Complete adverse effect profile including incidence rates and management
Important Safety Information
This is not a complete list of all possible side effects. Contact your healthcare provider if you experience any unexpected symptoms. For serious or life-threatening side effects, seek emergency medical attention immediately.
6 ADVERSE REACTIONS The following adverse reactions are discussed in greater detail in another section of the label: Hypercalcemia [see Warnings and Precautions ( 5.1 )] Serious Hypersensitivity Reactions [see Warnings and Precautions ( 5.3 )] Adynamic Bone Disease [see Warnings and Precautions ( 5.4 )] The most common adverse reactions in patients with Stage 3 or 4 CKD (incidence >5%) were infection, urinary tract infection, chest pain, angina pectoris, constipation, dyspepsia, anemia, leukopenia, dehydration, edema, depression, hypertonia, insomnia, asthenia, paresthesia, cough increased, dyspnea, pruritus, sinusitis, and rhinitis.
( 6.1 ) The most common adverse reactions in patients with CKD on dialysis (incidence >5%) were headache, malaise, edema, nausea/vomiting, dyspnea, dizziness, pruritus, and bradycardia.
( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Avet Pharmaceuticals Inc.
at 1-866-901-DRUG (3784) or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.
Adverse reactions in patients with stage 3 or 4 CKD Doxercalciferol capsules have been evaluated in two placebo-controlled, double-blind 24 week studies in patients with Stage 3 or 4 CKD.
Patients were treated with doxercalciferol capsules (n=27) or placebo (n=28) [see Clinical Studies ( 14.1 )] .
Adverse reactions occurring in the doxercalciferol capsules group at a frequency of 5% or greater and more frequently than in the placebo group are presented in Table
Table 1: Adverse Reactions Occurring in ≥5% Doxercalciferol Capsule-Treated Patients with CKD on Predialysis and Greater than Placebo in Two Double-Blind Clinical Studies Adverse Reaction Pooled data on adverse reactions from clinical study reports (Studies BCI-CH-115 and BCI-CH-119).
Doxercalciferol (n=27) % Placebo (n=28) % Infection/bacterial infection/viral infection 30 25 Constipation 26 11 Rhinitis 22 11 Anemia 19 4 Cough 19 4 Dyspnea 19 11 Paresthesia 15 11 Asthenia 15 11 Insomnia 15 4 Hypertonia 11 4 Angina pectoris 8 0 Dehydration 7 4 Depression 7 0 Dyspepsia 7 4 Edema 7 4 Urinary tract infection 7 4 Leukopenia 7 0 Chest pain 7 4 Pruritus 7 4 Sinusitis 7 4 Adverse reactions in patients with CKD on dialysis Doxercalciferol capsules have been evaluated in two placebo-controlled, double-blind studies in patients with CKD on hemodialysis.
5 WARNINGS AND PRECAUTIONS Hypercalcemia: Can occur during treatment with doxercalciferol and can lead to cardiac arrhythmias and seizures.
Severe hypercalcemia may require emergency attention.
Risk may be increased when used concomitantly with high dose calcium preparations, thiazide diuretics, or vitamin D compounds.
Monitor serum calcium prior to initiation and during treatment and adjust dose accordingly.
( 2 , 5.1 ) Digitalis Toxicity: Hypercalcemia increases the risk of digitalis toxicity.
Like all medications, Doxercalciferol can cause side effects. However, not everyone who takes this medication will experience them. Many side effects are dose-dependent and may improve as your body adjusts to the medication. Others may require dose adjustment or medical attention.
Contact your healthcare provider promptly if you experience:
Seek immediate emergency medical care if you experience signs of: