINGS AND PRECAUTIONS Immune-Mediated Adverse Reactions Immune-mediated adverse reactions, which may be severe or fatal, can occur in any organ system or tissue, including the following: immune-mediated pneumonitis, immune-mediated colitis, immune-mediated hepatitis, immune-mediated endocrinopathies, immune-mediated dermatologic adverse reactions, immune-mediated nephritis and renal dysfunction, and solid organ transplant rejection.
( 5.1 ) Monitor for early identification and management.
Evaluate liver enzymes, creatinine, and thyroid function at baseline and periodically during treatment.
Withhold or permanently discontinue based on severity and type of reaction.
Infusion-Related Reactions : Pause or slow the rate of injection, or permanently discontinue based on severity of the reaction.
Like all medications, Tecentriq Hybreza can cause side effects. However, not everyone who takes this medication will experience them. Many side effects are dose-dependent and may improve as your body adjusts to the medication. Others may require dose adjustment or medical attention.
Contact your healthcare provider promptly if you experience:
Seek immediate emergency medical care if you experience signs of: