20 mg / ml concentrate for solution for infusion 
avelumab

Read all of this leaflet carefully before you start using this medicine. It contains information that is important to you.

  • Save this information, you may need to read it again.
  • If you have any further questions, ask your doctor.
  • If you get any side effects, talk to your doctor. This also applies to any side effects not mentioned in this information. See section 4.

In this leaflet: 
1. What Bavencio is and what it is used for 
2. What you need to know before you use Bavencio 
3. How to use Bavencio 
4. Possible side effects 
5. How to store Bavencio 
6. Contents of the packaging and other information 

1. What Bavencio is and what it is used for

Bavencio contains the active substance avelumab, a monoclonal antibody (a kind of protein ) that attaches to a specific target in the body called PD-L1.

PD-L1 is found on the surface of certain tumor cells and protects them from the immune system (the body’s natural defenses). Bavencio binds to PD-L1 and blocks this protective effect, which allows the immune system to attack the tumor cells.

Bavencio is used in adults to treat:

  • Merkel cell carcinoma (MCC), an uncommon form of skin cancer, when metastasized (has spread to other parts of the body)
  • Kidney cell cancer (RCC), a form of kidney cancer, when it is advanced (has spread outside the kidney or to other parts of the body).

In renal cell carcinoma, Bavencio is used in combination with axitinib.

It is important that you also read the package leaflet for the medicine containing axitinib. If you have any further questions on the use of axitinib, ask your doctor.

2. What you need to know before using Bavencio

Do not use Bavencio

if you are allergic to avelumab or any of the other ingredients of this medicine (listed in section 6).

Warnings and cautions

Blood tests and weight checks:

Your doctor will check your general health before and during treatment with Bavencio.

You will be given blood samples during treatment and your doctor will monitor your weight before and during treatment.

Talk to your doctor before taking Bavencio:

This medicine may cause side effects (see section 4). Note that in some cases, symptoms may be delayed and may occur after your last dose. Seek medical attention immediately if you receive any of these:

  • infusion-related reactions
  • problems due to pneumonia ( Pneumonitis )
  • inflammation of the liver ( hepatitis ) or other liver problems
  • inflammation of the intestines ( colitis ), diarrhea (watery, loose or soft stools), more frequent bowel movements than usual
  • inflammation of the pancreas ( pancreatitis )
  • inflammation of the heart muscle ( myocarditis )
  • problems with hormone-producing glands (the thyroid gland, adrenal glands, and pituitary gland ) that can affect how these glands work
  • type 1 diabetes, including increased acidity in the blood due to diabetes (diabetic ketoacidosis )
  • kidney problems
  • inflammation of the muscles (myositis).

If you get any of these symptoms while taking Bavencio, do not try to treat them with other medicines on your own. The doctor can

  • give you other medicines to prevent complications and relieve symptoms
  • postpone the next dose of Bavencio
  • or discontinue treatment with Bavencio altogether.

Check with your doctor or nurse before receiving Bavencio if:

  • you have an autoimmune disease (a condition in which the body attacks its own cells)
  • you have human immunodeficiency virus ( HIV ) infection or acquired immune deficiency syndrome ( AIDS )
  • you have or have ever had a chronic viral infection in the liver, including hepatitis B (HBV) or hepatitis C ( HCV )
  • you are given medicines to suppress the immune system
  • you have undergone an organ transplant.

Children and young people

Bavencio has not been studied in children and adolescents under 18 years of age.

Other medicines and Bavencio

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.

Pregnancy

Bavencio can cause harm to your unborn baby. If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor for advice before using this medicine.

You must not use Bavencio if you are pregnant unless your doctor explicitly recommends it.

If you are a pregnant woman, you must use an effective method of contraception while you are being treated with Bavencio and for at least 1 month after the last dose.

Breast-feeding

Tell your doctor if you are breast-feeding.

Amma not during treatment with Bavencio and for at least 1 month after the last dose one.

It is not known if Bavencio passes into breast milk. A risk to the unborn child cannot be ruled out.

Driving and using machines

Do not drive or use machines after receiving Bavencio unless you are feeling well enough. Fatigue is a very common side effect of Bavencio and may affect your ability to drive or use machines.

Bavencio is low in sodium

Bavencio contains less than 1 mmol sodium (23 mg) per dose, ie essentially ‘sodium-free’.

3. How to use Bavencio

You will receive Bavencio in a hospital or doctor’s surgery under the supervision of an experienced doctor.

How much Bavencio you will get

The recommended dose of avelumab is 800 mg every two weeks. Your doctor will decide how many treatments you need.

How to get Bavencio

You will receive Bavencio as an infusion (drip) into a vein ( intravenously ) over a period of 1 hour. Bavencio is added to an infusion bag containing a sodium chloride solution before use.

Before you get Bavencio

To reduce the risk of side effects associated with the infusion, you will be given paracetamol and an antihistamine at least for the first four hours of treatment before receiving Bavencio. Depending on how your body responds to treatment, your doctor may decide to continue giving you these medicines before any subsequent treatment with Bavencio.

If you have missed a dose of Bavencio

It is very important to you that you come to your booked visits to get Bavencio. If you miss a visit, ask your doctor when to book the next visit.

If you stop getting Bavencio

Cancel not treatment with Bavencio without first discussing it with your doctor. If you stop treatment, the effect of the medicine may stop.

If you have any further questions on the use of this product, ask your doctor.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them. Some side effects may occur weeks or months after your last dose.

Bavencio acts on your immune system and can cause inflammation in parts of the body (see section 2). Inflammation can cause serious damage to the body and some inflammatory conditions can be life-threatening and require treatment or discontinuation of Bavencio.

Seek medical attention immediately if you experience inflammation in any part of the body, or if you get any of the following signs or symptoms or if they get worse.

  • Signs of infusion-related reactions such as shortness of breath or wheezing, chills or tremors, increased rash or hives, swelling, low blood pressure(dizziness, tiredness, nausea), fever, back pain, and abdominal pain. This is very common.
  • Signs of inflammation in hormone-producing glands (which can affect how the glands function) can include extreme fatigue, rapid heartbeat, increased sweating, mood or behavioral changes e.g. irritability or forgetfulness, feeling cold, very low blood pressure (fainting, dizziness, tiredness, nausea), weight change or headache. This is very common for the thyroid gland, common for the adrenal glands, and less common for the pituitary gland.
  • Signs of lung inflammation ( pneumonitis ) may be difficulty in breathing or coughing. This is common.
  • Signs of inflammation in the intestines ( colitis ) may include diarrhea (loose stools) or more frequent bowel movements than normal, bloody stools or black, tar-like, sticky stools, or severe pain or tenderness in the stomach (abdomen). This is common.
  • Signs of liver problems including inflammation of the liver ( hepatitis ) may include yellowing of the skin (jaundice) or yellowing of the eyes, severe nausea or vomiting, pain on the right side of the stomach (abdomen), drowsiness, dark urine (tea-colored), increased tendency to bleed or get bruising than normal, decreased appetite, fatigue or abnormal liver function tests. This is common.
  • Signs of inflammation of the pancreas ( pancreatitis ) may include abdominal pain, nausea, and vomiting. This is less common.
  • Signs of inflammation in the heart muscle ( myocarditis ) may include difficulty breathing, dizziness or fainting, fever, chest pain, and pressure over the chest, or flu-like symptoms. This is less common.
  • Signs of type 1 diabetes can include increased hunger or increased thirstneed to urinate more often, weight loss, and tiredness. This is less common.
  • Signs of inflammation in the kidneys may include abnormal kidney function valuesdecreased urine output, blood in the urine, or swollen ankles. This is less common.
  • Signs of inflammation in the muscles (myositis) may include muscle aches or weakness. This is less common.

Do not try to treat yourself with other drugs on your own.

Other side effects are

Some side effects may not cause any symptoms but can only be detected with blood tests.

The following adverse reactions have been reported in clinical trials with avelumab alone:

Very common (may affect more than 1 user in 10)

  • Reduced number of red blood cells
  • Nausea, loose stools, constipation, vomiting
  • Abdominal pain, back pain, joint pain
  • Cough, shortness of breath
  • Feeling tired or weak
  • Fever
  • Swelling in arms, feet, or legs
  • Weight loss decreased appetite

Common (may affect up to 1 in 10 people)

  • Decreased number of white blood cell types ( lymphocytes )
  • High or low blood pressure
  • Headache, dizziness
  • Feeling cold
  • Dry mouth
  • Elevated pancreatic enzymes in the blood
  • Skin rash, itching
  • Muscle pain
  • Influenza-like symptoms (includes the feeling of fever, muscle aches)
  • Numbness, tingling, weakness, burning sensation in arms or legs

Uncommon (may affect up to 1 in 100 people)

  • Reduced platelet count
  • Reddening of the skin
  • Intestinal obstruction
  • Red, itchy, scaly patches on the skin
  • Inflammatory reaction throughout the body ( Systemic inflammatory response syndrome)
  • Inflammation of the eye
  • Elevated liver enzymes in the blood
  • Increased number of a type of white blood cell ( eosinophils )
  • Elevated muscle enzymes in the blood
  • Guillain ‑ Barré syndrome (an immune disease that causes inflammation in the nerves which can result in pain, numbness, muscle weakness, and difficulty walking)
  • Myasthenia gravis, myasthenic syndrome, a disease that can cause muscle weakness

The following adverse reactions have been reported in clinical trials with avelumab in combination with axitinib:

Very common (may affect more than 1 user in 10)

  • Loose stools, nausea, constipation, vomiting
  • High blood pressure
  • Feeling tired or weak
  • Hoarseness, cough, shortness of breath
  • Decreased appetite, weight loss
  • Headache, dizziness
  • Joint pain, back pain, abdominal pain, muscle aches
  • Elevated liver enzymes in the blood
  • Feeling cold
  • Skin rash, itching
  • Fever

Common (may affect up to 1 in 10 people)

  • Red, itchy, scaly patches on the skin, acne-like rash
  • Swelling in arms, feet, or legs
  • Dry mouth
  • Elevated pancreatic enzymes in the blood
  • Impaired renal function
  • Reduced number of red blood cells
  • Low blood pressure
  • Elevated blood sugar
  • Influenza-like symptoms (includes a feeling of fever, muscle aches)
  • Elevated muscle enzymes in the blood
  • Reduced platelet count
  • Numbness, tingling, weakness, burning sensation in arms or legs
  • Reddening of the skin

Uncommon (may affect up to 1 in 100 people)

  • Decreased number of white blood cell types ( lymphocytes )
  • Increased number of a type of white blood cell ( eosinophils )
  • Intestinal obstruction
  • Myasthenia gravis, myasthenic syndrome, a disease that can cause muscle weakness

Reporting of side effects

If you get any side effects, talk to your doctor, pharmacist, or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly to the Medical Products Agency, www.lakemedelsverket.se. By reporting side effects, you can help increase drug safety information. 

5. How to store Bavencio

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 vial label and carton after EXP. The expiration date is the last day of the specified month.

Store in a refrigerator (2 ° C – 8 ° C).

Do not freeze.

Store in the original package. Sensitive to light.

Do not save excess concentrate or diluted infusion solution for later use.

Any unused product or waste material should be disposed of in accordance with local requirements.

6. Contents of the packaging and other information

Content declaration

The active substance is avelumab.

A vial of 10 ml contains 200 mg avelumab. Each ml of concentrate contains 20 mg of avelumab.

The other ingredients are mannitol, acetic acid, polysorbate 20, sodium hydroxide, water for injections (see section 2 “Bavencio has a low sodium content”).

What the medicine looks like and the contents of the pack

Bavencio is a clear, colorless to pale yellow concentrate for solution for infusion(sterile concentrate).

Pack size: 1 glass vial per carton.

Marketing Authorization Holder and Manufacturer

Merck Europe BV

Gustav Mahlerplein 102

1082 MA Amsterdam

Netherlands

Manufacturer

Merck Serono SpA

Via Delle Magnolie 15 (loc. Fraction Zona Industriale)

70026 – Modugno (BA)

Italy

Muhammad Nadeem

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