Opdivo in Civitatibus Foederatis Americae ad curationem cancri pulmonis inscriptus est. Multi cancer aegros propter varias causas curationes peregre exire non potest. Opdivo consule quomodo ea utatur et sperat ut medicinam peregre emere possit.
US FDA approbationem pro usu Opdivo tractandi cancer pulmonis dilatat
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 pulmonis cancer, trials. “Priority review
Hae elucidationes non omnes informationes comprehendunt quae tuto et efficaciter utuntur OPDIVO. Placere referri ad OPDIVO informationes praescriptionis completae.
OPDIVO iniectio ad usum intravenum
Comprobatio initialis in Civitatibus Foederatis Americae: 2014
Indicationes et usus
Maiores mutationes recentes (rubrum est nova versio)
Indicationes et usus (1.2) 3/2015
Monitiones et cautiones (5.1, 5.2, 5.3, 5.4, 5.5, 5.6) 3/2015
Indicationes et usus
OPDIVO programmatum morti receptor-I (PD-1) aptus est ad impediendum therationem anticorporis in sequentibus aegris;
(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 tuberculum 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 cellula parva non-pulmonis cancer. (1.2)
Forma et modus administrationis
3 mg / kg data est ab infusione intravenosa super 60 minuta singulis 2 septimanis. (2.1)
Cubits: et formulae sunt reperiendae,
Iniectio: 40 mg / 4 mL et 100 mg / 10 mL solutiones in phialis efficiendis (3).
contraindications
Monitis et cautiones
Immunes motus adversae mediatae: Glucocorticoides secundum reactionis severitatem dantur. (5.1, 5.2, 5.3, 5.4, 5.6).
⑴ Peripneumonia immune mediata: non mediocriter et perpetuo terminata ad duram vel minacem pneumonia. (5.1)
Colitis immune immediatis: Ne moderari vel severi et vitae minaces colitis terminum permanentem ne dederis. (5.2)
(3) Hepatitis immune mediatae: vigilantia mutationes in iecoris functione. Moderatus non-administratio et permanens terminationis severae vel vitae minitans transaminatae vel totali bilirubin elevatio. (5.3)
⑷ nephritis immunes mediatae et insufficientia renum: vigilantia mutationes in functione renum. Nam modica defectio et permanens terminationis gravium vel vitae minarum oritur in sero creatinine. (5.4)
⑸ hypothyroidismus et hyperthyroidismus immunis mediatus: monitor mutationum functionis thyroideae. Committitur thyroideum hormone repositum, cum opus fuerit. (5.5)
⑹ Foetus et foetus toxicity: foetus laedat. Monere de periculis potentialibus ad foetum usum et contraconceptionem efficax. (5.7, 8.1, 8.3).
adversa reactiones
Frequentissima reactionis adversa (≥20%) in aegris cum melanoma est temeraria. (6.1)
Frequentissima adversae reactiones (≥20%) in aegris cum processu squamoso non-miniculo cancer cellulae pulmonis sunt lassitudo, difficultas spirandi, dolor musculoskeletalis, inedia, tussis, nausea et constipatio.
In speciali populo
⑴ ubere: Terminate ubere.
