Durvalumab is an antineoplastic monoclonal antibody used to treat urothelial carcinoma and locally advanced, unresectable non-small cell lung cancer. It is a human immunoglobulin G1 kappa (IgG1κ) monoclonal antibody that blocks the interaction of programmed cell death ligand 1 (PD-L1) with the PD-1 (CD279).
Durvalumab is a human immunoglobulin G1 kappa (IgG1κ) monoclonal antibody and a novel immune-checkpoint inhibitor for cancer treatment.[rx] Produced by recombinant DNA technology in Chinese Hamster Ovary (CHO) cell suspension culture,[rx] durvalumab is a programmed death-ligand 1 (PD-L1) blocking antibody that works to promote normal immune responses that attack tumor cells.[rx,rx]
Durvalumab is marketed under the brand name Imfinzi, which is available for intravenous injections. It was granted accelerated approval by the FDA in May 2017 [rx] for the treatment of selected patients with locally advanced or metastatic urothelial carcinoma.[rx] In September 2018, durvalumab was approved by the EMA for the treatment of adult patients with locally advanced, unresectable non-small cell lung cancer (NSCLC), only if PD-L1 is expressed in ≥ 1% of tumor cells and there was no observable disease progression following platinum-based chemoradiation therapy.[rx,rx[ On March 27, 2020, durvalumab was approved by the FDA for use in combination with etoposide and either carboplatin or cisplatin as first-line treatment of patients with extensive-stage small cell lung cancer (ES-SCLC).[rx]
Durvalumab (dur val’ ue mab) is a human recombinant monoclonal IgG1 kappa-isotype antibody to the ligand for the programmed cell death receptor (PD-L1), which has distinctive immunomodulatory activity and is used as a checkpoint inhibitor in cancer immunotherapy. The programmed cell death receptor 1 (PD-1) is an important checkpoint molecule that is expressed on activated T and B cells. The binding of the ligand to PD-1 activates programmed cell death pathways that terminate or down-regulate cytotoxic T-cell responses. Monoclonal antibody binding to PD-L1 prevents its engagement with the PD-1 receptor and subsequent induction of the cellular pathways that down-regulate T-cell responses. Inhibition of this pathway allows for a continued activation and proliferation of cytotoxic T cells and proinflammatory cytokines. The enhancement of cytotoxic reactivity may play a beneficial role in cancer immunotherapy by breaking immunological tolerance to cancer cell neo-antigens. In several large multicenter studies, durvalumab therapy resulted in a prolongation of progression-free survival in patients with advanced, metastatic, or unresectable urothelial carcinoma. Durvalumab was granted accelerated approval for use in advanced urothelial cancer in the United States in 2017. This specific indication was withdrawn in 2021 when postmarketing trials failed to show improvement in survival with durvalumab therapy more than with conventional therapy. However, indications for durvalumab were expanded to include advanced, refractory non-small cell lung cancer (NSCLC) and extensive-stage small cell lung cancer (SCLC), and it continues to be evaluated as a therapy for other advanced malignancies. Durvalumab is available as a solution in single-use vials of 120 and 500 mg (50 mg/mL) under the brand name Imfinzi. The typical regimen is 10 mg/kg by intravenous infusion over 60 minutes every 2 weeks or 1500 mg every 4 weeks until disease progression or intolerance occurs.
Mechanism of action
Because cancer cells express antigens that are recognized and taken up by antigen-presenting cells (APCs), the immune responses prime and activate cytotoxic T cells and allow them to travel to the site of the tumour to destroy cancer cells. However, tumors often evade T-cell-mediated immune responses to enhance their survival.[rx] Inflammatory mediators, such as IFN-gamma, induce the expression of programmed cell death ligand-1 (PD-L1), which is a type 1 transmembrane protein expressed on tumor cells and tumor-associated immune cells in the tumor microenvironment.[rx,rx] PD-L1 acts as an immune checkpoint to regulate immune responses. PD-L1 is a ligand to PD-1, which is a cell surface receptor expressed on activated T cells in peripheral tissues following antigen exposure.[rx,rx] Both PD-L1 and PD-1 are co-inhibitory molecules involved in blocking T cell-mediated immune responses. PD-L1 also interacts with CD-80, which is a receptor constitutively expressed by T cells and is upregulated early after T cell activation.[rx]
The expression of PD-L1 is an adaptive immune response by tumour cells, resulting in the over-expression of the molecule in some cancers.[rx] PD-L1 interacts with PD-1 and CD80, which leads to blocked cytotoxic T-cell activation, T-cell proliferation, and cytokine production.[rx] By binding to PD-L1 and preventing its association with PD-1 and CD80, durvalumab activates the immune responses mediated by cytotoxic T cells that attack tumour cells.[rx] Durvalumab displays selective and high affinity toward PD-L1 but not PD-L2, which is a regulatory ligand expressed in tumor cells to a lesser extent and involved in regulating inflammation and differentiation of T cells.[rx]
Durvalumab is an anticancer antibody that works to promote the antitumor responses mediated by immune cells. By blocking the action of PD-L1, durvalumab exerts its anticancer effects by increasing T-cell activation and enhancing the detection and ablation of tumor cells.[rx] In in vitro assays, durvalumab inhibited the activity of PD-L1 in a concentration-dependent manner.[rx] In co-engrafted human tumor and immune cell xenograft mouse models, durvalumab was effective in decreasing tumor size. Durvalumab does not mediate antibody-dependent cell-mediated cytotoxicity (ADCC).7
Indications
Durvalumab is indicated for the treatment of adults with the following conditions:
- Unresectable Stage III non-small cell lung cancer (NSCLC) whose disease has not progressed following concurrent platinum-based chemotherapy and radiation therapy.[rx]
- Metastatic NSCLC with no sensitizing epidermal growth factor receptor (EGFR) mutations or anaplastic lymphoma kinase (ALK) genomic tumor aberrations, in combination with tremelimumab and platinum-based chemotherapy.[rx]
- Extensive-stage small cell lung cancer (ES-SCLC) in combination with etoposide and either carboplatin or cisplatin as first-line therapy.[rx]
- For patients with unresectable Stage III non-small cell lung cancer (NSCLC) whose disease has not progressed following concurrent platinum-based chemotherapy and radiation therapy
- Locally advanced or metastatic biliary tract cancer (BTC) in combination with gemcitabine and cisplatin.[rx]
- Unresectable hepatocellular carcinoma (uHCC) in combination with tremelimumab.[rx]
- Adults with locally advanced or metastatic urothelial carcinoma either have disease progression during or following platinum-containing chemotherapy or have disease progression within 12 months of neoadjuvant or adjuvant treatment with platinum-containing chemotherapy.
- Adults with unresectable, Stage III non-small cell lung cancer whose disease has not progressed following concurrent platinum-based chemotherapy and radiation therapy.
- In combination with etoposide and either carboplatin or cisplatin, as first-line treatment for adults with extensive-stage small cell lung cancer.
- In combination with gemcitabine and cisplatin for adults with locally advanced or metastatic biliary tract cancer (BTC)
- Extensive-stage Small Cell Lung Cancer (SCLC)
- Locally Advanced Biliary Tract Cancer
- Metastatic Biliary Tract Cancer
- Metastatic Non-Small Cell Lung Cancer
- Unresectable Hepatocellular Carcinoma (HCC)
- Unresectable Stage III Non-small Cell Lung Cancer
- Unresectable, locally advanced PD-L1 positive Lung Cancer Non-Small Cell Cancer (NSCLC)
Use in Cancer
Durvalumab is approved to treat adults with:
- Biliary tract cancer, including cholangiocarcinoma and gallbladder cancer, has spread. It is used with gemcitabine hydrochloride and cisplatin.
- Non-small cell lung cancer (NSCLC). It is used:
- Alone in patients with stage III cancer that cannot be removed by surgery but has not worsened after platinum-based chemotherapy and radiation therapy.
- Tremelimumab-act and platinum-based chemotherapy in patients with cancer that has spread to other parts of the body and do not have an abnormal EGFR gene or ALK gene.
- Small cell lung cancer. It is used with etoposide phosphate and either carboplatin or cisplatin as the first treatment in patients with extensive-stage cancer.
Durvalumab is also being studied in the treatment of other types of cancer.
Contraindications
- a bad infection
- overactive thyroid gland
- a condition with low thyroid hormone levels
- severely decreased function of cortex of adrenal gland
- inflammation of the large intestine
- high blood sugar
- abnormal liver function tests
- pregnancy
- a patient who is producing milk and breastfeeding
- lung tissue problem
- inflammation of the pituitary gland
Dosage
Strengths: 50 mg/mL
Urothelial Carcinoma
- 10 mg/kg IV over 60 minutes every 2 weeks until disease progression or unacceptable toxicity
Uses: For the treatment of patients with locally advanced or metastatic urothelial carcinoma who:
- Have disease progression during or following platinum-containing chemotherapy
- Have disease progression within 12 months of neoadjuvant or adjuvant treatment with platinum-containing chemotherapy
Non-Small Cell Lung Cancer
- 10 mg/kg IV over 60 minutes every 2 weeks until disease progression, unacceptable toxicity, or a maximum of 12 months
Small Cell Lung Cancer
30 kg or less:
- 20 mg/kg IV every 3 weeks (21 days) for 4 cycles, followed by 20 mg/kg every 4 weeks as a single agent until weight increases to greater than 30 kg
NOTE: When this drug is given in combination with chemotherapy, administer this drug prior to chemotherapy on the same day; refer to the Prescribing Information for etoposide and carboplatin or cisplatin for dosing information.
Greater than 30 kg:
- 1500 mg IV every 3 weeks (21 days) for 4 cycles, followed by 1500 mg every 4 weeks as a single agent until disease progression or unacceptable toxicity
NOTE: When this drug is given in combination with chemotherapy, administer this drug prior to chemotherapy on the same day; refer to the Prescribing Information for etoposide and carboplatin or cisplatin for dosing information.
Dose Adjustments
- Dose escalation or reduction is not recommended.
- Dose withholding or discontinuation may be required based on safety and tolerability.
PNEUMONITIS:
- GRADE 2: Withhold dose; initiate prednisone or equivalent at an initial dose of 1 to 2 mg/kg/day followed by a taper (unless otherwise specified); initiate corticosteroid when adverse reaction improves to less than Grade 1 and continue over at least 1 month; resume therapy when reaction is Grade 1 or less and the corticosteroid dose is less than 10 mg prednisone or equivalent per day
- GRADE 3 OR 4: Permanently discontinue therapy; initiate prednisone or equivalent at an initial dose of 1 to 4 mg/kg/day followed by a taper (unless otherwise specified); initiate corticosteroid when adverse reaction improves to less than Grade 1 and continue over at least 1 month; resume therapy when reaction is Grade 1 or less and the corticosteroid dose is less than 10 mg prednisone or equivalent per day
HEPATITIS:
- GRADE 2 alanine aminotransferase (ALT) or aspartate aminotransferase (AST) greater than 3 to 5 times upper limit of normal (ULN) or total bilirubin greater than 1.5 to 3 x ULN OR Grade 3 ALT or AST less than or equal to 8 x ULN or total bilirubin less than or equal to 5 x ULN: Withhold dose; initiate prednisone or equivalent at an initial dose of 1 to 2 mg/kg/day followed by a taper (unless otherwise specified); initiate corticosteroid when adverse reaction improves to less than Grade 1 and continue over at least 1 month; resume therapy when reaction is Grade 1 or less and the corticosteroid dose is less than 10 mg prednisone or equivalent per day
- GRADE 3 ALT or AST greater than 8 x ULN or total bilirubin greater than 5 x ULN OR concurrent ALT or AST greater than 3 x ULN and total bilirubin greater than 2 x ULN with no other cause: Permanently discontinue therapy; initiate prednisone or equivalent at an initial dose of 1 to 2 mg/kg/day followed by a taper (unless otherwise specified)
COLITIS OR DIARRHEA:
- GRADE 2: Withhold dose; initiate prednisone or equivalent at an initial dose of 1 to 2 mg/kg/day followed by a taper (unless otherwise specified); initiate corticosteroid when adverse reaction improves to less than Grade 1 and continue over at least 1 month; resume therapy when reaction is Grade 1 or less and the corticosteroid dose is less than 10 mg prednisone or equivalent per day
- GRADE 3 OR 4: Permanently discontinue therapy; initiate prednisone or equivalent at an initial dose of 1 to 2 mg/kg/day followed by a taper (unless otherwise specified)
HYPERTHYROIDISM OR THYROIDITIS:
- GRADE 2 TO 4: Withhold dose until clinically stable; initiate symptomatic management
ADRENAL INSUFFICIENCY, HYPOPHYSITIS/HYPOPITUITARISM:
- GRADE 2 TO 4: Withhold dose until clinically stable; initiate prednisone or equivalent at an initial dose of 1 to 2 mg/kg/day followed by a taper (unless otherwise specified) and hormone replacement as clinically indicated
TYPE 1 DIABETES MELLITUS:
- GRADE 2 TO 4: Withhold dose until clinically stable; initiate therapy with insulin as clinically indicated
NEPHRITIS:
- GRADE 2 creatinine greater than 1.5 to 3 x ULN: Withhold dose; initiate prednisone or equivalent at an initial dose of 1 to 2 mg/kg/day followed by a taper (unless otherwise specified); initiate corticosteroid when adverse reaction improves to less than Grade 1 and continue over at least 1 month; resume therapy when reaction is Grade 1 or less and the corticosteroid dose is less than 10 mg prednisone or equivalent per day
- GRADE 3 creatinine greater than 3 to 6 x ULN OR Grade 4 creatinine greater than 6 x ULN: Permanently discontinue therapy; initiate prednisone or equivalent at an initial dose of 1 to 2 mg/kg/day followed by a taper (unless otherwise specified)
RASH OR DERMATITIS:
- GRADE 2 for longer than 1 week OR Grade 3: Withhold dose; consider initiating prednisone or equivalent at an initial dose of 1 to 2 mg/kg/day followed by a taper (unless otherwise specified); initiate corticosteroid when adverse reaction improves to less than Grade 1 and continue over at least 1 month; resume therapy when reaction is Grade 1 or less and the corticosteroid dose is less than 10 mg prednisone or equivalent per day
- GRADE 4: Permanently discontinue therapy; consider initiating prednisone or equivalent at an initial dose of 1 to 2 mg/kg/day followed by a taper (unless otherwise specified)
INFECTION:
- GRADE 3 OR 4: Withhold dose; initiate symptomatic management; treat with anti-infectives for suspected or confirmed infections
INFUSION-RELATED REACTIONS:
- GRADE 1 OR 2: Interrupt or slow the rate of infusion; consider premedication with subsequent doses
- GRADE 3 OR 4: Permanently discontinue therapy
OTHER IMMUNE-RELATED ADVERSE REACTIONS:
- GRADE 3: Withhold dose; initiate symptomatic management (Based on severity of the adverse reaction, therapy should be withheld and a corticosteroid taper administered; consider increasing dose of corticosteroids and/or other systemic immunosuppressants if there is worsening or no improvement; initiate corticosteroid when adverse reaction improves to less than Grade 1 and continue over at least 1 month; resume therapy when reaction is Grade 1 or less and the corticosteroid dose is less than 10 mg prednisone or equivalent per day
- GRADE 4: Permanently discontinue therapy; consider initiating prednisone or equivalent at an initial dose of 1 to 4 mg/kg/day followed by a taper (unless otherwise specified)
NOTE: For myasthenia gravis permanently discontinue this drug if the adverse reaction does not resolve to Grade 1 or less within 30 days or if there are signs of respiratory and/or autonomic insufficiency.
PERSISTENT GRADE 2 OR 3 ADVERSE REACTION (EXCLUDING ENDOCRINOPATHIES):
- GRADE 2 OR 3 adverse reaction that does not recover to Grade 0 or 1 within 12 weeks after the last dose: Permanently discontinue therapy.
INABILITY TO TAPER CORTICOSTEROID:
- GRADE 2 OR 3 adverse reaction that does not recover to Grade 0 or 1 within 12 weeks after the last dose: Permanently discontinue therapy.
RECURRENT GRADE 3 OR 4 ADVERSE REACTION:
- RECURRENT GRADE 3 OR 4 (severe or life-threatening) adverse reaction: Permanently discontinue therapy.
Administration advice:
- Administer IV over 60 minutes through an IV line containing a sterile, low-protein binding 0.2 or 0.22 micron in-line filter.
- Administer infusion solution immediately after preparing; if the infusion 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 2C to 8C (36F to 46F) or 4 hours at room temperature up to 25C (77F).
- Do not shake the prepared solution.
Side Effects
The Most Common
- swelling of your arms or legs
- constipation
- hair loss
- trouble falling asleep or staying asleep
- new or worsening cough, chest pain, or shortness of breath
- yellowing of your eyes or skin, bleeding or bruising easily, decreased appetite, dark (tea-colored) urine, pain in the upper right part of the stomach, extreme tiredness, nausea or vomiting
- diarrhea, stomach pain, or black, tarry, sticky, or bloody stools
- decreased urination, blood in urine, swelling in your ankles, decreased appetite
- fever, cough, chills, flu-like symptoms, frequent or painful urination, or other signs of infection
- headaches that won’t go away or unusual headaches; extreme tiredness; weight loss or gain; increased hunger or thirst; feeling dizzy or faint; feeling cold; deepening of voice; or constipation; hair loss; changes in mood or behavior such as decreased sex drive, feeling irritable, confused, or forgetful; increased urination; increased sweating; stomach pain
- fast or irregular heartbeat
- numbness or tingling in the arms or legs
- persistent muscle pain, weakness, or muscle cramps
- rash or itching, scaling or blistering skin
- sores in the mouth, nose, throat, or genital area
- swollen glands
- neck stiffness
- blurry or double vision, sensitivity to light, or other vision problems, eye redness or pain
More common
- Bladder pain
- bloating or swelling of the face, arms, hands, lower legs, or feet
- bloody or cloudy urine
- body aches or pain
- chest pain or tightness
- chills
- cough
- depressed mood
- difficult, burning, or painful urination
- difficulty having a bowel movement
- dry skin and hair
- ear congestion
- feeling cold
- fever
- frequent urge to urinate
- general feeling of discomfort or illness
- hair loss
- headache
- hoarseness, husky, or loss of voice
- lower back or side pain
- muscle cramps and stiffness
- nervousness
- runny or stuffy nose
- sensitivity to heat
- slowed heartbeat
- sneezing
- sore throat
- stomach cramps
- sweating
- tenderness
- thickening of bronchial secretions
- tingling of the hands or feet
- trouble breathing
- trouble sleeping
- unusual tiredness or weakness
- unusual weight gain or loss
- watery or bloody diarrhea
Rare
- Back, leg, or stomach pains
- black, tarry stools
- bleeding gums
- bloody nose
- blurred vision or other changes in vision
- dark urine
- eye redness, irritation, or pain
- general body swelling
- heavier menstrual periods
- light-colored stools
- loss of appetite
- nausea
- nosebleeds
- pale skin
- pinpoint red spots on the skin
- sensitivity of the eye to light
- skin rash
- stiff neck or back
- tearing
- unusual bleeding or bruising
- upper right abdominal or stomach pain
- vomiting
- yellow eyes and skin
- Blistering, peeling, or loosening of the skin
- dizziness
- drowsiness
- fainting
- joint or muscle pain
- red skin lesions, often with a purple center
- sores, ulcers, or white spots in the mouth or on the lips
- swollen glands
Drug Interactions
| DRUG | INTERACTION |
|---|---|
| Abciximab | The risk or severity of adverse effects can be increased when Abciximab is combined with Durvalumab. |
| Adalimumab | The risk or severity of adverse effects can be increased when Adalimumab is combined with Durvalumab. |
| Aducanumab | The risk or severity of adverse effects can be increased when Durvalumab is combined with Aducanumab. |
| Alemtuzumab | The risk or severity of adverse effects can be increased when Alemtuzumab is combined with Durvalumab. |
| Alirocumab | The risk or severity of adverse effects can be increased when Alirocumab is combined with Durvalumab. |
| Amivantamab | The risk or severity of adverse effects can be increased when Durvalumab is combined with Amivantamab. |
| Anifrolumab | The risk or severity of adverse effects can be increased when Durvalumab is combined with Anifrolumab. |
| Ansuvimab | The risk or severity of adverse effects can be increased when Durvalumab is combined with Ansuvimab. |
| Anthrax immune | The risk or severity of adverse effects can be increased when Anthrax immune globulin human is combined with Durvalumab. |
| Antilymphocyte | The risk or severity of adverse effects can be increased when Antilymphocyte immunoglobulin (horse) is combined with Durvalumab. |
| Antithymocyte | The risk or severity of adverse effects can be increased when Antithymocyte immunoglobulin (rabbit) is combined with Durvalumab. |
| Articaine | The risk or severity of methemoglobinemia can be increased when Durvalumab is combined with Articaine. |
| Asfotase alfa | The risk or severity of adverse effects can be increased when Asfotase alfa is combined with Durvalumab. |
| Atezolizumab | The risk or severity of adverse effects can be increased when Atezolizumab is combined with Durvalumab. |
| Atoltivimab | The risk or severity of adverse effects can be increased when Durvalumab is combined with Atoltivimab. |
| Avelumab | The risk or severity of adverse effects can be increased when Durvalumab is combined with Avelumab. |
| Bamlanivimab | The risk or severity of adverse effects can be increased when Durvalumab is combined with Bamlanivimab. |
| Basiliximab | The risk or severity of adverse effects can be increased when Basiliximab is combined with Durvalumab. |
| Bebtelovimab | The risk or severity of adverse effects can be increased when Durvalumab is combined with Bebtelovimab. |
| Belantamab | The risk or severity of adverse effects can be increased when Durvalumab is combined with Belantamab mafodotin. |
| Belimumab | The risk or severity of adverse effects can be increased when Belimumab is combined with Durvalumab. |
| Benralizumab | The risk or severity of adverse effects can be increased when Durvalumab is combined with Benralizumab. |
| Benzocaine | The risk or severity of methemoglobinemia can be increased when Durvalumab is combined with Benzocaine. |
| Benzyl alcohol | The risk or severity of methemoglobinemia can be increased when Durvalumab is combined with Benzyl alcohol. |
| Besilesomab | The risk or severity of adverse effects can be increased when Durvalumab is combined with Besilesomab. |
| Betamethasone | The therapeutic efficacy of Durvalumab can be decreased when used in combination with Betamethasone. |
| Bevacizumab | The risk or severity of adverse effects can be increased when Bevacizumab is combined with Durvalumab. |
| Bezlotoxumab | The risk or severity of adverse effects can be increased when Durvalumab is combined with Bezlotoxumab. |
| Bimekizumab | The risk or severity of adverse effects can be increased when Durvalumab is combined with Bimekizumab. |
| Blinatumomab | The risk or severity of adverse effects can be increased when Blinatumomab is combined with Durvalumab. |
| Brentuximab | The risk or severity of adverse effects can be increased when Brentuximab vedotin is combined with Durvalumab. |
| Brodalumab | The risk or severity of adverse effects can be increased when Durvalumab is combined with Brodalumab. |
| Brolucizumab | The risk or severity of adverse effects can be increased when Durvalumab is combined with Brolucizumab. |
| Budesonide | The therapeutic efficacy of Durvalumab can be decreased when used in combination with Budesonide. |
| Bupivacaine | The risk or severity of methemoglobinemia can be increased when Durvalumab is combined with Bupivacaine. |
| Burosumab | The risk or severity of adverse effects can be increased when Durvalumab is combined with Burosumab. |
| Butacaine | The risk or severity of methemoglobinemia can be increased when Durvalumab is combined with Butacaine. |
| Butamben | The risk or severity of methemoglobinemia can be increased when Durvalumab is combined with Butamben. |
| Canakinumab | The risk or severity of adverse effects can be increased when Canakinumab is combined with Durvalumab. |
| Caplacizumab | The risk or severity of adverse effects can be increased when Caplacizumab is combined with Durvalumab. |
| Capromab | The risk or severity of adverse effects can be increased when Capromab pendetide is combined with Durvalumab. |
| Capsaicin | The risk or severity of methemoglobinemia can be increased when Durvalumab is combined with Capsaicin. |
| Casirivimab | The risk or severity of adverse effects can be increased when Durvalumab is combined with Casirivimab. |
| Catumaxomab | The risk or severity of adverse effects can be increased when Catumaxomab is combined with Durvalumab. |
| Cemiplimab | The risk or severity of adverse effects can be increased when Durvalumab is combined with Cemiplimab. |
| Certolizumab pegol | The risk or severity of adverse effects can be increased when Certolizumab pegol is combined with Durvalumab. |
| Cetuximab | The risk or severity of adverse effects can be increased when Cetuximab is combined with Durvalumab. |
| Chloroprocaine | The risk or severity of methemoglobinemia can be increased when Durvalumab is combined with Chloroprocaine. |
| Cilgavimab | The risk or severity of adverse effects can be increased when Durvalumab is combined with Cilgavimab. |
| Cinchocaine | The risk or severity of methemoglobinemia can be increased when Durvalumab is combined with Cinchocaine. |
| Cocaine | The risk or severity of methemoglobinemia can be increased when Durvalumab is combined with Cocaine. |
| Coestrogens | Conjugated estrogens may increase the thrombogenic activities of Durvalumab. |
| Corticotropin | The therapeutic efficacy of Durvalumab can be decreased when used in combination with Corticotropin. |
| Cortisone acetate | The therapeutic efficacy of Durvalumab can be decreased when used in combination with Cortisone acetate. |
| Daratumumab | The risk or severity of adverse effects can be increased when Daratumumab is combined with Durvalumab. |
| Darbepoetin alfa | The risk or severity of Thrombosis can be increased when Darbepoetin alfa is combined with Durvalumab. |
| Deflazacort | The therapeutic efficacy of Durvalumab can be decreased when used in combination with Deflazacort. |
| Denosumab | The risk or severity of adverse effects can be increased when Denosumab is combined with Durvalumab. |
| Dexamethasone | The therapeutic efficacy of Durvalumab can be decreased when used in combination with Dexamethasone. |
| Dienestrol | Dienestrol may increase the thrombogenic activities of Durvalumab. |
| Diethylstilbestrol | Diethylstilbestrol may increase the thrombogenic activities of Durvalumab. |
| Digoxin | The risk or severity of adverse effects can be increased when Digoxin Immune Fab (Ovine) is combined with Durvalumab. |
| Dinutuximab | The risk or severity of adverse effects can be increased when Dinutuximab is combined with Durvalumab. |
| Diphenhydramine | The risk or severity of methemoglobinemia can be increased when Durvalumab is combined with Diphenhydramine. |
| Dostarlimab | The risk or severity of adverse effects can be increased when Durvalumab is combined with Dostarlimab. |
| Dulaglutide | The risk or severity of adverse effects can be increased when Dulaglutide is combined with Durvalumab. |
| Dupilumab | The risk or severity of adverse effects can be increased when Durvalumab is combined with Dupilumab. |
| Dyclonine | The risk or severity of methemoglobinemia can be increased when Durvalumab is combined with Dyclonine. |
| Ebola Zaire vaccine | The therapeutic efficacy of Ebola Zaire vaccine (live, attenuated) can be decreased when used in combination with Durvalumab. |
| Eculizumab | The risk or severity of adverse effects can be increased when Eculizumab is combined with Durvalumab. |
| Efalizumab | The risk or severity of adverse effects can be increased when Efalizumab is combined with Durvalumab. |
| Eflapegrastim | The risk or severity of adverse effects can be increased when Durvalumab is combined with Eflapegrastim. |
| Eftrenonacog alfa | The risk or severity of adverse effects can be increased when Eftrenonacog alfa is combined with Durvalumab. |
| Elotuzumab | The risk or severity of adverse effects can be increased when Elotuzumab is combined with Durvalumab. |
| Emapalumab | The risk or severity of adverse effects can be increased when Durvalumab is combined with Emapalumab. |
| Emicizumab | The risk or severity of adverse effects can be increased when Durvalumab is combined with Emicizumab. |
| Eptinezumab | The risk or severity of adverse effects can be increased when Durvalumab is combined with Eptinezumab. |
| Erenumab | The risk or severity of adverse effects can be increased when Durvalumab is combined with Erenumab. |
| Erythropoietin | The risk or severity of Thrombosis can be increased when Erythropoietin is combined with Durvalumab. |
| Esterified | Esterified estrogens may increase the thrombogenic activities of Durvalumab. |
| Estetrol | Estetrol may increase the thrombogenic activities of Durvalumab. |
| Estradiol | Estradiol may increase the thrombogenic activities of Durvalumab. |
| Estradiol acetate | Estradiol acetate may increase the thrombogenic activities of Durvalumab. |
| Estradiol benzoate | Estradiol benzoate may increase the thrombogenic activities of Durvalumab. |
| Estradiol cypionate | Estradiol cypionate may increase the thrombogenic activities of Durvalumab. |
| Estradiol valerate | Estradiol valerate may increase the thrombogenic activities of Durvalumab. |
| Estriol | Estriol may increase the thrombogenic activities of Durvalumab. |
| Estrone | Estrone may increase the thrombogenic activities of Durvalumab. |
| Estrone sulfate | Estrone sulfate may increase the thrombogenic activities of Durvalumab. |
| Ethinylestradiol | Ethinylestradiol may increase the thrombogenic activities of Durvalumab. |
| Ethyl chloride | The risk or severity of methemoglobinemia can be increased when Durvalumab is combined with Ethyl chloride. |
| Etidocaine | The risk or severity of methemoglobinemia can be increased when Durvalumab is combined with Etidocaine. |
| Evolocumab | The risk or severity of adverse effects can be increased when Evolocumab is combined with Durvalumab. |
| Fanolesomab | The risk or severity of adverse effects can be increased when Durvalumab is combined with Fanolesomab. |
| Fludrocortisone | The therapeutic efficacy of Durvalumab can be decreased when used in combination with Fludrocortisone. |
| Flunisolide | The therapeutic efficacy of Durvalumab can be decreased when used in combination with Flunisolide. |
| Fluprednisolone | The therapeutic efficacy of Durvalumab can be decreased when used in combination with Fluprednisolone. |
| Fremanezumab | The risk or severity of adverse effects can be increased when Durvalumab is combined with Fremanezumab. |
| Galcanezumab | The risk or severity of adverse effects can be increased when Durvalumab is combined with Galcanezumab. |
| Gemtuzumab | The risk or severity of adverse effects can be increased when Gemtuzumab ozogamicin is combined with Durvalumab. |
| Golimumab | The risk or severity of adverse effects can be increased when Golimumab is combined with Durvalumab. |
| Guselkumab | The risk or severity of adverse effects can be increased when Durvalumab is combined with Guselkumab. |
| Hepatitis | The risk or severity of adverse effects can be increased when Hepatitis B immune globulin is combined with Durvalumab. |
| cytomegalovirus | The risk or severity of adverse effects can be increased when Durvalumab is combined with Human cytomegalovirus immune globulin. |
| Himmunoglobulin | The risk or severity of adverse effects can be increased when Human immunoglobulin G is combined with Durvalumab. |
| H immune globulin | The risk or severity of adverse effects can be increased when Human Rho(D) immune globulin is combined with Durvalumab. |
| Human globulin | The risk or severity of adverse effects can be increased when Human varicella-zoster immune globulin is combined with Durvalumab. |
| Hydrocortisone | The therapeutic efficacy of Durvalumab can be decreased when used in combination with Hydrocortisone. |
| Ibalizumab | The risk or severity of adverse effects can be increased when Durvalumab is combined with Ibalizumab. |
| Ibritumomab | The risk or severity of adverse effects can be increased when Ibritumomab tiuxetan is combined with Durvalumab. |
| Idarucizumab | The risk or severity of adverse effects can be increased when Idarucizumab is combined with Durvalumab. |
| Imdevimab | The risk or severity of adverse effects can be increased when Durvalumab is combined with Imdevimab. |
| Imlifidase | The therapeutic efficacy of Durvalumab can be decreased when used in combination with Imlifidase. |
| Inebilizumab | The risk or severity of adverse effects can be increased when Durvalumab is combined with Inebilizumab. |
| Infliximab | The risk or severity of adverse effects can be increased when Infliximab is combined with Durvalumab. |
| Inotuzumab | The risk or severity of adverse effects can be increased when Inotuzumab ozogamicin is combined with Durvalumab. |
| Ipilimumab | The risk or severity of adverse effects can be increased when Ipilimumab is combined with Durvalumab. |
| Isatuximab | The risk or severity of adverse effects can be increased when Durvalumab is combined with Isatuximab. |
| Ixekizumab | The risk or severity of adverse effects can be increased when Ixekizumab is combined with Durvalumab. |
| Lanadelumab | The risk or severity of adverse effects can be increased when Durvalumab is combined with Lanadelumab. |
| Levobupivacaine | The risk or severity of methemoglobinemia can be increased when Durvalumab is combined with Levobupivacaine. |
| Lidocaine | The risk or severity of methemoglobinemia can be increased when Durvalumab is combined with Lidocaine. |
| Loncastuximab | The risk or severity of adverse effects can be increased when Durvalumab is combined with Loncastuximab tesirine. |
| Maftivimab | The risk or severity of adverse effects can be increased when Durvalumab is combined with Maftivimab. |
| Margetuximab | The risk or severity of adverse effects can be increased when Durvalumab is combined with Margetuximab. |
| Meloxicam | The risk or severity of methemoglobinemia can be increased when Durvalumab is combined with Meloxicam. |
| Mepivacaine | The risk or severity of methemoglobinemia can be increased when Durvalumab is combined with Mepivacaine. |
| Mepolizumab | The risk or severity of adverse effects can be increased when Mepolizumab is combined with Durvalumab. |
| Meprednisone | The therapeutic efficacy of Durvalumab can be decreased when used in combination with Meprednisone. |
| Mestranol | Mestranol may increase the thrombogenic activities of Durvalumab. |
| Methoxy | The risk or severity of Thrombosis can be increased when Methoxy polyethylene glycol-epoetin beta is combined with Durvalumab. |
| Methylprednisolone | The therapeutic efficacy of Durvalumab can be decreased when used in combination with Methylprednisolone. |
| Mirvetuximab | The risk or severity of adverse effects can be increased when Durvalumab is combined with Mirvetuximab Soravtansine. |
| Mogamulizumab | The risk or severity of adverse effects can be increased when Durvalumab is combined with Mogamulizumab. |
| Mosunetuzumab | The risk or severity of adverse effects can be increased when Durvalumab is combined with Mosunetuzumab. |
| Muromonab | The risk or severity of adverse effects can be increased when Muromonab is combined with Durvalumab. |
| Natalizumab | The risk or severity of adverse effects can be increased when Natalizumab is combined with Durvalumab. |
| Necitumumab | The risk or severity of adverse effects can be increased when Necitumumab is combined with Durvalumab. |
| Nivolumab | The risk or severity of adverse effects can be increased when Nivolumab is combined with Durvalumab. |
| Obiltoxaximab | The risk or severity of adverse effects can be increased when Obiltoxaximab is combined with Durvalumab. |
| Obinutuzumab | The risk or severity of adverse effects can be increased when Obinutuzumab is combined with Durvalumab. |
| Ocrelizumab | The risk or severity of adverse effects can be increased when Durvalumab is combined with Ocrelizumab. |
| Odesivimab | The risk or severity of adverse effects can be increased when Durvalumab is combined with Odesivimab. |
| Ofatumumab | The risk or severity of adverse effects can be increased when Ofatumumab is combined with Durvalumab. |
| Olaratumab | The risk or severity of adverse effects can be increased when Olaratumab is combined with Durvalumab. |
| Omalizumab | The risk or severity of adverse effects can be increased when Omalizumab is combined with Durvalumab. |
| Oxetacaine | The risk or severity of methemoglobinemia can be increased when Durvalumab is combined with Oxetacaine. |
| Oxybuprocaine | The risk or severity of methemoglobinemia can be increased when Durvalumab is combined with Oxybuprocaine. |
| Palivizumab | The risk or severity of adverse effects can be increased when Palivizumab is combined with Durvalumab. |
| Panitumumab | The risk or severity of adverse effects can be increased when Panitumumab is combined with Durvalumab. |
| Peginesatide | The risk or severity of Thrombosis can be increased when Peginesatide is combined with Durvalumab. |
| Pembrolizumab | The risk or severity of adverse effects can be increased when Pembrolizumab is combined with Durvalumab. |
| Pertuzumab | The risk or severity of adverse effects can be increased when Pertuzumab is combined with Durvalumab. |
| Phenol | The risk or severity of methemoglobinemia can be increased when Durvalumab is combined with Phenol. |
| Polatuzumab | The risk or severity of adverse effects can be increased when Durvalumab is combined with Polatuzumab vedotin. |
| Polyestradiol | Polyestradiol phosphate may increase the thrombogenic activities of Durvalumab. |
| Pramocaine | The risk or severity of methemoglobinemia can be increased when Durvalumab is combined with Pramocaine. |
| Prednisolone | The therapeutic efficacy of Durvalumab can be decreased when used in combination with Prednisolone. |
| Prednisone | The therapeutic efficacy of Durvalumab can be decreased when used in combination with Prednisone. |
| Prilocaine | The risk or severity of methemoglobinemia can be increased when Durvalumab is combined with Prilocaine. |
| Procaine | The risk or severity of methemoglobinemia can be increased when Durvalumab is combined with Procaine. |
| Proparacaine | The risk or severity of methemoglobinemia can be increased when Durvalumab is combined with Proparacaine. |
| Propoxycaine | The risk or severity of methemoglobinemia can be increased when Durvalumab is combined with Propoxycaine. |
| Quinestrol | Quinestrol may increase the thrombogenic activities of Durvalumab. |
| Ramucirumab | The risk or severity of adverse effects can be increased when Ramucirumab is combined with Durvalumab. |
| Ranibizumab | The risk or severity of adverse effects can be increased when Ranibizumab is combined with Durvalumab. |
| Ravulizumab | The risk or severity of adverse effects can be increased when Ravulizumab is combined with Durvalumab. |
| Raxibacumab | The risk or severity of adverse effects can be increased when Raxibacumab is combined with Durvalumab. |
| Reslizumab | The risk or severity of adverse effects can be increased when Reslizumab is combined with Durvalumab. |
| Risankizumab | The risk or severity of adverse effects can be increased when Durvalumab is combined with Risankizumab. |
| Rituximab | The risk or severity of adverse effects can be increased when Rituximab is combined with Durvalumab. |
| Romosozumab | The risk or severity of adverse effects can be increased when Durvalumab is combined with Romosozumab. |
| Ropivacaine | The risk or severity of methemoglobinemia can be increased when Durvalumab is combined with Ropivacaine. |
| Sacituzumab | The risk or severity of adverse effects can be increased when Durvalumab is combined with Sacituzumab govitecan. |
| Sarilumab | The risk or severity of adverse effects can be increased when Durvalumab is combined with Sarilumab. |
| Secukinumab | The risk or severity of adverse effects can be increased when Secukinumab is combined with Durvalumab. |
| Siltuximab | The risk or severity of adverse effects can be increased when Siltuximab is combined with Durvalumab. |
| Sotrovimab | The risk or severity of adverse effects can be increased when Durvalumab is combined with Sotrovimab. |
| Spesolimab | The risk or severity of adverse effects can be increased when Durvalumab is combined with Spesolimab. |
| Sulesomab | The risk or severity of adverse effects can be increased when Durvalumab is combined with Sulesomab. |
| Sutimlimab | The risk or severity of adverse effects can be increased when Durvalumab is combined with Sutimlimab. |
| S Estrogens, A | Synthetic Conjugated Estrogens, A may increase the thrombogenic activities of Durvalumab. |
| SEstrogens, B | Synthetic Conjugated Estrogens, B may increase the thrombogenic activities of Durvalumab. |
| Tafasitamab | The risk or severity of adverse effects can be increased when Durvalumab is combined with Tafasitamab. |
| Teplizumab | The risk or severity of adverse effects can be increased when Teplizumab is combined with Durvalumab. |
| Tetanus immune | The risk or severity of adverse effects can be increased when Tetanus immune globulin, human is combined with Durvalumab. |
| Tetracaine | The risk or severity of methemoglobinemia can be increased when Durvalumab is combined with Tetracaine. |
| Tezepelumab | The risk or severity of adverse effects can be increased when Durvalumab is combined with Tezepelumab. |
| Tibolone | Tibolone may increase the thrombogenic activities of Durvalumab. |
| Tildrakizumab | The risk or severity of adverse effects can be increased when Durvalumab is combined with Tildrakizumab. |
| Tisotumab vedotin | The risk or severity of adverse effects can be increased when Durvalumab is combined with Tisotumab vedotin. |
| Tixagevimab | The risk or severity of adverse effects can be increased when Durvalumab is combined with Tixagevimab. |
| Tocilizumab | The risk or severity of adverse effects can be increased when Tocilizumab is combined with Durvalumab. |
| Tositumomab | The risk or severity of adverse effects can be increased when Tositumomab is combined with Durvalumab. |
| Tralokinumab | The risk or severity of adverse effects can be increased when Durvalumab is combined with Tralokinumab. |
| Trastuzumab | The risk or severity of adverse effects can be increased when Trastuzumab is combined with Durvalumab. |
| Trastuzumab | The risk or severity of adverse effects can be increased when Durvalumab is combined with Trastuzumab deruxtecan. |
| Trastuzumab | The risk or severity of adverse effects can be increased when Trastuzumab emtansine is combined with Durvalumab. |
| Tremelimumab | The risk or severity of adverse effects can be increased when Durvalumab is combined with Tremelimumab. |
| Triamcinolone | The therapeutic efficacy of Durvalumab can be decreased when used in combination with Triamcinolone |
Pregnancy And Lactation
AU TGA pregnancy category: D
US FDA pregnancy category: Not assigned.
Pregnancy
This drug caused an increase in premature delivery, fetal loss, and premature neonatal death in animal studies. Human immunoglobulin G1 (IgG1) crosses the placental barrier; therefore, this drug can be transmitted from the mother to the developing fetus. This drug can harm a developing fetus. Women of childbearing potential should use effective contraception during therapy and for at least 3 months after the last dose. If this drug is used during pregnancy, or if the patient becomes pregnant while taking this drug, the patient should be apprised of the potential harm to the fetus.
Lactation
There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.
How should this medicine be used?
Durvalumab injection comes as a as a liquid to be injected into a vein over 60 minutes by a doctor or nurse in a hospital or medical facility. For the treatment of NSCLC, it is usually given once every 2 or 4 weeks for as long as your doctor recommends you receive treatment or for NSCLC up to one year. For the treatment of ES-SCLC, it is usually given once every 3 weeks for 4 cycles with the other medications, and then alone once every 4 weeks for as long as your doctor recommends you receive treatment. For the treatment of BTC, it is usually given once every 3 weeks for 8 cycles with the other medications, and then alone once every 4 weeks for as long as your doctor recommends you receive treatment.
Durvalumab injection may cause serious or life-threatening reactions during an infusion. A doctor or nurse will watch you closely while you are receiving the infusion and shortly after the infusion to be sure you are not having a serious reaction to the medication. Tell your doctor or nurse immediately if you experience any of the following symptoms that may occur during or after the infusion: chills or shaking, itching, rash, flushing, difficulty breathing, wheezing, dizziness, fever, feeling faint, back or neck pain, or swelling of your face.
Your doctor may slow down your infusion, delay or stop your treatment with durvalumab injection, or treat you with additional medications depending on your response to the medication and any side effects that you experience. Talk to your doctor about how you are feeling during your treatment.
Your doctor or pharmacist will give you the manufacturer’s patient information sheet (Medication Guide) when you begin treatment with durvalumab injection and each time you receive a dose. Read the information carefully and ask your doctor or pharmacist if you have any questions. You can also visit the Food and Drug Administration (FDA) website (http://www.fda.gov/Drugs/DrugSafety/ucm085729.htm) or the manufacturer’s website to obtain the Medication Guide.
What special precautions should I follow?
Before receiving durvalumab injection,
- tell your doctor and pharmacist if you are allergic to durvalumab, any other medications, or any of the ingredients in durvalumab injection. Ask your pharmacist or check the Medication Guide for a list of the ingredients.
- tell your doctor and pharmacist what prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking or plan to take. Your doctor may need to change the doses of your medications or monitor you carefully for side effects.
- tell your doctor if you have ever had an organ or bone marrow transplant and if you have or have ever had radiation therapy to your chest area. Also tell your doctor if you have or have ever had an autoimmune disease (condition in which the immune system attacks a healthy part of the body) such as Crohn’s disease (condition in which the immune system attacks the lining of the digestive tract causing pain, diarrhea, weight loss, and fever), ulcerative colitis (condition that causes swelling and sores in the lining of the colon [large intestine] and rectum), or lupus (condition in which the immune system attacks many tissues and organs including the skin, joints, blood, and kidneys); any condition that affects your nervous system such as myasthenia gravis (a disorder of the nervous system that causes muscle weakness) or Guillain-Barré syndrome (weakness, tingling, and possible paralysis due to sudden nerve damage); any type of lung disease or breathing problems; diabetes; thyroid problems; or kidney or liver disease. Also tell your doctor if you have or have ever had cytomegalovirus (CMV; a viral infection that may cause symptoms in patients with weak immune systems).
- tell your doctor if you are pregnant or plan to become pregnant. You should not become pregnant while you are receiving durvalumab injection. You should use effective birth control to prevent pregnancy during your treatment with durvalumab injection and for at least 3 months after your final dose. Talk to your doctor about birth control methods that will work for you. If you become pregnant while receiving durvalumab injection, call your doctor immediately. Durvalumab injection may harm the fetus.
- tell your doctor if you are breastfeeding or plan to breastfeed. You should not breastfeed while receiving durvalumab injection and for at least 3 months after your final dose.
References