Imfinzi

Medical Editor: John P. Cunha, DO, FACOEP Last updated on RxList: 5/23/2022
Imfinzi Side Effects Center

What Is Imfinzi?

Imfinzi (durvalumab) is a programmed death-ligand 1 (PD-L1) blocking antibody indicated for the treatment of patients with locally advanced or metastatic urothelial carcinoma who have disease progression during or following platinum-containing chemotherapy; or who have disease progression within 12 months of neoadjuvant or adjuvant treatment with platinum-containing chemotherapy.

What Are Side Effects of Imfinzi?

Common side effects of Imfinzi include:

Dosage for Imfinzi

Administer Imfinzi in a dose of 10 mg/kg as an intravenous infusion over 60 minutes every 2 weeks.

What Drugs, Substances, or Supplements Interact with Imfinzi?

Imfinzi may interact with other drugs. Tell your doctor all medications and supplements you use.

Imfinzi During Pregnancy and Breastfeeding

Imfinzi is not recommended for use during pregnancy; it may harm a fetus. Females of reproductive are advised to use effective contraception during treatment with Imfinzi, and for at least 3 months following the last dose. It is unknown if Imfinzi passes into breast milk. Because of the potential for adverse reactions in breastfed infants, women are advised not to breastfeed during treatment with Imfinzi and for at least 3 months after the last dose.

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Additional Information

Our Imfinzi (durvalumab) Injection Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

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Imfinzi Consumer Information

Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Some side effects may occur during the injection. Tell your caregiver right away if you feel light-headed or itchy, or if you have a fever, chills, neck or back pain, trouble breathing, or flushing (warmth, redness, or tingly feeling).

Durvalumab causes your immune system to attack tumor cells, but it could also attack healthy organs and tissues in your body. This could lead to serious or life-threatening side effects on your lungs, liver, pancreas, kidneys, intestines, thyroid, or adrenal glands.

Call your doctor at once if you have:

  • chest pain, new or worsening cough, feeling short of breath;
  • severe stomach pain, diarrhea, bloody or tarry stools;
  • new or worsening skin rash, itching, or blistering;
  • fever, flu-like symptoms;
  • pain or burning when you urinate;
  • problems in other organs--mood or behavior changes, neck stiffness, confusion, eye pain or redness, vision problems;
  • liver problems--loss of appetite, upper stomach pain, drowsiness, easy bruising or bleeding, dark urine, jaundice (yellowing of the skin or eyes);
  • kidney problems--little or no urination, red or pink urine, swelling in your feet or ankles;
  • transplant rejection--rash with blisters and peeling, watery diarrhea, stomach pain, vomiting, loss of appetite, fever, bruising or bleeding, jaundice, pain or swelling near your transplanted organ; or
  • signs of a hormonal disorder--unusual headaches, feeling light-headed or very tired, hoarse or deepened voice, increased hunger or thirst, increased urination, constipation, vomiting, 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:

  • nausea, constipation;
  • decreased appetite;
  • feeling weak or tired;
  • bone or muscle pain;
  • cough, feeling short of breath;
  • cold symptoms such as stuffy nose, sneezing, sore throat;
  • painful urination;
  • hair loss;
  • rash; or
  • swelling in your arms and legs.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Read the entire detailed patient monograph for Imfinzi (Durvalumab Injection)

Imfinzi Professional Information

SIDE EFFECTS

The following adverse reactions are discussed in greater detail in other sections of the labeling.

  • Immune-Mediated Adverse Reactions [see WARNINGS AND PRECAUTIONS].
  • Infusion-Related Reactions [see WARNINGS AND PRECAUTIONS].

Clinical Trials Experience

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.

The data described in the Warnings and Precautions section reflect exposure to IMFINZI in 1889 patients from the PACIFIC study (a randomized, placebo-controlled study that enrolled 475 patients with Stage III NSCLC), Study 1108 (an open-label, single-arm, multicohort study that enrolled 970 patients with advanced solid tumors), and an additional open-label, single-arm trial that enrolled 444 patients with metastatic lung cancer, an indication for which durvalumab is not approved. In these trials, IMFINZI was administered at a dose of 10 mg/kg every 2 weeks. Among the 1889 patients, 38% were exposed for 6 months or more and 18% were exposed for 12 months or more. The data also reflect exposure to IMFINZI in combination with chemotherapy in 265 patients from the CASPIAN study (a randomized, open-label study in patients with ES-SCLC). In the CASPIAN study, IMFINZI was administered at a dose of 1500 mg every 3 or 4 weeks.

The data described in this section reflect exposure to IMFINZI in patients with Stage III NSCLC enrolled in the PACIFIC study and in patients with ES-SCLC enrolled in the CASPIAN study.

Non-Small Cell Lung Cancer

The safety of IMFINZI in patients with Stage III NSCLC who completed concurrent platinum-based chemoradiotherapy within 42 days prior to initiation of study drug was evaluated in the PACIFIC study, a multicenter, randomized, double-blind, placebo-controlled study. A total of 475 patients received IMFINZI 10 mg/kg intravenously every 2 weeks. The study excluded patients who had disease progression following chemoradiation, with active or prior autoimmune disease within 2 years of initiation of the study or with medical conditions that required systemic immunosuppression [see Clinical Studies].

The study population characteristics were: median age of 64 years (range: 23 to 90), 45% age 65 years or older, 70% male, 69% White, 27% Asian, 75% former smoker, 16% current smoker, and 51% had WHO performance status of 1. All patients received definitive radiotherapy as per protocol, of which 92% received a total radiation dose of 54 Gy to 66 Gy. The median duration of exposure to IMFINZI was 10 months (range: 0.2 to 12.6).

IMFINZI was discontinued due to adverse reactions in 15% of patients. The most common adverse reactions leading to IMFINZI discontinuation were pneumonitis or radiation pneumonitis in 6% of patients. Serious adverse reactions occurred in 29% of patients receiving IMFINZI. The most frequent serious adverse reactions reported in at least 2% of patients were pneumonitis or radiation pneumonitis (7%) and pneumonia (6%). Fatal pneumonitis or radiation pneumonitis and fatal pneumonia occurred in < 2% of patients and were similar across arms. The most common adverse reactions (occurring in ≥ 20% of patients) were cough, fatigue, pneumonitis or radiation pneumonitis, upper respiratory tract infections, dyspnea, and rash.

Table 3 summarizes the adverse reactions that occurred in at least 10% of patients treated with IMFINZI.

Table 3. Adverse Reactions Occurring in ≥ 10% Patients in the PACIFIC Study

Adverse Reaction IMFINZI
N = 475
Placebo1
N = 234
All Grades
(%)
Grades 3-4
(%)
All Grades
(%)
Grades 3-4
(%)
Respiratory, Thoracic, and Mediastinal Disorders
Cough/Productive Cough 40 0.6 30 0.4
Pneumonitis2/Radiation
Pneumonitis
34 3.4 25 3
Dyspnea3 25 1.5 25 2.6
Gastrointestinal Disorders
Diarrhea 18 0.6 19 1.3
Abdominal pain4 10 0.4 6 0.4
Endocrine Disorders
Hypothyroidism5 12 0.2 1.7 0
Skin and Subcutaneous Tissue Disorders
Rash6 23 0.6 12 0
Pruritus7 12 0 6 0
General Disorders
Fatigue8 34 0.8 32 1.3
Pyrexia 15 0.2 9 0
Infections
Upper respiratory tract
infections9
26 0.4 19 0
Pneumonia10 17 7 12 6
1 The PACIFIC study was not designed to demonstrate statistically significant difference in adverse reaction rates for IMFINZI, as compared to placebo, for any specific adverse reaction listed in Table 3
2 Includes acute interstitial pneumonitis, interstitial lung disease, pneumonitis, pulmonary fibrosis
3 Includes dyspnea, and exertional dyspnea
4 Includes abdominal pain, abdominal pain lower, abdominal pain upper, and flank pain
5 Includes autoimmune hypothyroidism and hypothyroidism
6 Includes rash erythematous, rash generalized, rash macular, rash maculopapular, rash papular, rash pruritic, rash pustular, erythema, eczema, rash, and dermatitis
7 Includes pruritus generalized and pruritus
8 Includes asthenia and fatigue
9 Includes laryngitis, nasopharyngitis, peritonsillar abscess, pharyngitis, rhinitis, sinusitis, tonsillitis, tracheobronchitis, and upper respiratory tract infection
10 Includes lung infection, pneumocystis jirovecii pneumonia, pneumonia, pneumonia adenoviral, pneumonia bacterial, pneumonia cytomegaloviral, pneumonia haemophilus, pneumonia klebsiella, pneumonia necrotising, pneumonia pneumococcal, and pneumonia streptococcal

Other adverse reactions occurring in less than 10% of patients treated with IMFINZI were dysphonia, dysuria, night sweats, peripheral edema, and increased susceptibility to infections.

Table 4 summarizes the laboratory abnormalities that occurred in at least 20% of patients treated with IMFINZI.

Table 4. Laboratory Abnormalities Worsening from Baseline Occurring in ≥ 20% of Patients in the PACIFIC Study

Laboratory Abnormality IMFINZI Placebo
All Grades1
(%)2
Grade 3 or 4
(%)
All Grades1
(%)2
Grade 3 or 4
(%)
Chemistry
Hyperglycemia 52 8 51 8
Hypocalcemia 46 0.2 41 0
Increased ALT 39 2.3 22 0.4
Increased AST 36 2.8 21 0.4
Hyponatremia 33 3.6 30 3.1
Hyperkalemia 32 1.1 29 1.8
Increased GGT 24 3.4 22 1.7
Hematology
Lymphopenia 43 17 39 18
1 Graded according to NCI CTCAE version 4.0
2 Each test incidence is based on the number of patients who had both baseline and at least one on-study laboratory measurement available: IMFINZI (range: 464 to 470) and placebo (range: 224 to 228)

Small Cell Lung Cancer

The safety of IMFINZI in combination with etoposide and either carboplatin or cisplatin in previously untreated ES-SCLC was evaluated in CASPIAN, a randomized, open-label, multicenter, active-controlled trial. A total of 265 patients received IMFINZI 1500 mg in combination with chemotherapy every 3 weeks for 4 cycles followed by IMFINZI 1500 mg every 4 weeks until disease progression or unacceptable toxicity. The trial excluded patients with active or prior autoimmune disease or with medical conditions that required systemic corticosteroids or immunosuppressants [see Clinical Studies]. Among 265 patients receiving IMFINZI, 49% were exposed for 6 months or longer and 19% were exposed for 12 months or longer.

Among 266 patients receiving chemotherapy alone, 57% of the patients received 6 cycles of chemotherapy and 8% of the patients received PCI after chemotherapy.

IMFINZI was discontinued due to adverse reactions in 7% of the patients receiving IMFINZI plus chemotherapy. These include pneumonitis, hepatotoxicity, neurotoxicity, sepsis, diabetic ketoacidosis and pancytopenia (1 patient each). Serious adverse reactions occurred in 31% of patients receiving IMFINZI plus chemotherapy. The most frequent serious adverse reactions reported in at least 1% of patients were febrile neutropenia (4.5%), pneumonia (2.3%), anemia (1.9%), pancytopenia (1.5%), pneumonitis (1.1%) and COPD (1.1%). Fatal adverse reactions occurred in 4.9% of patients receiving IMFINZI plus chemotherapy. These include pancytopenia, sepsis, septic shock, pulmonary artery thrombosis, pulmonary embolism, and hepatitis (1 patient each) and sudden death (2 patients). The most common adverse reactions (occurring in ≥ 20% of patients) were nausea, fatigue/asthenia and alopecia.

Table 5 summarizes the adverse reactions that occurred in patients treated with IMFINZI plus chemotherapy.

Table 5. Adverse Reactions Occurring in ≥ 10% Patients in the CASPIAN study

Adverse Reaction IMFINZI with etoposide and
either carboplatin or cisplatin
N = 265
Etoposide and either carboplatin
or cisplatin
N = 266
All Grades (%) Grade 3-4 (%) All Grades (%) Grade 3-4 (%)
Respiratory, thoracic and mediastinal disorders
Cough/Productive Cough 15 0.8 9 0
Gastrointestinal disorders
Nausea 34 0.4 34 1.9
Constipation 17 0.8 19 0
Vomiting 15 0 17 1.1
Diarrhea 10 1.1 11 1.1
Endocrine disorders
Hyperthyroidisma 10 0 0.4 0
Skin and subcutaneous tissue disorders
Alopecia 31 1.1 34 0.8
Rashb 11 0 6 0
General disorders and administration site conditions
Fatigue/Asthenia 32 3.4 32 2.3
Metabolism and nutrition disorders
Decreased appetite 18 0.8 17 0.8
a Includes hyperthyroidism and Basedow's disease
b Includes rash erythematous, rash generalized, rash macular, rash maculopapular, rash papular, rash pruritic, rash pustular, erythema, eczema, rash and dermatitis

Table 6 summarizes the laboratory abnormalities that occurred in at least 20% of patients treated with IMFINZI plus chemotherapy.

Table 6. Laboratory Abnormalities Worsening from Baseline Occurring in ≥ 20%1 of Patients in the CASPIAN study

Laboratory Abnormality IMFINZI with Etoposide and either Carboplatin or Cisplatin Etoposide and either Carboplatin or Cisplatin
Grade2 3 or 4 (%)3 Grade2 3 or 4 (%)3
Chemistry
Hyponatremia 11 13
Hypomagnesemia 11 6
Hyperglycemia 5 5
Increased Alkaline Phosphatase 4.9 3.5
Increased ALT 4.9 2.7
Increased AST 4.6 1.2
Hypocalcemia 3.5 2.4
Blood creatinine increased 3.4 1.1
Hyperkalemia 1.5 3.1
TSH decreased < LLN4 and ≥ LLN at baseline NA NA
Hematology
Neutropenia 41 48
Lymphopenia 14 13
Anemia 13 22
Thrombocytopenia 12 15
1 The frequency cut off is based on any grade change from baseline
2 Graded according to NCI CTCAE version 4.03
3 Each test incidence is based on the number of patients who had both baseline and at least one on-study laboratory measurement available: IMFINZI (range: 258 to 263) and chemotherapy (range: 253 to 262) except magnesium IMFINZI + chemotherapy (18) and chemotherapy (16)
4 LLN = lower limit of normal

Immunogenicity

As with all therapeutic proteins, there is a potential for immunogenicity. The detection of antibody formation is highly dependent on the sensitivity and specificity of the assay. Additionally, the observed incidence of antibody (including neutralizing antibody) positivity in an assay may be influenced by several factors including assay methodology, sample handling, timing of sample collection, concomitant medications, and underlying disease. For these reasons, comparison of the incidence of antibodies to durvalumab to the incidence of antibodies to other products may be misleading.

Of 2280 patients who received IMFINZI 10 mg/kg every 2 weeks or 20 mg/kg every 4 weeks as a singleagent, 69 patients (3%) tested positive for treatment-emergent anti-drug antibodies (ADA) and 12 (0.5%) tested positive for neutralizing antibodies. The development of ADA against durvalumab appears to have no clinically relevant effect on its pharmacokinetics or safety.

Of 201 patients in the CASPIAN study who received IMFINZI 1500 mg every 3 weeks in combination with chemotherapy for four doses followed by IMFINZI 1500 mg every 4 weeks no patients tested positive for treatment-emergent ADA.

DRUG INTERACTIONS

No Information Provided

Read the entire FDA prescribing information for Imfinzi (Durvalumab Injection)

© Imfinzi Patient Information is supplied by Cerner Multum, Inc. and Imfinzi Consumer information is supplied by First Databank, Inc., used under license and subject to their respective copyrights.

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