Velphoro

Velphoro is used to control the phosphorus levels in the blood of patients with chronic kidney disease 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 Velphoro, you must know all about the risks and complications associated with it. 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 Population: Appropriate studies have not been performed on the relationship of age to the effects of sucroferric oxyhydroxide in the pediatric population. Safety and efficacy have not been established.

Geriatric Population: Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of sucroferric oxyhydroxide in the elderly.

Pregnancy: All Trimesters: Category B: Animal studies have revealed no evidence of harm to the fetus, however, there are no adequate studies in pregnant women OR animal studies have shown an adverse effect, but adequate studies in pregnant women have failed to demonstrate a risk to the fetus.

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:

• Hemochromatosis (a genetic disorder which causes too much iron in the blood), history of 
• Liver disease 
• Major surgery in your stomach or bowels 
• Peritonitis (inflammation of peritoneum) 
• Stomach problems—This medicine has not been studied in patients with these conditions, but should be monitored for more serious side effects

Proper usage of Velphoro requires strict adherence to your doctor’s orders. 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 the tablet and do not swallow it whole. You may also crush the tablet. Take this medicine with meals. If you are taking doxycycline, take it at least 1 hour before taking Velphoro®.

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—500 milligrams (mg) three times a day with food. Your doctor may adjust your dose as needed. However, the dose is usually not more than 3000 mg per day.
• Children—Use and dose must be determined by your doctor.

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.

Before using Velphoro, there are some precautions you must take. 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.

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.

As with many medications, there are several potential side effects associated with Velphoro. 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:

• Dark-colored stools

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:

• Diarrhea
• nausea

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.