Rybrevant (Page 5 of 6)

16 HOW SUPPLIED/STORAGE AND HANDLING

How Supplied

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.

17 PATIENT COUNSELING INFORMATION

Advise the patient to read the FDA-approved patient labeling (Patient Information).

Infusion-Related Reactions

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.

Ocular Toxicity

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)].

Paronychia

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)].

Embryo-Fetal Toxicity

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)].

Lactation

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

Manufactured by:
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:
  • has spread to other parts of the body (metastatic) or cannot be removed by surgery, and
  • has a certain abnormal epidermal growth factor receptor “EGFR” gene(s) and
  • whose disease has worsened while on or after chemotherapy that contains platinum.
Your healthcare provider will perform a test to make sure that RYBREVANT is right for you.It is not known if RYBREVANT is safe and effective in children.
Before you receive RYBREVANT, tell your healthcare provider about all of your medical conditions, including if you:
  • have a history of lung or breathing problems
  • are pregnant or plan to become pregnant. RYBREVANT can harm your unborn baby.Females who are able to become pregnant:
    • Your healthcare provider should do a pregnancy test before you start treatment with RYBREVANT.
    • You should use effective birth control (contraception) during treatment and for 3 months after your final dose of RYBREVANT.
    • Tell your healthcare provider right away if you become pregnant or think you might be pregnant during treatment with RYBREVANT.
  • are breastfeeding or plan to breastfeed. It is not known if RYBREVANT passes into your breast milk. Do not breastfeed during treatment and for 3 months after your final dose of RYBREVANT.
Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.
How will I receive RYBREVANT?
  • RYBREVANT will be given to you by your healthcare provider by intravenous infusion into your vein.
  • Your healthcare provider will decide the time between doses as well as how many treatments you will receive.
  • Your healthcare provider will give you medicines before each dose of RYBREVANT to help reduce the risk of infusion-related reactions.
  • If you miss any appointments, call your healthcare provider as soon as possible to reschedule your appointment.
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:
  • infusion-related reactions. Infusion-related reactions are common with RYBREVANT and can be severe or serious. Tell your healthcare provider right away if you get any of the following symptoms during your infusion of RYBREVANT:
  • shortness of breath
  • fever
  • chills
  • nausea
  • flushing
  • chest discomfort
  • lightheadedness
  • vomiting
  • lung problems. RYBREVANT may cause lung problems that may lead to death. Symptoms may be similar to those symptoms from lung cancer. Tell your healthcare provider right away if you get any new or worsening lung symptoms, including shortness of breath, cough, or fever.
  • skin problems. RYBREVANT may cause rash, itching, and dry skin. You may use alcohol-free moisturizing cream for dry skin. Tell your healthcare provider right away if you get any skin reactions. Your healthcare provider may treat you with a medicine(s) or send you to see a skin specialist (dermatologist) if you get skin reactions during treatment with RYBREVANT. See “What should I avoid while receiving RYBREVANT?
  • eye problems. RYBREVANT may cause eye problems. Tell your healthcare provider right away if you get symptoms of eye problems which may include:
  • eye pain
  • dry eyes
  • eye redness
  • blurred vision
  • changes in vision
  • itchy eyes
  • excessive tearing
  • sensitivity to light
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:
  • rash
  • infusion-related reactions
  • infected skin around the nail
  • muscle and joint pain
  • shortness of breath
  • nausea
  • feeling very tired
  • swelling of hands, ankles, feet, face, or all of your body
  • sores in the mouth
  • cough
  • constipation
  • vomiting
  • changes in certain blood tests
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.

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