NEW
Rybrevant

Rybrevant

amivantamab

Manufacturer:

Janssen-Cilag

Distributor:

DKSH

Marketer:

Janssen-Cilag
Concise Prescribing Info
Contents
Amivantamab
Indications/Uses
Adults w/ locally advanced or metastatic NSCLC w/ epidermal growth factor receptor exon 20 insertion mutations, whose disease has progressed on or after platinum-based chemotherapy.
Dosage/Direction for Use
IV infusion Administer via peripheral line on wk 1 & 2. Premed: Diphenhydramine 25-50 mg or equiv, & acetaminophen 650-1,000 mg. Administer at all doses orally 30-60 min prior to infusion, or as IV 15-30 min prior to infusion. Dexamethasone 10 mg IV or methylprednisolone 40 mg IV or equiv 45-60 min prior to infusion. Administer at initial dose (wk 1, days 1 & 2) & optional for subsequent doses. Recommended dose: Adult weighing ≥80 kg 1,400 mg (as 4 vials), <80 kg 1,050 mg (as 3 vials). Dosing schedule: Wk 1-4: Wkly (total of 4 doses): Wk 1: Split infusion on days 1 & 2; wk 2-4: Infusion on day 1. Wk 5 onwards: Every 2 wk starting at wk 5. Dose reduction: Adult weighing ≥80 kg 1st reduction: 1,050 mg; 2nd reduction: 700 mg, <80 kg 1st reduction: 700 mg; 2nd reduction: 350 mg.
Special Precautions
Interrupt infusion if infusion-related reactions (IRR) including dyspnea, flushing, fever, chills, nausea, chest discomfort, hypotension & vomiting are suspected. Immediately withhold therapy in patients w/ suspected ILD/pneumonitis. Permanently discontinue infusion based on severity of IRR; if ILD/pneumonitis is confirmed. Monitor patients for any signs & symptoms of infusion reactions during infusion; new or worsening symptoms indicative of ILD/pneumonitis (eg, dyspnea, cough, fever). Withhold, reduce dose or permanently discontinue treatment based on severity of dermatologic adverse reactions; ocular toxicity including keratitis, dry eye symptoms, conjunctival redness, blurred vision, visual impairment, ocular itching, & uveitis. Rash (including dermatitis acneiform), pruritus, dry skin; TEN. Limit sun exposure during & for 2 mth after treatment, wear protective clothing & use broad-spectrum UVA/UVB sunscreen. Promptly refer patients presenting w/ severe rash, atypical appearance or distribution, or lack of improvement w/in 2 wk to dermatologist; w/ eye symptoms to ophthalmologist. Verify pregnancy status prior to initiating therapy. Advise females of reproductive potential to use effective contraception during treatment & for 3 mth after final dose. May cause fetal harm. Pregnancy. Not to breastfeed during treatment & for 3 mth after final dose. Ped patients.
Adverse Reactions
Pulmonary embolism, pneumonitis/ILD, dyspnea, musculoskeletal pain, pneumonia, & muscular weakness. Rash, IRR, paronychia, nausea, edema, cough, fatigue, stomatitis, constipation, vomiting & pruritus, decreased lymphocytes, phosphate, albumin, Na, & K, increased glucose, γ-glutamyl transferase, & alkaline phosphatase.
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
Register or sign in to continue
Asia's one-stop resource for medical news, clinical reference and education
Already a member? Sign in
Register or sign in to continue
Asia's one-stop resource for medical news, clinical reference and education
Already a member? Sign in