PhosLo

• Antacids

PhosLo is part of the drug class:

• CALCIUM

Medications can interact with certain foods. In some cases, this may be harmful and your doctor may advise you to avoid certain foods. In the case of calcium acetate, there are no specific foods that you must exclude from your diet when receiving this medication.

Tell your doctor if you are pregnant or plan to become pregnant.

The FDA categorizes medications based on safety for use during pregnancy. Five categories - A, B, C, D, and X, are used to classify the possible risks to an unborn baby when a medication is taken during pregnancy.

Calcium acetate falls into category C. No studies have been done in animals, and no well-controlled studies have been done in pregnant women. Calcium acetate should be given to a pregnant woman only if clearly needed.

In the U.S.

• Eliphos
• PhosLo
• Phoslyra

Available Dosage Forms:

• Tablet
• Solution
• Capsule

Therapeutic Class: Calcium Supplement

Calcium acetate is used to treat hyperphosphatemia (too much phosphate in the blood) in patients with end stage kidney disease who are on dialysis.

Calcium acetate works by binding with the phosphate in the food you eat, so that it is eliminated from the body without being absorbed.

This medicine is available only with your doctor's prescription.

This section provides information on the proper use of a number of products that contain calcium acetate. It may not be specific to PhosLo. 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 your symptoms or health problems do not get better or if they become worse, call your doctor.
• Do not share your drugs with others and do not take anyone else's drugs.
• Keep a list of all your drugs (prescription, natural products, vitamins, OTC) with you. Give this list to your doctor.
• Talk with the doctor before starting any new drug, including prescription or OTC, natural products, or vitamins.
• Some drugs may have another patient information leaflet. Check with your pharmacist. If you have any questions about this medicine, please talk with your doctor, nurse, pharmacist, or other health care provider.
• If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.

This information should not be used to decide whether or not to take PhosLo or any other medicine. Only the healthcare provider has the knowledge and training to decide which medicines are right for a specific patient. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about this medicine. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to PhosLo (calcium acetate capsules and tablets). This information is not specific medical advice and does not replace information you receive from the healthcare provider. You must talk with the healthcare provider for complete information about the risks and benefits of using this medicine.

Review Date: October 4, 2017

Hypercalcemia is discussed elsewhere [see Warnings and Precautions (5.1)].

6.1 Clinical Trials Experience

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.

In clinical studies, calcium acetate has been generally well tolerated.

Phoslo® was studied in a 3-month, open-label, non-randomized study of 98 enrolled ESRD hemodialysis patients and in a two week double-blind, placebo-controlled, cross-over study with 69 enrolled ESRD hemodialysis patients.  Adverse reactions (>2% on treatment) from these trials are presented in Table 1.

Mild hypercalcemia may be asymptomatic or manifest itself as constipation, anorexia, neusea, and vomiting.  More severe hypercalcemia is associated with confusion, delirium, stupor, and coma.  Decreasing dialysate calcium concentration could reduce the incidence and severity of Phoslo®-induced hypercalcemia.  Isolated cases of pruritus have been reported, which may represent allergic reactions.

6.2 Postmarketing Experience

Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to estimate their frequency or to establish a causal relationship to drug exposure.

The following additional adverse reactions have been identified during post-approval of calcium acetate:  dizziness, edema, and weakness.

13.1  CARCINOGENESIS & MUTAGENESIS & IMPAIRMENT OF FERTILITY

No carcinogenicity, mutagenicity, or fertility studies have been conducted with calcium acetate.