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Drug overview for IMPAVIDO (miltefosine):
Generic name: MILTEFOSINE (mil-te-FOS-een)
Drug class: Antiprotozoal Agents
Therapeutic class: Anti-Infective Agents
Miltefosine, an alkylphosphocholine analog, is an antiprotozoal agent.
No enhanced Uses information available for this drug.
Generic name: MILTEFOSINE (mil-te-FOS-een)
Drug class: Antiprotozoal Agents
Therapeutic class: Anti-Infective Agents
Miltefosine, an alkylphosphocholine analog, is an antiprotozoal agent.
No enhanced Uses information available for this drug.
DRUG IMAGES
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The following indications for IMPAVIDO (miltefosine) have been approved by the FDA:
Indications:
Cutaneous leishmaniasis
Leishmaniasis
Visceral leishmaniasis
Professional Synonyms:
Assam fever
Black fever - visceral leishmaniasis
Black sickness
Burdwan fever
Cachectic fever
Cachexial fever
Dumdum fever
Juccuya
Kala-Azar
Old world leishmaniasis
Tropical sore
Tropical splenomegaly
Indications:
Cutaneous leishmaniasis
Leishmaniasis
Visceral leishmaniasis
Professional Synonyms:
Assam fever
Black fever - visceral leishmaniasis
Black sickness
Burdwan fever
Cachectic fever
Cachexial fever
Dumdum fever
Juccuya
Kala-Azar
Old world leishmaniasis
Tropical sore
Tropical splenomegaly
The following dosing information is available for IMPAVIDO (miltefosine):
No enhanced Dosing information available for this drug.
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.
| DRUG LABEL | DOSING TYPE | DOSING INSTRUCTIONS |
|---|---|---|
| IMPAVIDO 50 MG CAPSULE | Maintenance | Adults take 1 capsule (50 mg) by oral route 3 times per day with food |
No generic dosing information available.
The following drug interaction information is available for IMPAVIDO (miltefosine):
There are 2 contraindications.
These drug combinations generally should not be dispensed or administered to the same patient. A manufacturer label warning that indicates the contraindication warrants inclusion of a drug combination in this category, regardless of clinical evidence or lack of clinical evidence to support the contraindication.
| Drug Interaction | Drug Names |
|---|---|
| Talimogene laherparepvec/Selected Immunosuppressants 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) |
IMLYGIC |
| Nadofaragene Firadenovec/Selected Immunosuppressants 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) |
ADSTILADRIN |
There are 1 severe interactions.
These drug interactions can produce serious consequences in most patients. Actions required for severe interactions include, but are not limited to, discontinuing one or both agents, adjusting dosage, altering administration scheduling, and providing additional patient monitoring. Review the full interaction monograph for more information.
| Drug Interaction | Drug Names |
|---|---|
| Sodium Iodide I 131/Myelosuppressives; Immunomodulators 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) |
HICON, SODIUM IODIDE I-131 |
There are 0 moderate interactions.
The following contraindication information is available for IMPAVIDO (miltefosine):
Drug contraindication overview.
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.
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.
There are 3 contraindications.
Absolute contraindication.
| Contraindication List |
|---|
| Lactation |
| Pregnancy |
| Sjogren-larsson syndrome |
There are 0 severe contraindications.
There are 0 moderate contraindications.
The following adverse reaction information is available for IMPAVIDO (miltefosine):
Adverse reaction overview.
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.
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.
There are 9 severe adverse reactions.
| More Frequent | Less Frequent |
|---|---|
|
Abnormal hepatic function tests Increased alanine transaminase Thrombocytopenic disorder |
Anemia Hyperbilirubinemia Increased aspartate transaminase |
| Rare/Very Rare |
|---|
|
Agranulocytosis Seizure disorder Stevens-johnson syndrome |
There are 37 less severe adverse reactions.
| More Frequent | Less Frequent |
|---|---|
|
Acute abdominal pain Anorexia Diarrhea Headache disorder Motion sickness Nausea Vomiting |
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/Very Rare |
|---|
|
Arthritis Black tarry stools Disorder of cornea Disorder of ejaculation Edema Keratitis Peripheral edema Scleritis Uveitis |
The following precautions are available for IMPAVIDO (miltefosine):
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.
Contraindicated
Severe Precaution
Management or Monitoring Precaution
Contraindicated
| None |
Severe Precaution
| None |
Management or Monitoring Precaution
| None |
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.
The following prioritized warning is available for IMPAVIDO (miltefosine):
WARNING: Women who are pregnant must not use miltefosine. It may harm an unborn baby. Women of childbearing age must have a negative pregnancy test before starting treatment with this medication.
To prevent pregnancy, use reliable forms of birth control during treatment and for 5 months after stopping miltefosine. Ask your doctor for more details.
WARNING: Women who are pregnant must not use miltefosine. It may harm an unborn baby. Women of childbearing age must have a negative pregnancy test before starting treatment with this medication.
To prevent pregnancy, use reliable forms of birth control during treatment and for 5 months after stopping miltefosine. Ask your doctor for more details.
The following icd codes are available for IMPAVIDO (miltefosine)'s list of indications:
| Cutaneous leishmaniasis | |
| B55.1 | Cutaneous leishmaniasis |
| Leishmaniasis | |
| B55 | Leishmaniasis |
| B55.0 | Visceral leishmaniasis |
| B55.1 | Cutaneous leishmaniasis |
| B55.2 | Mucocutaneous leishmaniasis |
| B55.9 | Leishmaniasis, unspecified |
| Visceral leishmaniasis | |
| B55.0 | Visceral leishmaniasis |
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