Impavido (miltefosine)

No dosing information is available for this tab.

Miltefosine is administered orally with food to ameliorate adverse GI effects.

Miltefosine capsules should be swallowed whole and should not be broken, chewed, or crushed.

No dosing information is available for this tab.

Miltefosine does not markedly induce or inhibit the activity of cytochrome P-450 (CYP) isoenzymes in vitro or in animal studies.

The potential for miltefosine to interact with drug transporters has not been established.

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

Selected Immunosuppressants/Nadofaragene Firadenovec

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: Nadofaragene firadenovec may contain low levels of replication-competent adenovirus.(1)

CLINICAL EFFECTS: Concurrent use of nadofaragene firadenovec in patients receiving immunosuppressive therapy may cause disseminated adenovirus infection.(1)

PREDISPOSING FACTORS: None determined.

PATIENT MANAGEMENT: Individuals who are immunosuppressed or immune-deficient should not receive nadofaragene firadenovec.(1)

DISCUSSION: Nadofaragene firadenovec is a non-replicating adenoviral vector-based gene therapy but may contain low levels of replication-competent adenovirus. Immunocompromised persons, including those receiving immunosuppressant therapy, may be at risk for disseminated adenovirus infection.(1)

Selected Immunosuppressants/Talimogene Laherparepvec

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: Talimogene laherparepvec is a live, attenuated herpes simplex virus.(1)

CLINICAL EFFECTS: Concurrent use of talimogene laherparepvec in patients receiving immunosuppressive therapy may cause a life-threatening disseminated herpetic infection.(1)

PREDISPOSING FACTORS: None determined.

PATIENT MANAGEMENT: Talimogene laherparepvec is contraindicated in immunosuppressed patients.(1) The magnitude of immunocompromise and associated risks due to immunosuppressant drugs should be determined by a physician.

DISCUSSION: Concurrent use of talimogene laherparepvec in patients receiving immunosuppressive therapy may cause a life-threatening disseminated herpetic infection.(1)

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.

Miltefosine is contraindicated in pregnant women; the drug may cause fetal harm. A urine or serum pregnancy test must be obtained prior to prescribing miltefosine for women of reproductive potential.

Miltefosine is contraindicated in patients with known hypersensitivity to the drug or any ingredient in the formulation.

The drug also is contraindicated in patients with Sjogren-Larsson syndrome.

• Lactation
• Pregnancy
• Sjogren-larsson syndrome

There are no severe contraindications for this drug.

There are no moderate contraindications for this drug.

Adverse effects occurring in 2% or more of patients receiving miltefosine for the treatment of cutaneous, mucocutaneous, or visceral leishmaniasis include GI effects (e.g., diarrhea, nausea, vomiting, abdominal pain, epigastralgia, decreased appetite), CNS effects (dizziness, headache, somnolence), motion sickness, asthenia, malaise, pyrexia, pruritus, lymphangitis, increased serum creatinine, increased BUN, and increased hepatic aminotransferase (ALT, AST) concentrations.

More Frequent

• Abnormal hepatic function tests
• Increased alanine transaminase
• Thrombocytopenic disorder

Less Frequent

• Anemia
• Hyperbilirubinemia
• Increased aspartate transaminase

Rare or Very Rare

• Agranulocytosis
• Seizure disorder
• Stevens-johnson syndrome

More Frequent

• Acute abdominal pain
• Anorexia
• Diarrhea
• Headache disorder
• Motion sickness
• Nausea
• Vomiting

Less Frequent

• Abdominal distension
• Constipation
• Decrease ejaculate volume
• Dizziness
• Drowsy
• Dysphagia
• Fatigue
• Fever
• Flatulence
• General weakness
• Lymphadenopathy
• Malaise
• Oligospermia
• Paresthesia
• Pruritus of skin
• Pustular skin infection
• Skin rash
• Swelling of scrotum
• Testicular pain
• Testicular swelling
• Urticaria

Rare or Very Rare

• Arthritis
• Black tarry stools
• Disorder of cornea
• Disorder of ejaculation
• Edema
• Keratitis
• Peripheral edema
• Scleritis
• Uveitis

No enhanced messaging available.

Safety and efficacy of miltefosine have not been established in children younger than 12 years of age.

Animal studies indicate that juvenile rats are more sensitive to miltefosine-induced adverse effects, especially retinal degeneration and kidney effects, than adult rats.

Category D. (See Users Guide and also see Fetal/Neonatal Morbidity and Mortality under Warnings/Precautions: Warnings, in Cautions.)

Miltefosine should not be used in pregnant women.

Embryofetal toxicity, including death and teratogenicity, was observed in rats and rabbits receiving miltefosine during organogenesis, and numerous visceral and skeletal fetal malformations were observed in rats receiving miltefosine prior to mating through day 7 of pregnancy.

It is not known whether miltefosine is distributed into human milk.

Because of the potential for serious adverse reactions to miltefosine in nursing infants, a decision should be made whether to discontinue nursing or the drug, taking into account the importance of the drug to the woman. In addition, breast-feeding should be avoided for 5 months after completion of miltefosine treatment.

Clinical studies of miltefosine did not include sufficient numbers of patients 65 years of age or older to determine whether they respond differently than younger adults.