Table of Contents
1. NAME OF THE MEDICINAL PRODUCT
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
3. PHARMACEUTICAL FORM
4. CLINICAL PARTICULARS
4.1 Therapeutic indications
4.2 Posology and method of administration
4.3 Contraindications
4.4 Special warnings and precautions for use
4.5 Interaction with other medicinal products and other forms of interaction
4.6 Pregnancy and lactation
4.7 Effects on ability to drive and use machines
4.8 Undesirable effects
4.9 Overdose
5. PHARMACOLOGICAL PROPERTIES
5.1 Pharmacodynamic properties
5.2 Pharmacokinetic properties
5.3 Preclinical safety data
6. PHARMACEUTICAL PARTICULARS
6.1 List of excipients
6.2 Incompatibilities
6.3 Shelf life
6.4 Special precautions for storage
6.5 Nature and contents of container
6.6 Special precautions for disposal and other handling
7. MARKETING AUTHORISATION HOLDER
8. MARKETING AUTHORISATION NUMBER(S)
9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
10. DATE OF REVISION OF THE TEXT
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1. NAME OF THE MEDICINAL PRODUCT
Vectibix® 20 mg/ml concentrate for solution for infusion.
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Each ml of concentrate contains 20 mg panitumumab.
Each vial contains either 100 mg of panitumumab in 5 ml, 200 mg in 10 ml, or 400 mg in 20 ml.
When prepared according to the instructions given in section 6.6, the final panitumumab concentration should not exceed 10 mg/ml.
Panitumumab is a fully human monoclonal IgG2 antibody produced in a mammalian cell line (CHO) by recombinant DNA technology.
Excipient:
Each ml of concentrate contains 0.150 mmol sodium, which is 3.45 mg sodium.
For a full list of excipients, see section 6.1.
3. PHARMACEUTICAL FORM
Concentrate for solution for infusion (sterile concentrate).
Colourless solution that may contain, translucent to white, visible amorphous, proteinaceous panitumumab particles.
4. CLINICAL PARTICULARS
4.1 Therapeutic indications
Vectibix is indicated for the treatment of patients with wild-type KRAS metastatic colorectal cancer (mCRC):
• in first-line in combination with FOLFOX
• in second-line in combination with FOLFIRI for patients who have received first-line fluoropyrimidine-based chemotherapy (excluding irinotecan).
• as monotherapy after failure of fluoropyrimidine-, oxaliplatin-, and irinotecan-containing chemotherapy regimens.
4.2 Posology and method of administration
Vectibix treatment should be supervised by a physician experienced in the use of anti-cancer therapy. Evidence of wild-type KRAS status is required before initiating treatment with Vectibix. KRAS mutational status should be determined using a validated test method by an experienced laboratory.
Posology
The recommended dose of Vectibix is 6 mg/kg of bodyweight given once every two weeks. Prior to infusion, Vectibix should be diluted in 0.9% sodium chloride injection to a final concentration not to exceed 10 mg/ml (for preparation instructions see section 6.6).
The severity of dermatological reactions often correlates with the clinical efficacy of the EGFR inhibitor. For patients who have not developed skin toxicity after 2-4 cycles of therapy, a reassessment of the treatment effect is recommended.
Modification of the dose of Vectibix may be necessary