Paricalcitol Intravenous

In the U.S.

• Zemplar

Available Dosage Forms:

• Solution

Therapeutic Class: Antithyroid Agent

Pharmacologic Class: Vitamin D (class)

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 paricalcitol, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to paricalcitol 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.

Pediatric

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.

Geriatric

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

Pregnancy

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.

Interactions with 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 paricalcitol, 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 paricalcitol 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

Interactions with Food/Tobacco/Alcohol

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 paricalcitol. 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.

It is very important that your doctor check your progress at regular visits while you are receiving paricalcitol. 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.

paricalcitol 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.

paricalcitol 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.

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:

• 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

• 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

• 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:

• 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

• 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.

Paricalcitol is a man-made active form of vitamin D, which is needed for building and keeping strong bones. Paricalcitol is used in patients with long-term kidney disease to treat or prevent high levels of a certain natural substance made by the body (parathyroid hormone). Too much parathyroid hormone can cause serious problems such as bone disorders.

Most people get enough vitamin D from exposure to the sun and from fortified food products (e.g., 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. Vitamin D helps control parathyroid hormone and the levels of certain minerals (e.g., calcium, phosphorus) that are needed for building and keeping strong bones.

How to use Paricalcitol 2 Mcg/Ml Intravenous Solution

Read the Patient Information Leaflet if one is available from your pharmacist before you start using paricalcitol. Ask your doctor, nurse, or pharmacist any questions that you may have about this medicine.

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

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

Headache, nausea, chills, or fever may occur. If any of these effects persist or worsen, tell your doctor promptly.

Remember that your doctor has prescribed this medication because he or she 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.

This medication may raise your vitamin D and calcium levels too high. Tell your doctor right away if any of these unlikely but serious effects of too much vitamin D/calcium occur: constipation, drowsiness, dry mouth, muscle/bone/joint pain, metallic taste in mouth, weakness, vomiting.

Tell your doctor right away if any of these rare but seriousloss of appetite, unusual weight loss, eye pain/redness/sensitivity to light, severe runny nose, stomach/abdominal pain.

Tell your doctor right away if you have any serious side effects, including: dizziness, fast/irregular/pounding heartbeat, swelling hands/ankles/feet, severe mental/mood changes (e.g., agitation, confusion), easy bleeding/bruising, bloody/tarry stool, vomit that looks like coffee grounds.

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.