LETERMOVIR

Other

Brand names: PREVYMIS

Oral, Intravenous

12.1 Mechanism of Action PREVYMIS is an antiviral drug against CMV [see Microbiology (12.4) ] .

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Contraindications

• which may lead to QT prolongation and torsades de pointes [see Warnings and Precautions (5.1) and Drug Interactions (7.2
• which may lead to ergotism [see Warnings and Precautions (5.1) and Drug Interactions (7.2
• which may lead to myopathy or rhabdomyolysis [see Warnings and Precautions (5.1) and Drug Interactions (7.2
• 7.3) ] . PREVYMIS is contraindicated with: Pimozide. ( 4 ) Ergot Alkaloids. ( 4 ) Pitavastatin and simvastatin when co-administered with cyclosporine. ( 4 )

5 WARNINGS AND PRECAUTIONS Risk of Adverse Reactions or Reduced Therapeutic Effect Due to Drug Interactions: The concomitant use of PREVYMIS with certain drugs may result in potentially significant drug interactions, some of which may lead to adverse reactions (PREVYMIS or concomitant drugs) or reduced therapeutic effect of PREVYMIS or the concomitant drug
3 ) Risks Associated with Hydroxypropyl Betadex Excipient in Intravenous Formulation: Intravenous formulation of PREVYMIS contains the excipient hydroxypropyl betadex
1 Risk of Adverse Reactions or Reduced Therapeutic Effect Due to Drug Interactions The concomitant use of PREVYMIS and certain drugs may result in potentially significant drug interactions, some of which may lead to adverse reactions (PREVYMIS or concomitant drugs) or reduced therapeutic effect of PREVYMIS or the concomitant drug [see Contraindications (4) and Drug Interactions (7
2 Risks Associated with Hydroxypropyl Betadex Excipient in Intravenous Formulation Intravenous formulation of PREVYMIS contains the excipient hydroxypropyl betadex

2 documented side effects by frequency

Drug Not Working

>10%

Diarrhea

0.1-1%

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Dosage Forms

Tablet

Route

Oral, Intravenous