Phoslyra

You should not use calcium acetate if you have high levels of calcium in your blood.

Take the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not take extra medicine to make up the missed dose.

Do not take additional calcium supplements unless your doctor has told you to.

Avoid using antacids without your doctor's advice. Use only the specific type of antacid your doctor recommends. Many antacids contain calcium and you could be getting too much of this mineral if you take a calcium antacid with calcium acetate.

Calcium acetate can make it harder for your body to absorb other medicines you take by mouth.

• Avoid taking an antibiotic such as ciprofloxacin (Cipro), moxifloxacin (Avelox), or levofloxacin (Levaquin) within 2 hours before or 6 hours after you take calcium acetate.

• Avoid taking an antibiotic such as doxycycline (Doryx, Oracea), minocycline (Solodyn), or tetracycline within 1 hour before you take calcium acetate.

• Avoid taking levothyroxine (Synthroid, Levothroid) within 4 hours before or 4 hours after you take calcium acetate.

Get emergency medical help if you have signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Stop using calcium acetate and call your doctor at once if you have:

• high levels of calcium in your blood--nausea, vomiting, constipation, increased thirst or urination, muscle weakness, bone pain, confusion, lack of energy, or tired feeling.

Common side effects may include:

• increased calcium in the blood

• nausea; or

• diarrhea.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

This section provides information on the proper use of a number of products that contain calcium acetate. It may not be specific to Phoslyra. Please read with care.

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.

It is best to take this medicine with meals.

Measure the oral liquid with a marked measuring spoon, oral syringe, or medicine cup. The average household teaspoon may not hold the right amount of liquid.

Follow carefully any diet program your doctor may recommend.

If you are taking other medicines, take them at least 1 hour before or 3 hours after you take calcium acetate oral liquid. If you need help deciding the best times to take your other medicines, ask your doctor or pharmacist.

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 too much phosphate in the blood:
  • For oral dosage form (solution):
    • Adults—At first, the dose is usually 10 milliliters (mL) with each meal. The dose is adjusted by your doctor depending on how high your blood phosphorus level is.
    • Children—Use and dose must be determined by your doctor.
  • For oral dosage form (tablets):
    • Adults—2 tablets three times a day with meals. Your doctor may increase your dose if needed.
    • Children—Use and dose must be determined by your doctor.

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.

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.

Throw away any unused oral liquid after 24 months.

• If you have an allergy to calcium or any other part of Phoslyra (calcium acetate oral solution).
• If you are allergic to any drugs like this one, any other drugs, foods, or other substances. Tell your doctor about the allergy and what signs you had, like rash; hives; itching; shortness of breath; wheezing; cough; swelling of face, lips, tongue, or throat; or any other signs.
• If you have high calcium levels.

This is not a list of all drugs or health problems that interact with this medicine.

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 Phoslyra with all of your drugs and health problems. Do not start, stop, or change the dose of any drug without checking with your doctor.

Oral Solution:  667 mg calcium acetate per 5 mL.

Pregnancy

Pregnancy Category C

Phoslyra contains calcium acetate.  Animal reproduction studies have not been conducted with Phoslyra, and there are no adequate and well controlled studies of Phoslyra use in pregnant women.  Patients with end stage renal disease may develop hypercalcemia with calcium acetate treatment [see Warnings and Precautions (5.1)].  Maintenance of normal serum calcium levels is important for maternal and fetal well being.  Hypercalcemia during pregnancy may increase the risk for maternal and neonatal complications such as stillbirth, preterm delivery, and neonatal hypocalcemia and hypoparathyroidism.  Phoslyra treatment, as recommended, is not expected to harm a fetus if maternal calcium levels are properly monitored during and following treatment.

Labor and Delivery

The effects of Phoslyra on labor and delivery are unknown.

Nursing Mothers

Phoslyra contains calcium acetate and is excreted in human milk.  Human milk feeding by a mother receiving Phoslyra is not expected to harm an infant, provided maternal serum calcium levels are appropriately monitored.

Pediatric Use

Safety and effectiveness of Phoslyra in pediatric patients have not been established.

Geriatric Use

Clinical studies of calcium acetate did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects.  Other reported clinical experience has not identified differences in responses between the elderly and younger patients.  In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy.

Inform patients to take Phoslyra with meals, adhere to their prescribed diets, and avoid the use of calcium supplements including nonprescription antacids.  Inform patients about the symptoms of hypercalcemia [see Warnings and Precautions (5.1) and Adverse Reactions (6.1)].

Advise patients who are taking an oral medication where a reduction in the bioavailability of that medication would have a clinically significant effect on its safety or efficacy to take the drug one hour before or three hours after Phoslyra.

Manufactured for:
Fresenius Medical Care North America
Waltham, MA  02451
1-800-323-5188

Manufactured by:
Lyne Laboratories
Brockton, MA  02301
1-800-525-0450

101087.C  10/2015

Applies to calcium acetate: compounding powder, injectable solution, oral capsule, oral liquid, oral tablet

General

The most common adverse events were hypercalcemia, nausea, and diarrhea.[Ref]

Metabolic

Very common (10% or more): Hypercalcemia (16.3%)[Ref]

Hypercalcemia was usually asymptomatic or manifested as constipation, anorexia, nausea, and vomiting, and in 0.1% of patients caused confusion, delirium, stupor, or coma.[Ref]

Gastrointestinal

Very common (10% or more): Nausea (14%), diarrhea (13.2%)
Common (1% to 10%): Vomiting
Uncommon (0.1% to 1%): Constipation[Ref]

Dermatologic

Common (1% to 10%): Pruritus[Ref]

Other

Uncommon (0.1% to 1%): Soft tissue calcification
Postmarketing reports: Edema, weakness[Ref]

Nervous system

Postmarketing reports: Dizziness[Ref]

Some side effects of Phoslyra may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.