Pronunciation:

pan-i-TOOM-ue-mab

Brand Names:

• Vectibix

Dosage Forms:

• Solution

Warnings:

Dermatologic toxicities were reported in 90% of patients and were severe in 15% of patients receiving panitumumab monotherapy .

Classifications:

Therapeutic—

Immunological Agent

Pharmacologic—

Monoclonal Antibody

Uses of This Medicine:

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 a wild type RAS (in both KRAS and NRAS) 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 of this medicine as well as the risks of using it.

This medicine will only be given by or under the immediate supervision of your doctor.

Before Using This Medicine:

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:

Allergies—

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.

Children—

Appropriate studies performed to date have not demonstrated pediatric-specific problems that would limit the usefulness of panitumumab injection in children. However, safety and efficacy have not been established.

Older adults—

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.

Breast-feeding—

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.

Other medicines—

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.

Other interactions—

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:

• Dehydration or
• Diarrhea or
• Electrolyte imbalance (eg, low magnesium, potassium, or calcium in the blood) or
• Eye disease or
• Kidney disease or
• Lung disease (eg, interstitial pneumonitis, pulmonary fibrosis), history of or
• Sensitivity to sunlight or
• Skin or nail disorder—Use with caution. May make these conditions worse.

Proper Use of This Medicine:

A nurse or other trained health professional will give you this medicine in a hospital or cancer treatment center. This medicine is given through a needle placed into one of your veins. Panitumumab needs to be given slowly, so the needle will have to 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.

Precautions While Using This Medicine:

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 with this medicine and for 2 months after the last dose. 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.

This medicine may cause scarring of the lungs (pulmonary fibrosis), swelling of the lungs (pneumonitis), or interstitial lung disease. These are life-threatening conditions and require immediate medical attention. The symptoms may be similar to the symptoms of lung cancer. Check with your doctor right away if you have new or worsening cough, fever, or trouble breathing.

This medicine may cause infusion-related reactions, which can be life-threatening and require immediate medical attention. Tell your doctor right away if you start to have a fever, chills or shaking, dizziness, trouble breathing, itching or rash, lightheadedness or fainting after receiving this medicine.

Check with your doctor right away if blurred vision, difficulty with reading, or any other change in vision occurs during or after your treatment. Your doctor may want your eyes be 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.

Side Effects of This Medicine:

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:

More common

Anxiety

bloating or swelling of the face, arms, hands, lower legs, ankles, or feet

chest pain

chills

confusion

constipation

convulsions

cough

decreased urination

deep cracks, grooves, or lines in the skin

diarrhea

difficulty with swallowing

discoloration of the fingernails or toenails

drowsiness

dry mouth, lips, or skin

fainting

fast or irregular heartbeat

fever

flushing or redness of the skin

increased thirst

itching, pain, and swelling of the eyelid

itching, skin rash

loosening of the fingernails

loss of appetite

muscle pain or cramps

muscle spasms or twitching

nausea

rapid weight gain

rapid, shallow breathing

redness or soreness around the fingernails

sores, ulcers, or white spots on the lips, tongue, or inside the mouth

stomach pain

sunken eyes

swelling or inflammation of the mouth

tearing of the eyes

tingling of the hands or feet

trembling

troubled breathing

unusual tiredness or weakness

unusual weight gain or loss

unusually warm skin

vomiting

Less common

Blurred vision

burning, dry, or itching eyes

discharge from the eyes or excessive tearing

dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position

facial swelling

headache

hives

noisy breathing

puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue

sweating

swelling of the eye, eyelid, or inner lining of the eyelid

tightness in the chest

Rare

Chest discomfort

painful breathing

quick, shallow breathing

slight fever

Incidence not known

Bleeding, blistering, burning, coldness, discoloration of the skin, feeling of pressure, hives, infection, inflammation, itching, lumps, numbness, pain, rash, redness, scarring, soreness, stinging, swelling, tenderness, tingling, or warmth at the injection site

large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs

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.