RYBREVANT® (amivantamab-vmjw) injection is a sterile, preservative-free, colorless to pale yellow solution for intravenous infusion. Each single-dose vial contains 350 mg/7 mL (50 mg/mL) RYBREVANT. Each vial is individually packed in a single carton. (NDC 57894-501-01).
Storage and Handling
Store in a refrigerator at 2°C to 8°C (36°F to 46°F) in original carton to protect from light. Do not freeze.
Advise the patient to read the FDA-approved patient labeling (Patient Information).
Advise patients that RYBREVANT can cause infusion-related reactions, the majority of which may occur with the first infusion. Advise patients to alert their healthcare provider immediately for any signs or symptoms of infusion-related reactions [see Warnings and Precautions (5.1)].
Interstitial Lung Disease/Pneumonitis
Advise patients of the risks of interstitial lung disease (ILD)/pneumonitis. Advise patients to immediately contact their healthcare provider for new or worsening respiratory symptoms [see Warnings and Precautions (5.2)].
Dermatologic Adverse Reactions
Advise patients of the risk of dermatologic adverse reactions. Advise patients to limit direct sun exposure, to use broad spectrum UVA/UVB sunscreen, and to wear protective clothing during treatment with RYBREVANT [see Warnings and Precautions (5.3)]. Advise patients to apply alcohol free emollient cream to dry skin.
Advise patients of the risk of ocular toxicity. Advise patients to contact their ophthalmologist if they develop eye symptoms and advise discontinuation of contact lenses until symptoms are evaluated [see Warnings and Precautions (5.4)].
Advise patients of the risk of paronychia. Advise patients to contact their healthcare provider for signs or symptoms of paronychia [see Adverse Reactions (6.1)].
Advise females of reproductive potential of the potential risk to a fetus, to use effective contraception during treatment with RYBREVANT and for 3 months after the final dose, and to inform their healthcare provider of a known or suspected pregnancy. [ see Warnings and Precautions (5.5), Use in Specific Populations (8.1, 8.3)].
Advise women not to breastfeed during treatment with RYBREVANT and for 3 months after the final dose [see Use in Specific Populations (8.2)].
Product of Ireland
Janssen Biotech, Inc.
Horsham, PA 19044U.S. License Number 1864
© 2022 Janssen Pharmaceutical Companies
|PATIENT INFORMATIONRYBREVANT® (RYE–breh–vant)(amivantamab-vmjw)Injection, for intravenous use|
|This Patient Information has been approved by the U.S. Food and Drug Administration. Revised: 05/2021|
|What is RYBREVANT? RYBREVANT is a prescription medicine used to treat adults with non-small cell lung cancer (NSCLC) that: |
|Before you receive RYBREVANT, tell your healthcare provider about all of your medical conditions, including if you: |
| How will I receive RYBREVANT? |
|What should I avoid while receiving RYBREVANT? RYBREVANT can cause skin reactions. You should limit your time in the sun during and for 2 months after your treatment with RYBREVANT. Wear protective clothing and use sunscreen during treatment with RYBREVANT.|
| What are the possible side effects of RYBREVANT?RYBREVANT may cause serious side effects, including: |
| || |
| || |
|Your healthcare provider may send you to see an eye specialist (ophthalmologist) if you get eye problems during treatment with RYBREVANT. You should not use contact lenses until your eye symptoms are checked by a healthcare provider.|
|The most common side effects of RYBREVANT include:|
| || |
|Your healthcare provider may temporarily stop, decrease your dose or completely stop your treatment with RYBREVANT if you have serious side effects. These are not all of the possible side effects of RYBREVANT. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.|
|General information about safe and effective use of RYBREVANT Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. You can ask your healthcare provider or pharmacist for information about RYBREVANT that is written for health professionals.|
|What are the ingredients of RYBREVANT? Active ingredient: amivantamab-vmjwInactive ingredients: EDTA disodium salt dihydrate, L-histidine, L-histidine hydrochloride monohydrate, L-methionine, polysorbate 80, sucrose, and water for injection.Product of IrelandManufactured by: Janssen Biotech, Inc., Horsham, PA 19044. U.S. License Number 1864© 2022 Janssen Pharmaceutical CompaniesFor more information, call 1-800-526-7736 (1-800-JANSSEN) or go to www.RYBREVANT.com.|
All MedLibrary.org resources are included in as near-original form as possible, meaning that the information from the original provider has been rendered here with only typographical or stylistic modifications and not with any substantive alterations of content, meaning or intent.