Impavido

Miltefosine

(mil TEF oh seen)

Impavido

Do not take if you are pregnant. Use of this drug during pregnancy may cause birth defects or death of the unborn baby. You will need to have a pregnancy test to show that you are NOT pregnant before starting this drug. Talk with the doctor. Use birth control you can trust to prevent pregnancy while you are taking this drug and for 5 months after you stop taking it. If you get pregnant while taking this drug or within 5 months after your last dose, call your doctor right away.

It is used to treat a certain type of infection (leishmaniasis).

If you have an allergy to miltefosine or any other part of this drug. If you are allergic to this drug; any part of this drug; or any other drugs, foods, or substances. Tell your doctor about the allergy and what signs you had. If you are breast-feeding. Do not breast-feed while you take this drug and for 5 months after you stop taking it. If you have a health problem called Sjogren-Larsson-Syndrome. This is not a list of all drugs or health problems that interact with this drug. Tell your doctor and pharmacist about all of your drugs (prescription or OTC, natural products, vitamins) and health problems. You must check to make sure that it is safe for you to take this drug with all of your drugs and health problems. Do not start, stop, or change the dose of any drug without checking with your doctor.

Tell all of your health care providers that you take this drug. This includes your doctors, nurses, pharmacists, and dentists. Have blood work checked as you have been told by the doctor. Talk with the doctor. This drug caused fertility problems in animals. It is not known if it will cause fertility problems in humans. Talk with the doctor. If diarrhea happens or you are throwing up, call your doctor. You will need to drink more fluids to keep from losing too much fluid. If you throw up or have diarrhea, birth control pills may not work as well. If you take birth control and this happens, use an extra form of birth control like condoms.

WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect: Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing, swallowing, or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat. Any unexplained bruising or bleeding. Fever. For males, testicle pain. Orgasm with less or no semen. A very bad skin reaction (Stevens-Johnson syndrome/toxic epidermal necrolysis) may happen. It can cause very bad health problems that may not go away, and sometimes death. Get medical help right away if you have signs like red, swollen, blistered, or peeling skin (with or without fever); red or irritated eyes; or sores in your mouth, throat, nose, or eyes.

All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away: Upset stomach or throwing up. Stomach pain or diarrhea. Not hungry. Feeling dizzy, sleepy, tired, or weak. Headache. Motion sickness. These are not all of the side effects that may occur. If you have questions about side effects, call your doctor. Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-332-1088. You may also report side effects at https://www.fda.gov/medwatch.

Use this drug as ordered by your doctor. Read all information given to you. Follow all instructions closely. Take with food. Swallow whole. Do not chew, break, open, or dissolve. Keep taking this drug as you have been told by your doctor or other health care provider, even if you feel well.

Take a missed dose as soon as you think about it. If it is close to the time for your next dose, skip the missed dose and go back to your normal time. Do not take 2 doses at the same time or extra doses.

Store in the original container at room temperature. Store in a dry place. Do not store in a bathroom. Keep all drugs in a safe place. Keep all drugs out of the reach of children and pets. Throw away unused or expired drugs. Do not flush down a toilet or pour down a drain unless you are told to do so. Check with your pharmacist if you have questions about the best way to throw out drugs. There may be drug take-back programs in your area.

If your symptoms or health problems do not get better or if they become worse, call your doctor. Do not share your drugs with others and do not take anyone else's drugs. This drug comes with an extra patient fact sheet called a Medication Guide. Read it with care. Read it again each time this drug is refilled. If you have any questions about this drug, please talk with the doctor, pharmacist, or other health care provider. If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.

This information should not be used to decide whether or not to take this medicine or any other medicine. Only the healthcare provider has the knowledge and training to decide which medicines are right for a specific patient. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about this medicine. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to this medicine. This information is not specific medical advice and does not replace information you receive from the healthcare provider. You must talk with the healthcare provider for complete information about the risks and benefits of using this medicine.