Label Changes for:
Zemplar (Paricalcitol) Injection
April 2011
Changes have been made to the WARNINGS, PRECAUTIONS and ADVERSE REACTIONS sections of the safety label.
Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER) – April 2011
WARNINGS
- Chronic hypercalcemia can lead...
- Prescription-based doses of vitamin D...
- Aluminum-containing preparations...
Drug Interactions
- Specific interaction studies were...
- ...care should be taken while paricalcitol is...
ADVERSE REACTIONS
Other Adverse Reactions Observed...
- Multiple changes to section
Adverse Events During Post-Marketing Experience
- ...allergic reactions, such as...have been reported
- Changes to Overdosage section
