IMFINZI Injection
Durvalumab
120mg/2.4ml (50mg/ml)
AstraZeneca UK Limited
| Pack size | 1 Glass Vial (2.4 ml) |
|---|---|
| Dispensing mode | POM |
| Source | UK |
| Agent | Modern Pharmaceutical Co. |
| Retail Price | 4292.50 AED |
Available as:
Indications
IMFINZI Injection is used for:
Indicated for locally advanced or metastatic urothelial carcinoma in patients who have disease progression during or following platinum-containing chemotherapy, or disease progression within 12 months of neoadjuvant or adjuvant treatment with platinum-containing chemotherapy,
Patients w/ unresectable stage III, non-small cell lung cancer (NSCLC), whose disease has not progressed following platinum-based chemo- & radiation therapy.
Adult Dose
Adult
10 mg/kg IV infusion over 60 min every 2 wk until disease progression, unacceptable toxicity or max period: 12 mth.
Child Dose
Renal Dose
Administration
IV Preparation
Withdraw the required volume for the dose from the vial(s) and transfer into an IV bag containing 0.9% NaCl or D5W
Mix diluted solution by gentle inversion; do not shake the solution
The final concentration of the diluted solution should be between 1-15 mg/mL
Discard partially used or empty vials
Administer infusion solution immediately once prepared (also see Storage)
IV Administration
Administer diluted solution via IV infusion over 1 hr through an IV line containing a sterile, low-protein binding 0.2 or 0.22 micron inline filter
Do not co-administer other drugs through the same infusion line
Contra Indications
Precautions
Immune-mediated pneumonitis or interstitial lung disease reported; monitor for signs and symptoms; evaluate patients with suspected pneumonitis with radiographic imaging
Administer corticosteroids, prednisone 1 to 2 mg per kg per day or equivalent for moderate (Grade 2) pneumonitis or prednisone 1 to 4 mg per kg per day or equivalent for more severe (Grade 3-4) pneumonitis, followed by taper; interrupt or permanently discontinue therapy based on the severity
Immune-mediated hepatitis reported; monitor for abnormal liver tests each cycle during treatment
Immune-mediated colitis or diarrhea reported; monitor for signs and symptoms
Immune-mediated endocrinopathies (eg, hypothyroidism, hyperthyroidism, adrenal insufficiency, type 1 diabetes mellitus, hypophysitis, hypopituitarism) have occurred; monitor for symptoms of these conditions
Rare reports of other immune-mediated adverse effects (eg, aseptic meningitis, hemolytic anemia, rash, ITP, myocarditis, myositis, nephritis, uveitis, keratitis) have occurred
Severe infusion-related reactions reported; monitor for signs and symptoms and slow infusion rate or interrupt infusion if needed; if severe, withhold or permanently discontinue
Can cause fetal harm
Lactation
Unknown if distributed in human breast milk; human IgG1 is excreted in human milk
Durvalumab was present in the milk of lactating cynomolgus monkeys and was associated with premature neonatal death
Because of the potential for adverse reactions in breastfed infants, advise breastfeeding women not to breastfeed during treatment and for at least 3 months after the last dose
Pregnancy-Lactation
Pregnancy
Based on its mechanism of action, can cause fetal harm if administered to a pregnant woman
Human immunoglobulin G1 (IgG1) is known to cross the placental barrier; therefore, durvalumab has the potential to be transmitted from the mother to the developing fetus
In animal reproduction studies, administration of durvalumab to pregnant cynomolgus monkeys from the confirmation of pregnancy through delivery resulted in increased in premature delivery, fetal loss, and premature neonatal death
Contraception: Advise females of reproductive potential to use effective contraception during treatment and for 3 months following the last dose
Lactation
Unknown if distributed in human breast milk; human IgG1 is excreted in human milk
Durvalumab was present in the milk of lactating cynomolgus monkeys and was associated with premature neonatal death
Because of the potential for adverse reactions in breastfed infants, advise breastfeeding women not to breastfeed during treatment and for at least 3 months after the last dose
Interactions
Durvalumab is an immunoglobulin, therefore no formal pharmacokinetic drug-drug interaction studies have been conducted with durvalumab.
Adverse Effects
Side effects of Durvalumab :
>10%
Adverse effects are for all grades unless otherwise specified Fatigue (39%) Infusion-related reactions (29.7%) Musculoskeletal pain (24%) Constipation (21%) Decreased appetite/hypophagia Nausea (16%) Peripheral edema (15%) Urinary tract infection (15%) Pyrexia/tumor associated fever (14%) Abdominal pain (14%) Dyspnea/exertional dyspnea (13%) Diarrhea/colitis (13%) Hyponatremia, grades 3-4 (12%) Lymphopenia, grades 3-4 (11%) Rash (11%)
1-10%
Adverse effects are for all grades unless otherwise specified
Cough (10%)
Anemia, grades 3-4 (8%)
Infusion-related reactions, grades 3-4 (6%)
Increased alkaline phosphatase, grades 3-4 (4%)
Hypermagnesemia, grades 3-4 (4%)
Hypercalcemia, grades 3-4 (3%)
Hyperglycemia, grades 3-4 (3%)
Immune-mediated pneumonitis or ILD (2.3%)
Increased AST, grades 3-4 (2%)
Immune-mediated hepatitis (1.1%)
Increased ALT, grades 3-4 (1%)
Hyperbilirubinemia, grades 3-4 (1%)
Increased creatinine, grades 3-4 (1%)
Neutropenia, grades 3-4 (1%)
Hyperkalemia, grades 3-4 (1%)
Hypokalemia, grades 3-4 (1%)
Hypoalbuminemia, grades 3-4 (1%)
<1%
Immune-mediated pneumonitis or ILD, grades 3-4 (0.4%)
Mechanism of Action
Human IgG1 kappa monoclonal antibody that blocks PD-L1 binding to PD-1 and CD80, and therefore overcoming/preventing PD-L1-mediated inhibition/suppression of T-cell activation
Blockade of PD-L1/PD-1 and PD-L1/CD80 interactions releases the inhibition of immune responses, without inducing antibody dependent cell-mediated cytotoxicity
Note
IMFINZI 120mg/2.4ml (50mg/ml) Injection manufactured by AstraZeneca UK Limited. Its generic name is Durvalumab. IMFINZI is availble in United Arab Emirates.
Farmaco UAE drug index information on IMFINZI Injection is not intended for diagnosis, medical advice or treatment; neither intended to be a substitute for the exercise of professional judgment.