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PREVYMIS is a brand name for Letermovir, supplied as a solution. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: 09/2023 4 DOSAGE AND ADMINISTRATION, 4.2 Recommended Dose and Dosage Adjustment 03/2024 7 WARNINGS AND PRECAUTIONS 09/2023 TABLE OF CONTENTS Sections or subsections that are not applicable at the time of authorization are not listed. RECENT MAJOR LABEL CHANGES…
Verbatim from this product's HC label. Tap a section to expand.
2 Recommended Dose and Dosage Adjustment 03/2024 7 WARNINGS AND PRECAUTIONS 09/2023 TABLE OF CONTENTS Sections or subsections that are not applicable at the time of authorization are not listed. RECENT MAJOR LABEL CHANGES ............................................................................................
2 TABLE OF CONTENTS .............................................................................................................. 2 PART I: HEALTH PROFESSIONAL INFORMATION ......................................................................
4 1 INDICATIONS ............................................................................................................... 4 2 CONTRAINDICATIONS .................................................................................................
4 4 DOSAGE AND ADMINISTRATION ................................................................................. 9 5 OVERDOSAGE..............................................................................................................
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1 Adverse Reaction Overview The safety summary for PREVYMIS® in HSCT recipients was based on data from a randomized, placebo- controlled Phase 3 clinical trials (P001 and P040) in which CMV seropositive HSCT recipients received letermovir or placebo.
The safety summary for PREVYMIS® in kidney transplant recipients was based on data from a randomized, active comparator-controlled Phase 3 clinical trial P002 in which kidney PREVYMIS® (letermovir) Page 13 of 49 Confidential transplant recipients [D+/R-] received letermovir or valganciclovir.
In P001, the most commonly reported adverse reactions in subjects treated with PREVYMIS® through Week 14 post-HSCT and followed for safety through Week 24 post-HSCT were nausea, diarrhea, and vomiting. In P002, the most commonly reported adverse reactions in subjects treated with PREVYMIS® or valganciclovir through Week 28 post-kidney transplant were leukopenia, neutropenia, and white blood cell count decreased.
In P040, the most commonly reported adverse reactions in subjects treated with PREVYMIS® from Week 14 post-HSCT through Week 28 post-HSCT were nausea and vomiting. 2 Clinical Trial Adverse Reactions Clinical trials are conducted under very specific conditions.
The adverse reaction rates observed in the clinical trials; therefore, may not reflect the rates observed in practice and should not be compared to the rates in the clinical trials of another drug. Adverse reaction information from clinical trials may be useful in identifying and approximating rates of adverse drug reactions in real-world use.
Adult CMV-seropositive Recipients [R+] of an Allogeneic HSCT Prophylaxis Through Week 14 (~100 days) Post-HSCT The safety of PREVYMIS® was evaluated in a Phase 3 randomized, double-blind, placebo-controlled trial (P001) through Week 14 post-HSCT and were followed for safety through Week 24 post-HSCT (see 14 CLINICAL TRIALS).
09/2023 TABLE OF CONTENTS Sections or subsections that are not applicable at the time of authorization are not listed. RECENT MAJOR LABEL CHANGES ............................................................................................
2 TABLE OF CONTENTS .............................................................................................................. 2 PART I: HEALTH PROFESSIONAL INFORMATION ......................................................................
4 1 INDICATIONS ............................................................................................................... 4 2 CONTRAINDICATIONS .................................................................................................
4 4 DOSAGE AND ADMINISTRATION ................................................................................. 9 5 OVERDOSAGE..............................................................................................................
9 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING ................................. 9 7 WARNINGS AND PRECAUTIONS ................................................................................ 12 8 ADVERSE REACTIONS ................................................................................................
16 9 DRUG INTERACTIONS ................................................................................................ 27 10 CLINICAL PHARMACOLOGY .......................................................................................
27 11 STORAGE, STABILITY AND DISPOSAL ......................................................................... 31 12 SPECIAL HANDLING INSTRUCTIONS ........................................................................... 31 PART II: SCIENTIFIC INFORMATION .......................................................................................
PREVYMIS® is contraindicated in patients who are hypersensitive to this drug or to any ingredient in the formulation, including any non-medicinal ingredient, or component of the container. For a complete listing, see 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING.
2 Drug Interactions Overview). 2 Drug Interactions Overview). 2 Drug Interactions Overview). 2 Drug Interactions Overview). PREVYMIS® (letermovir) Page 5 of 49 Confidential
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The most commonly reported adverse reactions occurring in at least 1% of subjects in the PREVYMIS® group through Week 24 post-HSCT and at a frequency greater than placebo were: nausea, diarrhea, and vomiting (see Table 2). 6%) in the placebo group.
The reported serious adverse reactions, which had a temporal association but no other plausible causal relationship to study treatment, were pancytopenia, thrombocytopenia, and delayed engraftment in the letermovir group and Bowen’s disease, mental status changes, and acute kidney injury in the placebo group.
Cardiac Adverse Events:
Cardiac adverse events were more common in subjects receiving PREVYMIS® (13%) compared to subjects receiving placebo (6%). 5% of PREVYMIS® subjects and in 1% of placebo subjects). These adverse events were mostly considered mild or moderate in severity.
PREVYMIS® (letermovir) Page 14 of 49 Confidential Hypersensitivity was reported with PREVYMIS® in one subject. 8% PREVYMIS® vs. 6% placebo). 5%). Prophylaxis From Week 14 (~100 days) Through Week 28 (~200 days) Post-HSCT The safety of PREVYMIS® was evaluated in a Phase 3 randomized, double-blind, placebo-controlled trial (P040) in which 218 subjects who completed PREVYMIS® prophylaxis through ~100 days post-HSCT were randomized to treatment with PREVYMIS® (N=144) or placebo (N=74) through Week 28 (~200 days) post-HSCT and were followed for safety through Week 48 post-HSCT.
The adverse reactions observed were consistent with those observed in P001. 4%). A total of 5% of subjects in the PREVYMIS® group and 1% of subjects in the placebo group discontinued due to adverse events; none of the adverse events were considered to be related to study medication (PREVYMIS® or placebo).
The cardiac adverse event rate (regardless of investigator-assessed causality) was 4% in the PREVYMIS® and placebo groups; no cardiac adverse event was reported more than once in either group. Adult Kidney Transplant Recipients [D+/R-] The safety of PREVYMIS® was evaluated in a Phase 3 randomized, double-blind, active comparator- controlled trial (P002) in which 589 subjects were treated with PREVYMIS® (N=292) or valganciclovir (N=297) through Week 28 post-transplant.
The most commonly reported adverse reactions occurring in at least 2% of subjects in the PREVYMIS® group or valganciclovir group are shown in Table 3. 8% of subjects in the valganciclovir group. 4%). PREVYMIS® (letermovir) […]
32 13 PHARMACEUTICAL INFORMATION ............................................................................ 32 14 CLINICAL TRIALS ........................................................................................................
38 15 MICROBIOLOGY ........................................................................................................ 42 16 NON-CLINICAL TOXICOLOGY .....................................................................................
43 PATIENT […]