Fosemred Dosage & Drug Information

Concise Prescribing Info Full Prescribing Info Contents Description Action Indications/Uses Dosage/Direction for Use Overdosage Contraindications Special Precautions Use In Pregnancy & Lactation Adverse Reactions Drug Interactions Storage MIMS Class ATC Classification Regulatory Classification Presentation/Packing

Concise Prescribing Info

Contents

Fosaprepitant

Indications/Uses

Prevention of acute & delayed nausea & vomiting associated w/ initial & repeat courses of highly & moderately emetogenic cancer chemotherapy in combination w/ other antiemetics.

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Dosage/Direction for Use

150 mg IV infusion on day 1 over 20-30 min initiated approx 30 min prior to chemotherapy in conjunction w/ corticosteroid & 5-HT₃ antagonist. Highly emetogenic chemotherapy Day 1: 150 mg IV infusion + dexamethasone PO 12 mg 30 min prior to chemotherapy & standard dose of 5-HT₃ antagonist. Day 2: Dexamethasone PO 8 mg in the morning. Days 3-4: Dexamethasone PO 8 mg bd (morning & evening). Moderately emetogenic chemotherapy 150 mg IV infusion + dexamethasone PO 12 mg 30 min prior to chemotherapy & standard dose of 5-HT₃ antagonist.

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Overdosage

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Contraindications

Hypersensitivity to fosaprepitant, aprepitant or polysorbate 80. Concurrent administration w/ pimozide, terfenadine, astemizole, cisapride. Not recommended in childn <12 yr.

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Special Precautions

Discontinue use & not to be reinitiated if hypersensitivity reactions & anaphylaxis/anaphylactic shock occur. Not to be given as bolus, IM or SC inj. Not recommended for chronic continuous use. Infusion-site reactions w/ concomitant vesicant eg, anthracycline-based chemotherapy. Avoid concomitant use w/ strong CYP3A4 inducers eg, rifampicin, phenytoin, carbamazepine, phenobarb. Not recommended in concomitant use w/ St. John's wort. Concomitant use w/ CYP3A4-metabolized medicinal products & chemotherapeutic agents (eg, docetaxel, paclitaxel, etoposide, irinotecan, ifosfamide, imatinib, vinorelbine, vinblastine, vincristine); ergot alkaloid derivatives; CYP3A4 inhibitors eg, ritonavir, ketoconazole, clarithromycin, telithromycin; warfarin; hormonal contraceptives. May affect ability to drive & use machines. Moderate & severe hepatic insufficiency. Pregnancy & lactation.

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Use In Pregnancy & Lactation

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Adverse Reactions

Decreased appetite; hiccups; dyspepsia; fatigue; increased ALT. Moderate emetogenic chemotherapy: Constipation; infusion site pain.

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Drug Interactions

Transient increased plasma conc of CYP3A4-metabolized drugs eg, cyclosporine, tacrolimus, sirolimus, everolimus, alfentanil, diergotamine, ergotamine, fentanyl, quinidine. Elevated plasma conc of pimozide, terfenadine, astemizole, cisapride. Decreased plasma conc of S(-) warfarin, tolbutamide. Increased AUC of dexamethasone, methylprednisolone, midazolam, diltiazem. Additional monitoring w/ etoposide, vinorelbine, docetaxel, ifosfamide, cyclophosphamide, irinotecan, paclitaxel. Decreased AUC of tolbutamide, ethinyl estradiol, norethindrone. Decreased AUC & C_max of paroxetine. Increased plasma conc of aprepitant w/ strong (eg, ketoconazole, itraconazole, nefazodone, troleandomycin, clarithromycin, ritonavir, nelfinavir) & moderate (diltiazem) CYP3A4 inhibitors. Reduced plasma conc & decreased efficacy of aprepitant w/ CYP3A4 inducers eg, rifampin, carbamazepine, phenytoin.

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Storage

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Description

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Action

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MIMS Class

Antiemetics / Supportive Care Therapy

ATC Classification

A04AD12 - aprepitant ; Belongs to the class of other antiemetics.

Regulatory Classification

Presentation/Packing

Form

Fosemred powd for infusion 150 mg

Packing/Price

1's

Fosemred

fosaprepitant

Manufacturer:

Dr. Reddy's Lab

Distributor:

DKSH