Description
Maralixibat is used to treat cholestatic pruritus (skin itching) in patients with Alagille syndrome (ALGS) and progressive familial intrahepatic cholestasis (PFIC).
This medicine is available only with your doctor's prescription.
This product is available in the following dosage forms:
- Solution
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 maralixibat to treat skin itching with Alagille syndrome (ALGS) in children younger than 3 months of age and to treat skin itching with progressive familial intrahepatic cholestasis (PFIC) in children younger than 12 months of age. Safety and efficacy have not been established.
Geriatric
Appropriate studies have not been performed on the relationship of age to the effects of maralixibat in geriatric patients. Safety and efficacy have not been established.
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. Tell your healthcare professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine.
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:
- Fat-soluble vitamin (vitamins A, D, E, and K) deficiency—Use with caution. May make this condition worse.
- Liver problems (variceal hemorrhage, ascites, hepatic encephalopathy), active or history of—Should not be used in patients with these conditions.
Proper Use
Take this medicine exactly 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 and patient instructions. Read and follow these instructions carefully. Ask your doctor if you have any questions.
Take this medicine at least 30 minutes before the first meal of the day.
Check the liquid in the bottle. It should be clear to almost clear and colorless to light yellow. Do not use the medicine if the liquid is discolored, or has particles in it.
To use:
- Write the date on the bottle when you first opened the medicine. Remove the plastic seal.
- Open the bottle by pushing down on the child-resistant cap and turn the cap to the left (counter-clockwise).
- If you are using a new dosing dispenser, remove it from the wrapper. If you are using a used dosing dispenser, make sure that it has been cleaned. Remove and throw away the cap of the dosing dispenser, if applicable.
- Measure the oral liquid medicine with the provided dosing dispenser. Make sure to use the correct dosing dispenser depending on the prescribed dose.
- Push the plunger down fully to remove air from the dispenser. Once the cap of the bottle is removed, insert the tip of the dispenser into the bottle. The tip should fit into the hole. Check for air bubbles. If you see any, push the plunger so that the medicine flows back into the bottle.
- Keep the dosing dispenser in place and turn the bottle upside down. Pull back the plunger slowly until the top of the plunger is even with the marking on the barrel of the dosing dispenser.
- Remove the dosing dispenser from the bottle by pulling straight up on the barrel. Place the tip of the dispenser against the inside of the cheek and slowly push the plunger all the way to give the entire dose.
- Swallow the whole dose. If you are not sure the full dose was swallowed, do not give another dose. Wait until the next scheduled dose.
Take this medicine at least 4 hours before or 4 hours after using bile acid sequestrants (eg, cholestyramine, colesevelam, colestipol).
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 (solution):
- For cholestatic pruritus in patients with Alagille syndrome:
- Adults and children 3 months of age and older—Dose is base on weight and must be determined by your doctor. The dose is usually 380 micrograms per kilogram (mcg/kg) of body weight once a day. However, the dose is usually not more than 28.5 milligrams (mg) or 3 mL per day.
- Weighing 70 kilograms (kg) or more—At first, 1.5 milliliters (mL) once a day for Days 1 to 7. Then, 3 mL once a day starting on Day 8. Your doctor may adjust your dose as needed and tolerated.
- Weighing 60 kg to 69 kg—At first, 1.25 mL once a day for Days 1 to 7. Then, 2.5 mL once a day starting on Day 8. Your doctor may adjust your dose as needed and tolerated.
- Weighing 50 kg to 59 kg—At first, 1 mL once a day for Days 1 to 7. Then, 2.25 mL once a day starting on Day 8. Your doctor may adjust your dose as needed and tolerated.
- Weighing 40 kg to 49 kg—At first, 0.9 mL once a day for Days 1 to 7. Then, 1.75 mL once a day starting on Day 8. Your doctor may adjust your dose as needed and tolerated.
- Weighing 35 kg to 39 kg—At first, 0.7 mL once a day for Days 1 to 7. Then, 1.5 mL once a day starting on Day 8. Your doctor may adjust your dose as needed and tolerated.
- Weighing 30 kg to 34 kg—At first, 0.6 mL once a day for Days 1 to 7. Then, 1.25 mL once a day starting on Day 8. Your doctor may adjust your dose as needed and tolerated.
- Weighing 25 kg to 29 kg—At first, 0.5 mL once a day for Days 1 to 7. Then, 1 mL once a day starting on Day 8. Your doctor may adjust your dose as needed and tolerated.
- Weighing 20 kg to 24 kg—At first, 0.45 mL once a day for Days 1 to 7, 0.9 mL once a day starting on Day 8. Your doctor may adjust your dose as needed and tolerated.
- Weighing 16 kg to 19 kg—At first, 0.35 mL once a day for Days 1 to 7. Then, 0.7 mL once a day starting on Day 8. Your doctor may adjust your dose as needed and tolerated.
- Weighing 13 kg to 15 kg—At first, 0.3 mL once a day for Days 1 to 7. Then, 0.6 mL once a day starting on Day 8. Your doctor may adjust your dose as needed and tolerated.
- Weighing 10 kg to 12 kg—At first, 0.2 mL once a day for Days 1 to 7. Then, 0.45 mL once a day starting on Day 8. Your doctor may adjust your dose as needed and tolerated.
- Weighing 7 kg to 9 kg—At first, 0.15 mL once a day for Days 1 to 7. Then, 0.3 mL once a day starting on Day 8. Your doctor may adjust your dose as needed and tolerated.
- Weighing 5 kg to 6 kg—At first, 0.1 mL once a day for Days 1 to 7. Then, 0.2 mL once a day starting on Day 8. Your doctor may adjust your dose as needed and tolerated.
- Children younger than 3 months of age—Use and dose must be determined by your doctor.
- Adults and children 3 months of age and older—Dose is base on weight and must be determined by your doctor. The dose is usually 380 micrograms per kilogram (mcg/kg) of body weight once a day. However, the dose is usually not more than 28.5 milligrams (mg) or 3 mL per day.
- For cholestatic pruritus in patients with progressive familial intrahepatic cholestasis:
- Adults and children 12 months of age and older—Dose is base on weight and must be determined by your doctor. The dose is usually 570 micrograms per kilogram (mcg/kg) of body weight 2 times a day. However, the dose is usually not more than 38 milligrams (mg) or 2 mL per day.
- Weighing 60 kilograms (kg) or more—At first, 0.9 milliliters (mL) once a day taken in the morning. Then, 0.9 mL 2 times a day taken in the morning and evening. Your doctor may adjust your dose as needed and tolerated.
- Weighing 50 kg to 59 kg—At first, 0.8 mL once a day taken in the morning. Then, 0.8 mL 2 times a day taken in the morning and evening. Your doctor may adjust your dose as needed and tolerated.
- Weighing 40 kg to 49 kg—At first, 0.6 mL once a day taken in the morning. Then, 0.6 mL 2 times a day taken in the morning and evening. Your doctor may adjust your dose as needed and tolerated.
- Weighing 35 kg to 39 kg—At first, 0.6 mL once a day taken in the morning. Then, 0.6 mL 2 times a day taken in the morning and evening. Your doctor may adjust your dose as needed and tolerated.
- Weighing 30 kg to 34 kg—At first, 0.45 mL once a day taken in the morning. Then, 0.45 mL 2 times a day taken in the morning and evening. Your doctor may adjust your dose as needed and tolerated.
- Weighing 25 kg to 29 kg—At first, 0.4 mL once a day taken in the morning. Then, 0.4 mL 2 times a day taken in the morning and evening. Your doctor may adjust your dose as needed and tolerated.
- Weighing 20 kg to 24 kg—At first, 0.3 mL once a day taken in the morning. Then, 0.3 mL 2 times a day taken in the morning and evening. Your doctor may adjust your dose as needed and tolerated.
- Weighing 16 kg to 19 kg—At first, 0.25 mL once a day taken in the morning. Then, 0.25 mL 2 times a day taken in the morning and evening. Your doctor may adjust your dose as needed and tolerated.
- Weighing 13 kg to 15 kg—At first, 0.2 mL once a day taken in the morning. Then, 0.2 mL 2 times a day taken in the morning and evening. Your doctor may adjust your dose as needed and tolerated.
- Weighing 10 kg to 12 kg—At first, 0.15 mL once a day taken in the morning. Then, 0.15 mL 2 times a day taken in the morning and evening. Your doctor may adjust your dose as needed and tolerated.
- Weighing 9 kg—At first, 0.15 mL once a day taken in the morning. Then, 0.15 mL 2 times a day taken in the morning and evening. Your doctor may adjust your dose as needed and tolerated.
- Weighing 8 kg—At first, 0.1 mL once a day taken in the morning. Then, 0.1 mL 2 times a day taken in the morning and evening. Your doctor may adjust your dose as needed and tolerated.
- Weighing 6 kg to 7 kg—At first, 0.1 mL once a day taken in the morning. Then, 0.1 mL 2 times a day taken in the morning and evening. Your doctor may adjust your dose as needed and tolerated.
- Weighing 5 kg—At first, 0.1 mL once a day taken in the morning. Then, 0.1 mL 2 times a day taken in the morning and evening. Your doctor may adjust your dose as needed and tolerated.
- Children younger than 12 months of age—Use and dose must be determined by your doctor.
- Adults and children 12 months of age and older—Dose is base on weight and must be determined by your doctor. The dose is usually 570 micrograms per kilogram (mcg/kg) of body weight 2 times a day. However, the dose is usually not more than 38 milligrams (mg) or 2 mL per day.
- For cholestatic pruritus in patients with Alagille syndrome:
Missed Dose
If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.
Once a day dosing: If a dose is missed by 12 hours or less, take it as soon as possible, and then go back to your regular schedule. If a dose is missed by more than 12 hours, do not take an extra dose. Take the next dose at the regular scheduled time.
Two times a day dosing: If a dose is missed by 6 hours or less, take it as soon as possible, and then go back to your regular schedule. If a dose is missed by more than 6 hours, do not take an extra dose. Take the next dose at the regular scheduled time.
Storage
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.
Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.
Store this medicine with the cap on the bottle.
Throw away any unused medicine 100 days after opening the bottle.
Precautions
It is very important that your doctor check your or your child's progress at regular visits to see if the medicine is working properly and to decide if you or your child should continue to take it. Blood tests may be needed to check for any unwanted effects.
Check with your doctor right away if you have dark urine, clay-colored stools, stomach pain, or yellow eyes or skin. These may be symptoms of a serious liver problem.
This medicine may cause stomach or bowel problems, including diarrhea, stomach pain, or vomiting. If you have any questions or if these symptoms continue or get worse, check with your doctor.
This medicine may cause bleeding problems and bone fractures. Call your doctor right away if you bleed more, bleed longer, or have pain or swelling in the arms or legs without any injury.
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
- Bloody or black, tarry stools
- bone fractures
- chills
- constipation
- dark urine
- diarrhea
- dizziness
- fever
- headache
- itching, rash
- light-colored stools
- loss of appetite
- nausea
- pain or swelling in the arms or legs without any injury
- stomach pain
- unpleasant breath odor
- unusual bleeding
- unusual tiredness or weakness
- vomiting
- vomiting of blood or material that looks like coffee grounds
- yellow eyes or skin
Incidence not known
- Confusion
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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