Durvalumab

Registered South African indications:

• Non-small cell lung cancer (NSCLC)
  - For the treatment of patients with locally advanced, unresectable NSCLC whose disease has not progressed following platinum-based chemoradiation therapy
• Small cell lung cancer (SCLC)
  - In combination with etoposide and either carboplatin or cisplatin for the first-line treatment of patients with extensive-stage small cell lung cancer (ES-SCLC)
• Hepatocellular carcinoma (HCC)
  - In combination with tremelimumab for the treatment of patients with unresectable hepatocellular carcinoma (uHCC)
• Biliary tract cancer (BTC)
  - In combination with chemotherapy for the treatment of patients with locally advanced or metastatic biliary tract cancer (BTC)

Use with caution in the following patient groups

• Pregnancy
• Breastfeeding
• Women of childbearing potential and for at least 3 months after the last dose of durvalumab
• Severe renal impairment
• Severe hepatic impairment

Immune-mediated pneumonitis

• Immune-mediated pneumonitis or interstitial lung disease, requiring systemic corticosteroids without any clear alternative cause, has been reported in patients receiving durvalumab or durvalumab in combination with tremelimumab
• Monitor patients for signs and symptoms of pneumonitis
• Suspected cases should be confirmed with radiographic imaging, excluding other infections or diseases like tuberculosis

Pneumonitis and radiation pneumonitis

• In the PACIFIC Study, pneumonitis, including both immune-mediated pneumonitis and radiation pneumonitis, occurred in patients who received durvalumab. This was particularly noted in patients who had completed concurrent chemoradiation within 1 to 42 days before starting the trial
• It is important to monitor patients for signs of pneumonitis and manage as recommended by specialist

Immune-mediated hepatitis

• Immune-mediated hepatitis, requiring systemic corticosteroids and with no clear alternate cause, has been reported in patients receiving durvalumab or durvalumab in combination with tremelimumab
• Regular monitoring of liver tests is advised before and during treatment with durvalumab
• Management guidelines for immune-mediated hepatitis should be followed

Immune-mediated colitis

• Immune-mediated colitis or diarrhoea, requiring systemic corticosteroids and without a clear alternative cause, has been observed in patients receiving durvalumab or durvalumab combined with tremelimumab
• Monitor patients for signs and symptoms of colitis or diarrhoea and manage accordingly

Immune-mediated endocrinopathies

• Hypothyroidism

  • Immune-mediated hypothyroidism has occurred in patients treated with durvalumab or its combination with tremelimumab
  • Monitor thyroid function tests before and during treatment, managing as advised

• Hyperthyroidism/ thyroiditis

  • Monitor for thyroid function abnormalities during durvalumab treatment

• Adrenal insufficiency

  • Immune-mediated adrenal insufficiency has been reported in patients on durvalumab, alone or with tremelimumab
  • Monitor for clinical signs and symptoms of adrenal insufficiency
  • Manage symptomatic adrenal insufficiency as recommended by a specialist
• Type 1 diabetes mellitus
  • Immune-mediated Type 1 diabetes mellitus, which can manifest as diabetic ketoacidosis, has been observed in patients receiving durvalumab or durvalumab in combination with tremelimumab
  • Monitor patients for clinical signs and symptoms of Type 1 diabetes mellitus
  • Manage symptomatic Type 1 diabetes mellitus as recommended by a specialist

Immune-mediated hypophysitis/ hypopituitarism

• Durvalumab treatment has been associated with immune-mediated hypophysitis or hypopituitarism
• Patients should be monitored for signs and symptoms of hypophysitis or hypopituitarism
• Symptomatic hypophysitis or hypopituitarism should be managed according to recommended guidelines

Immune-mediated nephritis

• Immune-mediated nephritis, necessitating systemic corticosteroids and without a clear alternate cause, has occurred in patients treated with durvalumab or its combination with tremelimumab
• Regular monitoring of renal function is advised before and during treatment with durvalumab
• Manage immune-mediated nephritis as recommended

Immune-mediated rash

• Immune-mediated rash or dermatitis, including conditions like pemphigoid, requiring systemic corticosteroids and with no clear alternative cause, has been reported in patients receiving durvalumab or durvalumab in combination with tremelimumab
• Monitor for signs and symptoms of rash or dermatitis and manage as recommended

Immune-mediated myocarditis

• Immune-mediated myocarditis, potentially fatal, occurred in patients treated with durvalumab or in combination with tremelimumab
• Monitor patients for signs and symptoms of immune-mediated myocarditis and manage as recommended

Other immune-mediated adverse reactions

• Due to the mechanism of action of durvalumab or its combination with tremelimumab, various other immune-mediated adverse reactions may occur
• Continuously monitor for signs and symptoms of other potential immune-mediated reactions
• These may include myasthenia gravis, myositis, polymyositis, immune thrombocytopenia, pancreatitis, and encephalitis

Infusion-related reactions

• Patients should be monitored for signs and symptoms of infusion-related reactions
• Severe infusion-related reactions have been reported in patients receiving durvalumab or durvalumab in combination with tremelimumab
• Infusion-related reactions should be managed as recommended by a specialist

Ability to drive and use machines

• Based on its pharmacodynamic properties, durvalumab is unlikely to affect the ability to drive and use machines
• However, if patients experience adverse reactions affecting their ability to concentrate and react, they should be advised to use caution when driving or operating machinery

South African recommendations

Human immunodeficiency virus (HIV)

• The safety and efficacy of durvalumab in patients with HIV have not been established

Recommendations in other jurisdictions

Traceability

• In order to improve the traceability of biological medicinal products, the tradename and the batch number of the administered product should be clearly recorded

Registered contraindications in South Africa & other jurisdictions

• Hypersensitivity to the active ingredient or any of its excipients

Forms avail. in SA and covered in this monograph: inf

South African registered indications and dosages

Non-small cell lung cancer (NSCLC)
- For the treatment of patients with locally advanced, unresectable NSCLC whose disease has not progressed following platinum-based chemoradiation therapy

• IV: 10mg/kg, as an infusion over 60min, every 2 weeks OR 1500mg, as an infusion over 60min, every 4 weeks; Treatment duration: Until disease progression or unacceptable toxicity

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Patients with a body weight of 30kg or less must receive weight-based dosing, equivalent to durvalumab 10mg/kg every 2 weeks or 20mg/kg every 4 weeks as monotherapy until weight increases to greater than 30kg

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Small cell lung cancer (SCLC)
- In combination with etoposide and either carboplatin or cisplatin for the first-line treatment of patients with extensive-stage small cell lung cancer (ES-SCLC)

• IV: 1500mg, as an infusion over 60min, every 3 weeks (21 days) for 4 cycles in combination with chemotherapy; Followed by: 1500mg, as an infusion over 60min, every 4 weeks as monotherapy; Treatment duration: Until disease progression or unacceptable toxicity

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Patients with a body weight of 30kg or less must receive weight-based dosing, equivalent to durvalumab 20mg/kg in combination with chemotherapy every 3 weeks (21 days) for 4 cycles, followed by 20mg/kg every 4 weeks as monotherapy until weight increases to greater than 30kg
Administer durvalumab prior to chemotherapy when given on the same day
When durvalumab is administered in combination with chemotherapy, refer to the Prescribing Information for etoposide and carboplatin or cisplatin for dosing information

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Hepatocellular carcinoma (HCC)
- In combination with tremelimumab for the treatment of patients with unresectable hepatocellular carcinoma (uHCC)

• IV: Single Tremelimumab Regular Interval Durvalumab (STRIDE): 300mg tremelimumab as a single priming dose in combination with durvalumab 1500mg, as an infusion over 60min at Cycle 1/Day 1; Followed by durvalumab as monotherapy, every 4 weeks; Treatment duration: As long as clinical benefit is observed or until unacceptable toxicity

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Patients with a body weight of 30kg or less must receive weight-based dosing, equivalent to durvalumab 20mg/kg and tremelimumab 4mg/kg until weight is greater than 30kg

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Administer tremelimumab prior to durvalumab on the same day. When durvalumab is administered in combination with tremelimumab, refer to the Prescribing Information for tremelimumab dosing information

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Biliary tract cancer (BTC)
- In combination with chemotherapy for the treatment of patients with locally advanced or metastatic biliary tract cancer (BTC)

• IV: 1500mg, as an infusion over 60min, every 3 weeks (21 days) in combination with chemotherapy; Followed by: 1500mg, as an infusion over 60min, every 4 weeks as monotherapy; Treatment duration: Until disease progression or until unacceptable toxicity

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Patients with a body weight of 30kg or less must receive weight-based dosing, equivalent to durvalumab 20mg/kg in combination with chemotherapy every 3 weeks (21 days) for 4 cycles, followed by 20mg/kg every 4 weeks as monotherapy until weight increases to greater than 30kg

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When durvalumab is administered in combination with chemotherapy, refer to the Prescribing Information for appropriate chemotherapeutic medicine for dosing information

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All indications
Dose escalation or reduction is not recommended. Dose withholding or discontinuation may be required based on individual safety and tolerability. In general, withhold durvalumab for severe (Grade 3) immune-mediated adverse reactions
Permanently discontinue durvalumab 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 10mg or less of prednisone or equivalent per day within 12 weeks of initiating corticosteroids

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Consult specialist for dose modifications during the management of adverse reactions

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For instructions on dilution of the medicine before administration, see Additional Prescribing Points

Not established for use in children and adolescents below 18 years

Pregnancy

South African recommendations

• Caution; not recommended
• Animal studies with durvalumab in pregnant cynomolgus monkeys showed no maternal toxicity or effects on embryofoetal development, pregnancy outcome, or postnatal development at exposure levels about 22 times higher than the clinical dose of 10 mg/kg (based on AUC)
• No available data on durvalumab use in pregnant women
• Due to its mechanism of action, durvalumab may impact pregnancy maintenance and potentially harm the foetus if administered to a pregnant woman
• Human IgG1, like durvalumab, can cross the placental barrier
• Durvalumab is not recommended during pregnancy and for women of childbearing potential not using effective contraception during treatment and for at least 3 months after the last dose

Recommendations in other jurisdictions

• Caution; not recommended
• There are no data on the use of durvalumab in pregnant women
• Based on its mechanism of action, durvalumab has the potential to impact maintenance of pregnancy, and in a mouse allogeneic pregnancy model, disruption of PD-L1 signalling was shown to result in an increase in foetal loss
• Animal studies with durvalumab are not indicative of reproductive toxicity
• Human IgG1 is known to cross the placental barrier and placental transfer of durvalumab was confirmed in animal studies
• Durvalumab may cause foetal harm when administered to a pregnant woman and is not recommended during pregnancy and in women of childbearing potential not using effective contraception during treatment and for at least 3 months after the last dose
• Women of childbearing potential should use effective contraception during treatment with durvalumab and for at least 3 months after the last dose of durvalumab

Breastfeeding

South African recommendations

• Caution; not recommended
• No information available on the presence of durvalumab in human milk, its effects on the breastfed infant, or its impact on milk production
• Human IgG, is known to be excreted in human milk. Animal studies show low-level excretion of durvalumab in breast milk when administered to pregnant cynomolgus monkeys
• Due to potential adverse effects on breastfed infants from durvalumab, it is advised that lactating women do not breastfeed during treatment and for at least 3 months following the last dose

Recommendations in other jurisdictions

• Caution; not recommended
• It is unknown whether durvalumab is secreted in human breast milk
• Available toxicological data in cynomolgus monkeys have shown low levels of durvalumab in breast milk on Day 28 after birth
• In humans, antibodies may be transferred to breast milk, but the potential for absorption and harm to the newborn is unknown. However, a potential risk to the breastfed child cannot be excluded
• A decision must be made whether to discontinue breastfeeding or to discontinue or abstain from durvalumab therapy taking into account the benefit of breastfeeding for the child and the benefit of therapy for the woman

Fertility

South African recommendations

• No data available on the potential effects of durvalumab on human fertility
• Repeat-dose toxicology studies in sexually mature cynomolgus monkeys (up to 3 months duration) showed no significant effects on male and female reproductive organs

Recommendations in other jurisdictions

• There are no data on the potential effects of durvalumab on fertility in humans or animals

Recommendations below are applicable to South Africa and other jurisdictions

• Mild to moderate: No dose adjustment recommended
• Severe: Caution; no information available

Recommendations below are applicable to South Africa and other jurisdictions

• Mild to moderate: No dose adjustment recommended
• Severe: Caution; no information available
  Durvalumab has not been studied in patients with severe hepatic impairment

Recommendations below are applicable to South Africa and other jurisdictions

• No dose adjustment recommended

Monotherapy

Infections and Infestations

Very common

• Upper respiratory tract infections
  • Laryngitis
  • Nasopharyngitis
  • Peritonsillar abscess
  • Pharyngitis
  • Rhinitis
  • Sinusitis
  • Tonsillitis
  • Tracheobronchitis

Common

• Pneumonia
  • Pneumocystis jirovecii pneumonia
  • Adenoviral pneumonia
  • Bacterial pneumonia
  • Cytomegaloviral pneumonia
  • Haemophilus pneumonia
  • Pneumococcal pneumonia
  • Streptococcal pneumonia
  • Candida pneumonia
  • Legionella pneumonia
  • Including fatal outcome
• Influenza
• Oral candidiasis
• Dental and oral soft tissue infections
  • Gingivitis
  • Oral infection
  • Periodontitis
  • Dental pulpitis
  • Tooth abscess
  • Tooth infection

Blood and Lymphatic System Disorders

Rare

• Immune thrombocytopenia
  • Including fatal outcome

Endocrine Disorders

Very common

• Hypothyroidism
  • Autoimmune hypothyroidism
  • Immune-mediated hypothyroidism
  • Increased blood thyroid stimulating hormone

Common

• Hyperthyroidism
  • Basedow's disease
  • Immune-mediated hyperthyroidism
  • Decreased blood thyroid stimulating hormone

Uncommon

• Thyroiditis
  • Autoimmune thyroiditis
  • Subacute thyroiditis
• Adrenal insufficiency

Rare

• Type 1 diabetes mellitus
• Hypophysitis/Hypopituitarism
• Diabetes insipidus

Nervous System Disorders

Rare

• Myasthenia gravis (with no events at Grade >2)
• Meningitis
  • Noninfective meningitis

Not known

• Noninfective encephalitis
  • Immune-mediated encephalitis
  • Autoimmune encephalitis
• Guillain-Barré syndrome
• Transverse myelitis (post-marketing data)

Cardiac Disorders

Rare

• Myocarditis

Respiratory, Thoracic and Mediastinal Disorders

Very common

• Cough/Productive cough

Common

• Pneumonitis
  • Including fatal outcome
• Dysphonia

Uncommon

• Interstitial lung disease

Gastrointestinal Disorders

Very common

• Diarrhoea
• Abdominal pain
  • Lower abdominal pain
  • Upper abdominal pain
  • Flank pain

Uncommon

• Colitis
  • Enteritis
  • Enterocolitis
  • Proctitis
• Pancreatitis
  • Acute pancreatitis

Hepatobiliary Disorders

Common

• Increased aspartate aminotransferase or increased alanine aminotransferase
  • Including fatal outcome
  • Increased hepatic enzyme
  • Increased transaminases

Uncommon

• Hepatitis
  • Including fatal outcome
  • Autoimmune hepatitis
  • Toxic hepatitis
  • Hepatic cytolysis
  • Hepatocellular injury
  • Acute hepatitis
  • Hepatotoxicity
  • Immune-mediated hepatitis

Skin and Subcutaneous Tissue Disorders

Very common

• Rash
  • Drug eruption
  • Eczema
  • Erythema
  • Palmar-plantar erythrodysaesthesia syndrome
  • Erythematous rash
  • Macular rash
  • Maculo-papular rash
  • Morbilliform rash
  • Papular rash
  • Pruritic rash
  • Pustular rash
  • Vesicular rash
• Pruritus

Common

• Night sweats
• Dermatitis
  • Acneiform dermatitis
  • Urticarial dermatitis

Uncommon

• Psoriasis

Rare

• Pemphigoid
  • Bullous dermatitis
  • Pemphigus

Musculoskeletal and Connective Tissue Disorders

Very Common

• Arthralgia

Common

• Myalgia

Uncommon

• Myositis

Rare

• Polymyositis
  • Including fatal outcome

Renal and Urinary Disorders

Common

• Increased blood creatinine
• Dysuria

Uncommon

• Nephritis
  • Autoimmune nephritis
  • Tubulointerstitial nephritis
  • Glomerulonephritis
  • Membranous glomerulonephritis

Rare

• Noninfective cystitis

General Disorders and Administration Site Conditions

Very common

• Pyrexia

Common

• Peripheral oedema
  • Peripheral swelling

Injury, Poisoning and Procedural Complications

Common

• Infusion-related reaction
  • Urticaria with onset on the day of dosing or 1 day after dosing

Combination with Chemotherapy

Infections and Infestations

Common

• Pneumonia
  • Pneumocystis jirovecii pneumonia
  • Adenoviral pneumonia
  • Bacterial pneumonia
  • Cytomegaloviral pneumonia
  • Haemophilus pneumonia
  • Pneumococcal pneumonia
  • Streptococcal pneumonia
  • Candida pneumonia
  • Legionella pneumonia
  • Including fatal outcome
• Upper respiratory tract infections
  • Laryngitis
  • Nasopharyngitis
  • Peritonsillar abscess
  • Pharyngitis
  • Rhinitis
  • Sinusitis
  • Tonsillitis
  • Tracheobronchitis

Uncommon

• Oral candidiasis
• Influenza
• Dental and oral soft tissue infections
  • Gingivitis
  • Oral infection
  • Periodontitis
  • Dental pulpitis
  • Tooth abscess
  • Tooth infection

Blood and Lymphatic System Disorders

Very common

• Anaemia
• Leukopenia
  • Decreased white blood cell count
• Neutropenia
  • Decreased neutrophil count
• Thrombocytopenia
  • Decreased platelet count

Common

• Febrile neutropenia
• Pancytopenia
  • Including fatal outcome

Endocrine Disorders

Common

• Adrenal insufficiency
• Hyperthyroidism
  • Basedow's disease
  • Immune-mediated hyperthyroidism
  • Decreased blood thyroid stimulating hormone
• Hypothyroidism
  • Autoimmune hypothyroidism
  • Immune-mediated hypothyroidism
  • Increased blood thyroid stimulating hormone

Uncommon

• Thyroiditis
  • Autoimmune thyroiditis
  • Subacute thyroiditis
• Type 1 diabetes mellitus

Metabolism and Nutrition Disorders

Very Common

• Decreased appetite

Nervous System Disorders

Common

• Peripheral neuropathy
  • Paraesthesia
  • Peripheral sensory neuropathy

Respiratory, Thoracic and Mediastinal Disorders

Very common

• Cough/Productive cough

Common

• Pneumonitis

Uncommon

• Interstitial lung disease
• Dysphonia

Gastrointestinal Disorders

Very common

• Diarrhoea
• Abdominal pain
  • Lower abdominal pain
  • Upper abdominal pain
  • Flank pain
• Constipation
• Nausea
• Vomiting

Common

• Stomatitis
  • Mucosal inflammation

Uncommon

• Colitis
  • Enteritis
  • Enterocolitis
  • Proctitis
• Pancreatitis
  • Acute pancreatitis

Hepatobiliary Disorders

Very common

• Increased aspartate aminotransferase or increased alanine aminotransferase
  • Increased hepatic enzyme
  • Increased transaminases

Uncommon

• Hepatitis
  • Including fatal outcome
  • Autoimmune hepatitis
  • Toxic hepatitis
  • Hepatic cytolysis
  • Hepatocellular injury
  • Acute hepatitis
  • Hepatotoxicity
  • Immune-mediated hepatitis

Skin and Subcutaneous Tissue Disorders

Very common

• Rash
  • Drug eruption
  • Eczema
  • Erythema
  • Palmar-plantar erythrodysaesthesia syndrome
  • Erythematous rash
  • Macular rash
  • Maculo-papular rash
  • Morbilliform rash
  • Papular rash
  • Pruritic rash
  • Pustular rash
  • Vesicular rash
• Alopecia
• Pruritus

Common

• Dermatitis
  • Acneiform dermatitis
  • Urticarial dermatitis

Uncommon

• Pemphigoid
  • Bullous dermatitis
  • Pemphigus
• Night sweats
• Psoriasis

Musculoskeletal and Connective Tissue Disorders

Common

• Arthralgia
• Myalgia

Renal and Urinary Disorders

• Increased blood creatinine
• Dysuria

General Disorders and Administration Site Conditions

Very common

• Pyrexia
• Fatigue
  • Asthenia

Common

• Peripheral oedema
  • Peripheral swelling

Injury, Poisoning and Procedural Complications

Common

• Infusion-related reaction
  • Urticaria with onset on the day of dosing or 1 day after dosing

• Systemic corticosteroids or immunosuppressants (see Additional Prescribing Points)

• Hepatic function
• Renal function
  - Creatinine
• Thyroid function (at baseline and periodically during treatment)
• Blood glucose
• Pregnancy status verification
  - Prior to durvalumab initiation in patients who could become pregnant
• Hepatitis B virus (HBV) screening with hepatitis B surface antigen, hepatitis B core antibody, total Ig or IgG, and antibody to hepatitis B surface antigen (prior to or at the beginning of systemic anticancer therapy)
• Cardiovascular function
  - Comprehensive assessment including history, physical examination, and screening for cardiovascular disease risk factors
  - Baseline ECG, natriuretic peptides, troponins (all patients), and echocardiogram (high-risk patients)
  - Serial ECGs and cardiac troponins prior to doses 2, 3, and 4
  - Cardiovascular risk assessment every 6 to 12 months

Additional suggested monitoring

Prior to therapy

• Full blood count (FBC) with differential
• Serum chemistries
• Creatine kinase
• Comprehensive clinical assessment
  - Including performance status, weight, body mass index, heart rate, blood pressure, and oxygen saturation
• Chest x-ray, electrocardiogram, and CT scan

During therapy

• Blood pressure
• Weight
• Heart rate
• Oxygen saturation
• Full blood count (FBC) with differential
• Serum chemistries
• Creatine kinase
• Eye exam (including intraocular pressure after 6 weeks)
• Bone mineral density
  - With long-term therapy

Additional Observations

• Clinical signs/symptoms of immune-mediated adverse reactions (including adrenal insufficiency, colitis/diarrhoea, dermatologic toxicity, diabetes/hyperglycemia, hepatitis/hepatotoxicity, hypophysitis or hypopituitarism, pneumonitis, ocular toxicity, and thyroid disorders)
• Signs/symptoms of infusion reactions
• Early signs/symptoms of transplant-related complications (if received/receiving hematopoietic stem cell transplant)
• Assess history of autoimmune conditions, organ-specific disease, endocrinopathies, neuropathy, and infectious disease (prior to therapy)
• Assess bowel habits, respiratory symptoms, skin (for rash), arthralgias, and neurologic symptoms (prior to therapy)
• Screen for infections and hyperglycemia/diabetes (during therapy)

South African recommendations

Durvalumab handling and disposal precautions

• Durvalumab is supplied as a single-dose vial without preservatives; aseptic technique is necessary
• Inspect visually for particulate matter and discolouration. Durvalumab should be clear to opalescent, colourless to slightly yellow. Discard if cloudy, discoloured, or if visible particles are present. Do not shake the vial
• Withdraw the required amount of durvalumab and transfer it into an intravenous (IV) bag containing 0.9% sodium chloride injection or 5% dextrose injection. Gently invert to mix the diluted solution. The final concentration should be between 1mg/ml and 15mg/ml. Avoid freezing or shaking the solution
• Ensure sterility of the prepared solutions
• Avoid re-entering the vial after withdrawing the medicine; use one dose per vial only
• Dispose of any unused portion remaining in the vial
• Unopened vial: Store vials under refrigeration between 2-8°C in original carton to protect from light. Do not freeze. Do not shake
• Diluted solution: Durvalumab does not contain a preservative. Administer infusion solution immediately once prepared. If infusion solution is not administered immediately and it needs to be stored, the total time from vial puncture to the start of administration should not exceed
  • 30 days at 2-8°C
  • 12 hours at or below 25°C, up to 24 hours if dilution took place in controlled and validated aseptic conditions

Administration of infusion solution

• Administer intravenously over 60 minutes using an intravenous line equipped with a sterile, low-protein binding 0.2 or 0.22 micron in-line filter
• Avoid co-administration of other medications through the same infusion line
• Any unused medicinal product or waste should be disposed of following local regulatory requirements

Recommendations in other jurisdictions

Use of systemic corticosteroids or immunosuppressants

• The use of systemic corticosteroids or immunosuppressants before starting durvalumab, except physiological dose of systemic corticosteroids (≤10mg/day prednisone or equivalent), is not recommended because of their potential interference with the pharmacodynamic activity and efficacy of durvalumab
• However, systemic corticosteroids or other immunosuppressants can be used after starting durvalumab to treat immune-related adverse reactions

Durvalumab is a fully human, immunoglobulin G1 kappa (IgG1κ) monoclonal antibody that selectively blocks the interaction of programmed cell death ligand-1 (PD-L1) with PD-1 and CD80 (B7.1). Expression of PD-L1 protein is an adaptive immune response that helps tumours evade detection and elimination by the immune system. PD-L1 can be induced by inflammatory signals (e.g., IFN-gamma) and can be expressed on both tumour cells and tumour-associated immune cells in tumour microenvironment. PD-L1 blocks T-cell function and activation through interaction with PD-1 and CD80 (B7.1). By binding to its receptors, PD-L1 reduces cytotoxic T-cell activity, proliferation and cytokine production. Durvalumab does not induce antibody-dependent cell-mediated cytotoxicity (ADCC). Selective blockade of PD-L1/PD-1 and PD-L1/CD80 interactions enhances antitumour immune responses and increases T-cell activation.

Infusion (per 2.4ml) 120mg

• Imfinzi (AstraZeneca Pharmaceuticals) originator

Infusion (per 10ml) 500mg

• Imfinzi (AstraZeneca Pharmaceuticals) originator