Nivolumab (Opdivo / Opdyta): What It Is and How It Is Used
Nivolumab is an intravenous immunotherapy medicine of the PD-1 checkpoint inhibitor class. Outside India the same molecule is sold as Opdivo; inside India the originator product is branded Opdyta, and since January 2026 a domestically manufactured biosimilar called Tishtha has been on the market too. Three names, one active molecule — which is why the word on an Indian prescription so often fails to match what a search engine returns. This page explains what nivolumab is, which cancers it is approved for in India, how it is given, and, just as importantly, who it is not for.
Medically reviewed by Dr. T. Raghavender Reddy, Medical Oncologist, MBBS · DM (Medical Oncology) · MD (Radiation Oncology) · Last reviewed August 2026
What is nivolumab (Opdivo / Opdyta)?
Nivolumab is a laboratory-made antibody that blocks PD-1, a switch on immune T-cells that some tumours use to avoid attack. Blocking it aims to let the immune system recognise the cancer again. It is given by drip, not as a tablet. Opdivo and Opdyta are brand names for this same molecule.
Nivolumab belongs to the checkpoint inhibitor family, alongside pembrolizumab, atezolizumab and others. It does not attack cancer cells directly the way chemotherapy does. It removes one of the brakes the immune system puts on itself, so that a patient's own T-cells can act. That mechanism is also why its side effects look nothing like chemotherapy side effects: the risk is inflammation in healthy organs, not hair loss and low counts.
The naming causes real confusion in Indian clinics. Bristol Myers Squibb sells nivolumab as Opdivo in most of the world, but registered it in India as Opdyta. A patient handed an Opdyta prescription finds relatively little online, while searching Opdivo returns American pricing and approval details for a brand not sold here. Since January 2026 a third name is in circulation too — Tishtha, the Zydus Lifesciences biosimilar.
Opdivo, Opdyta, Tishtha: which name is which?
All four rows below describe the same active molecule. The differences are about who makes it and where it is sold, not about what it does.
| Name | What it is | Where you will see it |
|---|---|---|
| Nivolumab | The generic (non-proprietary) molecule name | Prescriptions, treatment guidelines, hospital billing lines |
| Opdivo | The originator brand used outside India | International websites, foreign trial reports, overseas price lists |
| Opdyta | The same originator product, registered under its Indian brand name | Indian prescriptions, hospital pharmacy labels and invoices |
| Tishtha | A nivolumab biosimilar from Zydus Lifesciences, launched in India in January 2026 | Indian prescriptions and pharmacy invoices from 2026 onwards |
If the name on your paperwork and the name on your screen disagree, check the generic line first. It will read nivolumab.
Did you know?
Searching "Opdivo" from India mostly returns American approval and pricing information for a brand that is not marketed here. The Indian brand of the identical molecule is Opdyta, and since January 2026 there is also the Zydus biosimilar Tishtha. Reading foreign Opdivo prices as though they applied in India is one of the commonest reasons families arrive at a consultation with the wrong cost expectation.
Which cancers is nivolumab approved for in India?
Nivolumab is approved by CDSCO for a defined list of advanced cancers, not for cancer in general. The list includes selected cases of advanced melanoma, non-small cell lung cancer, kidney (renal cell) cancer, head and neck cancer and urothelial bladder cancer. Approval for a cancer type does not mean approval for every patient with it.
As of August 2026, nivolumab is approved and marketed in India by its originator under the brand Opdyta, and the Zydus biosimilar Tishtha holds CDSCO approval and has been commercially available since January 2026. The approved indication list is not fixed. It has been widened over the years as CDSCO has cleared additional uses, including a first-line combination with cisplatin and gemcitabine in advanced urothelial carcinoma, recommended by the regulator's Subject Expert Committee in November 2024.
Being on the list and being eligible are different questions. In practice the treating team weighs:
- Stage and extent of disease — checkpoint inhibitors are largely used in advanced or metastatic settings, with a small number of approved adjuvant uses.
- Line of treatment — several indications apply only after platinum-based chemotherapy has been tried.
- Biomarker results — PD-L1 expression, MSI or mismatch-repair status and, in some cancers, tumour mutational burden.
- General fitness — performance status, organ function and the ability to attend regular monitoring.
- Autoimmune and transplant history — often the deciding factor against treatment.
Indian oncologists work from the CDSCO-approved label alongside the evidence positions published by NCCN, ASCO and ESMO. Whether nivolumab is on the table for your diagnosis is answered by your oncologist reading your reports, not by a list on a web page.
How is nivolumab given?
Nivolumab is given as an intravenous infusion in a hospital day-care unit, usually over about thirty minutes. Cycles commonly repeat every two, three or four weeks, depending on the regimen. There is no tablet form. Most patients go home the same day, and no overnight admission is needed for the infusion itself.
- Before the first dose Baseline blood tests are done — blood counts, kidney and liver function, and thyroid hormones — along with a careful history of autoimmune conditions, transplants and current medicines. In India, hepatitis B and C status and tuberculosis risk are also normally assessed first.
- On infusion day Blood tests are usually repeated and reviewed before the pharmacy releases the drug. The infusion runs through a cannula or an existing port. None of the scalp-cooling or hair-loss preparation associated with chemotherapy applies.
- Between cycles Report new symptoms early rather than waiting for the next visit — particularly breathlessness, a new cough, loose motions, jaundice, palpitations or unusual weakness. Immune-related reactions are far easier to control when caught early.
- Response assessment Imaging is typically repeated after roughly eight to twelve weeks, then at intervals your team sets. Early immunotherapy scans can look unusual, so radiology is read alongside how you are actually feeling.
- How long it continues Some protocols run for a fixed period, such as up to two years. Others continue while the disease is controlled and side effects stay manageable. Treatment stops earlier if the cancer progresses or a serious immune reaction occurs.
Dosing is set by your oncologist against the approved label and your body weight or a flat-dose schedule. Nothing here is a dosing instruction.
Who nivolumab is not for
Nivolumab is not suitable for most people with cancer. Checkpoint inhibitors apply to a defined minority of diagnoses and situations. If your oncologist has not raised nivolumab as an option for your specific cancer, stage and biomarker profile, that is the ordinary case, not an oversight.
Beyond eligibility by cancer type, nivolumab is generally avoided, or used only with close specialist supervision, in these situations:
- Active, significant autoimmune disease — conditions such as active inflammatory bowel disease, lupus or poorly controlled rheumatoid disease can flare severely when the PD-1 brake is released.
- Ongoing high-dose immunosuppression — high-dose steroids or other immunosuppressants taken for another condition can both blunt the intended effect and complicate management.
- Solid-organ transplant recipients — there is a recognised risk of graft rejection.
- A previous severe immune-related reaction to a checkpoint inhibitor, particularly involving the lungs, heart, liver or bowel.
- Untreated active infection — in India, hepatitis B or C and tuberculosis status is normally checked and addressed before immunotherapy begins.
Nivolumab is also not a replacement for surgery, radiotherapy or chemotherapy where those are the indicated treatment; not an immunity booster, tonic or preventive for people without a confirmed cancer diagnosis; and not something this page can arrange, price or supply. This is editorial information only. Whether nivolumab is unsuitable in your case is a clinical judgement your treating oncologist makes against your full history.
How well does nivolumab work?
Nivolumab does not work for everyone. In its approved settings, trial data summarised by bodies such as NCCN, ASCO and ESMO describe tumour shrinkage in a minority of treated patients — broadly somewhere between one in five and one in three, varying by cancer type, line of treatment and biomarker status.
Those are population figures from trial cohorts, not a prediction for an individual. What is distinctive about checkpoint inhibitors is less how often they work than what happens in the group where they do: responses can be unusually durable, and can persist after treatment has stopped. That possibility, in a proportion of patients, is why immunotherapy earns its place in the approved settings.
Assessment is by imaging plus clinical review. Response can be misleading in the first weeks — a lesion can look larger on an early scan because immune cells have moved into it, before it settles. That is why oncologists rarely act on a single early scan in isolation, and why imaging is read against how the patient is actually doing.
Nivolumab is intended to control disease in the situations where it is approved. No honest page can promise an outcome for a named medicine in an individual patient.
What does nivolumab cost in India now?
Nivolumab pricing in India shifted sharply in 2026. In its January 2026 launch announcement, Zydus Lifesciences priced the biosimilar Tishtha at ₹13,950 for a 40 mg vial and ₹28,950 for a 100 mg vial, stating these were approximately one fourth of the reference product's price.
News reporting at the time placed Opdyta at roughly ₹36,000 to over ₹90,000 per vial, depending on the presentation. Both sets of figures are published, dated numbers and are indicative only, as of August 2026. They are not CION rates. What a course actually costs depends on the dose, the number of cycles, day-care and monitoring charges, and any insurance or scheme cover, so an itemised estimate from the treating hospital's billing team is worth more than any figure on a web page.
The change is regulatory rather than clinical. Nivolumab's Indian patent expired on 2 May 2026, and the biosimilar reached the market a few months ahead of that date following a Delhi High Court ruling. Pembrolizumab, the other widely used PD-1 inhibitor, is not expected to face equivalent Indian competition until its protection begins lapsing around 2028 to 2029.
One safety consequence of a high-value molecule going off patent: counterfeit checkpoint inhibitors have been reported entering the Indian market around patent and exclusivity changes. Asking the treating hospital how a vial's authenticity and cold-chain storage were verified is a fair question, not a challenge to your care team. The full pricing picture is set out in Nivolumab Cost in India After the Biosimilar Launch.
What side effects does nivolumab cause?
Nivolumab's side effects come from immune inflammation in healthy organs, not from cell-killing toxicity. Most are mild — fatigue, rash, itching, joint aches, thyroid changes. A minority are serious and can affect the bowel, lungs, liver, heart or hormone glands. They can begin weeks or months in, and sometimes after treatment has finished.
The single most useful thing a patient or carer can do is report new symptoms early instead of waiting for the next cycle. Immune-related reactions respond well to prompt treatment and badly to delay. Some warrant same-day assessment rather than a phone update:
- Breathlessness, a new or worsening cough, or chest tightness — go to hospital the same day; do not manage this at home.
- Chest pain or palpitations — treat as an emergency and go to the nearest emergency department.
- Loose motions several times above your normal, or any blood in the stool — contact your oncology team immediately; do not take anti-diarrhoeal medicine on your own.
- Yellowing of the eyes or skin, dark urine, or severe abdominal pain — same-day medical assessment.
- Confusion, collapse, severe weakness or persistent vomiting — go to the emergency department without delay.
Because nivolumab can alter thyroid, pituitary and adrenal function quietly, hormone blood tests are checked at intervals even when a patient feels well. Anyone treating you for anything else — a dentist, a physician, an emergency doctor — needs to know you are on, or have recently had, a checkpoint inhibitor.
Organ-by-organ detail is in Nivolumab Side Effects. This page is an overview, not a home-management guide.
Where to read next
- Nivolumab Cost in India After the Biosimilar Launch — the dated cost picture in full, including what changed when the patent lapsed in May 2026.
- Which Checkpoint Inhibitors Are Approved in India? — where nivolumab sits alongside pembrolizumab, atezolizumab and the rest of the approved list.
- Nivolumab Side Effects — organ by organ, what to watch for, and which symptoms need same-day assessment.
- Immunotherapy Medicines Explained — the reference section this page belongs to, and how its regulatory and pricing information is sourced.
- Immunotherapy for Cancer — the wider picture: how checkpoint inhibitors work, who is eligible, and what treatment involves.
This page is editorial information about a prescription medicine, published from a scientific standpoint. It is not an advertisement, an offer, a price list or a recommendation to use nivolumab. It does not state or imply that any named product is supplied here. Pricing and regulatory details are indicative, dated to August 2026, and drawn from published manufacturer announcements, regulatory records and news reporting. Whether nivolumab applies to your treatment is a decision for your treating oncologist.