350 mg concentrate for solution for infusion
amivantamab
What Rybrevant is and what it is used for
What Rybrevant is
Rybrevant is a cancer drug. It contains the active substance amivantamab, which is an antibody (a kind of protein ) that is designed to recognize and attach 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 cancer has spread to other parts of your body and has undergone certain changes (insertion mutations in exon 20) in a gene called EGFR.
How Rybrevant works
The active substance in Rybrevant, amivantamab, targets two proteins found on cancer cells:
- epidermal growth factor receptor (EGFR) and
- mesenchymal-epithelial transition factor (MET).
This drug works by attaching to these proteins. It can help slow down or stop your lung cancer from growing. It can also help reduce the size of the tumor.
What you need to know before you get 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 the above applies to you. If you are not sure, talk to your doctor or nurse before taking this medicine.
Warnings and cautions
Talk to a doctor or nurse before receiving Rybrevant:
- if you have suffered from pneumonia (a condition called interstitial lung disease or pneumonitis ).
Tell your doctor or nurse immediately if you get any of the following side effects during treatment (see section 4 for more information):
- Any side effects are while the drug is being given into your vein.
- Sudden difficulty breathing, cough, or fever may indicate pneumonia.
- Skin problems. To reduce the risk of skin problems, do not expose yourself to direct sun, wear protective clothing, use sunscreen and apply emollient cream regularly on the skin and nails while taking this medicine. You will need to continue to do so for 2 months after stopping treatment.
- Eye problems. Contact a doctor or nurse immediately if you experience vision problems or eye pain. If you wear contact lenses and get new eye symptoms, stop using the contact lenses and contact a doctor immediately.
Children and young people
Do not give this medicine to children or young people under 18 years of age. This is because it is not known if the drug is safe and effective for this age group.
Other medicines and Rybrevant
Tell your doctor or nurse if you have recently taken, or might take any other medicines.
Pregnancy, breastfeeding, and fertility
Preventive method
- If you could become pregnant, you must use an effective method of contraception during treatment with Rybrevant and for 3 months after stopping treatment.
Pregnancy
- Talk to your doctor or nurse before receiving this medicine if you are pregnant, think you may be pregnant, or are planning to have a baby.
- This medicine may harm an unborn baby. If you become pregnant while being treated with this medicine, tell your doctor or nurse immediately. You and your doctor will decide if the benefit of getting the medicine outweighs the risk to your unborn baby.
Breast-feeding
It is not known if Rybrevant passes into breast milk. Consult your doctor before receiving this medicine. You and your doctor will decide if the benefit of breastfeeding outweighs the risk to your baby.
Driving and using machines
If you feel tired or dizzy, if your eyes are irritated or your vision is affected after taking Rybrevant, do not drive or use machines.
Rybrevant contains sodium
This medicine contains less than 1 mmol (23 mg) sodium per dose, ie essentially ‘sodium-free’. Before you receive Rybrevant, however, it can be mixed with a solution that contains sodium. Talk to your doctor if you are on a low-sodium diet.
How to get Rybrevant
What do you get
Your doctor will work out which dose of Rybrevant is right for you. The dose of one of these drugs depends on your body weight at the beginning of treatment.
The recommended dose of Rybrevant is:
- 1,050 mg if you weigh less than 80 kg.
- 1,400 mg if you weigh 80 kg or more.
How to get the medicine
This medicine is given to you by a doctor or nurse. It is given as a drip into a vein ( intravenous infusion ) for several hours.
Rybrevant is given as follows:
- once a week for the first 4 weeks
- then every two weeks from week 5 onwards, as long as you continue to benefit from the treatment.
During the first week, your doctor will give you Rybrevant- dose spread over two days.
Medicines are given during treatment with Rybrevant
Before each infusion of Rybrevant, you will also receive medicines that help reduce the risk of infusion-related reactions. These may include:
- medicines for allergic reactions ( antihistamines )
- anti- inflammatory drugs ( corticosteroids )
- antipyretic drugs (eg paracetamol )
You may also be given additional medicines based on any symptoms you may be experiencing.
If you have received too much Rybrevant
This medicine is given to you by a doctor or nurse. If you are suspected of taking too much (an overdose), your doctor will check to see if any side effects occur.
If you forget to come to your visit to get Rybrevant
You must come to all booked visits. If you miss a visit, book a new one as soon as possible.
If you have any further questions on the use of this product, ask your doctor or nurse.
Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Serious side effects
If you experience the following serious side effects, talk to your doctor or nurse immediately:
Very common (may affect more than 1 user in 10):
- Signs of a reaction to infusion one – such as chills, shortness of breath, nausea, redness, chest discomfort, and vomiting while receiving the medicine. This can especially happen with the first dose. Your doctor may give you other medicines, or your infusion may need to be slowed down or stopped.
- Skin problems – such as a 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.
Common (may affect up to 1 in 10 people):
- Eye problems – such as dry eyes, swollen eyelids, itchy eyes, vision problems, and eyelash growth.
- Signs of inflammation in the lungs – such as sudden difficulty breathing, cough, or fever. This can lead to permanent damage (interstitial lung disease). Your doctor may want to stop your treatment with Rybrevant if you experience this side effect.
Uncommon (may affect up to 1 in 100 people):
- inflammation of the cornea (front of the eye)
- inflammation inside the eye that can affect vision
- life-threatening rash with blisters and flaky skin on large parts of the body ( toxic epidermal necrolysis ).
Other side effects are
Tell your doctor if you experience any of the following side effects:
Very common (may affect more than 1 user in 10):
- low levels of protein and albumin in the blood
- swelling caused by fluid accumulation in the body
- great feeling of tiredness
- sores in the mouth
- constipation or diarrhea
- decreased appetite
- increased levels of the liver enzyme ‘alanine aminotransferase’ ( ALT ) in the blood, a possible sign of liver disease
- increased levels of the enzyme an ‘aspartate aminotransferase’ ( ASAT ) in the blood, a possible sign of liver disease
- dizziness
- increased levels of the enzyme alkaline phosphatase in the blood
- muscle aches
- low level of calcium in the blood.
Common (may affect up to 1 in 10 people)
- magnet.
How Rybrevant should be stored
Rybrevant will be stored at the hospital or clinic.
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 the vial label after EXP. The expiration date is the last day of the specified month.
Chemical and physical in-use stability has been demonstrated for up to 10 hours when stored at 15 ° C to 25 ° C in room lighting. From a microbiological perspective, the product should be used immediately, unless the dilution method eliminates the risk of microbial contamination. If the product is not used immediately, storage times and storage conditions are the responsibility of the user.
Store in a refrigerator (2 ° C – 8 ° C). Do not freeze.
Store in the original package. Sensitive to light.
Medicines should not be disposed of via wastewater or household waste. Healthcare professionals discard all medicines that are no longer used. These measures will help to protect the environment.
Contents of the packaging and other information
Content declaration
- The active substance is amivantamab. One ml concentrate for solution for infusion contains 50 mg amivantamab. One vial of 7 ml concentrate contains 350 mg amivantamab.
- The other ingredients are disodium edetate, L-histidine, L-histidine hydrochloride monohydrate, L-methionine, polysorbate 80, sucrose, and water for injections (see section 2).
What the medicine looks like and the contents of the pack
Rybrevant is a concentrate for infusion solution and is a colorless to pale yellow liquid. This medicine is available in a carton containing 1 vial of 7 ml concentrate.
Marketing Authorisation Holder
Janssen-Cilag International NV
Turnhoutseweg 30
B-2340 Beerse
Belgium
Manufacturer
Janssen Biologics BV
Einsteinweg 101
2333 CB Leiden
Netherlands
Contact the representative of the marketing authorization holder to find out more about this medicine.