Instructions for using Opdivo -nivolumab for patients with non-small cell lung cancer

Share This Post

Opdivo has been listed in the United States for the treatment of lung cancer. Many cancer patients cannot go abroad for treatment for various reasons. Consult Opdivo on how to use it and hope to be able to buy medicine from abroad.

US FDA expands approval for use of Opdivo to treat lung cancer

Richard Pazdur, MD, Director of the Hematology and Oncology Products Division at the FDA ’s Center for Drug Evaluation and Research, said: “When the results of this clinical trial were first available in December 2014, FDA ’s active work with the company facilitated this early submission and review. , “” This approval will provide patients and health care providers with the knowledge that accompanies the survival benefits of Opdivo and will help guide patient care and future lung cancer trials. “Priority review

These highlights do not include all the information needed to use OPDIVO safely and effectively. Please refer to OPDIVO for complete prescription information.

OPDIVO (nivolumab) injection for intravenous use

Initial approval in the United States: 2014

Indications and uses

Recent major changes (red is the new version)

Indications and uses (1.2) 3/2015

Warnings and precautions (5.1, 5.2, 5.3, 5.4, 5.5, 5.6) 3/2015

Indications and uses

OPDIVO is a human programmed death receptor-1 (PD-1) suitable for blocking antibody therapy in the following patients:

(1) Treatment of patients with unresectable metastatic melanoma and ipilimumab [ipilimumab] and, for example, BRAF V600 mutation-positive, disease progression after a BRAF inhibitor. (1.1) This indication is approved under accelerated approval based on the tumor response rate and the durability of the response. Continued approval of this indication may depend on verification and the description of clinical benefit in the verification trial. (1.1, 14)

⑵ Use platinum-based chemotherapy or advanced metastatic squamous non-small cell lung cancer. (1.2)

Dosage and method of administration

3 mg / kg was given by intravenous infusion over 60 minutes every 2 weeks. (2.1)

Formulations and specifications

Injection: 40 mg / 4 mL and 100 mg / 10 mL solutions in disposable vials (3)


Warnings and precautions

Immune-mediated adverse reactions: Glucocorticoids are given according to the severity of the reaction. (5.1, 5.2, 5.3, 5.4, 5.6)

⑴ Immune-mediated pneumonia: not given moderately and permanently terminated for severe or life-threatening pneumonia. (5.1)

⑵ Immune-mediated colitis: Do not give permanent termination to moderate or severe and life-threatening colitis. (5.2)

(3) Immune-mediated hepatitis: monitoring changes in liver function. Moderate non-administration and permanent termination of severe or life-threatening transaminase or total bilirubin elevation. (5.3)

⑷ Immune-mediated nephritis and renal insufficiency: monitoring changes in renal function. For moderate failure and permanent termination of severe or life-threatening rise in serum creatinine. (5.4)

⑸ Immune-mediated hypothyroidism and hyperthyroidism: monitor changes in thyroid function. Start thyroid hormone replacement when needed. (5.5)

⑹ Fetal and fetal toxicity: may cause fetal harm. Advise on potential risks to the fetus and the use of effective contraception. (5.7, 8.1, 8.3)

Adverse reactions

The most common adverse reaction (≥20%) in patients with melanoma is rash. (6.1)

The most common adverse reactions (≥20%) in patients with advanced squamous non-small cell lung cancer are fatigue, difficulty breathing, musculoskeletal pain, loss of appetite, cough, nausea, and constipation. 

Used in special people

⑴ Breastfeeding: Terminate breastfeeding. 

Subscribe To Our Newsletter

Get updates and never miss a blog from Cancerfax

More To Explore

Cancer statistics in India 2024

Cancer statistics in India 2024: Incidence, estimates and projections

In 2024, cancer will remain a significant health challenge in India. The country sees over 1.5 million new cases a year. Breast and oral cancers are most prevalent among women and men, respectively. Sadly, many cases are diagnosed late, impacting survival rates. Improved awareness and access to healthcare are crucial. By 2030, cancer incidence is expected to surpass 1.7 million cases annually. Efforts to enhance prevention, early detection, and treatment access are crucial to mitigate this growing burden. Check our cancer statistics in India for 2024 and future projections.

Need help? Our team is ready to assist you.

We wish a speedy recovery of your dear and near one.

Start chat
Need help with cancer treatment?
Scan the code
Welcome to CancerFax !

CancerFax is the most trusted international patient facilitator working with top cancer hospital's in the world like MD Anderson, Dana Farber, Asan, NCC Japan, Sheba, Beijing Cancer Institute and Apollo to bring you best of therapies and drugs.

Let us know what services would you like to avail?

1) Cancer treatment in the USA, Japan, Israel, India, Korea or Singapore?
2) CAR T-Cell therapy treatment
3) Cancer vaccine
4) Online video consultation
5) Proton therapy