Rapivab (Pf) (peramivir/PF)

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Peramivir is administered by IV infusion.

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There is no enhanced messaging for this drug.

Contraindicated Drug Combination: This drug combination is contraindicated and generally should not be dispensed or administered to the same patient.

Selected Antiviral Agents/Influenza Virus Vaccine Live

SEVERITY LEVEL: 1-Contraindicated Drug Combination: This drug combination is contraindicated and generally should not be dispensed or administered to the same patient.

MECHANISM OF ACTION: Amantadine,(1) oseltamivir,(2) rimantadine,(3) zanamivir,(4) and baloxavir,(5) may inactivate the intranasal live influenza virus vaccine, preventing the body from developing an immune response.

CLINICAL EFFECTS: Administration of amantadine,(1) oseltamivir,(2) rimantadine,(3) zanamivir,(4) and baloxavir,(5) may render the intranasal live influenza virus vaccine ineffective.

PREDISPOSING FACTORS: None determined.

PATIENT MANAGEMENT: The US manufacturers of amantadine,(1) oseltamivir,(2) rimantadine,(3) zanamivir(4), baloxavir(5), and the intranasal live influenza virus vaccine(6) state that these agents should not be initiated within 2 weeks of the administration of the intranasal live influenza virus vaccine and that the vaccine should not be administered within 48 hours of the discontinuation of these agents. Inactivated influenza vaccine may be used at any time.(1)

DISCUSSION: Because antiviral drugs such as amantadine,(1) oseltamivir,(2) rimantadine,(3) zanamivir,(4) and baloxavir (5) inhibit the replication of live viruses, these agents may interfere with the efficacy of the intranasal live influenza virus vaccine.

Severe Interaction: Action is required to reduce the risk of severe adverse interaction.

Myelosuppressives; Immunomodulators/Sodium Iodide I 131

SEVERITY LEVEL: 2-Severe Interaction: Action is required to reduce the risk of severe adverse interaction.

MECHANISM OF ACTION: Sodium iodide I 131 can cause depression of the hematopoetic system. Myelosuppressives and immunomodulators also suppress the immune system.(1)

CLINICAL EFFECTS: Concurrent use of sodium iodide I 131 with agents that cause bone marrow depression, including myelosuppressives or immunomodulators, may result in an enhanced risk of hematologic disorders, including anemia, blood dyscrasias, bone marrow depression, leukopenia, and thrombocytopenia. Bone marrow depression may increase the risk of serious infections and bleeding.(1)

PREDISPOSING FACTORS: None determined.

PATIENT MANAGEMENT: The US manufacturer of sodium iodide I 131 states that concurrent use with bone marrow depressants may enhance the depression of the hematopoetic system caused by large doses of sodium iodide I 131.(1) Sodium iodide I 131 causes a dose-dependent bone marrow suppression, including neutropenia or thrombocytopenia, in the 3 to 5 weeks following administration. Patients may be at increased risk of infections or bleeding during this time. Monitor complete blood counts within one month of therapy. If results indicate leukopenia or thrombocytopenia, dosimetry should be used to determine a safe sodium iodide I 131 activity.(1)

DISCUSSION: Hematologic disorders including death have been reported with sodium iodide I 131. The most common hematologic disorders reported include anemia, blood dyscrasias, bone marrow depression, leukopenia, and thrombocytopenia.(1)

There are no moderate interactions for this drug.

*Known serious hypersensitivity (e.g., anaphylaxis, erythema multiforme, Stevens-Johnson syndrome) to peramivir or any ingredient in the formulation.

There are no contraindication contraindications for this drug.

• Chronic kidney disease stage 3A (moderate) GFR 45-59 ml/min
• Chronic kidney disease stage 3B (moderate) GFR 30-44 ml/min
• Chronic kidney disease stage 4 (severe) GFR 15-29 ml/min
• Chronic kidney disease stage 5 (failure) GFr<15 ml/min
• Hemodialysis with high-flux membrane

• Acute cognitive impairment
• Delirium
• Neutropenic disorder
• Proteinuria
• Suicidal ideation

Adverse effects occurring in 2% or more of adults or pediatric patients receiving peramivir include diarrhea, vomiting, constipation, insomnia, and hypertension.

Less Frequent

• Abnormal hepatic function tests
• Neutropenic disorder

Rare or Very Rare

• Anaphylaxis
• Erythema multiforme
• Exfoliative dermatitis
• Stevens-johnson syndrome

More Frequent

• Diarrhea

Less Frequent

• Delirium
• Insomnia
• Vomiting

Rare or Very Rare

• Behavioral disorders
• Constipation
• Hallucinations
• Hyperglycemia
• Hypertension
• Skin rash

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Safety and efficacy of peramivir have not been established in pediatric patients younger than 6 months of age.

Safety and efficacy of peramivir for the treatment of acute, uncomplicated influenza in pediatric patients 6 months to 17 years of age have been established and are supported by evidence from adequate and well-controlled trials of the drug in adults and additional data from a randomized, open-label, active-controlled trial in pediatric patients in this age group (86 patients 6 months to 12 years of age and 21 patients 13-17 years of age received peramivir). Data from the open-label pediatric study indicated that the safety profile of the drug in pediatric patients 6 months to 17 years of age generally is similar to that reported in adults. The only adverse effects reported in 2% or more of pediatric patients treated with peramivir and not reported in adults were vomiting and proteinuria.

Data regarding use of peramivir in pregnant women are insufficient to determine whether the drug is associated with a risk of adverse developmental outcomes.

In animal reproduction studies, no adverse embryofetal effects were observed in pregnant rats when peramivir was administered by IV injection once daily at the maximum feasible dosage, resulting in systemic drug exposures approximately 8 times those in humans at the recommended dosage. However, when peramivir was administered to pregnant rats by continuous IV infusion, fetal abnormalities (reduced renal papilla, dilated ureters) were observed. In rabbits, peramivir administered by IV injection once daily during organogenesis at exposures 8 times those in humans at the recommended dosage resulted in developmental toxicity (abortion or premature delivery) at maternally toxic doses.

Pregnant women are at increased risk for severe complications from influenza, which may lead to adverse pregnancy and/or fetal outcomes including maternal death, stillbirths, birth defects, preterm delivery, low birthweight, and small size for gestational age.

CDC states that only limited data are available regarding use of peramivir for the treatment of influenza in pregnant women. Oseltamivir is the preferred antiviral for the treatment of suspected or confirmed influenza in women who are pregnant or up to 2 weeks postpartum.

It is not known whether peramivir is distributed into human milk, affects milk production, or has any effects on breast-fed infants. Peramivir is distributed into milk in rats. (See Distribution under Pharmacokinetics.)

The benefits of breast-feeding and the importance of peramivir to the woman should be considered along with potential adverse effects on the breast-fed child from the drug or from the underlying maternal condition.

Clinical studies of peramivir did not include sufficient numbers of patients 65 years of age and older to determine whether geriatric patients respond differently than younger adults. Other reported clinical experience has not identified differences in responses between geriatric and younger adults.

Peramivir pharmacokinetics in geriatric adults are similar to the pharmacokinetics of the drug reported in younger adults; therefore, dosage adjustments based solely on age are not necessary in adults 65 years of age and older.