during treatment with OPDIVO. Your doctor may treat you with corticosteroid medicines and delay or completely stop treatment with OPDIVO, if you have severe side effects.
Pregnancy and Nursing:
Tell your healthcare provider if you are pregnant or plan to become pregnant. OPDIVO can harm your unborn baby. Females who are able to become pregnant should use an effective method of birth control during and for at least 5 months after the last dose of OPDIVO. Talk to your doctor about birth control methods that you can use during this time. Tell your doctor right away if you become pregnant during treatment with OPDIVO. Before receiving OPDIVO, tell your healthcare provider if you are breastfeeding or plan to breastfeed. It is not known if OPDIVO passes into your breast milk. Do not breastfeed during treatment with OPDIVO.
Tell your healthcare provider about:
•Your health problems or concerns if you: have immune system problems such as Crohn’s disease, ulcerative colitis, or lupus; have had an organ transplant; have lung, or breathing problems; have liver problems; or have any other medical conditions
•All the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements
The most common side effects of OPDIVO include: rash.
Tell your doctor if you have any side effect that bothers you or that does not go away. These are not all the possible side effects of OPDIVO. For more information, ask your healthcare provider or pharmacist.
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.
Please see U.S. FULL PRESCRIBING INFORMATION and MEDICATION GUIDE for OPDIVO® (nivolumab).
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New Drugs Online Report for nivolumab
Information
Generic Name: nivolumab
Trade Name: Opdivo
Synonym: BMS-936558
Entry Type: Licence extension / variation
Development and Regulatory status
UK: Phase III Clinical Trials
EU: Phase III Clinical Trials
US: Phase III Clinical Trials
UK launch Plans: Available only to registered users
Actual UK launch date:
Comments
Jan 14: Nivolumab is the first PD-1 compound to receive Promising Innovative Medicine status from the MHRA for treatment of advanced skin cancer [10].
08/01/2015 11:44:12
Sep 14: Bristol-Myers and marketing partner Ono Pharmaceutical launch Opdivo in Japan for unresectable melanoma at an annual cost of $143,000 per patient. Analysts expect an annual cost of at least $110,000 in the US [8].
05/09/2014 10:47:33
Apr 13: The FDA has granted Fast Track designation for nivolumab in three tumour types: NSCLC, renal cell carcinoma and advanced melanoma [2].
26/04/2013 13:58:17
Trial or other data
Sep 14: BMS announce that interim analysis of a PIII trial showed nivolumab produced a 32% objective response rate among patients with advanced melanoma vs. 11% with chemotherapy control. The nivolumab arm also experienced a significantly lower rate of serious adverse events compared to the control - 9% to 31%. In addition, investigators reported that the median response rate had yet to be met in the nivolumab arm as responses were continuing [9].
30/09/2014 10:49:48
Jun 14: Bristol-Myers Squibb announce follow up results from Study -004, a multi-arm Phase 1b dose |
