Managing Select TECENTRIQ Adverse Reactions
Recommendations from the TECENTRIQ Prescribing Information 1
No dose reduction for TECENTRIQ is recommended. In general, withhold TECENTRIQ for severe (Grade 3) immune-mediated adverse reactions. Permanently discontinue TECENTRIQ for life-threatening (Grade 4) immune-mediated adverse reactions, recurrent severe (Grade 3) immune-mediated reactions that require systemic immunosuppressive treatment, or an inability to reduce corticosteroid dose to 10 mg or less of prednisone or equivalent per day within 12 weeks of initiating steroids.
In general, if TECENTRIQ requires interruption or discontinuation, administer systemic corticosteroid therapy (1 to 2 mg/kg/day prednisone or equivalent) until improvement to Grade 1 or less. Upon improvement to Grade 1 or less, initiate corticosteroid taper and continue to taper over at least 1 month. Consider administration of the other systemic immunosuppressants in patients whose immune-mediated adverse reactions are not controlled with corticosteroid therapy.
- 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
Any adverse reactions that require management different from the general guidelines above are summarized in the following tabs. For more information, please refer to the TECENTRIQ Prescribing Information.
Immune-Mediated Pneumonitis
MONITOR
Monitor patients for signs and symptoms of pneumonitis
Patient symptoms may include
- 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
If no complete or partial resolution within 12 weeks of initiating steroids or inability to reduce prednisone to 10 mg per day or less (or equivalent) within 12 weeks of initiating steroids
- Permanently discontinue TECENTRIQ
Grade 3 or 4 pneumonitis
- Permanently discontinue TECENTRIQ
Immune-Mediated Colitis
MONITOR
Monitor patients for signs and symptoms of colitis
Patient symptoms may include
- Diarrhea (loose stools) or more frequent bowel movements than usual
- Stools that are black, tarry, sticky, or have blood or mucus
- Severe stomach area (abdomen) pain or tenderness
MANAGE AND FOLLOW UP
Grade 2 or 3 colitis
-
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
If no complete or partial resolution within 12 weeks of initiating steroids or inability to reduce prednisone to 10 mg per day or less (or equivalent) within 12 weeks of initiating steroids
- Permanently discontinue TECENTRIQ
Grade 4 colitis
- Permanently discontinue TECENTRIQ
Immune-Mediated Hepatitis (with no tumor involvement of the liver)
MONITOR
Monitor patients for signs and symptoms of hepatitis
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)
- Dark urine (tea colored)
- Bleeding or bruising more easily than normal
MANAGE AND FOLLOW UP
AST or ALT >3 and ≤8 times the ULN or total bilirubin >1.5 and ≤3 times the ULN
-
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
If no complete or partial resolution within 12 weeks of initiating
steroids or inability to reduce prednisone to 10 mg per day
or less (or equivalent) within 12 weeks of initiating steroids
- Permanently discontinue TECENTRIQ
AST or ALT >8 times the ULN or total bilirubin >3 times the ULN
- Permanently discontinue TECENTRIQ
Immune-Mediated Hepatitis (with tumor involvement of the liver*)
MONITOR
Monitor patients for signs and symptoms of hepatitis
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)
- Dark urine (tea colored)
- Bleeding or bruising more easily than normal
MANAGE AND FOLLOW UP
AST or ALT >1 and ≤3 times the ULN at baseline and increases to >5 and ≤10 times the ULN
-
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
If no complete or partial resolution within 12 weeks of initiating steroids or inability to reduce prednisone to 10 mg per day or less (or equivalent) within 12 weeks of initiating steroids
- Permanently discontinue TECENTRIQ
AST or ALT >3 and ≤5 times the ULN at baseline and increases to >8 and ≤10 times the ULN
-
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
If no complete or partial resolution within 12 weeks of initiating steroids or inability to reduce prednisone to 10 mg per day or less (or equivalent) within 12 weeks of initiating steroids
- Permanently discontinue TECENTRIQ
AST or ALT >10 times the ULN or total bilirubin >3 times the ULN
- Permanently discontinue TECENTRIQ
Immune-Mediated Endocrinopathies
MONITOR
Monitor patients for clinical signs and symptoms of
- Adrenal insufficiency
- Hyperglycemia or other signs and symptoms of diabetes
Additionally, monitor thyroid function prior to and periodically during treatment with TECENTRIQ
Patient symptoms may include
- Headaches that will not go away or unusual headaches
- Eye sensitivity to light
- Eye problems
- Rapid heartbeat
- Increased sweating
- Extreme tiredness
- Weight gain or weight loss
- Feeling more hungry or thirsty than usual
- Urinating more often than usual
- Hair loss
- Feeling cold
- Constipation
- Voice gets deeper
- Dizziness or fainting
- Changes in mood or behavior, such as decreased sex drive, irritability, or forgetfulness
MANAGE AND FOLLOW UP
Grade 3 or 4 endocrinopathies
-
Withhold or permanently discontinue TECENTRIQ depending on the severity
- Initiate treatment as clinically indicated
When clinically stable
- Resume TECENTRIQ
Additional management information for select endocrinopathies
- For grade 2 or higher adrenal insufficiency, initiate symptomatic treatment, including hormone replacement as clinically indicated
- For hypophysitis, initiate symptomatic treatment, including hormone replacement as clinically indicated
- For thyroiditis, hyperthyroidism, or hypothyroidism, initiate symptomatic treatment, including hormone replacement for hypothyroidism or medical management for hyperthyroidism, as clinically indicated
- For type 1 diabetes mellitus, initiate insulin therapy as clinically indicated
Immune-Mediated Nephritis With Renal Dysfunction
MONITOR
Monitor patients for signs and symptoms of nephritis with renal dysfunction
Patient symptoms may include
- Decrease in amount of urine
- Blood in urine
- Swelling of ankles
- Loss of appetite
MANAGE AND FOLLOW UP
Grade 2 or 3 increased blood creatinine
-
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
If no complete or partial resolution within 12 weeks of initiating steroids or inability to reduce prednisone to 10 mg per day or less (or equivalent) within 12 weeks of initiating steroids
- Permanently discontinue TECENTRIQ
Grade 4 increased blood creatinine
- Permanently discontinue TECENTRIQ
Immune-Mediated Dermatologic Adverse Reactions
MONITOR
Monitor patients for signs and symptoms of dermatologic adverse reactions
Patient symptoms may include
- Rash
- Itching
- Skin blistering or peeling
- Painful sores or ulcers in mouth or nose, throat, or genital area
- Fever or flu-like symptoms
- Swollen lymph nodes
MANAGE AND FOLLOW UP
Suspected SJS, TEN, or DRESS
-
Withhold TECENTRIQ
- Refer to dermatologist for further diagnosis and management 9
Confirmed SJS, TEN, or DRESS
- Permanently discontinue TECENTRIQ
Topical emollients and/or topical corticosteroids may be adequate to treat mild to moderate non-exfoliative rashes.
Other Immune-Mediated Adverse Reactions
MONITOR
Monitor patients for signs and symptoms of other immune-mediated adverse reactions
Patient symptoms may include
- Chest pain, irregular heartbeat, shortness of breath, or swelling of ankles
- Confusion, sleepiness, memory problems, changes in mood or behavior, stiff neck, balance problems, tingling or numbness of the arms or legs
- Double vision, blurry
vision, sensitivity to light, eye pain, changes in eyesight
- Persistent or severe muscle pain or weakness, muscle cramps
- Low red blood cells, bruising
MANAGE AND FOLLOW UP
Grade 2, 3, or 4 myocarditis
- Permanently discontinue TECENTRIQ
Grade 2 neurological toxicities
-
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
If no complete or partial resolution within 12 weeks of initiating steroids or inability to reduce prednisone to 10 mg per day or less (or equivalent) within 12 weeks of initiating steroids
- Permanently discontinue TECENTRIQ
Grade 3 or 4 neurological toxicities
- Permanently discontinue TECENTRIQ
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
- Dizziness
- Feeling like passing out
- Fever
- 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
ALT=alanine aminotransferase; AST=aspartate aminotransferase; DRESS=drug rash with eosinophilia and systemic symptoms; HCC=hepatocellular carcinoma; SJS=Stevens-Johnson syndrome; TEN=toxic epidermal necrolysis; ULN=upper limit of normal.
*If AST and ALT are less than or equal to ULN at
baseline, withhold or permanently discontinue TECENTRIQ based on the
recommendations for hepatitis with no liver involvement. For
patients with HCC, please see the Adverse
Reaction Profile.