Opdivo 100 mg is a medicine for the treatment of
- advanced melanoma (a type of skin cancer) in adults
- advanced non-small cell lung carcinoma (a form of lung cancer) in adults
- advanced renal cell carcinoma (advanced kidney cancer) in adults.
It contains the active ingredient Nivolumab, a monoclonal antibody. This is a type of protein, which is designed to recognize a specific target substance in the body and bind to.
Nivolumab binds to a target protein called “Programmed Death-1 receptor” (PD-1), which can shut down the activity of T-cells (T-cells are a type of white blood cells that are part of the immune system, the body’s natural defenses, ). Through its binding to PD-1 Nivolumab blocks the action of this protein, thereby preventing the switching off your T-cells. Thus, the activity of T cells is promoted against melanoma, lung or kidney cancer cells.
What you need to consider before using it?
Opdivo 100 mg Do not use taken,
- if you are allergic against said Nivolumab or in Section 6 (Content of the pack and other information) excipients of the formulation. Ask yourself if you are not sure your doctor.
Warnings and Precautions
Please talk to your doctor before you apply Opdivo 100 mg. OPDIVO can cause the following:
- Problems with the lungs such as wheezing or coughing. These may be signs of pneumonia (pneumonitis or interstitial lung disease).
- Diarrhea (watery, loose or soft stools) or symptoms of bowel inflammation (colitis) such as abdominal pain and mucus or blood in the stool.
- Inflammation of the liver (hepatitis) signs and symptoms of hepatitis may include abnormal liver function tests, yellowing of the eyes or skin (jaundice), be pain in the right abdomen area or fatigue.
- Abnormal renal function tests or kidney problems. Signs and symptoms may include among other abnormal renal function tests or a debased urine volume.
- Problems of the endocrine glands (including the pituitary, thyroid and adrenal glands), whereby the gland function may be impaired. Signs and symptoms that the glands do not work properly, including fatigue (extreme tiredness), weight changes or headaches and vision problems may be.
- Diabetes (symptoms include excessive thirst, greatly increased urine output, increased appetite with weight loss, feeling of tiredness, sleepiness, weakness, depression awareness, irritability and general malaise) or diabetic ketoacidosis (caused by diabetes acid in the blood).
- Skin inflammation, which rash and itching of the skin may result.
Inform your doctor immediately if you have any of these signs or symptoms or they get worse. You do not own, try to treat your symptoms with other medicines. Your doctor may
- Give you other medicines to prevent complications and to reduce the symptoms,
- omit the next dose Opdivo 100 mg
- cancel or treatment with OPDIVO entirely.
Please note that these signs and symptoms sometimes delayed and may develop weeks or months after the last infusion. Before treatment, your doctor will examine your overall health. It also occurs during your treatment
Blood tests performed.
Discuss with your doctor or nurse before you receive Opdivo 100 mg when
- They have an autoimmune disease (a condition in which the body attacks its own cells);
- You have a melanoma of the eye;
- You have previously received ipilimumab, another drug for the treatment of melanoma, and have been caused by this drug serious side effects with you;
- You were informed that have formed in your cancer metastases in the brain;
- occurred in your medical history pneumonia;
- They have taken medicines that suppress your immune system.
Children and adolescents
Opdivo 100 mg should not be used in children and adolescents under 18 years.
Application of OPDIVO with other medicines
Before you apply OPDIVO, tell your doctor if you are taking medicines / apply that suppress the immune system, such as corticosteroids, as these medicines may influence the effect of OPDIVO. If you are treated once with Opdivo 100 mg, but your doctor may prescribe corticosteroids to alleviate possible side effects during treatment. This will not affect the effect of the drug.
Tell your doctor if you take other medicines / taking or have recently taken any other medicines / applied. Take during your treatment any other medicines without having the previously discussed with your doctor.
pregnancy and breast feeding period
Tell your doctor if you are pregnant, think you may be pregnant, if you are planning to become pregnant or if you are breastfeeding.
Use Opdivo 100 mg not, if you are pregnant, unless your doctor have been specifically arranged. The effects of OPDIVO during pregnancy are not known, but it is possible that the active ingredient Nivolumab can harm the unborn baby.
- If you can get children as a woman, you have to use effective contraception while you are being treated with OPDIVO and up to and including at least 5 months after the last dose Opdivo 100 mg.
- If you become pregnant during treatment with OPDIVO, tell your doctor.
It is not known whether Nivolumab passes into breast milk. A risk to breastfed infants can not be excluded. Ask your doctor whether you can breast-feed during or after treatment with Opdivo 100 mg.
Driving and using machines
It is unlikely that Nivolumab impair the ability to drive and the ability to operate machinery; but you should be careful until you are sure that you Nivolumab not impaired in these activities.
Opdivo 100 mg contains sodium
Tell your doctor before you are treated with OPDIVO if you are on a controlled sodium diet. This medicinal product contains 2.5 mg sodium per ml of concentrate.
You also find this information in the patient card that was handed out by your doctor. It is important that you keep this patient card with you and your partner or caregivers show.
How is it used?
How much OPDIVO is administered?
The law applicable to you lot OPDIVO is calculated from your body weight.The recommended dose is 3 mg per kilogram of your body weight Nivolumab.
Depending on your dose before applying the appropriate amount OPDIVO is diluted with sodium chloride 9 mg / ml (0.9%) solution for injection or glucose 50 mg / ml (5%) solution for injection. Maybe more than one vial OPDIVO for the required dose is needed.
How to use Opdivo 100 mg?
OPDIVO will be given to you in a hospital or clinic under the supervision of an experienced physician.
OPDIVO you will be given every 2 weeks as an infusion (drip) into a vein (intravenously) over a period of 60 minutes. Your doctor will administer OPDIVO as long as you benefit from it, or until you no longer tolerate the treatment.
If you miss a dose Opdivo 100 mg
It is very important that you follow all the events where you will be given OPDIVO. If you miss an appointment, ask your doctor for an appointment for the next dose.
If you stop using OPDIVO
With discontinuation of treatment, the effect of the drug can stop.Therefore, do not stop treatment with Opdivo 100 mg unless you have discussed this with your doctor.
If you have further questions about the treatment or the use of this product, ask your doctor
What are the possible side effects?
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.
Pay attention to significant symptoms of inflammation. Opdivo 100 mg acts on your immune system and may cause inflammation in the body.Inflammation can damage your body seriously. Some infections can be life threatening and require treatment or require discontinuation of Nivolumab.
The following adverse reactions have been reported in clinical trials with Nivolumab:
Very common (may affect more than 1 in 10 patients)
- decreased appetite
- Diarrhea (watery, loose or soft stools), nausea
- Rash, itching
- Feeling weak or tired
Common (may affect up to 1 in 10 patients)
- Infections of the upper respiratory tract
- Allergic reaction, reactions related to the infusion of the drug
- Underactive thyroid, which can cause tiredness or weight gain, overactive thyroid gland, which can cause a more rapid heartbeat, sweating and weight loss
- High blood sugar levels (hyperglycemia)
- cause neuritis, numbness, weakness, tingling, or burning pain in the arms and legs; Headache, dizziness
- Blurred vision, dry eyes
- High blood pressure (hypertension)
- Pneumonia (pneumonitis), characterized by coughing and breathing difficulties; Shortness of breath (dyspnea), cough
- Intestinal inflammation (colitis), mouth ulcers and cold sores (stomatitis), vomiting, stomach pain, constipation, dry mouth
- Stained changes in skin color (vitiligo), dry skin, rash, unusual hair loss or thinning of hair
- Pain in muscles, bones and joints
- Fever, swelling (edema)
Uncommon (may affect up to 1 in 100 patients)
- Severe pneumonia (pneumonia), bronchitis
- Elevated levels of certain white blood cells
- Decreased secretion of hormones that the adrenal glands (glands above the kidneys are) produced, underactive (hypopituitarism) or inflammation (Hypophysitis) pituitary, a gland that lies at the base of the brain, swelling of the thyroid gland, resulting from diabetes acid in blood (diabetic ketoacidosis)
- Dehydration, increased acid in the blood
- Inflammation of the liver (hepatitis)
- Yellowing of the skin and / or eyes (jaundice)
- Nerve damage, the numbness and weakness caused (polyneuropathy)
- Eye irritation, pain or redness caused blurred vision or blurred vision
- Fast heartbeat
- Inflammatory disease of the blood vessels
- Accumulation of fluid around the lungs
- Inflammation of the pancreas
- Severe skin disease, the red, often itchy spots, similar to the rash in measles, causes and starts on the limbs and sometimes the face and rest of the body (erythema multiforme); Skin disease with thickened patches of red skin, often with silvery scaling (psoriasis), skin disorder of the face, are unusually red in nose and cheeks (rosacea); Hives (itchy, nodular rash)
- Muscle inflammation that causes pain or stiffness, pain in the joints
- Nephritis, kidney failure
- Pain, chest pain
Rare (may affect up to 1 in 1000 patients)
- Disease are inflamed or enlarged in the lymph nodes (lymphadenitis Kikuchi)
- Blockage of the bile ducts
- Temporary inflammation of the nerves causing pain, weakness and paralysis in the extremities caused (Guillain-Barré syndrome); Loss of the protective coating around the nerves around (demyelination); a condition in which the muscles become weak and tire easily (myasthenic syndrome); Neuritis, triggered by the own body attacks itself, causing numbness, weakness, tingling, or burning pain
- Changes in heart rhythm or rate of the heartbeat, rapid heartbeat, abnormal heart rhythm
- Fluid accumulation in the lungs
- Gastritis (stomach inflammation), small bowel ulcer
- Serious and fatal as possible peeling of the skin (toxic epidermal necrolysis)
- Myopathy (muscle pain, tenderness of the muscles or muscle weakness, which are not caused by physical activity)
Tell your doctor if you get an instant these side effects. You do not own, try to treat your symptoms with other medicines.
Changes of test results
Opdivo 100 mg can alter the results of tests carried out by your doctor. These include:
- Abnormal liver function tests (elevation of liver enzymes aspartate aminotransferase, alanine aminotransferase or alkaline phosphatase in the blood, elevated blood levels of degradation product bilirubin)
- Abnormal renal function tests (increased creatinine levels in the blood)
- Decreased number of red blood cells (carry oxygen), white blood cells (fight infections from) or platelets (support blood clotting)
- degrades increasing the amount of enzyme which degrades fats and the amount of enzyme, the starch
- Increased or decreased levels of calcium or potassium
- Increased or decreased blood levels of magnesium or sodium
- loss in weight
Reporting of adverse reactions
If you notice any side effects, talk to your doctor. This includes any possible side effects not listed in this leaflet. You can view side effects directly via the products listed in Annex V national reporting system. By reporting side effects, you can help ensure that more information is provided about the safety of this product available
How should it be stored?
Keep this medicine out of reach of children.
Do not use this medicine after the expiry date stated on the carton after “EXP” and on the container after “EXP”. The expiry date refers to the last day of that month.
Store in a refrigerator (2 ° C to 8 ° C). Do not freeze.
Store in the original package in order to protect from light.
Please do not store unused infusion solution for re-use. Not product or waste material should be disposed of in accordance with local requirements.