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IMPAVIDO may cause fetal harm. Fetal death and teratogenicity occurred in animals administered miltefosine at doses lower than the recommended human dose. Do not administer IMPAVIDO to pregnant women. Obtain a serum or urine pregnancy test in females of reproductive potential prior to prescribing IMPAVIDO. Females of reproductive potential should be advised to use effective contraception during IMPAVIDO therapy and for 5 months after therapy.
IMPAVIDO capsules contain the active ingredient miltefosine, an antileishmanial agent. The chemical name of miltefosine is 2-[[(hexadecyloxy)hydroxyphosphenyl]oxy]-N,N,Ntrimethylethylammonium inner salt. Miltefosine is a white powder that is freely soluble in water, 0.1 N HCl or NaOH, methanol, and ethanol. It has the empirical formula of C21H46NO4P with a molecular weight of 407.6
| Mechanism of Action:
Miltefosine is an anti-leishmanial agent.
Indications and usage
INDICATIONS AND USAGE:
IMPAVIDO (miltefosine) capsules are indicated in adults and adolescents ≥ 12 years of age weighing ≥30 kg for the treatment of:
- Visceral leishmaniasis caused by Leishmania donovani [see see package insert for Clinical Trials].
- Cutaneous leishmaniasis caused by Leishmania braziliensis, Leishmania guyanensis, and Leishmania panamensis [see package insert for Clinical Trials].
- Mucosal leishmaniasis caused by Leishmania braziliensis [see see package insert for Clinical Trials].
Limitations of Use
- Leishmania species studied in clinical trials evaluating IMPAVIDO were based on epidemiologic data .
- There may be geographic variation in clinical response of the same Leishmania species to IMPAVIDO.
- The efficacy of IMPAVIDO in the treatment of other Leishmania species has not been evaluated.
Hypersensitivity to miltefosine or any of its excipients
| WARNINGS AND PRECAUTIONS:
- Embryo Fetal Toxicity. Do not use in pregnant women. Obtain a urine or serum pregnancy test prior to initiation of therapy. Advise use of effective contraception in females of reproductive potential (Boxed
- Reproductive effects. Miltefosine caused testicular atrophy and impaired fertility in male rats and impaired fertility in female rats. Advise patients of reproductive toxicities in animal studies and that the
potential effects on human fertility have not been adequately evaluated
- Renal Effects. Monitor serum creatinine during therapy and for 4 weeks
after end of therapy
- Hepatic Effects. Monitor transaminases and bilirubin during therapy
- Gastrointestinal Effects. Encourage fluid intake (5.5).
- Thrombocytopenia. Monitor platelet count during therapy for visceral
- Absorption of Oral Contraceptives. Advise use of alternative method of contraception if vomiting and/or diarrhea occur
- Stevens-Johnson syndrome. Discontinue IMPAVIDO
| ADVERSE REACTIONS:
Adverse reactions occurring in ≥2% of patients include nausea,
vomiting, diarrhea, headache, decreased appetite,dizziness, abdominal
pain, pruritus, somnolence, elevated transaminases, and elevated creatinine
See PACKAGE INSERT for PATIENT COUNSELING INFORMATION and Medication Guide.
•IMPAVIDO did not inhibit human cytochrome P450 enzymes in vitro.
•IMPAVIDO did not induce cytochrome 3A activity in rats
Dosage and administration
| DOSAGE AND ADMINISTRATION:
The treatment duration is 28 consecutive days. Administer with food to ameliorate gastrointestinal adverse reactions.
||Dosage and Administration
|30 kg to 44 kg
||One 50 mg capsule twice daily with food (breakfast and dinner)
|45 kg or greater
||One 50 mg capsule three times daily with food (breakfast, lunch, and dinner)
| DOSAGE FORMS AND STRENGTHS:
IMPAVIDO® (miltefosine) oral capsules are opaque, red, hard gelatin capsules with “PLB” imprinted on the capsule body and “MILT 50” imprinted on the cap using a white ink. Each capsule contains 50 mg miltefosine [see DESCRIPTION, Storage and Handling].
Storage And Handling
Each IMPAVIDO capsule contains 50 mg miltefosine in an opaque, red, hard gelatin capsule. IMPAVIDO capsules are supplied in a folded peel/push-through blister card. Each blister card contains 14 capsules. Each carton contains two blister cards (NDC 61744-050-01).
Store at 20-25°C (68–77 °F); excursions permitted to 15-30°C (59 – 86°F). [See USP Controlled Room Temperature]. Protect from moisture.
Dispense only in the original carton.
National Institutes of Health, U.S. National Library of Medicine, DailyMed Database.
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