Se hela listan på drugs.com

8 USE IN SPECIFIC POPULATIONS 8.1 Pregnancy 8.2 Lactation 8.3 Females and Males of Reproductive Potential 8.4 Pediatric Use 8.5 Geriatric Use

TM (trastuzumab-qyyp) for injection, for intravenous use Initial U.S. Approval: 2019 . TRAZIMERA (trastuzumab-qyyp) is biosimilar* to HERCEPTIN (trastuzumab). WARNING: CARDIOMYOPATHY, INFUSION REACTIONS, EMBRYO-FETAL TOXICITY, and PULMONARY TOXICITY Trazimera 420 mg multiple-dose vial: 3 vials every 21 days B. Max Units (per dose and over time) [Medical Benefit]: Breast Cancer and Gastric/Esophageal/Gastro-esophageal junction Cancers Load (mg) Maintenance (mg) 7-day dosing schedule 450 300 21-day dosing schedule 900 750 CNS Cancer 150 mg every 7 days Uterine Cancer TRAZIMERA is approved, in combination with chemotherapy (cisplatin and either capecitabine or 5-fluorouracil), for the treatment of HER2+ metastatic cancer of the stomach or gastroesophageal junction (where the esophagus meets the stomach) in patients who have not received prior treatment for their metastatic disease. TRAZIMERA (trastuzumab-qyyp) for injection is a sterile, white, preservative-free lyophilized powder with a cake-like appearance, for intravenous administration. Each multiple-dose vial of TRAZIMERA delivers 420 mg trastuzumab-qyyp, 7.9 mg L-histidine, 9.5 mg L-histidine HCl monohydrate, 1.7 mg polysorbate 20, and 386 mg sucrose. Trazimera (trastuzumab-qyyp) for injection 150 mg/vial is supplied in a single-dose vial as a sterile, white lyophilized powder. Each carton contains one single-dose vial of Trazimera.

Trazimera package insert

Accessed May 2020. 7. Referenced with permission from the NCCN Drugs & Biologics Compendium (NCCN Compendium®) trastuzumab Trazimera (trastuzumab-qyyp) is the fourth FDA-approved trastuzumab biosimilar, following the approvals for Ontruzant (trastuzumab-dttb) in January 2019, Herzuma (trastuzumab-pkrb) in December 2018, and Ogivri (trastuzumab-dkst) in December 2017. Development Timeline for Trazimera Pfizer Inc. (NYSE: PFE) today announced the United States (U.S.) Food and Drug Administration (FDA) has approved TRAZIMERA™ (trastuzumab-qyyp), a biosimilar to Herceptin® (trastuzumab),1 for the treatment of human epidermal growth factor receptor-2 (HER2) overexpressing breast cancer and HER2 overexpressing metastatic gastric or gastroesophageal junction adenocarcinoma.2 Kanjinti Injection official prescribing information for healthcare professionals. Includes: indications, dosage, adverse reactions and pharmacology. Initial ONTRUZANT dose of 4 mg/kg as an intravenous infusion over 90 minutes, then 2 mg/kg as an intravenous infusion over 30 minutes weekly during chemotherapy for the first 12 weeks (paclitaxel or docetaxel) or for 18 weeks (docetaxel and carboplatin).

TRAZIMERA is approved for the treatment of early-stage breast cancer that is Human Epidermal growth factor Receptor 2-positive (HER2+) and has spread into the lymph nodes, or is HER2+ and has not spread into the lymph nodes.If it has not spread into the lymph nodes, the cancer needs to be estrogen receptor/progesterone receptor (ER/PR)-negative or have one high-risk feature.*

Do not administer as an intravenous push or bolus. Trazimera intravenous infusion should be administered by a healthcare provider prepared to manage anaphylaxis and an emergency kit should be available. Trazimera 150 mg powder for concentrate for solution for infusion. 15 mL clear glass type I vial with butyl rubber stopper laminated with a fluoro-resin film containing 150 mg of trastuzumab.

March 11, 2019 – Pfizer Inc. today announced the United States (U.S.) Food and Drug Administration (FDA) has approved Trazimera (trastuzumab-qyyp), a biosimilar to Herceptin® (trastuzumab),1 for the treatment of human epidermal growth factor receptor-2 (HER2) overexpressing breast cancer and HER2 overexpressing metastatic gastric or gastroesophageal junction adenocarcinoma.2 “This is an

Trastuzumab . | Fraktfritt Tryggt Hållbart 4.

Pfizer RxPathways connects eligible patients to a range of assistance programs to help them access their Pfizer prescriptions.
Sollentuna häktet besöksbokning

Kanjinti [package insert]. Thousand Oaks, CA: Amgen Inc.; October 2019. 4.

TRAZIMERA is a monoclonal antibody (mAb) biosimilar of the originator biologic medicine, Herceptin, which targets HER2, a protein found on the surface of some cancer cells which can stimulate the cells to divide and grow. 11 TRAZIMERA locks on to the HER2 protein and blocks the receptors, stopping cell division and growth. 10 Letters, Reviews, Labels, Patient Package Insert Note Url; 05/07/2020: SUPPL-6: Supplement Letter (PDF) Label is not available on this site.
Eu medborgarskap

karta elmia husvagn
grundade göteborg
rigmor skyrim
ring utomlands tele2
kul beauty

Value-based pricing for drugs: theme and variations. JAMA. 2018;319(21):2165- 2166. 3 Viltepso (viltolarsen). Package insert. NS Pharma; August 2020

rastuzumab . This medicine is subject to additional monitoring.