Rybrevant

Rybrevant

amivantamab

Manufacturer:

Janssen

Distributor:

DCH Auriga - Healthcare
Concise Prescribing Info
Contents
Amivantamab
Indications/Uses
Monotherapy for treatment of adult patients w/ advanced NSCLC w/ activating epidermal growth factor receptor (EGFR) Exon 20 insertion mutations, after failure of platinum-based therapy.
Dosage/Direction for Use
IV infusion Adult weighing ≥80 kg 1,400 mg wkly for wk 1-4 (total of 4 doses), then every 2 wk at wk 5 onwards, weighing <80 kg 1,050 mg wkly for wk 1-4 (total of 4 doses), then every 2 wk at wk 5 onwards.
Contraindications
Special Precautions
Risk of infusion-related reactions (IRRs); ILD or ILD-like adverse reactions (eg, pneumonitis); rash (including dermatitis acneiform), pruritus & dry skin; TEN; eye disorders, including keratitis. Administer premedications to reduce IRR risk. Interrupt treatment at 1st sign of IRRs & administer supportive medicinal products (eg, glucocorticoids, antihistamine, antipyretics, antiemetics) as clinically indicated. Monitor patients for symptoms indicative of ILD/pneumonitis; permanently discontinue in case of confirmed ILD. Patients should limit sun exposure during therapy & for 2 mth after Rybrevant therapy. Reduce dose, interrupt therapy or permanently discontinue based on severity of skin/nail reactions. Promptly refer patients to ophthalmologist in case of worsening eye symptoms; modify dose for Grade 3/4 eye disorders. Caution in patients w/ severe renal impairment & patients w/ moderate or severe hepatic impairment. Moderate influence on the ability to drive & use machines. Women of child-bearing potential should use effective contraception during & for 3 mth after cessation of treatment. Pregnancy & lactation.
Adverse Reactions
Rash, infusion-related reactions, nail toxicity, hypoalbuminaemia, oedema, fatigue, stomatitis, nausea, constipation. Decreased appetite, hypocalcaemia; dizziness; diarrhoea, vomiting; increased ALT, AST, blood alkaline phosphatase; dry skin, pruritus; myalgia. Visual impairment, growth of eyelashes, other eye disorders; ILD; abdominal pain.
Drug Interactions
Avoid use of live or live-attenuated vaccines while taking amivantamab.
MIMS Class
Targeted Cancer Therapy
ATC Classification
L01FX18 - amivantamab ; Belongs to the class of other monoclonal antibodies and antibody drug conjugates. Used in the treatment of cancer.
Presentation/Packing
Form
Rybrevant conc for soln for infusion 350 mg/7 mL
Packing/Price
1's
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