(Nivolumab )

What is it?

Xtramab® is a fully human Immunoglobulin G4 (IgG4) monoclonal antibody that selectively inhibits Programmed cell Death-1 (PD-1) activity. Each vial of Xtramab® contains 40, 100, and 240 mg of Nivolumab in 4, 10, and 24 mL concentrate solution for Intravenous Infusion.

How does Xtramab® work?Xtramab® attaches to a target protein called Programmed Death-1 receptor (PD-1) that can switch off the activity of T cells (a type of white blood cell that forms part of the immune system, the body’s natural defenses). By attaching to PD-1, nivolumab blocks its action and prevents it from switching off your T cells. This helps increase their activity against the melanoma, lung, kidney, lymphoid, head and neck, bladder, colon, rectal, stomach, esophageal or gastro-esophageal junction cancer cells.


What is Xtramab® used for?

Xtramab® is a medicine used to treat:

  • Advanced melanoma (a type of skin cancer) in adults
  • Melanoma after complete resection in adults (treatment after surgery is called adjuvant therapy)
  • Non-small cell lung cancer (a type of lung cancer) prior to resection in adults (treatment prior to surgery is called neoadjuvant therapy)
  • Advanced non-small cell lung cancer (a type of lung cancer) in adults
  • Malignant pleural mesothelioma (a type of cancer that affects the lining of the lung) in adults
  • Advanced renal cell carcinoma (advanced kidney cancer) in adults
  • Classical Hodgkin lymphoma that has come back after or has not responded to previous therapies, including an autologous stem-cell transplant (a transplant of your own blood-producing cells) in adults
  • Advanced cancer of the head and neck in adults
  • Advanced urothelial carcinoma (bladder and urinary tract cancer) in adults
  • Urothelial carcinoma after complete resection in adults
  • Advanced colorectal cancer (colon or rectal cancer) in adults
  • Advanced esophageal cancer in adults
  • Esophageal or gastro-esophageal junction cancer with residual disease after chemoradiation followed by surgery in adults
  • Advanced gastric, gastro-esophageal junction or esophageal adenocarcinoma (stomach or gullet cancer) in adults
  • Hepatocellular carcinoma (a type of liver cancer) in adults who have been previously treated with sorafenib


Who should not use Xtramab®?

Do not use Xtramab® if you are allergic to nivolumab or any of the other ingredients of this medicine.

Important information

Check with your doctor or nurse before you are given Xtramab® if:

  • You have an autoimmune disease (a condition where the body attacks its own cells);
  • You have melanoma of the eye;
  • You were previously given ipilimumab, another medicine for treating melanoma, and experienced serious side effects because of that medicine;
  • You have been told that your cancer has spread to your brain;
  • You have any history of inflammation of the lungs;
  • You have been taking medicines to suppress your immune system;
  • You have had a donor stem cell transplant (allogeneic).

Children and Adolescents

Xtramab® should not be used in children and adolescents below 18 years of age.

Other Medicines and Xtramab®

Before you are given Xtramab®, tell your doctor if you are taking any medicines that suppress your immune system, such as corticosteroids, since these medicines may interfere with the effect of Xtramab®. However, once you are treated with Xtramab®, your doctor may give you corticosteroids to reduce any possible side effects that you may have during your treatment and this will not impact the effect of the medicine.

Tell your doctor if you are taking or have recently taken any other medicines. Do not take any other medicines during your treatment without talking to your doctor first.

Pregnancy and Breast-Feeding

Tell your doctor if you are pregnant or think you might be, if you are planning to become pregnant, or if you are breast-feeding.

Do not use Xtramab® if you are pregnant unless your doctor specifically tells you to. The effects of Xtramab® in pregnant women are unknown, but it is possible that the active substance, nivolumab, could harm an unborn baby.

  • You must use effective contraception while you are being treated with Xtramab® and for at least 5 months following the last dose of Xtramab® if you are a woman who could become pregnant.
  • If you become pregnant while using Xtramab®, tell your doctor.

It is not known whether Xtramab® gets into breast milk. A risk to the breast-fed infant cannot be excluded. Ask your doctor if you can breast-feed during or after treatment with Xtramab®.

Driving and Using Machines

Xtramab® in combination with ipilimumab may have a minor influence on the ability to drive and use machines; however, use caution when performing these activities until you are sure that Xtramab® does not adversely affect you.

How much Xtramab® is given?

Your doctor will give you Xtramab® based on your diagnosis and whether it is indicated alone or in combination with other anti-cancer drugs.

Depending on your dose, the appropriate amount of Xtramab® will be diluted with sodium chloride 9 mg/mL (0.9%) solution for injection or glucose 50 mg/mL (5%) solution for injection before use. More than one vial of Xtramab® may be necessary to obtain the required dose.

If you miss a dose of Xtramab®

It is very important for you to keep all your appointments to receive Xtramab®. If you miss an appointment, ask your doctor when to schedule your next dose.

If you stop using Xtramab®

Stopping your treatment may stop the effect of the medicine. Do not stop treatment with Xtramab® unless you have discussed this with your doctor.

If you have any further questions about your treatment or the use of this medicine, ask your doctor.

How is Xtramab® given?

You will receive treatment with Xtramab® in a hospital or clinic under the supervision of an experienced doctor.

Xtramab® will be given to you as an infusion (a drip) into a vein (intravenously) over a period of 30 or 60 minutes, every 2, 3 or 4 weeks, depending on the dose you are receiving. Your doctor will continue giving you Xtramab® for as long as you keep benefitting from it or until you no longer tolerate the treatment. When Xtramab® is given with other anti-cancer medicines, you will first be given Xtramab® followed by the other medicine.

Side Effects

What are the possible side effects of Xtramab®?

Like all medicines, this medicine can cause side effects, although not everybody gets them. Your doctor will discuss these with you and will explain the risks and benefits of your treatment.

Be aware of important symptoms of inflammation. Xtramab® acts on your immune system and may cause inflammation in parts of your body. Inflammation may cause serious damage to your body and some inflammatory conditions may be life-threatening and need treatment or withdrawal of Xtramab®.

The following side effects have been reported with Xtramab® alone:

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

  • Infections of the upper respiratory tract
  • A decreased number of red blood cells (which carry oxygen), white blood cells (which are important in fighting infection) or platelets (cells which help the blood to clot)
  • High (hyperglycemia) or low (hypoglycemia) sugar levels in the blood
  • Diarrhea (watery, loose or soft stools), vomiting, nausea, constipation, stomach pain
  • Skin rash sometimes with blisters, itching
  • Feeling tired or weak, fever, oedema (swelling)
  • Decreased appetite
  • Headache
  • Shortness of breath (dyspnea), cough
  • Pain in the muscles, bones (musculoskeletal pain), and joints (arthralgia)

The following side effects have been reported with Xtramab® in combination with other anti-cancer

medicines (the frequency and severity of side effects may vary with the combination of anti-cancer

medicines received):

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

  • Infections of the upper respiratory tract, serious lung infection (pneumonia)
  • A decreased number of red blood cells (which carry oxygen), white blood cells (which are important in fighting infection) or platelets (cells which help the blood to clot)
  • Underactive thyroid gland (which can cause tiredness or weight gain), overactive thyroid gland (which can cause rapid heart rate, sweating and weight loss), high (hyperglycemia) or low (hypoglycemia) sugar levels in the blood
  • Decreased appetite, decrease in body weight, decreased levels of albumin in the blood, altered sense of taste
  • Inflammation of the nerves (causing numbness, weakness, tingling or burning pain in the arms and legs), headache, dizziness
  • High blood pressure (hypertension)
  • Abnormal speaking sound (dysphonia)
  • Shortness of breath (dyspnea), cough
  • Inflammation of the intestines (colitis), diarrhea (watery, loose or soft stools), constipation, vomiting, nausea, stomach pain, mouth ulcers and cold sores (stomatitis)
  • Skin rash sometimes with blisters, itching, pain of the hands or soles of the feet: rash or redness of the skin, dry skin, tingling and tenderness developing to symmetrical redness, swelling and pain primarily on the palm of the hand and sole of the foot (palmar-plantar erythrodysaesthaesia syndrome)
  • Pain in the joints (arthralgia), pain in the muscles and bones (musculoskeletal pain), muscle spasm
  • Excess protein in urine
  • Feeling tired or weak, fever, oedema (swelling)

Tell your doctor immediately if you get any of the side effects listed above or other side effects that are not listed above or in the product’s leaflet. Do not try to treat your symptoms with other medicines on your own.

For more information, please refer to the product’s leaflet.


How to store Xtramab®?

  • Keep this medicine out of the sight and reach of children.
  • Do not use this medicine after the expiry date, stated on the carton and the vial label after EXP.
  • Store in a refrigerator (2-8°C).
  • Do not freeze.
  • Store in the original package in order to protect from light.
  • The unopened vial can be stored at controlled room temperature up to 25°C with room light for up to 48 hours.
  • Do not store any unused portion of the infusion solution for reuse. Any unused medicine or waste material should be disposed of in accordance with local requirements.


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