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 most common reported adverse reactions are headache, dysgeusia, and fatigue.
( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Progenics Pharmaceuticals, Inc.
at 1-800-362-2668 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.
The safety of PYLARIFY was evaluated in 593 patients, each receiving one dose of PYLARIFY.
The average injected activity was 340 ± 26 MBq (9.2 ± 0.7 mCi).
The adverse reactions reported in >0.5% of patients within the studies are shown in Table
In addition, a hypersensitivity reaction was reported in one patient (0.2%) with a history of allergic reaction.
Adverse Reactions with a Frequency >0.5% in Patients Who Received PYLARIFY (n = 593) Adverse Reaction n (%) Headache 13 (2%) Dysgeusia 10 (2%) Fatigue 7 (1%)
5 WARNINGS AND PRECAUTIONS Risk of Image Misinterpretation : PYLARIFY uptake can be seen in a variety of tumor types as well as in non-malignant processes and normal tissues.
Image interpretation errors can occur with PYLARIFY imaging.
( 5.1 ) Hypersensitivity Reactions : Monitor patients for hypersensitivity reactions, particularly patients with a history of allergy to other drugs and foods.
( 5.2 ) Radiation Risk : Ensure safe drug handling to protect patients and health care workers from unintentional radiation exposure.
( 5.3 ) 5.1 Risk of Image Misinterpretation Imaging interpretation errors can occur with PYLARIFY imaging.
Like all medications, Pylarify 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: