Pronunciation:

PAN-i-toom-ue-mab

Brand Names:

• Vectibix

Dosage Forms:

• Solution

Warnings:

• Dermatologic Toxicity and Infusion Reactions
  • Dermatologic toxicity: Dermatologic toxicities occurred in 89% of patients and were severe (NCI-CTC grade 3 and higher) in 12% of patients receiving panitumumab monotherapy.
  • Infusion reactions: Severe infusion reactions occurred in approximately 1% of patients. Although not reported with panitumumab, fatal infusion reactions have occurred with other monoclonal antibody products .

Dermatologic toxicities were reported in 89% of patients and were severe in 12% of patients receiving panitumumab monotherapy. Severe infusion reactions occurred in approximately 1% of patients. Although not reported with panitumumab, fatal infusion reactions have occurred with other monoclonal antibody products .

Classifications:

Therapeutic—

Immunological Agent

Pharmacologic—

Monoclonal Antibody

Uses of This Medicine:

Panitumumab is used to treat patients with metastatic cancer of the colon or rectum. This medicine is given to patients who have already received other cancer treatments.

Panitumumab interferes with the growth of cancer cells, which are eventually destroyed. 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 hair loss, 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 good this medicine will do as well as the risks of using it.

Panitumumab is to be administered only by or under the immediate supervision of your doctor.

This medicine is available only with your doctor's prescription.

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 have not been performed on the relationship of age to the effects of panitumumab in the pediatric population. 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 in the elderly.

Pregnancy—

	Pregnancy Category	Explanation
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.

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:

• Electrolyte imbalance (e.g., low magnesium or calcium in the blood) or
• Eye disease or
• Diarrhea or
• Lung disease, history of or
• Sensitivity to sunlight or
• Skin or nail disorder—Use with caution. May make these conditions worse.

Proper Use of This Medicine:

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.

Medicines used to treat cancer are very strong and can have many side effects. Before receiving this medicine, make sure you understand all the risks and benefits. It is important for you to work closely with your doctor during your treatment.

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 this medicine is working properly and to check for unwanted effects. 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 therapy 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.

If you plan to have children, talk with your doctor before using this medicine. Some women using this medicine have become infertile (unable to have children).

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 start having pimples; skin rash, itchiness, redness, or swelling; dry skin; skin peeling or fissures; or nail changes.

Tell your doctor right away if you are having shortness of breath, chest tightness, or any type of breathing problem while being treated with this medicine.

This medicine may cause a rare but serious type of allergic reaction. Tell your doctor right away if you start to have cough, difficulty swallowing, dizziness, fast heartbeat, wheezing, trouble breathing, chest tightness, swelling in your face or hands, fever, chills, itching or hives, or lightheadedness or faintness while you are receiving this medicine.

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 to have your eyes checked by an ophthalmologist (eye doctor).

This medicine may cause diarrhea. This may also increase your risk of having electrolyte imbalance (such as low magnesium or calcium in the blood). Tell your doctor right away if you start having muscle cramps or twitching, mood or mental changes, or unusual tiredness or weakness while being treated with this medicine.

Avoid overexposing your skin to sunlight. Always use sunscreen or sun blocking lotions. Also, wear protective clothing and hats.

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

Abdominal pain

anxiety

blemishes on the skin

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

chest pain

chills

confusion

constipation

convulsions

cough

cracked lips

decreased urination

diarrhea

difficulty in swallowing

discoloration of fingernails or toenails

dizziness or lightheadedness

drowsiness

dry mouth

dry skin

fainting

fast, irregular heartbeat

fever

flaking and falling off of skin

flushing, redness of skin

growth of eyelashes

increase in heart rate

increased thirst

itching and swelling of eyelid

itching skin

loosening of the fingernails

loss of appetite

mood or mental changes

muscle pain or cramps

muscle spasms (tetany) or twitching

nausea

pain or redness of the eye

pimples

rapid weight gain

rapid, shallow breathing

rash

redness or soreness around fingernails

seizures

shortness of breath

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

sudden shortness of breath or troubled breathing

sunken eyes

swelling or inflammation of the mouth

tearing

tingling of hands or feet

trembling

unusual tiredness or weakness

unusual weight gain or loss

unusually warm skin

vomiting

wrinkled skin

Less common

Blurred vision

burning, dry, or itching eyes

difficulty breathing

discharge or excessive tearing

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

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

wheezing

Rare

Chest discomfort

painful breathing

slight fever

troubled or quick, shallow breathing

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.