Important drug safety information
Please read the full Prescribing Information and Medication Guide before use. IMPAVIDO is available by prescription only.
Use
IMPAVIDO (miltefosine) is a prescription medicine used to treat certain forms of leishmaniasis in adults and adolescents 12 years of age and older who weigh at least 30 kg (66 lbs), including:
- Visceral leishmaniasis
- Cutaneous leishmaniasis
- Mucosal leishmaniasis
IMPAVIDO has only been studied in certain Leishmania species. Ask your healthcare provider if you have questions about whether IMPAVIDO is right for you.
Important safety information
Always take IMPAVIDO exactly as your healthcare provider directs.
Do not take IMPAVIDO if you:
- are pregnant.
- have Sjögren-Larsson syndrome.
- are allergic to miltefosine or any of the ingredients in IMPAVIDO.
Pregnancy
- IMPAVIDO can cause serious harm to an unborn baby.
- Before starting treatment, your healthcare provider will perform a pregnancy test if you are able to become pregnant.
- Use effective birth control during treatment and for 5 months after your last dose. If you experience vomiting or diarrhea while taking IMPAVIDO, birth control pills may not work as well. Talk with your healthcare provider about using another reliable form of birth control.
- Do not become pregnant while taking IMPAVIDO. Tell your healthcare provider right away if you become pregnant or think you may be pregnant.
Warnings and precautions
Fertility
IMPAVIDO may affect fertility. Talk with your healthcare provider if you have concerns about fertility before starting treatment.
Kidney and liver problems
IMPAVIDO may affect your kidneys or liver. Your healthcare provider will perform blood tests before, during, and after treatment to monitor kidney and liver function.
Vomiting and diarrhea
Vomiting and diarrhea are common with IMPAVIDO and may lead to dehydration. Drink plenty of fluids during treatment. Contact your healthcare provider if vomiting or diarrhea is severe or persistent.
Low platelet counts
Patients treated for visceral leishmaniasis may develop low platelet counts. Your healthcare provider may monitor your blood counts during treatment.
Serious skin reactions
Serious skin reactions, including Stevens-Johnson syndrome, have been reported. Stop taking IMPAVIDO and contact your healthcare provider immediately if you develop blistering, peeling, or a severe skin rash.
Side effects
The most common side effects of IMPAVIDO include nausea, vomiting, diarrhea, headache, decreased appetite, dizziness, stomach pain, itching, sleepiness, and changes in certain blood tests that measure liver and kidney function.
Do not breastfeed while taking IMPAVIDO or for 5 months after your last dose. IMPAVIDO has not been established as safe or effective in children younger than 12 years of age.
You are encouraged to report negative side effects of prescription drugs by contacting Eton Pharmaceuticals, Inc. at 1-855-224-0233 or the U.S. Food and Drug Administration (FDA) at www.fda.gov/medwatch or by calling 1-800-FDA-1088.
Please see Full Prescribing Information, including Boxed Warning, for more information.
Full Important Safety Information
Warning: Embryo-Fetal Toxicity
IMPAVIDO® (miltefosine) 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.
Use
IMPAVIDO® (miltefosine) is a prescription medicine used to treat certain forms of leishmaniasis in adults and adolescents 12 years of age and older who weigh at least 30 kg (66 lbs), including:
- Visceral leishmaniasis
- Cutaneous leishmaniasis
- Mucosal leishmaniasis
IMPAVIDO has only been studied in certain Leishmania species. Ask your healthcare provider if you have questions about whether IMPAVIDO is right for you.
Important Safety Information
Important Warning: IMPAVIDO can cause serious harm to an unborn baby.
Before starting treatment, your healthcare provider will perform a pregnancy test if you are able to become pregnant.
Use effective birth control during treatment and for 5 months after your last dose. If you experience vomiting or diarrhea while taking IMPAVIDO, birth control pills may not work as well. Talk with your healthcare provider about using another effective form of birth control that is not taken by mouth.
Do not become pregnant while taking IMPAVIDO. Tell your healthcare provider right away if you become pregnant or think you may be pregnant.
Always take IMPAVIDO exactly as your healthcare provider directs.
Do not take IMPAVIDO if you:
- are pregnant.
- have Sjögren-Larsson syndrome.
- are allergic to miltefosine or any of the ingredients in IMPAVIDO.
Fertility
IMPAVIDO may affect male fertility. Changes in sperm have been observed after treatment, and it is not known how long some effects may last. IMPAVIDO affected female fertility in animal studies; its effects on fertility in women have not been adequately evaluated. Talk with your healthcare provider if you have concerns about fertility before starting treatment.
Kidney and Liver Problems
IMPAVIDO may affect your kidneys or liver. Your healthcare provider should monitor your kidney function weekly while you take IMPAVIDO and for 4 weeks after treatment ends. Your healthcare provider should also monitor your liver during treatment.
Vomiting and Diarrhea
Vomiting and diarrhea are common with IMPAVIDO and may lead to dehydration. Drink plenty of fluids during treatment. Contact your healthcare provider if vomiting or diarrhea is severe or persistent.
Low Platelet Counts
Patients treated for visceral leishmaniasis may develop low platelet counts. Your healthcare provider should monitor your blood counts during treatment.
Serious Skin Reactions
Serious skin reactions, including Stevens-Johnson syndrome, have been reported. Stop taking IMPAVIDO and contact your healthcare provider immediately if you develop blistering, peeling, or a severe skin rash.
Eye Problems
Serious eye problems have been reported in people taking IMPAVIDO and may affect vision. Stop taking IMPAVIDO right away and contact an eye doctor if you develop eye pain, redness, sensitivity to light, increased tearing, or changes in your vision.
The most common side effects of IMPAVIDO include nausea, vomiting, diarrhea, headache, decreased appetite, dizziness, stomach pain, itching, sleepiness, and changes in certain blood tests that measure liver and kidney function.
Do not breastfeed while taking IMPAVIDO or for 5 months after your last dose. IMPAVIDO has not been established as safe or effective in children younger than 12 years of age.
For more information, please visit IMPAVIDO.com.
You are encouraged to report negative side effects of prescription drugs by contacting Eton Pharmaceuticals, Inc. at 1-855-224-0233 or the U.S. Food and Drug Administration (FDA) at www.fda.gov/medwatch or by calling 1-800-FDA-1088.
Please see Full Prescribing Information, including Boxed Warning, for more information.