Paricalcitol (intravenous route)

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.

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.

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

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.

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

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.

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.

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

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