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Nivolumab, sold with the brand name Opdivo, is a medication used to treat several types of cancer. This includes melanoma, lung cancer, malignant pleural mesothelioma, renal cell carcinoma, Hodgkin lymphoma, head and neck cancer, urothelial carcinoma, colon cancer, esophageal squamous cell carcinoma, gastric liver cancer, and esophageal or gastroesophageal junction (GEJ) cancer. It is used by slow injection into a vein.
Opdivo contains the active ingredient Nivolumab, a cancer drug that affects a patient’s immune system to interfere with the growth and spread of cancer cells in the body.
It is used to treat certain types of cancer, including melanoma (skin cancer), non-small cell lung cancer, bladder cancer, kidney cancer, liver cancer, and lung cancer. Head and neck human squamous cell carcinoma, colorectal cancer, classical Hodgkin Lymphoma, and urothelial carcinoma.
Active ingredient nivolumab is a human immunoglobulin G4 (IgG4) monoclonal antibody that binds to the death-1 (PD-1) receptor preventing its interaction with PD-L1 and PD-L2. The PD-1 receptor is a negative regulator of T-cell activity that has been shown to be involved in the control of T-cell immune responses.
PD-1 with the ligands PD-L1 and PD-L2 are expressed in antigen-presenting cells and possibly expressed by tumor or other cells in the tumor microenvironment, leading to inhibition of T-cell proliferation and cytokine secretion.
Nivolumab enhances T-cell responses, including anti-tumor responses, by blocking PD-1 binding to the ligands PD-L1 and PD-L2. In syngeneic mouse models, blocking PD-1 activity resulted in decreased tumor growth.
The combination of nivolumab (anti-PD-1) and ipilimumab (anti-CTLA-4)-mediated inhibition leads to an improved anti-tumor response in metastatic melanoma. In synthetic murine tumor models, dual blockade of PD-1 and CTLA-4 resulted in synergistic anti-tumor activity.
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Melanoma: as monotherapy or in combination with ipilimumab is indicated to treat advanced (unresectable or metastatic) melanoma in adults.
Adjuvant melanoma: monotherapy is indicated for the adjuvant treatment of adults with melanoma with lymph node involvement or metastatic disease who have undergone surgical resection.
Non-small cell lung cancer (NSCLC): in combination with ipilimumab for the first-line treatment of metastatic non-small cell lung cancer.
Renal cell carcinoma (RCC): monotherapy is indicated to treat advanced renal cell carcinoma. The drug can be treated in combination with ipilimumab or cabozantinib.
Hodgkin lymphoma: monotherapy is indicated to treat adult patients with relapsed or refractory Hodgkin lymphoma following stem cell transplantation.
Squamous cell cancer of the head and neck (SCCHN): monotherapy is indicated to treat recurrent or metastatic squamous cell cancer of the head and neck in adults.
Oesophageal squamous cell carcinoma (OSCC): monotherapy is indicated to treat adult patients with unresectable progressive, recurrent, or metastatic esophageal squamous cell carcinoma.
Who should not take Opdivo?
Hypersensitivity to the active substance Nivolumab or to any of the excipients.
Important information about the drug Opdivo 100mg/10ml. Buy Opdivo online
Drugs Opdivo can change how to operate your immune system, can cause specific side effects that can lead to serious health problems.
Call your doctor at once if you have: chest pain, cough, trouble breathing, vision changes, tiredness, severe muscle pain or weakness, diarrhea and severe stomach pain, blood in your stools, little or no urinating, swelling in your feet, bruising, or bleeding, dark urine, yellowing of the skin or eyes, skin sores or blisters, confusion, hallucinations, seizures, or a hormonal disorder (pain) frequent headaches, feeling light-headed, increased thirst or urination, a deeper voice, feeling cold, weight gain or loss).
Opdivo is approved by the U.S. Food and Drug Administration (FDA) on an “accelerated” basis for certain types of cancer. The drug produced complete or partial response or prolonged survival without cancer progression in clinical studies. However, further research is needed.
Opdivo side effects can cause symptoms in many different parts of the body. Some side effects may need to be treated with other drugs, and your cancer treatments may be delayed. You will need regular medical tests to help your doctor determine if it is safe for you to continue receiving Opdivo.
Some notes before you start using Opdivo
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You should not use Opdivo if you are allergic to nivolumab. To make sure the medicine is safe for you, tell your doctor if you have ever had:
- Lung problems;
- Liver failure;
- Kidney disease;
- Thyroid disorders;
- Autoimmune disorders such as lupus, Crohn’s disease, or ulcerative colitis ;
- People who have had an organ transplant.
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Effects on pregnant or lactating women
Do not use Opdivo if you are pregnant. It can harm an unborn baby. Use effective birth control to prevent pregnancy while using this medicine and for at least 5 months after your last dose.
It is unknown whether nivolumab passes into breast milk or could harm a nursing baby. You should not breastfeed while using this medicine.
Diarrhea may occur. If this effect persists or worsens, tell your doctor or pharmacist promptly.
People using this medication may have serious side effects. However, your doctor has prescribed this drug because they have judged that your benefit is greater than the risk of side effects. Careful monitoring by your doctor may decrease your stake.
Talk to your doctor immediately if you have any severe side effects, including signs of infection (such as fever, runny/stuffy nose, new/worsening cough), diarrhea with blood/mucus, mouth/throat sores, severe stomach pain, constant nausea/vomiting, loss of appetite, yellowing eyes/skin, dark urine), signs of kidney problems (such as a change in the amount of urine, pink/bloody urine), easy bruising/bleeding, swelling hands/ankles/feet, unusual weakness, joint stiffness/pain, muscle weakness/tenderness/pain/spasms/cramps, numbness/tingling of arms/legs, loss of coordination, eye redness/pain, sensitivity to light, vision changes, persistent/unusual headache, seizures.
Nivolumab may cause hormone gland problems (thyroid, pituitary, adrenal, pancreas). Your body could create too much or too little hormone. Inform your doctor straight away if you have any manifestations such as:
- Cold or heat intolerance.
- Unexplained weight loss/gain.
- Increased thirst/urination.
- Mood or behavior changes (decreased sex drive, irritability, forgetfulness).
- Slow/fast/pounding/irregular heartbeat.
- Unusual tiredness.
Acquire medical help right away if you have any severe side effects, including chest pain and shortness of breath.
Nivolumab can commonly cause itching or a rash that is usually not serious. However, you may not be able to tell it apart from a rare rash that could be a sign of a severe reaction. Therefore, get medical help right away if you develop any rash or itching.
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A severe allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a severe allergic reaction. Including rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.
This is not a complete list of possible side effects. Contact your doctor or pharmacist if you notice other effects not listed above.
In the US – Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch.
In Canada – Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.
Warnings & Precautions. Buy Opdivo online
Before using nivolumab, tell your doctor or pharmacist if you are allergic to it or have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.
Before using this medication, tell your doctor or pharmacist your medical history, especially of: organ transplant, stem cell transplant with donor cells.
Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).
Tell your doctor if you are pregnant or plan to become pregnant. You should not become pregnant while using nivolumab. Nivolumab may harm an unborn baby. Your doctor should order a pregnancy test before you start this medication. Ask about reliable forms of birth control while using this medication and for 5 months after stopping treatment. If you become pregnant, talk to your doctor right away about the risks and benefits of this medication.
It is unknown if this drug passes into breast milk. Because of the possible risk to the infant, breastfeeding while using this drug and for 5 months after stopping treatment is not recommended. Consult your doctor before breastfeeding.
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Buy opdivo bristol Myers online. Storage
Not applicable. This medication is given in a hospital or clinic and will not be stored at home.
Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor’s approval.
If you Overdose
If someone has overdosed and has severe symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call their local poison control center at 1-800-222-1222. Canadian residents can call a provincial poison control center.
For the best possible benefit, it is important to receive each scheduled dose of this medication as directed. If you miss a dose, contact your doctor or pharmacist right away to establish a new dosing schedule.
Whats Opdivo (Nivolumab) medicine treatment prices
The price for a monthly or yearly Opdivo (Nivolumab) treatment relies on your prescription requirements, including the dosage in mg/ml and medicine type (Single vial).
The price of the medications you see on sale is the cost levied by the manufacturer. In addition, shipping costs and a Named Patient support fee will apply.
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Please refer to the official prescribing information for a comprehensive list of side effects and adverse reactions [1,2,3].
- Summary of Product Characteristics [FDA]: Opdivo (nivolumab)[PDF]
- Bristol-Myers Squibb, Mar. 2018.
- Summary of Product Characteristics [EMA]: Opdivo (nivolumab)
- Bristol-Myers Squibb Pharma EEIG, Mar. 2017
- 3. Summary of Product Characteristics [TGA]: Opdivo (nivolumab)
- Bristol-Myers Squibb Australia Pty Ltd, May 2017
- 4. Report on deliberation results (Japan) [PDF]
- PMDA.go.jp, June 2014
- Report on deliberation results (Japan)[PDF]
- PMDA.go.jp, August 2016
- Human Medicines: Opdivo (nivolumab)
- EMA, cited Sept 2015
- Nivolumab versus chemotherapy in patients with advanced melanoma who progressed after anti-CTLA-4 treatment (CheckMate 037): a randomized, controlled, open-label, phase 3 trial
- Weber J.S., et al. The Lancet Oncology, April 2015
- Approved Drugs: Nivolumab (Opdivo) for Hodgkin Lymphoma
- FDA, May 2016
- Approved Drugs: Nivolumab for SCCHN
- FDA, Nov 2016
- FDA Approves Nivolumab for Urothelial Carcinoma
- OncLive, Feb 2017
- Opdivo Approval History
- Drugs.com cited May 2016
- EMA Press Release. New treatment for an advanced form of kidney cancer
- EMA, Feb 2016
- Bristol-Myers Squibb Receives FDA Approval for Opdivo (nivolumab) in MSI-H or dMMR Metastatic Colorectal Cancer That Has Progressed Following Treatment.
- Drugs.com, Aug 2017
- FDA Approves Nivolumab for Hepatocellular Carcinoma
- Olive, Sept 2017
- FDA grants regular approval to nivolumab for adjuvant treatment of melanoma
- FDA, Dec 2017
- Report on deliberation results (Japan)[PDF]
- PMDA.go.jp, October 2016.
- Report on deliberation results (Japan)[PDF]
- PMDA.go.jp, February 2017.
- Report on deliberation results (Japan)[PDF]
- PMDA.go.jp, August 2017.
- Medsafe Product Detail [Medsafe]: Opdivo (nivolumab)[PDF]
- Bristol-Myers Squibb, Apr. 2016.
- U.S. Food and Drug Administration Approves Opdivo® (nivolumab) as Adjuvant Treatment of Completely Resected Esophageal or Gastroesophageal Junction Cancer in Patients who have Received Neoadjuvant Chemoradiotherapy
- Bristol-Myers Squibb, May 2021
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