Portrazza Injection
Necitumumab
16mg/ml
ELI LILLY AND COMPANY
| Pack size | 1 Glass Vial |
|---|---|
| Dispensing mode | POM |
| Source | USA |
| Agent | PHARMATRADE |
| Retail Price | 21403.00 AED |
Indications
Portrazza Injection is used for:
Non-small Cell Lung Cancer
Indicated for first-line treatment of metastatic squamous NSCLC in combination with gemcitabine and cisplatin
Adult Dose
Non-small Cell Lung Cancer
Indicated for first-line treatment of metastatic squamous NSCLC in combination with gemcitabine and cisplatin
800 mg IV infused over 1 hr on days 1 and 8 of each 3-week cycle prior to gemcitabine and cisplatin infusion
Continue therapy until disease progression or unacceptable toxicity
Dosage Modifications
Infusion-related reactions
Grade 1: Reduce the infusion rate by 50%
Grade 2: Stop the infusion until signs and symptoms have resolved to grade 0 or 1; resume infusion at 50% reduced rate for all subsequent infusions
Grade 3 or 4 IRR: Permanently discontinue
Also see Administration
Dermatologic toxicity
Grade 3 rash or acneiform rash: Withhold until symptoms resolve to grade ?2, then resume infusion at reduced dose of 400 mg for at least 1 treatment cycle; if symptoms do not worsen, may increase dose to 600 mg and 800 mg in subsequent cycles
Permanently discontinue if
Grade 3 rash or acneiform rash do not resolve to grade ?2 within 6 wk
Reactions worsen or become intolerable at a dose of 400 mg
Patient experiences grade 3 skin induration/fibrosis
Grade 4 dermatologic toxicity
Child Dose
Renal Dose
Administration
IV Preparation
Inspect vial contents for particulate matter and discoloration prior to dilution
Discard vial if particulate matter or discoloration is identified
Dilute the required dosage volume with 0.9% NaCl in an IV infusion container to a final volume of 250 mL
Do not use solutions containing dextrose
Do not dilute with other solutions or coinfuse with other electrolytes or medication
Gently invert the container to ensure adequate mixing (do not shake)
IV Administration
Administer diluted solution via infusion pump over 1 hr through a separate infusion line
Flush line with 0.9% NaCl at the end of the infusion
Premedication
For patients who have experienced a previous grade 1 or 2 infusion-related reaction (IRR), premedicate with diphenhydramine (or equivalent) prior to all subsequent necitumumab infusions
For patients who have experienced a second grade 1 or 2 occurrence of IRR, premedicate for all subsequent infusions with diphenhydramine (or equivalent), acetaminophen, and dexamethasone (or equivalent) prior to each necitumumab infusion
Contra Indications
Hypersensitivity
Precautions
Cardiopulmonary arrest and/or sudden death occurred in 3% of patients treated with necitumumab in combination with gemcitabine and cisplatin
Closely monitor serum electrolytes, including serum magnesium, potassium, and calcium, with aggressive replacement when warranted during and after necitumumab (administer drug through dedicated IV line; do not mix with electrolyte or dextrose solutions)
Hypomagnesemia occurred in 83% of patients receiving necitumumab in combination with gemcitabine and cisplatin, and was severe in 20% of patients
Monitor patients for hypomagnesemia, hypocalcemia, and hypokalemia prior to each dose during treatment and for at least 8 weeks following completion
Withhold drug for grade 3 or 4 electrolyte abnormalities. Replete electrolytes as medically appropriate
Discontinue if severe venous or arterial thrombosis occurs
Dermatologic toxicities, including rash, dermatitis acneiform, acne, dry skin, pruritus, generalized rash, skin fissures, maculopapular rash and erythema, occurred in 79% of patients, typically within the first 2 weeks of therapy; limit sun exposure and discontinue for severe toxicity
Infusion-related reactions may occur; discontinue for severe reactions
Lactation
Unknown if distributed in human breast milk
Advise a nursing woman not to breastfeed during treatment and for 3 months following the final dose
Pregnancy-Lactation
Based on animal data and its mechanism of action, can cause fetal harm when administered during pregnancy
Interactions
Adverse Effects
Side effects of Necitumumab :
>10%
Hypomagnesemia (83%)
Hypocalcemia (45%)
Rash (44%)
Hypocalcemia (albumin corrected) (36%)
Hypophosphatemia (31%)
Vomiting (29%)
Hypokalemia (28%)
Hypomagnesemia, grade 3-4 (20%)
Diarrhea (16%)
Dermatitis acneiform (15%)
Weight decreased (13%)
Stomatitis (11%)
Headache (11%)
1-10%
Hemoptysis (10%)
Venous thromboembolic events (9%)
Acne (9%)
Hypophosphatemia, grade 3-4 (8%)
Paronychia (7%)
Conjunctivitis (7%)
Pruritus (7%)
Dry skin (7%)
Hypocalcemia, grade 3-4 (6%)
Hypokalemia, grade 3-4 (5%)
Skin fissures (5%)
Pulmonary embolism (5%)
Venous thromboembolic events, grade 3-4 (5%)
Hypocalcemia (albumin corrected), grade 3-4 (4%)
Vomiting, grade 3-4 (3%)
Diarrhea, grade 3-4 (2%)
Stomatitis, grade 3-4 (1%)
Mechanism of Action
Epidermal growth factor receptor (EGFR) inhibitor; monoclonal antibody that binds to the human EFGR and blocks interaction between EGFR and its ligands
Expression and activation of EGFR has been correlated with malignant progression, induction of angiogenesis, and inhibition of apoptosis
Note
Portrazza 16mg/ml Injection manufactured by ELI LILLY AND COMPANY. Its generic name is Necitumumab. Portrazza is availble in United Arab Emirates.
Farmaco UAE drug index information on Portrazza Injection is not intended for diagnosis, medical advice or treatment; neither intended to be a substitute for the exercise of professional judgment.