Colorectal cancer

Most common adverse reactions-
Rash, pruritus, headache, diarrhea and infection

Most serious adverse reactions-
infusion reactions, cardiopulmonary arrest, dermatologic toxicity, and radiation dermatitis,
renal failure, interstital lung disease and pulmonary embolism.

CNS-  asthenia 53%  headache 16%

Dermatologic - acneform rash 83%  application site reaction 15%   pruritus  13%
                          radiation dermatitis 83%

GI - diarrhea  16%  dyspepsia 12%   emesis 25%  nausea  45%

Metabolic/nutritional - dehydration  23%   weight loss   82% 

Respiratory -     pharyngitis   23%

Miscellaneous -  chills  14%  fever 25%  infection 11%   infusion reaction 13%

Special precautions/Warnings-

Infusion reaction- approximately major portion of infusion reactions occured with the first infusion despite premedication with antihistamines

Monitor patients following cetuximab infusion in a setting with resuscitation equipment and other agents necessary to treat anaphylaxis reaction

Cardiopulmonary arrest- closely monitor serum electrolyte, including serum magnesium,
 potassium and calcium during and after cetruximab

Pulmonary  toxicity - permanantly discontinue cetuximab for confirmed
interstitial lung disease ILD

Dermatologic toxicity -  instruct patients to limit sun exposure during cetuximab

Photosensitivity - patients should wear sunscreen and hats and limit sun exposure  while
receiving cetuximab because sunlight exacerbate any skin reactions that may occur

Pregnancy- if the patients becomes pregnant appraise her of the potential hazard to the
fetus and potential risk of loss of the pregnancy

Lactation- do not resume breast feeding earlier than 60 days following the last of cetuximab

Children - safety and efficacy for use in children have not been established

Monitoring- monitor patients for 1 hour following cetuximab infusion . Longer observation
period is required in those who experience infusion reactions.

Periodically monitor patients for infectious sequelae  while receiving cetuximab and initiate
appropiate treatment

Periodically monitor patients for hypocalcemia, hypokalemia during and for at least 8 weeks
following completion of cetuximab therapy

Indication

Colorectal cancer

Dosage-
The recommended dose of cetuximab either as monotherapy or in combination with irrinotecan is 400mg/m2 administered as a 120 minute intravenous IV infusion ( maximin infusion rate 10mg/min )

The recommended subsequent weekly dose either as monotherapy or in combination with
ironotecan is 250mg/m2 infused over 60 minutes ( maximium infusion rate 10mg/min ) until
disease progression or unacceptable toxicity occurs

Storage- store vials under refrigeration at 2 to 8C ( 36 to 46F ). Do nt freeze. increased particulate formation occurs at temperature below 0C (32F )

1. Advice patients to to report  signs or symptoms of infusion reactions such as chills or fever or  breathing problems

2. Advice patients of potential risks of using cetuximab during pregnancy or breast feeding and
    of the need to use adequate contraception in both men and women during and for 6 months
     following the last dose of cetuximab therapy

3. Inform patients that breast feeding is not recommended during and for 2 months following
    the last dose of cetuximab therapy

4. Advice patients to limit sun exposure ( use sunscreen, wear hats ) while receiving and for
   2 months following the last dose of cetuximab

Pregnancy-
If the patients becomes pregnant appraise her of the potential hazard to the
fetus and potential risk of loss of the pregnancy

Lactation-
Do not reume breast feeding earlier than 60 days following the last of cetuximab

Children -
Safety and efficacy for use in children have not been established