Aprepitant is greater than 95% bound to plasma proteins. Talk to your healthcare provider about the best way to feed your baby if you receive fosaprepitant for injection. Fosaprepitant is bioequivalent to Emend® and provides clinicians a treatment alternative with a 24-month shelf life. Fresenius Kabi (www.fresenius-kabi.com/us) is a global health care company that specializes in medicines and technologies for infusion, transfusion and clinical nutrition. CYP3A4 Interactions: Fosaprepitant is a weak inhibitor of CYP3A4, and aprepitant, the active moiety, is a substrate, inhibitor, and inducer of CYP3A4.

If symptoms occur, discontinue the drug. (, Most common adverse reactions in adults (≥ 2%) are: fatigue, diarrhea, neutropenia, asthenia, anemia, peripheral neuropathy, leukopenia, dyspepsia, urinary tract infection, pain in extremity. The Cmax was 10% higher on Day 1 and 24% higher on Day 5 in elderly relative to younger adults. Instruct patients to use effective alternative or back-up methods of contraception (such as condoms and spermicides) during treatment with fosaprepitant for injection and for 1 month following administration of fosaprepitant for injection [see Warnings and Precautions (5.5), Use in Specific Populations (8.3)]. Advise patients to seek immediate medical attention if they experience signs or symptoms of a hypersensitivity reaction, such as hives, rash and itching, skin peeling or sores, flushing, difficulty in breathing or swallowing, or dizziness, rapid or weak heartbeat or feeling faint [see Warnings and Precautions (5.2)].

Substantially decreased exposure of aprepitant in patients chronically taking a strong CYP3A4 inducer may decrease the efficacy of fosaprepitant for injection, 150 mg intravenously over 20 to 30 minutes approximately 30 minutes prior to chemotherapy. Refer to the ondansetron prescribing information for the current recommended dose. Hormonal Contraceptives: Advise patients that administration of fosaprepitant for injection may reduce the efficacy of hormonal contraceptives. These differences are not considered clinically meaningful [see Use in Specific Populations (8.5)]. 150 mg per vial. Treatment with aprepitant produced skin fibrosarcomas at 125 and 500 mg/kg/day doses in male mice.

LAKE ZURICH, Ill., November 13, 2019 – Fresenius Kabi announced today the immediate availability in the United States of Fosaprepitant for Injection 150 mg per vial, the newest addition to the company’s generic oncology portfolio.

These highlights do not include all the information needed to use FOSAPREPITANT FOR INJECTION safely and effectively. Citations, 2.1 Prevention of Nausea and Vomiting Associated with HEC and MEC in Adult Patients, 2.3 Preparation of Fosaprepitant for Injection, 5.1 Clinically Significant CYP3A4 Drug Interactions, 5.4 Decrease in INR with Concomitant Warfarin, 5.5 Risk of Reduced Efficacy of Hormonal Contraceptives, 7.1 Effect of Fosaprepitant/Aprepitant on the Pharmacokinetics of Other Drugs, 7.2 Effect of Other Drugs on the Pharmacokinetics of Fosaprepitant/Aprepitant, 8.3 Females and Males of Reproductive Potential, 13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility, 14.1 Prevention of Nausea and Vomiting Associated with HEC in Adults, 14.2 Prevention of Nausea and Vomiting Associated with MEC in Adults, Report Adverse Do not use with solutions containing divalent cations (e.g., Ca2+, Mg2+) including Lactated Ringer's Solution and Hartmann's Solution. 10 mL in 1 VIAL, SINGLE-DOSE; Type 0: Not a Combination Product, ANALYSIS(63323-972) , MANUFACTURE(63323-972), 5 Fresenius Kabi is a leading developer and supplier of generic injectable medicines used in the treatment of cancer helping to make oncology therapies more affordable and accessible. The apparent terminal half-life ranged from approximately 9 to 13 hours. acute and delayed nausea and vomiting associated with initial and repeat courses of highly emetogenic cancer chemotherapy (HEC) including high-dose cisplatin. Wholesale Item Numbers. • CYP3A4 Interactions: Fosaprepitant is a weak inhibitor of CYP3A4, and aprepitant, the active moiety, is a substrate, inhibitor, and inducer of CYP3A4; see Full Prescribing Information for recommendations regarding contraindica- tions, risk of adverse reactions, and dosage adjustment of Fosaprepitant for injection and concomitant drugs. The company’s global headquarters is in Bad Homburg, Germany. PACKAGE LABEL - PRINCIPAL DISPLAY - Fosaprepitant 150 mg Single Dose Vial Label, fosaprepitant injection, powder, lyophilized, for solution, All Drug In patients with moderate hepatic impairment (Child-Pugh score 7 to 9), the AUC0-24hr of aprepitant was 10% higher on Day 1 and 18% higher on Day 3, as compared with healthy subjects given the same regimen. 0 #CA2Q3( !1AQa"2Bq����R��#3%&�� ? Advise patients that hypersensitivity reactions, including anaphylaxis and anaphylactic shock, have been reported in patients taking fosaprepitant for injection. Alternative to Emend® prevents nausea and vomiting associated with moderately and highly emetogenic chemotherapy in adult patients, Fresenius Kabi Introduces Fosaprepitant for Injection 150 mg per vial as an alternative to Emend® to prevent nausea and vomiting associated with moderately and highly emetogenic chemotherapy in adult patients. Fresenius Kabi is a global health care company that specializes in medicines and technologies for infusion, transfusion and clinical nutrition. Aprepitant is a substrate, an inhibitor, and an inducer of CYP3A4. Fresenius Kabi is a leading developer and supplier of generic injectable medicines used in the treatment of cancer helping to make oncology therapies more affordable and accessible. Fresenius Kabi – Recall of fosaprepitant. /Producer (�� Q t 4 .

Hypersensitivity Reactions (including anaphylaxis and anaphylactic shock): May occur during or soon after infusion. /SM 0.02 PubMed, Pharmaceutical Product Availability Fresenius Kabi USA provides product availability information to assist healthcare professionals learn more about how Fresenius Kabi products may help their drug shortage needs. To learn more about Fresenius Kabi, including its expanding U.S. centers for pharmaceutical research, manufacturing and distribution, please visit www.fresenius-kabi.com/us. Use effective alternative or back-up methods of contraception. & Articles, All Fosaprepitant is a prodrug of aprepitant and accordingly, its antiemetic effects are attributable to aprepitant. Thus, it appears that the conversion of fosaprepitant to aprepitant can occur in multiple extrahepatic tissues in addition to the liver. �r�PXWZ!a�hh4g*v����a?F�rTV�i6ȩ3��_ξCv��FN�ߐON�O��e��j���I3rQNj(�}� �~_�YG����E��r���4�>����cu��]�n���~\���h��Xq,Ãi���^L'��!.�MNNҨ�n�e�|m��C5揤i� ִ�yaT�N���3W��g6���LD��y��e�O.���4_�]TN��؞���f��Q�s��msN�l�9/��kƣ�֒RF��n�l8��1m �+mIm�8����0~�����Q;�VE����W���ͷl�G�WW_�ϧ}���zp}+�q6 Fosaprepitant for injection has not been studied for the treatment of established nausea and vomiting. Carcinogenicity studies were conducted in Sprague-Dawley rats and in CD-1 mice for 2 years.

h�b``�a``�``e`[email protected] !�(��>����`r?��c~�/��f�i�{E0���v� Rl��i9 ���30���,`.e b�bIfY�r���c?s�cS�3��zN1.eJe8��ɨ`t���Ԇ�X�� �l���4#Ei�#��4��J�/�؞߆�b� Aprepitant after Fosaprepitant Administration. Methylprednisolone: When oral aprepitant as a 3-day regimen (125-mg/80-mg/80-mg) was administered with intravenous methylprednisolone 125 mg on Day 1 and oral methylprednisolone 40 mg on Days 2 and 3, the AUC of methylprednisolone was increased by 1.34-fold on Day 1 and by 2.5-fold on Day 3 [see Drug Interactions (7.1)]. Administer Fosaprepitant for injection on Day 1 as an intravenous infusion over 20 to 30 minutes (adults), completing the infusion approximately 30 minutes prior to chemotherapy.
/CA 1.0 Files, All Mapping Who should not receive fosaprepitant for injection? 90 0 obj <> endobj Use of fosaprepitant for injection with other drugs that are CYP3A4 substrates, may result in increased plasma concentration of the concomitant drug. Fresenius Kabi is a leading developer and supplier of generic injectable medicines used in the treatment of cancer helping to make oncology therapies more affordable and accessible. Fosaprepitant is bioequivalent to Emend® and provides clinicians a treatment alternative with a 24-month shelf life. In the fertility studies conducted with fosaprepitant and aprepitant, the highest systemic exposures to aprepitant were obtained following oral administration of aprepitant. This recall is being performed to the user level. DailyMed will deliver this notification to your desktop, Web browser, or e-mail depending on the RSS Reader you select to use. Fosaprepitant Dimeglumine 265121-04-8 150 mg/vial Product: Fosaprepitant Dimeglumine for Injection | Manufacturer: Fresenius Kabi USA, LLC | Revison:06/10/2015, Version:0 Page 1 of 5. edetate disodium 6381-92-6 18.8 mg/vial Polysorbate 80 9005-65-6 75 mg/vial Lactose anhydrous 64044-51-5 … Seven metabolites of aprepitant, which are only weakly active, have been identified in human plasma. acute and delayed nausea and vomiting associated with initial and repeat courses of highly emetogenic cancer chemotherapy (HEC) including high-dose cisplatin. Due to inconsistencies between the drug labels on DailyMed and the pill images provided by RxImage, we no longer display the RxImage pill images associated with drug labels. Biochemical Data Summary. /Subtype /Image It is not known if fosaprepitant for injection can harm your unborn baby. RxNorm, This letter is to notify you that Fresenius Kabi USA, LLC (“Fresenius Kabi”) is voluntarily recalling the above-mentioned batches of Fosaprepitant for Injection, 150 mg / vial in a 10 mL vial. << antagonists: In clinical drug interaction studies, aprepitant did not have clinically important effects on the pharmacokinetics of ondansetron, granisetron, or hydrodolasetron (the active metabolite of dolasetron). A single 240-mg oral dose of aprepitant was administered to patients with severe renal impairment (creatinine clearance less than 30 mL/min/1.73 m2 as measured by 24-hour urinary creatinine clearance) and to patients with end stage renal disease (ESRD) requiring hemodialysis. Hormonal Contraceptives: Efficacy of contraceptives may be reduced during and for 28 days following administration of Fosaprepitant for Injection. 1 2 . Events, TALLman Labeling.

Inhibition of CYP3A4 by aprepitant, the active moiety, could result in elevated plasma concentrations of this drug, which is a CYP3A4 substrate, potentially causing serious or life-threatening reactions, such as QT prolongation, a known adverse reaction of pimozide. For more information ask your healthcare provider or pharmacist.

Aprepitant is a selective high-affinity antagonist of human substance P/neurokinin 1 (NK1) receptors.

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