Miltefosine - For Kalazar-(Apr 2008)
Drug Name:Miltefosine - For Kalazar-(Apr 2008)
List Of Brands:
Indication Type Description:
Drug Interaction
Indication
Adverse Reaction
Contra-Indications
Dosages/ Overdosage Etc
Patient Information
Pharmacology/ Pharmacokinetics
Pregnancy and lactation
Drug Interaction:
. IMPAVIDO did not inhibit human cytochrome P450 enzymes in vitro.
. IMPAVIDO did not induce cytochrome 3A activity in rats
Indication:
U.S.FDA APPROVED DRUGS FROM 01-01-08 TO 31-12-08
Drug name Indication Date of Approval
112. Miltefosin Capsule 10mg/50mg 16-04-08
(Addl.Indication)
For the treatment of irritable bowel syndrome
IMPAVIDO (miltefosine) capsules, for oral use
Initial U.S. Approval: 2014
WARNING: EMBRYO-FETAL TOXICITY
See full prescribing information for complete boxed warning.
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.
Advise females of reproductive potential to use effective contraception
during therapy and for 5 months after therapy (4.1, 5.1, 8.1, 8.8, 13.1).
Kalazar
Approved by (DCI) Drug Controller GENERAL - India For Marketing
(Ref- IDMA Publication)
Name of Drug Indication Date of Approval
1.Miltefosine Kalazar 15-03-2002
2.Miltefosine capsule 10mg/50mg 16-04-2008
Addl.Indcn.
Addl.Indcn.
Treatment of cutaneous Leishmaniasis
Adverse Reaction:
Adverse reactions occurring in .2% of patients include nausea,
vomiting, diarrhea, headache, decreased appetite, dizziness, abdominal
pain, pruritus, somnolence, elevated transaminases, and elevated
creatinine
Contra-Indications:
CONTRAINDICATIONS
. Pregnancy
. Sjogren-Larsson-Syndrome
. 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
Warning, )
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
Thrombocytopenia. Monitor platelet count during therapy for visceral
leishmaniasis
.
Absorption of Oral Contraceptives. Advise use of alternative method of
contraception if vomiting and/or diarrhea occur
Stevens-Johnson syndrome. Discontinue IMPAVIDO
Dosages/ Overdosage Etc:
Treatment of cutaneous Leishmaniasis
INDICATIONS AND USAGE
IMPAVIDO is an antileishmanial drug indicated in adults and adolescents
12 years of age weighing .30 kg (66 lbs) for treatment of:
Visceral leishmaniasis due to Leishmania donovani
Cutaneous leishmaniasis due to Leishmania braziliensis, Leishmania
guyanensis, and Leishmania panamensis .
Mucosal leishmaniasis due to Leishmania braziliensis
Limitations of use: Leishmania species evaluated in clinical trials were based
on epidemiologic data. There may be geographic variation in the response of
the same Leishmania species to IMPAVIDO
The efficacy of IMPAVIDO in the treatment of other Leishmania species has
not been evaluated.
DOSAGE AND ADMINISTRATION
Administer with food to ameliorate gastrointestinal adverse reactions.
30 to 44 kg: one 50 mg capsule twice daily for 28 consecutive days
45 kg or greater: one 50 mg capsule three times daily for 28 consecutive
days
DOSAGE FORMS AND STRENGTHS
Each IMPAVIDO capsule for oral use contains 50 mg miltefosine
Patient Information:
PATIENT COUNSELING INFORMATION
See the FDA-approved Medication Guide
1. Dosing Instructions
IMPAVIDO is administered with food to ameliorate gastrointestinal side effects.
Instruct the patient to swallow the capsule whole and not to chew it or break it apart.
Instruct the patient to complete the full course of therapy.
2. Inform the patient that abdominal pain, nausea, vomiting, and diarrhea are common side
effects of therapy with IMPAVIDO and instruct the patient to inform their healthcare
provider if these gastrointestinal side effects are severe or persistent. Instruct the patient
to consume sufficient fluids to avoid dehydration and, consequently, the risk of kidney
injury.
3. Females and Males of Reproductive Potential
Advise women of reproductive potential to use effective contraception during
IMPAVIDO therapy and for 5 months after therapy ends
6.Advise women who use oral contraceptives to use additional non-hormonal or alternative
method(s) of effective contraception during IMPAVIDO therapy if vomiting and/or
diarrhea occurs
7. Advise nursing mothers not to breastfeed during IMPAVIDO therapy and for 5 months
after therapy is completed .
8. Advise women and men that IMPAVIDO caused infertility in male rats, impaired fertility
in female rats, and caused atresia in ovarian follicles in female dogs. Advise patients that
the potential of impaired fertility in humans has not been adequately evaluated
Distributed by:
Paladin Therapeutics Inc.
Corporation Trust Center
1209 Orange Street
Wilmington, DE 19801
USA
Pharmacology/ Pharmacokinetics:
CLINICAL PHARMACOLOGY
1. Mechanism of Action
Miltefosine is an anti-leishmanial agent
2. Pharmacokinetics
The pharmacokinetic parameters of miltefosine in patients with visceral and cutaneous
leishmaniasis treated for 28 days with IMPAVIDO are listed.
Due to the long half-life of miltefosine (> 6 days), trough plasma concentrations did not
appear to reach a steady state at the end of treatment (i.e., Day 28)
Pregnancy and lactation:
USE IN SPECIFIC POPULATIONS
1. Pregnancy:
IMPAVIDO should not be used during pregnancy. Obtain a urine or
serum pregnancy test in females of reproductive potential prior
to prescribing
2. Nursing Mothers:
Discontinue drug or nursing depending on importance of drug to mother.
Avoid breastfeeding for 5 months after IMPAVIDO therapy
3. Females and Males of Reproductive Potential:
Advise females to use effective contraception during therapy and for
5 months after therapy.
Advise patients of reproductive toxicities in animals, and that the
potential for impaired fertility in humans has not been adequately
evaluated
4 Pediatric Use
Safety and effectiveness in pediatric patients < 12 years have not been established.
5. Geriatric Use
Clinical studies of IMPAVIDO did not include sufficient numbers of subjects 65 years
of age and over to determine if they respond differently than younger subjects.
6. Renal Impairment
Patients with serum creatinine or BUN levels .1.5 times the upper limit of normal were
excluded from the clinical studies. Miltefosine pharmacokinetics have not been studied
in patients with renal impairment
