RYBREVANT 1600 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 quicker identification of new safety information. You can help by reporting any side effects you may get. The last section of this 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 experience any side effects, talk to your doctor or nurse, even if they are not listed in this leaflet. See section 4.

Contents of the pack

1. What is Rybrevant and what is it used for
2. What you need to know before you receive Rybrevant
3. How Rybrevant is administered
4. Possible side effects
5. Storage of Rybrevant
6. 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, blood clots in the veins can occur, especially in the lungs or legs. The signs may include sharp chest pain, difficulty breathing, rapid breathing, leg pain, and swelling in the arms or legs.
• 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

if you feel tired, dizzy, or have irritated eyes or blurred vision after using Rybrevant, do not drive or use 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 can 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 administer Rybrevant to you as an injection under the skin (subcutaneous injection) for 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.

if you experience pain during the injection, the doctor or nurse may interrupt the injection and administer the rest of the injection in another area of the abdomen.

Rybrevant is administered as follows:

• once a week for the first 4 weeks
• and then once every 2 weeks from week 5 onwards, while 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 that you attend all appointments. If you miss an appointment, make another one as soon as possible.

if you have any other questions about the use of this medicine, ask your doctor or nurse.

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, blood clots in the veins can occur, especially in the lungs or legs. The 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.
• inflammation of the cornea (front part of the eye).

the following side effects have been reported in clinical studies with Rybrevant when administered alone 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 toxicity
• swelling caused by fluid accumulation in the body
• feeling very tired
• strange sensation in the skin (such as tingling or prickling)
• 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