Vectibix Infusion
Panitumumab
20mg/ml
Amgen Europe B.V
| Pack size | 20ml Vial |
|---|---|
| Dispensing mode | POM |
| Source | NETHERLANDS |
| Agent | CITY MEDICAL STORE |
| Retail Price | 13872.50 AED |
Available as:
Indications
Vectibix Infusion is used for:
Metastatic melanoma, As adjuvant treatment of cutaneous melanoma
Adult Dose
Intravenous
Metastatic colorectal cancer
Adult: In combination with fluoropyrimidine-containing chemotherapy or as monotherapy after failure of fluoropyrimidine-, oxaliplatin-, and irinotecan-containing chemotherapy in patients with wild-type RAS cases: 6 mg/kg via infusion every 14 days over 60 minutes for dosage <1,000 mg and over 90 minutes for >1,000 mg, continued until disease progression or unacceptable toxicity.
Dose reduction, dosing interruption or discontinuation may be required according to individual safety and tolerability
Child Dose
Renal Dose
Administration
IV Preparation
Inspect vial; discard if discolored
Some particulate matter may be present, OK to use (will be removed by filter)
Withdraw dose amount & dilute to 100 mL with 0.9% NaCl (if dose >1 g, in 150 mL)
Mix by gentle inversion, do not shake
Final concentration not to exceed 10 mg/mL
Use diluted solution within 6 hr if stored at room temp, or within 24 hr if stored at 2-8°C
IV Administration
For IV infusion only; not for IV push or bolus
Use low-protein-binding 0.2-0.22 micron in-line filter
Flush IV line with 0.9% NaCl before and after administration
Use infusion pump
Doses <1 g: Infuse over 60 min through peripheral line or indwelling catheter; ; if first infusion tolerated, administer subsequent infusion over 30-60 min
Doses >1 g: Infuse IV over 90 min
Contra Indications
Interstitial pneumonitis or pulmonary fibrosis, RAS mutation-positive metastatic colorectal cancer or unknown RAS mutation status. Lactation. Concomitant use of bevacizumab-containing and IFL (irinotecan, 5-fluorouracil and leucovorin)-containing chemotherapy.
Precautions
Patient with history of keratitis, ulcerative keratitis or severe dry eye. Pregnancy.
Lactation
There are no data on presence of drug in human milk or effects of panitumumab on breastfed infant or on milk production; human IgG is present in human milk, but published data suggest that breast milk antibodies do not enter neonatal and infant circulation in substantial amounts; because of potential for serious adverse reactions in breastfed infants from therapy, advise women not to breastfeed during treatment and for 2 months after final dose
Pregnancy-Lactation
Pregnancy
Based on data from animal studies and mechanism of action; therapy can cause fetal harm when administered to pregnant women; limited available data on use of therapy in pregnant women are not sufficient to inform a risk of adverse pregnancy-related outcomes; panitumumab is a human IgG monoclonal antibody and may be transferred across the placenta during pregnancy; advise pregnant women of the potential risk to the fetus
Contraception
Females: Therapy can cause fetal harm when administered to a pregnant woman; advise females of reproductive potential to use effective contraception during treatment and for 2 months after last dose
Infertility
Females: Based on results from animal fertility studies conducted in female cynomolgus monkeys, therapy may reduce fertility in females of reproductive potential; effects in animal studies were reversible.
Lactation
There are no data on presence of drug in human milk or effects of panitumumab on breastfed infant or on milk production; human IgG is present in human milk, but published data suggest that breast milk antibodies do not enter neonatal and infant circulation in substantial amounts; because of potential for serious adverse reactions in breastfed infants from therapy, advise women not to breastfeed during treatment and for 2 months after final dose
Interactions
Potentially Fatal: Increased incidence of adverse reactions (e.g. dermatologic toxicities, severe diarrhoea and dehydration) with bevacizumab-containing chemotherapy. Increased incidence of severe diarrhoea with IFL-containing chemotherapy.
Adverse Effects
Side effects of Panitumumab :
>10%
Erythema (65%)
Acneiform dermatitis (57%)
Pruritus (57%)
Hypomagnesemia (39%)
Fatigue (26%)
Abdominal pain (25%)
Paronychia (25%)
Skin exfoliation (25%)
Nausea (23%)
Rash (22%)
Constipation (21%)
Diarrhea (21%)
Vomiting (21%)
Skin fissures (20%)
Cough (14%)
Dermatologic toxicity, Grade 3 and 4 (14% )
Acne (13%)
Peripheral edema (12%)
1-10%
Abdominal pain, Grade 3 and 4 (7% )
Pulmonary embolism, Grades 3 to 5 (7% )
Hypomagnesemia, Grade 3 and 4 (4% )
Angioedema, All grades (3% to 4% )
Complication of infusion, All grades (3% to 4% )
Constipation, Grade 3 and 4 (3% )
Binding antibodies (0.4-3.8%)
Diarrhea, Grade 3 and 4 (2% )
Vomiting, Grade 3 and 4 (2% )
Nausea, Grade 3 and 4 (1% )
Anaphylaxis (1% )
Complication of infusion, Grade 3 and 4 (1% )
Sepsis (1%)
<1%
Pulmonary fibrosis
Mechanism of Action
Panitumumab is a recombinant, human IgG2 kappa monoclonal antibody that binds to the epidermal growth factor receptor (EGFR), thereby inhibiting phosphorylation and activation of intracellular tyrosine kinases resulting in inhibition of cell growth, proliferation, transformation and overall survival of tumour cells.
Note
Vectibix 20mg/ml Infusion manufactured by Amgen Europe B.V. Its generic name is Panitumumab. Vectibix is availble in United Arab Emirates.
Farmaco UAE drug index information on Vectibix Infusion is not intended for diagnosis, medical advice or treatment; neither intended to be a substitute for the exercise of professional judgment.