Panitumumab

IV Preparation

Inspect vial; discard if discolored

Some particulate matter may be present, OK to use (will be removed by filter)

Withdraw dose amount & dilute to 100 mL with 0.9% NaCl (if dose >1 g, in 150 mL)

Mix by gentle inversion, do not shake

Final concentration not to exceed 10 mg/mL

Use diluted solution within 6 hr if stored at room temp, or within 24 hr if stored at 2-8°C

IV Administration

For IV infusion only; not for IV push or bolus

Use low-protein-binding 0.2-0.22 micron in-line filter

Flush IV line with 0.9% NaCl before and after administration

Use infusion pump

Doses &lge;1 g: Infuse over 60 min through peripheral line or indwelling catheter; ; if first infusion tolerated, administer subsequent infusion over 30-60 min

Doses >1 g: Infuse IV over 90 min

Storage

Unopened vials

• Store vials in the original carton under refrigeration at 2-8°C (36-46°F) until time of use
• Protect from direct sunlight
• Do not freeze
• Discard any unused solution remaining in the vial

Diluted solution

• Room temperature: Administer within 6 hr of preparation
• Refrigerated (2-8°C [36-46°]): Administer within 24 hr of preparation
• Do not freeze

Serious side effects have been reported with panitumumab including the following:

Serious skin and subcutaneous tissue reactions. Those experiencing skin and subcutaneous tissue (the layer below the skin) reactions may experience redness, itching, acne, acneiform dermatitis (severe inflammation of the skin that resembles acne), rash, skin fissures (folds or tears in the skin), dry skin, skin exfoliation (loss of cells from the top layer of the skin), or skin ulcers when receiving panitumumab. Talk to your doctor or pharmacist if you notice any changes to your skin.

Paronychia. Paronychia is redness or swelling around the edges of fingernails or toenails caused by an infection.

Increased Sensitivity to Sunlight. Exposure to sunlight may cause your skin to become irritated. Limit going out into the sunlight as much as possible during treatment with panitumumab. When you do go outside, use sunscreen or wear a hat and long sleeves to protect yourself from the sun's rays.  

Allergic Reactions. Symptoms of a severe allergic reaction can include difficulty breathing and swelling of the lips, tongue, or throat. Tell your doctor if you are allergic to panitumumab, or any other medications.

Lung Disease. Panitumumab has the potential to cause serious lung disease. Tell your doctor if you have ever had lung disease.

Acute Kidney Failure. Acute (sudden and short-term) kidney failure has occurred in patients receiving panitumumab along with other chemotherapy (medicines that stop or slow the growth of cancer cells). 

Infusion Reactions. Panitumumab may cause fever, chills, difficulty breathing, or low blood pressure during the infusion (when injected into a vein). Tell your doctor, pharmacist or nurse in the clinic if you experience any of these symptoms. Your doctor may provide other medications to prevent infusion reactions.

Ocular Keratitis. Panitumumab may cause serious ocular (eye) problems that may lead to corneal perforation (a hole in the outer layer of the eye). Tell your doctor or pharmacist right away if you notice any changes in your vision such as blurriness.

Use panitumumab exactly as prescribed. You will more than likely receive treatment of panitumumab in a clinic.

This medication is available in an injectable form to be given as an infusion (injected into a vein over a period of time) by a healthcare professional.

If you miss an appointment to receive a dose of panitumumab, call your doctor right away.

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

Panitumumab may cause severe skin problems that can lead to widespread infection and possibly death. Seek emergency medical attention at the first sign of any skin rash.

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

Some side effects may occur during the injection. Tell your caregiver right away if you feel dizzy, nauseated, light-headed, chilled, feverish, or have chest tightness or trouble breathing.

Seek emergency medical attention at the first sign of any skin rash. Panitumumab may cause severe skin problems that can lead to widespread infection and possibly death.

Call your doctor at once if you have:

• severe or ongoing diarrhea;

• sudden chest pain or discomfort, wheezing, dry cough or hack, feeling short of breath;

• redness, swelling, or irritation of your eyes or eyelids, vision changes;

• swelling in your face;

• dehydration symptoms--feeling very thirsty or hot, being unable to urinate, heavy sweating, or hot and dry skin;

• signs of a kidney problem--little or no urinating; painful or difficult urination; swelling in your feet or ankles; feeling tired or short of breath; or

• skin problems--severe or worsening acne, swelling or infection around your fingernails or toenails, skin itching, redness, dryness, peeling, cracking, or oozing.

Your cancer treatments may be delayed or permanently discontinued if you have certain side effects.

Common side effects may include:

• acne, dry skin, rash, itching;

• swelling or irritation around your fingernails or toenails;

• loss of appetite, nausea, diarrhea;

• blisters or ulcers in your mouth, red or swollen gums, trouble swallowing;

• tired feeling, weakness; or

• low potassium--confusion, uneven heart rate, extreme thirst, increased urination, leg discomfort, muscle weakness or limp feeling.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Antineoplastic agent; a recombinant human IgG2 kappa monoclonal antibody that binds to the human epidermal growth factor receptor (EGFR; also called an epidermal growth factor receptor [EGFR] inhibitor).1 2 3 4 5 6 7 8 9 13 14 22 31 35 37 42

No formal drug interaction studies have been performed.1 16

Specific Drugs or Therapies

If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.

• Vectibix

Infusion reactions, mild-to-moderate (grade 1 or 2): Reduce the infusion rate by 50% for the duration of infusion.

Infusion reactions, severe (grade 3 or 4): Stop infusion; consider permanent discontinuation (depending on severity or persistence of reaction).

Dermatologic toxicity:

Grade 3 toxicity (first occurrence): Withhold 1 to 2 doses; if reaction improves to <grade 3, resume therapy at initial dose.

Grade 3 toxicity (second occurrence): Withhold 1 to 2 doses; if reaction improves to <grade 3, resume therapy at 80% of initial dose.

Grade 3 toxicity (third occurrence): Withhold 1 to 2 doses; if reaction improves to <grade 3, resume therapy at 60% of initial dose.

Grade 3 toxicity (fourth occurrence), grade 3 toxicity that does not recover to <grade 3 after withholding 1 or 2 doses, or grade 4 toxicity: Permanently discontinue.

Ocular toxicity (acute or worsening keratitis): Interrupt or discontinue treatment.

Pulmonary toxicity:

Acute onset or worsening pulmonary symptoms: Interrupt treatment.

Interstitial lung disease: Permanently discontinue treatment.

Dermatologic toxicities occurred in 90% of patients and were severe (National Cancer Institute Common Toxicity Criteria [NCI-CTC] grade 3 and higher) in 15% of patients receiving panitumumab monotherapy.

Data not available

This drug should only be given during pregnancy when there are no alternatives and benefit outweighs risk. AU TGA pregnancy category: C US FDA pregnancy category: Not assigned. Risk Summary: Based on data from animal studies and its mechanism of action, this drug can cause fetal harm when administered to a pregnant woman. It is a human IgG monoclonal antibody and may be transferred across the placenta. Animal reproduction studies at doses 1.25 to 5 times the recommended human dose resulted in significant embryolethality and abortions; however, no other evidence of teratogenesis was noted in offspring. Comments: -Women of childbearing potential should use adequate contraception during administration of this drug and for 2 months (UK, US) to 6 months (AU) after the last dose. -If this drug is used during pregnancy or the patient becomes pregnant while receiving this drug, she should be apprised of the potential risk for loss of the pregnancy or potential hazard to the fetus. -Based on results from animal studies, this drug may reduce fertility in females of reproductive potential. The effects in animal studies were reversible.

EGFR has been implicated in the control of prenatal development and may be essential for normal organogenesis, proliferation, and differentiation in the developing embryo. Therefore, this drug has the potential to cause fetal harm when administered to a pregnant woman and has been shown to be embryolethal and abortifacient in animals when administered during the period of organogenesis (gestation day 20 to 50) at doses achieving an exposure (on an AUC basis) similar to that of the recommended human dose. There are no controlled data in human pregnancy. Women who become pregnant during treatment with panitumumab should be advised to enroll in Amgen's pregnancy surveillance program. Contact details are provided in the patient information leaflet. AU TGA pregnancy category C: Drugs which, owing to their pharmacological effects, have caused or may be suspected of causing, harmful effects on the human fetus or neonate without causing malformations. These effects may be reversible. Accompanying texts should be consulted for further details. US FDA pregnancy category Not Assigned: The US FDA has amended the pregnancy labeling rule for prescription drug products to require labeling that includes a summary of risk, a discussion of the data supporting that summary, and relevant information to help health care providers make prescribing decisions and counsel women about the use of drugs during pregnancy. Pregnancy categories A, B, C, D and X are being phased out.