NEW APPROVAL
NEW APPROVAL
Patients receive Q4W IMFINZI maintenance after induction therapy1
For patients with a body weight of ≥30 kg
IMFINZI
1500-mg
fixed dose
PLATINUM-BASED
CHEMOTHERAPY
ETOPOSIDE
IMFINZI
1500-mg
fixed dose
until disease progression or
unacceptable toxicity
Patients with a body weight of <30 kg must receive weight-based dosing, equivalent to IMFINZI 20 mg/kg in combination with chemotherapy every 3 weeks (21 days) for 4 cycles, followed by 10 mg/kg every 2 weeks as a single agent. EP consists of etoposide 80 mg/m2 to 100 mg/m2 with either carboplatin AUC 5 mg/mL/min or 6 mg/mL/min or cisplatin 75 mg/m2 to 80 mg/m2. For more information, please refer to the Prescribing Information for each treatment.1
Administer IMFINZI + EP Q3W for 4 cycles followed by Q4W IMFINZI maintenance1
ES-SCLC=extensive-stage small cell lung cancer; Q4W=once every 4 weeks; Q3W=once every 3 weeks; EP=etoposide and either carboplatin or cisplatin; AUC=area under the curve; IV=intravenous.
Dosage reduction of IMFINZI is not recommended1
WITHHOLD IMFINZI*Specifc immune-mediated adverse reactions
Pneumonitis†: Grade 2
Colitis†: Grade 2 or 3
Hepatitis with no tumor involvement of the liver†:
ALT or AST >3 and up to 8 × ULN
or
Total bilirubin >1.5 and up to 3 × ULN
Hepatitis with tumor involvement of the liver†‡:
ALT or AST at baseline >1 and up to 3 × ULN and increases to >5 and up to 10 × ULN
or
ALT or AST at baseline >3 and up to 5 × ULN and increases to >8 and up to 10 × ULN
Endocrinopathies: Grade 3 or 4, withhold until stable
Nephritis with renal dysfunction†: Grade 2 or 3 increased blood creatinine
Exfoliative dermatologic conditions†: Suspected SJS, TEN, or DRESS
Myocarditis: N/A
Neurological toxicities†: Grade 2
General guidance
Other adverse reactions
Infusion-related reactions: Grade 1 or 2 slow rate of infusion
After complete or partial resolution (Grade 0 or 1) and corticosteroid taper
PERMANENTLY DISCONTINUE IMFINZI*Specifc immune-mediated adverse reactions
Pneumonitis: Grade 3 or 4
Colitis: Grade 4
Hepatitis with no tumor involvement of the liver:
ALT or AST >8 × ULN
or
Total bilirubin >3 × ULN
Hepatitis with tumor involvement of the liver‡:
ALT or AST >10 × ULN
or
Total bilirubin >3 × ULN
Endocrinopathies: Grade 3 or 4, permanently discontinue depending on severity
Nephritis with renal dysfunction: Grade 4 increased blood creatinine
Exfoliative dermatologic conditions: Confirmed SJS, TEN, or DRESS
Myocarditis: Grade 2, 3, or 4
Neurological toxicities: Grade 3 or 4
General guidance
Other adverse reactions
Infusion-related reactions: Grade 3 or 4
Prescribing Information has additional information for dosage modification and management specific to adverse reactions.
ALT=alanine aminotransferase; AST=aspartate aminotransferase; ULN=upper limit of normal; SJS=Stevens Johnson Syndrome; TEN=toxic epidermal necrolysis; DRESS=Drug Rash with Eosinophilia and Systemic Symptoms; N/A=not applicable.
*Based on National Cancer Institute Common Terminology Criteria for Adverse Events, version 4.03.
†Resume in patients with complete or partial resolution (Grade 0 to 1) after corticosteroid taper. Permanently discontinue if no complete or partial resolution within 12 weeks of initiating steroids or inability to reduce prednisone 10 mg per day or less (or equivalent) within 12 weeks of initiating steroids.
‡If AST and ALT are less than or equal to ULN at baseline in patients with liver involvement, withhold or permanently discontinue IMFINZI based on recommendations for hepatitis with no liver involvement.
Preparation1
Visually inspect drug product for particulate matter and discoloration prior to administration, whenever solution and container permit. Discard the vial if the solution is cloudy, discolored, or visible particles are observed
Do not shake the vial
Withdraw the required volume from the vial(s) of IMFINZI and transfer into an IV bag containing 0.9% Sodium Chloride Injection, USP or 5% Dextrose Injection, USP. Mix diluted solution by gentle inversion. Do not shake the solution. The final concentration of the diluted solution should be between 1 mg/mL and 15 mg/mL
Discard partially used or empty vials of IMFINZI
Storage of infusion solution1
IMFINZI does not contain a preservative.
Administer infusion solution immediately once prepared. If infusion solution is not administered immediately and needs to be stored, the total time from vial puncture to the start of the administration should not exceed:
24 hours in a refrigerator at
2°C to 8°C (36°F to 46°F)
8 hours at room temperature up to
25°C (77°F)
Additionally:
Do not freeze
Do not shake
Administration1
Administer infusion solution intravenously over 60 minutes through an IV line containing a sterile, low-protein binding 0.2 or 0.22 micron in-line filter
Do not co-administer other drugs through the same infusion line
Dosage forms and strengths1
Injection: 120 mg/2.4 mL (50 mg/mL) and 500 mg/10 mL (50 mg/mL) clear to opalescent, colorless to slightly yellow solution in a single-dose vial
Help support your patients to take ownership of their treatment with IMFINZI® (durvalumab) by calling 1-855-LHOUSE1 (1-855-546-8731)
IMFINZI, in combination with etoposide and either carboplatin or cisplatin, is indicated for the first-line treatment of adult patients with extensive-stage small cell lung cancer (ES-SCLC).
Important immune-mediated adverse reactions listed under Warnings and Precautions may not include all possible severe and fatal immune-mediated reactions. Immune-mediated adverse reactions, which may be severe or fatal, can occur in any organ system or tissue. Immune-mediated adverse reactions can occur at any time after starting treatment or after discontinuation. Monitor patients closely for symptoms and signs that may be clinical manifestations of underlying immune-mediated adverse reactions. Evaluate liver enzymes, creatinine, and thyroid function at baseline and periodically during treatment. In cases of suspected immune-mediated adverse reactions, initiate appropriate workup to exclude alternative etiologies, including infection. Institute medical management promptly, including specialty consultation as appropriate. Withhold or permanently discontinue IMFINZI depending on severity. See Dosing and Administration for specific details. In general, if IMFINZI requires interruption or discontinuation, administer systemic corticosteroid therapy (1 mg 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 other systemic immunosuppressants in patients whose immune-mediated adverse reactions are not controlled with corticosteroid therapy.
Important immune-mediated adverse reactions listed under Warnings and Precautions may not include all possible severe and fatal immune-mediated reactions. Immune-mediated adverse reactions, which may be severe or fatal, can occur in any organ system or tissue. Immune-mediated adverse reactions can occur at any time after starting treatment or after discontinuation. Monitor patients closely for symptoms and signs that may be clinical manifestations of underlying immune-mediated adverse reactions. Evaluate liver enzymes, creatinine, and thyroid function at baseline and periodically during treatment. In cases of suspected immune-mediated adverse reactions, initiate appropriate workup to exclude alternative etiologies, including infection. Institute medical management promptly, including specialty consultation as appropriate. Withhold or permanently discontinue IMFINZI depending on severity. See Dosing and Administration for specific details. In general, if IMFINZI requires interruption or discontinuation, administer systemic corticosteroid therapy (1 mg 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 other systemic immunosuppressants in patients whose immune-mediated adverse reactions are not controlled with corticosteroid therapy.
IMFINZI can cause immune-mediated pneumonitis. The incidence of pneumonitis is higher in patients who have received prior thoracic radiation. In patients who did not receive recent prior radiation, the incidence of immune-mediated pneumonitis was 2% (28/1414), including fatal (<0.1%), and Grade 3-4 (0.4%) adverse reactions. In patients who received recent prior radiation, the incidence of pneumonitis (including radiation pneumonitis) in patients with unresectable Stage III NSCLC following definitive chemoradiation within 42 days prior to initiation of IMFINZI in PACIFIC was 16.6% (79/475) in patients receiving IMFINZI and 13.2% (31/234) in patients receiving placebo. Of the 79 patients who received IMFINZI, 1.1% were fatal and 2.5% were Grade 3-4 adverse reactions. The frequency and severity of immune-mediated pneumonitis in patients who did not receive definitive chemoradiation prior to IMFINZI were similar in patients who received IMFINZI as a single agent or with ES-SCLC when in combination with chemotherapy.
IMFINZI can cause immune-mediated colitis that is frequently associated with diarrhea. Cytomegalovirus (CMV) infection/reactivation has been reported in patients with corticosteroid-refractory immune-mediated colitis. In cases of corticosteroid-refractory colitis, consider repeating infectious workup to exclude alternative etiologies. Immune-mediated colitis occurred in 1.6% (31/1889) of patients receiving IMFINZI, including Grade 4 (0.1%) and Grade 3 (0.3%) adverse reactions.
IMFINZI can cause immune-mediated hepatitis. Immune-mediated hepatitis occurred in 1% (19/1889) of patients receiving IMFINZI, including fatal (<0.1%) and Grade 3 (0.6%) adverse reactions.
IMFINZI can cause immune-mediated nephritis. Immune-mediated nephritis occurred in 0.3% (5/1889) of patients receiving IMFINZI, including Grade 3 (0.1%) adverse reactions.
IMFINZI can cause immune-mediated rash or dermatitis. Exfoliative dermatitis, including Stevens Johnson Syndrome (SJS), drug rash with eosinophilia and systemic symptoms (DRESS), and toxic epidermal necrolysis (TEN), have occurred with PD-1/L-1 blocking antibodies. Topical emollients and/or topical corticosteroids may be adequate to treat mild to moderate non-exfoliative rashes. Immune-mediated rash or dermatitis occurred in 1.6% (30/1889) of patients receiving IMFINZI, including Grade 3 (0.4%) adverse reactions.
The following clinically significant, immune-mediated adverse reactions occurred at an incidence of less than 1% each in patients who received IMFINZI or were reported with the use of other PD-1/PD-L1 blocking antibodies.
IMFINZI can cause severe or life-threatening infusion-related reactions. Monitor for signs and symptoms of infusion-related reactions. Interrupt, slow the rate of, or permanently discontinue IMFINZI based on the severity. See Dosing and Administration for specific details. For Grade 1 or 2 infusion-related reactions, consider using pre-medications with subsequent doses. Infusion-related reactions occurred in 2.2% (42/1889) of patients receiving IMFINZI, including Grade 3 (0.3%) adverse reactions.
Fatal and other serious complications can occur in patients who receive allogeneic hematopoietic stem cell transplantation (HSCT) before or after being treated with a PD-1/L-1 blocking antibody. Transplant-related complications include hyperacute graft-versus-host-disease (GVHD), acute GVHD, chronic GVHD, hepatic veno-occlusive disease (VOD) after reduced intensity conditioning, and steroid-requiring febrile syndrome (without an identified infectious cause). These complications may occur despite intervening therapy between PD-1/L-1 blockade and allogeneic HSCT. Follow patients closely for evidence of transplant-related complications and intervene promptly. Consider the benefit versus risks of treatment with a PD-1/L-1 blocking antibody prior to or after an allogeneic HSCT.
Based on its mechanism of action and data from animal studies, IMFINZI can cause fetal harm when administered to a pregnant woman. Advise pregnant women of the potential risk to a fetus. Advise females of reproductive potential to use effective contraception during treatment with IMFINZI and for at least 3 months after the last dose of IMFINZI.
There is no information regarding the presence of IMFINZI in human milk; however, because of the potential for adverse reactions in breastfed infants from IMFINZI, advise women not to breastfeed during treatment and for at least 3 months after the last dose.
The safety and effectiveness of IMFINZI have not been established in pediatric patients.
IMFINZI, in combination with etoposide and either carboplatin or cisplatin, is indicated for the first-line treatment of adult patients with extensive-stage small cell lung cancer (ES-SCLC).
Please see complete Prescribing Information, including Medication Guide.
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There are no contraindications for IMFINZI® (durvalumab).