Description
Sucroferric oxyhydroxide is used to control the phosphorus levels in the blood of patients with chronic kidney disease (CKD) that are on dialysis.
This medicine is available only with your doctor's prescription.
This product is available in the following dosage forms:
- Tablet, Chewable
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
Safety and efficacy of this medicine have been established in pediatric patients 6 years to less than 9 years of age; however, it is not approved for this age range because of the lack of an appropriate dosage strength. Appropriate studies have not been performed on the relationship of age to the effects of sucroferric oxyhydroxide in children younger than 6 years of age. 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 sucroferric oxyhydroxide in the elderly.
Breastfeeding
Studies in women suggest that this medication poses minimal risk to the infant when used during 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.
- Erdafitinib
- Mycophenolate Mofetil
- Mycophenolic Acid
Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.
- Tecovirimat
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:
- Hemochromatosis (a genetic disorder which causes too much iron in the blood), history of or
- Liver disease or
- Major surgery in your stomach or bowels or
- Peritonitis (inflammation of peritoneum) or
- Stomach problems—Use with caution. May make these conditions worse.
Proper Use
Take this medicine exactly as directed by your doctor. Do not take it more often, and do not take it for a longer time than your doctor ordered. To do so may increase the chance of side effects.
Chew or crush the tablet. Do not swallow it whole.
Take this medicine with food.
If you are using acetylsalicylic acid, cephalexin, or doxycycline, take them at least 1 hour before taking this medicine.
If you are using levothyroxine, take it at least 4 hours before taking this medicine.
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 (chewable tablets):
- For control of phosphorus levels in patients with chronic kidney disease on dialysis:
- Adults and children 12 years of age and older—At first, 500 milligrams (mg) 3 times a day. Your doctor may adjust your dose as needed. However, the dose is usually not more than 3000 mg per day.
- Children 9 to younger than 12 years of age—At first, 500 mg 2 times a day. Your doctor may adjust your dose as needed. However, the dose is usually not more than 3000 mg per day.
- Children younger than 9 years of age—Use and dose must be determined by your doctor.
- For control of phosphorus levels in patients with chronic kidney disease on dialysis:
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 that this medicine is working properly. Blood tests may be needed to check for unwanted effects.
This medicine may cause your stools to be black and stain your teeth.
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.
Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:
More common
- Dark stools
- diarrhea
- nausea
Less common
- Change in taste
Incidence not known
- Skin rash
- tooth discoloration
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.
DRG-20088503
