Panitumumab

What is Panitumumab?

• Panitumumab (Vectibix) is an epidermal growth factor receptor (EGFR) antagonist is used in the treatment of refractory metastatic colorectal cancer.

What are the uses of this medicine?

Panitumumab (Vectibix) is used to treat:

• Colorectal cancer that has metastasized (spread to other parts of the body).

It is used:

• With FOLFOX combination chemotherapy as first-line therapy.
• Alone in patients whose disease got worse after treatment with chemotherapy that contained oxaliplatin, irinotecan hydrochloride, and a fluoropyrimidine.
• Panitumumab is approved for use in patients whose cancer does not have a mutation in any of the RAS genes.

How does this medicine work?

• Panitumumab (pan” i toom’ ue mab) is a human monoclonal IgG2 antibody to the epidermal growth factor receptor (EGFR, HER1), which is used to treat EGFR-expressing metastatic colorectal cancer.
• Panitumumab has been shown to induce objective responses in metastatic colorectal cancer and to improve progression free survival. Effects appear to be greater in patients with the wild type as opposed to mutant KRAS status.

Who Should Not Use this medicine ?

• This medicine have no usage limitations.

What drug interactions can this medicine cause?

• Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins and herbal supplements.

Be sure to mention any of the following:

• bevacizumab (Avastin), fluorouracil (Adrucil, 5-FU), irinotecan (Camposar), leucovorin, or oxaliplatin (Eloxatin)

Is this medicine FDA approved?

• Panitumumab was approved for use in the United States in 2006 and was the second monoclonal antibody to EGFR approved for use in metastatic colorectal cancer, the other agent being cetuximab (a chimeric mouse-human monoclonal IgG1 antibody) which has a similar profile of efficacy and safety.

How should this medicine be used?

Recommended dosage:

• The recommended dose of Vectibix is 6 mg/kg, administered as an intravenous infusion over 60 minutes, every 14 days.
• If the first infusion is tolerated, administer subsequent infusions over 30 to 60 minutes.
• Administer doses higher than 1000 mg over 90 minutes.

Administration:

• Panitumumab comes as a solution (liquid) to be given by infusion (injected into a vein).
• It is usually given by a doctor or nurse in a doctor's office or infusion center.
• Panitumumab is usually given once every 2 weeks.

What are the dosage forms and brand names of this medicine?

This medicine is available in fallowing doasage form:

• As Injection: 100 mg/5 mL (20 mg/mL) and 400 mg/20 mL (20 mg/mL) in single-dose vials.

This medicine is available in fallowing brand namesː

• Vectibix

What side effects can this medication cause?

The most common side effects of this medicine include: As monotherapy:

• skin rash with variable presentations
• paronychia
• fatigue
• nausea
• diarrhea

Vectibix in combination with FOLFOX chemotherapy:

• diarrhea
• stomatitis
• mucosal inflammation
• asthenia
• paronychia
• anorexia
• hypomagnesemia
• hypokalemia
• rash
• acneiform dermatitis
• pruritus
• dry skin

• Less common, but potentially severe side effects include infusion reactions, hypersensitivity reactions, severe skin toxicity, severe diarrhea and dehydration, pulmonary embolism and ocular toxicities.

What special precautions should I follow?

• Dermatologic toxicities occurred in patients and receiving Vectibix. Monitor for dermatologic and soft tissue toxicities and withhold or discontinue Vectibix for severe or life-threatening complications. Limit sun exposure.
• Increased tumor progression, increased mortality, or lack of benefit in patients with RAS-mutant mCRC.
• Progressively decreasing serum magnesium levels leading to severe (grade 3-4) hypomagnesemia occurred in patients across clinical trials. Monitor electrolytes and institute appropriate treatment.
• Infusion reactions, manifesting as fever, chills, dyspnea, bronchospasm, and hypotension, can occur following Vectibix administration. Terminate the infusion for severe infusion reactions.
• Severe diarrhea and dehydration, leading to acute renal failure and other complications, have been observed in patients treated with Vectibix in combination with chemotherapy.
• Fatal and nonfatal cases of interstitial lung disease (ILD) and pulmonary fibrosis have been observed in patients treated with Vectibix. Permanently discontinue Vectibix in patients developing ILD.
• Exposure to sunlight can exacerbate dermatologic toxicity. Advise patients to wear sunscreen and hats and limit sun exposure while receiving Vectibix.
• Serious cases of keratitis, ulcerative keratitis, and corneal perforation have occurred with Vectibix use. Monitor for keratitis, ulcerative keratitis, or corneal perforation. Interrupt or discontinue Vectibix for acute or worsening keratitis, ulcerative keratitis, or corneal perforation.
• Vectibix Can cause fetal harm. Advise females of reproductive potential of the potential risk to the fetus and to use effective contraception during treatment with Vectibix and for 2 months after the last dose.
• Panitumumab has been linked to minor serum enzyme elevations during therapy, but has not been implicated in cases of clinically apparent liver injury.

What to do in case of emergency/overdose?

Symptoms of overdosage may include:

• skin toxicity
• diarrhea
• dehydration
• fatigue

Management of overdosage:

• In case of overdose, call the poison control helpline of your country. In the United States, call 1-800-222-1222.

• Overdose related information is also available online at poisonhelp.org/help.
• In the event that the victim has collapsed, had a seizure, has trouble breathing, or can't be awakened, immediately call emergency services. In the United States, call 911.

Can this medicine be used in pregnancy?

• Based on data from animal studies and its mechanism of action, Vectibix can cause fetal harm when administered to pregnant women.
• Advise pregnant women of the potential risk to the fetus.

Can this medicine be used in children?

• The safety and effectiveness of Vectibix have not been established in pediatric patients.

What are the active and inactive ingredients in this medicine?

Active Ingredient:

• PANITUMUMAB

Inactive Ingredients:

• SODIUM ACETATE
• SODIUM CHLORIDE
• WATER

Who manufactures and distributes this medicine?

Manufactured by:

• Amgen Inc.
• One Amgen Center Drive
• Thousand Oaks, CA USA

What should I know about storage and disposal of this medication?

• Store vials in the original carton under refrigeration at 2° to 8°C (36° to 46°F) until time of use.
• Protect from direct sunlight.
• DO NOT FREEZE.
• Discard any unused portion remaining in the vial.

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• Dailymed label info on Panitumumab
• FDA Panitumumab