Opdivo: information, Uses, Dosage, Side Effects, Warnings

What is it Opdivo?

active substance
Nivolumab

Approval: Europe

Manufacturer: Bristol-Myers Squibb

ATC code: L01XC

What is it and how is it used?

OPDIVO is a medicine for the treatment of

Advanced melanoma (a form of skin cancer) in adults

Advanced non-small-cell lung carcinoma (a form of lung cancer) in adults

Advanced renal cell carcinoma (advanced renal cancer) in adults.
It contains the active substance nivolumab, a monoclonal antibody. This is a protein type that is designed to recognize and bind a specific target substance in the body.

Nivolumab binds to a target protein called "Programmed-Death-1-Receptor"
(T cells are a type of white blood cells that are part of the immune system, the natural body defense), which can deactivate the activity of T cells (PD-1). Due to its binding to PD-1, nivolumab blocks the effect of this protein and thus prevents the switching off of your T-cells. This promotes the activity of T cells against the melanoma, lung or renal cancer cells.

What should you watch out for before use?

OPDIVO should not be used if:

If you are allergic to nivolumab or any of the other ingredients in this medicinal product as specified in section 6 (package contents and other information). Ask your doctor if you are not sure.
Warnings and Precautions
Please discuss with your doctor before using OPDIVO. OPDIVO may cause:

Problems with the lungs such as respiratory distress or cough. These may be signs of lung inflammation (pneumonitis or interstitial pulmonary disease).

Diarrhea (watery, loose or soft stools) or symptoms of a daring inflammation (colitis) such as abdominal pain and mucus or blood in the stool.

Hepatic inflammation (hepatitis) Signs and symptoms of hepatitis may include, but are not limited to abnormal liver function tests, yellowing of the eyes or skin (gel), pain in the right abdomen, or fatigue.

Abnormal renal function tests or renal problems. Signs and symptoms may include, but are not limited to, abnormal renal function tests or decreased urine volume.

Problems of the hormonal glands (including the pituitary gland, the thyroid gland and the adrenal glands), which can affect glandular function. Signs and symptoms that the glands do not work properly can include, but are not limited to, exhaustion (extreme fatigue), weight changes, headaches, and vision problems.

Diabetes (symptoms include excessive thirst, increased urine excretion, increased appetite for weight loss, feeling of fatigue, drowsiness, weakness, depression, irritability and general malaise) or diabetic ketoacidosis (diabetes-induced acid in the blood).

Skin irritation, which can result in skin swelling and skin hurting.
Tell your doctor immediately if you have any of these signs or symptoms or if they become worse. Do not try to treat your symptoms with other medicines. Your doctor can

Give you other medicines to prevent complications and reduce symptoms,

The next dose OPDIVO

Or discontinue treatment with OPDIVO completely.
Please note that these signs and symptoms may be delayed and may develop weeks or months after your last infusion. Before the treatment, your doctor will examine your overall health. It will also be used during your treatment
Blood tests.
Discuss with your doctor or nurse before you get OPDIVO if

You 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 medication for melanoma treatment, and you have experienced serious side effects with this medication;

Have been told that cancer metastases have formed in your brain;

In your patient's history of pneumonia;

You have taken medicines that suppress your immune system.

Children and adolescents
OPDIVO should not be used in children and adolescents under 18 years of age.

Use of OPDIVO together with other medicines
Before using OPDIVO, tell your doctor if you are taking or are taking any medicines that suppress the immune system, e.g. Corticosteroids, since these drugs can affect the effect of OPDIVO. Once you are treated with OPDIVO, your doctor may prescribe corticosteroids to alleviate any side effects during treatment. This will not affect the effect of the drug.

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

pregnancy and breast feeding period
Tell your doctor if you are pregnant, think you may be pregnant if you plan to become pregnant or breastfeed.
Do not use OPDIVO if you are pregnant, unless your doctor has specifically ordered this. 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 are able to get children as a woman, you need to use an effective contraceptive method while you are treated with OPDIVO and up to and including at least
5 months after the last dose OPDIVO.

If you become pregnant during treatment with OPDIVO, tell your doctor.
It is not known whether nivolumab passes into the mother's milk. A risk for breast-feeding children can not be ruled out. Ask your doctor if you are breast-feeding during or after treatment with OPDIVO.
Ability to drive and operate machines
It is unlikely that nivolumab affects the ability to drive and operate machines; However, you should be careful with these activities until you are sure that nivolumab does not affect you.

OPDIVO contains sodium
Inform your doctor before using OPDIVO if you have a low salt diet. This medicine contains 2.5 mg sodium per ml of concentrate.
You will also find this information in the patient card given to you by your doctor. It is important that you keep this patient card with you and show it to your partner or nursing staff

How is it used?
How much OPDIVO is administered?
The amount of OPDIVO to be used is calculated based on your body weight. The recommended dose is 3 mg nivolumab per kilogram of your body weight.

Depending on your dose, the appropriate amount of OPDIVO is diluted with a solution of sodium chloride 9 mg / ml (0.9%) for injection or glucose solution 50 mg / ml (5%) for injection purposes. It may take more than one OPDIVO vial for the required dose.

How is OPDIVO used?
OPDIVO is given to you in a hospital or clinic under the supervision of an experienced physician.

OPDIVO is given to you as an infusion (drip) into a vein (intravenously) over a period of 60 minutes every 2 weeks. Your doctor will give you OPDIVO as long as you benefit, or until you can no longer tolerate the treatment.

If you missed a dose of OPDIVO
It is very important that you keep all the dates on which OPDIVO is administered to you. If you miss an appointment, ask your doctor for an appointment
Date for the next dose.

If you cancel the application of OPDIVO
If the treatment is discontinued, the effect of the drug may cease. Therefore, do not stop OPDIVO unless you have talked to your doctor.

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

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