Managing Select TECENTRIQ Adverse Reactions
Recommendations from the TECENTRIQ Prescribing Information 1
- This information should not be a substitute for the treating physician's professional medical judgment and should be individualized for the patient
- Side effects may be reported to the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch or to Genentech at
1-888-835-2555
For more information, please refer to the TECENTRIQ Prescribing Information.
Immune-Mediated Pneumonitis
MONITOR
Monitor patients for signs and symptoms of pneumonitis
- Evaluate patients with suspected pneumonitis with radiographic imaging
Patient symptoms may include
- New or worsening cough
- Shortness of breath
- Chest pain
MANAGE AND FOLLOW UP
Grade 2 pneumonitis
-
Withhold TECENTRIQ
- Administer corticosteroids, prednisone 1 to 2 mg/kg/day or
equivalents
- Taper corticosteroids
- Administer corticosteroids, prednisone 1 to 2 mg/kg/day or
equivalents
When adverse reaction recovers to grade 1 or is resolved and corticosteroid dose is less than or equal to prednisone 10 mg per day (or equivalent)
- Resume TECENTRIQ
Grade 3 or 4 pneumonitis
-
Permanently discontinue TECENTRIQ
- Administer corticosteroids, prednisone 1 to 2 mg/kg/day or equivalents
- Taper corticosteroids
SELECT IMPORTANT SAFETY INFORMATION
- Immune-mediated pneumonitis* or interstitial lung disease, including fatal cases, have occurred with TECENTRIQ treatment
- In clinical studies of TECENTRIQ as a single agent, 2.5% of
patients developed pneumonitis, including Grade 3 (0.6%), Grade 4
(0.1%), and Grade 5 (<0.1%) events
*Immune-mediated adverse reactions are defined as requiring the use of systemic corticosteroids.
Immune-Mediated Hepatitis (non-HCC)
MONITOR
Monitor patients for signs or symptoms of hepatitis, during and after discontinuation of TECENTRIQ, including clinical chemistry monitoring
Patient symptoms may include
- Yellowing of the skin or whites of the eyes
- Severe nausea or vomiting
- Pain on the right side of the stomach area (abdomen)
- Drowsiness
- Dark urine (tea colored)
- Bleeding or bruising more easily than normal
- Feeling less hungry than usual
MANAGE AND FOLLOW UP
≥Grade 2 elevations of ALT, AST, and/or total bilirubin
- Administer corticosteroids, prednisone 1 to 2 mg/kg/day or equivalents
- Taper corticosteroids
AST or ALT >3 and ≤8 times the ULN or total bilirubin >1.5 and ≤3 times the ULN
- Withhold TECENTRIQ
When adverse reaction recovers to grade 1 or is resolved and corticosteroid dose is less than or equal to prednisone 10 mg per day (or equivalent)
- Resume TECENTRIQ
AST or ALT >8 times the ULN or total bilirubin >3 times the ULN
- Permanently discontinue TECENTRIQ
SELECT IMPORTANT SAFETY INFORMATION
- Liver test abnormalities and immune-mediated hepatitis,* including fatal cases, have occurred with TECENTRIQ treatment
- In clinical studies of TECENTRIQ as a single agent, hepatitis occurred in 9% of patients, including Grade 3 (2.3%), Grade 4 (0.6%), and Grade 5 (<0.1%) events
- In clinical studies of TECENTRIQ in combination with platinum-based chemotherapy for NSCLC and SCLC, hepatitis occurred in 14% of patients, including Grades 3 to 4 (4.1%) events
ALT=alanine aminotransferase; AST=aspartate
aminotransferase; ULN=upper limit of normal.
*Immune-mediated
adverse reactions are defined as requiring the use of systemic corticosteroids.
Immune-Mediated Hepatitis (HCC)
MONITOR
Monitor patients for signs or symptoms of hepatitis, during and after discontinuation of TECENTRIQ, including clinical chemistry monitoring
Patient symptoms may include
- Yellowing of the skin or whites of the eyes
- Severe nausea or vomiting
- Pain on the right side
of the stomach area (abdomen)
- Drowsiness
- Dark urine (tea colored)
- Bleeding or bruising
more easily than normal
- Feeling less hungry than usual
MANAGE AND FOLLOW UP
≥Grade 2 elevations of ALT, AST, and/or total bilirubin
- Administer corticosteroids, prednisone 1 to 2 mg/kg/day or
equivalents
- Taper corticosteroids
AST or ALT is within normal limits at baseline and increases to >3 and ≤10 times the ULN
- Withhold TECENTRIQ
When adverse reaction recovers to grade 1 or is resolved and
corticosteroid dose is less than or equal to prednisone 10 mg per
day (or equivalent)
- Resume TECENTRIQ
AST or ALT >1 and ≤3 times the ULN at baseline and increases to >5 and ≤10 times the ULN
- Withhold TECENTRIQ
When adverse reaction recovers to grade 1 or is resolved and corticosteroid dose is less than or equal to prednisone 10 mg per day (or equivalent)
- Resume TECENTRIQ
AST or ALT >3 and ≤5 times the ULN at baseline and increases to >8 and ≤10 times the ULN
- Withhold TECENTRIQ
When adverse reaction recovers to grade 1 or is resolved and corticosteroid dose is less than or equal to prednisone 10 mg per day (or equivalent)
- Resume TECENTRIQ
AST or ALT increases to >10 times the ULN or total bilirubin increases to >3 times the ULN
- Permanently discontinue TECENTRIQ
SELECT IMPORTANT SAFETY INFORMATION
- Liver test abnormalities and immune-mediated hepatitis,* including fatal cases, have occurred with TECENTRIQ treatment
- In clinical studies of TECENTRIQ as a single agent, hepatitis
occurred in 9% of patients, including Grade 3 (2.3%), Grade 4
(0.6%), and Grade 5 (<0.1%) events
ALT=alanine aminotransferase; AST=aspartate
aminotransferase; HCC=hepatocellular carcinoma; ULN=upper limit of
normal.
*Immune-mediated adverse reactions are defined as
requiring the use of systemic corticosteroids.
Immune-Mediated Colitis
MONITOR
Monitor patients for signs and symptoms of diarrhea or colitis
Patient symptoms may include
- Diarrhea (loose stools) or more bowel movements than usual
- Blood or mucus in stools or dark, tarry, sticky stools
- Severe stomach area (abdomen) pain or tenderness
MANAGE AND FOLLOW UP
Grade 2 or 3 diarrhea or colitis
- Withhold TECENTRIQ
If symptoms persist for >5 days or recur
- Administer corticosteroids, prednisone 1 to 2 mg/kg/day or equivalents
- Taper corticosteroids
When adverse reaction recovers to grade 1 or is resolved and corticosteroid dose is less than or equal to prednisone 10 mg per day (or equivalent)
- Resume TECENTRIQ
Grade 4 diarrhea or colitis
- Permanently discontinue TECENTRIQ
SELECT IMPORTANT SAFETY INFORMATION
- Immune-mediated diarrhea or colitis* have occurred with TECENTRIQ treatment
- In clinical studies of TECENTRIQ as a single agent, diarrhea or colitis occurred in 20% of patients, including Grade 3 (1.4%) events
*Immune-mediated adverse reactions are defined as requiring the use of systemic corticosteroids.
Immune-Mediated Endocrinopathies
MONITOR
Monitor thyroid function prior to and periodically during treatment with TECENTRIQ
Additionally, monitor patients for clinical signs and symptoms of
- Adrenal insufficiency
- Hyperglycemia or other signs and symptoms of diabetes
Patient symptoms may include
- Headaches that will not go away or unusual headaches
- Extreme tiredness
- Weight gain or weight loss
- Dizziness or fainting
- Feeling more hungry or thirsty than usual
- Hair loss
- Changes in mood or behavior, such as decreased sex drive, irritability, or forgetfulness
- Feeling cold
- Constipation
- Voice gets deeper
- Urinating more often than usual
- Nausea or vomiting
- Stomach area (abdomen) pain
MANAGE AND FOLLOW UP
For grade 2, 3, or 4 endocrinopathies, withhold TECENTRIQ until grade 1 or resolved and clinically stable on hormone replacement therapies. See below for information on the management of select endocrinopathies.
Grade 2, 3, or 4 hyperthyroidism
-
Withhold TECENTRIQ based on the severity
- Initiate hormone replacement therapy or medical management of hyperthyroidism as clinically indicated
When adverse reaction recovers to grade 1 or is resolved and clinically stable on hormone replacement therapy
- Resume TECENTRIQ
Hypothyroidism
- Continue TECENTRIQ
Grade 2, 3, or 4 adrenal insufficiency
-
Withhold TECENTRIQ based on the severity
- Initiate prednisone 1 to 2 mg/kg/day or equivalents
- Follow with a taper and hormone replacement as clinically indicated
When adverse reaction recovers to grade 1 or is resolved and clinically stable on hormone replacement therapy
- Resume TECENTRIQ
Grade 2, 3, or 4 type 1 diabetes mellitus
-
Withhold TECENTRIQ based on the severity
- Initiate treatment with insulin as clinically indicated
When adverse reaction recovers to grade 1 or is resolved and clinically stable on hormone replacement therapy
- Resume TECENTRIQ
Grade 2, 3, or 4 hypophysitis
-
Withhold TECENTRIQ based on the severity
- Initiate prednisone 1 to 2 mg/kg/day or equivalents
- Follow with a taper and hormone replacement as clinically indicated
When adverse reaction recovers to grade 1 or is resolved and clinically stable on hormone replacement therapy
- Resume TECENTRIQ
SELECT IMPORTANT SAFETY INFORMATION
- TECENTRIQ can cause immune-mediated endocrinopathies,* including thyroid disorders; adrenal insufficiency; type 1 diabetes mellitus, including diabetic ketoacidosis; and hypophysitis/hypopituitarism
- Thyroid Disorders
- In clinical studies of TECENTRIQ as a single agent, hypothyroidism occurred in 4.6% of patients and hyperthyroidism occurred in 1.6% of patients
- Adrenal Insufficiency
- In clinical studies of TECENTRIQ as a single agent, adrenal insufficiency occurred in 0.4% of patients, including Grade 3 (<0.1%) events
- Type 1 Diabetes
Mellitus
- In clinical studies of TECENTRIQ as a single agent, type 1 diabetes mellitus occurred in <0.1% of patients
- Hypophysitis
- In clinical studies of TECENTRIQ as a single agent, Grade 2 hypophysitis occurred in <0.1% of patients
*Immune-mediated adverse reactions are defined as requiring the use of systemic corticosteroids.
Other Immune-Mediated Adverse Reactions
MONITOR
Monitor patients for signs and symptoms of immune-mediated adverse reactions involving a major organ. While immune-mediated reactions usually manifest during treatment with TECENTRIQ, immune-mediated adverse reactions can also manifest after discontinuation of TECENTRIQ.*
Patient symptoms may include
- Severe muscle weakness
- Numbness or tingling in hands or feet
- Confusion
- Blurry vision, double vision, or other vision problems
- Changes in mood or behavior
- Extreme sensitivity to light
- Neck stiffness
- Eye pain or redness
- Skin blisters or peeling
- Chest pain, irregular heartbeat, shortness of breath, or swelling of the ankles
MANAGE AND FOLLOW UP
Grade 2 immune-mediated adverse reactions involving a major organ
- For suspected grade 2 immune-mediated adverse reactions, exclude other causes and initiate corticosteroids as clinically indicated
Grade 3 immune-mediated adverse reactions involving a major organ
-
Withhold TECENTRIQ
- Administer corticosteroids, prednisone 1 to 2 mg/kg/day or equivalents
- Taper corticosteroids
When adverse reaction recovers to grade 1 or is resolved and corticosteroid dose is less than or equal to prednisone 10 mg per day (or equivalent)
- Resume TECENTRIQ
Grade 4 immune-mediated adverse reactions involving a major organ
-
Permanently discontinue TECENTRIQ
- Administer corticosteroids, prednisone 1 to 2 mg/kg/day or equivalents followed by a taper
Uveitis occurring in combination with other immune-mediated adverse reactions
- Evaluate for Vogt-Koyanagi-Harada syndrome, which has been observed with other products in this class and may require treatment with systemic steroids to reduce the risk of permanent vision loss
SELECT IMPORTANT SAFETY INFORMATION
- TECENTRIQ can cause severe and fatal immune-mediated adverse reactions. These immune-mediated reactions may involve any organ system
- In clinical studies of TECENTRIQ as a single agent or were reported in other products in this class, the immune-mediated adverse reactions occurring at an incidence of <1% were cardiac, dermatologic, gastrointestinal, general, hematological, musculoskeletal, neurological, ophthalmological, renal, and vascular
*Immune-mediated adverse reactions are defined as requiring the use of systemic corticosteroids.
Infections
MONITOR
Monitor patients for signs and symptoms of infection
Patient symptoms may include
- Fever
- Cough
- Flu-like symptoms
- Pain when urinating, frequent urination, or back pain
MANAGE AND FOLLOW UP
Grade 3 or 4 infections
- Withhold TECENTRIQ
When adverse reaction recovers to grade 1 or is resolved
- Resume TECENTRIQ
SELECT IMPORTANT SAFETY INFORMATION
- TECENTRIQ can cause severe infections including fatal cases
- In clinical studies of TECENTRIQ as a single agent, infections occurred in 42% of patients, including Grade 3 (8.7%), Grade 4 (1.5%), and Grade 5 (1%) events
Infusion-Related Reactions
MONITOR
Monitor patients for signs and symptoms of infusion-related reactions
Patient symptoms may include
- Chills or shaking
- Itching or rash
- Flushing
- Shortness of breath or wheezing
- Swelling of the face or lips
- Dizziness
- Fever
- Feeling like passing out
- Back or neck pain
MANAGE AND FOLLOW UP
Grade 1 or 2 infusion-related reactions
-
Interrupt or slow the rate of infusion
- Consider using premedications with subsequent doses
Grade 3 or 4 infusion-related reactions
- Permanently discontinue TECENTRIQ
SELECT IMPORTANT SAFETY INFORMATION
- TECENTRIQ can cause severe or life-threatening infusion-related reactions
- In clinical studies of TECENTRIQ as a single agent, infusion-related reactions occurred in 1.3% of patients, including Grade 3 (0.2%) events