Paricalcitol (Page 2 of 6)

5.2 Digitalis Toxicity

Digitalis toxicity is potentiated by hypercalcemia of any cause. Use caution when paricalcitol capsules are prescribed concomitantly with digitalis compounds.

5.3 Laboratory Tests

During the initial dosing or following any dose adjustment of medication, serum calcium, serum phosphorus, and serum or plasma iPTH should be monitored at least every two weeks for 3 months, then monthly for 3 months, and every 3 months thereafter.

In pre-dialysis patients, paricalcitol capsules may increase serum creatinine and therefore decrease the estimated GFR (eGFR). Similar effects have also been seen with calcitriol.

5.4 Aluminum Overload and Toxicity

Aluminum-containing preparations (e.g., antacids, phosphate binders) should not be administered chronically with paricalcitol, as increased blood levels of aluminum and aluminum bone toxicity may occur.

6 ADVERSE REACTIONS

Because clinical studies are conducted under widely varying conditions, adverse reaction rates observed in the clinical studies of a drug cannot be directly compared to rates in the clinical studies of another drug and may not reflect the rates observed in practice.

6.1 Clinical Trials Experience

CKD Stages 3 and 4

Adults

The safety of paricalcitol capsules has been evaluated in three 24-week (approximately six-month), double-blind, placebo-controlled, multicenter clinical studies involving 220 CKD Stages 3 and 4 patients. Six percent (6%) of paricalcitol capsules treated patients and 4% of placebo treated patients discontinued from clinical studies due to an adverse event. Adverse events occurring in the paricalcitol capsules group at a frequency of 2% or greater and more frequently than in the placebo group are presented in Table 3:

Table 3. Adverse Reactions by Body System Occurring in ≥ 2% of Subjects in the Paricalcitol-Treated Group of Three, Double-Blind, Placebo-Controlled CKD Stages 3 and 4 Studies

Number (%) of Subjects

Adverse Eventa

Paricalcitol Capsules (n = 107)

Placebo (n = 113)

Overall

88

(82%)

86

(76%)

Ear and Labyrinth Disorders

Vertigo

5

(5%)

0

(0%)

Gastrointestinal Disorders

Abdominal Discomfort

4

(4%)

1

(1%)

Constipation

4

(4%)

4

(4%)

Diarrhea

7

(7%)

5

(4%)

Nausea

6

(6%)

4

(4%)

Vomiting

5

(5%)

5

(4%)

General Disorders and Administration Site Conditions

Chest Pain

3

(3%)

1

(1%)

Edema

6

(6%)

5

(4%)

Pain

4

(4%)

4

(4%)

Immune System Disorders

Hypersensitivity

6

(6%)

2

(2%)

Infections and Infestations

Fungal Infection

3

(3%)

0

(0%)

Gastroenteritis

3

(3%)

3

(3%)

Infection

3

(3%)

3

(3%)

Sinusitis

3

(3%)

1

(1%)

Urinary Tract Infection

3

(3%)

1

(1%)

Viral Infection

8

(7%)

8

(7%)

Metabolism and Nutrition Disorders

Dehydration

3

(3%)

1

(1%)

Musculoskeletal and Connective Tissue Disorders

Arthritis

5

(5%)

0

(0%)

Back Pain

3

(3%)

1

(1%)

Muscle Spasms

3

(3%)

0

(0%)

Nervous System Disorders

Dizziness

5

(5%)

5

(4%)

Headache

5

(5%)

5

(4%)

Syncope

3

(3%)

1

(1%)

Psychiatric Disorders

Depression

3

(3%)

0

(0%)

Respiratory, Thoracic and Mediastinal Disorders

Cough

3

(3%)

2

(2%)

Oropharyngeal Pain

4

(4%)

0

(0%)

Skin and Subcutaneous Tissue Disorders

Pruritus

3

(3%)

3

(3%)

Rash

4

(4%)

1

(1%)

Skin Ulcer

3

(3%)

0

(0%)

Vascular Disorders

Hypertension

7

(7%)

4

(4%)

Hypotension

5

(5%)

3

(3%)

a. Includes only events more common in the paricalcitol treatment group.

Additional Adverse Reactions

The following additional adverse reactions occurred in <2% of the paricalcitol-treated adult patients in the above double-blind, placebo-controlled clinical trial.

Gastrointestinal Disorders: Dry mouth

Investigations: Hepatic enzyme abnormal

Nervous System Disorders: Dysgeusia

Skin and Subcutaneous Tissue Disorders: Urticaria

Pediatric use information for patients 10 to 16 years of age is approved for AbbVie Inc.’s Zemplar (paricalcitol) capsules. However, due to AbbVie Inc.’s marketing exclusivity rights, this drug product is not labeled with that pediatric information.

CKD Stage 5

Adults

The safety of paricalcitol capsules has been evaluated in one 12-week, double-blind, placebo-controlled, multicenter clinical study involving 88 CKD Stage 5 patients. Sixty-one patients received paricalcitol capsules and 27 patients received placebo.

The proportion of patients who terminated prematurely from the study due to adverse events was 7% for paricalcitol capsules treated patients and 7% for placebo patients.

Adverse events occurring in the paricalcitol capsules group at a frequency of 2% or greater and more frequently than in the placebo group are as follows:

Table 5. Adverse Reactions by Body System Occurring in ≥ 2% of Subjects in the Paricalcitol-Treated Group, Double-Blind, Placebo-Controlled CKD Stage 5 Study

Number (%) of Subjects

Adverse Eventsa

Paricalcitol Capsules (n=61)

Placebo (n = 27)

Overall

43

(70%)

19

(70%)

Gastrointestinal Disorders

Constipation

3

(5%)

0

(0%)

Diarrhea

7

(11%)

3

(11%)

Vomiting

4

(7%)

0

(0%)

General Disorders and Administration Site Conditions

Fatigue

2

(3%)

0

(0%)

Edema Peripheral

2

(3%)

0

(0%)

Infections and Infestations

Nasopharyngitis

5

(8%)

2

(7%)

Peritonitis

3

(5%)

0

(0%)

Sinusitis

2

(3%)

0

(0%)

Urinary Tract Infection

2

(3%)

0

(0%)

Metabolism and Nutrition Disorders

Fluid Overload

3

(5%)

0

(0%)

Hypoglycemia

2

(3%)

0

(0%)

Nervous System Disorders

Dizziness

4

(7%)

0

(0%)

Headache

2

(3%)

0

(0%)

Psychiatric Disorders

Anxiety

2

(3%)

0

(0%)

Insomnia

3

(5%)

0

(0%)

Renal and Urinary Disorders

Renal Failure Chronic

2

(3%)

0

(0%)

a. Includes only events more common in the paricalcitol treatment group.

Additional Adverse Reactions

The following adverse reactions occurred in <2% of the paricalcitol-treated patients in the above double-blind, placebo-controlled clinical trial.

Gastrointestinal Disorders: Gastroesophageal reflux disease

Metabolism and Nutrition Disorders: Decreased appetite, hypercalcemia, hypocalcemia

Reproductive System and Breast Disorders: Breast tenderness

Skin and Subcutaneous Tissue Disorders: Acne

Pediatric use information for patients 10 to 16 years of age is approved for AbbVie Inc.’s Zemplar (paricalcitol) capsules. However, due to AbbVie Inc.’s marketing exclusivity rights, this drug product is not labeled with that pediatric information.

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