Cetuximab

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Generic Name: Cetuximab Brand Name(s): Generics only. No brands available. Avability: Rx Pregnancy Category: C

Uses

What is Cetuximab used for?

Cetuximab is used to treat a certain type of cancer of the colon (large intestine) or rectum that has spread to other parts of the body. This medication is also used to treat head and neck cancer. Cetuximab works by slowing or stopping the growth of cancer cells. It binds to a certain protein (epidermal growth factor receptor-EGFR) in some tumors. Cetuximab is a man-made protein (monoclonal antibody).

How should I take Cetuximab?

Cetuximab is given by injection into a vein usually once a week by a healthcare professional. Another drug (e.g., diphenhydramine) may be given before you receive cetuximab to lessen the chance of certain side effects. The first dose (loading dose) is larger and is given over 2 hours. All other doses (maintenance doses) are smaller and are given over 1 hour if tolerated. The dosage is based on your medical condition, body size, and response to treatment.

A healthcare professional should watch you for at least 1 hour after your infusion is finished to make sure you do not have an infusion reaction. If you experience a severe infusion reaction, your infusion will be stopped and your doctor may decide to stop further treatments.

How do I store Cetuximab?

Store intact vials at 2°C to 8°C; do not freeze or shake. Increased particulate formation may occur at temperatures ≤0°C. Preparations in infusion containers are stable for up to 12 hours refrigerated at 2°C to 8°C and up to 8 hours at room temperature of 20°C to 25°C.

There may be different brands of Cetuximab that may have different storage needs. It is important to always check the product package for instructions on storage, or ask your pharmacist. For safety, you should keep all medicines away from children and pets.

You should not flush Cetuximab down the toilet or pour them into a drain unless instructed to do so. It is important to properly discard this product when it is expired or no longer needed. Consult your pharmacist for more details about how to safely discard your product.

Precautions & warnings

What should I know before using Cetuximab?

Before receiving cetuximab, tell your doctor or pharmacist if you are allergic to it, or if you have a severe allergy to meat (such as beef, pork), or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: lung disease, radiation therapy, heart disease (e.g., coronary artery disease, congestive heart failure, arrhythmias), tick bites.

This drug may make you drowsy. Alcohol or marijuana can make you more drowsy. Do not drive, use machinery, or do anything that needs alertness until you can do it safely. Limit alcoholic beverages. Talk to your doctor if you are using marijuana.

Sunlight may worsen any skin reactions that may occur while you are using this drug. Avoid prolonged sun exposure, tanning booths, and sunlamps during treatment and for 2 months after your last treatment with cetuximab. Use a sunscreen and wear protective clothing when outdoors.

This medication is not recommended for use during pregnancy. It may harm an unborn baby. Consult your doctor for more details and to discuss the use of reliable forms of birth control (such as condoms, birth control pills) while using this medication and for 2 months after the end of treatment.

Based on information from related drugs, cetuximab may pass into breast milk. Because of potential harm to the infant, breast-feeding is not recommended while using cetuximab and for 2 months after the end of treatment. Consult your doctor before breast-feeding.

Is it safe during pregnancy or breast-feeding?

There are no adequate studies in women for determining risk when using this Cetuximab during pregnancy or while breastfeeding. Please always consult with your doctor to weigh the potential benefits and risks before taking Cetuximab. Cetuximab is pregnancy risk category C according to the US Food and Drug Administration (FDA).

FDA pregnancy risk category reference below:

  • A=No risk,
  • B=No risk in some studies,
  • C=There may be some risk,
  • D=Positive evidence of risk,
  • X=Contraindicated,
  • N=Unknown

Side effects

What side effects can occur from Cetuximab?

Nausea, vomiting, constipation, diarrhea, headache, stomachache, backache, fever/chills, trouble sleeping, weight loss, fatigue, drowsiness, eye redness/itching, nail changes, dry skin, and mouth/throat sores may occur. Nausea and vomiting can be quite severe. In some cases, drug therapy may be necessary to prevent or relieve nausea and vomiting. Not eating before your treatment may help relieve vomiting. Changes in diet such as eating several small meals or limiting activity may help lessen some of these effects. If these effects persist or worsen, notify your doctor or pharmacist promptly.

People using this medication may have serious side effects. However, your doctor has prescribed this drug because he or she has judged that the benefit to you is greater than the risk of side effects. Careful monitoring by your doctor may decrease your risk.

An acne-like rash may occur. Depending on how severe this rash is, your doctor may delay your cetuximab treatment, lower your dose, treat the rash with antibiotics, or stop treatment with cetuximab to decrease this potentially serious side effect.

Tell your doctor right away if any of these unlikely but serious side effects occur: confusion, depression, swelling of hands/feet/lower legs, dehydration, serious infection (e.g., high fever, chills, persistent sore throat), signs of kidney problems (such as change in the amount of urine), decreased vision, severe dizziness, fast/slow/irregular heartbeat, severe muscle spasms.

Rarely, very serious lung problems may occur. Seek immediate medical attention if you develop: trouble breathing.

A very serious allergic reaction to this drug is unlikely, but seek immediate medical attention if it occurs. Symptoms of a serious allergic reaction may include: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

Not everyone experiences these side effects. There may be some side effects not listed above. If you have any concerns about a side-effect, please consult your doctor or pharmacist.

Interactions

What drugs may interact with Cetuximab?

Cetuximab may interact with other drugs that you are currently taking, which can change how your drug works or increase your risk for serious side effects. To avoid any potential drug interactions, you should keep a list of all the drugs you are using (including prescription drugs, nonprescription drugs and herbal products) and share it with your doctor and pharmacist. For your safety, do not start, stop, or change the dosage of any drugs without your doctor’s approval.

Does food or alcohol interact with Cetuximab?

Cetuximab may interact with food or alcohol by altering the way the drug works or increase the risk for serious side effects. Please discuss with your doctor or pharmacist any potential food or alcohol interactions before using this drug.

What health conditions may interact with Cetuximab?

Cetuximab may interact with your health condition. This interaction may worsen your health condition or alter the way the drug works. It is important to always let your doctor and pharmacist know all the health conditions you currently have.

Dosage

The information provided is not a substitute for any medical advice. You should ALWAYS consult with your doctor or pharmacist before using this Cetuximab.

What is the dose of Cetuximab for an adult?

Usual Adult Dose for Colorectal Cancer

Either as monotherapy or in combination with irinotecan or FOLFIRI (irinotecan, 5-fluorouracil, leucovorin):

-Initial Dose: 400 mg/m2 administered as a 2 hour IV infusion (maximum infusion rate 10 mg /min)

-Maintenance Dose: 250 mg/m2 infused over 1 hour (maximum infusion rate 10 mg/min) once a week

Comments:

-Determine EGFR-expression status using FDA-approved tests prior to initiating treatment. Also confirm the absence of a Ras mutation prior to initiation of treatment.

-If given in combination with FOLFIRI, the cetuximab infusion should be completed 1 hour prior to FOLFIRI.

-Patients should be premedicated with an H1 antagonist (e.g., 50 mg of diphenhydramine) IV 30 to 60 minutes prior to the first dose. Premedication should be administered for subsequent doses based upon clinical judgment and presence/severity of prior infusion reactions.

Uses:

Colorectal Cancer:

-K-Ras wild-type, EGFR-expressing, metastatic colorectal cancer as determined by approved tests.

-In combination with FOLFIRI for first-line treatment.

-In combination with irinotecan in patients who are refractory to irinotecan-based chemotherapy.

-As a single agent in patients who have failed oxaliplatin- and irinotecan-based chemotherapy or who are intolerant to irinotecan.

Usual Adult Dose for Squamous Cell Carcinoma

In combination with radiation therapy or in combination with platinum-based therapy with 5-FU:

-Initial dose: 400 mg/m2 administered as a 2 hour IV infusion (maximum infusion rate 10 mg/min) 1 week prior to initiation of a course of radiation therapy or 1 hour before the initiation of platinum-based therapy with 5-FU

-Maintenance dose: 250 mg/m2 infused over 1 hour (maximum infusion rate 10 mg/min) once a week for the duration of radiation therapy (6 to 7 weeks) or until disease progression or unacceptable toxicity when administered in combination with platinum-based therapy with 5-FU (complete the administration 1 hour prior to radiation therapy or platinum-based therapy with 5-FU)

Monotherapy:

-Initial dose: 400 mg/m2 administered as a 2 hour IV infusion (maximum infusion rate 10 mg/min)

-Maintenance dose: 250 mg/m2 administered as a 1 hour IV infusion (maximum infusion rate 10 mg/min) until disease progression or unacceptable toxicity

Comment:

-Patients should be premedicated with an H1 antagonist (e.g., 50 mg of diphenhydramine) IV 30 to 60 minutes prior to the first dose. Premedication should be administered for subsequent doses based upon clinical judgment and presence/severity of prior infusion reactions.

Uses:

Head and Neck Cancer:

-Locally or regionally advanced squamous cell carcinoma of the head and neck in combination with radiation therapy.

-Recurrent locoregional disease or metastatic squamous cell carcinoma of the head and neck in combination with platinum-based therapy with 5-FU.

-Recurrent or metastatic squamous cell carcinoma of the head and neck progressing after platinum-based therapy.

Dose Adjustments

Dose modification guidelines for infusion reactions:

-The infusion rate should be reduced by 50% for NCI CTC Grade 1 or 2 and non-serious NCI CTC Grade 3 infusion reactions.

-This drug should be immediately and permanently discontinued for serious infusion reactions, requiring medical intervention and/or hospitalization.

Dose modification guidelines for acneiform rash:

-If a patient experiences a severe skin reaction (NCI-CTC grade 3 or 4) for the first time, therapy should be interrupted for 1 to 2 weeks, until the reaction has improved. If improvement is evident, the infusion can be restarted at 250 mg/m2. If there is no apparent improvement, therapy should be discontinued.

-If a patient experiences a second occurrence of a severe skin reaction, therapy should be interrupted for 1 to 2 weeks until the reaction has improved. If improvement is evident, the infusion can be restarted at the reduced dosage of 200 mg/m2. If no improvement is apparent, therapy should be discontinued.

-If a patient experiences a third occurrence of a severe skin reaction, therapy should be interrupted for 1 to 2 weeks, until the reaction has improved. If improvement is evident, the infusion can be restarted at the reduced dosage of 150 mg/m2. If no improvement is apparent, therapy should be discontinued.

-If a patient experiences a fourth occurrence of a severe skin reaction, therapy should be discontinued.

For the dosage or recommended dose modifications of concomitantly used chemotherapeutic agents, refer to the product information for these products. They must not be administered earlier than 1 hour after the end of the cetuximab infusion.

What is the dose of Cetuximab for a child?

The dosage has not been established in pediatric patients. It may be unsafe for your child. It is always important to fully understand the safety of the drug before using. Please consult with your doctor or pharmacist for more information.

How is Cetuximab available?

Cetuximab is available in the following dosage forms and strengths:

  • Intravenous solution.

What should I do in case of an emergency or overdose?

In case of an emergency or an overdose, call your local emergency services or go to your nearest emergency room.

What should I do if I miss a dose?

If you miss a dose of Cetuximab, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and take your regular dose as scheduled. Do not take a double dose.

Hello Health Group does not provide medical advice, diagnosis or treatment.

Sources

Review Date: September 1, 2018 | Last Modified: September 1, 2018

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