Pronunciation:

par-i-KAL-si-tol

Brand Names:

• Zemplar

Dosage Forms:

• Solution

Classifications:

Therapeutic—

Endocrine-Metabolic Agent

Pharmacologic—

Vitamin D Analog

Uses of This Medicine:

Paricalcitol injection is used to treat and prevent hyperparathyroidism in patients with chronic kidney disease who are on dialysis. Hyperparathyroidism is a condition that is caused when the parathyroid glands located in the neck make too much parathyroid hormone (PTH). This hormone controls the concentrations of calcium and phosphorus in your blood. Paricalcitol helps lower the amount of PTH which lowers the calcium and phosphorus concentrations.

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

Before Using This Medicine:

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.

Children—

Appropriate studies performed to date have not demonstrated pediatric-specific problems that would limit the usefulness of paricalcitol injection in children 5 years of age and older.

Older adults—

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of paricalcitol injection in the elderly.

Breast-feeding—

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.

Other medicines—

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 receiving 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 not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.

• Burosumab-twza

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.

• Ketoconazole

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:

• Bone disease or
• Heart rhythm problems (e.g., arrhythmia) or
• Hypercalciuria (high calcium in the urine) or
• Hyperphosphatemia (high phosphate in the blood)—Use with caution. May make these conditions worse.

• Hypercalcemia (high calcium in the blood) or
• Vitamin D overdose—Should not be used in patients with these conditions.

Proper Use of This Medicine:

A nurse or other trained health professional will give you this medicine in a hospital or dialysis center. This medicine is given through a needle placed in one of your veins.

Carefully follow your doctor's instructions about any special diet. Do not use antacids or phosphate binders containing aluminum or supplements containing vitamin D, phosphate, or calcium without asking your doctor.

Your doctor may tell you to limit your dietary intake of phosphate. Foods that are high in phosphate include beans, beer, chocolate, cheese, cola soft drinks, ice cream, milk, nuts, peas, whole grain products, and yogurt.

Precautions While Using This Medicine:

It is very important that your doctor check your progress at regular visits while you are receiving this medicine. This will allow your doctor to see if the medicine is working properly and to decide if you should continue to receive it. Blood and urine tests may be needed to check for unwanted effects.

This medicine may increase the calcium in your blood (hypercalcemia). The symptoms of high calcium may include abdominal or stomach pain; confusion; constipation; depression; dry mouth; headache; incoherent speech; increased urination; loss of appetite; metallic taste; muscle weakness; nausea; thirst; unusual tiredness; vomiting; or weight loss. If you have any of these symptoms, check with your doctor right away.

This medicine may increase the aluminum in your blood and may cause harm to your bones if used together with products containing aluminum (eg, antacids or phosphate binders). Ask your doctor before you take any of these medicines.

Do not take other medicines unless they have been discussed with your doctor. Taking other medicines (especially digoxin, Lanoxin®) together with paricalcitol may require your doctor to change the dose of one of the medicines or paricalcitol.

Side Effects of This Medicine:

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.

Check with your doctor or nurse immediately if any of the following side effects occur:

Less common

Black, tarry stools

bleeding from the rectum or bloody stools

chest pain or discomfort

dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position

fainting

fast, slow, irregular, pounding, or racing heartbeat or pulse

swelling of the face, arms, hands, lower legs, or feet

unusual bleeding or bruising

unusual weight gain

vomiting of blood or material that looks like coffee grounds

Rare

Abdominal or stomach cramps or pain

chills

constipation

cough

depression

difficult or labored breathing

difficulty with swallowing

dry mouth or skin

fever

inability to speak

incoherent speech

increased thirst

increased urination

joint pain

loss of appetite

metallic taste

mood or mental changes

muscle aches and pains

muscle cramps in the hands, arms, feet, legs, or face

muscle spasms or weakness

nausea or vomiting

numbness and tingling around the mouth, fingertips, or feet

pain, redness, or swelling at the injection site

pale skin

pounding in the ears

rapid, shallow breathing

severe or sudden headache

shivering

shortness of breath

slurred speech

sweating

thirst

tightness in the chest

tingling of the hands or feet

tremor

trouble thinking

troubled breathing with exertion

unusual tiredness or weakness

weakness in the arm or leg on one side of the body, sudden and severe

weight loss

wheezing

Incidence not known

Blurred vision

confusion

hoarseness

large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs

slow or irregular breathing

trouble sleeping

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:

Less common

Abdominal or stomach discomfort

body aches or pain

burning feeling in the chest or stomach

burning sensations on the skin

burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings

burning, dry, or itching eyes

change in the color, amount, or odor of vaginal discharge

change in walking and balance

clumsiness or unsteadiness

confusion as to time, place, or person

decreased vision

difficulty with moving

discharge or excessive tearing

eye pain

hallucinations

holding false beliefs that cannot be changed by fact

increased hair growth, especially on the face

itching skin

lack or loss of strength

loss in sexual ability, desire, drive, or performance

loss of voice

muscle stiffness

muscle twitching or jerking

night sweats

pain in the breasts

rash

redness, pain, or swelling of the eye, eyelid, or inner lining of the eyelid

rhythmic movement of the muscles

sleeplessness

swollen joints

tearing

unusual excitement, nervousness, or restlessness

Incidence not known

Decreased interest in sexual intercourse

diarrhea

hives or welts

inability to have or keep an erection

indigestion

redness of the skin

stomach upset

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.