RYBREVANT 2240 mg INJECTABLE SOLUTION
How to use RYBREVANT 2240 mg INJECTABLE SOLUTION
Introduction
Package Leaflet: Information for the Patient
Rybrevant 1600 mg Solution for Injection
Rybrevant 2240 mg Solution for Injection
amivantamab
This medicine is subject to additional monitoring, which will allow for quick identification of new safety information. You can help by reporting any side effects you may get. The last section of the leaflet includes information on how to report side effects.
Read all of this leaflet carefully before you start receiving this medicine because it contains important information for you.
- Keep this leaflet, you may need to read it again.
- If you have any further questions, ask your doctor or nurse.
- If you get any side effects, talk to your doctor or nurse. This includes any possible side effects not listed in this leaflet. See section 4.
Contents of the pack
- What is Rybrevant and what is it used for
- What you need to know before you receive Rybrevant
- How Rybrevant is administered
- Possible side effects
- Storage of Rybrevant
- Contents of the pack and other information
1. What is Rybrevant and what is it used for
What is Rybrevant
Rybrevant is a cancer medicine. It contains the active substance amivantamab, which is an antibody (a type of protein) designed to recognize and bind to specific targets in the body.
What Rybrevant is used for
Rybrevant is used in adults with a type of lung cancer called non-small cell lung cancer. It is used when the cancer has spread to other parts of the body and has undergone certain changes in a gene called EGFR.
You may be prescribed Rybrevant:
- as the first medicine you receive for your cancer in combination with lazertinib, or
- when chemotherapy has stopped working against your cancer.
How Rybrevant works
The active substance in Rybrevant, amivantamab, targets two proteins present in cancer cells:
- the epidermal growth factor receptor (EGFR), and
- the mesenchymal-epithelial transition factor (MET).
This medicine works by binding to these proteins. This may help slow down or stop the growth of lung cancer. It may also help reduce the size of the tumor.
Rybrevant may be administered in combination with other cancer medicines. It is important that you also read the package leaflets of these other medicines. If you have any questions about these medicines, ask your doctor.
2. What you need to know before you receive Rybrevant
Do not use Rybrevant if
- you are allergic to amivantamab or any of the other ingredients of this medicine (listed in section 6).
Do not use this medicine if any of the above applies to you. If you are not sure, talk to your doctor or nurse before using this medicine.
Warnings and precautions
Tell your doctor or nurse before you start receiving Rybrevant if:
- you have had inflammation of the lungs (a condition called interstitial lung disease or pneumonitis).
Tell your doctor or nurse immediately if you experience any of the following side effects while receiving this medicine (for more information, see section 4):
- any side effect during the injection of the medicine.
- sudden difficulty breathing, cough or fever that may indicate the presence of lung inflammation. This condition can be life-threatening, so healthcare professionals will monitor you for possible symptoms.
- when used with another medicine called lazertinib, life-threatening side effects may occur (due to the formation of blood clots in the veins). Your doctor will give you additional medicines to help prevent blood clots during treatment and will monitor you for possible symptoms.
- skin problems. To reduce the risk of skin problems, stay out of the sun, wear protective clothing, apply sunscreen, and use moisturizing creams on the skin and nails while using this medicine. You will also need to do this during the 2 months following the permanent discontinuation of treatment. Your doctor may recommend starting to take one or more medicines to prevent skin problems, may treat you with a medicine, or refer you to a skin specialist (dermatologist) if you have skin reactions during treatment.
- eye problems. If you have vision problems or eye pain, contact your doctor or nurse immediately. If you wear contact lenses and have any new eye symptoms, stop wearing them and inform your doctor immediately.
Children and adolescents
Do not give this medicine to children or adolescents under 18 years of age. This is because it is not known if the medicine is safe and effective in this age group.
Other medicines and Rybrevant
Tell your doctor or nurse if you are taking, have recently taken, or might take any other medicines.
Contraceptives
Pregnancy
- this medicine may harm the fetus. If you become pregnant while being treated with this medicine, inform your doctor or nurse immediately. You and your doctor will decide if the benefit of taking the medicine is greater than the risk to the fetus.
Breast-feeding
it is not known if Rybrevant passes into breast milk. Consult your doctor before you are given this medicine. You and your doctor will decide if the benefit of breast-feeding is greater than the risk to your baby.
Driving and using machines
Rybrevant contains sodium
this medicine contains less than 1 mmol of sodium (23 mg) per dose; this is essentially "sodium-free".
Rybrevant contains polysorbate
this medicine contains 0.6 mg of polysorbate 80 per ml, which is equivalent to 6 mg per 10 ml vial or 8.4 mg per 14 ml vial. Polysorbates may cause allergic reactions. Inform your doctor if you have any known allergies.
3. How Rybrevant is administered
How much Rybrevant is administered
your doctor will determine the correct dose of Rybrevant for you. The dose of this medicine will depend on your body weight at the start of treatment.
the recommended dose of Rybrevant is:
- 1600 mg if you weigh less than 80 kg.
- 2240 mg if your weight is 80 kg or more.
How the medicine is administered
a doctor or nurse will give you Rybrevant as an injection under the skin (subcutaneous injection) over approximately 5 minutes. It is administered in the stomach area (abdomen), in no other part of the body, and never in areas of the abdomen where the skin is red, sensitive, painful, or hardened, or in areas where you have tattoos or scars.
Rybrevant is administered as follows:
- once a week for the first 4 weeks
- and then once every 2 weeks from week 5 onwards, as long as you continue to benefit from treatment.
Medicines administered during treatment with Rybrevant
before each injection of Rybrevant, you will be given medicines that help reduce the possibility of reactions related to administration. These may include:
- medicines for an allergic reaction (antihistamines)
- medicines for inflammation (corticosteroids)
- medicines for fever (such as paracetamol).
you may also be given additional medicines depending on the symptoms you experience.
If you receive more Rybrevant than you should
this medicine will be administered to you by your doctor or nurse. In the unlikely event that you are given too much (an overdose), your doctor will examine you to see if you have any side effects.
If you miss your appointment for the administration of Rybrevant
it is very important to attend all appointments. If you miss an appointment, make another one as soon as possible.
4. Possible side effects
like all medicines, this medicine can cause side effects, although not everybody gets them.
Serious side effects
tell your doctor or nurse immediately if you notice any of the following serious side effects:
Very common(may affect more than 1 in 10 people):
- signs of a reaction related to the injection - such as chills, shortness of breath, nausea, redness, chest discomfort, and fever. This may occur especially with the first dose. Your doctor may give you other medicines, or it may be necessary to stop the injection.
- skin problems - such as rash (including acne), infected skin around the nails, dry skin, itching, pain, and redness. Tell your doctor if your skin or nail problems get worse.
- when administered with another medicine called lazertinib, a blood clot in the veins may occur, especially in the lungs or legs. Signs may include sharp chest pain, difficulty breathing, rapid breathing, leg pain, and swelling in the arms or legs.
- eye problems - such as dry eye, swollen eyelid, or itchy eyes.
Common(may affect up to 1 in 10 people):
- signs of inflammation in the lungs - such as sudden difficulty breathing, cough, or fever. This could cause permanent damage (interstitial lung disease). Your doctor may want to stop the administration of Rybrevant if you have this side effect.
- eye problems - such as vision problems and eyelash growth.
- inflamed cornea (front part of the eye).
the following side effects have been reported in clinical studies with Rybrevant when administered as an intravenous infusion:
Other side effects
tell your doctor if you notice any of the following side effects:
Very common(may affect more than 1 in 10 people):
- low level of the protein "albumin" in the blood
- swelling caused by fluid accumulation in the body
- feeling very tired
- mouth sores
- nausea
- vomiting
- constipation or diarrhea
- loss of appetite
- increased level of the liver enzymes "alanine aminotransferase" and "aspartate aminotransferase" in the blood.
- feeling dizzy
- increased level of the enzyme "alkaline phosphatase" in the blood
- muscle pain
- fever
- low level of calcium in the blood
Common(may affect up to 1 in 10 people):
- stomach pain
- low level of potassium in the blood
- low level of magnesium in the blood
- hemorrhoids
in clinical studies with Rybrevant (administered as an intravenous infusion or subcutaneous injection) in combination with lazertinib, the following side effects have been reported:
Other side effects
tell your doctor immediately if you notice any of the following side effects:
Very common(may affect more than 1 in 10 people):
- low level of the protein "albumin" in the blood
- mouth sores
- liver damage
- swelling caused by fluid accumulation in the body
- feeling very tired
- strange sensation in the skin (such as tingling or numbness)
- constipation
- diarrhea
- loss of appetite
- nausea
- low level of calcium in the blood
- vomiting
- muscle pain
- low level of potassium in the blood
- muscle spasms
- feeling dizzy
- fever
- stomach pain
Common(may affect up to 1 in 10 people)
- hemorrhoids
- irritation or pain at the injection site
- low level of magnesium in the blood
- redness, swelling, peeling, or sensitivity, mainly on the hands or feet (palmar-plantar erythrodysesthesia syndrome)
- pruritic exanthem (hives).
Reporting of side effects
5. Storage of Rybrevant
Rybrevant will be stored in the hospital or medical center.
keep this medicine out of the sight and reach of children.
do not use this medicine after the expiry date which is stated on the carton and vial label after "EXP". The expiry date refers to the last day of the month stated.
store in a refrigerator (2 °C to 8 °C). Do not freeze.
store in the original package to protect from light.
chemical and physical stability of the prepared syringe has been demonstrated for a maximum period of 24 hours at a temperature of 2 °C to 8 °C followed by a maximum period of 24 hours at a temperature of 15 °C to 30 °C. From a microbiological point of view, unless the method of preparation of the injection prevents the risk of microbial contamination, the product should be used immediately. If not used immediately, in-use storage times and conditions are the responsibility of the user.
medicines should not be disposed of via wastewater or household waste. Your healthcare professional will dispose of any unused medicines. This will help protect the environment.
6. Container Contents and Additional Information
Rybrevant Composition
- The active ingredient is amivantamab. One ml of solution contains 160 mg of amivantamab. A 10 ml vial of injectable solution contains 1,600 mg of amivantamab. A 14 ml vial of injectable solution contains 2,240 mg of amivantamab.
- The other components are recombinant human hyaluronidase (rHuPH20), disodium dihydrate ethylenediaminetetraacetic acid (EDTA), glacial acetic acid, L-methionine, polysorbate 80 (E433), sodium acetate trihydrate, sucrose, and water for injectables (see "Rybrevant contains sodium" and "Rybrevant contains polysorbate" in section 2).
Product Appearance and Container Contents
Rybrevant injectable solution is a colorless to pale yellow liquid. This medicinal product is presented in a cardboard box containing 1 glass vial of 10 ml solution or 1 glass vial of 14 ml solution.
Marketing Authorization Holder
Janssen-Cilag International NV
Turnhoutseweg 30
B-2340 Beerse
Belgium
Manufacturer
Janssen Biologics B.V.
Einsteinweg 101
2333 CB Leiden
Netherlands
For further information on this medicinal product, please contact the local representative of the marketing authorization holder:
België/Belgique/Belgien Janssen-Cilag NV Tel/Tél: +32 14 64 94 11 janssen@jacbe.jnj.com | Lietuva UAB "JOHNSON & JOHNSON" Tel: +370 5 278 68 88 lt@its.jnj.com |
| Luxembourg/Luxemburg Janssen-Cilag NV Tél/Tel: +32 14 64 94 11 janssen@jacbe.jnj.com |
Ceská republika Janssen-Cilag s.r.o. Tel: +420 227 012 227 | Magyarország Janssen-Cilag Kft. Tel.: +36 1 884 2858 janssenhu@its.jnj.com |
Danmark Janssen-Cilag A/S Tlf.: +45 4594 8282 jacdk@its.jnj.com | Malta AM MANGION LTD Tel: +356 2397 6000 |
Deutschland Janssen-Cilag GmbH Tel: 0800 086 9247 / +49 2137 955 6955 jancil@its.jnj.com | Nederland Janssen-Cilag B.V. Tel: +31 76 711 1111 janssen@jacnl.jnj.com |
Eesti UAB "JOHNSON & JOHNSON" Eesti filiaal Tel: +372 617 7410 ee@its.jnj.com | Norge Janssen-Cilag AS Tlf: +47 24 12 65 00 jacno@its.jnj.com |
Ελλáδα Janssen-Cilag Φαρμακευτικ? Μονοπρóσωπη Α.Ε.Β.Ε. Tηλ: +30 210 80 90 000 | Österreich Janssen-Cilag Pharma GmbH Tel: +43 1 610 300 |
España Janssen-Cilag, S.A. Tel: +34 91 722 81 00 contacto@its.jnj.com | Polska Janssen-Cilag Polska Sp. z o.o. Tel.: +48 22 237 60 00 |
France Janssen-Cilag Tél: 0 800 25 50 75 / +33 1 55 00 40 03 medisource@its.jnj.com | Portugal Janssen-Cilag Farmacêutica, Lda. Tel: +351 214 368 600 |
Hrvatska Johnson & Johnson S.E. d.o.o. Tel: +385 1 6610 700 jjsafety@JNJCR.JNJ.com | România Johnson & Johnson România SRL Tel: +40 21 207 1800 |
Ireland Janssen Sciences Ireland UC Tel: 1 800 709 122 medinfo@its.jnj.com | Slovenija Johnson & Johnson d.o.o. Tel: +386 1 401 18 00 JNJ-SI-safety@its.jnj.com |
Ísland Janssen-Cilag AB c/o Vistor hf. Sími: +354 535 7000 janssen@vistor.is | Slovenská republika Johnson & Johnson, s.r.o. Tel: +421 232 408 400 |
Italia Janssen-Cilag SpA Tel: 800.688.777 / +39 02 2510 1 janssenita@its.jnj.com | Suomi/Finland Janssen-Cilag Oy Puh/Tel: +358 207 531 300 jacfi@its.jnj.com |
Κúπρος Βαρνáβας Χατζηπαναγnς Λτδ Τηλ: +357 22 207 700 | Sverige Janssen-Cilag AB Tfn: +46 8 626 50 00 jacse@its.jnj.com |
Latvija UAB "JOHNSON & JOHNSON" filiale Latvija Tel: +371 678 93561 lv@its.jnj.com | United Kingdom (Northern Ireland) Janssen Sciences Ireland UC Tel: +44 1 494 567 444 |
Date of Last Revision of this Leaflet:
Other Sources of Information
Detailed information on this medicinal product is available on the European Medicines Agency website: https://www.ema.europa.eu, and on the website of the Spanish Agency for Medicines and Health Products (AEMPS) (http://www.aemps.gob.es/).
This information is intended for healthcare professionals only: Rybrevant subcutaneous formulation should be administered by a healthcare professional. To avoid medication errors, it is essential to check the vial labels to ensure the administration of the correct formulation (intravenous or subcutaneous) and dose to the patient as prescribed. Rybrevant subcutaneous formulation should only be administered subcutaneously, in the specified dose. Rybrevant subcutaneous formulation is not intended for intravenous administration. This medicinal product should not be mixed with other medicinal products, except those indicated below. Prepare the subcutaneous injectable solution using an aseptic technique as follows: Preparation
Storage of the Prepared Syringe The prepared syringe should be administered immediately. If immediate administration is not possible, store the prepared syringe refrigerated for a maximum period of 24 hours at a temperature between 2 °C and 8 °C, followed by a maximum period of 24 hours at room temperature between 15 °C and 30 °C. The prepared syringe should be discarded if stored for more than 24 hours refrigerated or more than 24 hours at room temperature. If stored in the refrigerator, the solution should be at room temperature before administration. Traceability In order to improve the traceability of biological medicinal products, the name and batch number of the administered medicinal product should be clearly recorded. Disposal This medicinal product is for single use. Disposal of unused medicinal product and all materials that have come into contact with it should be carried out in accordance with local regulations. |
- Country of registration
- Active substance
- Prescription requiredYes
- Manufacturer
- CompositionACETATO DE SODIO TRIHIDRATO (51,30 mg mg), SACAROSA (994 mg mg), POLISORBATO 80 (8,40 mg mg)
- This information is for reference only and does not constitute medical advice. Always consult a licensed doctor before taking any medication. Oladoctor is not responsible for medical decisions based on this content.
- Alternatives to RYBREVANT 2240 mg INJECTABLE SOLUTIONDosage form: INJECTABLE, 1600 mgActive substance: amivantamabManufacturer: Janssen-Cilag International N.VPrescription requiredDosage form: INJECTABLE PERFUSION, 50 mg/mlActive substance: amivantamabManufacturer: Janssen-Cilag International N.VPrescription requiredDosage form: INJECTABLE INFUSION, 50 mgActive substance: brentuximab vedotinManufacturer: Takeda Pharma A/SPrescription required
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