Erbitux Infusion
Cetuximab
5 mg/ml
Janata Pharma
| Pack size | 20 ml |
|---|---|
| Dispensing mode | |
| Source | |
| Agent | |
| Retail Price | 28642.00 AED |
Indications
Erbitux Infusion is used for:
Advanced colorectal cancer, Squamous cell carcinoma of the head and neck
Adult Dose
Intravenous
KRAS Wild-type, EGFR Expressing Metastatic Colorectal Cancer
Indicated for KRAS mutation-negative (wild-type), epidermal growth factor receptor (EGFR)-expressing colorectal cancer (CRC) as determine by FDA-approved tests
Indicated in combination with irinotecan, fluorouracil, leucovorin for first-line treatment
Indicated in combination with irinotecan in patients refractory to irinotecan-based chemotherapy
Indicated as a single agent in failed oxaliplatin- and irinotecan-based chemotherapy or in patients intolerant to irinotecan
Weekly dosage
Initial dose: 400 mg/m2 via IV infusion over 120 minutes.
Subsequent doses: 250 mg/m2 once weekly via IV infusion over 60 minutes until disease progression or unacceptable toxicity
Biweekly dosage
Initial and subsequent doses: 500 mg/m2 IV q2Weeks until disease progression or unacceptable toxicity
BRAF V600E Mutation-Positive Metastatic Colorectal Cancer
Indication in combination with encorafenib for metastatic colorectal cancer (CRC) with a BRAF V600E mutation (as determine by FDA-approved test) after prior therapy
Initial: 400 mg/m2 via IV infusion over 120 minutes.
Subsequent doses: 250 mg/m2 once weekly via IV infusion over 60 minutes until disease progression or unacceptable toxicity
Advanced Squamous Cell Carcinoma of Head & Neck
Indicated in combination with radiation therapy for initial treatment of local or regional cancer
Indicated in combination with platinum-based therapy with 5-FU for first-line treatment of patients with recurrent locoregional disease or metastatic form
Indicated as monotherapy in patients with recurrent or metastatic carcinoma for whom prior platinum-based therapy failed
Weekly dosage
Initial dose: 400 mg/m2 via IV infusion over 120 minutes.
Subsequent doses: 250 mg/m2 once weekly via IV infusion over 60 minutes until disease progression or unacceptable toxicity
With radiation: Initiate 1 week prior to beginning radiation therapy, continue weekly for 6-7 weeks
Biweekly dosage
Initial dose and subsequent doses: 500 mg/m2 IV q2Weeks until disease progression or unacceptable toxicity
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 reactions
Severe infusion reactions occurred with this agent in ~3% of patients in clinical trials, with fatal outcome reported in less than 1 in 1000
Immediately interrupt and permanently discontinue cetuximab infusion for serious infusion reactions
Cardiopulmonary arrest
Cardiopulmonary arrest and/or sudden death occurred in 2% (4/208) of patients with squamous cell carcinoma of the head and neck treated with radiation therapy and cetuximab
Closely monitor serum electrolytes, including serum magnesium, potassium, and calcium, during and after cetuximab therapy
Infusion Reactions: Monitor patients following infusion.
Immediately stop and permanently discontinue Cetuximab for serious infusion reactions.
Cardiopulmonary Arrest: Monitor serum electrolytes during and after Cetuximab.
Pulmonary Toxicity: Interrupt or permanently discontinue for acute onset or worsening of pulmonary symptoms.
Dermatologic Toxicity: Monitor for dermatologic toxicities or infectious sequelae. Limit sun exposure.
Hypomagnesemia and Accompanying Electrolyte Abnormalities:
Monitor during treatment and for at least 8 weeks following the completion. Replete electrolytes as necessary.
Increased tumor progression, increased mortality, or lack of benefit observed in patients with Ras-mutant mCRC.
Embryo-Fetal Toxicity: Can cause fetal harm. Advise females of potential risk to the fetus and to use effective contraception.
MONITORING PARAMETERS
Monitor serum electrolytes during and after (for at least 8 wk) cetuximab therapy.
Monitor for signs and symptoms of infusion-related reactions.
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 5 mg/ml Infusion manufactured by Janata Pharma. Its generic name is Cetuximab. Erbitux is availble in Bangladesh.
Farmaco BD drug index information on Erbitux Infusion is not intended for diagnosis, medical advice or treatment; neither intended to be a substitute for the exercise of professional judgment.