Uses

Calcitriol is a man-made active form of vitamin D (vitamin D3). Vitamin D is a vitamin stored in the body that is needed for building and keeping strong bones. Calcitriol is used to treat or prevent certain problems that can happen with long-term kidney dialysis, such as low levels of calcium or high levels of parathyroid hormone. Calcitriol is usually used along with a certain diet, supplements, and sometimes other medications.

Most people get enough vitamin D from exposure to the sun and from fortified food products (such as dairy products, vitamins). Before regular vitamin D can be used by the body, it needs to be changed to the active form by the liver and kidneys. People with kidney disease cannot make enough of the active form of vitamin D. This medication works by affecting parathyroid hormone (PTH) levels and increasing blood calcium levels.

How To Use

This medication is given by injection into a vein as directed by your doctor, usually 3 times a week (every other day) or during dialysis. The dosage is based on your condition and response to treatment. Your doctor will do blood tests to find the best dose for you.

If you are giving this medication to yourself at home, learn all preparation and usage instructions from your health care professional. Before using, check this product visually for particles or discoloration. If either is present, do not use the liquid. Learn how to store and discard medical supplies safely.

It is very important to follow the diet recommended by your doctor to get the most benefit from this medication and to prevent serious side effects. Do not take other supplements/vitamins (such as calcium, vitamin D) unless directed by your doctor.

Side Effects

Nausea, headache, constipation, or pain/discomfort at the injection site may occur. If any of these effects last or get worse, tell your doctor promptly.

Remember that this medication has been prescribed because your doctor has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell your doctor right away if you have any serious side effects, including:

• back/bone/joint/muscle pain
• dry mouth
• metallic taste
• vomiting
• sleepiness
• weakness
• loss of appetite
• dizziness
• eye pain/redness/sensitivity to light
• fever
• fast/slow/irregular heartbeat
• decreased interest in sex
• mental/mood changes (such as confusion)
• stomach/abdominal pain
• swelling of the ankles/feet/hands (edema)
• increased thirst
• signs of kidney problems (such as change in the amount of urine)
• weight loss

A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including:

• rash
• itching/swelling (especially of the face/tongue/throat)
• severe dizziness
• trouble breathing

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

Precautions

Before using calcitriol, tell your doctor or pharmacist if you are allergic to it; or to other vitamin D products; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of:

• high calcium levels (hypercalcemia)
• heart problems (such as irregular heartbeat, coronary artery disease)
• kidney disease (such as kidney stones)

Notify your doctor beforehand if you will be having surgery or will be confined to a chair/bed (immobile) for a long time. Being immobile for long periods increases your risk of side effects.

Be sure to drink plenty of fluids unless otherwise directed by your doctor.

During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor.

It is unknown if this drug passes into breast milk. Consult your doctor before breast-feeding.

Drug Interactions

Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval.

Some products that may interact with this drug include:

• burosumab
• cardiac glycosides (such as digoxin, digitalis)
• magnesium-containing medications (such as antacids, milk of magnesia)
• phosphate binders
• vitamins/nutritional supplements (especially calcium and vitamin D)

Check the labels on all your prescription and nonprescription/herbal products (such as antacids, laxatives, vitamins) because they may contain calcium, magnesium, phosphate, and vitamin D. Ask your pharmacist about using those products safely.

Calcitriol is very similar to other forms of vitamin D. Do not use medications containing other forms of vitamin D while using calcitriol.

Overdose

If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call their local poison control center at 1-800-222-1222. Alberta residents can call PADIS (Poison and Drug Information Service) 24 hours a day at 1-800-332-1414. Canada residents can call a provincial poison control center. Symptoms of overdose may include: irregular heartbeat, severe stomach pain, unusually deep sleep.

Notes

Lab and/or medical tests (such as calcium, magnesium, phosphorus, parathyroid levels) should be done while you are using this medication. Keep all medical and lab appointments. Consult your doctor for more details.

It is important to closely follow your doctor's diet orders while taking this medication. Foods rich in vitamin D include: fortified dairy products, eggs, sardines, cod liver oil, chicken livers, and freshwater fish. Vitamin D is also obtained from short periods of exposure to the sun. Calcium supplements may be recommended in addition to this medication. The usual recommendation for calcium is 600-1200 milligrams per day. Discuss this with your doctor. Do not take supplements unless directed by your doctor.

Missed Dose

It is important to get each dose of this medication as scheduled. If you miss a dose, ask your doctor or pharmacist right away for a new dosing schedule. Do not double the dose to catch up.

If you have questions about missing a dose or you don't have more medication, contact your healthcare provider or pharmacist.

Storage

Store at room temperature away from light and moisture. Do not store in the bathroom. Keep all medications away from children and pets.

Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company.