Rybrevant: Side Effects & Dosing

Concise Prescribing Info Full Prescribing Info Contents Description Action Indications/Uses Dosage/Direction for Use Overdosage Contraindications Special Precautions Use In Pregnancy & Lactation Adverse Reactions Drug Interactions Caution For Usage Storage MIMS Class ATC Classification Regulatory Classification Presentation/Packing

Concise Prescribing Info

Contents

Amivantamab

Indications/Uses

In combination w/ carboplatin & pemetrexed for adults w/ advanced NSCLC w/ activating epidermal-growth factor receptor (EGFR) exon 19 deletions or exon 21 L858R substitution mutations after failure of prior therapy including an EGFR tyrosine kinase inhibitor. In combination w/ carboplatin & pemetrexed for 1st-line treatment of adults w/ locally advanced or metastatic NSCLC w/ activating EGFR exon 20 insertion mutations. Monotherapy for adults w/ locally advanced or metastatic NSCLC w/ activating EGFR exon 20 insertion mutations whose disease has progressed on or after platinum-based chemotherapy.

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Dosage/Direction for Use

IV infusion In combination w/ carboplatin & pemetrexed Adult ≥18 yr, ≥80 kg 1,750 mg wkly for wk 1-4 (total: 4 doses) & no dose on wk 5 & 6, then 2,100 mg every 3 wk starting wk 7, ≤80 kg 1,400 mg wkly for wk 1-4 (total: 4 doses) & no dose on wk 5 & 6, then 1,750 mg every 3 wk starting wk 7. Monotherapy Adult ≥18 yr, ≥80 kg 1,400 mg wkly for wk 1-4 (total: 4 doses), then every 2 wk starting wk 5, ≤80 kg 1,050 mg wkly for wk 1-4 (total: 4 doses), then every 2 wk starting wk 5.

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Overdosage

View Rybrevant overdosage for action to be taken in the event of an overdose.

Contraindications

Hypersensitivity.

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Special Precautions

Discontinue use permanently if recurrent grade 3 or 4 infusion-related reactions (IRRs) occur; ILD or ILD-like adverse reactions, TEN. Rash including dermatitis acneiform, pruritus & dry skin; eye disorders eg, keratitis. Monitor patients for symptoms indicative of ILD/pneumonitis; administer premed to reduce risk of IRRs. Reduce or discontinue use based on severity of skin & nail reactions. Promptly refer patients presenting w/ severe rash that has atypical appearance/distribution or lack improvement w/in 2 wk to dermatologist; w/ worsening eye symptoms to ophthalmologist. Limit sun exposure during & 2 mth after therapy. Patients on controlled Na diet. Avoid concomitant use of live or live-attenuated vaccines. May affect ability to drive & use machines. Severe renal & moderate or severe hepatic impairment. Women of childbearing potential should use effective contraception during & for 3 mth after cessation. Not to be given during pregnancy. Lactation.

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Use In Pregnancy & Lactation

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Adverse Reactions

Hypoalbuminaemia, decreased appetite, hypocalcaemia, hypokalaemia, hypomagnesaemia; dizziness; visual impairment, other eye disorders; ILD; diarrhoea, stomatitis, nausea, constipation, vomiting, abdominal pain, haemorrhoids; increased ALT, AST & blood alkaline phosphatase; rash, nail toxicity, dry skin, pruritus; myalgia; oedema, fatigue, pyrexia; IRRs. Monotherapy: Eyelash growth. In combination w/ carboplatin & pemetrexed: Neutropenia, thrombocytopenia; VTE.

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Caution For Usage

For caution against possible variation of physical aspect of medicine... Click to view Rybrevant detailed prescribing information

Storage

View Rybrevant storage conditions for details to ensure optimal shelf-life.

Description

View Rybrevant description for details of the chemical structure and excipients (inactive components).

Action

View Rybrevant mechanism of action for pharmacodynamics and pharmacokinetics details.

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.

Regulatory Classification

Presentation/Packing

Form

Rybrevant infusion conc (vial) 350 mg/7 mL

Packing/Price

1's

Rybrevant

amivantamab

Manufacturer:

Janssen

Distributor:

Zuellig Pharma