Erbitux solution for infusion
Cetuximab
5mg/ml
MERCK KGAA,
| Pack size | 20ml Glass Vial |
|---|---|
| Dispensing mode | POM |
| Source | GERMANY |
| Agent | Modern Pharmaceutical Co. |
| Retail Price | 1362.00 AED |
Indications
Erbitux solution for infusion is used for:
Advanced colorectal cancer, Squamous cell carcinoma of the head and neck
Adult Dose
Intravenous
Advanced colorectal cancer
Adult: Loading: As monotherapy or in combination with irinotecan, flourouracil, leucovorin (FOLFIRI): 400 mg/m2 via IV infusion over 120 minutes. Maintenance dose: 250 mg/m2 once weekly via IV infusion over 60 minutes.
Squamous cell carcinoma of the head and neck
Adult: As monotherapy or in combination with radiation therapy or platinum-based therapy and fluorouracil: Initial dose: 400 mg/m2 via IV infusion over 120 minutes 1 week prior to initiation of treatment. Maintenance dose: 250 mg/m2 infused over 60 minutes for 6-7 weeks during the duration of radiation therapy or until disease progression, or unacceptable toxicity when administered with platinum-based therapy.
Child Dose
Renal Dose
Administration
IV Preparation
Do not shake or dilute
Discard unused portion after 8 hr at room temp & 12 hr if refrigerated
IV Administration
Do not administer as an IV push or bolus
Administer via infusion pump or syringe pump IV infusion: initial dose over 2 hr and weekly maintenance dose over 1 hr
Do not exceed an infusion rate of 10 mg/min
Administer through low protein binding 0.22-micrometer in-line filter
Visually inspect for particulate matter and discoloration prior to administration; solution should be clear and colorless and may contain a small amount of easily visible, white, amorphous, cetuximab particulates
Do not shake or dilute
Contra Indications
Precautions
Infusion rate should be reduced if patient exhibits signs of toxicity. Discontinue treatment if there is severe infusion reactions. Caution when used in patients with history of coronary artery disease, heart failure and arrhythmias. Monitor serum electrolytes during and after (for at least 8 wk) cetuximab therapy. Exposure to sunlight may worsen skin reactions. Risk of interstitial lung disease in patients with preexisting lung disease. Dose should be modified if there is occurrence of severe acneiform rash, refer to product insert/SPG for dosing guidelines.
Lactation
There is no information regarding the presence of drug in human milk, the effects on the breastfed infant, or the effects on milk production
Human IgG antibodies can be excreted in human milk
Due to potential for serious adverse reactions in breastfed infants, advise women not to breastfeed during treatment and for 2 months after last dose
Pregnancy-Lactation
Pregnancy
Based on findings from animal studies and its mechanism of action, cetuximab can cause fetal harm when administered to pregnant women
There are no available data in pregnant women; advise pregnant women of the potential risk to a fetus
Verify pregnancy status in females of reproductive potential prior to initiating treatment
Human IgG is known to cross the placental barrier; therefore, cetuximab may be transmitted from the mother to the developing fetus
Contraception
Advise females of reproductive potential to use effective contraception during treatment and for 2 months after last dose
Infertility
Based on animal studies, cetuximab may impair fertility in females of reproductive potential
Lactation
There is no information regarding the presence of drug in human milk, the effects on the breastfed infant, or the effects on milk production
Human IgG antibodies can be excreted in human milk
Due to potential for serious adverse reactions in breastfed infants, advise women not to breastfeed during treatment and for 2 months after last dose
Interactions
Adverse Effects
Side effects of Cetuximab :
>10% (Monotherapy)
Rash/desquamation (95%)
Fatigue (91%)
Nausea (64%)
Other pain (59%)
Dry skin (57%)
Constipation (53%)
Dyspnea (49%)
Pruritus (47%)
Sensory neuropathy (45%)
Diarrhea (42%)
Vomiting (40%)
Headache (38%)
Infections with neutropenia (38%)
Other dermatology (35%)
Stomatitis (32%)
Fatigue (31%)
Nail changes (31%)
Insomnia (27%)
Fever (25%)
Other gastrointestinal (22%)
Infusion reactions (18%)
Confusion (18%)
Other pain, Grade 3 or 4 (18%)
Rigors or chills (16%)
Dyspnea, Grade 3 or 4 (16%)
Rash/desquamation, Grade 3 or 4 (16%)
Anxiety (14%)
Depression (14%)
Dehydration (13%)
Mouth dryness (12%)
Other gastrointestinal, Grade 3 or 4 (12%)
Infections with neutropenia, Grade 3 or 4 (11%)
1-10% (Monotherapy)
Taste disturbance (10%)
Nausea (6%)
Confusion, Grade 3 or 4 (6%)
Vomiting, Grade 3 or 4 (5%)
Bone pain (4%)
Infusion reactions, Grade 3 or 4 (3%)
Fever, Grade 3 or 4 (3%)
Constipation, Grade 3 or 4 (3%)
Arthralgia, Grade 3 or 4 (3%)
Diarrhea, Grade 3 or 4 (2%)
Pruritus, Grade 3 or 4 (2%)
Headache, Grade 3 or 4 (2%)
Rigors or chills, Grade 3 or 4 (1%)
Stomatitis, Grade 3 or 4 (1%)
Mechanism of Action
Cetuximab is a recombinant human/mouse chimeric monoclonal antibody. It binds specifically to the epidermal growth factor receptor (EGFR), thus competitively inhibiting the binding of epidermal growth factor (EGF) and other ligands. This blocks phosphorylation and activation of receptor-associated kinases, thus inhibiting cell growth, inducing apoptosis and decreases matrix metalloproteinase and vascular EGF production.
Note
Erbitux 5mg/ml solution for infusion manufactured by MERCK KGAA,. Its generic name is Cetuximab. Erbitux is availble in United Arab Emirates.
Farmaco UAE drug index information on Erbitux solution for infusion is not intended for diagnosis, medical advice or treatment; neither intended to be a substitute for the exercise of professional judgment.