Panitumumab

Name: Panitumumab

Inform MD

Before using panitumumab, tell your doctor about all of your medical conditions. Especially talk to your doctor if you:

  • Are allergic to panitumumab or any of its components
  • Are allergic to any other medications
  • Have, or have had, lung disease
  • Are pregnant or plan to become pregnant 
  • Are breastfeeding

Tell your doctor about all the medicines you take, including prescription and non-prescription medicines, vitamins, and herbal supplements. 

What happens if I miss a dose?

Call your doctor for instructions if you miss an appointment for your panitumumab injection.

Panitumumab dosing information

Usual Adult Dose for Colorectal Cancer:

6 mg/kg IV 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

Comments:
¬¬-Prior to initiation of therapy, assess RAS mutational status in colorectal tumors and confirm the absence of a RAS mutation in exon 2 (codons 12 and 13), exon 3 (codons 59 and 61), and exon 4 (codons 117 and 146) of both KRAS and NRAS.
-See Dose Adjustments for dosage modifications in patients experiencing infusion reactions or dermatologic toxicity.

Uses: For the treatment of wild-type RAS (defined as wild-type in both KRAS and NRAS as determined by an FDA-approved test for this use) metastatic colorectal cancer (mCRC):
-In combination with FOLFOX for first-line treatment.
-As monotherapy following disease progression after prior treatment with fluoropyrimidine, oxaliplatin, and irinotecan-containing chemotherapy.

What other drugs will affect panitumumab?

Other drugs may interact with panitumumab, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell your doctor about all your current medicines and any medicine you start or stop using.

Panitumumab Dosage and Administration

General

  • Premedication to minimize the risk of infusion-related reactions does not appear to be necessary; however, appropriate medical resources for the treatment of severe reactions should be available during panitumumab infusions.1 7 8 9 15 19 22

Administration

IV Administration

For solution and drug compatibility information, see Compatibility under Stability.

Administer by IV infusion.1 Do not administer by rapid IV injection (e.g., IV push or “bolus”).1

Solution should be colorless and may contain a small amount of visible, translucent-to-white, amorphous, proteinaceous particulates of panitumumab; do not administer if discoloration observed.1

Do not shake vials.1

Use infusion pump to administer.1 Prior to and following administration, flush line with 0.9% sodium chloride injection.1 Administer drug through a low-protein-binding 0.2- or 0.22-mcm inline filter.1

Dilution

Withdraw appropriate dose of panitumumab injection solution (containing 20 mg/mL) and dilute in 0.9% sodium chloride injection to a total volume of 100 mL; doses >1 g should be diluted in 0.9% sodium chloride injection to a total volume of 150 mL.1 Final concentration should not exceed 10 mg of panitumumab per mL.1

Mix diluted solution by gentle inversion; do not shake.1

Do not mix or dilute panitumumab with other drugs or infusion solutions.1

Rate of Administration

Administer over 60 minutes if dose is ≤1 g; administer over 90 minutes if dose is >1 g.1

Dosage

Adults

Colorectal Cancer IV

For the management of previously treated, EGFR-expressing metastatic colorectal cancer as monotherapy, 6 mg/kg over 60 minutes every 14 days.1 2 4 9 13 Doses >1 g should be infused over 90 minutes.1 2 9 In the randomized controlled trial evaluating panitumumab monotherapy for metastatic colorectal cancer, a median of 5 doses was administered.1

Dosage Modification for Toxicity

Infusion-related Reactions

If mild or moderate (grade 1 or 2) infusion-related reactions occur, reduce infusion rate by 50% for the duration of that infusion.1 9

If severe (grade 3 or 4) infusion-related reactions occur, discontinue therapy immediately and permanently.1 9 15

Dermatologic Toxicity

If severe (grade 3 or 4) or intolerable dermatologic toxicity occurs, withhold therapy.1 If toxicity does not improve to ≤ grade 2 within 1 month, permanently discontinue therapy.1

If dermatologic toxicity improves to ≤ grade 2 and patient is symptomatically improved after withholding no more than 2 doses, resume treatment at 50% of the original dosage.1 Dosage may then be increased in increments of 25% of the original dosage up to the recommended dosage of 6 mg/kg if toxicity does not recur.1 If toxicity recurs, permanently discontinue therapy.1

Special Populations

No special population dosage recommendations at this time.1

What do I need to tell my doctor BEFORE I take Panitumumab?

  • If you have an allergy to panitumumab or any other part of panitumumab.
  • If you are allergic to any drugs like this one, any other drugs, foods, or other substances. Tell your doctor about the allergy and what signs you had, like rash; hives; itching; shortness of breath; wheezing; cough; swelling of face, lips, tongue, or throat; or any other signs.
  • If you have a certain gene mutation (RAS) or if you do not know if you have this type of gene mutation.

This medicine may interact with other drugs or health problems.

Tell your doctor and pharmacist about all of your drugs (prescription or OTC, natural products, vitamins) and health problems. You must check to make sure that it is safe for you to take this medicine with all of your drugs and health problems. Do not start, stop, or change the dose of any drug without checking with your doctor.

What are some things I need to know or do while I take Panitumumab?

  • Tell all of your health care providers that you take panitumumab. This includes your doctors, nurses, pharmacists, and dentists.
  • If you have upset stomach, throwing up, loose stools (diarrhea), or are not hungry, talk with your doctor. There may be ways to lower these side effects.
  • Have blood work checked as you have been told by the doctor. Talk with the doctor.
  • Have an eye exam as you have been told by your doctor.
  • Avoid sun, sunlamps, and tanning beds. Use sunscreen and wear clothing and eyewear that protects from the sun while taking this medicine and for at least 2 months after care ends.
  • Very bad and sometimes deadly side effects have happened during the infusion. Tell your doctor if you have any bad effects during the infusion.
  • Very bad loose stools (diarrhea) and fluid loss (dehydration) have happened with panitumumab when used with chemo drugs. This can lead to kidney problems or other health problems. Talk with your doctor.
  • Blood clots have happened with this medicine. Sometimes, these blood clots have been deadly. Talk with the doctor.
  • People with a certain gene mutation (RAS) may not benefit from panitumumab. Their tumor may also get worse and chance of death may be raised. Talk with the doctor.
  • If you are a man and have sex with a female who could get pregnant, protect her from pregnancy during care and for 6 months after care ends. Use birth control that you can trust.
  • This medicine may cause harm to the unborn baby if you take it while you are pregnant.
  • Use birth control that you can trust during care and for 6 months after care ends.
  • Tell your doctor if you are pregnant or plan on getting pregnant. You will need to talk about the benefits and risks of using this medicine while you are pregnant.
  • Tell your doctor if you are breast-feeding. You will need to talk about any risks to your baby.

Pronunciation

(pan i TOOM yoo mab)

Index Terms

  • ABX-EGF
  • MOAB ABX-EGF
  • Monoclonal Antibody ABX-EGF
  • rHuMAb-EGFr

Pharmacologic Category

  • Antineoplastic Agent, Epidermal Growth Factor Receptor (EGFR) Inhibitor
  • Antineoplastic Agent, Monoclonal Antibody

Pharmacology

Panitumumab is a recombinant human IgG2 monoclonal antibody which binds specifically to the epidermal growth factor receptor (EGFR, HER1, c-ErbB-1) and competitively inhibits the binding of epidermal growth factor (EGF) and other ligands. Binding to the EGFR blocks phosphorylation and activation of intracellular tyrosine kinases, resulting in inhibition of cell survival, growth, proliferation, and transformation. EGFR signal transduction may result in KRAS and NRAS wild-type activation; cells with RAS mutations appear to be unaffected by EGFR inhibition.

Half-Life Elimination

~7.5 days (range: 4 to 11 days)

Dosing Hepatic Impairment

There are no dosage adjustments provided in the manufacturer's labeling (has not been studied).

Drug Interactions

Aminolevulinic Acid (Systemic): Photosensitizing Agents may enhance the photosensitizing effect of Aminolevulinic Acid (Systemic). Avoid combination

Aminolevulinic Acid (Topical): Photosensitizing Agents may enhance the photosensitizing effect of Aminolevulinic Acid (Topical). Monitor therapy

Porfimer: Photosensitizing Agents may enhance the photosensitizing effect of Porfimer. Monitor therapy

Verteporfin: Photosensitizing Agents may enhance the photosensitizing effect of Verteporfin. Monitor therapy

Adverse Reactions

Monotherapy:

>10%:

Central nervous system: Fatigue (26%)

Dermatologic: Skin toxicity (90%; grades 3/4: 15%), erythema (66%; grades 3/4: 6%), pruritus (58%; grades 3/4: 3%), acneiform eruption (57%; grades 3/4: 7%), paronychia (25%; grades 3/4: 2%), rash (22%; grades 3/4: 1%), skin fissure (20%; grades 3/4: 1%), exfoliative dermatitis (18%; grades 3/4: 2%), acne vulgaris (14%; grades 3/4: 1%)

Endocrine & metabolic: Hypomagnesemia (grades 3/4: 7%)

Gastrointestinal: Nausea (23%), diarrhea (21%; grades 3/4: 2%), vomiting (19%)

Ophthalmic: Ocular toxicity (16%)

Respiratory: Dyspnea (18%), cough (15%)

Miscellaneous: Fever (17%)

1% to 10%:

Cardiovascular: Pulmonary embolism (1%)

Central nervous system: Chills (3%)

Dermatologic: Nail toxicity (10%), xeroderma (10%), desquamation (9%; grades 3/4: <1%), dermal ulcer (6%; grades 3/4: <1%), pustular rash (4%), papular rash (2%)

Endocrine & metabolic: Dehydration (3%)

Gastrointestinal: Mucositis (7%), stomatitis (7%), xerostomia (5%)

Immunologic: Antibody formation (≤5%)

Ophthalmic: Abnormal eyelash growth (6%), conjunctivitis (5%)

Respiratory: Epistaxis (4%), interstitial pulmonary disease (1%)

Miscellaneous: Infusion related reaction (3%; grades 3/4: <1%)

<1%: Hypersensitivity reaction, pulmonary fibrosis

Combination therapy with FOLFOX:

>10%:

Dermatologic: Skin rash (56%; grades 3/4: 17% to 26%), acneiform eruption (32%; grades 3/4: 10%), pruritus (23%; grades 3/4: <1%), paronychia (21%; grades 3/4: 3%), xeroderma (21%; grades 3/4: 2%), erythema (16%; grades 3/4: 2%), skin fissure (16%; grades 3/4: <1%), alopecia (15%), acne vulgaris (14%; grades 3/4: 3%)

Endocrine & metabolic: Hypomagnesemia (30%), hypokalemia (21%), weight loss (18%)

Gastrointestinal: Diarrhea (62%), anorexia (36%), abdominal pain (28%), stomatitis (27%), mucosal inflammation (25%)

Neuromuscular & skeletal: Weakness (25%)

Ophthalmic: Conjunctivitis (18%)

Respiratory: Epistaxis (14%)

1% to 10%:

Cardiovascular: Deep vein thrombosis (5%)

Central nervous system: Fatigue (≥1%), paresthesia (≥1%)

Dermatologic: Nail disorder (10%; grades 3/4: 1%), palmar-plantar erythrodysesthesia (9%; grades 3/4: 1%), cellulitis (3%)

Endocrine & metabolic: Dehydration (8%), hypocalcemia (6%)

Hypersensitivity: Hypersensitivity (≥1%)

Local: Localized infection (4%)

<1%: Antibody development

Postmarketing and/or case reports (Limited to important or life-threatening) (mono- and combination therapy): Abscess, angioedema, bullous skin disease (mucocutaneous), corneal ulcer, keratitis, necrotizing fasciitis, sepsis, skin necrosis, Stevens-Johnson syndrome, toxic epidermal necrolysis

Usual Adult Dose for Colorectal Cancer

6 mg/kg IV 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

Comments:
¬¬-Prior to initiation of therapy, assess RAS mutational status in colorectal tumors and confirm the absence of a RAS mutation in exon 2 (codons 12 and 13), exon 3 (codons 59 and 61), and exon 4 (codons 117 and 146) of both KRAS and NRAS.
-See Dose Adjustments for dosage modifications in patients experiencing infusion reactions or dermatologic toxicity.

Uses: For the treatment of wild-type RAS (defined as wild-type in both KRAS and NRAS as determined by an FDA-approved test for this use) metastatic colorectal cancer (mCRC):
-In combination with FOLFOX for first-line treatment.
-As monotherapy following disease progression after prior treatment with fluoropyrimidine, oxaliplatin, and irinotecan-containing chemotherapy.

Dose Adjustments

Data not available

Panitumumab Breastfeeding Warnings

-No information is available on the use of this drug during breastfeeding. Because it is a large protein molecule the amount in milk is likely to be very low and absorption is unlikely because it is probably destroyed in the infant GI tract. -Available data suggest that breast milk antibodies do not enter the neonatal and infant circulation in substantial amounts.

A decision should be made to discontinue breastfeeding or discontinue the drug, taking into account the importance of the drug to the mother. Excreted into human milk: Unknown; however, human IgG is excreted into human milk) Excreted into animal milk: Data not available Comments: -The effects in the nursing infant are unknown. -Women should not breastfeed during therapy and for 8 weeks after the last dose.

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