Paricalcitol (Intravenous)

Paricalcitol injection is used to treat and prevent hyperparathyroidism in patients with chronic kidney disease who are on dialysis. Hyperparathyroidism happens when the parathyroid glands in the neck produce too much parathyroid hormone (PTH). This hormone regulates the levels of calcium and phosphorus in your blood. Paricalcitol helps reduce the amount of PTH, which lowers the calcium and phosphorus levels.

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

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 (for example, 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.

In deciding to use a medicine, you must consider the risks versus the benefits. This decision is made between you and your doctor. For this medicine, the following should be kept in mind:

Allergies

Inform your doctor if you have ever had any unusual or allergic reactions to this medicine or any other medicines. Also, let your health care professional know if you have other allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, carefully read the label or package ingredients.

Pediatric

Current studies have not shown any specific problems in children 5 years of age and older that would limit the usefulness of paricalcitol injection.

Geriatric

Current studies have not shown any specific problems in the elderly that would limit the usefulness of paricalcitol injection.

Breast Feeding

There are no adequate studies in women to determine the risk to infants when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before using this medication while breastfeeding.

Interactions with Medicines

Some medicines should not be used together, while others may be used together even if an interaction might happen. In these cases, your doctor may adjust the dose, or other precautions may be needed. When receiving this medicine, it is especially important for your healthcare professional to know if you are taking any of the medicines listed below. The following interactions have been selected based on their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following medicines is not recommended. Your doctor may choose not to treat you with this medication or change some of your other medicines.

• Burosumab-twza

Using this medicine with any of the following medicines may increase the risk of certain side effects, but using both might be the best treatment for you. If both medicines are prescribed together, your doctor may adjust the dose or the frequency of use for one or both of the medicines.

• Ketoconazole

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used around the time of eating food or specific types of food due to potential interactions. Using alcohol or tobacco with certain medicines may also lead to interactions. Discuss with your healthcare professional about using your medicine with food, alcohol, or tobacco.

Other Medical Problems

Having other medical problems may affect the use of this medicine. Make sure to inform your doctor if you have any other medical issues, 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 worsen these conditions.

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

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.

In the U.S.

• Zemplar

Available Dosage Forms:

• Solution

Therapeutic Class: Endocrine-Metabolic Agent

Pharmacologic Class: Vitamin D Analog

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.