Dermatologic toxicities were reported in 90% of patients and were severe in 15% of patients receiving panitumumab monotherapy .
Panitumumab injection is used alone or in combination with other medicines to treat metastatic cancer (cancer that spreads to other parts of the body) of the colon or rectum in patients who have already received other cancer treatments. Panitumumab injection should only be used in patients who have had a KRAS gene mutation test. This test helps the doctor decide whether the medicine will treat their cancer.
Panitumumab interferes with the growth of cancer cells, which are eventually destroyed by the body. Since the growth of normal body cells may also be affected by panitumumab, other effects will also occur. Some of these may be serious and must be reported to your doctor. Other effects, such as a skin rash, may not be serious but may cause concern. Some effects do not occur until months or years after the medicine is used.
Before you begin treatment with panitumumab, you and your doctor should talk about the benefits this medicine will do as well as the risks of using it.
This medicine will only be given by or under the immediate supervision of your doctor.
In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:
Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.
Appropriate studies have not been performed on the relationship of age to the effects of panitumumab injection in the pediatric population. Safety and efficacy have not been established.
Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of panitumumab injection in the elderly. However, some elderly patients are more likely to have unwanted side effects (eg, diarrhea), which may require caution in patients receiving this medicine.
|All Trimesters||C||Animal studies have shown an adverse effect and there are no adequate studies in pregnant women OR no animal studies have been conducted and there are no adequate studies in pregnant women.|
There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.
Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. Tell your healthcare professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine.
Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.
Other medical problems
The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:
You will receive this medicine while you are in a hospital or cancer treatment center. A nurse or other trained health professional will give you this medicine. This medicine is given through a needle placed in one of your veins. Panitumumab needs to be given slowly, so the needle will remain in place for at least an hour.
This medicine sometimes causes nausea and vomiting. However, it is very important that you continue to receive the medicine, even if you begin to feel ill. Ask your doctor for ways to lessen these effects.
It is very important that your doctor check your progress at regular visits to make sure that this medicine is working properly. Blood tests may be needed to check for unwanted effects.
Using this medicine while you are pregnant can harm your unborn baby. Use an effective form of birth control to keep from getting pregnant during treatment and for 6 months after the last dose of this medicine. If you think you have become pregnant while using the medicine, tell your doctor right away.
You should not receive this medicine if you are also using oxaliplatin and have mutant KRAS metastatic colorectal cancer or if your KRAS tumor status is unknown.
Some patients who use this medicine develop serious skin problems that may lead to infections that can become life-threatening. Tell your doctor right away if you have skin changes such as a skin rash, itchiness, skin redness or swelling, dry, peeling skin or fissures, or fingernail changes while using this medicine.
Tell your doctor right away if you are having shortness of breath, chest tightness, or any type of breathing problem while receiving this medicine.
This medicine may cause a rare but serious type of an allergic reaction called an infusion reaction. This can be life-threatening and requires immediate medical attention. Tell your doctor right away if you have a fever, chills, trouble breathing, chest tightness, swelling in your face or hands, lightheadedness, or if you feel like fainting within a few hours after you receive it.
Check with your doctor immediately if blurred vision, difficulty in reading, or any other change in vision occurs during or after your treatment. Your doctor may want you to have your eyes checked by an ophthalmologist (eye doctor).
This medicine may cause severe kidney disease in patients who have severe diarrhea and dehydration. This medicine may also increase your risk of having an electrolyte imbalance (eg, low magnesium, potassium, or calcium in the blood). Tell your doctor right away if you start having bloating or swelling of the face, arms, hands, lower legs, ankles, or feet, decreased urination, dizziness, headache, lethargy, muscle cramps or twitching, mood or mental changes, nausea, rapid weight gain, or unusual tiredness or weakness while being treated with this medicine.
Avoid overexposing your skin to sunlight. Always use sunscreen or sun blocking lotions and wear protective clothing and hats while you are receiving this medicine and for 2 months after the last dose.
Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.
Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.
Check with your doctor or nurse immediately if any of the following side effects occur:
Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.
Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.