Vectibix

DRUG DESCRIPTION

Vectibix (panitumumab) is a recombinant, human IgG2 kappa monoclonal antibody that binds specifically to the human epidermal growth factor receptor (EGFR). Panitumumab has an approximate molecular weight of 147 kDa. Panitumumab is produced in genetically engineered mammalian (Chinese Hamster Ovary) cells.

Vectibix (panitumumab injection for intravenous use) is a sterile, colorless, pH 5.6 to 6.0 liquid for intravenous (IV) infusion, which may contain a small amount of visible translucent-to-white, amorphous, proteinaceous, panitumumab particulates. Each single-use 5 mL vial contains 100 mg of panitumumab, 29 mg sodium chloride, 34 mg sodium acetate, and Water for Injection, USP. Each single-use 10 mL vial contains 200 mg of panitumumab, 58 mg sodium chloride, 68 mg sodium acetate, and Water for Injection, USP. Each single-use 20 mL vial contains 400 mg of panitumumab, 117 mg sodium chloride, 136 mg sodium acetate, and Water for Injection, USP.

What are the possible side effects of panitumumab (Vectibix)?

Some people receiving a panitumumab injection have had a reaction to the infusion (when the medicine is injected into the vein). Tell your caregiver right away if you feel dizzy, nauseated, light-headed, itchy, short of breath, or if you have a fever or chills during the injection.

Some of the side effects of panitumumab may not appear when you first start using the medication. Severe skin or eye reactions may occur up to 2 weeks after the start of your treatment. These effects may not clear up for weeks or even months after you stop...

Read All Potential Side Effects and See Pictures of Vectibix

What are the precautions when taking panitumumab injection for intravenous use (Vectibix)?

Before receiving panitumumab, tell your doctor or pharmacist if you are allergic to it; 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 (e.g., pulmonary fibrosis, interstitial pneumonitis), low magnesium/calcium blood levels.

Sunlight may worsen any skin reactions that may occur while you are receiving this drug. Avoid prolonged sun exposure, tanning booths, and sunlamps. Use a sunscreen and wear protective clothing when outdoors.

This medication is not recommended for use during pregnancy. It may harm an unborn baby. Therefore,...

Read All Potential Precautions of Vectibix


Vectibix Consumer (continued)

SIDE EFFECTS: See also Warning section.

Diarrhea, nausea, vomiting, tiredness, constipation, abdominal pain, or growth of eyelashes may occur. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell your doctor right away if you have any serious side effects, including: swelling ankles/feet, unusual weakness, irregular heartbeat, severe muscle spasms, mouth sores, eye redness/itching/irritation, watery eyes, menstrual changes.

Rarely, panitumumab has caused very serious lung disease. Tell your doctor immediately if you develop symptoms of lung disease, including: cough, shortness of breath.

A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

PRECAUTIONS: Before receiving panitumumab, tell your doctor or pharmacist if you are allergic to it; 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 (e.g., pulmonary fibrosis, interstitial pneumonitis), low magnesium/calcium blood levels.

Sunlight may worsen any skin reactions that may occur while you are receiving this drug. Avoid prolonged sun exposure, tanning booths, and sunlamps. Use a sunscreen and wear protective clothing when outdoors.

This medication is not recommended for use during pregnancy. It may harm an unborn baby. Therefore, it is important to prevent pregnancy while using this medication. Consult your doctor for more details and to discuss using at least 2 reliable forms of birth control (e.g., condoms, birth control pills) while receiving this medication and for 6 months after the end of treatment. If you become pregnant or think you may be pregnant, tell your doctor immediately.

Based on information from related drugs, this medication may pass into breast milk. Therefore, breast-feeding is not recommended while using this medication and for 2 months after the end of treatment. Consult your doctor before breast-feeding.


Vectibix Patient Information Including Side Effects

Brand Names: Vectibix

Generic Name: panitumumab (Pronunciation: pan i TUE moo mab)

  • What is panitumumab (Vectibix)?
  • What are the possible side effects of panitumumab (Vectibix)?
  • What is the most important information I should know about panitumumab (Vectibix)?
  • What should I discuss with my health care provider before receiving panitumumab (Vectibix)?
  • How is panitumumab given (Vectibix)?
  • What happens if I miss a dose (Vectibix)?
  • What happens if I overdose (Vectibix)?
  • What should I avoid while taking panitumumab (Vectibix)?
  • What other drugs will affect panitumumab (Vectibix)?
  • Where can I get more information?

What is panitumumab (Vectibix)?

Panitumumab is a cancer medication. It interferes with the growth of cancer cells and slows their growth and spread in your body.

Panitumumab is used to treat metastatic colorectal cancer that has progressed after treatment with other chemotherapy.

Panitumumab may also be used for other purposes not listed in this medication guide.

What are the possible side effects of panitumumab (Vectibix)?

Some people receiving a panitumumab injection have had a reaction to the infusion (when the medicine is injected into the vein). Tell your caregiver right away if you feel dizzy, nauseated, light-headed, itchy, short of breath, or if you have a fever or chills during the injection.

Some of the side effects of panitumumab may not appear when you first start using the medication. Severe skin or eye reactions may occur up to 2 weeks after the start of your treatment. These effects may not clear up for weeks or even months after you stop receiving panitumumab.

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have any of these serious side effects:

  • fever, sore throat, and headache with a severe blistering, peeling, and red skin rash;
  • swelling of your hands or ankles;
  • acne, dryness, peeling, cracking, bleeding, oozing, pus, or any other sign of skin infection;
  • cough or wheezing, running out of breath easily;
  • white patches or sores inside your mouth or on your lips;
  • drowsiness, restless feeling, confusion, muscle stiffness, fast or uneven heart rate, chest pain;
  • redness, swelling, or irritation of your eyes or eyelids; or
  • swelling or infection around your fingernails or toenails.

Less serious side effects may include:

  • nausea, vomiting, stomach pain;
  • diarrhea or constipation; or
  • tired feeling.

This is not a complete list of side effects and others may occur. Tell your doctor about any unusual or bothersome side effect. You may report side effects to FDA at 1-800-FDA-1088.

What is the most important information I should know about panitumumab (Vectibix)?

Before receiving this medication, tell your doctor if you have any allergies or breathing problems. You may not be able to receive panitumumab, or you may need a dosage adjustment or special tests during treatment.

Panitumumab may cause severe skin problems such as acne, itching, redness, skin rash, dryness, peeling, cracking, or oozing, and swelling or infection around your fingernails or toenails. This medication can also cause redness or irritation of your eyes or eyelids. More severe forms of skin problems can lead to widespread infection and possibly death. Seek emergency medical attention at the first sign of any skin rash.

Some people receiving a panitumumab injection have had a reaction to the infusion (when the medicine is injected into the vein). Tell your caregiver right away if you feel dizzy, nauseated, light-headed, itchy, short of breath, or if you have a fever or chills during the injection.

The side effects of panitumumab may not appear when you first start using the medication. Severe skin or eye reactions may occur up to 2 weeks after the start of your treatment. These effects may not clear up for weeks or even months after you stop receiving panitumumab.

Avoid exposure to sunlight or artificial UV rays (sunlamps or tanning beds). Panitumumab can make your skin more sensitive to sunlight and sunburn may result. Use a sunscreen (minimum SPF 15) and wear protective clothing if you must be out in the sun.

This medication may affect a woman's fertility (ability to have children). You may also have irregular menstrual periods while receiving panitumumab.

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