Description
Atrasentan is used to reduce levels of protein in the urine (proteinuria) in patients who have a kidney disease called primary immunoglobulin A nephropathy (IgAN), who are at risk of their disease worsening quickly.
This medicine is available only with your doctor's prescription.
This product is available in the following dosage forms:
- Tablet
Before Using
In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:
Allergies
Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.
Pediatric
Appropriate studies have not been performed on the relationship of age to the effects of atrasentan in the pediatric population. Safety and efficacy have not been established.
Geriatric
Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of atrasentan in the elderly.
Breastfeeding
There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.
Drug Interactions
Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.
Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.
- Apalutamide
- Asunaprevir
- Atazanavir
- Bempedoic Acid
- Bosentan
- Carbamazepine
- Cenobamate
- Clarithromycin
- Cobicistat
- Cyclosporine
- Dabrafenib
- Daclatasvir
- Darolutamide
- Dipyrone
- Efavirenz
- Elagolix
- Elbasvir
- Eltrombopag
- Eluxadoline
- Enasidenib
- Encorafenib
- Enzalutamide
- Etravirine
- Fosphenytoin
- Fostemsavir
- Gemfibrozil
- Glecaprevir
- Grazoprevir
- Ibrexafungerp
- Itraconazole
- Ivosidenib
- Lesinurad
- Letermovir
- Lopinavir
- Lorlatinib
- Lumacaftor
- Mitapivat
- Mitotane
- Modafinil
- Nafcillin
Other Interactions
Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.
Other Medical Problems
The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:
- Liver disease—Use with caution. May make this condition worse.
- Liver disease, severe—Use is not recommended in patients with this condition.
Proper Use
Take this medicine only as directed by your doctor. Do not take more of it, do not take it more often, and do not take it for a longer time than your doctor ordered.
This medicine comes with a Medication Guide. Read and follow the instructions carefully. Ask your doctor if you have any questions.
You may take this medicine with or without food.
Swallow the tablet whole. Do not cut, crush, or chew it.
Dosing
The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.
The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.
- For oral dosage form (tablets):
- For proteinuria:
- Adults—0.75 milligrams (mg) once a day.
- Children—Use and dose must be determined by your doctor.
- For proteinuria:
Missed Dose
If you miss a dose of this medicine, skip the missed dose and go back to your regular dosing schedule. Do not double doses.
Storage
Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.
Keep out of the reach of children.
Do not keep outdated medicine or medicine no longer needed.
Ask your healthcare professional how you should dispose of any medicine you do not use.
Precautions
It is very important that your doctor check your progress at regular visits to make sure this medicine is working properly. Blood tests may be needed to check for unwanted effects.
Using this medicine while you are pregnant can harm your unborn baby. If you can get pregnant, you must have a negative pregnancy test before starting treatment with this medicine to make sure you are not pregnant. Use an effective form of birth control before starting, during treatment, and for 2 weeks after your final dose to keep from getting pregnant. Ask your doctor which form of birth control is the right for you. If you think you have become pregnant while using the medicine, tell your doctor right away.
This medicine may cause serious liver problems. Check with your doctor right away if you have dark urine, fatigue, loss of appetite, nausea or vomiting, severe stomach pain, or yellow eyes or skin.
This medicine may cause fluid retention (too much water in the body). Check with your doctor right away if you have decrease in amount of urine, noisy, rattling, or trouble breathing, swelling of the face, hands, feet, or lower legs, or weight gain.
This medicine may decrease sperm count in some males and may cause infertility (unable to have children). Talk with your doctor before using this medicine if you plan to have children.
Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.
Side Effects
Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.
Check with your doctor immediately if any of the following side effects occur:
More common
- Bloating or swelling of the face, arms, hands, lower legs, or feet
- pale skin
- rapid weight gain
- tingling of the hands or feet
- trouble breathing
- unusual bleeding or bruising
- unusual tiredness or weakness
- unusual weight gain or loss
Incidence not known
- Clay colored stools
- dark urine
- decrease sperm count
- decreased appetite
- fever
- headache
- itching, skin rash
- loss of appetite
- nausea and vomiting
- yellow eyes or skin
Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.
Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.
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