[Product Name] Panitumumab for Injection

[English Name] Panitumumab

[Specification] 100 mg, 5 mL × 1 vial/box

[Manufacturer] Dr. Reddy's Laboratories Ltd.

[Indications]

Panitumumab is indicated for the treatment of patients with wild-type RAS metastatic colorectal cancer (mCRC)—defined as wild-type KRAS and NRAS as determined by an FDA-approved test—as a monotherapy following disease progression after prior treatment with fluoropyrimidine-, oxaliplatin-, and irinotecan-containing chemotherapy, or in combination with FOLFOX as a first-line treatment.

Panitumumab for injection is a colorless solution; it may contain small amounts of visible, translucent-to-white, amorphous proteinaceous panitumumab particulates.

[Dosage and Administration]

1. Pre-treatment: Before initiating panitumumab therapy, the physician will assess the RAS mutation status of the colorectal tumor and confirm the absence of RAS mutations in KRAS and NRAS exons 2 (codons 12 and 13), 3 (codons 59 and 61), and 4 (codons 117 and 146).

2. Recommended Dosage: The recommended dose of panitumumab is 6 mg/kg administered as an intravenous infusion over 60 minutes every 14 days. If the first infusion is tolerated, subsequent infusions may be administered over 30–60 minutes; doses exceeding 1000 mg should be administered over 90 minutes.

3. Dosage Adjustment: For patients experiencing mild or moderate (Grade 1 or 2) infusion reactions during administration, the infusion rate will be reduced by 50%. Infusion must be stopped in patients experiencing severe infusion reactions, and panitumumab should be permanently discontinued depending on the severity and/or persistence of the reaction. (1) Skin toxicity:

Upon the first occurrence of a Grade 3 skin reaction, withhold 1–2 doses of panitumumab; if the reaction improves to <Grade 3, resume panitumumab at the original dose. Upon the second occurrence of a Grade 3 skin reaction, withhold 1–2 doses; if the reaction improves to <Grade 3, resume panitumumab at 80% of the original dose. Upon the third occurrence of a Grade 3 skin reaction, withhold 1–2 doses; if the reaction improves to <Grade 3, resume panitumumab at 60% of the initial dose. Permanently discontinue panitumumab upon the fourth occurrence of a Grade 3 skin reaction. Permanently discontinue panitumumab following a Grade 4 skin reaction or a Grade 3 skin reaction that does not resolve after withholding 1 or 2 doses.

【Adverse Reactions】

In panitumumab monotherapy, the most common adverse reactions (≥20%) are rash (various manifestations), paronychia, fatigue, nausea, and diarrhea; the most common (>5%) serious adverse reactions are general physical health deterioration and intestinal obstruction. In panitumumab combination therapy, the most frequently reported adverse reactions (≥20%) are diarrhea, stomatitis, mucosal inflammation, asthenia, paronychia, anorexia, hypomagnesemia, hypokalemia, rash, acneiform dermatitis, pruritus, and dry skin; serious adverse reactions include diarrhea and dehydration. Post-marketing adverse events include skin necrosis, angioedema, life-threatening and fatal bullous mucocutaneous disease, infusion reactions, keratitis/ulcerative keratitis, and corneal perforation.

【Storage】

Prior to use, store panitumumab vials in the original carton under refrigeration at 2 to 8°C (36 to 46°F). Protect from direct sunlight. Do not freeze. Discard any unused portion remaining in the vial. If stored at room temperature, use the diluted panitumumab infusion solution within 6 hours of preparation; if stored at 2 to 8°C (36 to 46°F), use it within 24 hours of dilution.

[Special Populations]

Women: Because infants breastfed by mothers using panitumumab may experience serious adverse reactions, women are advised not to breastfeed during treatment with panitumumab and for 2 months after the last dose; women of reproductive potential should use effective contraception during treatment with panitumumab and for 2 months after the last dose.

[Mechanism of Action]

Panitumumab binds specifically to EGFR on normal and tumor cells and competitively inhibits the binding of EGFR ligands. EGFR is a transmembrane glycoprotein and a member of the type I receptor tyrosine kinase subfamily, which includes EGFR, HER2, HER3, and HER4. EGFR is constitutively expressed in normal epithelial tissues, including the skin and hair follicles. EGFR is overexpressed in certain human cancers, including colon and rectal cancers. Non-clinical studies indicate that the binding of panitumumab to EGFR prevents ligand-induced receptor autophosphorylation and the activation of receptor-associated kinases, thereby inhibiting cell growth, inducing apoptosis, reducing the production of pro-inflammatory cytokines and angiogenic growth factors, and promoting EGFR internalization. In vitro assays and in vivo animal studies demonstrate that panitumumab inhibits the growth and survival of selected human tumor cell lines expressing EGFR.

Specifications

Product Name: Panitumumab for Injection (Vectibix)

Common Name: Panitumumab for Injection

Ingredients: Panitumumab

Dosage Form: Panitumumab for injection is a colorless solution; the solution may contain small amounts of visible translucent-to-white, amorphous proteinaceous panitumumab particulates. Specifications: 100 mg × 1 vial/box

Manufacturer: Dr. Reddy's Laboratories Ltd.

Indications: Panitumumab is indicated for the treatment of patients with wild-type RAS metastatic colorectal cancer (mCRC)—defined as wild-type KRAS and NRAS as determined by an FDA-approved test—as a single agent following disease progression after prior treatment with fluoropyrimidine-, oxaliplatin-, and irinotecan-containing chemotherapy; or in combination with FOLFOX as a first-line treatment.

Limitations of Use: Panitumumab is not indicated for the treatment of patients with RAS-mutant mCRC or patients with unknown RAS mutation status.

Dosage and Administration:

1. Pre-treatment: Before initiating Panitumumab therapy, the physician will assess the RAS mutation status of the colorectal tumor and confirm the absence of RAS mutations in KRAS and NRAS exons 2 (codons 12 and 13), 3 (codons 59 and 61), and 4 (codons 117 and 146).

2. Recommended Dosage: The recommended dose of Panitumumab is 6 mg/kg administered as an intravenous infusion over 60 minutes every 14 days. If the first infusion is tolerated, subsequent infusions may be administered over 30–60 minutes; doses exceeding 1000 mg should be administered over 90 minutes.

3. Dosage Adjustments: For patients experiencing mild or moderate (Grade 1 or 2) infusion reactions during administration, the infusion rate should be reduced by 50%. Patients experiencing severe infusion reactions should discontinue the infusion and permanently stop Panitumumab therapy, depending on the severity and/or persistence of the reaction.